NHSN Patient Safety Component Manual 2019

Transcript

1 National Healthcare Safety Network (NHSN) Patient Safety Component Manual Table of Contents Chapter 1: National Healthcare Safety Network ( NHSN) Overview associated Infections (HAI) for NHSN Surveillance Chapter 2: Identifying Healthcare- Chapter 3: Patient Safety Monthly Reporting Plan and Annual Surveys Bloods tre am I nfect ion E al Line- Chapter 4: Associated Bloodstream Infection and non- vent (Centr ce ntr e-associ ated Bloods tream al lin ection) Inf Chapter 5: Central Line Insertion Practices (CLIP) Adherence Monitoring Chapter 6: Pneumonia (Ventilator-associated [VAP] and non- ventilator -associated Pneumonia [PNEU]) Eve nt ion (Catheter Chap ter 7: Uri nary Tr act Infect -Associated U ri nary Tract I nfecti on [ CAUT I] a nd non- cathet iate d U rinary Tra ct I nfect ion [ UTI]) a nd O the r Urinary Syst em Infe ct ion ( USI ) Events er-a ssoc Chapter 9: Surgical Site Infection (SSI) Event Chapter 10: Ventilator- Associated Event (VAE) Chapter 11: Pediatric Ventilator -Associated Event (pedVAE) Chapter 12: Multidrug- Resistant Organism & Clostridium difficile Infection (MDRO/CDI) Module Antimicrobial Use and Resistance (AUR) : 4 1 Chapter Chapter 15: CDC Locations and Descriptions and Instructions for Mapping Patient Care Locations Chapter 16: General Key terms Chapter 17: CDC/NHSN Surveillance Definitions for Specific Types of Infections : The NHSN Patient Safety Component Manual is updated annually based on subject matter expert Please Note review and user feedback. Over time, certain chapters have been retired or moved to other components. To avoid chapters 8 and 13 confusion, the chapters in the PSC manual do not shift to account for these changes ; therefore, are not listed in the Table of Contents or included in this document. 201 9 January

2 NHSN Overview National Healthcare Safety Network (NHSN) Overview The NHSN is a secure, Internet -based surveillance system that expands and integrates patient and healthcare personnel safety surveillance systems managed by the Division of Healthcare Quality Promotion (DHQP) at the Centers for Disease Control and Prevention. In addition, facilities that participate in certain reporting programs operated by the Centers for Medicare and Medicaid Services , some U.S. states use NHSN as a means for (CMS) can do so through use of NHSN. Furthermore and transfusion- healthcare facilities to submit data on healthcare -associated infections (HAIs) related adverse events mandated through their specific state legislation. NHSN enables healthcare facilities to collect and use data about HAIs, adherence to clinical practices resistant organisms within their known to prevent HAIs, the incidence or prevalence of multidrug- organizations, trends and coverage of healthcare personnel safety and vaccination, and adverse events related to the transfusion of blood and blood products. Long- term Care Facility, Outpatient Dialysis, components: Patient Safety, The NHSN includes six Healthcare Personnel Safety, Biovigilance, and Outpatient Procedure (Figure 1). Figure 1: NHSN Components NHSN Components Outpatient Outpatient Long-term Care Healthcare Patient Safety Biovigilance Facility Procedure Personnel Safety Dialysis January 2019 1-1

3 NHSN Overview Patient Safety Component The includes four modules that focus on events associated with medical devices, surgical procedures, antimicrobial agents used during healthcare, and multidrug resistant organisms. • Device- associated Module: o Bloodstream Infection (CLABSI – Central line -associated bloodstream infection) o Central line insertion practices (CLIP) adherence o Urinary Tract Infection (CAUTI – Catheter -associated urinary tract infection) o -associated events (VAE) (adult locations only) Ventilator o Ventilator-associated pneumonia) - in pediatric locations (in -plan* or Pneumonia (VAP – off-plan*), or NICU and adult locations (off-plan* only) • Procedure-associated Module: o Surgical site infection (SSI) • Antimicrobial Use and Resistance Module (AUR) Infection (MDRO/CDI) Module • Multidrug -Resistant Organism and Clostridium difficile *Note : -plan” surveillance means that the facility has committed to following the NHSN surveillance “In NHSN monthly reporting protocol, in its entirety, for that particular event, as shown in the facility’s plan. “Off- plan” surveillance is surveillance that is done because a facility has decided to track a particular event for internal use. Data that are entered into NHSN “off -plan” are not included in NSHN annual reports or other NHSN publications. A facility makes no commitment to follow the NHSN protocol for “off-plan” events. Further, “off-plan” data cannot be uploaded into NHSN via Clinical Document Architecture (CDA) and must be manually entered . Instruction s and standardized surveillance methods and definitions for each module of the Patient Safety Component are provided in this manual www.cdc.gov/nhsn). Modules may be used singly or simultane ously. and on the NHSN website ( The NHSN Long -term Care Facility Component provides long- term care facilities (LTCFs) with standardized surveillance methods and definitions for three modules: (1) Multidrug resistant organism (MDRO) and Clostridium difficile Infection (CDI) laboratory -identified (LabID) Events; (2) Urinary Tract Infections (UTI); and (3) Prevention Process Measures. The component is ideal for use by nursing homes, skilled nursing facilities, chronic care facilities, and assisted living and residential care facilities. LTCF surveillance protocols, training materials, data collection forms, instructions, and other supporting materials are provided on the Long- term Care Facility Component website: https://www.cdc.gov/nhsn/ltc/index.html . Outpatient hemodialysis centers have several surveillance options tailored to their patients and setting in the Dialysis Component . The component consists of 3 modules: 1) Dialysis Event; (2) Prevention Proce ss Measures; and (3) Dialysis Patient Influenza Vaccination. Facilities that treat hemodialysis outpatients should refer to the Dialysis Component instructions and standardized surveillance methods and definitions at www.cdc.gov/nhsn/dialysis/index.html . There are two modules in the Healthcare Personnel Safety (HPS) C omponent of NHSN: the Healthcare Personnel Exposure Module and the Healthcare Personnel Vaccination Module. These modules may be used separately or simultaneously. Instructions and standardized surveillance methods and definitions for each module are provided in the NHSN Manual: HPS Component Protocol -vaccine-protocol.pdf https://www.cdc.gov/nhsn/pdfs/hps-manual/vaccination/hps- flu 1-2 January 2019

4 NHSN Overview The omponent , Hemovigilance Module facilitates national surveillance of NHSN Biovigilance C transfusion- related recipient adverse events. The Hemovigilance Module is designed for transfusion service staff to collect data on annual facility and transfusion service characteristics, individual reports on adverse transfusion reactions, errors or accidents associated with adverse reactions, and monthly counts of transfused or discarded components. The Hemovigilance Module surveillance protocol, training materials, data collection forms, instructions, and other supporting materials are provided on the Hemovigilance Module website: www.cdc.gov/nhsn/acute- care -hospital/bio -hemo/index.html . The Outpatient Procedure Component (OPC) includes two modules that focus on adverse events associated with surgical procedures performed (ASCs) . The two in Ambulatory Surgery Centers modules include Same Day Outcome Measures and Surgical S ite Infections. • Same D ay Outcome M easures (OPC -SDOM) are a grouping of outpatient care quality indicators that represent a broad range of risks encountered by patients accessing care in various outpatient settings. The four individual outcome measures are: o Patient Burn o Patient Fall o Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant o All -Cause Hospital Transfer/Admission • Surgical Site Infection (OPC -SSI) - SSI surveillance for outpatient operative procedures using the Outpatient Procedure Component (OPC) replaces the use of the Patient Safety Component SSI event chapter for ASCs . The OPC surveillance protocols, training materials, data collection forms, instructions, and other supporting materials are provided on the Outpatient Procedure Component website: https://www.cdc.gov/nhsn/ambulatory-surgery/index.html . Surveillance Techniques Some of the options in the following modules require active, patient-based, prospective surveillance of events and their corresponding denominator data by a trained Infection Preventionist (IP). This means that the IP shall seek out infections during a patient’s stay by screening a variety of data sources, such as laboratory, pharmacy, admission/discharge/transfer, radiology/imaging, and pathology databases, as well as patient charts, including history and physical exam notes, nurses’/physicians’ notes, temperature charts, etc. Others may be trained to screen data sources for these infections, but the IP must make the final determination. Laboratory -based surveillance should not be used alone, unless all possible criteria for identifying an infection are solely determined by laboratory evidence (for example , LabID event detection in the MDRO/CDI Module). Retrospective chart reviews should be used only when patients to collect all are discharged before all information can be gathered. NHSN forms should be used required data, using the NHSN definitions of each data field. To minimize the IP’s data collection 1-3 January 2019

5 NHSN Overview burden, others may be trained to collect the denominator data and process of care data (for example, central line insertion practices). Associated Module Procedure- requires active, Surgical site infection (SSI) monitoring is offered through this module. SSI surveillance patient -based, prospective surveillance techniques (see Surveillance Techniques above). To minimize IPs’ workload of collecting denominator data, operating room data may be downloaded (see file specifications at: https://www.cdc.gov/nhsn/pdfs/ps- analysis -resources/ImportingProce dureData.pdf ) Both pre-discharge and post-discharge surveillance methods should be used to detect SSIs. Surveillance may include both inpatient and outpatient operative procedures. These methods include 1) direct examination of patients’ wounds during hospitalization, or follow -up visits to either surgery clinics or physicians’ offices, 2) review of medical records or surgery clinic patient records, 3) surgeon surveys by mail or telephone, and 4) patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods is acceptable for use; however, CDC criteria for SSI must be applied. Device- Associated Module Medical instrumentation increases the risk of development of an HAI and most patients admitted for health care are exposed to some kind of medical device in the course of their treatment. Such devices include, but are not limited to, vascular and urinary catheters, and ventilators. NHSN enables facilities to monitor infectio us complications associated with the use of these devices and also to monitor processes related to their use which might increase infection risk. Specifically, surveillance of central line -associated bloodstream infection (CLABSI), catheter -associated uri nary tract infection (CAUTI), ventilator-associated events (VAE), and/or ventilator- associated pneumonia (VAP) is possible using the NHSN. In addition, central line insertion practices (CLIP) can be monitored to inform facilities of the appropriateness of their processes and how they may relate to HAI development. See Dialysis Component for detailed instructions for Dialysis Event (DE) surveillance of hemodialysis outpatients (www.cdc.gov/nhsn/dialysis/index.html ). Device-associated denominator data should be collected at the same time each day, or by weekly sampling methods , in certain locations, for CLABSI and CAUTI surveillance (see the CLABSI and CAUTI protocols for guidance). When denomina for tor data are available from electronic databases ( example , ventilator days from respiratory therapy), these sources may be used as long as the counts are not substantially different (+/ - 5%) from manually -collected counts that have been validated for a minimum of three months. See the respective device- associated event protocols for detailed surveillance instructions. 1-4 January 2019

6 NHSN Overview Antimicrobial Use and Resistance (AUR) Module The use of antimicrobial agents has a direct effect on antimicrobial resistance patterns of pathogens. The observed increase in multidrug resistance is in part due to inappropriate prescription of, as well as only partial completion of courses of antibiot ics. The AUR Module allows facilities to collect information on the amount of antimicrobials that are used -resistant for patient care within their systems, as well as to collect data on the prevalence of drug organisms in their inpatient and outpatient areas. Electronic capture and reporting of microbiology and pharmacy data are the only available options for reporting data into this module. See the Antimicrobial Use and Resistance protocol for detailed surveillance instructions. Multidrug -resistant Organism and Clostridium difficile Infection (MDRO/CDI) Module The NHSN MDRO/CDI Module offers a means for facilities to meet criteria and metrics that are nizational guidelines to control and measure the spread of MDROs and CDI outlined in several orga within their healthcare system. The module has two separate and independent reporting options, Laboratory -identified (LabID) Event and Infection Surveillance that may be tailored to meet the needs of participating NHSN facilities . are available: (1) adherence to hand hygiene; (2) In addition, the following process measures adherence to contact precautions when caring for patients infected or colonized with an MD RO or C. difficile ; and (3) adherence to active surveillance testing (AST) of MRSA and/or VRE. Active surveillance testing outcome measures is also available in locations where AST adherence is being performed, and enables facilities to use the results of AST to monitor the incidence and prevalence of positive MRSA and/or protocol for detailed surveillance instructions. VRE cultures . See the MDRO/CDI January 2019 1-5

7 Identifying Healthcare -associated Infections -associated Infections (HAI) for Surveillance Identifying Healthcare NHSN standardize the classification of an infection as present on admission (POA) or a To -associated infection (HAI), the following objective surveillance definitions and healthcare guidance are used for NHSN surveillance : • 7-day Infection Window Period (IWP) • Date of Event (DOE) • POA • HAI • 14-day Repeat Infection Timeframe (RIT) • Secondary B SI Attribution Period (SBAP) • Pathogen Assignment Guidance • Location of Attribution (LOA) Transfer Rule • The intention of this approach is to align criteria and definitions and decrease subjectivity while maintaining epidemiologic standardization and clinical relevance. A variety of rent infections of differing scenarios to include repeat infections of the same type, concur ent in multi -pathogen infections are addressed. See Appendix types, and pathogen assignm Flow Diagram for NHSN Event Determination . General Instructions 1. The guidance found in this Chapter is not applicable when performing SSI, VAE, PedVAE or LabID surveillance. Infection window period, Date of Event, POA, HAI, and R IT, SBAP definitions as defined in this chapter do not apply to SSI, VAE, LabID Events ( Table 1). PedVAE, or Please refer to C hapters 9, 10, 11 and 12 r espectively for guidance specific to these event determinations 2. Organisms belonging to the following genera are typically causes of community- associated infections and are rarely or are not known to be causes of healthcare- associated infections. They are excluded, and cannot be used to meet any NHSN definition: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis. Additionally refer to individual event protocols for pathogen exclusions specific to the event being reported for example, BSI, UTI, PNEU, ENDO, GIT, IAB. 2-1 January 2019

8 -associated Infections Identifying Healthcare of documentation of evidence 3. If the date of specimen collection is on or after the date of consent AND the patient is being supported for orga n donation purposes , an event culture based identified using the specimen culture result or microbiologic non- . The patient should, however, diagnostic test result should not be reported as an HAI device and patient day denominator data collection. still be included in 4. Hospice, palliative or comfort care patients are not excluded from NHSN surveillance. 5. Identification of organisms from specimens collected during post- mortem examination (autopsy) are only eligible for use in meeting the CNS/IC (Intracranial) infection definition and the PNEU infection definition using lung tissue specimen mortem. obtained by transthoracic or transbronchial biopsy immediately post- For all reports are not eligible for use. other NHSN definitions autopsy specimens/ 6. Infections occurring in newborns with date of event on hospital day 1 or day 2 are considered POA. Those with date of event on day 3 or later are HAI. This includes infections acquired transplacentally ( for example but not limited to herpes simplex, toxoplasmosis, rubella, cytomegalovirus, or syphilis) or as a result from passage . Exception : See guidance about non-reporting of CLABSIs through the birth canal with Group B Streptococcus during a neonate’s first 6 days of life found in the Comment s and Reporting Instr uctions section of the Bloodstream Infection Event central line -Associated Bloodstream Infection and Non- -associated (Central Line Bloodstream Infection) protocol. tion of a latent 7. Reactiva infection (for example but not limited to herpes, shingles, syphilis, or tuberculosis) is not considered to be an HAI. pplication of Chapter 2 Table 1 : Exceptions to a * SSI * VAE * PedVAE * - LabID † Infection Window Period Date of Event POA Not Not Not Not HAI † Repeat Infection Timeframe (RIT) Applicable Applicable Applicable Applicable † Secondary BSI Attribution Period ,† See ENDO criteria in Chapter 17: CDC/NHSN Surveillance Definitions for Specific Types of Infections for endocarditis s , and PedVAE surveillance protocol *See SSI, LabID ,VAE 2-2 January 2019

9 Identifying Healthcare -associated Infections Observation Patients in Inpatient Locations : For purposes of NHSN surveillance, i f an observation patient is admitted to an inpatient location, the patient must be included in all surveillance events designated in the monthly reporting plan and included in patient and device day counts. The patient is being housed, monitored, and cared for in an inpatient location and therefore is at risk for acquisition of an HAI. Infection Window Period: during which all site -specific The Infection Window Period (IWP) is defined as the 7-days first positive diagnostic infection criteria must be met. It includes the collection date of the to meet the site- test that is used as an element , the 3 calendar specific infection criterion days before and the 3 calendar days after ( Table 2 ). For purposes of defining the Infection Window Period the following examples are considered diagnostic tests: laboratory specimen collection • imaging test • • pr ocedure or exam Table 2 : Infection Window Period 3 days before Date of f irst positive diagnostic test that is used as an element of the site -specific criterion OR In the absence of a diagnostic test, use the date of the first documented localized sign or symptom that is used as an element of the site -specific criterion 3 days Infection Window Period after 2-3 January 2019

10 Identifying Healthcare -associated Infections It is important to use the first diagnostic test that creates an infection window period during which all elements of the criterion can be found. See e xample below. Example When meeting PNEU definition using the PNU2 criterion, identification of an eligible organism from blood or from a site- specific specimen, and an imaging test may be available. Both the organism identification and the imaging test are diagnostic tests. Use the first diagnostic test for which all elements of the PNU2 criterion occur within the infection window period. In this example , Option 1 uses the imaging test (not the blood culture) t o set the below creates an infection window infection window period. This is the first diagnostic test that NU2 criterion occur. period in which all elements of P Option 1: Correct diagnostic test Option 2: Incorrect diagnostic test selection selection Infection Window Hospital Hospital Infection Window Day Period Day Period -2 -2 -1 -1 1 1 New onset cough New onset cough 2 2 POA Imaging test: Infiltrate Imaging test: Infiltrate 3 3 HAI Fever > 38.0 C 4 Fever > 38.0 C 4 Fever > 38.0 C 5 Fever > 38.0 C 5 A. baumannii Blood culture: 6 Blood culture: A. baumannii 6 Rales, Fever > 38.0 C 7 Rales, Fever > 38.0 C 7 Cough, Rales 8 Cough, Rales 8 9 9 10 10 11 11 12 12 13 13 14 14 15 16 15 17 16 17 2-4 January 2019

11 -associated Infections Identifying Healthcare Infection Window Period Special Considerations Infection criteria that do not include a diagnostic test: 1. For site -specific infection criteria that do not include a diagnostic test , the date of the first documented localized sign or the site - symptom that is used as an element of specific infection criterion is used to define the infection window period for example, diarrhea, site -specific pain, purulent drainage. Note that a non- specific sign or symptom for example, fever is not considered to be localized and therefore is not to be used to define the infection window period. For example, when meeting EMET using crit erion 2, there is no diagnostic test as a part of this criterion. The date of the first documented localized sign or symptom, EMET as an element to meet is used purulent drainage or pain or tenderness that to set the infection window period. Fever is not a localized criterion 2 is to be used sign. 2. More than one criterion can be met: When more than one criterion of a site -specific infection definition is met, identify the infection window period that results in the earliest date of event. Example A patient has purulent drainage noted at a superficial wound site on hospital day 2. It is present. S. is documented on day 3 that the wound site is painful and swelling IN aureus is identified from a wound specimen with collection date on day 4. SK definition can be met using criterion 2a with pain, swelling and positive culture from (diagnostic test) and also met using criterion 1 the site- specific specimen with purulent drainage (sign). Using the sign of infection, purulent drainage, to set the being met and provides the earliest date infection window period results in Criterion 1 of event. 2-5 January 2019

12 Identifying Healthcare -associated Infections 2a SKIN Criterion 1 SKIN Criterion Correct Determination Hospital Infection Window Infection Window Hospital Day Period Period Day -2 -2 -1 -1 1 1 Purulent Drainage from 2 POA 2 wound Pain, Swelling 3 HAI (SKIN Criterion 1) (SKIN Criterion 2a) 3 4 Drainage culture : S. 4 aureus 5 5 6 6 7 7 8 8 9 9 10 10 11 11 12 12 13 13 14 14 15 15 16 16 17 17 3. Endocarditis: When meeting the Endocarditis ( ENDO) definition, the Infection Window Period (IWP) is defined as the 21 days during which all site- specific infection criteria must be met. It includes the date the first positive diagnostic test that is used as an element of the ENDO infection criterion was obtained, the 10 calendars days before and the 10 calendar days after. The IWP is lengthened for ENDO to accommodate the extended diagnostic timeframe that is frequently required to reach a clinical determination of endocarditis. 2-6 January 2019

13 Identifying Healthcare -associated Infections Date of Event (Event Date): The Date of Event (DOE) is the date the first element used to meet an NHSN site -specific infection criterion occurs for the first time within the sev en-day infection window period (Table 3 and Table 4). An infection is considered Present on A dmission (POA) if the date of event of the NHSN site -specific infection criterion occurs during the POA time period, which is defined as the day of admission to an inpatient location (calendar day 1), the 2 days . For purposes of NHSN before admission, and the calendar day after admission surveillance and determination of the Repeat Infection Timeframe (as defined below) if the date of event is determined to be either of the two days prior to inpatient admission, then the date of event will be hospital day 1. An infection is considered a Healthcare-associated Infection (HAI) if the date of event of the N HSN site -specific infection criterion occurs on or after the 3rd calendar day of admission to an inpatient location where day of admission is calendar day 1. Note: Accurate determination of DOE is critical because DOE is used to determine: • if an event is HAI or POA location of attribution • • device association day 1 of the Repeat Infection Timeframe • Table 3 : Date of Event and Classification Determination Hospital Day Date of Event Classification Assignment for RIT 2 days before admit Hospital Day 1 1 day before admit Hospital Day 1 POA 1 Hospital Day 1 2 Hospital Day 2 3 Hospital Day 3 4 Hospital Day 4 HAI 5 Hospital Day 5 2-7 January 2019

14 Identifying Healthcare -associated Infections Table 4 : Infection Window Period and Date of Event age (Patient < 65) Note the date of event is the date the first element used to meet the site- specific infection time in the infection window period. In the first example, it is criterion occurs for the first day 2, the date the fever occurs for the first time in the infection window period and this results in a POA determination. In the second example it is day 4, the date of the diagnostic test , which is the first element in the infection window period and this results in an HAI Date of event may be, but is not always, the date of the diagnostic test which determination. is used to set the infection window period. Example 1 Example 2 HOSPITAL INFECTION HOSPITAL INFECTION DAY WINDOW PERIOD DAY WINDOW PERIOD 1 1 Fever > 38.0 C Date of Event 2 2 3 3 Urine culture : 4 Date of Event 4 Urine culture: >100,000 CFU/ml >100,000 CFU/ ml E. coli E. coli Fever > 38.0 C 5 5 Fever > 38.0 C 6 6 7 7 8 8 9 9 10 10 11 11 12 12 13 13 14 14 15 15 16 16 17 17 18 18 SUTI -HAI SUTI -POA Date of Event = 4 Date of Event = 2 Pathogen = E. coli Pathogen = E. coli 2-8 January 2019

15 -associated Infections Identifying Healthcare : Notes Acceptable documentation includes pa tient-reported signs or symptoms within the POA • documented in the medical record timeframe, . Information by a healthcare professional communicated verbally from facility to facility , or information found in another facility’s medical record cannot be used unless also documented in the current facility’s medical record (with the exception of post –discharge SSI surveillance.) For example, the : following would be eligible for use if documented in the current facilit y’s medical record patients states measured fever > 38.0° C or >100.4° F occurring in the POA o timeframe l and occurring in the o nursing home reports fever prior to arrival to the hospita POA timeframe o patient complains of dysuria o copy of laboratory test result from another facility Physician diagnosis can be accepted as evidence of an infection only when physician • diagnosis is an element of the specific infection definition. For example, physician diagnosis is not an element of any UTI criteria; therefore, physician diagnosis of a UTI . may not be used to satisfy POA status of a UTI Repeat Infection Timeframe: -day timeframe during which no new The Repeat Infection Timeframe ( RIT ) is a 14 infections of the same type are reported. • The RIT applies to both POA and HAI determinations. • The date of event is Day 1 of the 14-day RIT. are met and the date of event is • If criteria for the same type of infection within the day RIT, a new event is not identified or report ed. 14- • during the RIT from the same type of infection are Additional pathogens recovered added to the event. • Note the original date of event is maintained as is the original 14-day RIT. • Device association determination and location of attribution are not to be amended. See examples in below. Table Table 5 and 6 2-9 January 2019

16 -associated Infections Identifying Healthcare • The RIT will apply at the level of specific type of infection with the exception of BSI, UTI, and PNEU where the RIT will apply at the major type of infection. fic Type Example: Speci Patients will have no more than one SKIN infection reported in a SKIN RIT, but may have overlapping or simultaneous SKIN RIT and DECU RIT Major Type Examples: • Patients will have no more than one BSI reported in a BSI RIT (LCBI 1, LCBI 2, MBI -LCBI 1,MBI -LCBI 2, MBI -LCBI 3 ) reported in a PNEU RIT • Patients will have no more than one PNEU (PNU1, PNU2, PNU3). Patients will have no more than one UTI reported in a UTI RIT • (SU TI, ABUTI, USI ) • The RIT applies during a patient’s single admission, including the day of discharge and the day after, in keeping with the Transfer Rule. An RIT does not carry over from one admission to another even if readmission is to the same facility. RIT for Endocarditis (ENDO) is • The extended to include the remainder of the patient’s current admission. 2-10 January 2019

17 Identifying Healthcare -associated Infections In the example below ( Table 5 ), the Date of Event is hospital day 4. The 14-day RIT is hospital day 4 through day 17. On hospital day 12, within the RIT, a urine culture with > 100,000 CFU/ml S. aureus is identified. The urine pathogen identified from the hospital day of Determination ly identified infection on hospital day 4. 12 culture is added to the original a new infection or continuation of ongoing infection is not required. The original date of event and the RIT are maintained. : Repeat Infection Timeframe Table 5 2-11 January 2019

18 Identifying Healthcare -associated Infections ) a non Table 6 In the example below ( -catheter associated UTI is identified with date of event on day 4. This sets an RIT day 4 -17. On day 5 a Foley catheter is inserted. On day 8, within the RIT, a urine culture with > 100,000 CFU/ml E.coli is identified. The E.coli is added to the originally identified day 4 event. The device association does not change and the date of event and RIT are maintained. Table 6 . Repeat Infection Timeframe and Interim Device Insertion Notes: • A patient may have negative cultures during the RIT without impact on the RIT. • Do not change the device- asso ciation determination during the RIT. Do not change location of attribution determination during the RIT. • 2-12 January 2019

19 -associated Infections Identifying Healthcare Secondary BSI Attribution Period BSI ) Guide of the BSI Event (R efer to Appendix B, Secondary Bloodstream Infection ( Protocol) The Secondary BSI Attribution Period is the period in which a blood specimen must *(SBAP) be collected for a secondary bloodstream infection to be attributed to a primary site infection. This period includes the Infection Window Period combined with the Repeat Infection Timeframe (RIT). It is 14 -17 days in length depending upon the date of event. For purposes of NHSN, in order for a bloodstream infection to be determined secondary to another site of infection the following requirements must be met : ‡ An NHSN site -specific defi nition must be met; either one of the CDC/NHSN Surveillance Definitions for Specific Types of Infections (defined in Chapter 17), or UTI , PNEU or SSI definition. AND One of the following scenarios m : ust be met Scenario 1: At least one organism from the blood specimen matches an organism -specific infection that is used as an element to meet the NHSN identified from the site site criterion and the blood specimen is collected in the secondary -specific infection BSI attribution period.(infection window period + repeat infection timeframe). OR An organism identified in the blood specimen is an element that is used Scenario 2: to meet the NHSN site -specific infection criterion, and therefore is collect ed during the site-specific infection window period. *Note s: When meeting the Endocarditis (ENDO) definition, the secondary BSI attribution • s the 21- day infection window period period include and all subsequent days of the patient’s current admission. o As a result of this lengthy ENDO secondary BSI attribution period, secondary BSI pathogen assignment for ENDO, is limited to organism(s) identified in blood specimen that match the organism(s) used to meet the ENDO definition. For example, if the ENDO definition was met using a site- specific specimen (cardiac vegetation) or using a blood specimen where was the S. aureus 2-13 January 2019

20 -associated Infections Identifying Healthcare identified organism and subsequently a blood specimen collected during the E.coli e for ENDO secondary S. aureus and BSI attribution period is positiv , while the S. aureus can be assigned to the ENDO event, it cannot be assumed E.coli the can be assigned as a secondary BSI pathogen. The blood organism ( ) does not match the organism ( S. aureus ) used to meet the ENDO E.coli definition. If the blood specimen can be used to meet an ENDO definition criterion both organisms can be assigned. Otherwise the E.coli will need to be investigated as a separate BSI and be identified as a secondary BSI to another site-specific infection or determined to be a primary BSI. ‡ Exception: -specific specimen nor organism Necrotizing enterocolitis (NEC) criteria include neither a site , however an exception for assigning a BSI secondary to NEC identified from blood specimen is provided. A BSI is considered secondary to NEC if the patient meets one of the two NEC criteria AND a n organism identified from blood specimen collected during the secondary BSI attribution period is an LCBI pathogen, or the same common commensal wh ich is identified from two or more blood specimens drawn on separate occasions collected on the same or consecutive days. 2-14 January 2019

21 Identifying Healthcare -associated Infections Secondary BSI Attribution Period Tables: In the example belo w ( Table 7 ), the Date of Event is hospital day 4. The 14-day RIT is hospital day 4 through day 17. The Secondary BSI Attribution Period is the Infection Window Period combined with the Repeat Infection Timeframe (RIT), 17 days in this site thogen to the - example. The blood cul ture collected on hospital day 10 has a matching pa specific culture used to meet SUTI definition , and therefore, a secondary BSI is identified . Table 7 : Secondary BSI Attribution Period 2-15 January 2019

22 Identifying Healthcare -associated Infections In the example below ( Table 8 ), the Date of Event is hospital day 4. The 14-day RIT is hospital day 4 through day 17. The secondary BSI Attribution Period is 17 days in length. The blood culture collected on hospital day 5 is used as an element to meet the PNU2 infection definition and therefore a secondary BSI is identified . Table 8 : Secondary BSI Attribution Period 2-16 January 2019

23 -associated Infections Identifying Healthcare Guidance Pathogen Assignment : The following provides guidance for reporting pathogens associated with site -specific infections that are identified during the RIT or during the secondary BSI attribution period. • Additional eligible pathogens recovered during the RIT from the same type of infection are added to the event. -specific pathogens before secondary BSI pathogens. Report all site • SUTIs can only have two organisms entered according to NHSN application o rules. However, if yes is selected for the secondary BSI field, the third pathogen field will become available for data entry. If at least one BSI pathogen with a collection date in the secondary BSI attribution period • matches organism from a specimen (either a site -specific specimen or a blood specimen) -specific infection criterion additional eligible BSI pathogens that was used to meet a site are also considered secondary to the event. • BSI pathogens may be assigned to more than one infection source at the same time in the following scenarios. (see -specific infections Secondary BSI pathogen assigned to two different site 1) Example 1) OR specific infection and assigned as Secondary BSI pathogen assigned to a site- 2) pathogen to a primary BSI event (see Example 2 ). Example 1: K. pneumoniae is identified in a blood culture during the RIT of a SUTI with K. pneumoniae . The patient is also recovering from COLO surgery performed at your facility in the past week and now ha s: o Fever > 38.0° C, Abdominal pain, and o CT showing abdominal abscess o These th ree elements, when combined with a positive blood culture, meet IAB criterion their monthly reporting 3b. If a facility includes both UTI and SSI (for COLO) in plan, a UTI and SSI w ill be reported , both with a secondary BSI and with pathogen K. pneumonia e. -IAB does not have an Infection Window Period or Note : As per the SSI protocol, the SSI RIT. The secondary BSI attribution period is 17 days in duration including the date of t. event, 3 days prior and 13 days after the date of even 2-17 January 2019

24 -associated Infections Identifying Healthcare Example 1 Cont. 2-18 January 2019

25 Identifying Healthcare -associated Infections Example 2 : On day 4 of hospital admission, S. aureus is identified in a blood culture meeting the HAI, LCBI 1 criterion . On day 8 the patient has a fever > 38.0° C and is identified in a urine culture meeting the SUTI definition. On E. coli hospital day 13, a blood culture positive for E.coli is identified. Because the blood culture occurs within both the LCBI RIT and the SUTI secondary E.coli is assigned to both events. BSI attribution period , the pathogen, • Pathogens excluded from specific infection definitions ( for example . yeast in UTI, or Enterococcus spp. in PNEU ) are also excluded as pathogens for BSIs secondary to that type of infection ( specifically they cannot be added to one of these infections as a pathogen). The excluded organism must be accounted for as either: 1) A primary bloodstream infection (BSI/CLABSI) (see Example 3) OR 2) A secondary BSI attributed to another primary infection (for example, to an IAB or SINU), in accordance with Appendix B, Secondary BSI Guide of the BSI (see Example 4) Event protocol 2-19 January 2019

26 Identifying Healthcare -associated Infections Example 3 : and a subsequent blood culture A SUTI with Enterococcus faecalis is identified with yeast and E. faecalis is collected during the SUTI secondary BSI attribution period. A BSI secondary to SUTI is identified. E. faecalis is already documented as a pathoge n, but the yeast will not be reported as a secondary BSI pathogen, because yeasts are excluded as organisms in the UTI definition. In this example, no other primary source of infection for which the yeast BSI can be assigned as secondary is identified. Therefore a primary BSI with yeast only is identified. Note: The as a pathogen for the primary is not assigned Enterococcus faecalis BSI because if an excluded organism had not been identified, a primary BSI would not have been report ed. 2-20 January 2019

27 Identifying Healthcare -associated Infections Example 4 : A PNU2 with Acinetobacter baumannii cultured from blood is identified . Note : the positive chest imaging result is the diagnostic test that is used to define the infection window period. A subsequent blood culture with baumannii A. is collected during the secondary BSI Enterococcus faecalis and Enterococcus faecalis will not be attribution period of this PNU2 event. reported as a pathogen for the PNU2 , because Enterococcus spp. are ary source of excluded as organisms in the PNEU definition. Another prim infection is assigned as a secondary , SUTI, is found and Enterococcus faecalis BSI pathogen. 2-21 January 2019

28 -associated Infections Identifying Healthcare • Determination of a secondary BSI to a primary site of infection does not set an RIT for all subsequent BSIs. If a blood culture occurs during a site specific infection’s secondary BSI attribution period and it cannot be used as an element to meet the infection definition specific infection culture used or does not have at least one matching pathogen to the site- to meet the site -specific infection criterion the BSI must be evaluated as a new BSI event (see Example 5) Example 5: E. A SUTI with Enterococcus faecalis is identified and a blood culture with faecalis collected on hospital day 11 within the SUTI secondary BSI attribution period is also identified. On hospital day 15 (also within the SUTI RIT and secondary BSI attribution period), a blood culture growing Because the blood growing Staphylococcus aureus is identified. S. aureus does not have at least one pathogen that matches the urine culture used to SUTI criterion the BSI cannot be attributed as secondary to the meet the SUTI. The BSI will need t o be investigated as a new BSI event and either or determined assigned as a secondary BSI to another primary site of infection to be a primary BSI. Note: T he secondary BSI attribution period for a primary site of infection does timeframe for all subsequent BSIs. not establish a repeat infection 2-22 January 2019

29 Identifying Healthcare -associated Infections • When identifying a BSI which appears to fall within a BSI- RIT, it is important to verify specific event. the initial BSI was indeed a primary BSI and not a secondary BSI to site- RIT, therefore, incorrectly establishing a BSI -RIT for a Only primary BSIs create a BSI secondary BSI event can result in the inaccurate assignment of a BSI pathogen(s) and the identification of a true CLABSI event will likely be missed (see Example 6 ). Example 6: identified as POA and therefore not further investigated. Upon Initially a BSI was identification of a subsequent BSI it cannot be assumed that the POA BSI set a BSI RIT. Instead, it must be verified that the initial BSI was indeed a primary BSI and not a secondary BSI to a site -specific infection. In the example below, upon further review the initial BSI was actually determined to be a secondary BSI to a SKIN dary BSI Attribution P eriod does not capture all infection. The SKIN Secon subsequent BSIs . In this example it can only account for BSIs that have at least one specific specimen matching pathogen to the site- (wound drainage) used to meet SKIN. The BSI on hospital day 9 does not mat ch and it also was determined not to be specific infection and therefore a CLABSI is identified. secondary to another site- 2-23 January 2019

30 Identifying Healthcare -associated Infections Location of Attribution (LOA) : The inpatient location where the patient was assigned on the date of event is the location of attr ibution (see Date of Event definition). Non -bedded patient locations, (for example, Operating Room (OR) or Interventional Radiology (IR)) are not eligible for assignment of location of attribution for HAI events. Location of attribution m ust be assigned to a location where denominator data (for example, patient days, device days) can be . collected Exception t o Location of Attribution: Transfer Rule : If the date of event is on the date of transfer or discharge, or the next day, the infection is attributed to the transferring/discharging location. This is called the Transfer Rule . If the patient was in multiple locations within the transfer rule time frame, attribute the infection to the first the infection’s day before location in which the patient was housed the date of event . Receiving locations or facilities should share information about such HAIs . See examples below. with the transferring location or facility to enable accurate reporting 2-24 January 2019

31 -associated Infections Identifying Healthcare Surveillance after the patient is discharged from the facility is not required. However, if Note: discovered, any infection with a date of event (DOE) on the day of discharge or the next day is attributable to the discharging location and should be included in any data reported to NHSN for that location. No additional device days are reported. Location Example : Patient Date Location of Attribution Location 3/22 Unit A -- Unit A 3/23 -- Unit B Unit B 3/24 Unit A Date of Event -- 3/25 Unit B Example: Facility Date Patient Location of Attribution Location 3/22 Facility 1 --- Facility 1 3/23 --- Facility 2 3/24 Facility 2 Facility 1 Date of Event Facility 2 --- 3/25 Multiple transfers within the same facility during the same admission Example : In instances where a patient has been transferred to more than one location on the date of an infection, or the day before, attribute the infection to the first location in which the patient was housed the day before the infection’s date of event. Date Pa tient Location of Location Attribution Unit A - 3/22 Unit A 3/23 - Unit B Unit C 3/24 Unit C Unit A Unit D Date of Event Unit D - 3/25 2-25 January 2019

32 Identifying Healthcare -associated Infections -specific infection criteria, and the site CDC/NHSN HAI Note: The complete set of comments and reporting instructions integral to the correct application of the criteria, can be Surveillance Definitions found in Chapter 17, CDC/NHSN for Specific Types of Infections, Chapter 7). Chapter 6), and UTI ( PNEU ( 2-26 January 2019

33 , I de nt ify th e di agno st ic t est : Flow Diagram for NHSN Event Determination APPENDIX or in the absence of a diagnostic test , t he loca liz ed si gn /sy m pt om t ha t wi ll determine the Infection Window ) (I WP P er io d ’s Using the patient age and IUC status d eci de w hi ch Do all el ements el ement s of t he UTI requi re d to meet definition are I s t he d iagn o sti c te st t he NHSN de fin it ion . D o eligible for use Ye s No No No a po sit iv e u ri ne o cc ur w it h in t he al l e lemen ts ? c ul tu re I nf ect io n W in do w requi re d to meet P er io d (I WP )? t he NHSN de fin it ion o cc ur w it h in t he I nf ect io n W in do w )? (I WP P er io d Dete rmine t he Da te of Event STOP STOP ) (DOE Ye s Ye s Not a n NHSN event Not a n NHSN event Is there a Is there a No Repeat UTI Repeat I nf ect io n No I nf ect io n Ye s Ti mef ra me Ti mef ra me I s t he D OE d u ri ng ) in place (R IT (R IT ? ) in place t he Heal thc are - Dete rmine if the for t he same assoc iat ed I nf ect ion POA HAI in fe ct ion is de vic e - ? event t ype ) or Present on (HAI associated Admi ssi on (POA ) t im efr ame ? Ye s STOP No new event is fo un d , ad d eli gib le pathogens to the Dete rmine the Dete rmine the 14 - ori gin al even t STOP location of day Repeat Inf ect ion No new event is ) at tr ib u ti on Ti mef ra me (R IT , ad d eli gib le fo un d pathogens to the ori gin al UTI If not a pri mary bloodstream (BSI in fe ct ion ), dete rmine the , Refer to the NHSN Patient Safety Co mp onent Manual Secondary BSI 2 for detailed guid ance. Chapter Attribution Period (SBAP )

34 Monthly Reporting Plan and Annual Surveys Patient Safety Monthly Reporting Plan and Annual Surveys Monthly Reporting Plan Th e Patient Safety Monthly Reporting Plan form (CDC 57.106) is u sed by NHSN atient Safety modules are used during a given month. facilitie s to inform CDC which P gate data analysis This allows CDC to select the data that should be included in the aggre may represent either “in - used for creating national benchmarks. Data entered into NHSN plan” or “off -plan” surveillance. Each participating facility must identify and enter a used, if any, and the events, locations and/or monthly plan to indicate the module (s) procedures that will be monitored in -plan. The modules and locations selected for the month represent in- plan surveillance and indicate that the NHSN surveillance protocols will be used in their entirety, for that surveillance . Only in- plan data are submitted to The Centers for Medicare and Medicaid • Services ( ) in accordance with CMS’s Quality Reporting Programs and CMS included in NHSN annual reports or other NHSN publications. • “Off- plan” surveillance is su rveillance that is done because a facility has decided to track a particular event for internal use. A facility makes no commitment to follow the NHSN protocol for “off-plan” events and such data are not included in CMS Quality Reporting Programs, NHSN ann ual reports or other NHSN publications. There must be a plan completed for every month that data are entered into NHSN although a facility may choose “No NHSN Patient Safety Modules Followed this Month” as an option. The reporting plan should take into account reporting requirements (for when applicable to , local, state, or CMS mandates) facility. The monthly the example reporting plan is the first step in indicating the data that should be submitted to CMS as part of the CMS Quality Reporting Programs. Instructions for completing the Patient Safety Monthly Reporting Plan form can be found Instructions . in the Table of Annual Facility Survey One or more annual facility surveys must be completed upon enrollment into NHSN, -certified units activation of an NHSN component, and/or identificatio n of select CMS . reafter The , a new facility survey(s) must be completed to , at the beginning of each year . For example, at the beginning of 2018, an acute reflect data from the prior calendar year care hospital completes a 2017Annual Hospital Survey containing data from 2017. 3 -1 201 9 January

35 Monthly Reporting Plan and Annual Surveys In the Patient Safety Component there are separate surveys for the following types of facilities: • ; Hospital (includes general, acute care hospitals; critical access hospitals; oncology; orthopedic; pediatric; women’s; women’s and children’s; military; psychiatric; and Veterans Affairs): Patient Safety Component – Annual Hospital 57.103) Survey ( • Patient Safety Component – Annual term Acute Care (LTAC) Hospital: Long- Facility Survey for LTAC ( 57.150) • - standing facilities and CMS Inpatient Rehabilitation Facility (includes free- Patient Safety certified inpatient rehabilitation units located within a hospital): 57.151) ( Component – Annual Facility Survey for IRF • Patient Safety Component – Annual Facility Ambulatory Surgery Center (ASC): 57.400) ( Survey for Ambulatory Surgery Center Instructions for completing the Annual Survey form can be found in the Table of Instruction the Table of Instructions form is included on each of the annual s. A link to survey forms. 3 -2 January 201 9

36 Device -associated Module BSI Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non -central Line Associated Bloodstream Infection) Table of Contents -associated BSI: Introduction Bloodstream infection event (Central line and non- central line 3 and settings. Key Terms and Abbreviations (universal) 3 Definitions specific to BSI / CLABSI surveillance: 3-5 Devices that are Not Central Lines 6 Table 1 : Laboratory Confirmed Bloodstream Infection Definitions: 7-9 LCBI 1, LCBI 2, LCBI 3 : Mucosal Barrier Injury LCBI (MB Table 2 -LCBI) Combined table 10 Comments and Reporting Instructions 11-14 Table 3: CLABSI Exclusions and Reporting of these events in 2019 1 3 Blood specimen collection 1 5 7 - 18 1 Table 4: Examples of Associating the Use of Central Lines to BSI Events (CLABSI) Pathogen Exclusions and Reporting Considerations 19 Table 5: Reporting Speciated and Unspeciated Organisms from Blood Specimens 2 0 Table 6: Examples Illustrating the MBI -LCBI Criteria for Neutropenia : (Rationale) 2 0 Monthly Summary Data (numerator data, reporting instruction, denominator data, collection 22 -2 4 methods) Data Analysis 28 29 Table 9: CLABSI Measures Available in NHSN 3 0 References 4-1 January 2019

37 Device -associated Module BSI Table of Contents 1 3 Appendix A: Partial List of Criterion 1 MBI -LCBI Eligible Enterobacteriaceae Genera 3 2 Appendix B. Secondary BSI Guide 5 -3 2 3 : Secondary BSI Scenarios Making Secondary BSI Determinations 3 6 Table B1: Secondary BSI Guide 3 7 Secondary BSI Reporting Instructions 8 -3 3 7 Matching Organisms 39 -4 3 Pathogen Assignment (Examples) 4 4 Figure B1: Secondary BSI Guide for Eligible Organisms (NEC Exception) 5 4 Figure B2: VAE Guidance for Secondary BSI Determination 4-2 January 2019

38 Device -associated Module BSI Introducti Although a 46% decrease in CLABSIs has occurred in hospitals across the U.S. from on: 2008-2013, a n estimated 30,100 central line-associated bloodstream infections (CLABSI) still occur in 1 . intensive care units and wards of U.S. acute care facilities each year CLABSIs ar e serious infections ing a prolongation of hospital stay and increased cost and risk of mortality. ly caus typical an be prevented through proper insertion techniques and management of the central line. CLABSI c These techniques are addressed in the CDC’s Healthcare Infection Control Practices Advisory ICP AC) Guidelines for the Prevention of Intravascular Catheter-Related Infections, Committee (CDC/H 2 . 2011 Settings : Surveillance may occur in any inpatient location where denominator data can be which can include critical/intensive care units (ICU), specialty care areas (SCA), neonatal collected, , step down units, wards, and long term care units. units including neonatal intensive care units (NICUs) A complete listing of inpatient locations and instructions for mapping can be found in the CDC Locations and Descriptions chapter. Note: CLABSI surveillance after patient discharge from a facility is not required. However, if discovered, any CLABSI with a date of event (DOE) on the day of or the day after discharge is attributed to th e discharging location and should be communicated to that facility to encourage te NHSN reporting of CLABSI appropria s. (See Transfer Rule, Chapter 2). Do not collect or report additional central line days after discharge. Key Terms and Abbreviations Refer to th e NHSN Patient Safety Manual, Chapter 2 Identifying Healthcare Associated Infections in and Chapter 16 NHSN for definitions of the following universal concepts for NHSN Key Terms conducting HAI surveillance. I. Date of event (DOE) II. Healthcare associated infection (HAI) III. Infectio n window period (IWP) IV. Present on admission (POA) V. Repeat infection timeframe (RIT) VI. Secondary BSI attribution period (SBAP) VII. Location of Attribution (LOA) VIII. Transfer rule Definitions Specific to BSI / CLABSI Surveillance: onfirmed Bloodstream Infection (LCBI) that is Primary bloodstream infection (BSI): Labo ratory C A not secondary to an infection at another body site (see Appendix B. Secondary BSI Guide and Ch CDC/NHSN Surveillance Definitions f or Specific Types of Infection [ Ch -17], UTI [ -7], Pneumonia (Ch -6), and SSI (Ch-9). 4-3 January 2019

39 -associated Module Device BSI LCBI Hiera rchy; Types of L CBI s (s ee Table 1 and Table 2 ): BSIs LCBI 2 LCBI 3 LCBI 1 LCBI 1 LCBI 3 MBI- LCBI 2 MBI- MBI- A BSI Secondary B SI: th at is thought to be seeded from a site- specific infection at another body site (see Appendix B. Secondary BSI Guide and CDC/NHSN Surveillance Definitions for Specific Types of Infection [Ch -17], UTI [Ch-7], Pneumonia (Ch-6), and SSI (Ch- 9). the period in which a blood specimen must be collected for a ribution Period (SBAP) : Secondary BSI Att secondary BSI to be attributed to a primary site of infection. This period includes the Infection Window Period (IWP) combined with the Repeat Infection Timeframe (RIT). It is 14-17 days in length depending page 2 -13). upon the date of event (see Ch. 2 The administration of any solution through the lumen of a catheter into a blood vessel. Infusion: Infusions include continuous infusion (for example, nutritional fluids or medications), intermittent infusion (for example, IV flush), IV antimicrobial administration, and blood transfusion or hemodialysis treatment. activities during the current inpatient admission: The performance of any of the following Access: Line placem • ent Use of (ent any central line for: ering the line with a needle or needless device) • Infusion o Withdrawal of blood o Use for he modynamic • monitoring. Notes: already in place, and it If a patient is admitted to a 1. location with a central line (CL) ent an inpati an inpatient location begins the central line is the patient’s only CL, the day of first access in day CL Day 1 ) for making central line -associated determinations . Note: simply “de - count ( removal of port needle but port remains in for example, central line ( accessing” any type of counts for body) does not remove the patient from CLABSI surveillance nor from device day reporting denominator summary data. 4-4 January 2019

40 Device -associated Module BSI An inpatient location , for making determinations about central line access, includes but is not 2. for limited to, any department or unit within the facility that provides service to inpatients [ ialysis, O perating Room (OR), Interventional Radiology, G astroent erology example, inpatient D Lab (GI) , C ardiac C atheterization lab (CC) , wards, ICUs, etc. ]. 3. s Include any inpatient receiving dialysis in CLABSI surveillance conducted in the patient’ assigned inpatient location, regardless of whether or not the patient only has one CL and dialysis staff are the only providers to access it during dialysis treatment. Examples: CLABSIs in the following examples will be attributed to Unit A • Patient on Unit A receives onsite dialysis by contracted dialysis staff • Dialysis staff travels to Unit A to provide dialysis to Unit A patient • Patient in Unit A for inpatient care is transported to dialysis unit within the facility for dialysis Because CLABSI event s cannot be attributed to a non-bedded location, such events must be attributed to the inpatient location housing the patient. An intravascular catheter that terminates at or Central line (CL): in one of the OR close to the heart, great vessel s that is used for infusion, withdrawal of blood, or hemodynamic monitoring. Consider the following great vessels when making determinations about CLABSI events and counting CL device days: • Aorta • Pulmonary artery • Superior vena cava • Inferior vena cava • Brac hiocephalic veins • Internal jugular veins Subclavian veins • • External iliac veins • Common iliac veins • Femoral veins • In neonates, the umbilical artery/vein. Notes: 1. Neither the type of device nor the insertion site are used to determine if a device is considered a central line for NHSN reporting purposes. 2. At times, a CL may migrate from its original central location after confirmation of proper placement. NHSN does not require ongoing verification of proper line placement. Therefore, , regardless of migration, until once a line has been designated a CL it continues to be a CL removed from the body or patient discharge, whichever comes first. CL days are included for any CLABSI surveillance conducted in that location. 4-5 January 2019

41 Device -associated Module BSI is an intravascular catheter, and depending on the location of the tip and its use, 3. An introducer may be considered a CL. that terminates at or close to the heart or in a great vessel A non-l umened intravascular cat 4. heter is not of infusion, withdrawal hemodynamic monitoring blood considered used for that is not or NHSN reporting purposes (for a CL umened pacemaker wires. Please note: for example, non-l there are some pacemaker wires that be considered a central line). do have lumens, which may ines for NHSN reporting purposes: entral L Types of C 1. Permanent central line: Includes: a. Tunneled catheters, including tunneled dialysis catheters b. Implanted catheters (including ports) Temporary central line: A non-tunneled, non- 2. implanted catheter 3. : A vascular catheter inserted through the umbilical artery or vein in a neonate. Umbilical catheter All umbilical catheters are central lines. ce for L t hat ha s b een i n pl a : A C mor e than two con secutive calendar days (on Eligible Central Line ter C L d ay 3) , following the first a ccess of or af central l ine, in an inpatient location, dur ing the the current admission. Such l for CLABSI events and r emain eligible for CLABSI ev ents ines are eligible comes from body until the day after removal patient discharge, whichever the first. S ee Table 4 for or examples confirmed bloods tream i nfection where an Ce aboratory ntral line A l -associated BSI (CLABSI): the LCBI organism n eligible c entral line i s present on ntified and a DO E or the day eligible BSI is ide before. line days : t he number of da ys a central l ine has be en accessed t Central etermine if a LCBI i s a o d CLA I BS uni minator device days: he count of central monthly s on an inpatient t t that is r e corded in the line Deno denominator summary data a. I Eligible BSI Or rganism that is e ligible f or us e to me et LCBI or M BI -L CBI cr iteri Any o n ganism: other words, an organism that is not an excluded pathogen for use in meeting LCBI or MBI- LCBI criteria. T hese organism s may or may not be included on the NHSN organism list. P lease contact N HSN list organisms that are not included on the NHSN organism e regarding for guidanc ting P urposes: Devices N ot C onsidered CLs for NH SN Repor • Arterial catheters • Arteriovenous fistula • Arteriovenous graft 4-6 January 2019

42 Device -associated Module BSI • Atrial catheters ( also known a s transthoracic intra- cardiac catheters, those catheters inserted left atrium via the heart wall) directly into the right or • Extracorp oreal membrane oxygenation ( ECMO) Hemodialy sis reliable outflow (HERO) dialysis catheter • • -aor tic balloon pump (IABP) devices Intra • Peripheral IV or Midlines • Ventricular Assist Device (VAD) Table 1: L aboratory- Confirmed Bloodstream Infection Criteria : Must meet one of the following LCBI criteria: specific criteria provide Comments and reporting instructions that follow the site- Criterion further explanation and are integral to the correct application of the criteria. Once an LCBI determination is made, proceed to the MBI- LCBI definitions and determine if the corresponding -LCBI criteria are also met MBI (for example, after meeting LCBI 2 , investigate for potential MBI -LCBI 2) Patient of any age has a recognized bacterial or fungal pathogen not included on the LCBI 1 NHSN common commensal list, identified from one or more blood specimens obtained If LCBI 1 by a culture or non- culture based microbiologic testing method s criteria is met, AND consider MBI -LCBI 1 Organism(s) identified in blood is not related to an infection at another site (See Appendix B: Secondary BSI Guide ). Notes: 1. If a patient meets both LCBI 1 and LCBI 2 criteria, report LCBI 1 with the recognized pathogen entered as pathogen #1 and the common commensal a s pathogen #2. No additional elements ( in other words, no sign or symptom such as fever) are 2. be the needed to meet LCBI 1 criteria; therefore, the LCBI 1 DOE will always collection date of the first positive blood specimen used to set the BSI IWP. 4-7 January 2019

43 Device -associated Module BSI one has at least of any age Patient of the following signs or symptoms: LCBI 2 o fever (>38 .0 C), chills, or hypotension If LCBI 2 criteria AND is met, blood is not related to an infection at another site Organism(s) identified in consider (See Appendix B: Secondary BSI Guide ). -LCBI 2 MBI AND The same NHSN common commensal is identified by a culture or non- culture based microbiologic testing method , from two or more blood specimens collected on separate Blood Specimen Collection). occasions (see Common Commensal organisms include, but not are not limited to, diphtheroids Corynebacterium spp. not C. diphtheria ( Bacillus spp. (not B. anthracis) , ), Propionibacterium spp., coagulase- negative staphylococci (including S. epidermidis) , Rhodococcus viridans group streptococci, spp. Micrococcus spp. and Aerococcus spp. For a full list of common commensals, see the Common Commensal tab of the NHSN Organisms List . Notes: Criterion elements must occur within the 7 ) 1. -day IWP (as defined in Chapter 2 which includes the collection date of the positive blood specimen, the 3 calendar days before and the 3 calendar days after. The two matching common comme specimens represent a single element for 2. nsal first specimen is used use in meeting LCBI 2 criteria and the collection date of the to determine the BSI IWP. 3. a sign or symptom of fever, chills or At least one element (specifically, hypotension) is required to meet LCBI 2 criteria DOE will always be ; the LCBI 2 first the date the occurs for the first time during the BSI IWP , whether that element be a sign or symptom or the positive blood specimen. Fever > 38.0 °C 6/1 - LCBI 2 DOE = 6/1 No LCBI element - 6/2 - No LCBI elemen t - - 6/3 st Single S. epidermidis (1 of 2) 6/4 diagnostic test = 6/4 Date of 1 element 6/5 S. epidermidis (2 of 2) - No LCBI element - 6/6 - No LCBI element - - 6/7 4-8 January 2019

44 Device -associated Module BSI one 1 year of age has at least ≤ of the following signs or symptoms: Patient LCBI 3 o o fever (>38 C), apnea, or bradycardia .0 C), hypothermia (<36.0 If LCBI 3 criteria is AND met, Organism(s) identified in blood is not related to an infection at another site consider (See Appendix B: Secondary BSI Guide ). -LCBI 3 MBI AND culture based The same NHSN common commensal is identified by a culture or non- microbiologic testing method, from two or more blood specimens collected on separate occasions (see Blood Specimen Collection ). Common Commensal organisms include, but not are not limited to, diphtheroids ( Corynebacterium spp. not C. diphtheria ), Bacillus spp. (not B. anthracis) , Propionibacterium spp., coagulase- negative staphylococci (including S. epidermidi s) , spp, and viridans group streptococci, Aerococcus spp. Micrococcus spp. Rhodococcus For a full list of common commensals, see the Common Commensal tab of the NHSN orga nisms list. Notes: Criterion elements must occur within the 7 -day IWP (as defined in Chapter 2 ) 1. which includes the collection date of the positive blood specimen, the 3 calendar days before and the 3 calendar days after. 2. The two matching common commensal specimens represent a single element for first is used to determine the BSI use in meeting LCBI 2 criteria and the date of the IWP. 3. ically, a sign or symptom of fever, hypothermia, apnea At least one element (specif DOE will always be or bradycardia) is required to meet LCBI 3 criteria; the LCBI 3 first element occurs for the first time during the BSI IWP whether that the date the be a sign or symptom or the positive blood specimen. - 6/1 No LCBI element - - 6/2 - No LCBI element st Single S. epidermidis (1 of 2) 6/3 Date of 1 diagnostic test = 6/3 element LCBI DOE = 6/3 6/4 (1 of 2) S. epidermidis - - 6/5 Apnea documented - - 6/6 No LCBI element - - No LCBI element - 6/7 4-9 January 2019

45 Device -associated Module BSI Table 2: Mucosal Barrier Injury Laboratory -Confirmed Bloodstream Infection (MBI -LCBI) Must meet LCBI cri teria one of the following MBI- -LCBI is a subset of the LCBI criteria; therefore, a BSI event must fully meet an LCBI An MBI on before evaluating for the corresponding MBI- LCBI criteria. criteri -LCBI DOE will always be the date the prerequisite LCBI criteri a was met. The MBI Abnormal ANC and WBC values reflect risk factors for acquiring an MBI -LCBI, not symptoms of infection and therefore are not used in DOE determinations. MBI MBI -LCBI 2 MBI -LCBI 3 -LCBI 1 Patient of any age fully meets fully <1 year of age Patient of any age fully meets Patient LCBI 1 criteria meets LCBI 3 criteria LCBI 2 criteria one blood with at least with at least two blood specimens specimen identified by culture or non- culture based microbiologic testing method with ONLY intestinal but no . spp Rothia with ONLY V iridans G roup Streptococcus or from the NHSN organisms other organisms MBI organism list* AND Patient meets at least one of the following: Is an allogeneic hematopoietic stem cell transplant recipient within the past year with one of the 1. following documented during same hospitalization as positive blood specimen: a. Grade III or IV gastrointestinal graft versus host disease [GI GVHD] ≥1 -liter diarrhea in a 24 b. hour period (or ≥20 mL/kg in a 24 -hour period for patients <18 - years of age) with onset on or within the 7 calen dar days before the date the positive blood specimen was collected. † 2. and/or WBC values <500 Is neutropenic, defined as at least two separate days with ANC 3 collected within a 7 -day time period which includes the collection date of the positive cells/mm blood specimen, the 3 calendar days before and the 3 calendar days after (See Table 6 ). Note: 1 and MBI-L 1. If a patient meets both MBI-LCBI CBI 2 criteria (specifically has Viridans Group Streptococcus or Rothia only spp. plus MBI organisms in the blood specimen), report other organisms as MBI-LCBI 1 with the recognized pathogen as pathogen #1 and the common commensal pathogen #2. as 2. Any combination of ANC WBC values can be used to meet neutropenic criteria provided and/or positive they ar e collected on separate days within the 7-day period that includes the date of the endar days after. blood specimen, the 3 calendar days before and the 3 cal 4-10 January 2019

46 Device -associated Module BSI When a blood specimen positive for an organism not included on the NHSN MBI organism list 3. during the BSI RIT of an MBI- LCBI, the initial MBI is collected -LCBI event is edited to an LCBI and the identified non-MBI organism is added. *A partial list of MBI -LCBI organisms is provided in Appendix A . See MBI organism tab o n the NHSN organism list for the full list of MBI organisms. † Formula for calculating ANC if not provided by your laboratory: • The ANC is not always reported directly in the chart 3 The WBC in the chart is usually reported in terms of thousand cell/mm • ANC = Absolute Segs + Absolute Bands OR ANC = WBC x %Segs + %Bands / 100 Example : 3 3 Segs: 20% Bands: 20% ANC = 2000 x (20+20)/100 = 800 cells/mm WBC: 2 k/mm : Reporting Instructions Central Line data field should be marked “Y es” if Extracorporeal life support, (ECMO) and ventricular assist device (VAD) are present: A BSI meeting LCBI criteria with an eligible central line where extracorporeal life support, (ECMO) and ventricular assist device (VAD) are present for more than 2 days on the BSI DOE, and is still in place on the DOE or the day before, will be considered an LCBI but not a CLABSI for NHSN reporting purposes. Starting in 2019, report such events, marking the “Central Line” risk factor field “Yes” as well field (See Table 3). as the ECMO or VAD Central Line data field should be marked “ ” regardless the presence of a CL: No See Table 3 for a Summary of CLABSI Exclusion and Reporting Requirements f or 2019. a. Patient Injection: A BSI meeting LCBI criteria that is accompanied by documentation of observed or suspected patient injection into the vascular access line, within the BSI IWP, will be considered an LCBI but not a CLABSI for NHSN reporting purposes. This exclusion is or tampering with the line (such as biting, very specific to “INJECTION”. Manipulating picking at, sucking on, etc.) DOES NOT meet the intent of this exclusion. The documentation must state specifically that the patient was “observed injecting...” or “suspected of vice. Insinuations or descriptive events that suggest such behavior DO injecting...” the de NOT meet the intent of this exclusion. If entering into NHSN, answer “No” to the risk factor 4-11 January 2019

47 Device -associated Module BSI field “Central line ” Device days should be included in summary denominator counts. A subsequent positive blood specimen collected after the BSI RIT must be investigated and meet the exclusion criteria again in a new BSI IWP in order to determine it is not central line associated. b. Also added to the pr otocol are reporting instructions for marking the “centra l line” data field “No” if during the current admission, there is either a diagnosis of Epidermolysis bullosa (EB) or documentation of known or suspected Munchausen Syndrome by Proxy (MSBP), also known as factitious disorder imposed on another. If a CL has been in place for more than 2 days on a BSI DOE, these events are considered LCBIs but are NOT considered central line associated. Optional fields for EB and MSBP are added to the BSI event form for use in 2019 and also will become required fields in 2020. Occasionally, c. a patient with both a central line and another vascular access device will have pus at the other access site. If there is pus at the site of one of the following vascular access ne matching organism to an devices and a specimen collected from that site has at least o organism identified in blood enter “No” in the risk factor field for central line on the NHSN BSI event form if reporting. Device days however, should be included in the summary denominator count. Vascular access devices included in this exception are limited to: • Arterial catheters • Arteriovenous fistulae • Arteriovenous grafts • Atrial catheters (also known as transthoracic intra -cardiac catheters, those catheters inserted directly into the right or left atrium via the heart wall) • Hemodialysis reliable outflow (HERO) dialysis catheters • Intra -aortic balloon pump (IABP) devices • Non-accessed CL (those neither inserted nor used during current admission) • Peripheral IV or Midlines d. Group B Strept identified from blood, with a date of event during the first 6 days of ococcus life, will not be reported as a CLABSI. A BSI RIT will be set but no central line association is made. If reported to NHSN, the data field “Central Line” should be marked “No”. Note: Meeting LCBI criteria in all of the situations noted above result in setting a BSI RIT and any associated device days should be included in counts for denominator summary data. 4-12 January 2019

48 Device -associated Module BSI Table 3: C LABSI Exclusions and Reporting of these events in 2019 : Exclusion Central CLABSI Exclusion Line Field Field Reporting Exclusions Marked Yes Requirement Marked or No in 2019 Yes or No Extracorporeal membrane oxygenation (ECMO) - - - ECMO present >2 days on BSI DOE and • Y Required Y in place on the DOE or the day before • NOT present > 2 days on BSI DOE, or Required N Y NOT present on DOE or day before - - Ventricular assist device (VAD) - • VAD present >2 days on BSI DOE and Y Y Required in place on the DOE or the day before NOT present > 2 days on BSI DOE, or • N Required Y NOT present on DOE or day before Epidermolysis Bullosa (EB) N Optional Y Munchausen’s syndrome by proxy (MSBP) N Y Optional -injection Optional N Y Patient self Optional N Y Pus at vascular site Group B Streptococcus BSI N Optional Y - 1st 6 days of life A CLABSI determination includes a LCBI with an eligible organism and an eligible CL present on the all of the following in place in eligible CL DOE or day before. Therefore, Table 3 implies there is an scenarios . 4-13 January 2019

49 Device -associated Module BSI g Instructions : Reportin 1. The “Any hemodialysis question” grouped with the others for consistency, is not new. Continued useto identify trends related to dialysis is optional but does not affect central line association. Do not report a BSI that has a DOE that occurs within a BSI RIT. However, add additional 2. organisms identified that are eligible for BSI events to the initial BSI event. See RIT guidance in Chapter 2 , Identifying Healthcare associated Infections or Chapter 16, Key Terms. 3. Only pri mary BSIs create a 14 -day BSI RIT : Primary BSI example : Patient has a positive blood specimen identifying S. aureus on hospital day 6, which is not secondary to another site-specific source of infection. A subsequent positive Pseudomonas aeruginosa . Because blood specimen is collected on hospital day 12 that identifies this occurs in the BSI RIT, no new BSI event is identified or reported and Pseudomonas is added to the initial BSI event. 4. Secondary BSIs do not create a 14 -day BSI RIT : Secondary BSI example: A SUTI with Enterococcus faecalis is identified and E. faecalis is also collected from a blood specimen on hospital day 11 within the SUTI secondary BSI attribution period. This BSI is secondary to the SUTI. Only a SUTI RIT is set, not a BSI RIT. On hospital day 15 (also within the SUTI RIT and secondary BSI attribution period), a blood culture which grows Staphylococcus aureus is collected . Because the blood growing S. aureus does not have at least one pathogen that matches the urine culture used to meet the SUTI criterion the BSI cannot be attributed as secondary to the SUTI. There is no BSI RIT in effect, therefore the BSI will need to be investigated as a new BSI event and either assigned as a secondary BSI to another primary site of infection or determined to be a primary BSI. Note: The secondary BSI attribution period of a primary source of infection is not a “catch all” for subsequent BSI s. There is no expectation that positive blood specimens collected during the present on admission 5. be investigated . If identified, they are not reported to NHSN. However, if a (POA) timeframe subsequent positive blood specimen is collected within 14 days of a positive blood specimen collected during the POA timeframe, it is imperative that a determination be made for the original blood specimen in order to make the correct determination about the subsequent blood specimen . Example 1: A patient has a p ositive blood specimen with E. coli that is POA 6/1 . On 6/10, a subsequent positive blood specimen with K. pneumonia is collected . The 6/1 blood specimen is investigated and if deter mined to be a primary BSI, it sets a 14 -day BSI RIT (6/1 -6/14). Therefore, the 6/10 specimen is not a new BSI event and K. pneumonia is added to the POA BSI t if reported even . 4-14 January 2019

50 Device -associated Module BSI A patient has a positive blood specimen that identifies S. aureus present on Example 2: admission 6/1. On 6/10, a subsequent positive blood specimen with K. pneumonia is collected. To make the correct determination about the second blood specimen, the init ial POA BSI event must be investigated to determine if it is primary or secondary to another site. In reviewing the chart, a right elbow culture from 5/31, also positive for S. aureus , plus the symptoms needed to meet JNT criteria 3c were documented making the 6/1 BSI secondary to JNT . The POA primary JNT infection creates a 14 -day JNT RIT (6/1 -6/14), during which no new JNT infections are reported. Because the subsequent blood specimen does not contain at least one matching pathogen to the specimen used to meet the JNT criteria, the positive blood with K. pneumonia cannot be attributed to the original JNT event and must be investigated as a primary or secondary BSI . Purulent phlebitis confirmed with a positive semi quantitative cultur e of a catheter tip, but with either a negative or no blood culture is considered a CVS-VASC, not an LCBI, SST-SKIN, or an SST -ST infection. Blood Sp ecimen Collection 1. In LCBI criteria 2 and 3, the phrase “two or more blood specimens drawn on separate occasions” means: a. blood from at least two separate blood draws was collected on the same or consecutive calendar days, and b. two separate site preparations (decontamination steps ) were performed during specimen collection. This will reduce misidentification of contaminated blood specimens as LCBIs. For example, aseptic technique indicates that separate site decontaminations would be performed for blood specimens drawn from different sites (in other words; different venipunctures, a combination of venipuncture and lumen withdrawal, or different lumens of the same central line), or at different times . Spe cimens collected in this manner would therefore be considered “separate occasions”. 2. Specimen Collection Considerations: Blo od specimens drawn through central lines can have a higher 3, 4 rate of contamination than blood specimens collected through peripheral venipuncture. However, all positive blood specimens, regardless of the site from which they are drawn or the purpose for which they are collected, must be included when conducting in- plan CLABSI surveillance (for example, weekly blood cultures performed in hematology and oncology locations). 3. Catheter tip cultures cannot be used in place of blood specimens for meeting LCBI criteria . 4. In MBI-LCBI 1, 2 and 3, “No other organisms” means there is no identification of a non- MBI -LCBI pathogen (such as S. aureus ) or 2 matching common commensals (such as coagulase- negative ) collected from the blood on separate occasions that would otherwise meet LCBI staphylococci LCBI criteria. criteria. If this occurs, the infection does not meet MBI- 4-15 January 2019

51 -associated Module Device BSI 5. When a blood specimen positive for an organism not included on the NHSN MBI organism list is -LCBI event is edited to an LCBI and collected during the BSI RIT of an MBI- LCBI , the initial MBI MBI organism is added. the identified non- 4-16 January 2019

52 Device -associated Module BSI This table Table 4 Event : Examples of Associating the Use of Central Lines to BSI s (CLABSI): provides examples that illustrate: Device association as determined by the presence of an eligible CL on the BSI DOE or the day before. • The goal o • f NHSN HAI surveillance is to identify risks to the patient that are the result of device use in general; therefore, NHSN will not require a BSI to be associated with a specific device when more than . one line is present Date Mar 1- Apr 2- Apr 3- Apr 4- Apr 5- Apr 6- Apr 31- Patient A: Port Status Port in Port in Port in Port in Port in Port in Port in Accessed Yes De - No Yes No No No Yes accessed* Eligible for - Yes Yes -eligible Yes -eligible No No No No CLABSI eligible CL CL event CL CL CL CL CL CL - - Day 2 Day 4 Day 3 Day 1 Day 5 becomes eligible for a CLABSI on 4/4 because an accessed port had been in place for some portion of > 2 consecutive Patient A calendar days making it an eligible CL on 4/4 (CL day 3). The port remains eligible for a CLABSI until it is removed or the patient is dis charged, whichever comes first. Date 1- Apr 2- Apr 3- Apr 4- Apr 5- Apr 6- Apr 31- Mar No Patient B: CL in / CL CL in CL in CL in CL in No device CL Status device out No - Accessed Yes - No Removed Yes Eligible for -eligible Yes CLABSI No No No No No Yes -eligible CL CL event CL CL CL - - - - Da y 2 Day 3 Day 1 Patient B, eligible for a CLABSI on 4/4 (CL Day 3) through 4/5. An accessed CL had been in place > 2 consecutive calendar days making it an eligible CL on 4/4 (CL day 3). A BSI DOE on the day of or the day after device removal or patient discharge is considered device- associated (CLABSI). 4-17 January 2019

53 Device -associated Module BSI Date Mar 1- Apr 31- 3- Apr 4- Apr 5- Apr 6- Apr 2- Apr No Patient C: CL in/ CL CL in CL in CL in CL in CL in/ CL out CL Status device out Yes Yes - Accessed Yes Removed Removed Placed Eligible for CLABSI Yes Yes Yes Yes Yes Yes Yes event CL CL CL CL CL CL - D Day 5 Day 4 Day 7 ay 6 Day 8 Day 3 Patient C, was admitted to an inpatient location on 3/29 with a central line in place. Patient C becomes eligible for a CLABSI on 3/31 (CL Day 3) through 4/6 because an accessed CL had been in place > 2 consecutive calendar days. A BSI DOE occurring on the day of or the day after device removal or patient discharge is considered a device- associated infection (CLABSI). The patient remains eligible for a CLABSI event through 4/6 because a full calendar day not pass without a CL in place, therefore, did device counts continue uninterrupted. Date 31- Mar 1- Apr 2- Apr 3- Apr 4- Apr 5- Apr 6- Apr Patient D: CL in/ CL CL in CL in No device CL in CL in CL in CL Status out Yes Yes Accessed Yes Yes - Removed Placed Eligible Yes - for Yes -eligible -eligible Yes Yes -eligible -eligible Yes No No eligible CLABSI CL CL CL CL CL event CL CL CL CL CL CL - Day 5 Day 4 Day 3 Day 2 Day 3 D ay 1 Patient D, was admitted to an inpatient location on 3/29 with a central line in place. Patient D becomes eligible for a CLABSI 3/31 (CL Day 3) through 4/3. An accessed CL had been in place > 2 consecutive calendar days, however, a full calendar day passed (4/3) with no CL in place , therefore, device day counts start over at CL day 1 when a new line is placed. After 4/3, the patient will not be eligible for a CLABSI event again until 4/6 when the new CL becomes an eligible CL (CL day 3). 1- Apr 6- Apr 3- Apr 4- Apr 5- Apr 2- Apr Mar 31- Date Patient E: CL in CL in CL in CL in CL in CL in No device CL Status Yes Accessed - Yes Yes Yes Yes Placed Eligible - Yes for -eligible Yes Yes -eligible No - No eligible -eligible CL Yes CLABSI CL CL CL event C CL CL CL CL L CL - Day 2 Day 6 Day 5 Day 4 Day 3 Day 1 eligible for a CLABSI on 4/3 (CL Day 3) through 4/6 because line placement is considered first access which begins Patient E, device day counts regardless of whether the line is being actively used or not and an accessed CL had been in place > 2 consecutive calendar days. = change in status BOLD The procedure for de- rt involves ensuring patency of the line prior to removal of the needle • accessing a po which involves blood withdrawal, an IV flush and injection of an anticoagulant. 4-18 January 2019

54 Device -associated Module BSI Pathogen Exclusions and Reporting Considerations: included on the “recognized pathogen” LCBI 1 criteria refers to any organism The not in 1. term that is t of common common commensal list (see NHSN Master Organism List for the complete lis NHSN reporting purposes). commensals used for NHSN Exceptions: Organisms that are parasites a. and viruses are excluded as LCBI pathogens. belonging following genera are excluded as LCBI p Organisms b. to the athogens: Campylobacter, Vibrio and Yersinia as well as C. d Salmonella, Shigella, L isteria, ifficile, Enterohemorrhagic coli, and Enteropathogenic E. coli . These organisms are eligible for use in secondary BSI E. will not be determinations but hogen in a primary BSI. reported as the sole pat belonging any NHSN definition: following genera cannot be used to meet Organisms c. to the Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus, and Pneumocystis. These organisms are excluded because they typically cause community-a ssociated infectio ns and ssociated infections. are rarely known to cause healthcare-a entry Business of the NHSN application prevent pathogen fields of a common rules written into the 2. as pathogen #1 when attempting to report both a recognized pathogen and commensal commensal LCBI 1 or enter the recognized MBI-LCBI 1. In order to save the event successfully, identified in an pathogen first as common commensal as pathogen #2. pathogen # 1 and the For LCBI criteria the common comme nsal is identified to th 3. 2 and 3, if or one level f e species blood specimen, and a companion blood specimen is identified with only a descriptive name, which is to the companion culture (in other words, to the genus complementary is assumed the level), then it the same. An organism identified to the species level should be reported along are organisms with the antibiogram, if available (see Table 5 ). Colony morphology, biotype, and antibiogram comparisons should not be used to determine the ‘sameness’ of organisms because laboratory testing tocols vary between facilities. To differences reduce reporting variabilities due to capabilities and pro practice should only be genus and species identification should be used and they in laboratory only reported once. If an tibiograms are available and the sensitivities d iffer for the same organisms in separate specimens, always report the more resistant panel (see Table 5). 4. identified in a single blood specimen i s considered a contaminant. It will not A common commensal be LCBI 2 or 3 c riteria nor will it prevent a case from m eeting MBI -LCBI criteria when used to meet (for the organism requirements call for ”only” a specific organism or type of organism example, “only intestinal organisms from the MBI list”). 4-19 January 2019

55 Device -associated Module BSI Table 5: Reporting Speciated and Unspe ciated Organisms Identified from Blood Specimens Culture Report Companion Culture Report Report as... S. aureus S. aureus taphylococci Coagulase-positive s negative staphylococci S. epidermidis Coagulase- S. epidermidis E. faecium E. faecium Enterococcus spp. spp. (not anthracis B. cereus B. cereus Bacillus ) S. salivarius Strep viridans S. salivarius When identification to the species level is not provided, the genus of the organism will be Note: reported to NHSN. When identification to the genus level is not provided, report the organism as positive bacilli). available on the NHSN all organism list (for example, Gram- Table 6: Examples Illustrating the MBI -LCBI Criteria for Neutropenia Day Day - - Day Day Day Day Day Day Day Day Day -4 -2 -6 -5 -1 -3 -7 1* 4 3 2 ND 100 WBC ND 300 400 800 Pt. 400 320 ND 600 550 A + BC* x 1 Candida spp. ND ND ND 110 ANC 410 130 120 ND 300 Pt. 320 110 +BC* x 2 B ans strep virid fever plus >38°C ND 300 400 800 100 WBC Pt. 400 ND 230 600 ND ND C x 1 + BC* spp. Candida 3 *Collection d ate of positive blood ; Highlight = ANC/WBC < 500 cells/mm ND = not done; ; red font = specimen ANC/WBC value used to meet neutropenic criteria Rationale for Table 6: : Positive blood specimen with intestinal -LCBI 1 criteria with neutropenia meets MBI Patient A organism ( spp.) and neutropenia * . In this case, the WBC values on Day 1 = 400, and Day - 1 = Candida 320 are used . Patient B meets MBI -LCBI 2 criteria with neutropenia : At least two positive blood specimens with viridans group streptococci, fever >38°C and neutropenia*. In this case, the ANC values on day -1 = 110 and Day -2 = 120 are used . 4-20 January 2019

56 Device -associated Module BSI Note: A ny two of Days -2, -1, 2, 3, and 4 could be used to meet this requirement since WBC and/or 3 were present on those days. ANC values of <500cells/mm -LCBI 1 criteri Patient C meets MBI a with neutropenia : Positive blood specimen with intestinal organism ( spp.) and neutropenia*. In this case, WBC values on Day 2 = 230 and Day 4 = 400 Candida are used . 3 *Neutropenia is d efined as : 2 separate days of ANC or WBC <500 cells/mm occurring on the collection date of the positive blood specimen ( Day 1 ) or during the 3 days before or the 3 days after Day 4-21 January 2019

57 Device -associated Module BSI Monthly Summary Data : The Primary Bloodstream Infection (BSI) Numerator D 57.108) is used to collect and ata form (CDC report each CLABSI that is identified during the month selected for surveillance. For CLABSI -LCBI that are identified as central -line associated must be included. surveillance, all LCBI and MBI Instructions for Completion of Primary Bloodstream Infection (BSI) form contains brief instructions The Primary BSI form includes patient for collection and entry of each data element on the form. The demographic information and whether a central line was present, and, if so, the type of c entral line the -specific infection rates. patient had if appropriate to the location; these data will be used to calculate line Additional data include the specific criteria met for identifying the primary BSI, whether the patient died, organisms identified from blood specimens , and the organisms’ antimicrobial susceptibilities. Reporting Instruction : During the month of surveillance, if no CLABSI events are identified , the “Report No Events” box must be checked on the appropriate denominator summary screen, (for example, Denominators for Intensive Care Unit [ ICU ]/other locations [not NICU or SCA], etc. Denomin ator Data: Device days and patient days are used for denominator reporting . Device- day denominator data that are collected differ according to the patient location . The following methods can be used for the collection of denominator data: Table 7: Examples of Denominator Day counts for Device Days This table provides examples that illustrate: • Denominator device day counts for a central line present on an inpatient location at th e time of t he device day count. 4- Apr 6- Apr 5- Apr 31- Mar 1- Apr 2- Apr 3- Apr Date Inpatient Patient A: ICU Location ICU ICU ICU ICU ICU CL in CL in CL in CL in CL in CL in CL ICU inserted Denominator Day Counts * Day 5 Day 1 Day 2 Day 3 Day 4 Day 7 Day 6 for Device Days has a CL inserted in the ICU. Because the CL was inserted in an inpatient location, Day 1 will Patient A begin the denominator day count for device days. Patient A will have 7 denominator device days for 3/31-4/6. 4-22 January 2019

58 Device -associated Module BSI 31- Mar 1- Apr 2- Apr 3- Apr 4- Apr 5- Apr 6- Apr Date Patient Patient B: ED Inpatient admitted to Inpatient CL in ICU place ICU ICU Location inpatient Location CL in at time of CL in CL in CL in location ICU CL in admission CL in Denominator Day 5 - Device Day Day 2 Day 4 Day 1 Day 3 Day 6 Count to the emergency Patient B, has a central at the time of admission. Because Patient B is admitted department on 3/31, the denominator device day count will not begin until the patient is transferred to the inpatient location on 4/1. Patient B will have 6 denominator device days for 4/1-4/6. 3- Apr Mar 1- Apr 2- Apr 31- 4- Apr 5- Apr 6- Apr Date Inpatient Patient C: ocation ICU L ICU ICU ICU ICU ICU ICU CL in CL in/ CL CL in/ CL CL in CL CL in in No device place at time out out of admission Denominator - Day 1 Day 2 Day 3 * Day 4 Device Day Day 6 * Day 5 Count central at the time of admission to ICU . Because Patient C is admitted to has a on 3/31, Patient C, ICU the denominator device day count will begin on the day of admission (3/31). Because there is no device on 4/6, the denominator device day count will end on 4/5. Patient C will have 6 denominator device days for 3/31-4/5. 6- Apr 31- Mar 1- Apr 2- Apr 3- Apr 4- Apr 5- Apr Date Inpatient Inpatient D: Patient Location ICU Location ICU ICU ICU ICU ICU CL CL in in CL CL in in ICU CL in CL No device inserted Denominator Device Day Day 6 - Day 1 * Day 2 Day 3 Day 4 Day 5 Count Patient D , does not have a central line in place at the time of admission to ICU . Because there is no central line in place on admission , the denominator device day count will not begin until the central line is placed in the inpatient location on 4/1. Patient D will have 6 denominator device days for 4/1-4/6. 4-23 January 2019

59 Device -associated Module BSI 1- Apr 31- Mar 5- Apr 2- Apr 3- Apr 4- Apr 6- Apr Date Inpatient E: Patient Location Inpatient ICU Location ICU ICU ICU ICU ICU Patient ICU Port not Port accessed Port accessed Port accessed Port accessed admitted Port not accessed with non- accessed accessed port Denominator Device Day Day 7 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Count Patient E, has a non- accessed port at the time of admission to ICU . The denominator device day count will begin on the date the patient is admitted to ICU (3/31). Accessing the port on 4/3 does not change the denominator device day count. Patient E will have 7 for 3/31-4/6. denominator device days *If the central line is in place at the time of the denominator device count, it is included in the daily denominator device day count. 4-24 January 2019

60 Device -associated Module BSI Table 8: Denominator Data Collection Methods Details Data Collection Method Denominator data (patient days and device days) should be collected at the Manual, Daily same time, every day, for each location performing surveillance to ensure that differing collection methods don’t inadvertently result in device days being > patient days. For loc ation s other than specialty care areas/oncology (SCA/ONC) and • NICUs, the number of patients with at least one central line, of any type, is collected daily, at the same time each day during the month and is recorded on the Denominators for Intensive Care Unit (ICU)/Other Locations (Not NICU or SCA/ONC) form (CDC 57.118). Only the totals for the month are entered into NHSN Note s: 1. calendar day Only one central line per patient is counted per regardless of the number of central lines present. All central lines on inpatient units should be included in device day 2. counts regardless of access. • For specialty care areas/oncology, the number of patients with at least one central line are separated into those with permanent central lines and those with temporary central lines. The number of patients with at least one central line, of either or both type(s), is collected daily, at the same time each day during the month and is recorded o n the Denominators for Specialty Care Area (SCA)/Oncology (ONC) form (CDC 57.117). Only the totals for the month are entered into NHSN. Temporary and permanent lines are reported separately in this location because permanent lines are more commonly used in this patient population and may be associated with a lower BSI rate when compared to temporary central lines. Note s: 1. Only one central line per patient is counted per calendar day regardless of the number of central lines present. 2. All central lines on inpatient units should be included in device day counts regardless of access. 3. If a patient has both a temporary and a permanent central line, only ry line because it is associated with a higher risk report the tempora of bloodstream infection. 4-25 January 2019

61 Device -associated Module BSI Details Data Collection Method Instructions for Completion of Denominators for Intensive Care The and Unit (ICU)/Other Locations (Not NICU and SCA/ONC) Instructions for Completion of Denominators for Specialty Care Areas (SCA)/Oncology (ONC ) contain brief instructions for collection and entry of e ach data element on the form. • In NICUs, t he number of patients with at least one central line is stratified by birth weight in five categories because the risk of BSI varies by birth weight. These data are reported on the Denominators for Neonatal Intensive Care Unit (NICU) form (CDC 57.116). Note: 1. Report only birth weight when entering BSI denominator data. The infant’s weight at the time of BSI identification is not used and should not be rep orted . For example, a neonate weighs 1006 grams at birth but remains in the NICU for two months and has a body weight of 1650 grams whe n a CLABSI SI form. develops; enter the birth weight of 1006 grams on the B 2. All central lines on inpatient units should be included in device day counts rega . The Instructions for Completion of rdless of access Denominators for Neonatal Intensive Care Unit (NICU) form contains brief instructions for collection and entry of each data element on the forms. Manual, sampled taff time spent collecting surveillance data, once weekly To reduce s • once/week sampling of denominator data to generate estimated central line days, (collected at the may be used as an alternative to daily collection in non -oncology ICUs same time on the . Sampling may not be used in SCA/ONC and wards (see Notes below) same designated locations or NICUs. During the month, the number of patients in the day, once per week) location (patient-days) and the number of patients with at least one central line of any type (central line days) is collected on a designated day each week ( for example, every Tuesday), and at the same time each day . Evaluations of this method have repeatedly shown that use of Saturday • or Sund ay generate the least accurate estimates of denominator data, therefore, weekend days should not be selected as the designated 4-26 January 2019

62 Device -associated Module BSI Data Collection Details Method 6-8 denominator data collection day. If the designated day is missed, collect the denominator data on the next available week day. • The following must be collected and entered into NHSN: 1. The monthly total for patient-days, collect ed daily 2. The sampled total for patient- days 3. The sampled total central line- days ata are entered, the NHSN application will calculate When these d an estimate of central line -days. Notes: 1. To ensure the accuracy of estimated denominator data obtained by sampling, only ICU and ward location types with an average of 75 or more central line -days per month are eligible to use this method. A review of each location’s central line denominator data for the past twelve months in NHSN will help determine which locations are eligible. The accura 2. cy of estimated denomi nator data generated by sampling can be heavily influenced by incorrect or missing data. Careful implementation of data collection following the guidance in this protocol is essential to avoid erroneous fluctuations in rates or SIRs. For any location, denominator data from electronic sources (in other Electronic words, central line days from electronic charting may be used only after a validation of a minimum 3 consecutive months proves the data to be within 5% (+/ -) of the manually collected once-a-day counts. he validation of electronic counts separately for each location Perform t conducting CLABSI surveillance. 4-27 January 2019

63 Device -associated Module BSI Data Analyses : SIR ) is calculated by dividing the number of observed The standardized infection ratio ( events by the number of predicted events. The number of predicted events is calculated using probabilities estimated from negative binomial models constructed from 2015 NHSN data, which represents the baseline population. The CLABSI SIR reports exclude MBI -LCBI events and MBI -LCBI events have their own SIR reports. Beginning with 2019 data, CLABSI SIR reports exclude ECMO and VAD events. For more information on using the CLABSI SIR reports , please see the troubleshooting guide: https://www.cdc.gov/nhsn/pdfs/ps- analysis -resources/clabsicauti_sirtroubleshooting.pdf . Pred Note: The SIR will be calculated only if the number of predicted events (num ) is ≥1 to help enforce a minimum precision criterion . s can be calculated for single locations, the measure also allows you to summarize your data While SIR multiple locations, adjusting for differences in the incidence of infection among the location across types. For example, you can obtain one CLABSI SIR adjusting for all locations reported. Similarly, you can obtain one CLABSI SIR for all in your facility. ICUs The SUR , or Standardized Utilization Ratio, is a risk adjusted summarized measure for device use. Similar to the SIRs, the SUR can be calculated for single locatio ns as well as be summarized across multiple locations. The CLABSI rate per 1000 central line days is calculated by dividing the number of CLABSIs by the number of central line days and multiplying the result by 1000. The Central Line Utilization Ratio is calculated by dividing the number of central line days by the number of patient days. These calculations will be performed separately for different types of ICUs, specialty care areas, oncology units, and other locations in the institution. Separate r ates and ratios will also be calculated for different types of central lines in specialty care areas/oncology locations and for birth weight categories in NICUs. Descriptive analysis output options of numerator and denominator data, such as line listings, frequency tables, and bar and pie charts are available in the NHSN application. CLABSI SIRs, rates, and run charts are also available. Guides on using NHSN analysis features are available from: analysis . -resources/reference-guides.html https://www.cdc.gov/nhsn/ps- 4-28 January 2019

64 Device -associated Module BSI Table 9: CLABSI Measures Available in NHSN Calculation Application Measure CLABSI SIR Both location The number of Observed CLABSIs (Excluding MBI- specific and LCBIs , ECMO, The number of Predicted CLABSIs summarized measure and VAD) Both location MBI -LCBI SIR The number of Observed MBI- LCBIs specific and (ACH Only) The number of Predicted MBI- LCBIs summarized measure The number of CLABSIs for a location x 1000 Location specific CLABSI Rates Line Days for that location measure only The number of C entral The number MBI-LCBIs for a location x 1000 Location specific -LCBI Rates MBI The number of Central Line Days for that location measure only Both location The number of Observed Central Line Days Central Line SUR specific and The number of Predicted Central Line Days summarized measure Location specific The Central Line Days for a location DUR measure only The Patient Days for that location 4-29 January 2019

65 -associated Module Device BSI REFERENCES 1 CDC National and State Healthcare-Associated Infections Progress Report, published -report.html https://www.c dc.gov/hai/data/portal/progress October 2018, available at 2 O’Grady, NP., Alexander, M., Burns, LA., Dellinger, EP., Garland, J., Heard, SO., Maki, DG., et al. “Guidelines for the Prevention of Intravascular Catheter- related Infections”. Clinical Infectious Diseases 52 (a): (2011): 1087-99. 3 Clini cal and Laboratory Standards Institute (CLSI). Principles and Procedures for Blood Cultures; Approved Guideline . CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007. 4 Baron, EJ., Weinstein, MP., Dunne, WM., Yagupsky, P., Welch, DF., Wilson, DM. Blood Cultures; Approved Guideline. Washington, DC: ASM Press; 2005. 5 Lee, A., Mirrett, S., Reller, LB., Weinstein, MP. “Detection of Bloodstream Infections In Adults: How Many Blood Cultures are Needed?” Journal of Clinical Microbiology , Nov; 45(11): (2007): 3546-8. 6 Klevens, RM., et al. “Sampling for Collection of Central Line Day Denominators in Surveillance for Healthcare- associated Bloodstream Infections”. Infection Control Hospital Epidemiology . 27: (2006):338-42. 7 Thompson, ND., et al.” Evaluating the Accuracy of Sampling to Estimate Central Line–Days: Simplification of NHSN Surveillance Methods” . Infection Control Hospital Epidemiology . 34(3): (2013): 221-228. 8 See, I., et al. ID Week 2012 (Abstract #1284): Evaluation of Sampling Denominator Data to Estimate Urinary Catheter - and Ventilator-Days for the NHSN. San Diego, California. October . 19, 2012 4-30 January 2019

66 Device -associated Module BSI Appendix A: Partial List of MBI- LCBI Organisms Pantoea (+E) Abiotrophia Escherichia (E) Alistipes Eubacterium Parabacteroides Peptostreptococcus Alloscardovia Ewingella (E) Pichia Faecalibacterium Anaerobiospirillum Filifactor Anaerococcus Porphyromonas Anaerorhabdus Finegoldia Prevotella Flavonifractor Proteus (E) Arcobacter Fusobacterium Atopobium Providencia (E) Gemella Pseudoflavonifractor Averyella (+E) Geotrichum Bacteroides Pseudoramibacter Granulicatella Rahnella (E) Bifidobacterium Hafnia (E) Raoultella (+E) Bilophila Helcococcus Rothia Blautia Buttiauxella (E) Helicobacter Ruminococcus Klebsiella (E) Saccharomyces Campylobacter Kluyvera (E) Sarcina Candida Capnocytophaga Kluyveromyces Serratia (E) CDC Enteric Group 58 (+E) Lactobacillus Shigella (E) Cedecea (E) Leclercia (E) Slackia Streptococcus (VGS Leminorella (E) Citrobacter (E) subset) Leptotrichia Clostridium Tannerella Collinsella Leuconostoc Tatumella (E) Cronobacter (+E) Megamonas Tetragenococcus Dialister Tissierella Megasphaera Mitsuokella Dichelobacter Trabulsiella (E) Edwardsiella (E) Moellerella (E) Veillonella Eggerthella Mogibacterium Weissella Eggerthia Yersinia (E) Morganella (E) Enterobacter (E) Obesumbacterium (+E) Yokenella (E) Enterococcus Odoribacter E = Family Enterobacteriaceae including species by selecting the MBI Organisms Note: See complete list of MBI Pathogens tab at the bottom of the NHSN Organism List 4-31 January 2019

67 Device -associated Module BSI pendix B: Secondary B SI Guide ( not applicable to Ventilator -associated Events [VAE ] Ap ) The purpose of using the CDC/NHSN infection criteria is to identify and consistently categorize infections that are healthcare -associated into major and site -specific infection types. LCBI criteria include the caveat that the organism(s) identified from the blood cannot be related to infection at another site (in other words, it must be a primary BSI). One must be sure that there is no other CDC/NHSN defined primary site -specific infection that may have seeded the bloodstream secondarily; otherwise the bloodstream infection may be misclassified as a primary BSI and erroneously associated with the use of a central line, specifically called a CLABSI. For locations performing in -plan VAE surveillance, refer to Figure B2 in this a ppendix, as well as the VAE chapter for specific guidance on assigning a secondary BSI to a VAE . When conducting BSI surveillance the PNEU definitions (as well as UTI, SSI and all definitions found in Chapter 17) are available for attributing a secondary B SI for any patient in any location. For e xample, a ventilated patient in an adult location where VAE surveillance is being conducted can have a secondary BSI assigned to VAE or PNEU. A ventilated patient in a neonatal location where in -plan PedVAP surveillance is not an option can have a secondary BSI assigned to PNEU. Secondary BSI Scenarios : , in order for a bloodstream infection to be For purposes of NHSN reporting determined secondary to another site of infection the following requirements must be met:* An NHSN site -specific definition must be met ; either one of the CDC/NHSN Surveillance Definitions for Specific Types of Infections (defined in Chapter 17), or UTI, PNEU or SSI definition s. AND One of the following scenarios must be met: Scenario 1: At least one organism from the blood specimen matches an organism identified from the site -specific specimen that is used as an element to meet the NHSN site -specific infection criterion AND the blood specimen is collected during the secondary BSI attribution period (infection window period + † repeat infection timeframe) . OR Scenario 2: An organism identified in the blood specimen is an element that is used to meet the NHSN site nfection criterion, and therefore is collected during t he site -specific infection window -specific i period. Exception Notes: 1. *The necrotizing enterocolitis (NEC ) definition does not include criteria for a matching site -specific specimen nor an organism identified from a blood specimen that can be used as an element to meet the NEC criteria, however an * exception for assigning a BSI secondary to NEC is provided. secondary to NEC if the patient meets one of the two NEC criteria AND an 2. A BSI is considered organism identified from a blood specimen, collected during the secondary BSI attribution identified from two or more blood period, is an LCBI pathogen, or the same common commensal specimens drawn on separate occasions that are on the same or consecutive days. 4-32 January 2019

68 Device -associated Module BSI † The ENDO criteria have different rules for infection window period, RIT, pathogen assignment 2. and secondary BSI attribution period. ( See ENDO criteria in C h. 17). Below are examples with guidance on how to distinguish between the primary or secondary nature • he definition of “matching organisms”, important notes and reporting instructions are of a BSI. T Figure B1 : Secondary BSI Guide for algorithmic display of the following also provided. See instructions. : An organis m identified from the site -specific infection is used as an element to meet the Scenario 1 site -specific infection criterion, AND the blood specimen contains at least one matching organism to that site-specific specimen. The positive blood specimen must be collected during the site- specific infection’s secondary BSI attribution period. (For your convenience, a list of infection criteria that include a blood specimen with at least one matching pathogen to the site -specific specimen that was used as an element to meet the definition are included in Table B1 ). a. Example: Patient meets NHSN criteria for a symptomatic urinary tract infection (suprapubic 5 CFU/ml of ) and blood specimen collected during the SUTI E. coli tenderness and >10 E. coli . This is a SUTI with a secondary BSI secondary BSI attribution period is positive for and the reported organism is E. coli . b. Example: Patient meets NHSN criteria for a symptomatic urinary tract infection (suprapubic 5 collected ) and blood specimen during the SUTI CFU/ml of E. coli tenderness and >10 secondary BSI attribution period E. coli and P. aeruginosa . This is a SUTI with a grows E. coli and P. aeruginosa , since both site and secondary BSI and the reported organisms are blood specimens are positive for at least one matching pathogen . c. Patient meets NHSN criteria for a symptomatic urinary tract infection (suprapubic Example: 5 during the collected E. coli ) and a single blood specimen CFU/ml of tenderness and >10 . This is a SUTI with a E. coli SUTI secondary BSI attribution period S. epidermidis and E. coli , since the single common secondary BSI and the reported organism is only commensal S. epidermidis positive blood specimen by itself does not meet BSI criteria. Scenario 2: - An organism identified from a blood specimen is an element used to meet the site specific infection criterion, and is collected during the site -specific infection window period. (For your convenience, a list of infection criteria that include positive blood c ulture as an element are included in Table B1 ). a. Example: Patient becomes febrile and complains of nausea and abdominal pain. CT scan done that day shows fluid collection suggestive of infection. Blood specimen collected that iterion Because the patient meets IAB cr day results in identification of Bacteroides fragilis. 3b, using the identification of an organisms from the blood specimen as an element (fever, nausea or abdominal pain, positive blood specimen and CT scan showing infection in abdominal cavity), the BSI is considered secondary to IAB. 4-33 January 2019

69 Device -associated Module BSI b. Example: Patient is febrile, has a new onset of cough and has positive chest imaging test Pseudomonas indicating the presence of an infiltrate. Blood specimens collected identify Because the patient can meet PNU2 definition using the identification of aeruginosa. orga nisms from a blood specimen as one of the elements of the infection criterion (specifically , infiltrate on chest imaging test, fever, new onset of cough and organism identified from blood specimen ), the BSI is considered secondary to PNEU. Note: In sit an NHSN infection definition can be met using more than one uations where criterion of the infection definition, it is possible that identification of an organism from the blood and site- specific specimens may not match and a BSI may still be considered a secondary BSI. Consider the following: a. Example: During the SSI surveillance period, a postoperative patient becomes febrile and complains of nausea and abdominal pain. CT scan done that day shows fluid collection T-tube drainage suggestive of infection. Culture results show Escherichia coli from the Bacteroides fragilis. Although the organisms in the specimen and the blood specimen grows blood culture and site-specific culture do not match for at least one organism, the blood organ/space SSI culture is considered secondary to IAB. This is because the patient meets IAB criteri on 3b, using the identification of organism in a blood specimen as an element (fever, nausea or abdominal pain, organism identified from a blood specimen and CT scan showing infection in abdominal cavity). This patient also meets IAB criterion 3a using the positive site culture plus fever, and nausea or abdominal pain even though the organism involved is different from that used for IAB criterion 3b. In this case, the BSI is conside red secondary to the organ/space SSI IAB and both organisms would be listed as IAB infection pathogens. b. Example: Patient is febrile, has a new onset of cough and has positive chest imaging test indicating the presence of an infiltrate. Blood and bronchoalveolar lavage (BAL) specimens 4 CFU /ml from the BAL and are collected. R Klebsiella pneumoniae > 10 esults identify Pseudomonas aeruginosa from the blood. Although the organisms in the blood specimen and site- specific specimen do not match for at least one organism, because the patient can meet PNU2 definition using either the identification of organism from blood specimen or BAL specimen as one of the elements of the infection criterion (i.e. infiltrate on chest or imaging test, fever, new onset of cough and organism identified from blood specimen identified from BAL specimen ), the blood is considered a secondary BSI to PNEU and both organisms would be listed as PNEU pathogens. 4-34 January 2019

70 Device -associated Module BSI Note: If no matching organism is identified from the blood and the site -specific specimen, which is used to meet the site -specific infection definition , and the organism identified from the blood specimen cannot be used to meet the site a, secondary BSI -specific infection criteri attribution cannot be assigned. The BSI would be primary in nature. a. Example: Patient has pustules on their abdomen with tenderness and swelling. Purulent material is obtained from the pustules and is positive for Streptococccus Group B. A blood specimen collected the same day identifies methicillin r esistant Staphylococcus aureus. Because the organisms from the site and blood specimens do not match, and there is no site- specific criterion for SKIN that includes organisms identified from blood specimen , both a site -specific infection , SKIN (criteri a 1 and 2a) and a primary BSI would be reported. b. Example: A patient has an abscess in the soft tissue around a percutaneous endoscopic gastrostomy (PEG) tube, identified by CT scan, and there is also purulent drainage from that site. No site -specific specimen was collected, but a blood specimen is positive for Staphylococcus aureus. No other sites of infection are identified. Because no culture of the site was collected, and the patient therefore cannot meet ST criterion 1, and because there is no ST criterion which uses identification of organism from blood specimen as an element, this patient has a ST infection with unknown pathogen (criterion 2), and a primary BSI with for NHSN reporting purposes . Staphylococcus aureus the pathogen 4-35 January 2019

71 Device-associated Module BSI Table B1: Secondary BSI Guide: List of all NHSN primary site-specific definitions available for making secondary BSI determinations using Scenario 1 or Scenario 2 Scenario 1 Scenario 2 Positive blood specimen must be an A positive blood specimen must contain at least one element of the eligible matching organism to the site-specific site-specific definition specimen specimen is collected in the site- blood specimen is collected in the site-specific And the blood And secondary BSI attribution period specific infection window period identified in a blood identified from the site- And an eligible organism And an eligible organism specific specimen specimen is used as an element to meet the site- is used as an element to meet the site-specific definition specific definition Criterion Site Criterion Site 3a BONE ABUTI ABUTI 1 BURN 1 BONE 3a DISC BRST 1 4a, 4b, 5a or 5b 1 CARD (specific 2 or 3 CIRC organisms) ENDO 1 CONJ 6e or 7e plus other 1 DECU criteria as listed 1 DISC 1b or 2c GIT 1, 3, 5 or 7, EAR 2b or 3b IAB 1 EMET JNT 3c 1 ENDO 2c or 3c MEN 1 EYE 3a OREP 2a GE 2 or 3 EU PN 2a, 2b (only yeast) GIT SA 3a 3a 1 or IAB UMB 1b 1 IC USI 3b or 4b JNT 1 LUNG 1 MED 1 MEN 1 ORAL 1 or 3a OREP 1 PJI 1 PNEU 2 or 3 SA 1 SINU 1 SSI SI, DI or OS SKIN 2a ST 1 1a UMB UR 1a or 3a USI 1 SUTI 1a , 1b or 2 VASC only as SSI 1 VCUF 3 4-36 January 2019

72 Device -associated Module BSI : Secondary BSI Reporting Instructions • For reporting secondary BSI for possible VAP (PVAP), see Figure B 2 and Chapter 10. Do not report secondary bloodstream infection for vascular (VASC) infections, Ventilator- • ted Conditions (VAC), or Infection- related Ventilator -Associated Complications Associa (IVAC), pneumonia 1 (PNEU 1). • When a BSI is suspected to be secondary to a lowe r, respi ratory tract infection the BSI can be determined to be secondary to VAE or PNEU definitions. (See Figure B2 ). • -specific organism exclusions apply to secondary BSI attribution as well. Site A matching or ganism is defined as one of the following: 1. If genus and species are identified in both specimens, they must be the same. a. Example: An intraabdominal specimen is used as an element to meet IAB definition and is growing A blood specimen with a collection date in the IAB Enterobacter cloacae. secondary BSI attribution period is reported to be growing Enterobacter cloacae. These are considered matching organisms. b. Example: An intraabdominal specimen is used as an element to meet IAB definition and is growing Enterobacter aerogenes. A blood specimen with a collection date in the IAB secondary BSI attribution period is reported to be growing These are Enterobacter cloacae. NOT considered matching organisms as the species are different. 2. If one org anism is less definitively identified than the other , the lesser identified organism must be identified at least to the genus level and at that level the organisms must be the same. Example: A surgical wound growing Pseudomonas species is used to meet deep incisional a. Pseudomonas aeruginosa is collected in the SSI SSI criteria and a blood specimen growing secondary BSI attribution period. The organisms are considered matching at the genus level and therefore the BSI is secondary to the SSI. PCR identifying Example: Enterococcus faecalis b. in CSF meets the MEN definition. A subsequent blood culture collected in the MEN secondary BSI attribution period is identified Enterococcus species. The organisms are considered to be matching and therefore the BSI as is secondary to MEN. 3. There are two e xceptions to the definition: a. Infections meeting LCBI 2 criteria with Staphylococcus or Streptococcus Example ( Staphylococcus ): A patient has a fever and a previous chest tube site is reddened, swollen and a culture is collected from the soft tissue. A culture of the chest species. SST/ST definition is met. The next day, tube site is positive for Staphylococcus two blood culture sets are collected. Both are positive for coagulase negative . The organisms are NOT considered matching, because Staphylococcus Staphylococcus 4-37 January 2019

73 Device -associated Module BSI Staphylococcus. species could represent a coagulase negative or a coagulase positive Therefore, the BSI would not be considered secondary to SST/ST. Streptococcus): A patient has a fever and a previous chest tube is red and Example ( swollen and a culture is collected from the soft tissue. The chest tube site culture is rep orted positive for Streptococcus species. SST/ST definition is met. The next day 2 blood culture sets are collected. The blood cultures are both positive for , Streptococcus viridans group. The organisms are NOT considered matching, because Streptococcus species could represent a Streptococcus , viridans group or non- Streptococcus , viridans group. Therefore, the BSI would not be considered secondary to SST/ST. b. In cases where an organism is identified only as “yeast” or “yeast not otherwise specified”, the organism can be considered a match to other yeasts, when collected during the required timeframe, whether more fully identified or not. Example: A culture of tissue from the ulcer margin of a decubiti reported positive for yeast is used as an element to meet the DECU definition. A blood specimen collected in Candida albicans the secondary BSI attribution period of the DECU is reported as . In this example the two organisms are considered matching organisms as the organisms are ry (i.e., Candida is a type of yeast) and because yeasts isolated from non- complementa sterile sites are commonly not identified to the genus or genus and species level. Note: This exception is limited to yeast. It does not apply to identification of organisms as Gram positive cocci, Gram negative rods, etc. Example : A c ulture of tissue from ulcer margin of a decubiti reported positive for Gram negative rod is used as an element to meet DECU definition. A blood specimen collected in the secondary BSI attribution period of the DECU is reported as E.coli . In this example the two organisms are NOT considered matching organisms. Notes : 1. Antibiograms of the blood and potential primary site isolates do not have to match. 2. If the blood specimen by itself does not meet BSI criteria (for example, only one blood specimen positive for a common commensal), that specimen may not be used to meet secondary BSI criteria (see S cenario 1c ). 4-38 January 2019

74 Device -associated Module BSI Pathogen Assignment • Additional pathogens identified from sec ondary BSIs, should be added to the pathogens reported for the primary infection type. The Secondary BSI data collection field should be checked yes. • BSI pathogen may be assigned to two different primary site s of infection (for example, A secondary UTI and an IAB infection). In example 1 below, two primary site s of infection have been identified and a blood culture is collected within both the SUTI and the IAB secondary BSI attribution period. The blood culture pathogen matches the pathogens for both primary site s of infection (SUTI and IAB). Therefore, the pathogen is reported for both primary sites of infection as a secondary bloodstream infection. If at least o ne BSI pathogen with a collection date in the secondary BSI attribution period matches • an organism from a specimen that was used to meet a site- specific infection criterion (either a site - specific specimen or a blood specimen) the BSI is considered secondary to the event. However, if no matching pathogen is identified , the subsequent BSI pathogen must be evaluated and deemed primary or secondary to another site- specific infection . For example: A patient with a primary UTI with E. coli and a secondary BSI with E. coli has a subsequent positive blood specimen with yeast. Yeast is an excluded pathogen for meeting UTI criteria; therefore, the subsequent blood must be evaluated as primary or secondary to another site- specific infection. 4-39 January 2019

75 -associated Module Device BSI Example 1: Pathogen Assignmen t UTI UTI UTI Hospital IAB Infection IAB Infection IAB SBAP RIT RIT Window Period SBAP Window Period (HD) Day 1 Infection Window Period 2 (First positive diagnostic test, 3 days before and 3 days after) 3 Urine culture 1 : 4 >100,000 cfu/ml K. pneumonia e Repeat Infection Timeframe 5 Fever > 38.0 C 2 (RIT) (DOE = day 1) 3 6 7 4 8 5 Fever >38.0 C, Abdominal pain Secondary BSI Attribution 6 9 CT Scan : Period (SBAP) (Infection Window Period + RIT) Abdominal abscess Blood culture: 7 10 Blood culture: DOE) Date of Event ( e K. pneumonia e K. pneumonia Date the first element occurs for the first 8 11 within the infection window period time 12 9 13 10 11 14 15 12 13 16 17 14 18 19 20 21 22 23 IAB & SUTI & Secondary BSI Secondary BSI DOE = HD 4 DOE = HD 8 Pathogen: K. K. Pathogen: pneumonia e pneumonia e Pathogens excluded from speci yeast in UTI, or Enterococcus spp. fic infection definitions (for example, EU) are also excluded as pathogens for BSIs secondary t for PN they c annot be o that type of infection ( added on to one of these infections as a pathogen). In example 2 below, the excluded organism must be accounted for as either 1) a primary bloodstream infection (BSI/CLABSI) or, 2) a secondary . A blood culture bloodstream infection attributed to another primary infection (for example, IAB, SINU) with yeast and is collected during the SUTI RIT. A BSI secondary to SUTI is identified. E. E. faecalis faecalis is already documented as a pathogen, but the yeast will not be reported as a secondary BSI pathogen, because yeasts are excluded as organisms in the UTI definition. Because no other primary source of infection for which the yeast BSI can be assigned as secondary is found, a primary BSI with yeast is identified. is not reported as a pathogen for the primary BSI because if an Note: The Enterococcus faecalis excluded organism had not been identified, a primary BSI would not have been reported. 4-40 January 2019

76 -associated Module Device BSI Example 2: Pathogen Assignment (continued) BSI Hospital Infection BSI UTI Infection UTI UTI (HD) SBAP Window Period Day Window Period RIT RIT Infection Window Period 3 days (First positive diagnostic test, 1 before and 3 days after) 2 3 Dysuria 1 Repeat Infection Timeframe : Urine culture 4 2 (RIT) > 100,000 cfu/ml (date of event = day 1) E. faecalis 5 3 6 4 Attribution Secondary BSI 7 5 Period (SBAP) (Infection Window Period + RIT) 8 6 9 7 10 8 Date of Event ( DOE) 11 Blood culture: Date the first element occurs for the first Blood culture: 1 9 time within the infection window period Yeast E. faecalis / Yeast E.faecalis / 12 10 2 13 3 11 14 12 4 15 13 5 16 14 6 17 7 18 8 19 9 20 10 21 11 22 12 23 13 24 14 25 Primary BSI UTI & Secondary BSI 11 = HD DOE Pathogen: Yeast DOE = HD 3 Pathogen: E. faecalis January 2019 4-41

77 Device -associated Module BSI Example 3: Pathogen Assignment (continued) IAB Infection tion Window IAB Infec IAB Hospital IAB Period Day (HD) Window Period SBAP RIT Admit Abdominal pain & 1 Infection Window Period distention 3 days itive diagnostic test, (First pos 2 PICC before and 3 days after) placed 3 4 US guided drainage -5L Repeat Infection Timeframe purulent peritoneal fluid: (RIT) (date of event = day 1) Klebsiella pneumoniae E.coli and 5 Secondary BSI Attribution 6 (SBAP) Period 7 (Infection Window Period + RIT) 8 9 Date of Event ( DOE) Abdominal pain 10 Date the first element occurs for the first CTS multiple liver 11 time within the infection window period abscesses Blood culture: C. glabrata, L. casei 12 13 jaundice, fever 14 15 IAB 1 DOE = HD 4 IAB 3b & Secondary Pathogen DOE = HD 4 BSI s: K. pneumoniae, E. coli Pathogen s: C. glabrata, L casei for BSI, UTI and pneumonia) type (or specific type infection of a one is reported during an major Only m ajor (or type for B SI, UTI the same specific type RIT f or t hat t ype of event. H owever, a new event of and pneumonia) can be elements occur within a new IWP and the if all required an RIT identified during DOE is within th is met on hospital day-4 using e RIT of the initial event. In example 3, IAB criteria 1 pur ), IAB day 17 day 4-hospital (hospital RIT fluid. During the IAB ulent s identified from organism hos and of an abscess imaging pital day 10) using two symptoms, positive evidence t (on 3a is me criteria itive a pos pos itive blood specimen occurs within the IAB secondary BSI blood specimen. The have attribution period, therefore, it to IAB. The pathogens, in this is considered secondary case, do not tal day 8- ully me hospi w IAB IWP ( t within a ne to match because ) is f 3b definition (IAB another . Because DOE the l day 14) hospita w ne 1, a initial IAB the of RIT occurs within the tal (hospi day 10) and device association are not changed but any additional event is not reported. The DOE, RIT if reported. tial IAB event ini added to the ) are ei L cas and C. glabrata identified ( organisms 4-42 January 2019

78 Device -associated Module BSI Example 4: Pathogen Assignment (continued) GIT Infection GIT RIT Hospital Infection GIT GIT SBAP Day (HD) Window Period Window Period Admit 1 Fever & vomiting Infection Window Period PICC 2 iagnostic test, 3 days (First positive d placed before and 3 days after) 3 CT bowel abscess 4 Repeat Infection Timeframe 5 (RIT) 6 Blood culture: (date of event = day 1) Enterococcus faecalis X2 7 Secondary BSI Attribution 8 Period (SBAP) 9 (Infection Window Period + RIT) 10 11 Blood culture: Date of Event ( DOE) Candida glabrata Date the first element occurs for the first 12 within the infection window period time 13 Abscess drainage: Candida glabrat a and Abdominal pain nausea 14 15 -2a GIT -2c DOE & GIT & Secondary DOE = HD 1 Secondary BSI BSI DOE= HD 1 Pathogen: Pathogen: C. glabrata E. faecalis ) is r eported during an c t ype ( or m aj or t yp e f or BSI, UT I and pneumonia nfection of Onl a s pecifi y one i ype for B he s ame specific type (or m ajor t wever, a new event of t SI, UTI o hat t or t RIT f ype of event. H g an RI T i f all required elements oc cur w ithin a new IWP an d the an be and pneumonia ) c identified durin riterion . In example 4, G tial event IT of the ini ithin the R DOE is w IT c 2c i s me t on hospi ta l da y-1 using he G g t ood specimen. Durin iti ve bl pos nd a s a n absces f a e o videnc g e magin ve i two symptoms, positi IT (on hospita l da y 11) using t w o s ymptoms hospi RI T ( ta l da y 1 -hospita y 14) , GIT criteria 2a i s m et l da he GIT s econdar iti ve bl he pos ulture. T s c ithin t bsces iti ve a pos and a y BSI s w ood specimen occur m the abscess culture. Therefore, it is the organism identified fr o attribution period and matches GIT infection considered secondary to the have to match because . do not s pathogen he In this case, t IT 2a) is fully met within a new GIT IWP definition (G another 14). Because day 8-hospital day (hospital is not reported. ccurs within the RIT of the initial GIT 2c, a new event The the DOE (hospital day 11) o C. glabrata ) i s DOE, R IT and dev ice association are not ch ange d but a ny additiona l or ganis m identified ( ded to the ini tial G IT e vent i f repor ted. ad ite-s ny s Note: This scenario is a pplicable to a major pecifi c i nfec tion definition fr om C hapte r 17 or umonia. I o e i ncluding BSI, UT infection typ r pne 4-43 January 2019

79 Device -associated Module BSI Figure B1 : S econdary BSI Guide for eligible organisms*‡ (Not applicable to Ventilator- associated Events [VAE], See Figure B2 ) * Exception: The n criteria for a matching definition does not include ecrotizing enterocolitis (NEC) site -specific specimen nor an organism identified from a blood specimen , however an exception for assigning a BSI secondary to NEC is provided. A BSI is considered secondary to NEC if the patient meets one of the two NEC criteria AND an organism identified from a blood specimen, collected during the secondary BSI attribution period, is an LCBI pathogen or the same common commensal specimens drawn on separate occasions but on the same or is identified from 2 or more blood consecutive days. 44 4- January 2019

80 Device -associated Module BSI Figure B2 : VAE Guidance for Secondary BSI Determination Positive blood specimen. Lower respiratory tract infection suspected as source. VA C , I VA C P VA P or No VAE BSI secondary to Determine if BSI is BSI NOT P VA P p e r VA E secondary to another secondary to PVAP surveillance site -specific infection protocol * Refer to Figure B1 Determine if BSI is secondary to another site -specific infection Refer to Figure B1 Secondary BSIs may be reported for possible VAP (PVAP) events, provided that at least one organism * identified matches an organism identified from an appropriate respiratory tract from the blood specimen specimen (including respiratory secretions, pleural fluid and lung tissue). The respiratory tract specimen must have been collected on or after the 3rd day of mechanical ventilation and within 2 calendar days r after the day of onset of worsening oxygenation to be considered as a criterion for meeting the before o PVAP definitions. In addition, the blood specimen must have been collected during the 14- day event period, where day 1 is the day of onset of worsening oxygenation. culture • In cases where PVAP is met with only the histopathology criterion and no culture or non- , and there is also a positive blood on an eligible respiratory specimen is performed ased test b specimen, a secondary BSI to VAE is not reported. -culture based test of respiratory secretions, pleural fluid or lung In c ases wher e a culture or non • tissue is performed and does not identify an organism that matches an organism identified from blood, a secondary BSI to VAE is not reported. : species, and coagulase-negative Staphylococcus Candida species or yeast not otherwise specified, Note species identified from blood cannot be deemed secondary to a PVAP, unless the Enterococcus pleural fluid or lung tissue. from organism was also identified 45 4- January 2019

81 Device -associated Module CLIP Central Line Insertion Practices (CLIP) Adherence Monitoring : Central line -associated bloodstream infections (CLABSIs) may be prevented Introduction 1-4 through proper placement and management of the central line. The CDC’s Healthcare Infection Control Practices Advisory Committee (CDC/HICPAC) Guidelines for the 1 Prevention of Intravascular Catheter-Related Infections , 2011 recommend evidence -based central line insertion practices known to reduce the risk of subsequent central line- associated bloodstream infection. These include hand hygiene by inserters, use of maximal sterile barriers during insertion, proper use of a skin antiseptic prior to insertion, and time to allow the skin antiseptic to dry before catheter insertion . based central line Several centers have found it useful to monitor adherence to evidence- insertion practices as a method for identifying quality improvement opportunities and strategically targeting interventions. Feedback of adherence data has been a component of multifaceted interventions that have successfully reduced CLABSI rates. Participation enables participating facilities and CDC to: in NHSN CLIP surveillance • Monitor central line insertion practices in individual patient care units and facilities and provide aggregate adherence data for all participating facilities ; f acilities have the option of recording i -specific adherence data nserter • gaps in adherence to Facilitate quality improvement by identifying specific recommended prevention practices, thereby helping to target intervention strategies for reducing CLABSI rates Participating facilities may perform surveillance for insertion practices during the following: • a month when concurrent CLABSI surveillance is being conducted • a month when no CLABSI surveillance is being conducted If participating facilities wish to identify associations between insertion practices and outcomes ( specifically , CLABSI), surveillance for insertion practices and CLABSI must be done concurrently. : Surveillance may occur in any type of patient care location where central lines are Settings inserted. Numerator and Denominator Data : The Central Line Insertion Practices Adherence Monitoring Form (CDC 57.125) is used to collect and report central line insertion practices for every central line insertion attempt occurring during the month in the unit(s) selected for surveillance. If an insertion attempt is unsuccessful, report a new CLIP event only if a new site preparation was performed. The Table of Instructions for Completion of the Central Line Insertion Practices Adherence Monitoring Form contains directions for collection and entry of each data element on the form. The form can be completed at or near the time of , a nurse or an observer present at the insertion (for example insertion , either by the inserter 5 -1 January 2019

82 Device -associated Module CLIP ), or the form can be completed from documentation in assisting with the catheter insertion only if all elements of the monitoring form have been incorporated into the patient chart ( ntral -line insertion procedure notes). The form includes information pertaining to standard ce demographics of the patient, informa tion pertaining to the inserter, information on maximal sterile barriers used, the reason for central line insertion, whether the inserti on was successful , skin antisepsis, hand hygiene practice before insertion, type of central line including whether it was antimicrobial coated, insertion site and , if placed because of suspected existing central line infection, the use of a guide wire . Ele ments of some of t hese data will be used to calculate adherence to recommended insertion practices. Data Analyses : Adherence rates for specific insertion practices will be calculated by dividing the number of bundle- compliant central line insertions (numerator ) by the total number of central line insertions (denominator) and multiplying the result by 100. Such calculations can also be done for a bundle of practices that have been shown to reduce the incidence of CLABSI (specifically, NHSN CLIP Bundle ). In NHSN for CLIP insertions dated January 1 , adherence to the bundle requires a “Yes” to all of the , 2016 and forward following: • Hand hygiene performed • Appropriate skin prep* ne gluconate (CHG) 60 days old unless there is a o Chlorhexidi for patients ≥ documented contraindication to CHG o Povidone iodine, alcohol, C HG, or other specified for children <60 days old • Skin prep agent has completely dried before insertion All 5 maximal sterile barriers used • o Sterile gloves Sterile gown o o Cap o Mask worn o Large sterile drape (a large sterile drape covers the patient’s entire body) Note: Th ese calculation s are performed separately for different types of locations in the institution. Participants have the option of calculating ins erter -specific adherence rates . and Drug Administration (FDA) has labeled CHG to be used with care in *The Food premature infants and infants < 2 months of age. 5 -2 January 2019

83 -associated Module Device CLIP REFERENCES 1 O’Grady , NP., Alexander, M., Burns, LA., Dellinger, EP., Garland, J., Heard, SO., Maki, DG., et al. “Guidelines for the Prevention of Intravascular Catheter -related Infections”. Clinical Infectious Diseases 52 (a): (2011): 1087-99 . 2 The Impact of central line insertion Hang HJ, Lin HL, Lin YH, Leung PO, Chuang YC, Lai. -associated bloodstream infection. BMC Infectious. bundle on central line 2014;14:356. 3 Feb; Infusion Nurses Society. Infusion Therapy Standard of Practice. J Inf Nurs.2016 Jan- 39 number 1S. 4 Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter -related bloodstream infections in the ICU. New England Journal of Medicine. 2006;355:2725-2732. 5 -3 January 2019

84 Device -associated Module PNEU (Ventilator VAP] and non-ventilator -associated Pneumonia -a ssociated [ [PNEU] ) Event Pneumonia Introduction: associated pneumonias In 2011, an estimated 157,000 healthcare- in acute care hos occurred pitals in U.S.; 39% of these pneumonias were ventilator- 1 associated (VAP). Patients receiving invasive mechanical ventilation are at risk for numerous complications, including pneumonia. V entilator -associated pneumonia (VAP) and other healthcare- - associated pneumonias are important, common healthcare associated infections , but national surveillance for VAP has long been a challenge because of the lack of objective, reliable definitions. Due to these challenges , in January 2013 the National Healthcare Safety Network (NHSN) replaced surveillance for ventilator -associated pneumonia (VAP) in adult inpatient locations with surveillance for 2 -associated events . ventilator (VAE) Based on discussions with an expert working group in 2012-2013, NHSN also discontinued in-plan VAP surveillance in neonatal locations. As of January 2014, in- plan VAP surveillance is only available in pediatric inpatient locations. Settings : Su rveillance may occur in any inpatient pediatric location where denominator such as critical/intensive care units ( areas ICUs), specialty care ped data can be collected, (SCA), step In-plan surveillance for -down units, wards, and long term care units. -associated pneumonia ( pedVAP ) using the criteria found in this chapter is ventilator patients of any age in pediatric locations (excludes neonatal locations) restricted to . In- plan surveillance conducted for mechanically- ventilated patients in adult locations (regardless of age) will use the Ventilator -Associated Event (VAE ) protocol (see VAE chapter) . The PNEU definitions are still available for those units seeking to conduct off- plan PNEU surveillance for mechanically -ventilated adult, pediatric and neonatal patients . The PNEU definitions are also and non- ventilated adults , pediatric or neonatal patients available for secondary bloodstream infection assignment when performing Central - Line Associated Bloodstream Infection (CLABSI) ventilated surveillance in ventilated or non- patients in any location . A complete listing of inpatient locations and instructions for mapping can be found in the CDC Locations and Descriptions chapter. : Note If you are following pedVAP in your monthly reporting plan it is not required to monitor for VAPs after the patient is discharged from the facility owever, if . H discovered, a ny VAPs with event date on the day of discharge or day after discharge should be reported to NHSN (s ee Transfer Rule below). No additional ventilator days are reported. Definitions : , are not Infections that are POA, as def ined in Chapter 2 Present on Admission (POA): considered HAIs and therefore are never reported to NHSN. 6-1 January 2019

85 -associated Module Device PNEU Healthcare- associated infections (HAI): All NHSN site -specific infections m ust first meet the HAI definition as defined in Chapter 2 before a site -specific infection can be reported to NHSN. Guidance for Determination of Eligible Imaging Test Evidence • If only one imaging test is available it is acceptable for this to satisfy the imaging regardless of whether the requirement for PNEU /VAP -POA determinations patient has underlying pulmonary or cardiac disease. • When multiple imaging test results are available, persistence of imaging test evidence of pneumonia is a requirement for all patients not just those with underlying cardiac or pulmonary disease. • When identifying persistence of imaging test evidence of pneumonia, the second imaging test must occur within seven days of the first but is not required to occur within the Infection Window Period. The date of the first eligible imaging test will be utilized when determining if the PNEU/VAP criteria are met within the infection window period. All other elements of PNEU/VAP definition must be present within the infection window period. Pneumonia (PNEU) is identified by using a combination of imaging , clinical and laboratory criteria. The following pages detail the various criteria that may be used for meeting the surveillance definition of healthcare- associated pneumonia (Tables 1- 4 and Figures 1 and 2 ), general comments applicable to all site -specific criteria, and reporting instructions. Table 5 shows threshold values for cultured specimens used in the surveillance diagnosis of pneumonia. : For a PNEU/ VAP the date of event is the date when the first element used Date of e vent to meet the PNEU infection criteri on occurred for the first time within the 7 -day Infection Window Period. Ventilator : any device used to support, assist or control respiration (inclusive of the weaning period) through the application of positive pressure to the airway when del ivered via an artificial airway, specifically an oral/nasal endotracheal or tracheostomy tube. Note: Ventilation and lung expansion devices that deliver positive pressure to the airway or PEEP) via non-invasive means (f (for example: CPAP, Bipap, bi- level, IPPB and example: nasal prongs, nasal mask, full face mask, total mask, etc.) are not considered oral/nasal ventilators unless positive pressure is delivered via an artificial airway ( endotracheal or tracheostomy tube). 6-2 January 2019

86 Device -associated Module PNEU -associated pneumonia ( VAP) : A pneumonia where the patient is on Ventilator mechanical ventilation for >2 calendar days on the date of event , with day of ventilator placement being Day 1, * AND the ventilator was in place on the date of event or the day before. *If the ventilator was in place prior to inpatient admission, the ventilator day count begins with the admission date to the first inpatient location. pplicable to All Pneumonia Specific Site C General Comments A : riteria Physician’s diagnosis of pneumonia alone is not an acceptable criterion for POA 1. healthcare- associated ) pneumonia. (present on admission) or HAI ( Although specific criteria are included for infants and children and 2. immunocompromised patients, all patients may meet any of the other pneumonia site -specific criteria. 3. Pneumonia due to gross aspiration (for example, in the setting of intubation in the field , emergency department , or operating room) that meets the PNEU/VAP - definition with a date of event during the HAI timeframe is considered healthcare associated (HAI). 4. -associated pne umonia may occur in critically ill Multiple episodes of healthcare patients with lengthy hospital stays. When determining whether to report multiple associated pneumonia in a single patient, follow the Repeat episodes of healthcare- Infection Timeframe (RIT) guidance found in Chapter 2 . 5. Excluded organisms that cannot be used to meet the PNEU/VAP definition are as follows: “Normal respiratory flora,” “normal oral flora,” “mixed respiratory flora,” a. “mixed oral flora,” “altered oral flora” or other similar results indicating isolation of commensal flora of the oral cavity or upper respiratory tract b. The following organisms unless identified from lung tissue or pleural fluid (where specimen was obtained during thoracentesis or initial placement of chest tube and NOT from an indwelling chest tube): i. Any Candida species as well as a report of “ yeast ” that is not otherwise specified ii. Any coagulase-negative Staphylococcus species iii. Any Enterococcus species 6. If the excluded pathogens, Candida species *or yeast not otherwise specified, coagulase -negative Staphylococcus species, and Enterococcus species are only be attributed as a secondary BSI to PNEU if can identified from blood they 6-3 January 2019

87 Device -associated Module PNEU tching organisms identified from a pleural fluid PNU2 or PNU3 is met with a ma (where specimen was obtained during thoracentesis or initial placement of chest tube and NOT from an indwelling chest tube) or lung tissue and the blood specimen collection date is within the Secondary BSI Attribution Period (SBAP) *The exception to this is Candida species or yeast not otherwise specified identified from blood can be attributed as a secondary BSI to PNEU if PNU3 is met usin g the blood and a sputum, endotracheal aspirate, BAL or protected specimen brushing with matching Candida species and both specimens have a collection date in the Infection Window Period. 7. Additionally, because organisms belonging to the following genera a re typically causes of community-associated infections and are rarely or are not known to be causes of healthcare-associated infections, they are also excluded, and cannot be NHSN used to meet any definition: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis . : 8. Abbreviations used in the PNEU laboratory criteria –bronchoalveolar lavage BAL –enzyme immunoassay EIA –immunofluorescent antibody IFA LRT –lower respiratory tract –polymorphonuclear leukocyte PMN RIA –radioimmunoassay Reporting I nstructions : If the There is a hierarchy of specific categories within the major site pneumonia. • patient meets criteria for more than one specific site during the infection window period or the RIT, report only one: o If a patient meets criteria for both PNU1 and PNU2, report PNU2. o If a patient meets criteria for both PNU2 and PNU3, report PNU3. o If a patient meets criteria for both PNU1 and PNU3, report PNU3. • Pathogens and secondary bloodstream infections can only be reported for PNU2 and PNU3 specific events. at least one matching organism(s) as Report concurrent LUNG and PNEU with • PNEU. 6-4 January 2019

88 -associated Module Device PNEU Table 1: Specific Site Algorithms for Clinically Defined Pneumonia (PNU1) Imaging Test Signs/Symptoms/Laboratory Evidence For ANY PATIENT, at least one of the following: Two or more serial chest results with test imaging one of the at least • F) .0°C or >100.4° Fever (>38 1, 2,14 3 3 : following ) or leukocytosis ( >12,000 WBC/mm ) Leukopenia ( ≤ 4000 WBC/mm • • For adults > 70 years old, altered mental status with no other recognized cause persistent and New or And at least two of the following: and Progressive 4 3 persistent or change in character of sputum , or increased • New onset of purulent sputum respiratory secretions, or increased suctioning requirements 5 Infiltrate • • New onset or worsening cough, or dyspnea, or tachypnea 6 or bronchial breath sounds Rales • • Consolidation for example • desaturations ( O : PaO /FiO for example: Worsening gas exchange ( 2 2 2 7 , increased oxygen requirements, or increased ventilator demand) <240) • Cavitation 1 year old: ALTERNATE CRITERIA, for infants < • Pneumatoceles, in year old infants ≤1 pulse oximetry for example desaturations [ Worsening gas exchange ( for example: 2 <94%], increased oxygen requirements, or increased ventilator demand) : Note In patients And at least three of the following: underlying without pulmonary or cardiac Temperature instability • for example : disease ( 3 3 ) and left shift >15,000 WBC/mm ) or leukocytosis ( • Leukopenia ( ≤ 4000 WBC/mm respiratory distress (> 10% band forms) syndrome, 3 4 New onset of purulent sputum or change in character of sputum • , or increased bronchopulmonary respiratory secretions or increased suctioning requirements dysplasia, pulmonary 5 , nasal flaring with retr action of chest wall or nasal flaring with • Apnea, tachypnea edema, or chronic grunting obstructive pulmonary 6 , or rhonchi • Wheezing, rales disease), one definitive Cough • imaging test result is 1 Bradycardia (<100 beats/min) or tachycardia (>170 beats/min) • acceptable. of the three ALTERNATE CRITERIA, for child >1 year old or ≤12 years old, at least following: °F) or hypothermia (<36. 0. 4 C or >10 °F) 6. 8 C or <9 0° 0° Fever (>38. • 3 3 ) ) or leukocytosis (≥15,000 WBC/mm ≤ • Leukopenia ( 4000 WBC/mm 3 4 or change in character of sputum , or increased New onset of purulent sputum • respiratory secretions, or increased suctioning requirements 5 . • New onset or worsening cough, or dyspnea, apnea, or tachypnea 6 • or bronchial breath sounds Rales desaturations [ O pulse • for example Worsening gas exchange ( for example: 2 oximetry <94%], increased oxygen requirements, or increased ventilator demand) 6-5 January 2019

89 Device -associated Module PNEU Table 2: Specific Site Algorithms for Pneumonia with Common Bacterial or Filamentous Fungal Pathogens and Specific Laboratory Findings (PNU2) Laboratory Imaging Test Signs/Symptoms Evidence of the following: one At least At least Two or more serial chest of the following: one imaging test results with at 8,13 of the one least blood ) • Organism identified from Fever (>38 .0°C or >100.4°F • 1, 2,14 : following 3 • 4000 WBC/mm ≤ Leukopenia ( ) • Organism identified from pleural or leukocytosis ( >12,000 9,13 and persistent New fluid 3 ) WBC/mm or persistent and Progressive • or Positive quantitative culture For adults > • 70 years old, altered -quantitative culture corresponding semi mental status with no other 9 Infiltrate • from minimally -contaminated t resul recognized cause , BAL specifically, LRT specimen ( Consolidation • or protected specimen brushing And at least one of the following: endotracheal aspirate) • Cavitation 3 or • New onset of purulent sputum • ≥5% BAL -obtained cells contain 4 change in character of sputum , or intracellular bacteria on direct Pneumatoceles, in • increased respiratory secretions, microscopic exam (for example: infants ≤1 year old or increased suctioning Gram ’s stain) requirements • or Positive quantitative culture -quantitative culture corresponding semi New onset or worsening cough, or • without Note : In patients 9 5 of lung tissue result dyspnea or tachypnea underlying pulmonary or for cardiac disease ( 6 or bronchial breath sounds • Rales example : respiratory • Histopathologic exam shows at least distress syndrome, one of the following evidences of • Worsening gas exchange ( for bronchopulmonary pneumonia: desaturations [ for O example: 2 dysplasia, pulmonary 7 , < 240] /FiO PaO example: 2 2 edema, or chronic o Abscess formation or foci of increased oxygen requirements, or obstructive pulmonary consolidation with intense PMN increased ventilator demand) definitive one disease), accumulation in bronchioles and test result is chest imaging alveoli 1 acceptable. Evidence of lung parenchyma o invasion by fungal hyphae or pseudohyphae 6-6 January 2019

90 Device -associated Module PNEU Table 3: Specific Site Algorithms for Viral, Legionella, and other Bacterial Pneumonias with Definitive Labora tory Findings (PNU2) Signs/Symptoms Imaging Test Laboratory Evidence At least one of the following: Two or more serial chest At least one of the following: imaging test results with of the at least one Virus .0°C or >100.4°F) • , , Legionella • Bordetella, Fever (>38 1, 2,14 following : identified or Mycoplasma Chlamydia 3 • 4000 WBC/mm ≤ Leukopenia ( ) from respiratory secretions or tissue or leukocytosis ( >12,000 and persistent New by a culture or non- culture based 3 WBC/mm ) or microbiologic testing method which Progressive and persistent is performed for purposes of clinical For adults > 70 years old, altered • diagnosis or treatment ( for example: mental status with no other • Infiltrate veillance not Active Sur recognized cause Culture/Testing (ASC/AST). • Consolidation one at least And of the following: Fourfold rise in paired sera (IgG) for • influenza for example: pathogen ( • Cavitation 3 or • New onset of purulent sputum viruses, Chlamydia ) 4 , or change in character of sputum • Pneumatoceles, in increased respiratory secretions, or • egionella L Fourfold rise in infants ≤1 year old increased suctioning requirements ophila pneum 1 antibody titer serogroup to ≥1:128 in paired acute and Note: In patients without • New onset or worsening cough or convalescent sera by indirect IFA. underlying pulmonary or 5 dyspnea, or tachypnea for cardiac disease ( example: respiratory L. pneumophila • Detection of serogroup 6 or bronchial breath sounds • Rales distress syndrome, 1 antigens in urine by RIA or EIA bronchopulmonary • Worsening gas exchange ( for dysplasia, pulmonary desaturations [ for example: O 2 edema, or chronic 7 < 240] /FiO , PaO example: 2 2 obstructive pulmonary increased oxygen requirements, or definitive disease), one increased ventilator demand) chest imaging test result 1 is acceptable. 6-7 January 2019

91 Device -associated Module PNEU Table 4: Specific Site Algorithm for Pneumonia in Immunocompromised Patients (PNU3) Laboratory Signs/Symptoms Imaging Test Evidence of the following: one At least Two or more serial chest Patient who is imaging test results with (see immunocompromised 10 ) has at of the one at least definition in footnote • Candida spp. Identification of matching 1, 2,14 least of the following: following one : from blood and one of the following: sputum , endotracheal aspirate, BAL or 11 ,12,13 and persistent New • Fever (>38.0°C or >100.4°F protected specimen brushing . or a nd Progressive • 70 years old, altered For adults > • Evidence of fungi from minimally- persistent mental status with no other specifically contaminated LRT specimen ( recognized cause or , protected specimen brushing BAL Infiltrate • endotracheal aspirate) from one of the 3 following: • New onset of purulent sputum , • Consolidation or change in character of 4 , or increased respiratory sputum − Direct microscopic exam secretions, or increased • Cavitation − Positive culture of fungi suctioning requirements agnostic laboratory test − Non -culture di Pneumatoceles, in • • New onset or worsening cough, infants ≤1 year old OR 5 or dyspnea, or tachypnea In patients Note: : Any of the following from 6 underlying without or bronchial breath sounds Rales • pulmonary or cardiac LABORATORY CRITERIA DEFINED disease ( for example: • Worsening gas exchange ( for UNDER PNU2 respiratory distress for desaturations [ O example: 2 7 syndrome, , < 240] /FiO example: PaO 2 2 bronchopulmonary increased oxygen requirements, dysplasia, pulmonary or increased ventilator demand) edema, or chronic obstructive pulmonary Hemoptysis • disease), one definitive chest imaging test result • Pleuritic chest pain 1 is acceptable. 6-8 January 2019

92 -associated Module Device PNEU Figure 1: Pneumonia Flow Diagram for Patients of Any Ag e Facility ID#_______________Event #______________________ Event Date __/__/____ 1,2, 14 1,2, 14 Patient with without underlying diseases un derlyin g dise ases Patien t w i th on e w i th 1 or mo re im aging te st re sults ha s 2 or mo re im aging te st re sults ha s of th e fo llowing : : on e of th e fo llowing OR & persisten t New OR & persisten t New & persisten t Progressive & persisten t Progressive Infiltrate   Infiltrate Con solida tio n   Con solida tio n  Cavitation  Cavitation IMAGIN G 1 y.o , in Pn eumatoc eles Pn eumatoc eles   1 y.o. ≤ , in ≤ A t l ea st of th e fo llowing on e : A t l ea st of the following in an on e  Fe ver (> 38 .4 °F) /10 0 .0 °C : 10 3 imm un oco mprom ise d patient ,00 0 ) or l eu koc yt o si s ( ≥ 12 WBC Le uko pe nia  ( /mm ≤ 4, 00 0 3 WBC /mm ) /10 0 .0 °C .4 °F) (> 38 Fe ver  Alte re d me ntal sta tus with no o ther cau se 70 y.o. in ≥ ,  Alte re d me ntal sta tus with no  70 in ≥ oth er c ause , y.o. 3 , or  New on se t o f purulen t sputum on e : of th e fo llowing A t l ea st change in character of sputum , or of th e fo llowing t wo A t l ea st :  New on se t o f purulen t , or ↑ respirato ry se cretion s  New on se t o f purulen t 3 , or ch ange in s pu t um 4 3 suc tio ning re qu ire me nts ↑ , or ch ange in s pu t um , or ch aracte r of sputu m , or New on se t o r worsenin g co ugh  ch aracte r of sputu m , or ↑ respirato ry ↑ 5 dyspnea , or tach ypn ea , or respirato ry se cretion s secretio ns , or 6 ↑ suc tio ning or bro nch ial brea th Rales  ↑ suc tio ning 4 requireme nts sou nds 4 requireme nts  New on se t o r worsenin g (e.g. , Worsen ing gas excha nge   New on se t o r worsenin g 7 , or co ugh , or dyspnea desats [e.g. ] < 24 0 , /FiO , PaO O 2 2 2 , or , or dyspnea co ugh & SYMPTOMS 5 tach ypn ea ↑ ) ven tilatio n de man d ↑ , or req O 2 5 tach ypn ea 6  Rales or bro nch ial brea th Hem op t y si s  6 or bro nch ial  Rales sou nds  Pleu ritic ch est pain bre ath sou nds Worsen ing gas excha nge   Worsen ing gas , [e.g. desats , O (e.g. 2 exch ange (e.g. , O 2 SIGNS 7 PaO O < 24 0 ] , /FiO ↑ Immunocompromised 2 2 2 /FiO [e.g. , PaO desats 2 2 req , or ↑ ventilation 7 , O ↑ req , or ] < 24 0 2 d ema nd ) ↑ ven tilatio n de man d on e : A t l ea st of th e fo llowing : A t l ea st on e of th e fo llowing A t l ea st on e of th e fo llowing : Organ ism iden tif ied f rom  8, 13  Iden tif ica tio n of match ing blood , , Le gio ne lla Bordetella ,  Virus s pp .f ro m blo od and Can di d a  Organ ism iden tif ied f rom Chlamydia or Mycoplasma 13 : s pu t um on e of th e fo llowing , pleural fluid identif ie d f ro m respiratory en do tra che al aspirate , BAL or  Positive quantitative culture or b y a secretio ns o r tissu e pro tected spec imen brush in g co rrespon din g semi - -cu ltu re ba se d culture or non ,12 ,13 11 9 f ro m quan tita tive result microbiologic testing method  Evide nc e of f un gi fro m minimally- co ntam inate d LRT which is pe rf orm ed f or min imally con tamin ated LRT , pro tected specimen (e.g. , B AL purposes of clinical diagnosis : B AL (specifically specimen , , or spe cime n bru sh ing (e.g. , no t Active or treatment pro tected spec imen brush in g ) en do tra che al aspirate /Testing Su rveillan ce Cultu re or en do trac he al a spirate )  B AL 5% -obtain ed c ells ≥ ). (ASC /AST on e : of th e fo llowing f ro m co ntain in trac ellula r bacteria ) (IgG 4- f old rise in pa ired sera  • Dire ct microsco pic on direct mic ro sc opic exam , In flu enza f or path ogen (e.g. exam Positive quantitative culture or  viruses ) , Chlamydia Positive culture of fungi • - co rrespon din g semi . pneumophila  4- fold rise in L 9 Non • -cu ltu re diagn ostic of lung quan tita tive result LABORATORY in 1: 12 8 antibody titer to ≥ laborato ry te st parenc hyma paired a cute an d c onva le scen t Histopatho logic exa m sho ws at  sera by indire ct IFA on e l ea st : of th e fo llowing  Detec tio n of Legion ella • Absce ss f ormatio n or pneumophila serogroup 1 f oci of con solida tio n with antigens in urine by RIA or EIA inten se PMN ac cum ula tio n in bronchioles and alveoli • Evide nc e of lu ng parenc hyma in vasion by f ungal hypha e or pse udoh yph ae Immunocompromised 3 PNU PNU 1 PNU 2 January 2019 6-9

93 Device -associated Module PNEU Figure 2: Pneumonia Flow Diagram, Alternative Criteria for Infants and Children Facility ID#_______________Event #______________________ Event Date __/__/____ 14 1,2, 1,2, 14 ha s 1 or mo re without underlying diseases Patien t Patient with ha s 2 or un derlyin g dise ases imaging test results w i th on e of th e fo llowing : on e w i th mo re imaging te st results : of th e fo llowing & persisten t New New & persisten t OR OR Progressive & persisten t & persisten t Progressive  Infiltrate Infiltrate  Con solida tio n   Con solida tio n IMAGIN G  Cavitation Cavitation  1 y.o. ≤  Pn eumatoc eles , in  1 y.o ≤ , in Pn eumatoc eles f or I nf ants A LT ER NAT E CRI TE RI A A LT ER NAT E CRI TE RI A for Children <1 year old years old 12 or ≤ > 1 T HRE E A t l ea st : of th e fo llowing  Worsen ing gas excha nge (e.g. , O 2 [e.g. , pulse ox imetry desaturation s . 0°C or (> 38 Fe ver  >10 0 . 4°F) or , inc re ased o xygen <94 %] <96 . 0°C or (< 36 hypoth ermia . 8°F) requireme nts , or increa sed ven tila to r 3 d ema nd ) ) or ( Le uko pe nia ≤ /mm WBC 40 00  3 WBC ) l eu koc yt o si s (> 15 ,00 0 /mm 3 of th e fo llowing : AND T HRE E  New on se t o f purulen t sputum , or 4 , or change in character of sputum & SYMPTOMS Temperature instability  , or increased respiratory secretions 3 4 ) or /mm  WBC ≤ ( Le uko pe nia 40 00 inc re ased su ction in g requirements 3 /mm WBC ,00 0 (> 15 l eu koc yt o si s ) an d  New on se t o r worsenin g co ugh , or 5 band forms left shift (> 10 % ) , or tach ypn ea dyspnea 3 6  New on se t o f purulen t sputum or Rales  or bronchial breath sounds SIGNS 4 , or change in character of sputum (e.g.  , O Worsen ing gas excha nge 2 7 inc re asd respirato ry secretion s o r desats [e.g. , PaO ] , O < 24 0 ↑ /FiO 2 2 2 . inc re ased su ction in g requirements ↑ ven tilatio n de man d ) req , or 5 , nasal flaring with  A pn ea , tach ypn ea retra ction o f ch est wall or grun tin g 6 or rhonchi Whe ez ing , rales   Cou gh  B ra dy ca rd i a (< 10 0 beats /min ) or /min tach ycardia (> 17 0 beats ) 1 PNU January 2019 6-10

94 -associated Module Device PNEU Footnotes to Algorithms and Flow Diagrams: 1. To help confirm difficult cases ,multiple imaging test results spanning over several calendar days must be considered when determining if there is imaging test evidence of pneumonia.. Pneumonia may have rapid onset and progression, but does not resolve quickly. Imaging test evidence of pneumonia will persist. Rapid imaging resolution suggests that the patient does not have pneumonia, infectious process such as atelectasis or congestive h but rather a non- eart failure. In non- ventilated patients, the diagnosis of healthcare-associated pneumonia may be quite • igns, s clear on the basis of s ymptoms and a single definitive chest imaging test result . Therefore, in a patient without underlying pulmonary or cardiac disease and when there is only one imaging test available, if it is an eligible finding, the imaging test evidence requirement can be met. st is available serial • In patients without underlying disease if more than one imaging te imaging test results must also be evaluated and demonstrate persistence. In patients with underlying disease, serial chest imaging test results must be examined to help • n patients with pulmonary or separate infectious from non- infectious pulmonary processes. I cardiac disease (for example: interstitial lung disease or congestive heart failure), the diagnosis of pneumonia may be particularly difficult. For e xample: P ulmonary edema from decompensated congestive heart failure may simulate the presentati on of pneumonia. Note that there are many ways of describing the imaging appearance of pneumonia. Examples 2. -space disease”, “focal opacification”, “patchy areas of increased include, but are not limited to, “air density”. Although perhaps not specifically delineated as pneumonia by the radiologist, in the appropriate clinical setting these alternative descriptive wordings should be seriously considered as potentially positive findings. If provided and the finding s are not documented as attributed to anothe r edema, chronic lung disease) they are eligible for meeting imaging test issue (for example pulmonary evidence of pneumonia. 3. Purulent sputum is defined as secretions from the lungs, bronchi, or trachea that contain >25 neutrophils and <10 squamous epithelial cells per low power field (x100). Refer to the table below if -quantitatively or uses a different format for reporting Gram your laboratory reports these data semi stain or direct examination results (for example: “many WBCs” or “few squamous epithelial cells”). This laboratory confirmation is required since written clinical descriptions of purulence are highly variable. 6-11 January 2019

95 Device -associated Module PNEU Instruction How do I use the purulent respiratory secretions criterion if ... Assume that counts of cells identified by these other My laboratory reports counts of “white blood descriptors (for example “white blood cells”) are cells” or “polymorphonuclear leukocytes” or equivalent to counts of neutrophils, unless the “leukocytes” rather than counts of laboratory tells you this is not the case. “neutrophils”? Check with the laboratory to get information about -quantitative My laboratory reports semi results (not quantitative results) for numbers what quantitative ranges the semi- quantitative reports correspond to. of neutrophils and squamous epithelial cells? Use the following direct examin ation results to meet My laboratory cannot provide additional the purulent respiratory secretions criterion: heavy, 4+, information on how its semi-quantitative or ≥25 neutrophils per low power field (lpf) [x100], reporting corresponds to quantitative AND rare, occasional, few, 1+ or 2+, or ≤10 squamous reporting ranges for neutrophils and epithelial cells per lpf [x100] [19]. squamous epithelial cells? the numbers of My laboratory reports only In this situation, the purulent secretions criterion may be met using the specified quantitative and semi - neutrophils present, without reporting the quantitative thresholds for neutrophils alone number of squamous epithelial cells? (specifi cally heavy, 4+, or ≥25 neutrophils per lpf [x100]). In this situation, the purulent secretions criterion may My laboratory uses different reporting be met using the laboratory’s specified maximum thresholds for neutrophils and squamous quantitative threshold for neutrophils, and/or minimum epithelial cells (for example: maximum ial cells. quantitative threshold for squamous epithel report of ≥ 20 neutrophils per low power field [x100], or minimum report of ≤ 15 sq uamous epithelial cells per low power field [x100])? In this situation, a report indicating the presence of My laboratory processes respiratory white blood cells, without quantitation, is sufficient to specimens such as bronchoalveolar lavage meet the purulent secretions criterion. fluid using a centrifugation procedure (for example, “cytospin”), and there is no quantitation or semi-quantitation of neutrophils or white blood cells in the direct examination report? 4. Change in character of sputum refers to the color, consistency, odor and quantity. In adults, tachypnea is defined as respiration rate >25 breaths per minute. Tachypnea is defined as 5. th >75 breaths per minute in premature infants born at <37 weeks gestation and until the 40 week; >60 breaths per minute in patients <2 months old; >50 breaths per minute in patients 2-12 months old; and >30 breaths per minute in children >1 year old. 6. Rales may be described as “crackles”. ) to the 7. This measure of arterial oxygenation is defined as the ratio of the arterial tension (PaO 2 of oxygen (FiO inspiratory fraction ). 2 Staphylococcus 8. Coagulase- negative species or yeast not species, Enterococcus species and Candida otherwise specified that are identified from blood cannot be deemed secondary to a PNEU, unless the organism was also identified pleural fluid (where specimen was obtained during thoracentesis or from initial placement of chest tube and NOT from an indwelling chest tube) or lung tissue. Identification January 2019 6-12

96 Device -associated Module PNEU Candida of matching spp. from blood and sputum, endotracheal aspirate, BAL or protected specimen brushing can be used to satisfy PNU3 definition for immunocompromised patients. 9. Refer to threshold values for cultured specimens with growth of eligible pathogens. ( Table 5 ). s: Note A specimen that is not obtained through an artificial airway ( specifically endotracheal tube or • tracheostomy is not considered minimally contaminated and is not ) from a ventilated patient eligible for use in meeting the laboratory criteria for PNU2. Sputum or tracheal secretions collected from a non- ventilated patient are not minimally -contaminated specimen s. • Because they are an indication of commensal flora of the oral cavity or upper respiratory ntified tract, the following organisms can only be used to meet PNEU definitions when ide from pleural fluid obtained during thoracentesis or initial placement of chest tube (not from an indwelling chest tube) or lung tissue: o negative Staphylococcus species Coagulase- o Enterococcus species o Candida species or yeast not otherwise specified. Exception: identification of matching Candida spp. from blood and sputum, endotracheal aspirate, BAL or protected specimen brushing can be used to satisfy PNU3 definition for immunocompromised patients. 10. only Immunocompromised patients include • absolute neutrophil count or total white blood cell count those with neutropenia defined as 3 (WBC) <500/mm those with leukemia, lymphoma or who are HIV positive with CD4 count <200 • those who have undergone splenectomy • • those who have a history of solid organ or hematopoietic stem cell transplant • those on cytotoxic chemotherapy • those on steroids (excluding inhaled steroids ) daily for >2 weeks on the date of event and sputum, endotracheal aspirate, BAL or protected specimen brushing specimens 11. Blood specimen must have a collection date that occurs within the Infection Window Period. -quantitative or non-quantitative cultures of sputum obtained by deep cough, Semi 12. induction, aspiration, or lavage are acceptable. 13. Identification of organism by a culture or non- culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example: not Active Surveillance Culture/Testing (ASC/AST). is 14. If the imaging test result equivocal fo r pneumonia, check to see if subsequent imaging test infiltrate vs. s are definitive. For example, if a chest imaging test result states atelectasis and a subsequent imaging test result is definitive for infiltrate —the initial imaging test would be eligi ble for use. In the absence of finding a subsequent imaging finding, if there is the equivocal clinical correlation then the equivocal result that clarifies eligible for use. test is imaging 6-13 January 2019

97 -associated Module Device PNEU Table 5: Threshold values for cultured specimens used in the diagnosis of pneumonia * Specimen collection/technique Values 4 >10 Lung tissue † CFU /g tissue Bronchoscopically (B) obtained specimens 4 -BAL) >10 Bronchoalveolar lavage (B CFU /ml 4 Protected BAL (B >10 CFU /ml -PBAL) 3 PSB) >10 Protected specimen brushing (B- CFU /ml Nonbronchoscopically (NB) obtained (blind) specimens 4 CFU /ml NB -BAL ≥ 10 3 NB >10 CFU /ml -PSB 5 ≥ 10 CFU /ml Endotracheal aspirate (ETA) CFU = colony forming units g = gram ml = milliliter * Consult with your laboratory to determine if reported semi- quantitative results match the quantitative thresholds. In the absence of additional information available from your laboratory, a semi -quantitative result of “moderate” or “heavy” growth, or 2+, 3+ or 4+ growth is considered to correspond. †Open -lung biopsy specimens and immediate post-mortem specimens obtained by transthoracic or transbronchial biopsy : The Pneumonia (PNEU) form (CDC 57.111) is used to collect and Numerator Data report each VAP that is identified during the month selected for surveillance. The tions for Completion of Pneumonia (PNEU) form contains brief instructions for Instruc collection and entry of each data element on the form. The pneumonia form includes patient demographic information and information on whether or not mechanically- assisted ventilation was present. Additional data include the specific criteria met for identifying pneumonia, whether the patient developed a secondary bloodstream infection, from culture or non- culture based whether the patient died, the organisms identified microbiolog ic testing method s, and the organisms’ antimicrobial susceptibilities. Reporting Instruction: If no VAPs are identified during the month of surveillance, the box must be checked on the appropriate denominator summary “ Report No Events” screen, for example: Denominators for Intensive Care Unit (ICU)/Other Locations (Not /ONC NICU or SCA ), etc. 6-14 January 2019

98 -associated Module Device PNEU Denominator D ata : Device days and patient days are used for denominators (see Key ). Ventilator days, which are the number of patients managed with a chapter Terms , are collected daily, at the same time each day, according to the chosen ventilatory device location using the appropriate form ( CDC 57.116, 57.117, and 57.118). These daily only the total for the month counts are summed and is entered into NHSN. Ventilator days and patient days are collected for each of the locations where VAP is monitored. When denominator data are available from electronic sources (for example: ventilator therapy), these sources may be used as long as the counts are not from respiratory days substantially different (+/- 5%) from manually-collected counts, validated for a m inimum months. of three d by dividing the Data Analyses: The VAP rate per 1000 ventilator days is calculate number of VAPs by the number of ventilator days and multiplying the result by 1000. The Ventilator Utilization Ratio is calculated by dividing the number of ventilator days days. These calculations will be performed separately for the by the number of patient SCA s, and other locations in the institution. different types of ICUs, Descriptive analysis options of numerator and denominator data are available in the NHSN application, such as line listings, frequency tables, and bar and pie charts. VAP rates and run charts are also available. Guides on using NHSN analysis features are Analysis available from: www.cdc.gov/nhsn/PS- -resources/reference-guides.ht ml. 6-15 January 2019

99 Device -associated Module PNEU References: 1 - Multistate Point- et al. “ Prevalence Survey of Health Care Magill SS ., Edwards , JR ., Bamberg , W., 370: ( : 1198-1 Associated Infections, 2011” . N ew England J ournal of Medicine. 208. 2014) 2 Magill SS, Klompas M, Balk R, et al. Developing a new, national approach to surveillance for ventilator - -75. associated events. Critical Care Medicine 2013;41:2467 6-16 January 2019

100 Device- associated Module UTI Urinary Tract Infection (Catheter- Associated Urinary Tract Infection ssociated Urinary Tract Infection [UTI]) and [CAUTI ] and Non-C atheter -A Other Urinary System Infection [USI ]) Event s the fourth most common type of Introduction: Urinary tract infection s (UTIs) are healthcare -associated infection, with an estimated 93,300 UTIs in acute care hospitals in 2011. UTIs additionally account for more than 12% of infections reported by acute c are 1 hospitals . Virtually all healthcare -associated UTIs are caused by instrumentation of the urinary tract. Approximately 12%-16% of adult hospital inpatients will have an indwelling urinary catheter (IUC) at some time during their hospitalization, and each day the indwelling urinary catheter -7% increased risk of acquiring a catheter -associated urinary tract remains, a patient has a 3% 2-3 infection (CAUTI). CAUTI can lead to such complications as prostatitis, epididymitis, and orchitis in males, and -negative bacteremia, endocarditis, vertebral osteomyelitis, cystitis, pyelonephri tis, gram in patients. Complications associated with septic arthritis, endophthalmitis, and meningitis CAUTI cause discomfort to the patient, prolonged hospital stay, and increased cost and 4 . It has been estimated that each year, more than 13,000 deaths are associated with mortality 5 UTIs. Prevention of CAUTI is discussed in the CDC/HICPAC document, Guideline for Prevention 6 associated Urinary Tract Infection . of Catheter- Settings : Surveillance may occur in any inpatient location(s) where denominator data can be collected, such as critical intensive care units (ICU), specialty care areas (SCA), step - down locations units, wards, inpatient rehabilitation locations, and long term acute care . Neonatal . A may participate, but only off plan (not as a part of their monthly reporting plan) ICUs and instructions for mapping are located in the CDC complete listing of inpatient locations Locations and Descriptions chapter. Note : after the patient is discharged from the facility is not Surveillance for CAUTI required. However, if discovered, any CAUTI with a date of event (DOE) on the day of discharge or the next day is attributable to the discharging location and should be included in ). No any CAUTIs reported to NHSN for that location (see Transfer Rule Chapter 2 days are reported. additional indwelling urinary catheter January 2019 7-1

101 associated Module Device- UTI Identifying Healthcare Associated Refer to the NHSN Patient Safety Manual, Chapter 2 and Chapter 16 NHSN Key Terms for definitions of the following Infections in NHSN universal concepts for conducting HAI surveillance. I. Date of event (DOE) II. Healthcare associated infection (HAI) III. Infection window period (IWP) Present on admission (POA) IV. V. Repeat infection timeframe (RIT) VI. Secondary BSI attribution period (SBAP) Location of Attribution (LOA) VII. Transfer rule VIII. Definitions : Urinary tract infections (UTI) are defined using S ymptomatic Urinary T ract I nfection (SUTI) , Asymptomatic Bacteremic UTI (ABUTI), and Urinary System Infection (USI) criteria criteria. (See Table 1 and 2 and Figure 2). Note cannot be considered secondary to another site of : UTI is a primary site of infection and infection. catheter : A drainage tube that is inserted into the urinary bladder through Indwelling urinary the urethra , is left in place, and is connected to a drainage bag (including leg bags). These devices are also called Foley catheter s. Condom or straight in -and-out catheters are not included nor are nephrostomy tubes, ileoconduits, or suprapubic catheters unless a Fo ley catheter is also present . Indwelling urethral catheters that are used for intermittent or continuous irrigation are included in CAUTI surveillance . : A UTI where a n indwelling urinary catheter was in place Catheter -associated UTI (CAUTI) for > ar days on the date of event , with day of device placement being Day 1*, 2 calend AND an indwelling urinary catheter was in place on the date of event or the day before. If an indwelling urinary catheter was in place for more than 2 consecutive days in an inpatient device location and then removed, the date of event for the UTI must be the day of discontinuation or the next day for the UTI to be catheter -associated . *If the IUC was in place prior to inpatient admission, the catheter day count that determine s allow s device –association begins with the admission date to the first inpatient location . This for consistency with device denominator count (see Table 3 Denominator Data Collection ) Methods January 2019 7-2

102 associated Module Device- UTI ssociating Catheter Use to UTI: Example of A n IUC inserted and the following day is the date of event A patient in an inpatient unit has a more than 2 consecutive days in an for a UTI. Because the IUC has not been in place for inpatient location on the date of event, this is not a CAUTI. However, depending on the date and sets an RIT . Please refer to SUTI of admission, this may be a healthcare- associated UTI . CAUTI 1b: Non- Notes : SUTI 1b and USI cannot be catheter- associated. • 0 • SUTI 1b cannot be met in a patient > 65 years of age with fever >38 C as the only element within the Infection Window Period . Indwelling urinary catheters that are removed and reinserted: If, after an IUC removal, the patient is without an IUC for at least 1 full calendar day (NOT to be read as 24 hours), then the IUC day count will start anew. If instead, a new IUC is inserted before a full calendar day has passed, device day count, to determine eligibility for a the indwelling urinary catheter CAUTI , will continue uninterrupted. Figure 1: Associating Catheter Use to UTI April 6 April 5 March 31 April 4 April 3 April 2 April 1 - (Hospital day 3) IUC IUC IUC IUC IUC IUC Patient A No IUC removed replaced removed Day 7 Day 3 Day 4 8 Day (Foley (Foley Day 5) Day 6) No IUC IUC IUC IUC IUC IUC IUC Patient B replaced removed Day 3 Day 4 Day 3 Day 2 ( IUC Day (IUC 1) Day 5) NHSN surveillance for infection is not aimed at a specific device. Instead Rationale: surveillance is aimed at identifying risk to the patient that is the result of device use in general. Notes: • A is eligible for a CAUTI beginning o n March 31, In the examples above, Patient th , since an IUC was in place for some portion of each calendar day through April 6 th th . A UTI with date of event on April 6 would be a CAUTI since the until April 6 IUC had been in place greater than 2 days and was removed the day before the date of event. 7-3 January 2019

103 Device- associated Module UTI B is eligible for a CAUTI on March 31 ( Patient Day 3) through April 3. The • IUC IUC had been in place > 2 days an d an HAI occurring on the day of device discontinuation or the following calendar day is considered a device- associated infection . If the patient did not have a CAUTI by April 3, the patient is not eligible for a CAUTI • until April 6, when the second IUC had been in place for greater than 2 days. January 2019 7-4

104 Device- associated Module UTI Table 1. Urinary Tract Infection Criteria Criterion Urinary Tract Infection (UTI) Symptomatic UTI (SUTI) Must meet at least of the following criteria: one SUTI 1a 3 below: Patient must meet 1, 2, and Catheter- 1. d an indwelling urinary catheter that had been in place for more Patient ha associated than D inpatient location on the date of event AN 2 consecutive days in an Urinary was either: Tract † • Present for any portion of the calendar day on the date of event , Infection OR (CAUTI) ‡ • Removed the day before the date of event in any age patient 2. at least one of the following signs or symptoms: Patient has • fever (>38.0°C): Reminder: To use fever in a patient > 65 years of age, the for more than 2 consecutive days in an inpatient needs to be in place IUC location on date of event was removed the day and is either still in place OR . before the DOE • suprapubic tenderness* • costovertebral angle pain or tenderness* • urinary urgency ^ • urinary frequency ^ • dysuria ^ 3. Patient has a urine culture with no more than two species of organisms 5 CFU/ml (See identified , at least one of which is a bacterium of ≥10 UTI criterion must occur during the IWP Comment s). All elements of the S (See IWP Definition Chapter 2 Identifying HAIs in NHSN ). † ” for Risk Factor for IUC When entering event into NHSN choose “INPLACE ‡ When entering event into NHSN choose “REMOVE ” for Risk Factor for IUC * With no other recognized cause (see Comments ) ^ These symptoms cannot be used when catheter is in place . An IUC in place could cause patient complaints of “frequency” “urgency” or “dysuria”. Note: • Fever is a non -specific symptom of infection and cannot be excluded from UTI determination because it is clinically deemed due to another recognized cause. January 2019 7-5

105 associated Module Device- UTI SUTI 1b Patient must meet 1, 2, and 3 below: Non - One of the following is true: 1. Catheter- • Patient has/had an indwelling urinary catheter but it has/had not been in associated inpatient location on the date place for more than 2 consecutive days in an Urinary † of event Tract OR Infection n indwelling urinary catheter in place on the date of Patient did not have a • - (Non † CAUTI) event nor the day before the date of event in any age patient 2. Patient has at least one of the following signs or symptoms: that is ≤ 65 years of age fever (>38°C) in a patient • suprapubic tenderness * • • costovertebral angle pain or tenderness * • urinary frequency ^ • urinary urgency ^ • dysuria ^ Patient has a urine culture with no more than two species of organisms 3. 5 CFU/ml. (See identified , at least one of which is a bacterium of ≥10 s) All elements of the SUTI criterion must occur during the IWP Comment (See IWP Definition Chapter 2 Id ). entifying HAIs in NHSN † When entering event into NHSN choose “NEITHER” for Risk Factor for IUC ) * With no other recognized cause (see Comments An IUC in place could ^These symptoms cannot be used when IUC is in place. cause patient complaints of “frequency” “urgency” or “dysuria”. Note: of infection and cannot be excluded from • Fever is a non -specific symptom clinically deemed due to another recognized UTI determination because it is cause. January 2019 7-6

106 associated Module Device- UTI 3 below: Patient must meet 1, 2, and SUTI 2 ‡ (with 1. Patient is ≤1 year of age or without an indwelling urinary catheter) CAUTI or Patient 2. one of the following signs or symptoms: has at least Non - fever (>38 .0°C) • CAUTI in • hypothermia (<36.0°C) patients 1 * • apnea year of age • bradycardia * or less * lethargy • • * vomiting • suprapubic tenderness* Patient has a urine culture with no more than two species of organisms 3. 5 , at least one of which is a bacterium of ≥10 identified CFU/ml. (See Comment s) All elements of the S UTI criterion must occur during the IWP (See IWP Definition Chapter 2 Identifying HAIs in NHSN). ‡ more than 2 consecutive days atient had an IUC in place for in an inpatient If p location and the IUC was in place on the date of event or the previous day the CAUTI criterion is met. If no such IUC was in place, UTI (non -catheter associated) criterion is met. s) * With no other recognized cause (See Comment Note: Fever and hypothermia are non- specific symptoms of infection and cannot be excluded from UTI determination because they are clinically deemed due to another recognized cause. January 2019 7-7

107 Device- associated Module UTI “Mixed flora” is not available in the pathogen list within NHSN. Therefore, it Comments cannot be reported as a pathogen to meet the NHSN UTI criteria. Additionally, “mixed flora” represent at least two species of organisms. Therefore, an additional organism recovered from the same culture wou ld represent >2 species of organisms. Such a specimen also cannot be used to meet the UTI criteria. The following excluded organisms cannot be used to meet the UTI definition: as well as a report of “  Any Candida species ” that is yeast not otherwise specified mold  dimorphic fungi or  parasites  may include these organisms as long as one An acceptable urine specimen bacterium of greater than or equal to 100,000 CFU/ml is also present. Additionally, these non-bacterial organisms identified from blood cannot be deemed secondary to a UTI since they are excluded as organisms in the UTI definition.  Suprapubic tenderness whether elicited by palpation (tenderness-sign) or provided as a subjective complaint of suprapubic pain (pain- symptom), documentation of either found in the medical record is acceptable as a part nfection of SUTI criterion if documented in the medical record during the I Window Period. Lower abdominal pain or bladder or pelvic discomfort are examples of  symptoms that can be used as suprapubic tenderness. Generalized “abdominal pain” in the medical record is not to be interpreted as suprapubic tenderness as there are many causes of abdominal pain and this symptom is too general.  Left or right lower back or flank pain are examples of symptoms that can be ebral angle pain or tenderness. Generalized "low back used as costovert pain" is not to be interpreted as costovertebral angle pain or tenderness. January 2019 7-8

108 associated Module Device- UTI Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) (in any age patient) Patient must meet 1, 2, and 3 below: 1. Patient with * or without an indwelling urinary catheter has no signs or symptoms of SUTI 1 or 2 according to age ( : Patients > 65 years of age Note -associated ABUTI may have a fever and still meet the catheter with a non- ABUTI criterion) 2. Patient has a urine culture with no more than two species of organisms 5 , at least one of which is a bacterium of ≥10 identified CFU/ml ( see Comment section below) 3. Patient has organism identified** from blood specimen with at least one matching bacterium to the bacterium identified in the , or urine specimen (without fever) and matching common meets LCBI criterion 2 commensal(s) in the urine. All elements of the ABUTI criterion must occur during the Infection Window Period (See Definition Chapter 2 Identifying HAIs in NHSN). Patient had an IUC in place for more than 2 consecutive days in an inpatient * location on the date of event, and IUC was in place on the date of event or the day Catheter - associated ABUTI is reportable if CAUTI is in the facility’s before. . reporting plan for the location ** Organisms identified by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (e.g., not Active Surveillance Culture/Testing (ASC/AST). A urine specimen with “Mixed flora ” cannot be used to meet the urine criterion. Comments Additionally, the following excluded organisms cannot be used to meet the UTI definition: Any Candida • not otherwise ” that is species as well as a report of “ yeast specified • mold dimorphic fungi or • • parasites An acceptable urine specimen may include these excluded organisms as long as one bacterium of greater than or equal to 100,000 CFU/ml is also present. from blood cannot be bacterial organisms identified Additionally, these non- are excluded as organisms in the UTI deemed secondary to a UTI since they definition . January 2019 7-9

109 associated Module Device- UTI Table 2. Urinary System Infection Criteria Criterion Urinary System Infection (USI) Criterion (kidney, ureter, bladder, urethra, or perinephric space) Other infections of the urinary system must meet at least one of the following criteria: from fluid (excluding urin e) or 1. Patient has organisms identified** tissue from affected site 2. Patient has an abscess or other evidence of infection on gross anatomical exam, during invasive procedure, or on histopathologic exam 3. Patient has at least one of the following signs or symptoms: • fever (>38.0°C) • localized pain or tenderness* And at least one of the following: purulent drainage from affected site a) organisms identified** from blood and imaging test evidence of b) infection (e.g., ultrasound, CT scan, magnetic resonance imaging [MRI], or radiolabel scan [gallium, technetium]) which if equivocal is supported by clinical correlation (i.e., physician documentation of antimicrobial treatment for urinary system infection). 4. Patient < 1 year of age h as at least one of the following signs or symptoms: fever (>38.0°C) • hypothermia (<36.0°C) • apnea* • • bradycardia* • lethargy* • vomiting* And at least one of the following: a) purulent drainage from affected site b) organisms identified** from blood and imaging test evidence of infection, (for example , ultrasound, CT scans, magnetic resonance imaging [MRI], or radiolabel scan [gallium, technetium]) January 2019 7-10

110 associated Module Device- UTI * With no other recognized cause ** Organisms identified by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (e.g., not Active Surveillance Culture/Testing (ASC/AST). Notes: • Fever and hypothermia are non-specific symptoms of infection and cannot be excluded from U SI determination because they a re clinically deemed due to another recognized cause. (See IWP All elements of the USI criterion must occur during the IWP • Definition Chapter 2 Identifying HAIs in NHSN). Reporting Report infections following circumcision in newborns as SST- CIRC. • Instructions If patient meets USI criteria and they also meet UTI criteria, report UTI • only, unless the USI is a surgical site organ/space infection, in which case, only USI should be reported. • For NHSN reporting purposes, Urinary System Infection (USI) cannot be catheter associated, therefore, USI will only present as specific event type if urinary catheter status is marked “Neither”. January 2019 7-11

111 associated Module Device- UTI Figur e 2: Identifying SUTI and ABUTI Flowchart 7-12 January 2019

112 Device- associated Module UTI Monthly Summary Data Numerator Data: The Urinary Tract Infection (UTI) form (CDC 57.114 ) is used to collect and report each CAUTI that is identified during the month selected for surveillance. The include brief instructions for Instructions for Completion of Urinary Tract Infection form collection and entry of each data element on the form. USIs are never included in CAUTI data and are reported separately on the HAI Custom Event Form . The UTI form includes patient demographic information and information on whether or not an indwelling urinary catheter was present. Additional data include the specific criteria met for identifying the UTI, whether the patient developed a secondary bloodstream infection, whether the patient died, and the organisms isolated from cultures and their antimicrobial susceptibilities. Reporting Instructions : If no CAUTIs are identified during the month of surveillance, the ” Report No Events” box must be checked on the appropriate denominator summary screen, ( for example , ). (Not NICU or SCA/ONC Denominators for Intensive Care Unit (ICU)/Other Locations Denominator Data: Device days and patient days are used for denominators (See Key Terms chapter ).The method of collecting device-day denominator data may differ depending on the location of patients being monitored. The following methods may be used: Table 3: Denominator Data Collection Methods Denominator Data Details Collection Method Denominator data (patient days and device days) should be collected Manual, Daily (specifically , collected at the same time, every day, for each location performing every at the same time surveillance to ensure that differing collection methods don’t day of the month) inadvertently result in device days being > patient days. The Instructions for Completion of Denominators for Intensive Care Unit (ICU)/Other Locations (Not NICU and SCA/ONC) and Instructions for Completion of Denominators for Specialty Care Areas (SCA)/Oncology (ONC) contain brief instructions for collection and entry of each data element on the form. Indwelling urinary ca theter days, which are the number of patients with an indwelling urinary catheter device, are collected daily, at the same time each day, according to the chosen location using the appropriate form (CDC 57.117 and 57.118). These daily counts are summed and only the total for the month is entered into NHSN. Indwelling urinary catheter days and patient days are collected separately for each of the locations monitored. January 2019 7-13

113 Device- associated Module UTI Denominator Data Details Collection Method To reduce staff time spent collecting surveillance data, once weekly Manual, sampled estimated urinary catheter sampling of denominator data to generate once/week (collected at days may be used as an alternative to daily collection in non- the same time on the oncology ICUs and wards (see Notes below). Sampling may not be same designated day, used in SCA/ONC locations or NICUs. During the month, the ) once per week number of patients in the location (patient-days) and the number of days) is patients with an indwelling urinary catheter (urinary catheter- for example, every collected on a designated day each week ( Tuesday), at the same time during the month. Evaluations of this method have repeatedly shown that use of Saturday or Sunday generate the least accurate estimates of denominator data, and, therefore, these days should not be selected as 7-9 the designated day. If the day designated for the collection of sampled data is missed, collect the data on the next available day instead. The following must be collected and entered into NHSN: 1. The monthly total for patient-days, based on collection daily days 2. The sampled total for patient- 3. The sampled total urinary catheter- days When these data are entered, the NHSN application will calculate an estimate of urinary catheter -days. Notes : • To ensure the accuracy of estimated denominator data obtained by sampling, only ICU and ward location types with an average of 75 or more urinary catheter -days per month are eligible to use this method. A review of each location’s urinary catheter deno minator data for the past 12 months in NHSN will help determine which locations are eligible. • The accuracy of estimated denominator data generated by sampling can be heavily influenced by incorrect or missing data. Careful implementation of data collection following the guidance in this protocol is essential to avoid erron eous ). fluctuations in rates or Standardized Infection Ratios ( SIRs January 2019 7-14

114 Device- associated Module UTI Denominator Data Details Collection Method for For any location, denominator data from electronic sources ( Electronic example, urinary catheter days from electronic charting), may be validation of a minimum three consecutive months proves used after the data to be within 5% (+/ -) of the manually-collected, once a day counts. Perform the validation of electronic counts separately for each location conducting CAUTI surveillance. Data Analyses: The Standardized Infection Ratio ( SIR ) is calculated by dividing the number of observed infections by the number of predicted infections. The number of using probabilities from negative binomial regression predicted infections is calculated models constructed from 2015 NHSN data, which represents a standard population. More information regarding the CAUTI SIR model and the parameter estimates can be found in the SIR Guide . Notes : The SIR will be calculated only if the number of predicted CAUTIs (num Pred) is ≥1 to help enfo rce a minimum precision criterion . While the CAUTI SIR can be calculated for si ngle locations, the measure also allows you to summarize your data by multiple locations, adjusting for differences in the incidence of infection among the location types. For example, you will be able to obtain one CAUTI SIR adjusting for all locations reported. Similarly, you can obtain one CAUTI SIR for all ICUs in your facility. -adjusted summary measure for device The SUR, or Standardized Utilization Ratio, is a risk use. Similar to the SIR, the SUR can be calculated for single locations as well as be summarized across multiple locations . More information regarding the CAUTI SUR model and the parameter estimates can be found in the SUR Guide . The CAUTI rate per 1000 urinary catheter days is calculated by dividing the number of CAUTIs by the number of catheter days and multiplying the result by 1000. The Urinary Catheter Utilization Ratio is calculated by dividing the number of urinary catheter days by the number of patient days. These calculations will be performed separately for the different types of ICUs, specialty care areas, and other locations in the institution, except for neonatal locations. Descriptive analysis output options of nume rator and denominator data, such as line listings, . SIRs are available in the NHSN application , SURs frequency tables, and bar and pie charts January 2019 7-15

115 Device- associated Module UTI and CAUTI rates and run charts are also available. Guides on using NHSN analysis features resources/reference-guides.html are available at: www.cdc.gov/nhsn/PS-Analysis- . A de for the CAUTI SIR is available at: https://www.cdc.gov/nhsn/pdfs/ps- troubleshooting gui analysis- resources/nhsn -sur-guide-508.pdf Table 3. CAUTI Measures Available in NHSN Measure Application Calculation Both location specific and s The number of Observed C AUTI CAUTI SIR CAUTI summarized The number of Predicted s measure Location specific The number of CAUTIs for a location x 1000 Rates CAUTI The number of Urinary Catheter Days for a location measure only Both location specific and Urinary Catheter The number of Observed Urinary Catheter Days summarized The number of Predicted Urinary Catheter Days SUR measure Location specific The Urinary Catheter Days for a location DUR measure only The Patient Days for that location January 2019 7-16

116 associated Module Device- UTI REFERENCES 1 SS., Edwards, JR., Bamberg, W., et al. “Multistate Point-Prevalence Survey of Health Care- Magill New England Journal of Medicine. 370: (2014): 1198- 1208 Associated Infections, 2011”. . 2 and The patient survival guide: 8 simple solutions to prevent hospital McGuckin M. associated infections. New York, NY: Demos Medical Publishing; healthcare- 2012. 3 Lo E, Nicolle LE, Coffin SE, Gould C, Maragakis LL, Meddings J, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect ion Control and Hosp ital Epidemiology 2014;35:464-79. 4 Scott Rd. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention, 2009. Division of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, February 2009. 5 Klevens, RM., Edward, JR., et al. “Estimating Healthcare-associated Infections and D eaths in U.S. Hospitals”. Public Health Reports -166. 122: (2007):160 6 Gould, CV., Umscheid, CA.,Agarwal, RK., Kuntz, G., Pegues, DA. “Guideline for Prevention of Catheter -associated Urinary Tract Infections”. Infection Control and Hospital Epidemiology . 3 1: (2010): 319-26. 7 Klevens, RM., et al. “Sampling for Collection of Central Line Day Denominators in Infection Control and Surveillance for Healthcare-associated Bloodstream Infections”. Hospital Epidemiology -42. . 27: (2006):338 8 Thompson, ND., et al.” Evaluating the Accuracy of Sampling to Estimate Central Line – Days: Simplification of NHSN Surveillance Methods” . Infection Control and Hospital Epidemiology . 34(3): (2013): 221-228. 9 See, I., et al. ID Week 2012 (Abstract #1284): Evaluation of Sampling De nominator Data to Estimate Urinary Catheter and Ventilator Days for the NHSN. San Diego, California. October 19, 2012. January 2019 7-17

117 Procedure-associated Module SSI Surgical Site Infection (SSI) Event Introduction: In 201 4, a total of 14.2 millon operative procedures were performed in the 1 inpatient setting in United States . The CDC healthcare-associated infection (HAI) hospitals prevalence survey found that there were an estimated 157,500 surgical site infections (SSIs) 2 associated with inpatient surgeries in 2011 s following . NHSN data included 16,147 SSI 849,659 operative procedures in all groups reported, for an overall SSI rate of 1.9% between 3 . A 2006-2008 17% decrease in SSI related to 10 select procedures was reported between 2008 4 and 2014 . While advances improved operating have been made in infection control practices, including room ventilation, sterilization methods, barriers, surgical technique, and availability of antimicrobial prophylaxis, SSIs remain a substantial cause of morbidity, prolonged with a mortality rate of 3%, and 75% of SSI- hospitalization, and death. SSI is associated 5 . SSI is associated deaths are directly attributable to the SSI the most costly HAI type with an estimated annual cost of $3.3 billion, and is associated with nearly 1 million additional 6,7 inpatient-days annually . Surveillance of SSI with feedback of appropriate data to surgeons has been shown to be an 8-11 . A successful surveillance program important component of strategies to reduce SSI risk includes the use of epidemiologically-sound infection definitions and effective surveillance methods, stratification of SSI rates according to risk factors associated with SSI development, 9, 10 The most recent CDC and Healthcare Infection Control Practices . and data feedback Infection was Advisory Committee Guideline for the Prevention of Surgical Site published in 11 2017; this guideline provides evidence-based strategies for SSI prevention . Settings: Surveillance of surgical patients will occur in any inpatient facility and/or hospital where the selected NHSN o perative procedure(s) are department (HOPD) outpatient procedure performed. Note: SSI surveillance in Ambulatory Surgery Centers (ASCs) should be performed using the Outpatient Procedure Component (OPC). The OPC replaces the use of the SSI protocol for ASCs. Requirements: surveillance for SSI following at least one NHSN operative procedure  Perform ICD-10-PCS and/or CPT NHSN operative procedure code category (that is included in Patient Safety Monthly Reporting Plan indicated in the (CDC 57.106 mapping) as ). data on  Co llect SSI event (numerator ) and operative procedure category (denominator) all procedures included in the selected operative procedure categorie s indicated on the facility’s monthly reporting plan. A procedure must meet the NHSN definition of an operative procedure in order to be  procedures included in the NHSN monthly All included in SSI surveillance. -1 9 January 2019

118 Procedure-associated Module SSI surveillance plan are followed for superficial incisional, deep incisional, and est tissue events and the type of SSI reported must reflect the deep organ/space SSI level where SSI criteria is met during the surveillance period.  An SSI event is attributed to the facility in which the NHSN operative procedure was performed. = YES are reported  SSI events where infection present at the time of surgery (PATOS) to NHSN. SSI monitoring requires active, patient-based, prospective surveillance. Concurrent and post- discharge surveillance methods should be used to detect SSIs following inpatient operative procedures and post-discharge surveillance for outpatient operative procedures. Note: Ambulatory Surgery Centers (ASCs) please refer to the OPC protocol for guidance. For example, these methods include:  Review of medical records or surgery clinic patient records o Admission, readmission, ED, and OR logs Patient charts for signs and symptoms of SSI o Lab, imaging, other diagnostic test reports o Clinician notes o o ICD-10-CM Infection Diagnosis Codes to prompt further review talk to primary care staff  Visit the ICU and wards –  Surgeon surveys by mail or telephone  Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods is acceptable for use; however, NHSN criteria for SSI must workload of collecting denominator data, IPs) nists’ ( Infection Preventio be used. To minimize operating room data may be downloaded. (See file specifications at: https://www.cdc.gov/nhsn/pdfs/ps-analysis- resources/ImportingProcedureData.pdf ). Operative Procedure Codes: Operative procedure codes are used in health care settings as a way to communicate uniform operative procedure codes allows NHSN to incorporate the information. This wide use of NHSN SSI surveillance reporting. The operative procedure codes as a means to standardize the correct NHSN operative procedure are required to determine operative procedure codes category to be reported. -2 9 January 2019

119 Procedure-associated Module SSI NHSN uses the following operative procedure coding systems: th Revision Clinical International Classification of Diseases, 10  (ICD- 10-CM Modifications/Procedure Coding System by the ICD- 10 /PCS), as defined Coordination and Maintenance Committee of the National Center for Health Statistics and the Centers for Medicare and Medicaid Services (CMS).  Current Procedural Terminology (CPT) , as defined by the American Medical Association (AMA). The mapping for ICD-10 -PCS and CPT NHSN operative procedure s is found in the “ Supporting Materials ” section of the SSI Protocol on the NH SN website. The mapping documents include a general definition for each NHSN operative procedure category as well as Entering the operative procedure a description for each individual operative procedure code. code into the NHSN application remains optional. is not ” -PCS and CPT mapped to ICD-10 - other The former NHSN Category “OTH Note: a procedure that is not NHSN operative procedure codes. An infection associated with included in one of the NHSN operative procedure categories is not considered an NHSN SSI , although the infection may be investigated as a healthcare-associated infection. Definition of an NHSN Operative Procedure: An NHSN Operative Procedure is a p rocedure: and/or  that is included in the ICD-10 -PCS CPT NHSN operative procedure code mapping And  (including laparoscopic takes place during an operation where at least one incision and cranial Burr hole s) is made through the skin or mucous membrane, or approach reoperation via an incision that was left open during a prior operative procedure And  takes place in an operating room (OR), defined as a patient care area that met the Facilities Guidelines Institute’s (FGI) or American Institute of Architects’ (AIA) 12 This may include criteria for an operating room when it was constructed or renovated . an operating room, C -section room, interventional radiology room, or a cardiac catheterization lab. Exclusions: Otherwise eligible procedures that are assigned an ASA score of 6 are not eligible for NHSN SSI surveillance. Incisional closure method is NOT a part of the NHSN operative procedure definition; all Note: otherwise eligible procedures are included, regardless of closure type. Therefore both primarily closed procedures and those that are not closed primarily should be entered into the -3 9 January 2019

120 Procedure-associated Module SSI denominator data f or procedures in the facility’s monthly reporting plan. Any SSIs attributable -primarily closed procedures should be reported. to either primarily closed or non SSI Event Details: The Infection Window Period (IWP), Present on Admission (POA), Hospital Associated Infection (HAI), and Repeat Infection Timerame (RIT) definitions do not apply to the SSI protocol. For additional POA and PATOS details, see SSI Event Reporting Instructions #2 and #3. Date of event (DOE): For an SSI, the date of event is the date when the first element used to meet the SSI infection criterion occurs for the first time during the SSI surveillance period. The date of event must fall within the SSI surveillance period to meet SSI criteria. The type of SSI (superficial incisional, deep incisional, or organ/space) reported and the date of event assigned must reflect the deepest tissue level where SSI criteria are met during the surveillance Synonym: infection date. period. All elements required to meet an SSI criterion usually occur within a 7-10 day timeframe with lements. The elements must be relational to each other, no more than 2-3 days between e and this can only happen if meaning you should ensure the elements all associate to the SSI, elements occur in a relatively tight timeframe. Each case differs based on the individual elements occurring and the type of SSI. Secondary BSI Attribution Period for SSI: The secondary BSI attribution period for SSI is a 17-day period that includes the date of event, 3 days prior, and 13 days after. For detailed instructions on determining whether identi fication of organisms from a blood specimen represents a secondary BSI, refer to the Secondary BSI Guide (Appendix B of the BSI Event Protocol ). Denominator for Procedure Details: can be found within the Instructions for Completion of Denominator for Additional guidance Procedure Form (CDC 57.121). ASA physical status : Assessment by the anesthesiologist of the patient’s preoperative physical s’ (ASA) Classification of Physical condition using the American Society of Anesthesiologist 13 Status . Patient is assigned an ASA score of 1-6 at time of surgery. Do NOT report procedures with an ASA physical status of 6 (a declared brain-dead Note: patient whose organs are being removed for donor purposes) to NHSN. Diabetes: The NHSN SSI surveillance definition of diabetes indicates that the patient has a -diabetic agent. diagnosis of diabetes requiring management with insulin or a non-insulin anti This includes: -4 9 January 2019

121 Procedure-associated Module SSI “insulin resistance” who are on management with anti -diabetic agents.  Patients with  Patients with gestational diabetes.  Patients who are noncompliant with their diabetes medications. The ICD-10 -CM diagnosis codes that reflect the diagnosis of diabetes are also acceptable for use to answer YES to the diabetes field question on the denominator for procedure entry if they are documented during the admission where the procedure is performed. These codes are found on the NHS Supporting Materials ” . N website in the SSI section under “ The NHSN definition of diabetes excludes patients with no diagnosis of diabetes. The definition also excludes patients who receive insulin for perioperative control of hyperglycemia but have no diagnosis of diabetes. Duration of operative procedure: The interval in hours and minutes between the Procedure/Surgery Start Time and the Procedure/Surgery Finish Time, as defined by the 14 Association of Anesthesia Clinical Directors ( AACD ) :  : Time when the procedure is begun (for example, Procedure/Surgery Start Time (PST) incision for a surgical procedure).  Procedure/Surgery Finish (PF): Time when all instrument and sponge counts are completed and verified as correct, all postoperative radiologic studies to be done in the OR are completed, all dressings and drains are secured, and the physicians/surgeons have completed all procedure-related activities on the patient. protocol to Emergency operative procedure: A procedure that is documented per the facilit y’s be an Emergency or Urgent procedure. or gases that enter the general circulation and General anesthesia: The administration of drugs affect the central nervous system to render the patient pain free, amnesic, unconscious, and This does not include conscious sedation. often paralyzed with relaxed muscles. Height : The patient’s most recent height documented in the medical record in feet (ft.) and ), or meters ( m) inches (in. . NHSN Inpatient Operative Procedure: An NHSN operative procedure performed on a patient whose date of admission to the healthcare facility and the date of discharge are different calendar days. An NHSN operative procedure performed on a patient NHSN Outpatient Operative Procedure: whose date of admission to the healthcare facility and date of discharge are the same calendar day. Non-primary Closure: The closure of the surgical wound in a way which leaves the skin level completely open following the surgery. Closure of any portion of the skin represents primary closure (see Primary Closure definition below). For surgeries with non-primary closure, the -5 9 January 2019

122 Procedure-associated Module SSI left open), or the deep deep tissue layers may be closed by some means (with the skin level and superficial layers may both be left completely open. Wounds with non-primary closure may or may not be described as "packed” with gauze or other material, and may or may not be covered with plastic, “wound vacs,” or other synthetic devices or materials. Examples:  Laparotomy in which the incision was closed to the level of the deep tissue layers, sometimes called “fascial layers” or “deep fascia,” but the s kin level was left open. .  (an “open abdomen”) The abdomen is left completely open after the surgery Primary Closure: The closure of the skin level during the original surgery, regardless of the presence of wires, wicks, drains, or other devices or objects extruding through the incision. This category includes surgeries where the skin is closed by some means. Thus, if any portion of the incision is closed at the skin level, by any manner, a designation of primary closure should be assigned to the surgery. Note : If a procedure has multiple incision/laparoscopic trocar sites and any of the incisions are closed primarily then the procedure technique is recorded as primary closed. used to visualize the interior of a body cavity or organ. In the context of n instrument Scope: A an NHSN operative procedure, use of a scope involves creation of several small incisions to perform or assist in the performance of an operation rather than use of a traditional larger , open approach). incision (specifically ICD-10-PCS codes can be helpful in answering this scope question. The fifth character indicates the approach to re ach the procedure site: th ICD-10 5 Scope Approach Character Field Open approach No 0 Yes Percutaneous endoscopic approach 4 Yes Via natural or artificial opening with endoscopic F assistance approach If a procedure is coded as open and scope then the procedure should be entered into Note: . The NHSN as Scope = NO open designation is considered a higher risk procedure. Complex Trauma: Blunt or penetrating injury occurring prior to the start of the procedure. trauma cases may require multiple trips to the OR during the same admission to repair the es. initial trauma. In such cases, trauma = Y -6 9 January 2019

123 Procedure-associated Module SSI Weight : The patient’s most recent weight documented in the medical record in pounds ( lbs.) or kilograms (kg) prior to or otherwise closest to the procedure. Wound class : An assessment of the degree of contamination of a surgical wound at the time of the operation. Wound class should be assigned by a person involved in the surgical procedure (for example, surgeon, circulating nurse, etc. ). The wound class system used in NHSN is adapted from the American College of Surgeons wound classification schema. The four wound classifications available include Clean, Clean-Contaminated, Contaminated, and Dirty/Infected. Based on feedback from external experts in the field of surgery, there are a group of NHSN procedures that can never be recorded se operative procedure categories are as clean. The APPY, BILI, CHOL, COLO, REC, SB, Therefore, for these procedures in the and VHYS. application clean is not an option on the drop down menu. can be entered as clean procedures within the NHSN All other operative procedure categories application. For example CSEC, HYST, or OVRY can be a clean wound class if documented as such. -7 9 January 2019

124 Procedure-associated Module SSI Table 1. Surgical Site Infection Criteria Surgical Site Infection (SSI) Criterion Superficial incisional SSI Must meet the following criteri a: Date of event occurs within 30 days after any NHSN operative procedure (where day 1 = the procedure date) AND involves only skin and subcutaneous tissue of the incision AND p atient has at least one of the following: a. purulent drainage from the superficial incision. b. an aseptically-obtained specimen organism(s) identified from from the superficial incision or subcutaneous tissue by a culture or non -culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)). c. superficial incision that is deliberately opened by a surgeon, and culture or non-culture attending physician* or other designee is of the superficial incision or subcutaneous tissue based testing not performed AND patient has at least one of the following signs or symptoms: localized pain or tenderness; localized swelling; erythema; or heat. d. diagnosis of a superficial incisional SSI by the surgeon, attending physician* or other designee. * The term attending physician for the purposes of application of the NHSN SSI criteria may be interpreted to mean the surgeon(s), infectious or physician’s disease, other physician on the case, emergency physician, designee (nurse practitioner or physician’s assistant). -8 9 January 2019

125 Procedure-associated Module SSI Superficial Incisional SSI There are two specific types of superficial incisional SSIs: Comments 1. Superficial Incisional Primary (SIP) a superficial incisional SSI – that is identified in the primary incision in a patient that has had an operation with one or more incisions (for example, C-section incision or chest incision for CBGB) 2. Superficial Incisional Secondary (SIS) – a superficial incisional SSI that is identified in the secondary incision in a patient that has had an operation with more than one incision (for example, donor site incision for CBGB) Reporting The following do not qualify as criteria for meeting the NHSN Instructions : definition of superficial incisional SSI for Diagnosis/treatment of cellulitis (redness/warmth/swelling), by itself,  Superficial “d” Conversely, does not meet criterion superficial incisional SSI. for SSI an incision that is draining or that has organisms identified by culture or non-culture based testing is not considered a cellulitis. A stitch abscess alone (minimal inflammation and discharge confined  to the points of suture penetration).  Circumcision is not an NHSN operative procedure. An infected circumcision site in newborns is classified as CIRC and is not an SSI.  An infected burn wound is classified as BURN and is not an SSI. For an NHSN operative procedure, a laparoscopic trocar site is  considered a surgical incision and not a stab wound. not considered an SSI;  A localized stab wound or pin site infection is depending on the depth, these infections might be considered either a skin (SKIN) or soft tissue (ST) infection. -9 9 January 2019

126 Procedure-associated Module SSI Deep incisional SSI Must meet the following criteri a: The date of event occurs within 30 or 90 days after the NHSN operative procedure (where day 1 = the procedure date) according to the list in Table 2 AND involves deep soft tissues of the incision (for example, fascial and muscle layers) AND p atient has at least one of the following: purulent drainage from the deep incision. a. b. a deep incision that spontaneously dehisces, or is deliberately * or other opened or aspirated by a surgeon, attending physician designee AND organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which rformed for purposes of clinical diagnosis or treatment (for is pe or ple, not Active Surveillance Culture/Testing (ASC/AST)) exam cult ure or non-culture based microbiologic testing method is not performed. A culture or non-culture based test from the deep soft tissues of the incision that has a negative finding does not meet thi s criterion. AND of the following signs or symptoms: fever pati ent has at least one (>38°C); localized pain or tenderness. an abscess or other evidence of infection involving the deep c. incision that is detected on gross anatomical or histopathologic exam, or imaging test. * The term attending physician for the purposes of application of the NHSN SSI criteria may be interpreted to mean the surgeon(s), infectious disease, other physician on the case, emergency physician, or physician’s designee (nurse practitioner or physician’s assistant). There are two specific types of deep incisional SSIs: Comments 1. Deep Incisional Primary (DIP) – a deep incisional SSI that is identified in a primary incision in a patient that has had an operation with one or more incisions (for example, C-section incision or chest incision for CBGB) – a deep incisional SSI that is Deep Incisional Secondary (DIS) 2. identified in the secondary incision in a patient that has had an operation with more than one incision (for example, donor site incision for CBGB) -10 January 2019 9

127 Procedure-associated Module SSI SSI Organ/Space Must meet the following criteria: Date of event occurs within 30 or 90 fter the NHSN ope rative days a date) accor ding to the list in procedure (where day 1 = the procedure Table 2 AND ves any par t of the body deeper than the invol al/muscle layers that is fasci manipulated during the operative procedure opened or AND patient has at lea st one of the following: a. purulent drainage from a drain that is placed into the organ/space (for example, closed suction drainage system, open drain, T-tube drain, CT-guided drainage). b. organism(s) identified from fluid or tissue in the organ/space by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)). c. an abscess or other evidence of infection involving the organ/space that is detected on gross anatomical or histopathologic exam, or imaging test evidence suggestive of infection. AND criterion for a specific organ/space infection site listed meets at least one . These criteria are found in the in Table 3 Surveillance Definitions for Specific Types of Infections chapter. 9-11 January 2019

128 Procedure-associated Module SSI . Surveillance Periods SSI Following Selected NHSN Operative Procedure Table 2 for Categories. Day 1 = the date of the procedure. 30-day Surveillance Operative Procedure Category Operative Procedure Category AAA LAM Laminectomy Abdominal aortic aneurysm repair AMP LTP Liver transplant Limb amputation APPY Appendix surgery NECK Neck surgery AVSD Shunt for dialysis NEPH Kidney surgery BILI Bile duct, liver or pancreatic Ovarian surgery OVRY surgery CEA Carotid endarterectomy PRST Prostate surgery Gallbladder surgery REC Rectal surgery CHOL SB Colon surgery Small bowel surgery COLO CSEC Ces SPLE Spleen surgery arean section Gastric surgery THOR Thoracic surgery GAST HTP Heart transplant THYR Thyroid and/or parathyroid surgery HYST Abdominal hysterectomy VHYS Vaginal hysterectomy Kidney transplant XLAP Exploratory laparotomy KTP 90-day Surveillance Operative Procedure Category Breast surgery BRST CARD Cardiac surgery Coronary artery bypass graft with both chest and donor site incisions CBGB CBGC Coronary artery bypass graft with chest incision only CRAN Craniotomy Spinal fusion FUSN FX Open reduction of fracture HER Herniorrhaphy HPRO Hip prosthesis Knee prosthesis KPRO PACE Pacemaker surgery PVBY Peripheral vascular bypass surgery VSHN Ventricular shunt Notes: Superficial incisional SSIs are only followed for a 30-day period for all procedure types. Secondary incisional SSIs are only followed for a 30-day period regardless of the surveillance period for the primary site. -12 January 2019 9

129 Procedure-associated Module SSI . Specific Sites of an Organ/Space SSI. Table 3 Category Specific Site Category Specific Site Osteomyelitis MED Mediastinitis BONE Breast abscess or mastitis Meningitis or ventriculitis MEN BRST Myocarditis or pericarditis Oral cavity infection ORAL CARD (mouth, tongue, or gums) DISC OREP Deep pelvic tissue infection or other Disc space infection infection of the male or female reproductive tract EAR Ear, mastoid infection PJI Periprosthetic joint infection EMET Endometritis SA Spinal abscess/infection ENDO Endocarditis SINU Sinusitis Upper respiratory tract, pharyngitis, GIT Gastrointestinal (GI) tract UR laryngitis, epiglottitis infection IAB USI Urinary System Infection Intraabdominal infection, not specified elsewhere IC Intracranial infection VASC Arterial or venous infection JNT Joint or bursa infection VCUF Vaginal cuff infection LUNG Other infection of the lower respiratory tract (Criteria for these sites can be found in the Surveillance Definitions for Specific Types of Infections chapter. ) Note: Appendix contains a list of all NHSN operative procedure categories and the site to each category. specific SSIs that may be attributable SSI Numerator (SSI Event) Reporting Numerator Data: All patients having any of the procedures included in the selected NHSN operative procedure category(s) are monitored for SSI. The Surgical Site Infection (SSI) form is completed for each SSI. If no SSI events are identified during the surveillance month, check the “ Report No field in the Missing PA Events tab of the Incomplete/Missing List. Events ” The Instructions for Completion of the Surgical Site Infection (CDC 57.120) form include SSI form brief instructions for collection and entry of each data element on the form. The includes patient demographic information and specific event details that pertain to the SSI event. 9-13 January 2019

130 Procedure-associated Module SSI SSI Event Reporting Instructions: 1. Excluded organisms: Well-known community associated organisms (organisms belonging to the following genera: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis) and/or organisms associated with latent infections (for example, herpes, shingles, syphilis, or tuberculosis) are excluded from meeting SSI criteria. 2. Attributing SSI to an NHSN procedure when there is evidence of infection at the time of the primary surgery: The Present on Admission (POA) definition does not apply to the SSI If evidence of infection is present at the time of the protocol. procedure and the patient meets the NHSN SSI criteria during the SSI surveillance period, an SSI is attributed to the procedure (see PATOS below). A high wound class is not an exclusion for a patient later meeting criteria for an SSI, but in most cases is included as a risk factor for SSI in risk modeling. Infection present at time of surgery (PATOS) : PATOS denotes that there is 3. evidence of an infection or abscess at the start of or during the index surgical procedure (in other words, it is present preoperatively). PATOS is a YES/NO field on the SSI Event form. The evidence of infection or abscess must be noted/documented intraoperatively in an operative note or report of surgery. Only select PATOS = YES if a it applies to the depth of SSI that is being attributed to the procedures (for example, if patient has rgery and then later an intraabdominal infection at the time of su evidence of as a YES. If the returns with an organ/space SSI the PATOS field would be selected SSI the PATOS field would be or deep incisional patient returned with a superficial as a NO ). The patient does not have to meet the NHSN definition of an SSI at selected that there is evidence of the time of the primary procedure, but there must be notation an infection or abscess present at the time of surgery. PATOS is not necessarily diagnosis driven. The use of the ending “itis” in an operative note/report does not necessarily  meet PATOS, as it may only reflect inflammation which is not infectious in diverticulitis, peritonitis, and appendicitis). nature (for example,  Identification of an organism alone using culture or non-culture based microbiologic testing method or on a pathology report from a surgical specimen does not = PATOS (specifically, a positive culture/path report without surgical documentation of infection is not PATOS = YES).  The following verbiage alone without specific mention of infection does not meet the PATOS definition: colon perforation, necrosis, gangrene, fecal spillage, nicked bowel during procedure, or a note of inflammation. contaminated case  Fresh trauma resulting in a does not necessarily meet the PATOS fresh gunshot wound to the abdomen will For example, a requirement. -14 January 2019 9

131 Procedure-associated Module SSI be a trauma case with a high wound class but there would not have been time develop. for infection to  PATOS can be met when an abscess is noted, there is mention of infection in “ ” feculent peritonitis the OR note, purulence or pus is noted, or is noted, etc. An appendix that has ruptured will meet PATOS = YES, if the patient has a subsequent intraabdominal organ space SSI. Examples: 1. Patient admitted with an acute abdomen. Sent to OR for an XLAP where there is a finding of an abscess due to ruptured appendix and an APPY is performed. Patient returns two weeks later and meets criteria for an organ/space IAB SSI. The since an abscess was PATOS field would be selected as YES on the SSI event noted at the time of surgery in the same level as the subsequent SSI. 2. Patient is admitted with a ruptured diverticulum. In the OR note the surgeon documents that there are multiple abscesses in the intraabdominal cavity. Patient weeks later and meets criteria for a superficial SSI. The PATOS field returns three would be selected as NO since there was no documentation of evidence of infection or abscess of the superficial area at the time of the procedure. surgeon nicks the bowel and During an unplanned cesarean section (CSEC) the 3. there is contamination of the intraabdominal cavity. One week later the patient returns and meets criteria for an organ/space OREP (other reproductive) SSI. The PATOS field would be selected as NO since there was no documentation of evidence of infection or abscess at the time of the CSEC. The colon nick was a complication but there was no infection present at the time of surgery. gangrene” of the foot from - 4. Patient undergoes a foot amputation (AMP) due to “dry chronic ischemia. There is no evidence of infection at the time of surgery. The word gangrene is not sufficient to qualify for infection. The patient returns two weeks later and has a superficial SSI. The PATOS field would be selected as NO since there was no documentation of evidence of infection or abscess at the time of the AMP. earn titled “ Surgical Site Infections : For more information about PATOS, see Quick L Note (SSI) Event Form for PATOS ” 4. Multiple tissue levels are involved in the infection: The type of SSI (superficial incisional, or organ/space) reported must reflect the deepest tissue incisional, deep . level where SSI criteria is met during the surveillance period Report infection that involves the organ/space as an organ/space SSI, whether  or not it also involves the superficial or deep incision sites. -15 January 2019 9

132 Procedure-associated Module SSI  Report infection that involves the superficial and deep incisional sites as a deep incisional SSI. If an SSI started as a deep incisional SSI on day 10 of the SSI surveillance  period and then a week later (d ay 17 of the SSI surveillance period) meets of the organ/ criteria for an organ space SSI , the date of event would be the date SSI space . 5. Attributing SSI to a NHSN procedure when several are performed on different dates: If a patient has several NHSN operative procedures performed on different dates prior to an infection, attribute the SSI to the operative procedure that was performed most closely in time prior to the infection date, unless there is evidence that the infection was associated with a different operation. Note: For multiple NHSN operative procedures performed within a 24 hour period, see Deno minator Reporting Instruction #9 . Attributing SSI to NHSN procedures that involve multiple primary incision sites: 6. If multiple primary incision sites of the same NHSN operative procedure become infected, only report as a single SSI, and assign the type of SSI (superficial incisional, deep incisional, or organ/space) that represents the deepest tissue level where SSI t at any of the involved primary incision sites during the surveillance criteria is me period. Examples :  If one laparoscopic incision meets criteria for a superficial incisional SSI and another meets criteria for a deep incisional SSI, only report one deep incisional SSI.  If one or more laparoscopic incision sites meet criteria for superficial incisional SSI but the patient also has an organ/space SSI related to the laparoscopic only report one organ/space SSI. procedure, If an operative procedure is limited to a single breast and involves multiple  incisions in that breast that become infected, only report a single SSI.  In a colostomy reversal (take down) procedure, the stoma and formation or other abdominal incision sites are considered primary incisions. I f both the stoma and another abdominal incision site develop superficial incisional SSI , (SIP). SSI report only as one Attributing SSI to NHSN procedures that have secondary incision sites : Certain 7. procedures can involve secondary incisions (specifically the following, BRST, CBGB, VSHN). The surveillance period for all secondary CEA, FUSN, PVBY, REC , and incision is 30 days, regardless of the required deep incisional or organ/space SSI sites -16 January 2019 9

133 Procedure-associated Module SSI surveillance period for the primary incision site(s) ( Table 2 ). Procedures meeting this designation are reported as only one operative procedure. For example:  A saphenous vein harvest incision site in a CBGB procedure is considered the secondary incision site . One CBGB procedure is reported, the saphenous vein the chest harvest site is monitored for 30 days after surgery for SSI, and incision is monitored for 90 days after surgery for SSI. If the patient develops an SSI of the leg site (such as a superficial incisional SSI) and an SSI of the chest site (such as a deep incisional SSI) two SSI s are reported.  A tissue harvest site (for example, Transverse Rectus Abdominis Myocutaneous [TRAM] flap ) in a BRST procedure is considered the secondary incision site. One BRST procedure is reported, and if the secondary incision site gets infected, report as either SIS or DIS as appropriate. f an SSI is detected at SSI detected at another facility: a facility 8. It is required that i other than the one in which the operation was performed, the IP of the index facility can be reported to NHSN. When will be provided with enough detail so the infection reporting the SSI, the index facility should indicate that Detected = RO (Readmission to facility other than where procedure was performed). SSI a 9. ttribution after multiple types of NHSN procedures are performed during a single trip to the OR : If more than one NHSN operative procedure category was performed through a single incision/laparoscopic sites during a single trip to the operating room, attribute the SSI to the procedure that is thought to be associated with the infection. If it is not clear, as is often the case when the infection is an incisional SSI, use the NHSN Principal Operative Procedure Category Selection Lists ( Table 4) to select the operative procedure to which the SSI should be attributed. For example, if a patient develops SSI after a single trip to the OR in which both a COLO and SB were performed, and the source of the SSI is not apparent, assign the SSI to the COLO procedure. An SSI will not SSI following invasive manipulation/accession of the operative site: 10. be attributed if the following 3 criteria are ALL met:  during the post-operative period the surgical site is without evidence of infection and, invasive manipulation/accession of the site is performed for diagnostic or  an therapeutic purposes (for example, needle aspiration, accession of ventricular and, shunts, accession of breast expanders)  an infection subsequently develops in a tissue level which was entered during the manipulation/accession. -17 January 2019 9

134 Procedure-associated Module SSI Tissue levels that are BELOW the deepest entered level will be eligible for SSI. For example, a superficial debridement following a COLO procedure, where the muscle/fascia and organ/space was not entered, a subsequent organ/space SSI following the debridement may be an SSI attributable to the index COLO procedure. This reporting instruction does NOT apply to closed manipulation (for example, closed reduction of a dislocated hip after an orthopedic procedure). Invasive manipulation does not include wound packing, or changing of wound packing materials as part of postoperative care. 11. Reporting instructions for post-operative infection scenarios: An SSI that otherwise meets the NHSN definitions should be reported to NHSN without regard to post- operative accidents, falls, inappropriate showering or bathing practices, or other r unintentional occurrences that may or may not be attributable to patients’ intentional o postoperative actions. SSI should also be reported regardless of the presence of certain skin conditions (for example, dermatitis, blister, impetigo) that occur near an incision, t from an unrelated and regardless of the possible occurrence of a “seeding” even procedure (for example, dental work). This instruction concerning various postoperative circumstances is necessary to reduce subjectivity and data collection burden. -18 January 2019 9

135 Procedure-associated Module SSI Table 4. NHSN Principal Operative Procedure Category Selection List (The categories with the highest risk of SSI are listed before those with lower risks.) Abdominal Operative Procedures Priority Category 1 Liver transplant LTP 2 Colon surgery COLO 3 BILI Bile duct, liver or pancreatic surgery 4 SB Small bowel surgery REC 5 Rectal surgery Kidney transplant 6 KTP 7 Gastric surgery GAST Abdominal aortic aneurysm repair 8 AAA 9 Abdominal hysterectomy HYST CSEC Cesarean section 10 Laparotomy XLAP 11 APPY 12 Appendix surgery 13 HER Herniorrhaphy 14 NEPH Kidney surgery Vaginal h ysterectomy VHYS 15 16 SPLE Spleen surgery 17 Gall bladder surgery CHOL Ovarian surgery 18 OVRY Thoracic Operative Procedures Category Priority 1 HTP Heart transplant Coronary artery bypass graft with donor incision(s) CBGB 2 CBGC Coronary artery bypass graft, chest incision only 3 4 CARD Cardiac surgery 5 THOR Thoracic surgery Neurosurgical (Brain/Spine Category ) Operative Procedures Priority 1 VSHN Ventricular shunt Craniotomy CRAN 2 Spinal fusion 3 FUSN Laminectomy LAM 4 Priority Neck Operative Procedures Category Neck surgery NECK 1 THYR 2 Thyroid and or parathyroid surgery -19 January 2019 9

136 Procedure-associated Module SSI SSI Denominator for Procedure Reporting Denominator Data: Denominator data are collected for each individual NHSN operative procedure category selected for monitoring on the Patient Safety Monthly Reporting Plan . For all patients having perative procedure category(s) for which SSI any of the procedures included in the NHSN o Denominator for Procedure surveillance is being performed during the month, complete the form. An operative procedure code is required to determine the correct NHSN operative procedure category to be reported. The Instructions for Completion of the Denominator for form include brief instructions for collection and entry of each data element on the Procedure form. Denominator Reporting Instructions: closure type does not exclude a procedure from SSI surveillance. Closure type : Incisional 1. All otherwise eligible procedures are included in the denominator reporting, regardless of closure technique is entered for each denominator for procedure. If a closure type. The procedure has multiple incision sites and any of the incisions are closed primarily then the procedure is entered as a primary closure. If a patient returns to the OR within 24 hours of the end of the first procedure, assign Note: the surgical wound closure that applies when the patient leaves the OR from the first operative procedur e. 2. Wound class : A high wound class is not an exclusion for denominator reporting. If the procedure meets the definition of an NHSN operative procedure it should be reported in the denominator data regardless of wound class. NHSN will use the wound class for risk adjustment, as appropriate. If Different operative procedure categories performed during same trip to the OR: 3. procedures in more than one NHSN operative procedure category are performed during the Denominator for through the same or different incisions, a same trip to the operating room Procedure form is reported for each NHSN operative procedure category being monitored. For example, if a CARD and CBGC are done through the same incision, a Denominator is reported for each. In another example, if following a motor vehicle form for Procedure accident, a patient has an open reduction of fracture (FX) and splenectomy (SPLE) performed during the same trip to the operating room and both procedure categories are form for each. being monitored, complete a Denominator for Procedure If a patient has both a CBGC and CBGB during the same trip to the EXCEPTION: operating room, report only as a CBGB. Only report as a CBGC if there is only a chest incision. CBGB and CBGC are never reported for the same patient for the same trip to the operating room. -20 January 2019 9

137 Procedure-associated Module SSI Duration of the procedure when more than o ne category of NHSN operative 4. If more than one NHSN operative procedure is performed through the same incision: procedure category is performed through the same incision during the same trip to the operating room, record the combined duration of all procedures, which is the time from procedure/surgery start time to procedure/surgery finish time. For example, if a CBGC and a CARD are performed on a patient during the same trip to the operating room, the time from start time to finish time is reported for both operative procedures. 5. Duration of operative procedures if patient has two different NHSN operative procedures performed via separate incisions on the same trip to the OR: Try to determine the correct duration for each separate procedure (if this is documented); otherwise, take the time for both procedures and split it evenly between the two. Same operative procedure category but different ICD-10-PCS or CPT codes during 6. same trip to the OR: If procedures of different ICD-10-PCS or CPT codes from the same rocedure category are performed through the same incision/laparoscopic NHSN operative p sites, record only one procedure for that category. For example, a facility is performing surveillance for CARD procedures. A patient undergoes a replacement of both the mitral and tricuspid valves during the same trip to the operating room. Complete one CARD Denominator for Procedure form because both procedures are in the sam e operative procedure category ( CARD). PR If total or partial revision H HPRO and KPRO procedures: For revision O or KPRO 7. is performed, determine if any of the ICD-10-PCS/CM diagnosis or procedure codes indicating infection (see link below) were assigned to the index joint in the 90 days prior to and including the index HPRO or KPRO revision. If any of the specified codes are , indicate on the denominator for procedure form that the revision assigned to the procedure ’ was associated with ‘ prior infection at index joint = YES. T he ‘prior infection at in dex joint’ variable only applies to revision HPRO and KPRO. The cases designated ‘prior infection at index joint ’ = YES should be validated before the procedure is submitted to joint This validation is necessary to ensure the code is aligned with the index NHSN. The ICD-10-PCS/CM code mapping guidance is found on the NHSN website in revision. the SSI section under “ Supporting Materials .” incisions: For operative procedures that 8. Same NHSN operative procedure via separate om (specifically can be performed via separate incisions during same trip to operating ro CEA, FUSN, FX the following, AMP, BRST, , HER , HPRO, KPRO, LAM, NEPH, OVRY, PVBY), separate Denominator for Procedure forms are completed. To document the procedures, indicate the procedure/surgery start time to the duration of procedure finish time for each procedure separately or, alternatively, take the total /surgery procedures and split it evenly between procedures. time for the -21 January 2019 9

138 Procedure-associated Module SSI Notes:  A COLO procedure with a colostomy formation is entered as one COLO procedure.  Laparoscopic hernia repairs are considered one procedure, regardless of the number of hernias that are repaired in that trip to the OR. In most cases there will be only one incision time documented for this procedure. If more than one time is documented, total the durations. Open (specifically, non-laparoscopic) hernia repairs are reported as one procedure for each hernia repaired via a separate incision, (specifically, if two incisions are made to repair two defects, then two procedures will be reported). It is anticipated that separate incision times will be recorded for these procedures. If not, take the total time for both procedures and split it evenly between the two. 9. More than one operative procedure through same incision within 24 hours: When a patient has more than one operative procedure via the same incision and the second procedure start time is within 24 hours of the first procedure finish time, report only one combining the durations for form for the original procedure, Denominator for Procedure based on the procedure start times and finish times for both procedures. both procedures For example, a patient has a CBGB lasting 4 hours. He returns to the OR six hours later for another operative procedure via the same incision (for example, CARD). The second operation has duration of 1.5 hours. Record the operative procedure as one CBGB and the duration of operation as 5 hour 30 minutes. If the wound class has changed, report the higher wound class. If the ASA class has changed, report the higher ASA class. Do not report the CARD procedure in your denominator data. Note: When the patient returns to the OR within 24 hours of the end of the first procedure assign the surgical wound closure technique that applies when the patient leaves the OR from the first operative procedure. If a patient expires in the operating room, do not complete a Patient expires in the OR: 10. form. This operative procedure is excluded from the Denominator for Procedure denominator. 9-22 January 2019

139 Procedure-associated Module SSI For the purpose of NHSN SSI reporting, hysterectomy procedure codes 11. HYST or VHYS: are listed in the that involve an incision made into the abdomen, including trocar insertion, abdominal hysterectomy (HYST) category. The correct CPT hysterectomy procedure codes should be assigned by a medical record coder using current guidelines and conventions. Hysterectomy procedures should be designated as an HYST or VHYS, based on the approach of the procedure (5th character of the ICD-10 operative procedure code) s to the hysterectomy procedure. that the facility’s medical coder assign th ICD-10 5 Approach Procedure Cha racter HYST 0 Open Percutaneous endoscopic 4 Via natural or artificial opening with percutaneous F endoscopic assistance VHYS 7 Via natural or artificial opening Via natural or artificial opening with endoscopic 8 -23 January 2019 9

140 Procedure-associated Module SSI The Standardized Infection Ratio (SIR) is calculated by dividing the number Data Analyses: of observed infections by the number of predicted (expected) infections. The number of predicted infections is calculated using SSI probabilities estimated from multivariate logistic regression models constructed from NHSN data during a baseline time period, which 3 . The procedures/SSI occurring in adults are represents a standard population’s SSI experience modeled separately from those occurring in pediatrics. s available from NHSN, each briefly described in the table There are three main SSI SIR Model below. The first two models, the All SSI SIR and the Complex A/R SSI SIR models, are available for all NHSN operative procedures/SSI occurring in both adults and pediatric patients, while the third model, the Complex 30-day SSI SIR is available for colon and abdominal hysterectomy procedures/SSI occurring in adults only. Please see the NHSN SIR Guide for more m odel specific information : https://www.cdc.gov/nhsn/pdfs/ps-analysis-resources/nhsn-sir-guide.pdf All SSI SIR  Includes separa te models for inpatient and hospital outpatient procedures ) (under the 2015 baseline Model  Includes Superficial, Deep & Organ/Space SSIs  Superficial & Deep incisional SSIs limited to primary incisional SSIs only  Includes SSIs identified on admission, readmission & via post-discharge surveillance Complex Includes only Deep incisional primary SSIs & Organ/Space SSIs  Includes only SSIs identified on Admission/Readmission to facility where  A/R SSI procedure was performed Model Includes only  inpatient procedures Used for the HAI Progress Report, published annually by CDC  Complex  Includes only in-plan, inpatient COLO and HYST procedures in adult , ≥ 18 years of age) patients (specifically 30-day SSI  Includes only deep incisional primary SSIs and organ/space SSIs with an model (used event date within 30 days of the procedure for CMS  Includes SSIs identified on admission, readmission & via post-discharge IPPS) surveillance  Uses Diabetes, ASA score, gender, age, BMI, oncology hospital and clos ure technique to determ ine risk for COLO (under the 2015 baseline, BS2) Uses Diabetes, ASA score, age, BMI and oncology hospital to determine risk for HYST (under the 2015 baseline, BS2)  NOTE: The Complex 30-day SSI model, under the 2006-2008 baseline, BS1, uses only age and ASA to determine risk for both COLO and HYST (BS1 applies to data up to 2016) Used only for CMS IPPS reporting and for public reporting on Hospit  al Compare 9-24 January 2019

141 Procedure-associated Module SSI While the SSI SIR can be calculated for single procedure categories and for specific surgeons, the measure also allows you to summarize your data across multiple procedure categories while adjusting for differences in the estimated probability of infection among the patients included across the procedure categories. For example, you will be able to obtain one SSI SIR adjusting for all procedures reported. Alternatively, you can obtain one SSI SIR for all COLO only within your facility. Additional Notes about SSI SIRS: 1. Rebaseline of NHSN data: The new baseline, termed BS2, and updated risk- adjustments of HAI data using the 2015 NHSN data is available in the application as of January 2017. The new baseline can be applied to 2015 data and forward. The older baseline, termed BS1, which used the 2006-2008 NHSN data, will also be available in the application and may be applied to only the 2016 data and older. 2. Closure technique: All of the SSI SIRs that use the 2006-2008 SSI baseline data will All of include only those procedures that were reported with a primary closure method. the SSI SIRs that use the 2015 baseline data will include all procedures that were reported with primary or other than primary closure methods. All of the SSI SIR reports that use the Infection present at time of surgery (PATOS): 3. 2006 -2008 SSI baseline will include SSIs that are reported as present at time of surgery. Meaning the PATOS event is included in the numerator of the SIR and the procedure from which the event occurred is included in the denominator of the SIR. All of the SSI SIR reports that use the new 2015 SSI baseline will exclude SSIs that are reported as present at time of surgery from both the numerator and denominator. Meaning the PATOS event is excluded in the numerator of the SIR and the procedure from which the event occurred is excluded in the denominator of the SIR. SSIs will be included in the numerator of an SIR SIRs based on Procedure Date: 4. based on the date of procedure, not the date of event. This is because the procedure carries the risk for the infection/SSI. Calculation of the SIR: The SIR will be calculated only if the number of predicted 5. number of HAIs (“numPred” in the NHSN application, previously known as the expected HAIs, “numExp”) is ≥ 1 to help enforce a minimum precision criterion. SIR = Observed (O) HAIs Predicted (P) HAIs SSI rates per 100 operative procedures are calculated by dividing the number of SSIs by the number of specific operative procedures and multiplying the results by 100. SSIs will be included in the numerator of a rate based on the date of procedure, not the date of event. Using the advanced analysis feature of the NHSN application, SSI rate calculations can be performed separately for the different types of operative procedures and stratified by the basic risk index. -25 January 2019 9

142 Procedure-associated Module SSI Descriptive analysis options of numerator and denominator data are available in the NHSN application, such as line listings, frequency tables, and bar and pie charts. SIRs and SSI rates and run charts are also available. Guides on using NHSN analysis features are available from: www.cdc.gov/nhsn/PS-Analysis-resources/reference-guides.html -26 9 January 2019

143 Procedure-associated Module SSI specific event types APPENDIX. SSI attributed to each NHSN procedure category. Operative Procedure Category Specific Event Type AAA - Abdominal aortic aneurysm repair DIP - Deep Incisional Primary ENDO - Endocarditis GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary VASC - Arterial or venous infection AMP - Limb amputation BONE - Osteomyelitis DIP - Deep Incisional Primary JNT - Joint or bursa SIP - Superficial Incisional Primary APPY - Appendix surgery DIP - Deep Incisional Primary ct GIT - Gastrointestinal tra IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary DIP - Deep Incisional Primary AVSD - AV shunt for dialysis SIP - Superficial Incisional Primary VASC - Arterial or venous infection BILI - Bile duct, liver or pancreatic surgery DIP - Deep Incisional Primary GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary BRST - Breast surgery BRST - Breast abscess or mastitis DIP - Deep Incisional Primary DIS - Deep Incisional Secondary SIP - Superficial Incisional Primary - Superficial Incisional Secondary SIS CARD - Cardiac surgery BONE - Osteomyelitis CARD - Myocarditis or pericarditis DIP - Deep Incisional Primary ENDO - Endocarditis IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract MED - Mediastinitis SIP - Superficial Incisional Primary VASC - Arterial or venous infection -27 9 January 2019

144 Procedure-associated Module SSI Operative Procedure Category Specific Event Type BONE - Osteomyelitis CBGB - Coronary bypass with chest & donor CARD - Myocarditis or pericarditis incisions DIP - Deep Incisional Primary DIS - Deep Incisional Secondary ENDO - Endocarditis IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract MED - Mediastinitis SIP - Superficial Incisional Primary SIS - Superficial Incisional Secondary VASC - Arterial or venous infection BONE - Osteomyelitis CBGC - Coronary bypass graft with chest incision CARD - Myocarditis or pericarditis DIP - Deep Incisional Primary ENDO - Endocarditis IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract MED - Mediastinitis SIP - Superficial Incisional Primary VASC - Arterial or venous infection CEA - Carotid endarterectomy DIP - Deep Incisional Primary DIS - Deep Incisional Secondary SIP - Superficial Incisional Primary SIS - Superficial Incisional Secondary VASC - Arterial or venous infection DIP - Deep Incisional Primary CHOL - Gallbladder surgery GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary COLO - Colon surgery DIP - Deep Incisional Primary GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection BONE - Osteomyelitis CRAN - Craniotomy DIP - Deep Incisional Primary IC - Intracranial infection MEN - Meningitis or ventriculitis SINU - Sinusitis SIP - Superficial Incisional Primary -28 9 January 2019

145 Procedure-associated Module SSI Operative Procedure Category Specific Event Type CSEC - Cesarean section DIP - Deep Incisional Primary EMET - Endometritis GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection FUSN - Spinal fusion BONE - Osteomyelitis DIP - Deep Incisional Primary DIS - Deep Incisional Secondary DISC - Disc space infection IAB - Intraabdominal, not specified elsewhere IC - Intracranial infection LUNG - Other infections of the lower respiratory tract MEN - Meningitis or ventriculitis SA - Spinal scess/infection ab SIP - Superficial Incisional Primary SIS - Superficial Incisional Secondary FX - Open reduction of fracture BONE - Osteomyelitis DIP - Deep Incisional Primary JNT - Joint or bursa SIP - Superficial Incisional Primary DIP - Deep Incisional Primary GAST - Gastric surgery GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract SIP - Superficial Incisional Primary DIP - Deep Incisional Primary HER - Herniorrhaphy IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary HPRO - BONE - Osteomyelitis Hip prosthesis DIP - Deep Incisional Primary PJI - Periprosthetic joint infection SIP - Superficial Incisional Primary -29 9 January 2019

146 Procedure-associated Module SSI Operative Procedure Category Specific Event Type HTP - Heart transplant BONE - Osteomyelitis CARD - Myocarditis or pericarditis DIP - Deep Incisional Prima ry ENDO - Endocarditis IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract MED - Mediastinitis SIP - Superficial Incisional Primary VASC - Arterial or venous infection HYST - Abdominal hysterectomy DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary VCUF - Vaginal cuff infection BONE - Osteomyelitis KPRO - Knee prosthesis DIP - Deep Incisional Primary PJI - Periprosthetic joint infection SIP - Superficial Incisional Primary KTP - Kidney transplant DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection VASC - Arterial or venous infection BONE - Osteomyelitis LAM - Laminectomy ry DIP - Deep Incisional Prima DISC - Disc space infection IAB - Intraabdominal, not specified elsewhere IC - Intracranial infection MEN - Meningitis or ventriculitis SA - Spinal abscess/infection SIP - Superficial Incisional Primary LTP - Liver transplant DIP - Deep Incisional Primary GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary VASC - Arterial or venous infection -30 January 2019 9

147 Procedure-associated Module SSI Operative Procedure Category Specific Event Type NECK - Neck surgery DIP - Deep Incisional Primary EAR - Ear, mastoid infection ORAL - Oral cavity infection (mouth, tongue, or gums) SIP - Superficial Incisional Primary UR - Upper respiratory tract infection, pharyngitis, laryngitis, epiglottitis DIP - Deep Incisional Primary NEPH - Kidney surgery IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection OVRY - Ovarian surgery DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection CARD - Myocarditis or pericarditis PACE - Pacemaker surgery DIP - Deep Incisional Primary ENDO - Endocarditis IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary VASC - Arterial or venous infection DIP - Deep Incisional Primary PRST - Prostate surgery IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection PVBY - Peripheral vascular bypass surgery DIP - Deep Incisional Primary DIS - Deep Incisional Secondary SIP - Superficial Incisional Primary SIS - Superficial Incisional Secondary VASC - Arterial or venous infection REC - Rectal surgery DIP - Deep Incisional Primary DIS - Deep Incisional Secondary GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary - Superficial Incisional Secondary SIS USI - Urinary System Infection -31 9 January 2019

148 Procedure-associated Module SSI Specific Event Type Operative Procedure Category SB - Small bowel surgery DIP - Deep Incisional Primary GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection SPLE - Spleen surgery DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere SIP - Superficial Incisional Primary THOR - Thoracic surgery BONE - Osteomyelitis BRST - Breast abscess or mastitis DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere LUNG - Other infections of the lower respiratory tract SIP - Superficial Incisional Primary THYR - Thyroid and/or parathyroid surgery DIP - Deep Incisional Primary EAR - Ear, mastoid infection GIT - Gastrointestinal tract SIP - Superficial Incisional Primary UR - Upper respiratory tract infection, pharyngitis, laryngitis, epiglottitis VHYS - Vaginal hysterectomy DIP - Deep Incisional Primary IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection VCUF - Vaginal cuff infection BONE - Osteomyelitis VSHN - Ventricular shunt DIP - Deep Incisional Primary DIS - Deep Incisional Secondary IAB - Intraabdominal, not specified elsewhere IC - Intracranial infection Other infections of the lower respiratory tract – LUNG MEN - Meningitis or ventriculitis SA - Spinal abscess/infection SIP - Superficial Incisional Primary - Superficial Incisional Secondary SIS -32 9 January 2019

149 Procedure-associated Module SSI Specific Event Type Operative Procedure Category XLAP - Exploratory laparotomy DIP - Deep Incisional Primary EMET - Endometritis GIT - Gastrointestinal tract IAB - Intraabdominal, not specified elsewhere OREP - Deep pelvic tissue infection or other infection of the male or female reproductive tract SIP - Superficial Incisional Primary USI - Urinary System Infection -33 9 January 2019

150 Procedure-associated Module SSI References 1 McDermott K.W., et al., Overview of Operating Room Procedures During Inpatient Stays in U.S. Hospitals, 2014. HCUP Statistical Brief #233. December 2017. Agency for Healthcare Research and Quality, Rockville, MD. Available from: https://www.hcup- us.ahrq.gov/reports/statbriefs/sb233-Operating-Room-Procedures-United-States- 2014.jsp 2 Magill, S.S., et al., "Multistate point-prevalence survey of health care-associated ): 1198-1208. , 370(13): (2014 England Journal of Medicine infections". N ew 3 Mu, Y., et al., "Improving risk-adjusted measures of surgical site infection for the Infection Co national healthcare safety network". ntrol Hospital Epidemiology , 32(10): (2011): 970-86. 4 onal and State Healthcare-Associated Infections Progress Report, published March 2016, CDC Nati available from: https://www.cdc.gov/HAI/pdfs/progress-report/hai-progress-report.pdf 5 Awad, S.S., "Adherence to surgical care improvement project measures and post- operative surgical site infections ". Surgical Infection (Larchmt), 13(4): (2012 ): 234-7. 6 Zim lichman, E., et al., "Health Care-Associated Infections. A Meta-analysis of Costs and Financial , 173(22): (2013): 2039-46. JAMA Intern Med Impact on the US Health Care System". 7 de Lissovoy, G., et al., "Surgical site infection: Incidence and impact on hospital utilization and treatment costs". Am J Infect Control, 37(5): (2009): 387-97. 8 Condon, R.E., et al., "Effectiveness of a surgical wound surveillance program" . Archives of Surg ery , 118(3): (1983): 303-7. 9 Consensus paper on the surveillance of surgical wound infections. The Society for Hospital Epidemiology of America; The Association for Practitioners in Infection Control; The Centers for Disease Control ; Th e Surgical Infection Society . Infection Control Hospital Epidemiology, 13(10): (1992): 599-605. 10 Haley, R.W., et al., "The efficacy of infection surveillance and control programs erican Journal of Epidemiology , Am in preventing nosocomial infections in US hospitals" . ):182-205. 121(2) :(1985 11 Berríos-Torres, SI. et al., Centers for Disease Control and Prevention Guideline for the Prevention of JAMA Surg, Surgical Site Infection. 152(8): (2017):784-91. 12 Institute, F.G., Guidelines for design and construction of health care facilities. 2010, Chicago, IL: American Society for Healthcare Engineering. 13 American Society of Anesthesiologists. ASA Physical Status Classification System . Available from: http://www.asahq.org/quality-and-practice-management/standards-guidelines-and- related-resources/asa-physical-status-classification-system. 14 Donham, R.T., W.J. Mazzei, and R.L. Jones, Association of Anesthesia Clinical Directors' Procedure Times Glossary ):S1 - . Am erican Journal of Anesthesiology , 23(5S): (1996 S12. -34 9 January 2019

151 Device- associated Module VAE Ventilator -Associated Event (VAE) For use in adult locations only Table of Contents: Introduction 1 3 Settings 3 Definitions Reporting Instructions 16 Figure 1 VAE Algorithm 19 Numerator Data 20 Denominator Data 20 Data Analyses 21 References 23 24 Appendix of Antimicrobial Agents 26 Frequently -Asked Questions Introduction: -saving therapy for patients with Mechanical ventilation is an essential, life spiratory failure. Studies have estimated that more than 300,000 patients critical illness and re receive mechanical ventilation in the United States each year [1 -3]. These patients are at high risk for complications and poor outcomes, including death [1-5]. Ventilator -associated pneumonia (VAP), sepsis, Acute Respiratory Distress Syndrome (ARDS), pulmonary embolism, barotrauma, and pulmonary edema a re among the comp lications that can occur in patients receiving mechanical ventilation; such complications can lead to longer duration of mechanical ventilation, longer stays in the ICU and hospital , increased healthcare costs, and increased risk of with acute lung injury on mechanical ventilation has disability a nd death. M ortality in patients 19 years of age to 60% for patients 85 years and been estimated to range from 24% in persons 15- older [4]. Surveillance for ventilator -associated events in the National Healthcare S afety Network (NHSN) prior to 2013 was limited to VAP. For the year 2012, VAP incidence for various types of However, there is currently no hospital units ranged from 0.0-4.4 per 1,000 ventilator days [6]. definitions valid, reliable definition for VAP, and even the m ost widely -used VAP criteria and are nei ther sensitive nor specific [7-10]. difficulty with many commonly- VAP definitions, including the NHSN PNEU used A particular definitions (revised in 2002), is that they require radiographic findings of pneumonia. Evidence suggests that chest radiograph findings do not accurately identify VAP. The subjectivity and variability inherent in chest radiograph technique, interpretation, and reporting make chest imaging ill- for inclusion in a definition algorithm to be used for the potential purposes of suited January 2019 10-1

152 Device- associated Module VAE performance public reporting, inter-facility comparisons, and pay-for-reporting and pay- for- programs. Ano ther major difficulty with available VAP definitions is their reliance on specific clinical signs or symptoms, which are subjective and may be poorly or inconsistently documented in the medical record. T he NHSN PNEU protocol includes multiple definition pathways and special criteria for selected patient populations (for example, children, immunocompromis complexity. ed patients), increasing its The limitations of VAP surveillance definitions have implications for prevention. Valid and reliable surveillance data are necessary for assessing the effectiveness of prevention strategies. It is notable that som e of the most effective measures for improving outcomes of patients on mechanical ventilation do not specifically target pneumonia prevention [11-14]. of several stakeholder In 2011, CDC convened a Working Group composed of members ss the limitations of the NHSN PNEU definitions and propose a new organizations to addre for NHSN [15]. The approach to surveillance for Ventilator- Associated Events (VAE) organizations represented in the Working Group include: the Critical Care Societies Collaborative (the American Association of Critical- Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society for Critical Care Medicine); the Control American Association for Respiratory Care; the Association of Professionals in Infection and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection ous Diseases Control Practices Advisory Committee’s Surveillance Working Group; the Infecti and the Society for Healthcare Epidemiology of America. Society of America; The VAE surveillance definition algorithm developed by the Working Group and implemented based on objective, streamlined, and potentially automatable in the NHSN in January 2013 is criteria that identify a broad range of conditions and complications occurring in mechanical ly- 16]. ventilated adult patients [ Several modifications to the VAE definitions have been made since January 2013. These modifications address issues raised by NHSN users and discussed with the Working Group. There are t hree definition tiers within the VAE algorithm: 1) Ventilator -Associated Condition (VAC); 2) Infection- related Ventilator -Associated VAP Complication (IVAC); and 3) Possible VAP (P ata indicate that streamlined, objective ). D ciated complications -asso algorithms to detect ventilator (similar to the VAC tier of the VAE algorithm) are easily implemented, can make use of electronic health record systems to automate event detection, and identify events that are clinica lly important and associated with outcomes such as ICU and hospital leng Research suggests that most VACs 16,17]. th of stay and mortality [ are due to pneumonia, ARDS , atelectasis, and pulmonary edema [16]. These are significant clinical conditions that may be preventable. VAE rates and event characteristics in 2014 in adult o NHSN have been published [18]. inpatient locations reporting data t The VAE definition algorithm is for use in surveillance; it is not a clinical definition NOTE: algorithm and is not intended for use in the clinical management of patients. Examples provided e for illustration throughout this protocol and in the VAE “Frequently-Asked Questions” ar purposes only and are not intended to represent actual clinical scenarios. January 2019 10-2

153 Device- associated Module VAE Settings adult locations : Inpatient locations eligible to participate in VAE surveillance are those in acute care hospitals, long term acute care hospitals, and inpatient rehabilitation facilities where denominator data (ventilator and patient days) can be collected for patients. Such locations may -down units and include critical/intensive care units (ICU), specialty care areas (SCA), step . A complete lis wards ting of adult inpatient locations can be found in Chapter 15. NOTE : Non -acute care mapped locations in acute care facilities (chronic care units in acute care facilities) are not eligible to participate in VAE surveillance. NOTE: It is not r r s after discharge if a patient is transferred to anothe equired to monitor for VAE facility while still on mechanical ventilation. H owever, VAEs discovered within 2 calendar days of discharge (where the day of discharge is day 1) should be reported to NHS N. No additional ventilator days are reported. : Definitions : VAEs are in identified by using a combination of objective criteria: deterioration VAE respiratory status after a period of stability or improvement on the ventilator, evidence of infection or inflammation, and laboratory evidence of respiratory infection. The followi ng pages outline the criteria that must be used for meeting the VAE surveillance definition s ( Figure 1 ). To -Associated Event form ( report VAEs, use the Ventilator Instructions for CDC 57.112) and Completion. NOTE: Patients must be mechanically ventilated for at least 4 calendar days to fulfill VAE criteria (where the day of intubation and initiation of mechanical ventilation is day 1). The earliest date of event for VAE (the date of onset of worsening oxygenation) is day 3 of mechanical ventilation. Line lists of VAE data elements demonstrating scenarios that meet and do not meet the VAE definitions are presented in “Frequently-Asked Questions (FAQs)” number (no.) 2 at the end of this chapter. NOTE: The baseline period of stability or improvement on the ventilator is defined as the 2 calendar days immediately preceding the first day of incr eased daily minimum PEEP or and must be characterized by ≥ 2 calendar days of stable or decreasing daily FiO 2, specifically on the or PEEP values ( the daily minimum PEEP or FiO minimum FiO 2 2 second day of the baseline period of stability or improvement must be equal to or less on the first day of the baseline period of stability than the daily minimum PEEP or FiO 2 or improvement). The definition ” s of “daily minimum PEEP” and “daily minimum FiO 2 Note that the minimum daily PEEP or FiO2 us are included below. ed for VAE surveillance is the lowest setting during a calendar day that was maintained for > 1 hour (see daily minimum PEEP and FiO2 definitions for exception to 1 hour requirement). January 2019 10-3

154 Device- associated Module VAE For the purposes of VAE surveillance, PEEP values between 0 cmH O and 5 cmH O will 2 2 be considered equivalent. This means that patients with daily minimum PEEP values from 0 to 5 cmH O must then have an increase in the daily minimum PEEP to at least 8 2 cmH O, sustained for at least 2 calendar days, to meet the VAC definition. 2 EXAMPLE: In the example below, the baseline period is defined by mechanical ventilation (MV) days 1 through 4 (shaded in light gray), and the period of worsening oxygenation by MV days 5 and 6 (shaded in darker gray), where the daily minimum PEEP is ≥ mH 3 c O greater than the daily minimum PEEP of the first day in the baseline 2 5 cmH period. Note that there is no VAC on MV day 3, because PEEP values 0- O are 2 considered equivalent for the purposes of this surveillance. Daily minimum Daily minimum MV Day VAE PEEP (cmH (oxygen concentration, %) O) FiO 2 2 0 1 - 1.00 (100%) (5) 2 (5) 0.50 (50%) - 0 5 3 - 0.50 (50%) - 0.50 (50%) 5 4 5 VAC 0.50 (50%) 8 6 0.50 (50%) - 8 EXAMPLE: In the example below, the baseline period is defined by mechanical ventilation (MV) days 1 through 4 (shaded in light gray), and the period of worsening oxygenation by MV days 5 and 6 (shaded in darker gray), where the daily minimum PEEP is ≥ 3 cmH O greater than the daily minimum PEEP of the first day in the baseline 2 4 are considered a baseline period even period. In this example, note that MV days 1- O during this time though the daily minimum PEEP increases from 0 to 3 to 5 cmH 2 period—because PEEP values from 0-5 O are considered equivalent for the cmH 2 purposes of this surveillance. Daily minimum Daily minimum MV Day VAE PEEP (cmH (oxygen concentration, %) O) FiO 2 2 1.00 (100%) - 1 0 (5) - 2 0 (5) 0.50 (50%) 0.50 (50%) 3 (5) 3 - - 5 0.50 (50%) 4 VAC 5 8 0.50 (50%) 8 6 - 0.50 (50%) 2019 10-4 January

155 Device- associated Module VAE EXAMPLE: In the example below, the baseline period is defined by mechanical ) days 3 and 4 (shaded in light gray), and the period of worsening ventilation ( MV where the daily minimum FiO oxygenation by MV days 5 and 6 (shaded in darker gray), 2 of the first day in the baseline period. is ≥ 0.20 (20 points) over the daily minimum FiO 2 Daily minimum Daily minimum MV Day VAE PEEP (cmH ( oxygen concentration, %) O) FiO 2 2 1.00 1 8 (100%) - (50%) 2 6 0.50 - (40%) 3 5 - 0.40 0.40 (40%) - 5 4 6 0.70 (70%) 5 VAC 6 0.70 (70%) - 6 , because the FiO EXAMPLE: In the example below, there is no VAC on MV day 4 is 2 on MV day 3 (and therefore not stable or decreasing) higher than the FiO – even though 2 on MV days 3 and 4 meets the 20-point threshold when compared with the daily the FiO 2 on MV days 5 and 6. minimum FiO 2 Daily minimum Daily minimum VAE MV Day O) FiO ( oxygen concentration, %) PEEP (cmH 2 2 1.0 8 (100%) 1 0.50 6 2 (50%) 5 3 0.35 (35%) (40%) 4 0.40 5 0.70 6 5 No event (70%) 6 (70%) 0.70 6 NOTE: Patients on high frequency ventilation, extracorporeal or paracorporeal life support are EXCLUDED from VAE surveillance during periods of time when the support is in place the entire calendar day (see FAQ no. 22). NOTE: Patients who are receiving a conventional mode of mechanical ventilation while in the prone position and patients who are receiving a conventional mode of mechanical , helium-oxygen mixtures (heliox) or ventilation while receiving nitric oxide therapy in VAE surveillance. epoprostenol therapy are INCLUDED entilation (APRV) or related modes (see ressure Release V NOTE: Patients on Airway P FAQ no s. 22 and 23), are INCLUDED, but when this mode is in use the VAE period of stability or improvement on the ventilator and the period of worsening oxygenation only, since changes in PEEP as indicated in this should be determined by changes in FiO 2 not be applicable to APRV. In addition, patients with VAE surveillance algorithm may who are on APRV or related modes of mechanical ventilation can optionally be indicated 7.112). CDC 5 as such on the VAE Form ( 2019 January 10-5

156 Device- associated Module VAE NOTE: VAEs are defined by a 14 -day period, starting on the day of onset of worsening oxygenation (the event date, day 1). A new VAE cannot be identified or reported until this 14-day period has elapsed. See FAQ no. 4. Date of event : The da te of onset of worsening oxygenation. This is defined as the first calendar day in which the daily minimum PEEP or FiO increases above the thresholds outlined in the 2 VAE definition algorithm ( specifically day 1 of the required ≥ 2 -day period of worsening ox ygenation following a ≥ 2 -day period of stability or improvement on the ventilator). EXAMPLE: A patient is intubated in the Emergency Room for severe community - acquired pneumonia and admitted to the MICU (day 1). The patient stabilizes and improves on day -5, with a daily minimum FiO s 2 of 0.35 (35%) on days 4 and 5. On day 2 6, the patient experiences respiratory deterioration, and requires a minimum FiO of 0.60 2 (60%) on days 6 and 7, meeting the criteria for a VAC. The date of the VAC event is day 6. NOT E: The “date of event” is NOT the date on which all VAE criteria have been met. It is the first day (of a ≥ 2 -day period) on which either of the worsening oxygenation ) is met. thresholds ( for PEEP or FiO 2 eriod VAE Window P y of the da specifically : This is the period of days around the event date ( - onset of worsening oxygenation) within which other VAE criteria must be met. It is usually a 5 day period and includes the 2 days before, the day of, and the 2 days after the VAE event date (specifically the first day of worsening oxygenation, the day of VAE onset). There is an exception, however, in which the VAE Window Period is only 3 or 4 days, as follows: ate corresponds to MV day 3 or day 4, the window period In cases where the VAE event d described above may only be a 3- -day window, because it can NOT include any day or a 4 rd day of MV. F or example, if the VAE event date is MV d ay 3, then the days before the 3 window period includes only the day of VAE onset and the 2 days after VAE onset rd day of MV). (because the 2 days before VAE onset are before the 3 Positive End- Expiratory Pressure (PEEP): “A technique used in respiratory therapy in which airway pressure greater than atmospheric pressure is achieved at the end of exhalation by the introduction of a mecha nical impedance to exhalation” [1 9]. In patients on mechanical ventilation, PEEP is one of the key parameters that can be adjusted depending on the patient’s O. A sustained increase (defined oxygenation needs , and is typically in the range of 0 to 15 cmH 2 later in this protocol) O following a period of stability in the daily minimum PEEP of ≥ 3 cmH 2 or improvement on the ventilator is one of two criteria that can be used in meeting the VAC O are considered definition. For the purposes of this surveillance, PEEP values from 0 to 5 cmH 2 equivalent. ): The of oxygen in inspired gas. For example, the fraction Fraction of inspired oxygen (FiO 2 of ambient air is 0.21; the oxygen concentration of ambient air is 21%. In patients on FiO 2 January 2019 10-6

157 Device- associated Module VAE is one of the key parameters that can be adjusted depending on mechanical ventilation, the FiO 2 lly in the range of 0.30 (oxygen concentration of the patient’s oxygenation needs, and is typica . A sustained increase (defined later in this protocol) 30%) to 1.0 (oxygen concentration of 100%) in the daily minimum FiO of ≥ 0.20 (20%) following a period of stability or improvement on the 2 ventilator is the second of the two criteria that can be used in meeting the VAC definition. : The lowest value of PEEP during a calendar day that is set on the Daily minimum PEEP ventilator and maintained for > 1 hour . This requirement that the daily minimum PEEP be the lowest setting maintained for > 1 hour will ensure that units monitoring and recording PEEP settings hourly or more frequently than once per hour are able to apply the VAE surveillance PEEP criterion in a standardized way. In the event that ventilator settings are monitored and recorded less frequently than once per hour, the daily minimum PEEP is simply the lowest value of PEEP set on the ventilator during the calendar day. In circumstances where there is no value that is documented to have been maintained for > one hour ( for example., the lowest value of PEEP is set late in the calendar day, mechanical ventilation is discontinued early in the calendar day, PEEP settings are changed very frequently throughout the calendar day ) the dail y minimum (regardless of how long lowest PEEP set ng the calendar day duri ting PEEP should default to the as maintained) . For example, a patient who is intubated and started on mechanical that setting w ventilation at 11:30 pm on June 1, with a PEEP setting of 10 cmH O from 11:30 pm to midnight, 2 O on June 1 for the purposes of VAE would have a daily minimum PEEP of 10 cmH 2 surveillance. NOTE: In units tracking PEEP settings every hour or more frequently than every hour, there must be sufficient consecutive recordings of a specific PEEP setting to meet the minimum required duration of > 1 hour. For example, in units tracking PEEP every 15 minutes, 5 consecutive recordings of PEEP at a certain level would be needed to meet the required >1 hour minimum duration ( for example., at 09:00, 09:15, 09:30, 09:45 and 10:00). In units tracking PEEP every 30 minutes, 3 consecutive recordings of PEEP at a certain level would be needed to meet the required >1 hour minimum duration ( for example, at 09:00, 09:30, and 10:00). In units tracking PEEP every hour, 2 consecutive recordings of PEEP at a certain level would be needed to meet the required >1 hour , at (for example minimum duration 09:00 and 10:00). EXAMPLE: The patient is intubated at 6 pm. PEEP is set at the following values through the remainder of the calendar day: 10 pm Time 6 pm 7 pm 8 pm 9 pm 11 pm 8 5 8 5 8 10 PEEP O) (cmH 2 In this example, the daily minimum PEEP for the purposes of VAE surveillance is 5 O. PEEP settings are being monitored and recorded every hour. There are two cmH 2 consecutive hours where the PEEP setting is noted to be 5 cmH O (8 pm and 9 pm), and 2 therefore required minimum duration of >1 hour is met. January 2019 10-7

158 Device- associated Module VAE EXAMPLE: The patient is intubated at 6 pm. PEEP is set at the following values through the remainder of the calendar day: 8 pm 7 pm 11 pm 10 pm 9 pm Time 6 pm 8 8 5 5 8 8 PEEP (cmH O) 2 In this example, the daily minimum PEEP for the purposes of VAE surveillance is 8 cmH O. PEEP settings are being monitored and recorded every hour. Although the 2 lowest PEEP is 5 cmH consecutive time points only (8 pm, O, it is recorded at two non- 2 then 10 pm), and so the required >1 hour minimum duration is not met. There are two O (6 pm and 7 pm), and consecutive hours where the PEEP setting is noted to be 8 cmH 2 1 hour is met to allow use of this setting as therefore the required minimum duration of > the daily minimum value for VAE surveillance. EXAMPLE: PEEP is set at the following values through the course of a calendar day: 12 pm Time 12 am 4 am 8 am 4 pm 8 pm 10 8 8 5 8 5 PEEP O) (cmH 2 O. PEEP settings are being In this example, the daily minimum PEEP is 5 cmH 2 monitored and recorded every 4 hours; therefore the lowest recorded PEEP setting for the calendar day is the value used in VAE surveillance. EXAMPLE: You are reviewing a patient’s ventilator settings on Wednesday morning to determine the daily minimum PEEP values for Monday and Tuesday. The MICU monitors and records PEEP settings for mechanically ventilated patients every 30 O) was recorded at minu tes. You see that the lowest PEEP setting on Monday (5 cmH 2 11:30 pm when the episode of mechanical ventilation was initiated for this patient. T he patient remained at this PEEP setting for an additional 30 minutes on Tuesday morning, O for the rest of the day on Tuesday. What do was then maintained on PEEP 10 cmH and 2 you record as the daily minimum PEEP for Monday and for Tuesday? In this example, O. Because there is no value on the only PEEP setting recorded on Monday was 5 cmH 2 hat has > one hour, the lowest (and only) setting of 5 been maintained for Monday t 0 is recorded as the daily minimum PEEP for that calendar day . On Tuesday, the cmH 2 daily minimum PEEP should be recorded as 10 cmH O, which is the lowest PEEP setting 2 maintained for > 1 hour on Tuesday. January 2019 10-8

159 Device- associated Module VAE Time Day PEEP (cmH O) 2 Monday 23:30 5 Tuesday 5 00:00 Tuesday 00:30 5 Tuesday 01:00 10 Tuesday 01:30 10 10 02:00 through 23:30 Tuesday Daily minimum FiO The lowest value of FiO during a calendar day that is set on the ventilator 2 2: maintained for > 1 hour . This requirement that the daily minimum FiO be the lowest setting and 2 settings hourly or FiO maintained for > 1 hour will ensure that units monitoring and recording 2 more frequen criterion in a tly than once per hour are able to apply the VAE surveillance FiO 2 standardized way. In the event that ventilator settings are monitored and recorded less frequently is simply the lowest value of than once per hour, the daily minimum FiO set on the FiO 2 2 ventilator during the calendar day. Similarly, in circumstances where there is no value that has is set late in the calendar FiO been maintained for > 1 hour ( for example , the lowest value of 2 day, mechanical ventilation is discontinued earl is y minimum FiO y in the calendar day) the dail 2 FiO the lowest value of set on the ventilator dur ing the calendar day. 2 settings every hour or more frequently than every hour, NOTE: In units tracking FiO 2 setting to meet the FiO there must be sufficient consecutive recordings of a specific 2 minimum required duration of >1 hour. For example, in units tracking FiO every 15 2 minutes, 5 consecutive recordings of FiO at a certain level would be needed to meet the 2 for example, 09:00, 09:15, 09:30, 09:45 and 10:00). required >1 hour minimum duration ( at a certain FiO every 30 minutes, 3 consecutive recordings of In units tracking FiO 2 2 for example, level would be needed to meet the required >1 hour minimum duration ( every hour, 2 consecutive recordings of 09:00, 09:30, and 10:00). In units tracking FiO 2 at a certain level would be needed to meet the required >1 hour minimum duration FiO 2 (for example, 09:00 and 10:00). is set at the following values through EXAMPLE: The patient is intubated at 6 pm. FiO 2 the rem ainder of the calendar day: 6 pm 10 pm 7 pm 11 pm Time 9 pm 8 pm 1.0 0.8 0.8 0.5 0.5 0.8 FiO 2 for the purposes of VAE surveillance is 0.5. In this example, the daily minimum FiO 2 FiO settings are being monitored and recorded every hour. There are two consecutive 2 hours where the FiO setting is noted to be 0.5 (8 pm and 9 pm), and therefore required 2 minimum duration of >1 hour is met. January 2019 10-9

160 Device- associated Module VAE EXAMPLE: The patient is intubated at 6 pm. FiO is set at the following values through 2 the remainder of the calendar day: 9 pm 8 pm 7 pm 11 pm 10 pm Time 6 pm 0.8 0.5 0.8 0.5 0.8 0.8 FiO 2 In this example, the daily minimum FiO for the purposes of VAE surveillance is 0.8. 2 is FiO settings are being monitored and recorded every hour. Although the lowest FiO 2 2 0.5, it is recorded at two non-consecutive time points only (8 pm, and then 10 pm), and so the required 1 hour minimum duration is not met. There are two consecutive hours where the FiO setting is noted to be 0.8 (6 pm and 7 pm), and therefore the required minimum 2 duration of > 1 hour is met to allow use of this setting as the daily minimum value for VAE surveillance. EXAMPLE: FiO course of a calendar day: is set at the following values through the 2 Time 2 pm 4 pm 6 pm 8 pm 10 pm 12 am 0.55 0.60 1.0 0.50 0.40 0.60 FiO 2 is 0.40. FiO In this example, the patient was intubated at 2 pm. The daily minimum FiO 2 2 settings are being monitored and recorded every 2 hours; therefore, the lowest recorded FiO setting for the calendar day is the value used in VAE surveillance. 2 EXAMPLE: You are reviewing a patient’s ventilator settings on Friday morning to determine the daily minimum FiO2 value for Thursday. The patient was intubated and initiated on mechanical ventilation at 21:45 hours on Thursday. The ICU monitored and recorded FiO2 settings for the patient every 15 minutes during the remainder of the day on Thursday. Based on the information recorded in the table below, what should you record as the daily minimum FiO2 for Thursday? In this example, since there is no setting that is maintained for > 1 hour during the calendar day, the daily minimum FiO2 for Thursday is 0.70 (70%). This is the lowest value of FiO2 set on the ventilator during the calendar day. January 2019 10-10

161 Device- associated Module VAE FiO Time Day 2 Thursday 21:45 Intubated; 1.0 22:00 1.0 0.90 22:15 0.90 22:30 22:45 0.70 23:00 0.80 23:15 0.85 23:30 0.85 23:45 0.85 Ventilator: a device used to support, assist or control respiration (inclusive of the weaning period) through the application of positive pressure to the airway when del ivered via an artificial airway, specifically oral/nasal endotracheal or tracheostomy tube. Note: Ventilation and lung expansion devices that deliver positive pressure to the airway (f or or example: nasal example: CPAP, Bipap, bi-level, IPPB and PEEP) via non-invasive means (f prongs, nasal mask, full face mask, total mask, etc.) are not considered ventilators unless positive pressure is delivered via an artificial airway (oral/nasal endotracheal or tracheostomy tube). Episode of mechanical v entilation : Defined as a period of days during which the patient was mechanically ventilated for some portion of each consecutive day. NOTE: A break in mechanical ventilation of at least one fu ll calendar day, followed by reintubation and/or reinitiation of mechanical ventilation during the same hospitalization, defines a new episode of mechanical venti lation. EXAMPLE: A patient is intubated and mechanical ventilation is initia ted at 11 pm on ains intubated and mechanically ventilated from hospital day 1. The patient rem hospital days 2 -10. The patient is extubated at 9 am on hospital day 11, and remai ns extubated on hospital day 12. The patient is reintubated and mechanical ventilation is reinitiated on hospital day 13. The patient remains intubated and mechanically ventilated from hospital (days 1 day 14-18. This patient has had two episodes of mechanical vent ilation -11 and . days 13-18) , separated by at least one full calendar day off of mechanical ventilation New antimicrobial agent: Defined as any agent listed in the on or after that is initiated Appendix the third calendar day of mechanical ventilation AND in the VAE Window Period ( specifically, the period typically defined by the 2 calendar days before, the day of, and the 2 calendar days after the onset date of the VAE ). The agent is considered new for the purposes of this definition days preceding the current start date. if it was NOT given to the patient on either of the 2 EXAMPLE: A patient is intubated and mechanically ventilated on hospital day 1 in the . After MSICU. Ceftriaxone and azithromycin are started on day 1 and administered daily , the patient’s oxygenation deteriorates on days 4 respiratory status 3 days of improving January 2019 10-11

162 Device- associated Module VAE and 5, with a daily minimum PEEP that is 4 cmH O higher than it was on days 2 and 3. 2 Criteria for the VAC definition are met; the date of the event is hospital day 4. Ceftriaxone is discontinued and meropenem is begun on day 5. Azithromycin is continued. In this case, meropenem is a new antimicrobial agent: 1) it was begun on day 5 of mechanical ventilation, and 2) within the VAE Window Period (on the day after VAE onset), and 3) it was not given to the patient on either of the 2 days preceding the current start date. By contrast, ceftriaxone and azithromycin would not be considered new antimicrobial agents, since they were beg un on day 1 of mechanical ventilation and continued daily into the VAE Window Period. must have been given by one of the routes of administration outlined The antimicrobial agent (s) in Table 1 , and therapy with one or more new antimicrobial agents must be continued for at least 4 calendar days (referred to as 4 “qualifying antimicrobial days” or “QADs”). For further guidance on identification of new antimicrobial agents and on how to determine whether the FAQs nos. 6-10 at the end of this chapter. requirement for 4 QADs i s met , refer to : Definitions of routes of administration Table 1 b a Definition Route of Administration Intravenous An intravascular route that begins with a vein. Intramuscular A route that begins within a muscle. Digestive Tract A route that begins anywhere in the digestive tract extending from the mouth through rectum. A route that begins within the respiratory tract, including the Respiratory Tract oropharynx and nasopharynx. a , antibiotic locks, intraperitoneal, intraventricular, irrigation, Other routes of administration are excluded (for example topical). b Definitions per SNOMED Reference Terminology Qualifying Antimicrobial Day (QAD) : A day on which the patient was administered an antimicrobial agent that was determined to be “new” within the VAE Window Period. Four —starting within the consecutive QADs are needed to meet the IVAC antimicrobial criterion VAE Window Period. Days on which a new antimicrobial agent is administered count as QADs. Days between administrations of a new antimicrobial agent also count as QADs as long as there is a gap of no more than 1 calendar day between administrations. For example, if levofloxacin is given on VAE Day 1, has not been given in the 2 preceding calendar days, and is given again on VAE Days 3, 5 and 7, there are 7 QADs—because the days between levofloxacin doses also count as QADs. By contrast, days between administrations of different antimicrobial agents do -1 NOT count as QADs; for example, if levofloxacin is given to the patient on VAE Days - 2 and only, no antimicrobials are given on VAE Day 1, and meropenem is given only on VAE Day 2 2 and (remember there is no VAE Day 0), then there are not 4 consecutive QADs. V -1 AE Days - count as 2 consecutive QADs, but VAE Day 1 cannot be counted as a QAD because it is a day between different antimicrobial agents. January 2019 10-12

163 Device- associated Module VAE : Defined as secretions from the lungs, bronchi, or trachea that Purulent Respiratory Secretions contain >25 neutrophils and <10 squamous epithelial cells per low power field [lpf, x100]. esults r eporting formats for direct NOTE: Some clinical laboratories may use different r examinations of respiratory secretions. Additional instructions for using the purulent respiratory secretions cri terion are provided in Table 2 , below (see also FAQ no. 19). January 2019 10-13

164 Device- associated Module VAE : I nstructions for using the purulent re Table 2 spiratory secretions criterion, based on laboratory reporting of respiratory secretion direct examination results. How do I use the purulent respiratory Instruction secretions criterion if ... Assume that counts of cells identified by My laboratory reports counts of “white blood these other descriptors ( for example, “white cells” or “polymorphonuclear leukocytes” or blood cells”) are equivalent to counts of “leukocytes” rather than counts of neutrophils, unless the laboratory tells you “neutrophils”? this is not the case . Check with the laboratory to get information quantitative My laboratory reports semi- results (not quanti tative results) for numbers about what quantitative ranges the semi- of neutrophils and squamous epithelial cells? quantitative reports correspond to. aboratory cannot provide additional My l Use the following direct examination results -quantitative information on how i ts semi to meet the purulent respiratory secretions reporting corresponds to quantitative criterion: heavy, 4+, or ≥25 neutrophils per reporting ranges for neutrophils and , AND rare, low power field (lpf) [x100] ? squamous epithelial cells occasional, few, 1+ or 2+, or ≤10 squamous epithelial cells per lpf [x100] [20 ]. In this situation, the purulent secretions My laboratory reports only the numbers of criterion may be met using the specified neutrophils present, without reporting the quantitative and semi-quantitative thresholds number of squamous epithelial cells? specifically for neutrophils alone ( heavy, 4+, or ≥25 neutrophils per lpf [x100]). My laboratory uses different reporting In this situation, the purulent secretions thresholds for neutrophils and squamous y be met using the laboratory’s criterion ma epithelial cells ( for example, maximum specified maximum quantitative threshold for report of ≥ 20 neutrophils per low power neutrophils, and/or minimum quantitative field [x100], or minimum report of ≤ 15 threshold for squamous epithelial cells. squamous epithelial cells per low power field [x100])? My laboratory processes respiratory In this situation, a report indicating the specimens such as bronchoalveolar lavage presence of white blood cells, without fluid using a centrifugation procedure ( for quantit ation, is sufficient to meet the purulent example, “cytospin”), and there is no secretions criterion. quantitation of quantitation or semi- neutrophils or white blood cells in the direct examination report? January 2019 10-14

165 Device- associated Module VAE Location of attribution: The inpatient location where the patient was assigned on the date of the , which is further defined as the date of onset of worsening oxygenation. VAE : Patient is intubated and ventilated in the Operating Room on hospital day 1, EXAMPLE and then is admitted post-operatively to the SI CU on hospital day 1, still on the ventilator . On hospital day 3, the patient experiences the onset of worsening oxygenation, manifested by an increase in the daily minimum FiO of ≥ 0.20 (20%). On 2 th the patient meets criteria for a VAC. day 4 (also the 4 day of mechanical ventilation) This is reported to NHSN as a VAC for the SICU. EXCEPTION : Transfer Rule : If a VA E develops on the day of transfer or the day following transfer from one inpatient location to another in the same facility or to a new facility (where the is attributed to the transferring location. This is called the event day of transfer is day 1), and examples are shown below: the Transfer Rule, EXAMPLE: Patient on a ventilator in the SICU who has had improving oxygenation for 3 days is transferred to the MICU, still on the ventilator. On the day of transfer, after the patient has arrived in the MICU, the patient experiences an acute d ecompensation, requiring an increase of 0.30 (30 points) in FiO that persists during the following 2 calendar day. VAC criteria are met on calendar day 2 in the MICU. Because the onset of worsening oxygenation occurred on the day of transfer to the MICU, the VAC event is attributed to the SICU. EXAMPLE: Patient is extubated in the MICU and transferred to the medical stepdown unit on hospital day 6. The next day, while in the stepdown unit (day 7) , the patient experiences worsening oxy genation and is reintubated and transferred back to the MICU. Criteria for VAC are met the next day (day 8). In this case, the day prior to extubation and the day of extubation (hospital days 5 and 6) count as the required 2-day period of stability or impr ovement. The day of reintubation (day 7) and the following day (day 8) count as the required 2-day period of worsening oxygenation. Because the onset of worsening oxygenation occurred on the day following transfer out of the MICU, the event is reported to NHSN as a VAC for the MICU. EXAMPLE: Patient intubated and mechanically ventilated for 8 days in the MSICU of Hospital A is transferred for further care on day 8 to the MS ICU of Hospital B. The patient was stable on the ventilator in Hospital A from days 3-8. On the day of transfer to Hospital B (day 1 in Hospital B ), the patient’s respiratory status deteriorates. The patient’s respiratory status continues to worsen on the day after transfer (day 2 in Hospi tal B), the patient meets criteria for VAC on hospital day 3. The date of the event is day 2in Hospital B, the first day of the period of worsening oxygenation meeting VAE thresholds . The infection preventionist (IP) from Hospital B calls the PEEP or FiO 2 . This VAC Hospital A IP to report that this patient was admitted to Hospital B with a should be reported to NHSN for and by Ho VAC , and attributed to the Hospital A spital A January 2019 10-15

166 Device- associated Module VAE MS ICU. Date of event was day following transfer. No additional ventilator days are reported by Hospital A . (additional guidance may be found in the FAQs at the end of REPORTING INSTRUCTIONS this chapter) : Conducting in-plan VAE surveillance means assessing patients for the presence of ALL • events included in the algorithm—from VAC to IVAC to PVAP unit . At this time, a conducting in -plan VAE surveillance cannot decide, for example, that only surveillance for VAC (and not for IVAC or PVAP) will be performed. • There is a hierarchy of definitions within VAE: o ient meets criteria for VAC and IVAC, report as IVAC. If a pat o and PVAP, report P VAP. If a patient meets criteria for VAC, IVAC • Do not upgrade an event using findings that occur outside the VAE Window period. • If the date of event (date of onset of worsening oxygenation) is on or after the date of documentation of evidence of consent AND the patient is being supported for organ donation purposes, the event should not be reported as a VAE . • Pathogens are not reported for VAC or IVAC events. FAQ see reported for VAC or IVAC events ( are not Secondary BSIs no.11). • • be reported for PVAP events, provided they are isolated or identified Pathogens may from appropriate specimen types according to the requirements of the algorithm and are NOT on the list of excluded organisms and culture or non-culture based microbiologic results: testing method o Excluded organisms and culture or non-culture based microbiologic testing method results that cannot be used to meet the PVAP definition are as follows: “N ormal respiratory flora,” “normal oral flor • a,” “mixed respiratory flora,” “mixed oral flora,” “altered oral flora” or other similar results indicating isolation of commensal flora of the oral cavity or upper respiratory tract • Any Candida species or yeast not otherwise specified; an y coagulase- negative Staphylococcus species; and any Enterococcus species, when identified from sputum, endotracheal aspirates, bronchoalveolar lavage, or protected specimen brushings specimens . These organisms from lung tissue or can be reported as PVAP pathogens if identified pleural fluid (where specimen was obtained during thoracentesis or initial placement of chest tube and NOT from an indwelling chest tube) o Additionally, because organisms belonging to the following genera are typically causes of community -associated respiratory infection s and are rarely or are not known to be causes of healthcare- associated infections , they are also excluded, and cannot be used to meet the PVAP definition when isolated from any eligible specimen type (to inclu de lung and pleural fluid) : Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis. • (Figure 1): There are three criteria that can be used to meet the PVAP definition January 2019 10-16

167 Device- associated Module VAE o or semi -quantitative Criterion 1: Positive culture meeting specific quantitative threshold ( Table 3 ); Criterion 2: Purulent respiratory secretions AND identification of organisms o NOT meeting the quantitative or semi-quantitative thresholds specified in Table 3; o Criterion 3: (one of the following) • Organisms identified from pleural fluid specimen(where specimen was obtained during thoracentesis or initial placement of chest tube and NOT from an indwelling chest tube) Positive lung histopathology • • Lower respiratory specimen cytology findings suggestive of infection species or selected respiratory Positive diagnostic test for Legionella • viruses. the PVAP definition • See Table 3 f or the required quantitative culture thresholds meeting ou quantitative culture results, y (Criterion 1). Note that if your laboratory reports semi- should check with your laboratory to confirm that semi- quantitative results m atch the quantitative thresholds noted in Table 3 (see also FAQ no. 24). VAP definition Table 3: Threshold values for cultured specimens used in the P Values Specimen collection/technique 4 * Lung tissue ≥ 10 cfu/g tissue Bronchoscopically (B) obtained specimens 4 ≥ 10 -BAL) cfu/ml* Bronchoalveolar lavage (B 4 cfu/ml* ≥ 10 Protected BAL (B -PBAL) 3 Protected specimen brushing (B- cfu/ml* PSB) ≥ 10 Nonbronchoscopically (NB) obtained (blind) specimens 4 NB -BAL ≥ 10 cfu/ml* 3 cfu/ml* 10 NB -PSB ≥ 5 cfu/ml* 10 Endotracheal aspirate ≥ (ETA) cfu = colony forming units, g = gram, ml = milliliter *Or corresponding semi -quantitative result. • Secondary BSIs may be reported for PVAP events, provided that at least one organism identified from the blood matches an organism isolated from an appropriate respiratory tract specimen (including respiratory secretions, pleural fluid and lung tissue). The rd day of mechanical respiratory tract specimen must have been collected on or after the 3 ventilation and within 2 calendar days before or after the day of onset of worsening VAP definition . In addition, to be considered as a criterion oxygenation for meeting the P -day event from blood must have been collected during the 14 the organisms identified period, where day 1 is the day of onset of worsening oxygenation (See FAQ no.13). January 2019 10-17

168 Device- associated Module VAE o In cases where P VAP is met with only the histopathology criterion and no culture or non- culture based testing is performed on an eligible respiratory specimen, and there is also a positive blood specimen a secondary BSI is not reported. culture based testing In cases where a culture or non- of respiratory secretions, pleural o fluid or lung tissue is performed and does not identify organism that matches an an organism identified from blood, a secondary BSI is not reported . o A matching organism is defined as one of the following: 1. If genus and species are identified in both specimens , they must be the same. and a a. resulted with Enterobacter cloacae Example: A blood specimen BAL specimen resulted with Enterobacter cloacae are matching organisms. and a Example: A blood specimen resulted with Enterobacter cloacae b. Enterobacter aerogenes BAL specimen resulted with are NOT matching organisms as the species are different. 2. If the organism is less definitively identified in one specimen than the other, the lesser identified organism must be identified to at least the genus level and at that level the organisms must be the same. a. Example: A BAL resulted with Pseudomonas spp . and a blood specimen resulted with Pseudomonas aeruginosa are considered a match at the genus level and therefore the BSI can be reported as secondary BSI to VAE organism is identified only as “yeast” or In cases where an Exception: “yeast not otherwise specified”, the organism can be considered a match to other yeasts, when collected during the required timeframe, whether more fully identified or not. Example: A blood specimen reported as Candida albicans and a lung tissue re sulted with yeast not otherwise specified are considered to have matching organisms. In this example the two organisms are considered matching organisms because the organisms are complementary (specifically Candida is a type of yeast). NOTE: This exception is limited to yeast. It does not apply to identification of organisms as Gram positive cocci, Gram negative rods, etc. NOTE: Candida species or yeast not otherwise specified, coagulase - species, and species identified Enterococcus Staphylococcus negative VAP, unless the organism from blood cannot be deemed secondary to a P from pleural fluid or lung tissue. was also identified January 2019 10-18

169 Device- associated Module VAE Surveillance Algorithm -Associated Events (VAE) Figure 1: Ventilator defined by ≥ 2 calendar days of stable or decreasing daily minimum * improvement on the ventilator, Patient has a baseline period of stability or or PEEP values. The baseline period is defined as the 2 calendar days immediately preceding the first day of increased daily minimum PEEP or FiO 2 FiO . 2 * for Daily minimum defined by lowest value of FiO > 1 hour. or PEEP during a calendar day that is maintained 2 After a period of stability or improvement on the ventilator, the patient has at least one of the following indicators of wor sening oxygenation: * minimum 1) ily Increase in da FiO of the first day in the baseline period, sustained for ≥ 2 ≥ 0.20 (20 points) over the daily minimum FiO of 2 2 calendar days. † * PEEP values of , sustained for ≥ 3 cmH O over the daily minimum PEEP of the first day in the baseline period ≥ 2 2) Increase in d aily minimum 2 calendar days. -Associated Condition (VAC) Ventilator On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria: 3 3 . or ≤ 4,000 cells/mm cells/mm OR 1) Temperature > 38 °C or < 36°C, white blood cell count ≥ 12,000 AND continued for ≥ 4 qualifying antimicrobial days 2) A new antimicrobial agent(s) (see Appendix for eligible antimicrobial agents) is started, and is . (QAD) (IVAC) -Associated Complication Infection- related Ventilator On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, ONE of the taking into account organism exclusions specified in the protocol ): following criteria is met ( 1) Positive culture of one of the following specimens, meeting quantitative or semi - Criterion 1: quantitative thresholds as outlined in protocol, requirement for purulent respiratory secretions: without 5 E ndotracheal aspirate, ≥ 10 • CFU/ml or corresponding semi - quantitative result 4 semi B ronchoalveolar lavage, ≥ 10 • CFU/ml or corresponding - quantitative result 4 quantitative result corresponding or semi CFU/g - L ung tissue, ≥ 10 • 3 rotected specimen brush, ≥ 10 • P CFU/ml or corresponding semi quantitative result - erion 2: Crit 2) 25 neutrophils and defined as secretions from the lungs, bronchi, or trachea that contain > Purulent respiratory secretions ( † to include organism identified from ) 10 squamous epithelial cells per low power field [lpf, x100] < PLUS one of the following specimens ( - qualitative culture, or quantitative/semi quantitative culture without sufficient growth to meet criterion #1): • Sputum Endotracheal aspirate • • Bronchoalveolar lavage • Lung tissue • Protected specimen brush † quantitative results, those results must correspond to the quantitative thresholds. See additional If the laboratory reports semi- instructions for using the purulent respiratory secretions criterion in the VAE Protocol. Criterion 3: One of the following positive tests : 3) Organism identified from pleural fluid (where specimen was obtained during thoracentesis or initial placement of chest tube • and NOT from an indwelling chest tube) • Lung histopathology, defined as: 1) a bscess formation or foci of consolidation with in tense neutrophil accumulation in 3) evidence bronchioles and alveoli; 2) evidence of lung parenchyma invasion by fungi (hyphae, pseudohyphae or yeast forms); cytology, or micr of infection with the viral pathogens listed below based on results of immunohistochemical assays, oscopy performed on lung tissue Diagnostic test for • species Legionella • Diagnostic test on respiratory secretions for influenza virus, respiratory syncytial virus, adenovirus, parainfluenza virus, rhinovirus, human metapneumovirus, coronavirus January 2019 10-19 -Associated Pneumonia (PVAP) Possible Ventilator

170 Device- associated Module VAE : The Ventilator Numerator Data form (CDC 57.112) is used to collect and -Associated Event report each VA E that is identified during the month selected for surveillance. The Instructions for Completion of Ventilator- Associated Event Form includes brief instructions for collection and entry of each data element on the form. The form includes patient demographic VAE information and information on the start date and location of initiation of mechanical ventilation . Additional data include the specific criteria met for identifying VAE , whether the patient developed a secondary bloodstream infection, whether the patient died, and, where applicable, the organisms detected and their antimicrobial susceptibilities. Reporting Instruction: If no VAE s are identified during the month of surveillance, the “Report No Events” box must be checked on the appropriate denominator summary screen, for example, Denominators for Intensive Care Unit (ICU)/other locations (Not NICU or SCA), etc. Device days and patient days are used for denominators (see Chapter 16 : ata Denominator D Key Terms ). Ventilator days, which are the numbers of patients managed with ventilatory devices , are collected daily, at the same time each day, according to the chosen location using the appropriate form ( CDC 57.117 and 57.118). These daily counts are summed and only the total for the month is entered in to NHSN. Ventilator and patient days are collected for each of the locations monitored. When denominator data are available from electronic sources (for example, ventilator days from respiratory therapy), these sources may be used as long as the counts are not substantially different (+/- 5%) from manually-collected counts, pre-validated for a minimum of 3 consecutive months. NOTE: All ventilator days are counted, including ventilator days for patients on mechanical ventilation for < 3 days, and patients on high frequency ventilation and other therapies excluded from VAE surveillance . Patients with tracheostomies who are undergoing weaning from mechanical ventilation using tracheostomy collar trials are included in ventilator day counts as long as they spend some portion of the day on mechanical ventilation at a time that overlaps with the daily time during which ventilator day counts are performed. NOTE: In addition to the total number of patients on ventilators on each day of surveillance, the number of patients on ventilators who are on the APRV mode of mechanical ventilation or related modes (which is a subset of all patients on ventilators) can optionally be indicated on the appropriate form ( CDC 57.117 and 57.118). See FAQ nos. 22 and 23. Collection of an additional denominator, episodes of mechanical ve ntilation (EMV), is optionally available for VAE surveillance. The EMV denominator represents the sum of the number of episodes of mechanical ventilation that occurred in that location during the month. A single episode of mechanical ventilation for each p atient is to be counted only once per month. Do note, it is possible for a patient to have more than one episode of ventilation occur during a month ( for example, discontinuation of mechanical ventilation for greater than 1 calendar day followed by re-ini tiation of mechanical ventilation) . The EMV denominator is determined by patients in the location who are on mechanical ventilation on the first day of the counting all Then, on each subsequent day month regardless of eligibility for inclusion in VAE surveillance. 10-20 January 2019

171 Device- associated Module VAE of the month, count each additional patient that is started on mechanical ventilation. This would include those that are admitted to the location already on mechanical ventilation, those that are , and any previously ventilated patients who have new episodes of mechanical newly ventilated ventilation occurring during the same month. The sum of the count for the first day and each subsequent day of the month is entered in NHSN. EXAMPLE: On January 1, there are 5 patients on mechanical ventilation in the MICU (2 patients were started on mechanic al ventilation on December 24, 2 patients on December 31, and 1 patient on January 1). During the rest of the month, the following are noted: 1 patient is started on mechanical ventilation on January 8; 2 patients are transferred to the MICU on mechanical ventilation on January 15, and 1 patient who was previously ventilated (from January 1 through January 12) goes back on mechanical ventilation on January 20. No other patients are on mechanical ventilation during the month of January. The number of EMV for January is nine. This is calculated as f ollows: 5 patients (on mechanical ventilation on the first day of the month) + 4 patients who were either started on mechanical ventilation, transferred into the MICU on mechanical ventilation, or re- initiated on mechanical ventilation after being off of the vent for at least 1 calendar day = 9 EMV. Data Analyses: The VAE rate per 1000 ventilator days is calculated by dividing the number of VAEs by the number of ventilator days and multiplying the result by 1000 (ventilator days). T he AEs by is calculated by dividing the number of V rate per 100 episode s of mechanical ventilation 100 (episodes of the number of episodes of mechanical ventilation and multiplying the result by and SIRs that may be appropriate for use in public reporting, . Rates mechanical ventilation) inter -facility comparisons, and pay- for-reporting/pay- for -performance programs are the overall . Rates VAE rate (where the numerator consists of all events meeting at least the VAC definition) and SIRs that may be appropriate for internal use within an individual unit or facility include the “IVAC -plus” rate (where the numerator consists of all events meeting at least the IVAC definition) rates of specific event types (e.g., events meeting only the VAC definition, events meeting only the IVAC definition, events meeting only the P VAP definition) . The Ventilator Utilization Ratio is calculated by dividing the number of ventilator days by the number of patient s, and days. These calculations will be performed separately for the different types of ICUs, SCA other locations in the institution . s The Standardized Infection Ratio (SIR) is calculated by dividing the number of observed event by the number predicted events . The number of predicted event s, in the context of statistical using VAE rates from a standard population during a baseline time prediction, is calculated period as reported in the NHSN Report. NOTE: The SIR should be calculated only if the number of predicted VAE s is ≥ 1. VAEs SIR = Observed (O) VAEs / Predicted (O) While the VAE SIR can be calculated for single locations, the measure also allows you to summarize your data by multiple locations, adjusting for differences in the incidence of VAEs 10-21 January 2019

172 associated Module Device- VAE among the location types. For example, you can calculate one VAE SIR adjusting for all locations SIR for all specialty care areas in your facility. VAE reported. Similarly, you can calculate one Descriptive analysis options of numerator and denominator data are available in the NHSN application, such as line listings, frequency tables, and bar and pie charts. VAE rates and run charts are also available. Guides on using NHSN analysis features are available from: . www.cdc.gov/nhsn/PS- Analysis -resources/reference-guides.html 10-22 January 2019

173 Device- associated Module VAE References Behrendt CE. Acute respirato ry failure in the United States 1) -day survival. Chest : incidence and 31 5. 2000;118:1100- Kahn JM, Goss CH, Heagerty PJ, et al. Hospital volume and the outcomes of mechanical ventilation. N Engl J 2) 50. Med 2006;355:41- -Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of 3) Wunsch H, Linde -53. mechanical ventilation use in the United States. Crit Care Med 2010;38:1947 Rubenfeld GD, Caldwell E, Peabody E, et al. Incidence and outcomes of acute lung injury. N Engl J Med 4) 2005;353:1685- 93. 5) Esteban A, Anzueto A, Frutos F, et a l. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28 -day 55. international study. JAMA 2002;287:345- Weiner LM, Allen eck MA, 6) -Bridson K , et. al. National Healthcare Safety Network (NHSN) Report, Data Dud 2012 , Device- associated Module. Am J Infect Control 2013;41:1148- 66. Summary for 7) Klompas M. Does this patient have ventilator -associated pneumonia? JAMA 2007;297:1583- 93. 8) Klompas M. Interobserver variability in ventilator -associated pneumonia surveillance. Am J Infect Cont rol 2010;38:237-9. 9) Klompas M, Kulldorff M, Platt R. Risk of misleading ventilator -associated pneumonia rates with use of standard clinical and microbiological criteria. Clin Infect Dis 2008;46:1443- 6. a: the clinical pulmonary infection score as a -associated pneumoni Zilberberg MD, Shorr AF. Ventilator 10) surrogate for diagnostics and outcome. Clin Infect Dis 2010;51 Suppl 1:S131-5. Girard T, Kress JP, Fuchs BD, et al. Efficacy and safety of a paired sedation and ventilator weaning protocol for 11) ven tilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised mechanically 34. controlled trial. Lancet 2008;371:126- 12) Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation. La ncet 2010;375:475- 80. 13) The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301- 8. physical and occupational therapy in mechanically 14) Schweickert WD , Pohlman MC , Pohlman AS , et al. Early 82. 2009;373:1874- ventilated, critically ill patients: a randomised controlled trial. Lancet 15) Magill SS, Klompas M, Balk R, et al. Developing a new, national approach to surveillance for ventilator - associated events. Critical Care Medicine 2013;41:2467 -75. 16) Klompas M, Khan Y, Kleinman K, et al. Multicenter evaluation o f a novel surveillance paradigm for complications of mechanical ventilation. PLoS One 2011;6:e18062. 17) Klompas M, Magill S, Robicsek A, et al. Objective surveillance definitions for ventilator -associated pneumonia. Crit Care Med;2012 :3154- 61. 18) Magill SS, Li Q , Gross C, et al. Incidence and characteristics of ventilator -associated events reported to the National Healthcare Safety Network in 2014. Crit Care Med 2016; online ahead of print, available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113232/ th Stedman’s medical d ictionary . (28 ed). (2005). Philadelphia: Lippincott, Williams, & Wilkins. 19) Garcia, LS (Ed.). (2010). Clinical Microbiology Procedures Handbook. Herndon, VA: ASM Press, page 20) 3.2.1.16 10-23 January 2019

174 Device -associated Module VAE Appendix. List of Antimicrobials Agents Eligible for IVAC, PVAP Antimicrobial Agent AMIKACIN AMPHOTERICIN B AMPHOTERICIN B LIPOSOMAL AMPICILLIN AMPICILLIN/SULBACTAM ANIDULAFUNGIN AZITHROMYCIN AZTREONAM CASPOFUNGIN CEFAZOLIN CEFEPIME CEFOTAXIME CEFOTETAN CEFOXITIN CEFTAROLINE CEFTAZIDIME CEFTAZIDIME/AVIBACTAM CEFTIZOXIME CEFTOLOZANE/TAZOBACTAM CEFTRIAXONE CEFUROXIME CIPROFLOXACIN CLARITHROMYCIN CLINDAMYCIN COLISTIMETHATE DALBAVANCIN DELAFLOXACIN DORIPENEM DOXYCYCLINE ERTAPENEM FLUCONAZOLE FOSFOMYCIN GEMIFLOXACIN GENTAMICIN IMIPENEM/CILASTATIN ISAVUCONAZONIUM January 2019 10-24

175 Device -associated Module VAE ITRACONAZOLE LEVOFLOXACIN LINEZOLID MEROPENEM MEROPENEM/VABORBACTAM METRONIDAZOLE MICAFUNGIN MINOCYCLINE MOXIFLOXACIN NAFCILLIN ORITAVANCIN OSELTAMIVIR OXACILLIN PENICILLIN G PERAMIVIR PIPERACILLIN PIPERACILLIN/TAZOBACTAM POLYMYXIN B POSACONAZOLE QUINUPRISTIN/DALFOPRISTIN RIFAMPIN SULFAMETHOXAZOLE/TRIMETHOPRIM SULFISOXAZOLE TEDIZOLID TELAVANCIN TELITHROMYCIN TETRACYCLINE TICARCILLIN/CLAVULANATE TIGECYCLINE TOBRAMYCIN VANCOMYIN, intravenous only VORICONAZOLE ZANAMIVIR 2019 January 10-25

176 Device -associated Module VAE VAE Frequently Asked Questions (FAQs) 1) When should I use VAE? Are there circumstances in which I should still use PNEU? based, and restricted to adult inpatient units only. • VAE surveillance is location Pediatric and neonatal units are excluded from VAE surveillance (even in • care for patients who are 18 circumstances where a pediatric unit may occasionally years of age and older). • Locations mapped to mixed age CDC location codes are excluded from VAE surveillance. • Ventilated patients who are 18 years of age and older and who are cared for in pediatric units should be included in any in -plan PedVAP surveillance for that location . It is NOT recommended to include in VAE surveillance NOTE: young children housed in adult ICU locations who are not thought to be physiologically similar to the location’s adult patient population. Faci lities may want to evaluate their location mapping to be sure that locations are mapped appropriately to the correct CDC location codes. In circumstances where the populations of adults and children cared for example, 50% adult patients and for in the same physical location is more mixed ( 50% pediatric patients), it is recommended that facilities weigh the possibility of establishing a virtual pediatric location for the purposes of surveillance. More information on virtual locations and location mapping can be found here: www.cdc.gov/nhsn/PDFs/pscManual/15LocationsDescriptions_current.pdf • While on high frequency ventilation, extracorporeal or paracorporeal life support , patients are EXCLUDED from VAE surveillance. NOTE: Patients who are receiving a conventional mode of mechanical ventilation while in the prone position and patients who are receiving a conventional mode of mechanical ventilation while receiving nitric oxide therapy , helium-oxygen mixtures oprostenol therapy are INCLUDED. (heliox), or ep on Airway Pressure Release V NOTE: Patients entilation (APRV) and related modes of mechanical ventilation (see FAQ nos. 22 and 23) are INCLUDED; however, during periods of time while the patient is on APRV, the VAE period of stability or improvement on the ventilator and the period of worsening oxygenation should be only, since changes in PEEP as indicated in this determined by changes in FiO 2 surveillance algorithm may not be applicable to APRV. In addition, patients with VAE who are on APRV or a related mode of mechanical ventilation at the time of can be optionally indicated as such on the VAE Form ( CDC 57.112). VAE onset January 2019 10-26

177 Device -associated Module VAE -associated PNEU may still be conducted for • In- plan surveillance for ventilator (“PedVAP” surveillance) . pediatric patients ONLY • The PNEU definitions are still available for those units seeking to conduct off- plan patients of any age and for assignment of a secondary PNEU/VAP surveillance for BSI . 2) I am having difficulty visualizing how to arrange the VAE data elements to facilitate e asy identification of events. Can you provide some additional guidance? • For units in which VAE surveillance will be conducted manually, we recommend that you organize the necessary data elements in a table or spreadsheet to assist in e are a number of different ways in which to organize the data Ther identifying VAEs. – you may consider limiting your spreadsheet to just include the daily minimum PEEP and FiO values, and then, if a VAC event is identified, utilize other data 2 sources to gather information on the data elements included in the IVAC and PVAP . Alternatively, you may choose to include columns for all data elements definitions (fro m VAC through P VAP) in a single spreadsheet. NOTE: For most patients under surveillance for VAE, the only data elements you will s, minimum daily PEEP, and minimum daily need to record are the ventilator day . The maximum and minimum daily temperatures and white blood cell counts FiO 2 only need to be recorded for those patients who are identified as having met criteria for VAC. The antimicrobial criterion only needs to be assessed for those patients with VAC and with an abnormal temperature or white blood cell count that meets the criteria within the IVAC definition. Microbiology and related data elements included VAP definition only need to be assessed for those patients who as criteria in the P have met the IVAC definition. NOTE: Keep in mind that th e baseline period of stability or improvement on the ventilator is defined as the 2 calendar days immediately preceding the first day of and must be characterized by ≥ 2 calendar increased daily minimum PEEP or FiO 2, the days of stable or decreasing daily minimum FiO or PEEP values ( specifically 2 daily minimum PEEP or FiO on the second day of the baseline period of stability or 2 on the improvement must be equal to or less than the daily minimum PEEP or FiO 2 first day of the baseline period of stability or improvement). Keep in mind, too, that O are considered equivalent for the purposes of VAE PEEP values of 0 to 5 cmH 2 O will be surveillance. This means that any daily minimum value of 0 to 5 cmH 2 O when determining whether a VAC has occurred or evaluated as if it were 5 cmH 2 , the daily minimum PEEP or FiO2 is defined as the lowest setting during a not. Also calendar day that is maintained for > 1 hour. EXAMPLE: In the table below, the data elements used to meet VAC, IVAC and PVAP definition are organized in a fashion that facilitates identification of an event, highlighted in the shaded region. In this example, MV days 3 and 4 constitute the O on each day. On MV days 5 baseline period, with stable minimum PEEP of 5 cmH 2 rion for O, which meets the VAC crite and 6, the daily minimum PEEP is 8 cmH 2 2019 January 10-27

178 Device -associated Module VAE worsening oxygenation. If we scan across the table, we can see that the IVAC temperature/white blood cell count criterion is not met (there are no temperatures < 3 ≤ or ≥ 12,000 36°C or > 38°C, and no white blood cell counts 4,000 cells/mm 3 cells/mm – ) so even though the patient was started on a new antimicrobial agent and continued on that agent for 4 calendar days, IVAC is not met. Therefore, this event would be reported as a VAC, with the date of event being MV day 5. MV Day PEE P Patient FiO Temp Temp WBC WBC Abx Specimen Polys / Epis Organism VAE min max min max min 2min 1 1 10 1.0 37.1 37.6 4.3 4.3 None -- -- -- -- 1 0.60 36.8 37.2 4.6 5 4.6 None -- -- -- -- 2 -- 3 5 0.40 37.0 37.9 5.4 5.4 None -- -- -- 1 -- -- -- -- 1 4 5 0.40 36.5 37.3 9.2 9.2 Yes Yes S.aureus 8 0.50 36.3 36.9 8.4 8.4 5 ETA ≥ 25 / ≤ 10 1 VAC - 1 6 8 0.40 37.2 37.5 8.5 8.8 Yes -- -- -- -- - -- 1 7 5 0.40 37.8 37.9 7.6 7.6 Yes -- MV mechanical ventilation. PEEP = Daily minimum PEEP. FiO = Daily minimum FiO . Temp = Daily minimum temperature. Temp = = Daily 2 min max 2min min = Daily minimum white blood cell count. WBC = Daily maximum white blood cell count. Abx = antimicrobial agents. maximum temperature. WBC min max Polys / epis = Polymorphonuclear leukocytes and squamous epithelial cells from respiratory specimen. EXAMPLE: In the table below, by scanning across the data elements, you can see that there are no periods in which there is a stable, 2 -day baseline period followed by O or 20 points over the are increased 3 c mH a 2 -day period where the PEEP or FiO 2 2 first day in the baseline period O . On MV days 2 and 3, the PEEP values are 7 cmH 2 and 6 cmH O respectively, and then increase to 9 cmH O on MV days 4 and 5 – but 2 2 O, rather than the the difference between day 4 or day 5 and day 2 is only 2 cmH 2 required 3 cmH O. Also, the gradual increase in FiO from the time of initiation of 2 2 is at least mechanical ventilation means that there are not two days on which the FiO 2 20 points higher than on the 2 previous days. Therefore, although the temperature and white blood cell counts exceed the required thresholds for IVAC on several occasions, and the patient appears to have received a new antimicrobial agent for several days in the setting of a positive blood culture, the VAC definition is not met, and so no VAE is reported. 2019 10-28 January

179 Device -associated Module VAE Polys / Specime Organis WBC Temp MV ma ma Abx WBC VAE PEEP FiO Patient Temp min min min 2min m n Epis Day x x 37.6 37.1 0.30 5 1 2 -- None 4.3 4.3 -- -- -- 2 7 0.30 36.8 37.2 4.6 4.6 None -- -- -- -- 2 3 0.45 37.0 37.9 5.4 2 5.4 None -- -- -- -- 6 2 0.45 36.5 37.3 9.2 9 9.2 None -- -- -- -- 4 5 2 9 -- S.aureus ≥ 25 / ≤ 10 ETA None 8.4 8.4 36.9 36.3 0.60 -- 2 6 8 0.60 37.2 37.5 8.5 8.8 None -- -- -- 7.6 -- 6 0.75 37.8 37.9 2 7.6 None -- -- -- 7 38.2 0.75 6 8 2 -- S. aureus -- Blood Yes 11.9 10.5 38.4 2 -- -- -- Yes 12.7 -- 12.7 38.9 38.5 0.80 5 9 10 -- 2 -- -- -- Yes 12.9 12.9 38.1 37.4 0.75 5 5 37.9 9.4 9.4 Yes -- 11 -- -- -- 2 0.70 37.2 -- -- -- Yes 9.5 9.5 -- 37.5 37.3 0.60 5 12 2 -- Yes 8.2 37.8 37.2 0.60 7 13 -- 2 -- -- 8.2 0.60 8 14 2 -- -- -- -- Yes 8.6 8.6 37.7 37.0 Is there a hierarchy of reporting for VAE? How do I know whether to report a VAC, an 3) IVAC or a P VAP? Conducting in- plan VAE surveillance means assessing patients for the presence of • included in the algorithm—from VAC to IVAC to P VAP. At this time, a ALL events unit participating in in -plan VAE surveillance cannot decide, for example, that only surveillance for VAC (and not for IVAC or P VAP) will be performed. • There is a hierarchy of definitions within VAE: o If a patient meets criteria for VAC and IVAC, report as IVAC. If a patient meets criteria for VAC, IVAC VAP. and PVAP, report P o 4) How do I determine the duration of a VAE? Can a patient have more than one VAE during a hospitalization? ent period is • Patients may have multiple VAEs during a single hospitalization. The ev defined by the 14-day period that starts on the date of onset of worsening oxygenation. VAE criteria met during that 14 -day period are attributed to the current VAE. EXAMPLE: Pati ent is intubated and mechanical ventilation is initiated in the MICU during the following 4 calendar days (days 2 through 5). (day 1). The patient is stable is increased more than 0.20 (20 On days 6 and 7 the patient’s minimum daily FiO 2 irst day VAC FiO points) over the f in the baseline period, therefore meeting the 2 threshold. The VAC episode is defined by the period encompassing days 6 through 19 (14 days, starting on day 1 of worsening oxygenation, which in this case is day 6). If the patient were to ex perience a period of stability or improvement on the ventilator on days 18 and 19, followed by another 2-day period of worsening on days 20 and 21, a new VAE would be reported, since the second period of worsening oxygenation has occurred more than 14 days after the start of the initial period of worsening oxygenation. 2019 January 10-29

180 -associated Module Device VAE Sometimes patients are intubated, extubated, and reintubated several times during a 5) single hospitalization. How do I define an episode of mechanical ventilation, and can a VAE occur in a patient who has recently been extubated? • An episode of mechanical ventilation is defined as a period of days during which the patient was mechanically ventilated for some portion of each consecutive day during the period. mechanically ventilated on hospital day 1. The EXAMPLE: A patient is intubated and patient remains on mechanical ventilation from hospital day 2 through 12 noon on hospital day 6. At noon on hospital day 6, the patient is extubated. The patient remains extubated on hospital day 7, and is then reintubated on hospital day 8. In this case, the first episode of mechanical ventilation is defined by days 1 through 6. Since the patient was extubated on day 6 and remained extubated for a full calendar day on day 7, the re-intubation of the patient on day 8 defines the start of a second episode of See figure, below. mechanical ventilation. 2 7 6 5 4 3 10 1 No. Hosp Day 9 8 1 1 1 1 1 -- 2 2 2 MV Episode 1 extubated 6— 1 2 3 4 MV Day No. 3 2 1--reintubated -- 5 at noon 1 full calendar day off mechanical ventilation, followed by reintubation, defines a new episode of mechanical ventilation. EXAMPLE: A patient is intubated and mechanically ventilated on hospital day 1. The patient remains on mechanical ventilation from hospital day 2 through hospital day 6 at 12 noon. At noon on hospital day 6, the patient is extubated. The patient is reintubated at 9 pm on hospital day 7, and remains intubated and mechanically ventilated till 2 pm on day 10. The patient is extubated at 2 pm on day 10 and remains extubated until hospital discharge on day 15. In this case, there is only a single episode of mechanical ventilation, defined by days 1 through 10, because the patient was extubated on day 6 but reintubated the next calendar day (day 7). See figure, below. 6 7 8 9 10 1 No. Hosp Day 2 3 4 5 MV Episode 1 1 1 1 1 1 1 1 1 1 reintubated 6— extubated 10 — extubated at 7— 4 MV Day No. 8 9 5 3 2 1 at 2 pm noon at 9 pm -7). Because there is not 1 Patient was reintubated on the calendar day following extubation (days 6 calendar day off mechanical ventilation, there is only 1 episode of mechanical ventilation. extubated and is then reintubated, subject to the A VAE can occur in a patient who has been • amount of time the patient was off the ventilator, as noted in the examples below. 2019 10-30 January

181 Device -associated Module VAE EXAMPLE: A patient is intubated and mechanically ventilated on hospital day 1. The ion from hospital day 2 through 12 noon on patient remains on mechanical ventilat hospital day 6. At noon on hospital day 6, the patient is extubated. The patient remains extubated on hospital day 7, and is then reintubated on hospital day 8. In this case, because the patient has been extubated for 1 full calendar day (day 7), the “VAE clock” starts over with reintubation on hospital day 8. To meet VAE during this second episode of mechanical ventilation, the patient would have to have at least 2 days of stability or improvement and at least 2 days of worsening oxygenation on the ventilator; therefore, the earliest date on which the patient could meet VAE criteria would be hospital day 11 (stable or improving settings on days 8 and 9, increased ventilator settings on days 10 and 11) . The VAE even t date would be reported as day 10—the first day of worsening oxygenation meeting VAE criteria. See figure, below. Hosp Day No. 1 2 3 4 5 6 7 8 9 10 11 -- 1 1 1 1 1 1 MV Episode 2 2 2 2 extubated 1-- 6— 2 1 MV Day No. 4 3 2 -- 5 4 3 reintubated at noon Day 1 of Day 2 of Day 1 of Day 2 of -- -- VAE Criterion -- -- worsening stability or -- stability or -- worsening -- improvement oxygenation improvement oxygenation EXAMPLE: A patient is intubated and mechanically ventilated on hospital day 1. The patient remains on mechanical ventilation from hospital day 2 through 12 noon on hospital day 6, when the patient is extubated. The patient is reintubated at 9 pm on hospital day 7. In this case, there is no “new” episode of mechanical ventilation, since there was not a full, ventilator-free calendar day. Therefore, the period of worsening oxygenation may be determined to have started on day 7, the day of reintubation, as long as PEEP or FiO criteria are met. PEEP and FiO data from hospital days 5 and 6 2 2 (through the time of extubation) may be used to determine whether a period of stability and improvement occurred, and these data may be compared to PEEP and data obtained from the time of reintubation on day 7 and beyond to determine FiO 2 whether at least 2 days of worsening oxygenation occurred. The earliest that the patient could meet VAE criteria would be day 8 (assuming stable or improving ventilator settings on days 5 and 6, and two days of worsening oxygenation meeting criteria on days 7 and 8). The VAE event date would be reported as day 7— the first day of worsening oxygenation meeting VAE criteria. See figure, below. No. Hosp Day 5 1 2 6 7 8 3 4 9 10 1 1 1 1 1 1 1 1 MV Episode 1 1 6— extubated 7— reintubated 1 MV Day No. 10 9 5 8 4 3 2 at noon at 9 pm Day 2 of Day 1 of Day 1 of Day 2 of worsening VAE Criterion worsening stability or stability or improvement oxygenation oxygenation improvement • A patient may also meet criteria for VAC while intubated, and then meet criteria for IVAC (or P VAP) following extubation. 10-31 2019 January

182 Device -associated Module VAE EXAMPLE: A patient is intubated and mechanically ventilated on hospital day 1. The patient remains on mechanical ventilation till 11 am on hospital day 10, when the patient is extubated. Criteria for VAC are met during the episode of mechanical ventilation, based on 2 days of stability or improvement (MV days 5 and 6) followed by 2 days of worsening oxygenation (MV days 7 and 8). The date of the event is MV day 7, the day of onset of worsening oxygenation. Within the 2 days before and 2 days after the day of onset of worsening oxygenation, the patient has a temperature of 38.4°C, and a new antimicrobial agent is started (meropenem, on MV day 9—see FAQ no. 6-10). The new antimicrobial agent is continued for at least 4 days (hospital days 8 through 11). Therefore, even though the patient was extubated on hospital day 10 and remained extubated on hospital day 11 (the day on which all IVAC criteria were fulfilled), the event should be reported as an IVAC. See figure, below. 11 Hosp Day No. 4 5 6 7 8 9 10 7 8 4 5 6 MV Day No. 9 Extubated -- at 11 am Day 1 of Day 1 of Day 2 of VAE Criterion Day 2 of Temp -- -- stability or stability or worsening worsening -- 38.4°C improvement oxygenation improvement oxygenation Antimicrobial Ceftriaxone Meropenem Ceftriaxone Meropenem Ceftriaxone Meropenem Meropenem Ceftriaxone agent Patient has fulfilled all IVAC criteria, and IVAC should be reported. Date of the IVAC event is hospital day/MV day 7. What antimicrobial agents are included in the IVAC definition? 6) • for a list of the antimicrobial agents eligible for consideration in the See the Appendix (as well as the PVAP definition). IVAC definition See Table 1 for eligible routes of administration. • 7) How do I figure out if an antimicrobial agent is “new” for the IVAC definition? • A new antimicrobial agent is defined as any agent listed in the Appendix that is initiated on or after 3 da ys of mechanical ventilation AND in the VAE Window Period (defined by the two days before, the day of, and the two days after the onset rd day of mechanical date of the VAE —as long as all of these days are on or after the 3 ventilation) . The agent is considered new for the purposes of this definition if it was NOT given to the patient on either of the 2 days preceding the current start date. The agent must be administered via one of the routes listed in Table 1 . See the example in the figure below: January 10-32 2019

183 -associated Module Device VAE MV Day No. 5 6 7 8 9 10 11 4 - - - VAE Criterion - - - Onset (day 1) of worsening Day 2 of worsening oxygenation oxygenation meeting VAE PEEP meeting VAE PEEP or FiO 2 thresholds or FiO thresholds 2 Example of the 5- day period during which the first dose of a new antimicrobial agent must be given to meet requirements of IVAC definition EXAMPLE: A single dose of intravenous vancomycin is given to a patient on the VAE onset date (which is the day of onset of worsening oxygenation meeting VAE criteria, in this case MV day 7), and was not given to the patient during the 2 previous days (MV days 5 and 6). Vancomycin is therefore considered a new antimicrobial agent (see figure below). 7 4 5 MV Day No. 8 9 10 6 VAE Criterion Day 2 of Day 1 of Day 1 of Day 2 of stability or worsening stability or worsening - - -- oxygenation improvement oxygenation improvement Single dose of Antimicrobial Single dose of vancomycin vancomycin agent None None None None None ordered and ordered and administered administered A single dose of vancomycin is ordered and administered to the patient within the period defined by the two days before, the day of, and the two days after the VAE onset date. Note that no vancomycin was given in the 2 preceding days, and so vancomycin is a “new” antimicrobial agent for the purposes of the VAE definition. EXAMPLE: If meropenem is given to a patient on the VAE onset date (which is the day of onset of worsening oxygenation meeting VAE criteria, in this case MV day 7), and was not given to the patient during the 2 previous days (MV days 5 and 6), then meropenem is considered a new antimicrobial agent (see figure below). Note that the patient is also receiving ceftriaxone, and receives doses during the 5 -day period around the onset of worsening oxygenation (first dose during the 5-day period was on MV day 5). However, -day period because ceftriaxone was given to the patient the day before the 5 (on MV day 4), ceftriaxone does not count as a new antimicrobial agent for urposes of the IVAC definition. the p 8 9 10 6 4 MV Day No. 5 7 VAE Criterion Day 1 of Day 2 of Day 2 of Day 1 of - stability or worsening worsening - stability or -- oxygenation oxygenation improvement improvement Antimicrobial Ceftriaxone Ceftriaxone Meropenem Meropenem Meropenem Meropenem Ceftriaxone agent -day period around the onset of worsening First dose of meropenem during the 5 oxygenation. Note that no meropenem was given in the 2 preceding days, and so meropenem is a “new” antimicrobial agent for the purposes of the VAE definition. January 10-33 2019

184 Device -associated Module VAE I have figured out that a new antimicrobial agent was given to the patient. How do I 8) determine whether it was continued for 4 days? Make sure you are using the Medication Administration Record. You need to know • which antimicrobial agents were actually administered to the patient. Antimicrobial orders or dispensing information is not sufficient. • You do not need to know the dose or frequency of administration. Four consecutive Qualifying Antimicrobial Days (QADs) —starting within the VAE • Window Period—are needed to meet the IVAC criterion. A QAD is a day on which e “new” the patient was administered an antimicrobial agent that was determined to b within the VAE Window Period. Days between administrations of a new antimicrobial agent also count as QADs as long as there is a gap of no more than 1 calen For example, dar day between administrations of the same antimicrobial agent. if levofloxaci n is given on VAE Day 1, has not been given in the 2 preceding calendar days, and is given again on VAE Days 3, 5 and 7, there are 7 QADs— because the days between levofloxacin doses also count as QADs. • The requirement for 4 consecutive QADs can be met with 4 days of therapy with the same antimicrobial (with a gap of no more than 1 calendar day between administrations of that antimicrobial) —or it can be met with 4 days of therapy with multiple antimicrobial agents, as long as each antimicrobial was started within the VAE Window Period. EXAMPLE: In the figure below, meropenem would meet the antimicrobial criterion of the IVAC definition because at least one dose was given on 4 consecutive days. 1 2 3 4 5 6 7 MV Day No. Day 2 of Day 1 of VAE Criterion - - -- Day 1 of Day 2 of worsening stability or worsening Stability or oxygenation improvement oxygenation improvement Ceftriaxone Ceftriaxone Meropenem Antimicrobial Meropenem Meropenem Ceftriaxone Meropenem agent QAD No No No Yes Yes Yes Yes EXAMPLE: In the figure below, the 3 drugs shown in bold lettering all qualify as new antimicrobial agents, and therefore the antimicrobial criterion of IVAC is met, since the patient is given 4 consecutive days of new . antimicrobial agents 1 MV Day No. 6 2 3 4 5 7 - - VAE Criterion -- Day 1 of Day 1 of Day 2 of Day 2 of worsening stability or worsening Stability or oxygenation improvement oxygenation improvement Piperacillin/ Ceftriaxone Ceftriaxone Antimicrobial Ceftriaxone Meropenem Imipenem Piperacillin/ Tazobactam Tazobactam agent Yes Yes QAD No No No Yes Yes 10-34 2019 January

185 Device -associated Module VAE EXAMPLE: In the figure below, levofloxacin is a new antimicrobial agent (it was started during the VAE Window Period, on MV day 3, and was not given in the 2 days preceding the first day of administration). There are gaps of no more than 1 calendar days between days on which levofloxacin is given, and so the intervening days also count as QADs. In this example, there are 5 QADs (MV days 3 -7); therefore the antimicrobial criterion of IVAC is met. 1 2 3 4 5 6 7 MV Day No. Day 2 of Day 1 of VAE Criterion - - -- Day 1 of Day 2 of worsening stability or worsening Stability or oxygenation improvement oxygenation improvement Antimicrobial Levofloxacin Levofloxacin Levofloxacin agent Yes Yes No QAD No Yes Yes Yes There are many patients in my ICU with renal insufficiency and/or who are receiving 9) hemodialysis. These patients may receive certain antimicrobial agents on an infrequent dosing schedule (for example, every 48 hours). How do I determine whether they have received 4 consecutive days of new antimicrobial therapy? • See above. You do not need to know the patient’s renal function, the dose of the antimicrobial agent, or the frequency of administration. The antimicrobial criterion rule s remain the same, regardless of whether patients have renal dysfunction or not. 10) What if the patient is being given one-time doses of intravenous vancomycin? How do I take that into account when using the IVAC surveillance definition? The rules for deter mining whether the antimicrobial criterion is met do not r equire • that you know the dose or frequency of administration. • Make sure that vancomycin qualifies as a new antimicrobial agent —that it was not given in the 2 days preceding the day on which vancomycin was given during the VAE Window Period. • Check to see whether there are 4 consecutive QADs with vancomycin; if there are gaps of no more than 1 calendar day between days on which vancomycin is given, the intervening days may be counted as QADs. If there are gaps of longer than 1 calendar day between days of vancomycin therapy, the requirement for 4 consecutive QADs cannot be met using vancomycin alone—but make sure to check whether the 4 consecutive QAD requirement is met by considering any other antimicrobials being administered to the patient. MV EXAMPLE: A patient is given a single dose of vancomycin 1 gram IV on day 5. Since vancomycin was started on or after day 3 of mechanical ventilation, and no vancomycin was administered on MV days 2, 3 or 4, vancomycin qualifies as a new antimicrobial agent. A second, single dose of vancomycin 1 gram IV is administered on MV day 8. Because there is a gap of more than 1 calendar day between days of vancomycin administration (there is a gap of 2 days in this example), the requirement for 4 consecutive QADs is not met, and therefore the IVAC antimicrobial criterion is not met. 2019 10-35 January

186 Device -associated Module VAE 6 9 MV Day No. 2 3 4 5 8 7 - VAE Criterion -- -- Day 1 of - Day 2 of Day 1 of Day 2 of worsening worsening stability or Stability or improvement improvement oxygenation oxygenation None Vancomycin Vancomycin None None None None Antimicrobial None 1 gram IV x 1 1 gram IV x 1 agent dose dose Yes No QAD No No No Yes No No 11) Can I report pathogens or secondary BSIs for VAC and IVAC? are NOT reported for VAC or IVAC events. • Pathogens Secondary BSIs • are NOT reported for VAC or IVAC events. EXAMPLE: A patient hospitalized and mechanically -ventilated in the MICU for 14 days develops worsening oxygenation following a 7-day period of stab ility on the ventilator. VAC criteria are met on hospital day 15 (stable ventilator settings on days 12 and 13, increased ventilator settings on days 14 od cell count is noted to be and 15). The onset date is day 14. The white blo 3 15,500 cells/mm on day 14. Meropenem and intravenous vancomycin are begun on day 15, administered through the patient’s right- sided central line, which was inserted on ICU admission. The antibiotics continue to be administered on day 18, meeting IVAC criteria. Endotracheal aspirat e cultures done on days 15 and 16 grow scant upper respiratory flora. A blood culture collected on day 15 is positive for Klebsiella oxytoca . There are no other signs or symptoms of infection. This patient should be reported as having an IVAC and a central BSI cannot be attributed as secondary if the -associated BSI line to another primary site of infection . The BSI cannot be reported as secondary to the IVAC event. 12) Can I report p athogens for P VAP? be reported for PVAP events, provided they are isolated or identified • Pathogens may from appropriate specimen types according to the requirements of the algorithm and are NOT on the list of excluded organisms and culture results: o Excluded organisms and culture results that cannot be used to meet the PVAP definit ion are as follows: “Normal respiratory flora,” “normal oral flora,” “mixed respiratory flora,” “mixed oral flora,” “altered oral flora” or other similar results indicating isolation of commensal flora of the oral cavity or upper respiratory tract; Candida species or yeast not otherwise Enterococcus specified; coagulase- negative Staphylococcus species; and from sputum, endotracheal aspirates, species, when identified bronchoalveolar lavage, or protected specimen brushings. Only eligible pathogens identified from eligible specimens with a collection date occurring in the infection window period can be reported. January 2019 10-36

187 Device -associated Module VAE NOTE: When Candida species or yeast not otherwise specified, coagulase -negative species or Staphylococcus species are identified from lung tissue or Enterococcus be reported as PVAP pathogens. pleural fluid, these organisms may Additionally, because organisms belonging to the following genera are usually causes of community- associated respiratory infection s and rarely or are not known to be are also excluded, and cannot be used causes of healthcare- associated infections , they to meet the PVAP definition when isolated from any eligible specimen type (to include lung and pleural fluid) Blastomyces, Histoplasma, Coccidioides, : Paracoccidioides, Cryptococcus and Pneumocystis. • See Table 3 for the required quantitative culture thresholds associated with various specimen types in the PVAP definition. Note that if your laboratory reports semi - quantitative culture results, you should check with your laboratory to confirm that semi -quantitative results m atch the quantitative thresholds noted in Table 3 . 13) Can I report seco ndary BSIs for P VAP ? may Secondary BSIs be reported for PVAP events, provided that the organism • from an appropriate identified from blood specimen matches an organism identified respiratory tract specimen (including respiratory secretions, pleural fluid and lung . The respiratory tract specimen must have been collected within 2 calendar tissue) days before or after the day of onset of worsening oxygenation to be considered as a criterion for meeting the PVAP definition. In addition, the positive blood specimen must have been collected during the 14-day event period, where day 1 is the day of ons et of worsening oxygenation. o In cases where PVAP is met with only the histopathology criterion and no culture or non- culture based test is performed on an eligible respiratory specimen , and there is also a positive blood specimen, a secondary BSI for is not reported. VAE or non- of respiratory secretions, culture based test o In cases where a culture pleural fluid or lung tissue is performed and does not identify an organism that matches an organism identified from blood, a secondary BSI for VAE is not reported. Candida species or yeast not otherwise specified, coagulas e- negative NOTE: species identified Staphylococcus species, and Enterococcus from blood cannot VAP, unless the organism was also identified from be deemed secondary to a P pleural fluid or lung tissue. EXAMPLE: Patient hospitalized and mechanically ventilated in the MICU for 14 days develops worsening oxygenation following a 7-day period of stability on the ventilator. VAC criteria are met on hospital day 15 (stable ventilator settings on days 12 and 13, increased ventilator settings on days 14 and 15). The onset date is 3 on day 14. day 14. The white blood cell count is noted to be 15,500 cells/mm Meropenem and vancomycin are begun on day 15, administered through the 2019 January 10-37

188 Device -associated Module VAE patient’s right -sided central line (inserted on ICU admission). The antibiotics continue to be administered on day 18, meeting IVAC criteria. Endotracheal 5 aspirate specimens collected on days 15 and 16 grow ≥ 10 CFU/ml Klebsiella oxytoca . This oxytoca . A blood culture collected on day 15 is positive for K. K. patient should be reported as having a PVAP with a secondary BSI due to oxytoca . EXAMPLE: Patient hospitalized and mechanically ventilated in the MICU for 14 days develops worsening oxygenation following a 7-day period of stability on the ventilator. VAC criteria are met on hospital day 15 (stable ventilator settings on days 12 and 13, increased ventilator settings on days 14 and 15). The onset date is 3 day 14. The white blood cell count is noted to be 15,500 cells/mm on day 14. Meropenem and vancomycin are begun on day 15, administered through the patient’s right -sided central line (inserted on ICU admission). The antibiotics continue to be administered on day 18, meeting IVAC criteria. A thoracentesis is performed on day 15 at the patient’s bedside using aseptic technique. Pleural fluid is sent for culture and grows Candida albicans . A blood culture collected on day . This patient should be reported as having a P VAP C. albicans 16 is positive for C. albicans. with a secondary BSI due to EXAMPLE: Patient hospitalized and mechanically ventilated in the MICU for 14 days develops worsening oxygenation following a 7-day period of stability on the ventilator. VAC criteria are met on hospital day 15 (stable ventilator settings on he onset date is days 12 and 13, increased ventilator settings on days 14 and 15). T 3 on day 14. day 14. The white blood cell count is noted to be 15,500 cells/mm Meropenem and vancomycin are begun on day 15, administered through the patient’s right -sided central line (inserted on ICU admission). The antibiotics continue to be administered on day 18, meeting IVAC criteria. An endotracheal aspirate collected on day 15 is a good quality specimen, with ≥ 25 neutrophils and ≤ 10 squamous epithelial cells per low power field, and grows Staphylococcus aureus (qualitative result). A blood culture collected on day 24 is positive for S. . This patient should be aureus and for coagulase- negative staphylococci (CoNS) reported as the pathogen. A secondary S. aureus VAP, with reported as having a P BSI should also be reported for the PVAP, since the positive blood culture was -day period of the VAE, and an organism isolated from collected within the 14 blood ( S. aureus ) matched an organism isolated from culture of the endotracheal aspirate. The CoNS also isolated from the blood culture on day 24 is not reported as a pathogen for the P VAP because it is an excluded organism. 14) Can I only report pathogens if they are isolated in cultures of appropriate specimens? based diagnostic testing? What about pathogens identified by non-culture- • PVAP incorporates results of non-culture-based microbiological diagnostic testing. For PVAP, pathogens that are grown in culture OR selected pathogens that are for example, antigen tes identified as a result of other laboratory testing ( ting, PCR, immunohistochemistry, etc.) should be reported. Do not limit reporting to just those January 2019 10-38

189 -associated Module Device VAE organisms isolated in culture. For example, influenza A identified by polymerase chain reaction (PCR) in a patient meeting PVAP criteria should be reported as a pathogen for that event. 15) The “P VAP” criteri on 3 includes “positive diagnostic tests” for Legionella species, and selected viruses. What kinds of diagnostic tests can be used to meet the definition? Diagnostic testing practices may vary from facility to facility and change over time as • better tests are developed. Listed here are some examples of diagnostic tests for specific pathogens included in the P VAP definition. Positive results of these tests ma y be used in meeting the P VAP definition. Your facility may use other testing methods; positive results obtained using these methods may also be appropriate for use in meeting the PVAP definition. If you have a question regarding a diagnostic test method, check with your laboratory. • species, positive results of any of the following, performed on the For Legionella appropriate specimen: urinary antigen, Legionella- specific respiratory culture, paired -fold rise in titer between acute and convalescent specimens), direct serology (4 fluorescent antibody stain, immunohistochemistry stain, or nucleic acid detection assays (such as PCR) performed on a respiratory specimen. • For respiratory viruses (influenza, respiratory syncytial virus [RSV], parainfluenza viruses, human metapneumovirus, coronaviruses, rhinoviruses and adenovirus), positive results for any of the following: o Performed on an appropriate respiratory specimens – PCR or other viral nucleic acid detection methods, antigen detection methods, including rapid tests, viral cell culture, or o Performed on appropriate pathologic specimens – immunohistochemical assays, cytology, microscopy, or o Performed on appropriately timed paired sera (acute and convalescent) – serological assays demonstrating seroconversion or a significant rise in antibody titer. ventilated patient and is What about pneumonitis that occurs in a mechanically- 16) determined to be due to herpes simplex virus (HSV) or cytomegalovirus (CMV)? Can these infections be reported as VAEs? • In most cases pneumonitis due to HSV and CMV represents reactivation of a latent infection, and therefore would not be considered healthcare-associated, according to the NHSN definition of a healthcare- associated infection. 17) Are there any culture results or microorganisms that CANNOT be used to meet the PVAP definition? • The following pathogens and culture results may NOT be used to meet the definition from sputum, and may NOT be reported as causes of P VAP when they are identified s or protected specimen brushings: endotracheal aspirates, bronchoalveolar lavage Culture results reported as “Normal respiratory flora,” “normal oral flora,” o “mixed respiratory flora,” “mixed oral flora,” “altered oral flora” or other January 2019 10-39

190 -associated Module Device VAE similar results indicating isolation of commensal flora of the oral cavity or upper respiratory tract. o Candida species or yeast not otherwise specified o Coagulase-negative Staphylococcus species species o Enterococcus NOTE: These organisms are excluded because they are common upper respiratory tract commensals, colonizers or contaminants, and are unusual causes of VAP. Their exclusion from the surveillance definitions should NOT be used in clinical decision- making regarding p atient treatment. Providers must independently determine the clinical significance of these organisms identified from respiratory specimen s and the need for treatment. NOTE: When Candida species or yeast not otherwise specified, coagulase -negative Staphyl ococcus species or Enterococcus species are identified from lung tissue or pleural fluid, these organisms may be reported as PVAP pathogens. Additionally, because organisms belonging to the following genera are typically associated res piratory infections and are rarely or are not causes of community- associated infections known to be causes of healthcare- , they are also excluded, and cannot be used to meet the PVAP definition when isolated from any eligible Blastomyces, Histoplasma, : specimen type (to include lung and pleural fluid) Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis. When sputum, endotracheal aspirate, bronchoalveolar lavage or protected specimen • culture based testing results are mixed and contain one or brushing culture or non- more of the excluded pathogens in addition to one or more non-excluded pathogens, the culture may be used to meet the PVAP definition (depending on whether a qualitative, semi-quantitative or quantitative culture was performed, and whether the semi -quantita tive or quantitative cfu/ml thresholds were met) BUT only the non- excluded pathogen(s) should be reported. EXAMPLE: Patient intubated and mechanically ventilated in the MSICU meets IVAC criteria on day 8 of mechanical ventilation. On the day after the ons et of worsening oxygenation, an endotracheal aspirate is collected. The Gram stain shows 25 neutrophils and ≤ ≥ 10 squamous epithelial cells per low power field, and the Candida albicans culture grows “heavy ” and “heavy .” This Staphylococcus aureus patient should be reported as having a P VAP (criterion1) due to Staphylococcus as long as the semi -quantitative result “heavy” is equivalent to the aureus – 5 cfu/ml for endotracheal aspirates. If the semi - quantitative threshold of ≥ 10 5 cfu/ml for quantitative result is not equivalent to the quantitative threshold of ≥ 10 , the patient should still be reported as PVAP (criterion 2). endotracheal aspirates from the endotracheal aspirate culture is not reported, because it is Candida albicans . an excluded result January 2019 10-40

191 Device -associated Module VAE 18) What about organisms identified from pleural fluid and lung tissue specimens ? Can I specimen , report any pathogen identified from a lung tissue, or from a pleural fluid assuming the specimen was obtained during thoracentesis or at the time of chest tube insertion? • Any pathogen identified from lung tissue, when that lung tissue was obtained during an open lung biopsy, video-assisted thoracoscopic surgery, or via other transthoracic or transbronchial biopsy approach, may be reported with the exception of the excluded pathogens belonging to the following genera: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis . • Any pathogen identified from pleural fluid, when that fluid was obtained during thoracentesis or at the time of initial chest tube insertion, may be reported with the exception of the excluded pathogens belonging to the following genera: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis . How are “purulent respiratory secretions” defined? 19) • Purulent respiratory secretions used to meet Criterion #2 of the PVAP definition are defined as: ≤ 25 neutrophils and ≥ o Secretions from the lungs, bronchi, or trachea with 10 squamous epithelial cells per low power field [lpf, x100]. o If the laboratory reports semi -quantitative results, you should check with you r laboratory to be certain that the semi- quantitative results match the quantitative thresholds noted above. • - If you r laboratory is not able to provide additional information on how a semi quantitative reporting system corresponds to quantitative reporting ranges for neutrophils and squamous epithelial cells , here is some guidance from the Clinical rd ed., 2010)*: Microbiology Procedures Handbook (3 1+ = occasional or rare = <1 cell per low power field [lpf, x100] 2+ = few = 1 [lpf, x100] -9 cells per low power field 3+ = moderate = 10 -25 cells per low power field [lpf, x100] 4+ = heavy = >25 cells per low power field [lp f, x100] *Reference: Garcia, LS (Ed.). (2010). Clinical Microbiology Procedures Handbook. Herndon, VA: ASM Press, page 3.2.1.16. o With this range in mind, and in the absence of additional information from your laboratory, “purulent respiratory secretions” are defined as secretions that contain heavy, 4+ or ≥25 neutrophils per low power field [lpf, x100] AND rare, occasional, few, 1+ or 2+, or ≤10 squamous epith elial cells per low power field [lpf, x100]. • If your laboratory uses a different reporting format for results of direct examination of respiratory secretions, you may still be able to use the purulent respiratory secretions in meeting the PVAP definition. See the instructions available in the VAE Protocol, Table 2 . January 2019 10-41

192 -associated Module Device VAE 20) What is the definition of “positive lung histopathology” that can be used to meet the PVAP definition? • If the lung tissue specimen was obt ained via open lung biopsy, video- assisted thoracoscopic surgery, or via other transthoracic or transbronchial biopsy approach, it is eligible for consideration in meeting the P VAP definition (Criterion 3). Histopathological findings that can be used to meet the P VAP definition include: • o Abscess formation or foci of consolidation with intense neutrophil accumulation in bronchioles and alveoli; o Evidence of lung parenchy ma invasion by fungi (hyphae, pseudohyphae or yeast forms); o Evidence of infection with the viral pathogens listed in FAQ n o. 14 based on results of immunohistochemical assays, cytology, or microscopy performed on lung tissue. • Additionally, lower respiratory specimen cytology findings suggestive of infection are eligible for consideration in meeting the PVAP definition (Criterion 3). I am still having trouble understanding the time frame that defines a VAE. Can you 21) what is meant by this statement that appears in the algorithm: explain “On or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the ? onset of worsening oxygenation” • The intent of these criteria is to determine whether a VA C is due to an infectious process (IVAC) and/or pneumonia (PVAP) by looking for corroborating inflammatory and infectious signs at the time of VAC onset. The criterion, “on or after calendar day 3” is intended to exclude inflammatory and infectious signs present on the first two days of mechanical ventilation because they are more likely to be due to pre-existing conditions than vent ilator -acquired complications. The criterion, “within 2 calendar days before or after the onset of worsening oxygenation, ” is time as intended to identify infectious and inflammatory signs that arise at the same VAC and may therefore point to the cause of the VAC. + the time frame that defines a VAE. The event date is the The figures below illustrate • thresholds first day of worsening oxygenation, defined by the PEEP and FiO 2 outlined in the algorithm. Th e event date defines the time frame within which all other criteria must be met. In the examples below, the shaded area defines the VAE Window Period in which IVAC criteria (temperature or white count abnormalities, nd continued for at least 4 days) must be met, plus a new antimicrobial agent started a and in which a P VAP criterion must be met. NOTE: Keep in mind that VAE criteria must be met based on specimens collected or antimicrobial agents started after day 2 of mechanical ventilation . EXAMPLE 1: When the onset date of the VAE occurs early in the course of (for example, day 3 or 4 of mechanical ventilation), the period mechanical ventilation VAP in which certain inflammatory and infectious criteria are sought for IVAC and P is shorter, be cause the first 2 days of mechanical ventilation are excluded from the normal 5 day window surrounding the day of increased ventilator support. 2019 10-42 January

193 Device -associated Module VAE 2 3 4 1 6 7 MV Day No. 5 -- Worsening oxygenation - Day 2 of - Day 1 of Day 2 of Day 1 of worsening worsening stability or Stability or improvement oxygenation improvement oxygenation - Temperature abnormality or  An abnormal temperature or white blood cell count, according - to the algorithm parameters, must be documented within this white blood cell count - shaded period  abnormality - New agent must be started on any day within this shaded  Antimicrobial agent - - period, and then continued for at least 4 days  - Purulent respiratory secretions, -  Specimen must be collected on any day within this shaded positive culture, positive - period  histopathology EXAMPLE 2: When the onset date of the VAE occurs later in the course of mechanical ventilation, the period in which certain criteria must be met is a day longer, because the patient has already been on mechanical ventilation for more than 3 days and therefore inflammatory and infectious signs arising anywhere in the full 5 - day window surrounding the day of increased ventilator settings can count towards IVAC and P VAP . 16 15 MV Day No. 10 11 12 13 14 Day 2 of - -- Day 1 of - Worsening oxygenation Day 1 of Day 2 of stability or Stability or worsening worsening oxygenation oxygenation improvement improvement - - Temperature abnormality or  An abnormal temperature or white blood cell count, according to the algorithm white blood cell count parameters, must be documented within this shaded period  abnormality - Antimicrobial agent -  New agent must be started on any day within this shaded period, and then continued for at least 4 days  - - Purulent respiratory secretions,  Specimen must be collected on any day within this shaded period  positive culture, positive histopathology 22) Providers in my ICU use different types of mechanical ventilation for different patients. Can you explain the circumstances in which mechanically -ventilated patients are to be excluded from VAE surveillance, and the circumstances in which mechanically - ventilated patie nts should be included in VAE surveillance? ed to adult inpatient locations. P • VAE surveillance is restrict atients on mechanical ventilation -term acute care who are in adult inpatient locations in acute care and long hospitals and inpatient rehabilitation facilities are eligible for inclusion in VAE surveillance. • Patients are excluded from VAE surveillance during periods of time when they are receiving high frequency ventilation, or if they are receiving extracorporeal or paracorporeal life support ( for example extracorporeal membrane oxygenation - ). Patients may be on these types of support for a portion of a calendar day, but ECMO not for the entire calendar day. In these instances, the patient is eligible for inclusion in VAE surveillance during the portion of the calendar day when the patient was being mechanically ventilated using a conventional type of mechanical ventilation. 2019 10-43 January

194 -associated Module Device VAE Ventilator settings documented while on a conventional mode of ventilation are to be used to select daily minimum PEEP and FiO values for the calendar day. 2 • Patients are included in surveillance if they are on a ventilator (as defined in the VAE surveillance protocol), and are being mechanically ventilated through an endotracheal or tracheostomy tube using a conventional mode of mechanical ventilation (such as volume controlled, pressure controlled, or pressure support mechanical ventilation). e receiving nitric Patients on conventional mechanical ventilation who ar o oxide, helium-oxygen mixtures (heliox) or epoprostenol therapy are included in surveillance. o Patients on conventional mechanical ventilation who are being ventilated in the prone position are included in surveillance. • Patients are also i ncluded in surveillance if they are on a ventilator (as defined in the VAE surveillance protocol), and are being mechanically ventilated through an endotracheal or tracheostomy tube using Airway Pressure Release Ventilation (APRV) or related modes. Some te rms that are used to indicate APRV or a related mode of mechanical ventilation include (but may not be limited to): BiLevel, Bi Vent, BiPhasic, PCV+, and DuoPAP. For patients on APRV or related modes the entire calendar day , the period o of worsening oxygenation following a period of stability or improvement on the ventilator that is required for identification of a VAE will be defined by the FiO criterion within the VAE surveillance definition 2 algorithm. The PEEP criterion may not be applicable in patients on APRV or related modes of mechanical ventilation. o For p atients on APRV or related modes for a portion of the calendar day can be determined in either the PEEP or FiO identification of a VAE 2 parameter. However, only ventilator settings documented during the calendar day while on a conventional mode of ventilation are to be used to select the daily minimum PEEP. • If you have questions about mechanical ventilation, you should check with the Respiratory Care or Respiratory Therapy and/or Critical Care departments in your facility. 23) Do I need to indicate if a patient was on APRV at the time of VAE onset, and do I need to indicate the number of patients on APRV in my ICU for each day of VAE surveillance? • If the VAE occurred in a patient on Airway Pressure Release Ventilation (APRV) or a related mode of mechanical ventilation ( for example, BiLevel, Bi Vent, BiPhasic, in the “APRV” field is PCV+, DuoPAP) at the time of VAE onset, responding “Yes”. optional on the VAE Form ( CDC 57.112). Otherwise, indicate “No.” • On the appropriate denominator form ( CDC 57.117 or 57.118) ; in the column for “Number of patients on a ventilator,” you will see that there are two sub- columns. In ts on a ventilator on the sub- column, “Total patients,” enter the total number of patien that day. It is optional to provide,the “Number on APRV,” in the sub-column . If provided, enter the number for the subset of patients on a ventilator on that day who for example, are on the APRV mode of mechanical ventilation or related modes ( January 2019 10-44

195 Device -associated Module VAE BiLevel, Bi Vent, BiPhasic, PCV+, DuoPAP) at the time the count is performed. If ” echanical ventilation, enter “0 there are no patients on APRV or a related mode of m (zero). atory tract My laboratory only performs semi-quantitative cultures of lower respir 24) specimens, and cannot provide me with additional guidance to help me know what semi- quantitative culture result corresponds to the quantitative thresholds specified in Criterion1 of the PVAP definition. Can you provide more information? • For the purposes of this surveillance, and in the absence of additional information -quantitative result of “moderate” or “heavy” available from your laboratory, a semi growth, or 2+, 3+ or 4+ growth, meets the PVAP definition (Criterion 1). January 2019 10-45

196 Device -associated Module PedVAE Pediatric Ventilator -Associated Event (PedVAE) For use in neonatal and pediatric locations only Table of Contents: Introduction 1 3 Settings Definitions 3 Reporting Instructions 12 Figure 1 Ped VAE Algorithm 13 Numerator Data 14 14 Denominator Data 15 Data Analyses References 15 Appendix of Antimicrobial Agents 17 Introduction: Mechanical ventilation is an essential, life-saving therapy for patients with critical illness and respiratory failure. Hundreds of thousands of patients receive mechanical ventilation in the United States each year [1 -3]. These patients are at high risk for complications and poor outcomes, including death [1 -5]. Ventilator- associated pneumonia (VAP), sepsis, Acute Respiratory Distress Syndrome (ARDS), pulmonary embolism, barotrauma, and pulmonary edema are among the complications that can occur in patients receiving mechanical ventilation. Such complications can lead to longer duration of mechanical ventilation, longer stays in the ICU and hospital, increased healthcare costs, and increased risk of disability and death. In preterm neonates, prolonged mechanical ventilation for respiratory distress syndrome can contribute to the development of chronic lung disease [6]. Prolonged mechanical ventilation in extremely low birthweight infants is also associated with neurodevelopmental delay [7]. Surveillance for ventilator- associated events in the National Healthcare Safety Network (NHSN) prior to 2013 was limited to VAP. Traditional VAP definitions , including the NHSN PNEU -described limitations [8 definitions (revised in 2002), have well -11]. They typically require radiographic evidence of pneumonia, although data suggest that chest radiograph findings do not accurately identify VAP. The subjectivity and variability inherent in chest radiograph technique, interpretation, and reporting make chest i maging ill- suited for inclusion in a definition algorithm to be used for the potential purposes of public reporting, inter-facility comparisons, pay-for- ther major difficulty with available VAP reporting and pay- for -performance programs. Ano definitions is their reliance on specific clinical signs or symptoms, which are subjective and may be poorly or inconsistently doc umented in the medical record. January 2019 11-1

197 Device -associated Module PedVAE The limitations of VAP surveillance definitions have implications for prevention. Valid and reliable surveillance data are necessary for assessing the effectiveness of prevention strategies. It is notable that some effective measures for improving outcomes of patients on mechanical ventilation do not specifically target pneumonia prevention [12-15]. of several stakeholder In 2011, CDC organized a working group composed of members organizations to address the limitations of the NHSN PNEU definitions and propose a new -Associated Events (VAE) for NHSN [16], focusing on approach to surveillance for Ventilator adult patients . The organizations represented in the working group included: the Critical Care Societies Collaborative (the American Association of Critical -Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society for Critical Care Medicine); the American Association for Respiratory Care; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America. The VAE surveillance definition algorithm developed by the working group was implemented in the NHSN in January 2013 and is available for use in adult locations only. The definition based on objective, streamlined, and potentially automatable criteria algorithm is a that identify ients in ly-ventilated pat broad range of conditions and complications occurring in mechanical adult locations. D ata indicate that streamlined, objective algorithms to detect ventilator - associated events are easily implemented, can make use of electronic health record systems to automate event detection, and identify events that are clinica lly important and associated with outcomes such as ICU and hospital leng th of stay and mortality [17, 18]. Research suggests that , atelectasis, and pulmonary edema most VAEs in adult patients are due to pneumonia, ARDS [17]. These that may be preventable. VAE rates and event are significant clinical conditions reporting data t o NHSN have been published characteristics in 2014 in adult inpatient locations [19]. VAE surveillance was not initially made available for use in neonatal and pediatric locations, based on the recommendations of a separate working group that CDC organized in 2012 to consider whether the VAE surveillance approach could also be used in neonatal and pediatric inpatient populations. This working group included representatives from the following organizations: the American Academy of Pediatrics (AAP) Committee on the Fetus and Newborn and Committee on Infectious Diseases; the AAP Section on Critical Care and Section on Pediatric Pulmonology; the American Association of Critical- the American Care Nurses; College of Chest Physicians Pediatric Chest Medicine Network; the American Thoracic Society Scientific Assembly on Pediatrics; the American Association for Respiratory Care; the Children’s Hospital Association; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Pediatric Infectious Diseases Society; the Pediatric Cardiac Intensive Care Society; the Society for Healthcare January 2019 11-2

198 Device -associated Module PedVAE -Oxford Epidemiology of America; the Society of Critical Care Medicine, and the Vermont Network. In mid-2013, this working group determined that there were insufficient data to inform development of a pediatric VAE definition. F urther working group discussions were postponed until 2015, following publication of the results of a study on pediatric VAE definition criteria [20]. This study demonstrated that events defined by changes in the fraction of inspired oxygen (FiO ) and Mean Airway Pressure (MAP) were associated with increases in patient leng th of stay 2 as well as mortality [20]. After additional discussion with the working group, CDC decided to move forward with pediatric VAE (P edVAE) development and implementation in NHSN. AE NOTE: definition algorithm is for use in surveillance; it is not a clinical definition The PedV algorithm and is not intended for use in the clinical management of patients. Examples provided throughout this protocol are for illustration purposes only and are not intended to represent actual clinical scenarios. Settings : Inpatient locations eligible to participate in Ped VAE surveillance are those neonatal in acute care hospitals, long term acute care hospitals, and inpatient and pediatric locations rehabilitation faci lities where denominator data (ventilator and patient days) can be collected for patients . Such locations may include critical/intensive care units (ICU), specialty care areas pediatric inpatient (SCA), step -down units and wards . A complete listing of neonatal and locations can be found in Chapter 15. NOTE: All patients in the neonatal and pediatric inpatient locations found in Chapter 15 are patient’s age. included regardless of NOTE acute care mapped locations in acute care facilities (chronic care units in acute care : Non- VAE surveillance. facilities) are not eligible to participate in Ped NOTE: It is not required to monitor for Ped VAE s after discharge if a pat ient is transferred to another facility while still on mechanical ventilation. However, Ped VAEs discovered within 2 calendar days of discharge (where the day of discharge is day 1) should be reported to NHS N. No additional ventilator days are reported. Se e Transfer Rule below (page 11) for details on reporting. : Definitions Ped in respiratory status after a period of stability deterioration VAE : Ped VAEs are identified by be used for or improvement on the ventilator. The following pages outline the criteria that must meeting the Ped VAE surveillance definition s ( Figure 1). To report Ped VAEs, use the Pediatric Ventilator -Associated Event form (CDC 57.113) and Instructions for Completion of Pediatric Ventilator -Associated Event Form . days to fulfill calendar NOTE: Patients must be mechanically ventilated for at least 4 Ped (where the day of intubation and initiation of mechanical ventilation is VAE criteria January 2019 11-3

199 Device -associated Module PedVAE day 1). The earliest date of event for Ped VAE (the date of onset of worsening oxygenation) is day 3 of mechanical ventilation. NOTE: The baseline period of stability or improvement on the ventilator is defined as the 2 calendar days immediately preceding the first day of increased daily minimum MAP or FiO ≥ 2 calendar days of stable or decreasing daily and must be characterized by 2, minimum FiO or MAP values (specifically , the daily minimum MAP or FiO on the 2 2 second day of the baseline period of stability or improvement must be equal to or less than the daily minimum MAP or FiO on the first day of the baseline period of stability or 2 ” mum FiO ” and “daily mini are improvement). The definition s of “daily minimum MAP 2 included below. Note that the daily minimum MAP is the lowest value documented during a calendar day, and the daily minimum FiO value documented is the lowest 2 during a calendar day that was maintained for > 1 hour (see daily minimum FiO 2 definitions for exception to the > 1 hour requirement). For the purposes of surveillance, in patients < 30 days old, MAP values of 0-8 NOTE: O are considered equivalent; therefore, any day on which the daily minimum MAP cmH 2 O would be assigned a daily minimum value of 8 cmH O, and an increase -8 cmH was 0 2 2 in the daily minimum MAP to at least 12 cmH O, sustained for 2 calendar days, would be 2 needed to meet the PedVAE definition. O 30 days old, MAP values of 0-10 cmH For the purposes of surveillance, in patients ≥ 2 are considered equivalent; therefore, any day on which the daily minimum MAP was 0- O would be assigned a daily minimum value of 10 cmH O, and an increase in 10 cmH 2 2 the daily minimum MAP to at least 14 cmH O, sustained for 2 calendar days, would be 2 needed to meet the PedVAE definition. EXAMPLE: In the example below, in a patient < 30 days old, the baseline period is defined by mechanical ventilation (MV) days 1 through 4 (shaded in light gray), and the period of worsening oxygenation by MV days 5 and 6 (shaded in darker gray), where the O greater than the daily minimum MAP during the daily minimum MAP 4 cmH is ≥ 2 O in a (keeping in mind that daily minimum baseline period MAP values 0 -8 cmH 2 O for the purposes of patient <30 days should be considered to be equal to 8 cmH 2 surveillance.) Daily minimum Daily minimum MV Day Ped VAE MAP (cmH O) (oxygen concentration, %) FiO 2 2 1 7 (8) 1.00 (100%) - 7 0.50 (50%) (8) 2 - - 3 8 0.50 (50%) - 4 8 0.50 (50%)  5 12 0.50 (50%) 0.50 (50%) 12 - 6 January 2019 11-4

200 -associated Module Device PedVAE EXAMPLE: In the example below , the baseline period is defined by mechanical ventilation ( MV ) days 3 and 4 (shaded in light gray), and the period of worsening oxygenation by MV days 5 and 6 (shaded in darker gray), where the daily minimum FiO 2 is ≥ 0.25 (25 points) over the daily minimum FiO during the baseline period. 2 Daily minimum Daily minimum VAE Ped MV Day O) (oxygen concentration, FiO %) (cmH MAP 2 2 1 12 1. 00 (100%) - (50%) 2 11 0.50 - 9 3 - (40%) 0.40 (40%) - 0.40 9 4  11 (70%) 5 0.70 11 - 6 0.70 (70%) EXAMPLE: In the example below, there is no PedVAE , because the FiO on MV day 4 2 on MV day 3 (and therefore not stable or decreasing) is higher than the FiO even – 2 point threshold when compared with on MV days 3 and 4 meets the 25- though the FiO 2 the daily minimum FiO on MV days 5 and 6. 2 Daily minimum Daily minimum MV Day Ped VAE MAP (cmH (oxygen concentration, O) FiO %) 2 2 12 - 1.00 (100%) 1 - (50%) 0.50 11 2 3 9 0.35 (35%) - (40%) - 4 0.40 9 No event 0.70 5 (70%) 11 - (70%) 0.70 11 6 atients on extracorporeal life support or paracorporeal membrane oxygenation are NOTE: P EXCLUDED from Ped VAE surveillance during periods of time when the support is in place the entire calendar day . Patients on high- frequency oscillatory or jet ventilation are INCLUDED in NOTE Additionally, patients who are receiving a conventional mode of PedVAE surveillance. mechanical ventilation or high frequency oscillatory or jet ventilation while in the prone are INCLUDED in PedVAE surveillance, and patients who are receiving a position conventional mode of mechanical ventilation or high frequency oscillatory or jet ventilation while receiving surfactant, corticosteroids, nitric oxide therapy , helium- oxygen mixtures (heliox) or epoprostenol therapy are also INCLUDED in Ped VAE surveillance. NOTE: Ped VAEs are defined by a 14-day period, starting on the day of onset of VAE worsening oxygenation (the event date, day 1). A new Ped cannot be identified or reported until this 14-day period has elapsed. 11-5 January 2019

201 Device -associated Module PedVAE : The da te of onset of worsening oxygenation. This is defined as the first calendar Date of event day in which the daily minimum MAP or FiO increases above the thresholds outlined in the 2 VAE definition algorithm (specifically , day 1 of the required ≥ 2 Ped -day period of worsening oxygenation following a ≥ 2 -day period of stability or improvement on the ventilator). EXAMPLE: A patient is intubated in the Emergency Room for severe community - acquired pneumonia and admitted to the PICU (day 1). The patient stabilizes and improves on days 2- 5, with a daily minimum FiO of 0.35 (35%) on days 4 and 5. On day 2 6, the patient experiences respiratory deterioration, and requires a minimum FiO of 0.60 2 (60%) on days 6 and 7, meeting the criteria for a PedVAE . The date of the PedVAE event is day 6. NOTE: The “date of event” is NOT the date on which all Ped VAE criteria have been met. It is the first day (of a ≥ 2 -day period) on which either of the worsening oxygenation thresholds ( for MAP or FiO ) is met. 2 Mean Airway Pressure ( MAP ): The average pressure exerted on the airway and lungs from the beginning of inspiration until the beginning of the next inspiration [2 1]. In patients on mechanical ventilation, MAP is the most powerful influence on oxygenation and is determined by peak end- expiratory pressure (PEEP), peak inspiratory pressure (PIP), inspiratory time and O following a ≥ 4 cmH of mum MAP in the daily mini frequency [2 2]. A sustained increase 2 period of stability or improvement on the ventilator is one of two criteria that can be used in meeting the PedVAE definition. ): The fraction of oxygen in inspired gas. For example, the Fraction of inspired oxygen (FiO 2 0.21; the oxygen concentration of ambient air is 21%. In patients on FiO of ambient air is 2 is one of the key parameters that can be adjusted depending on mechanical ventilation, the FiO 2 the patient’s oxygenati on needs, and is typica lly in the range of 0.21 (oxygen concentration of 21%) to 1.0 (oxygen concentration of 100%) . A sustained increase (defined later in this protocol) 0.25 (2 5%) following a period of stability or improvement on the of ≥ in the daily minimum FiO 2 ventilator is the second of the two criteria that can be used in meeting the PedVAE definition. Daily minimum MA P: The lowest value of MAP during a calendar day. When determining the value, round MAP readings in the following manner MAP : a MAP of 1 0.00 – daily minimum 10.49 is rounded to 10 and a MAP of 10.50 – 10.99 is rounded to 11. For example, a patient who of 10.35 is intubated and started on mechanical ventilation at 9:30 pm on June 1, with a MAP O on O and a MAP of 10.54 at11:30 pm would have a daily minimum MAP of 10 cmH cmH 2 2 June 1 for the purposes of Ped VAE surveillance. January 2019 11-6

202 Device -associated Module PedVAE (<30 days old) is intubated at 6 pm. MAP values through the EXAMPLE: The patient remainder of the calendar day are as follows: Time 7 pm 8 pm 9 pm 10 pm 11 pm 6 pm 11 11 9 9 11 12 MAP (cmH O) 2 In this example, the daily minimum for the purposes of Ped VAE surveillance is 9 MAP cmH O. 2 EXAMPLE: The patient is intubated at 6 pm. MAP values are as follows through the remainder of the calendar day: Time 6 pm 7 pm 11 pm 8 pm 9 pm 10 pm 10 12 12 10 12 12 MAP (cmH O) 2 In this example, the daily minimum MAP VAE surveillance is 10 for the purposes of Ped O. This is the lowest value recorded during the calendar day. When making daily cmH 2 minimum MAP determinations the value does not need to be maintained for > 1 hour. values are as follows through the course of a calendar day for a patient EXAMPLE: MAP <30 days old: Time 4 am 8 am 12 pm 4 pm 8 pm 1 am 11 11 9 11 12 9 MAP O) (cmH 2 MAP In this example, the daily minimum is 9 cmH O. 2 EXAMPLE: You are reviewing a <30 -day-old patient’s ventilator data on Wednesday values for Monday and Tuesday. The morning to determine the daily minimum MAP on every 30 minutes. You see that the lowest MAP monitors and records MAP PICU O) was recorded at 11:30 pm when the episode of mechanical Monday (9 cmH 2 ventilation was initiated for this patient. T he patient remained at this MAP for an O for the rest 12 cmH MAP additional 30 minutes on Tuesday morning, and was then at 2 of the day on Tuesday. What do you record as the daily minimum MAP for Monday and 0 is recorded as the daily minimum for Tuesday? The lowest (and only) value of 9 cmH 2 for Monday. On Tuesday, the daily minimum MAP MAP should also be recorded as 9 O, as it is the lowest value recorded on Tuesday. cmH 2 January 2019 11-7

203 Device -associated Module PedVAE Time MAP (cmH Day O) 2 Monday 23:30 9 Tuesday 9 00:00 Tuesday 00:30 9 Tuesday 12 01:00 Tuesday 01:30 12 Tuesday 12 02:00 through 23:30 Daily minimum FiO The lowest value of FiO during a calendar day that is set on the ventilator 2: 2 and maintained for > 1 hour. This requirement that the daily minimum FiO be the lowest setting 2 settin gs hourly or maintained for > 1 hour will ensure that units monitoring and recording FiO 2 more frequently than once per hour are able to apply the Ped VAE surveillance FiO criterion in a 2 standardized way. In the event that ventilator settings are monitored and recorded less frequently set on the is simply the lowest value of FiO than once per hour, the daily minimum FiO 2 2 ventilator during the calendar day. Similarly, in circumstances where there is no value that has been maintained for > one hour ( for example , the lowest value of FiO is set late in the calendar 2 y minimum FiO is day, mechanical ventilation is discontinued early in the calendar day) the dail 2 set on the ventilator dur the lowest value of FiO ing the calendar day. 2 settings every hour or more frequently than every hour, NOTE: In units tracking FiO 2 there must be sufficient consecutive recordings of a specific FiO setting to meet the 2 minimum required duration of > 1 hour. For example, in units tracking FiO every 15 2 at a certain level would be needed to meet the minutes, 5 consecutive recordings of FiO 2 required > 1 hour minimum duration (for example, 09:00, 09:15, 09:30, 09:45 and every 30 minutes, 3 consecutive recordings of FiO at a 10:00). In units tracking FiO 2 2 certain level would be needed to meet the required > 1 hour minimum duration ( for example, 09:00, 09:30, and 10:00). In units tracking FiO every hour, 2 consecutive 2 recordings of FiO at a certain level would be needed to meet the required > 1 hour 2 , 09:00 and 10:00). for example minimum duration ( is set at the following values through EXAMPLE: The patient is intubated at 6 pm. FiO 2 the remainder of the calendar day: 10 pm 11 pm Time 6 pm 7 pm 8 pm 9 pm 0.5 1.0 0.8 0.5 0.8 0.8 FiO 2 VAE surveillance is 0.5. for the purposes of Ped In this example, the daily minimum FiO 2 FiO settings are being monitored and recorded every hour. There are two consecutive 2 setting is noted to be 0.5 (8 pm and 9 pm), and therefore required hours where the FiO 2 minimum duration of > 1 hour is met. January 2019 11-8

204 Device -associated Module PedVAE EXAMPLE: The patient is intubated at 6 pm. FiO is set at the following values through 2 the remainder of the calendar day: 9 pm 11 pm 10 pm Time 6 pm 7 pm 8 pm 0.8 0.8 0.5 0.8 0.5 0.8 FiO 2 In this example, the daily minimum FiO for the purposes of Ped VAE surveillance is 0.8. 2 FiO settings are being monitored and recorded every hour. Although the lowest FiO is 2 2 0.5, it is recorded at two non-consecutive time points only (8 pm, and then 10 pm) , and so the required > 1 hour minimum duration is not met. There are two consecutive hours where the FiO , and therefore the required setting is noted to be 0.8 (6 pm and 7 pm) 2 minimum duration of 1 hour is met to allow use of this setting as the daily minimum VAE surveillance. value for Ped EXAMPLE: FiO is set at the following values through the course of a calendar day: 2 Time 12 am 2 pm 4 pm 6 pm 8 pm 10 pm 1.0 0.60 0.60 0.55 0.50 0.40 FiO 2 In this example, the patient was intubated at 2 pm. The daily minimum FiO is 0.40. FiO 2 2 settings are being monitored and recorded every 2 hours; therefore, the lowest recorded FiO setting for the calendar day is the value used in Ped VAE surveillance. 2 EXAMPLE: You are reviewing a patient’s ventilator settings on Friday morning to determine the daily minimum FiO2 value for Thursday. The patient was intubated and initiated on mechanical ventilation at 21:45 hours on Thursday. The ICU monitored and recorded FiO2 settings for the patient every 15 minutes during the remainder of the day on Thursday. Based on the information recorded in the table below, what should you record as the daily minimum FiO2 for Thursday? In this example, since there is no setting 1 hour during the calendar day, the daily minimum FiO2 for that is maintained for > Thursday is 0.70 (70%). This is the lowest value of FiO2 set on the ventilator during the calendar day. January 2019 11-9

205 Device -associated Module PedVAE Day Time FiO 2 Thursday 21:45 Intubated; 1.0 22:00 1.0 0.90 22:15 22:30 0.90 0.70 22:45 23:00 0.80 23:15 0.85 23:30 0.85 23:45 0.85 : any device used to support, assist or control respiration (inclusive of the weaning Ventilator period) through the application of positive pressure to the airway when delivered via an artificial airway, specifically an oral/nasal endotracheal or tracheost omy tube. Note : Ventilation and lung expansion devices that deliver positive pressure to the airway (for example: CPAP, Bipap, bi-level, IPPB and PEEP) via non- invasive means (for example: nasal t considered ventilators unless positive prongs, nasal mask, full face mask, total mask, etc.) are no pressure is delivered via an artificial airway (oral/nasal endotracheal or tracheostomy tube). Episode of mechanical v entilation : Defined as a period of days during which the patient was some portion of each c onsecutive day. mechanically ventilated for NOTE: A break in mechanical ventilation of at least one full calendar day, followed by reintubation and/or re -initiation of mechanical ventilation during the same hospitalization, defines a new episode of mechanical ventilation. ted at 11 pm on EXAMPLE: A patient is intubated and mechanical ventilation is initia hospital day 1. The patient rem ains intubated and mechanically ventilated from hospital days 2-10. The patient is extubated at 9 am on hospital day 11, and remai ns extubated on hospital day 12. The patient is re -intubated and mechanical ventilation is reinitiated on hospital day 13. The patient remains intubated and mechanically ventilated from hospital day 14-18. This patient has had two episodes of mechanic al ventilation (days 1-11 and days 13-18) , separated by at least one full calendar day off of mechanical ventilation. Location of attribution: The inpatient location where the patient was assigned on the date of the VAE , which is further defined as the date of onset of worsening oxygenation. EXAMPLE: Patient is intubated and ventilated in the Operating Room on hospital day 1, and then is admitted post- CU on hospital day 1, still on the NI operatively to the January 2019 11-10

206 Device -associated Module PedVAE ventilator. On hospital day 3, the patient experiences the onset of worsening oxygenation, manifested by an increase in the daily minimum FiO of ≥ 0.25 (25%) . On 2 th day 4 (also the 4 day of mechanical ventilation) the patient meets criteria for a PedVAE . This is reported as a PedVAE for the N ICU. EXCEPTION : : If a Ped VAE develops on the day of transfer or the day following transfer Transfer Rule from one inpatient location to another in the same facility (where the or to a new facility day of transfer is day 1), the event is attributed to the transferring location. This is called the Transfer Rule, and examples are shown below: EXAMPLE: Patient is extubated in the PICU and transferred to the medical stepdown t (day 7), the patient unit on hospital day 6. The next day, while in the stepdown uni experiences worsening oxygenation and is re- intubated and transferred back to the P ICU. Criteria for PedVAE are met the next day (day 8). In this case, the day prior to extubation and the day of extubation (hospital days 5 and 6) count as the required 2-day period of stability or improvement. The day of reintubation (day 7) and the following day (day 8) count as the required 2-day period of worsening oxygenation. Because the onset of worsening oxygenation occurred on the day following transfer out of the PICU, the event for the P is reported as a PedVAE ICU. NICU of n the EXAMPLE: Patient intubated and mechanically ventilated for 8 days i Hospital A is transferred for further care on day 8 to the NICU of Hospital B. The patient stable on the ventilator in Hospital A from days 3-8. On the day of transfer to was Hospital B (day 1 in Hospital B ), the patient’s respiratory status deteriorates. The day after transfer (day 2 in Hospital B), the patient meets criteria for PedVAE . The date of the event is day 1 in Hospital B, the first day of the period of worsening oxygenation meeting thresholds. The infection preventionist (IP) from Hospital B calls Ped or FiO VAE MAP 2 the Hospital A IP to report that this patient was admitted to Hospital B with a PedVAE . , and attributed to the Hospital A NICU. This PedVAE should be reported by Ho spital A No additional ventilator days are reported by Hospital A. REPORTING INSTRUCTIONS : • Conducting in-plan Ped VAE surveillance means assessing patients for the presence of events meeting the PedVAE definition. • If the date of event (date of onset of worsening oxygenation) is on or after the date of documentation of evidence of consent AND the patient is being support ed for organ donation purposes, the event should not be reported as a Ped VAE. • Secondary BSIs are not reported or attributable to a PedVAE . Clinical findings associated with a PedVAE may assist in better understanding the • and focusing efforts to prevent PedVAEs. Should a facility choose to provide the etiology : fields to report following information, the PedVAE form includes optional data January 2019 11-11

207 Device -associated Module PedVAE that . Note Clinical diagnoses or events that were associated with the PedVAE o multiple events m ay be reported for a single PedVAE. o on the date of hat are administered Antimicrobial agent s listed in the Appendix t . The name of the event or within the 2 days before or 2 days after the event specific antimicrobial agent may also be and the administration initiation date reported. o Pathogens de tected by culture or non-culture-based microbiological testing of upper or lower respiratory specimens with a specimen collection date on the date of event or within the 2 days before or 2 days after the date of event or in blood with a specimen collection date within the 2 days before the date of event and up to 13 days after the date of event. Note: Because organisms belonging to the following genera are typically causes of community -associated respiratory infections and are rarely or are not known to be causes of healthcare- associated infections, they are excluded, and cannot be reported: Blastomyces, Histoplasma, Coccidioides, Para coccidioides, Cryptococcus and Pneumocystis. detected with by urine antigen testing o Legionella or Streptococcus pneumoniae a date of specimen collection on the date of event or within the 2 days before or 2 days after the event . January 2019 11-12

208 Device -associated Module PedVAE Figure 1: Pediatric Ventilator -Associated Events ( PedVAE) Surveillance Algorithm defined by ≥ 2 calendar Patient has a baseline period of stability or improvement on the ventilator, days of stable or decreasing daily minimum* FiO or MAP values. The baseline period is defined as 2 the 2 calendar days immediately preceding the first day of increased daily minimum MAP or FiO . 2 > 1 hour. * Daily minimum FiO is defined as the lowest value of FiO documented during a calendar day that is maintained for 2 2 Daily minimum MAP is the lowest value documented during the calendar day. O for the purposes of surveillance. O are considered equal to 8 cmH 8 cm H - For patients <30 days old, daily minimum MAP values 0 2 2 O for the purposes of surveillance. O are considered equal to 10 cmH For patients ≥30 da ys old, daily minimum MAP values 0 10 cmH - 2 2 After a period of stability or improvement on the ventilator, the patient has at least one of the following indicators of worsening oxygenation: 1) Increase in daily minimum FiO of ≥ 0.25 (25 points) over the daily minimum FiO of the first day in 2 2 the baseline period, sustained for ≥ 2 calendar days. MAP values of ≥ 4 cmH Increase in daily minimum 2) O over the daily minimum MAP of the first day in 2 calendar days . the baseline period, sustained for ≥ 2 Pediatric Ventilator -Associated Event (PedVAE) 11-13 January 2019

209 Device -associated Module PedVAE Numerator Data: The Pediatric Ventilator -Associated Event form (CDC 57.113) is used to VAE that is identified during the month selected for surveillance. collect and report each Ped Instructions for Completion of Pediatric Ventilator -Associated Event Form includes brief The instructions for collection and entry of each data element on the form. The Ped VAE form includes patient demographic information and information on the start date and location of initiation of mechanical ventilation. Additional data include the specific criteria met for identifying Ped VAE , information about whether the patient was on antimicrobial drugs or had culture -based microbiological testing, pathogens detected in culture or non- whether the patient died, and, where applicable, the organisms detected and their antimicrobial susceptibilities. Denominator Data: Device days and patient days are used for denominators (see Chapter 16 Key Terms). Ventilator days, which are the numbers of patients managed with ventilatory devices , are collected daily, at the same time each day, according to the chosen location using the appropriate form (CDC 57.116 [NICU] or CDC 57.117 [Specialty Car e Areas] or CDC 57.118 is reported only the total for the month ). These daily counts are summed and [ICU/Other Areas] . Ventilator and patient days are collected for each of the locations monitored. When denominator data are available from electronic sources ( for examp le, ventilator days from respiratory therapy), these sources may be used as long as the counts are not substantially different (+/ - 5%) -collected counts, pre-validated for a minimum of 3 months. from manually NOTE: All ventilator days are counted , includ ing ventilator days for patients on mechanical ventilation for < 3 days, and ventilator days for patients on extracorporeal life support or VAE surveillance. Patients paraco rporeal membrane oxygenation who are excluded from Ped with tracheostomies who are undergoing weaning from mechanical ventilation using tracheostomy collar trials are included in ventilator day counts as long as they spend some portion of the day on mechanical ventilation at a time that overlaps with the daily time during which ventilator day counts are performed. Collection of an additional denominator, episodes of mechanical ventilation (EMV), is optionally available for Ped VAE surveillance. The EMV denominator represents the sum of the number of episodes of mechanical ventilation that occurred in that location during the month. A single episode of mechanical ventilation for each patient is to be counted only once per month. Do patient to note, it is possible for a have more than one episode of ventilation occur during a month (for exa mple , discontinuation of mechanical ventilation for greater than 1 calendar day followed by re- initiation of mechanical ventilation). The EMV denominator is determined by counting all patients in the location who are on mechanical ventilation on the first day of the VAE surveillance. Then, on each subsequent month regardless of eligibility for inclusion in Ped day of the month, count each additional patient that is started on mechanical ventilation. This would include those that are admitted to the location already on mechanical ventilation, those that are newly ventilated , and any previously ventilated patients who have new episodes of mechanical ventilation occurring during the same month. The sum of the count for the first day . and each subsequent day of the month is reported January 2019 11-14

210 Device -associated Module PedVAE ICU (2 patients EXAMPLE: On January 1, there are 5 patients on mechanical ventilation in the P were started on mechanic al ventilation on December 24, 2 patients on December 31, and 1 patient on January 1). During the rest of the month, the following are noted: 1 patient is started on mechanical ventilation on January 8; 2 patients are transferred to the PICU on mechanical ventilation on January 15, and 1 patient who was previously ventilated (from January 1 through January 12) goes back on mechanical ventilation on January 20. No other patients are on mechanical ventilation during the month of January. The number of EMV for January is nine. ollows: 5 patients (on mechanical ventilation on the first day of the month) lculated as f is ca This + 4 patients who were either started on mechanical ventilation, transferred into the P ICU on mechanical ventilation, or re-initiated on mechanical ventilation after being off of the vent for at least 1 calendar day = 9 EMV. rate per 1000 ventilator days VAE is calculated by dividing the number Data Analyses: The Ped of V AEs by the number of ventilator days and multiplying the result by 1000 (ventilator days). 100 episodes of mechanical ventilation The rate per is calculated by dividing the number of Ped VAEs by the number of episodes of mechanical ventilation and multiplying the result by 100 dividing The Ventilator Utilization Ratio is calculated by (episodes of mechanical ventilation). the number of ventilator days by the number of patient days. January 2019 11-15

211 Device -associated Module PedVAE REFERENCES Behrendt CE. Acute respirato ry failure in the United States : incidence and 31 1) -day survival. Chest 2000;118:1100- 5. 2) Kahn JM, Goss CH, Heagerty PJ, et al. Hospital volume and the outcomes of mechanical ventilation. N Engl J Med 2006;355:41 -50. 3) Wunsch H, Linde -Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med 2010;38:1947 -53. 4) Rubenfeld GD, Caldwell E, Peabody E, et al. Incidence and outcomes of acute lung injury. N Engl J Med 2005;353:1685- 93. 5) Esteban A, Anzueto A, Frutos F, et al. Characteristics and outcomes in adult patients receiving mechanical 55. ventilation: a 28 -day international stu dy. JAMA 2002;287:345- 6) Fraser J, Walls M, McGuire W. Respiratory complications of preterm birth. BMJ 2004;329:962 -5 Dudeck MA, Weiner LM, Allen -Bridson K , et. al. National Healthcare Safety Network (NHSN) Report, Data Summary for 2012 , Device -associated Module. Am J Infect Control 2013;41:1148 -66. 7) Walsh MC, Morris BH, Wrage LA, et al. Extremely low birthweight neonates with protracted ventilation: -month neurodevelopmental outcomes. J Pediatrics 2005;146:798 mortality and 18 -804 8) Klompas M. Does this patie nt have ventilator -associated pneumonia? JAMA 2007;297:1583 -93. 9) Klompas M. Interobserver variability in ventilator -associated pneumonia surveillance. Am J Infect Control 2010;38:237-9. 10) Klompas M, Kulldorff M, Platt R. Risk of misleading ventilator -associated pneumonia rates with use of standard clinical and microbiological criteria. Clin Infect Dis 2008;46:1443 -6. Zilberberg MD, Shorr AF. Ventilator -associated pneumonia: the clinical pulmonary infection score as a 11) and outcome. Clin Infect Dis 2010;51 Suppl 1:S131 surrogate for diagnostics -5. 12) Girard T, Kress JP, Fuchs BD, et al. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awa kening and Breathing Controlled trial): a randomised controlled trial. Lancet 2008;371:126- 34. Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical 13) -80. ventilation. Lancet 2010;375:475 14) The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301- 8. 15) Schweickert WD , Pohlman MC , Pohlman AS , et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet 2009;373:1874 -8 2. 16) Magill SS, Klompas M, Balk R, et al. Developing a new, national approach to surveillance for ventilator - associated events. Critical Care Medicine 2013;41:2467- 75. Klompas M, Khan Y, Kleinman K, et al. Multicenter evaluation of a novel surveillance parad igm for 17) complications of mechanical ventilation. PLoS One 2011;6:e18062. 18) Klompas M, Magill S, Robicsek A, et al. Objective surveillance definitions for ventilator -associated pneumonia. Crit Care Med;2012 :3154- 61. 19) Magill SS, Li Q, Gross C, et al. Incidence and characteristics of ventilator -associated events reported to the National Healthcare Safety Network in 2014. Crit Care Med 2016; online ahead of print, available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113232/ Cocoros NM 20) , et al. Ventilator , Kleinman K , Priebe GP -Associated Events in Neonates and Children-- A New Paradigm. Crit Care Med. 2016 Jan;44:14 -22. 21) Heulitt M, Clement KC. (2015). Respiratory Mechanics in the Mechanically Ventilated Patient. In Pedia tric and Neonatal Mechanical Ventilation (p. 169). Rimensberger PC. New York City, NY: Springer Publishing. Pediatric and Neonatal Mechanical Ventilation (p. 307). 22) Donn SM, Sinha SK. (2015). Ventilator Modes. In Rimensberger PC. New York City, NY: Springer Publishing. January 2019 11-16

212 Device -associated Module PedVAE Appendix. List of Eligible Antimicrobial Agents Antimicrobial Agent AMIKACIN AMPHOTERICIN B AMPHOTERICIN B LIPOSOMAL AMPICILLIN AMPICILLIN/SULBACTAM ANIDULAFUNGIN AZITHROMYCIN AZTREONAM CASPOFUNGIN CEFAZOLIN CEFEPIME CEFOTAXIME CEFOTETAN CEFOXITIN CEFTAROLINE CEFTAZIDIME CEFTAZIDIME/AVIBACTAM CEFTIZOXIME CEFTOLOZANE/TAZOBACTAM CEFTRIAXONE CEFUROXIME CIPROFLOXACIN CLARITHROMYCIN CLINDAMYCIN COLISTIMETHATE DALBAVANCIN DELAFLOXACIN DORIPENEM DOXYCYCLINE ERTAPENEM FLUCONAZOLE FOSFOMYCIN GEMIFLOXACIN GENTAMICIN IMIPENEM/CILASTATIN ISAVUCONAZONIUM ITRACONAZOLE January 2019 11-17

213 Device -associated Module PedVAE LEVOFLOXACIN LINEZOLID MEROPENEM MEROPENEM/VABORBACTAM METRONIDAZOLE MICAFUNGIN MINOCYCLINE MOXIFLOXACIN NAFCILLIN ORITAVANCIN OSELTAMIVIR OXACILLIN PENICILLIN G PERAMIVIR PIPERACILLIN PIPERACILLIN/TAZOBACTAM POLYMYXIN B POSACONAZOLE QUINUPRISTIN/DALFOPRISTIN RIFAMPIN SULFAMETHOXAZOLE/TRIMETHOPRIM SULFISOXAZOLE TEDIZOLID TELAVANCIN TELITHROMYCIN TETRACYCLINE TICARCILLIN/CLAVULANATE TIGECYCLINE TOBRAMYCIN VANCOMYCIN, intravenous only VORICONAZOLE ZANAMIVIR January 2019 11-18

214 Device -associated Module PedVAE January 2019 11-19

215 CDI Module MDRO and Resistant Organism & Clostridioides Infection Multidrug- difficile (MDRO/CDI) Module Table of C ontents Background 2 3 Table 1: Core and Supplemental Reporting Choices for MDRO and CDI Module 6 Section I: Core Reporting Identified (LabID) Event Reporting Option 1: Laboratory- 6 1A: MDRO LabID Event Reporting 7 11 Table 2: Reporting Options for the MDRO Module Clostrid ioides difficile (C. difficile ) LabID Event Reporting 1B: 22 Table 3: Reporting Options for the CDI Module 24 Table 4. Measures Delivered to CMS For Facilities Participating in Quality 33 LabID Events C. difficile Reporting Programs: MRSA Bloodstream Infection and Option 2: Infection Surveillance Report ing 34 34 2A: MDRO Infection Surveillance Reporting Clostridioides difficile ( C. difficile ) Infection Surveillance 35 2B: Reporting 37 Section II: Supplemental Reporting 1. Prevention Process Measures Surveillance 37 a. Monitoring Adherence to Hand Hygiene 37 b. Monitoring Adherence to Gown and Gloves Use as Part of 38 Contact Precautions c. Monitoring Adherence to Active Surveillance Testing 39 2. Active Surve illance Testing Outcome Measures 41 Appendix 1 : Guidance for Handling MDRO and CD Module Infection Surveillance 44 and LabID Event Reporting When Also Following Other NHSN Modules Appendix 2 : Counts Involving Observation Patients 46 Appendix 3 50 : Differentiating Between LabID Event and Infection Surveillance - 1 12 January 2019

216 MDRO and CDI Module -resistant Staphylococcus aureus (MRSA), vancomycin- resistant : Methicillin Background Enterococcus spp. (VRE), and certain gram-negative bacilli have increased in prevalence in U.S. hospitals over the last three decades, and have important implications for patient safety. concern about these multidrug-r esistant organisms (MDROs) as options for treating There is patients with these infections are often extremely limited, and MDRO infections are associated with increased lengths of stay, costs, and mortality. Many of these traits have also been dioides Clostri difficile observed for infection (CDI). The Healthcare Infection Control Practices 1 Advisory Committee (HICPAC) has approved guidelines for the control of MDROs. These guidelines are a vailable at https://www.cdc.gov/infectioncontrol/guidelines/MDRO/index.html ). The MDRO and C. difficile module of NHSN can provide a tool to assist f acilities in meeting some of the criteria outlined in the guidelines. In addition, many of the metrics used in this module are consistent with “Recommendations for Metrics for Multidrug -Resistant Organisms in Healthcare Settings: 2 SHEA/HICPAC Position Paper.” C. difficile infections Clostridioides difficile (C. difficile) is responsible for a spectrum of (CDI), including uncomplicated diarrhea, pseudomembranous colitis, and toxic megacolon, which can, in some instances, lead to sepsis and even death. Although CDI represents a subset infection s in the current CDC definitions for HAIs, specific standard of gastrointestinal tract 3 should be incorporated to obtain a more complete understanding of how definitions for CDI C. difficile is being transmitted in a healthcare facility. 1 As outlined in the HICPAC guideline , these MDRO and C. difficile pathogens may require specialized monitoring to evaluate if intensified infection control efforts are required to reduce the occurrence of these organisms and related infections. The goal of th is module is to provide a mechanism for facilities to report and analyze these data that will inform infection prevention professionals of the impact of targeted prevention efforts. This module contains two core reporting options for MDRO and . difficil e – Laboratory C Identified (LabID) Event reporting and Infection Surveillance reporting. These reporting options function as two separate and independent reporting methods - one focused on laboratory based reporting and the second on infection criteria based s urveillance reporting. Reporting options are summarized in Table 1 . Participants may choose either one or both of the se reportin g options and then may also choose to participate in any of the supplemental monitoring methods described in Table 1 . for key Differentiating Between LabID Event and Infection Surveillance See Appendix 3: differences between the two options. - 2 12 January 2019

217 MDRO and CDI Module Table 1. Core and Supplemental Reporting Choices for MDRO and CDI Module MDRO CDI CephR Klebsiella - , CRE E. coli, Enterobacter, ( MRSA or C. difficile VRE g Choices Reportin Klebsiella ), MRSA/MSSA Acinetobacter spp. (MDR) Core Method Method Method Method Proxy Infection Measures ± A, B, C A, B, C, D A, B, C, D A, B, C, D Event LabID Choose ≥1 organism AND/ OR Infection Surveillance ± A, B A, B A, B A, B 1 organism Choose ≥ Method Method Supplemental Method Method Prevention Process Measures Options: Hand Hygiene • B B B B Adherence • Gown and Gloves Use B B B B Adherence • Active Surveillance Testing (AST) N/A B B N/A Adherence AST Outcome Measures • Incident and B B N/A N/A Prevalent Cases using AST N/A – not available or contraindicated ± No surveillance for C. difficile will be performed in Neonatal Intensive Care Units (NICU), Specialty Care Nurseries (SCN), babies in LDRP (Labor, Delivery, Recovery, and Post- partum), well -baby nurseries, or w -wide monitoring ell -baby clinics. And, if conducting facility days, encounters) for these locations (Method C), the denominator counts (admissions, patient- must be removed. - 3 12 January 2019

218 MDRO and CDI Module must choose to monitor by L abID Event or Infection Surveillance reporting Reporting Method ( before supplemental methods can also be used for monitoring ): Facili ty-wide by location. Report for each location separately and cover all locations in A: This reporting method r equires the most effort , but provides the most detail a facility. for local and national statistical data. Selected locations within the facility (1 B: or more). Report separately for one or more specific . This includes reporting individual events and locations within a facility denominator data for each of the selected locations. This reporting method is i deal for use during targeted prevention programs. Note: MDRO “ Blood Specimens Only” monitoring is the only MDRO LabID event reporting option for IRF, ED and 24-hr Observation locations. For Inpatient locations other than IRF , ED and 24-hr Observation (examples: IPF, Medical, Surgical, etc.) ‘All Specimens” monitoring is the only MDRO LabID event reporting option. -wide . Report individual LabID events from each inpatient location and C: Overall facility total denominator counts for the entire facility. Options include: Overall Facility -wide Inpatient (FacWideIN) to cover all inpatient locations where (1) denominator data are collected . When using FacWideIN reporting, facilities must ult also include location specific reporting for outpatient emergency department (ad and pediatric) and 24-h r O bservation location(s). denominators for all inpatient Note : When following FacWideIN, facilities must enter locations physically located in the hospital, as well as denominators for all inpatient ent psychiatric locations minus any inpatient rehabilitation facility (IRF) and inpati facility (IPF) locations . Totals reported should not include with separate CCNs facilities affiliated with the hospital that are enrolled separately in NHSN. Additionally, separate denominator data will be required to capture encounters for each mapped emergency department and 24 -hr observation location. Overall (2) Facility -wide Outpatient (FacWideOUT) to cover all outpatient locations where encounters are captured affiliated with the facility . Facilities may choose to monitor FacWideOUT in addition to FacWideIN monitoring. This method is available for MDRO Only. D: Overall facility -wide : Blood Specimens LabID Events only and targets the most invasive events. Report individual LabID events from each inpatient location and total denominator counts for the entire facility. Options include: (1) Overall Facility -wide Inpatient (FacWideIN) to cover all inpatient locations. Using this option, facilities must also include location specific reporting for each - 4 12 January 2019

219 MDRO and CDI Module , adult and pediatric) and 24-hr outpatient emergency department ( specifically observation location(s) . enter denominators for all inpatient When following FacWideIN, facilities must Note : locations physically located in the hospital, as well as denominators for all inpatient locations minus any inpatient rehabilitation facility (IRF) and inpatient psychiatric facility (IPF) locations with separate CCNs. Totals reported should not include facilities affiliated with the hospital that are enrolled separately in NHSN. Additionally, separate denominator data will be required to capture encounters for each mapped emergency department and 24 -hr observation location. -wide Outpatient (FacWideOUT) to cover all outpatient locations (2) Overall Facility affiliated with the facility. Facilities may choose to monitor FacWideOUT in addition to FacWideIN monitoring. - 5 12 January 2019

220 MDRO and CDI Module Reporting Core Option 1: Lab oratory- Identified (Lab ) Event Reporting ID Introduct LabID Event reporting option allows laboratory testing data to be used without ion: nd therefore is a much -intensive method to track less labor clinical evaluation of the patient, a C. difficile These provide proxy infection measures of MDRO and/or MDROs and C. difficile . healthcare acquisition, exposure burden, and infection burden based almost exclusively on laboratory data and limited admission date data , including patient care location. LabID Event reporting is ONLY for collecting and tracking positive laboratory results (for example, positive cultures) that are collected for “clinical” purposes (specifically for diagnosis and treatment). This means that the results of laboratory specimens coll ected for active surveillance testing (AST) purposes only should not be reported as LabID Events. Key point s for LabID Event Reporting: • LabID Events can be monitored at the overall facility -wide level for inpatient areas ). (FacWideIN) , and/or at the overall facility -wide level for outpatient areas ( FacWideOUT • can verall f , ED, and 24-hour observation, MDROs At the O IRF acility -w ide levels and for be monitored for A types or for Blood Specimens Only . All other locations can ll Specimen All Specimen only monitor for types. LabID Events can be monitored for specific locations and require unique denominator data • s ( specifically , facility from each of the specific location -wide locations monitored separately [Method A] allowing for both facility -wide and location- specific data, or by selected locations only [Method B]). • ing to conduct FacWideIN surveillance for LabID Events must also follow A facility choos location- specific surveillance for that same organism in each outpatient emergency department (pediatric and adult) and 24-hour observation location. Laborato ry and admission data can be used to calculate a variety of distinct proxy measures including: admission prevalence rate and overall patient prevalence rate (measures of exposure burden), MDRO bloodstream infection incidence rate (measure of infection burden and healthcare acquisition), overall MDRO infection/colonization incidence rate (measure of healthcare acquisition) , and CD incidence rate (measure of infection burden and healthcare acquisition). Use NHSN f orms to collect all required data, using the definitions of each data field as . When denominator data are available from electronic Tables of Instructions indicated in the databases, these sources may be used only after a validation of a minimum 3 consecutive months proves the data to be within 5% (+/-) of the manually collected once-a-day counts. - 6 12 January 2019

221 MDRO and CDI Module LabID Even MDRO t Reporting Methodology: Facilities may choose to monitor one or more of the following MDROs: MRSA, Klebsiella , CRE, and/or MRSA and MSSA, VRE, CephR- -resistant Acinetobacter multidrug spp. (see definitions below). For S. aureus , both the resistant (MRSA) and the susceptible (MSSA) phenotypes can be tracked to provide concurrent measures of the susceptible pathogens as a comparison to those of the resistant pathogens in a setting of active MRSA prevention efforts. Note: No A ctive Surveillance Culture/Testing (ASC/AST) results are to be included in this reporting of individual results (See ) . Do NOT enter surveillance General Key Terms chapter nasal swabs or other surveillance cultures as reports of LabID Events. AST tracking should be recorded under Process & Outcome Measures. MDRO Definition s: MDROs included in this module are defined below. MRSA: Includes S. aureus cultured from any specimen that tests oxacillin -resistant, cefoxitin -resistant, or methicillin -resistant by standard susceptibility testing methods, or any laboratory finding of MRSA (includes but not limited to PCR or other molecular based detection methods). S. aureus MSSA: cultured from a specimen testing intermediate or susceptible to oxacillin, cefoxitin, or methicillin by standard susceptibility test ing method. VRE: Enterococcus faecalis, Enterococcus faecium, or Enterococcus species unspecified (only those not identified to the species level) that is resistant to vancomycin, by standard susceptibility testing methods or a laboratory but not limited to PCR or other molecular based finding of VRE (includes detection methods). CephR- Klebsiella oxytoca or Klebsiella pneumoniae testing non- susceptible Klebsiella : (specifically , either resistant or intermediate) to ceftazidime, cefotaxime, ceftriaxone, or cefepime. CRE : Any Escherichia coli , Klebsiella oxytoca, Klebsiella pneumoniae , or Enterobacter spp . testing resistant to imipenem, meropenem, doripenem, or ertapenem by standard susceptibility testing methods (specifically , minimum inhibitory concentrations of ≥4 mcg/mL for doripenem, imipenem and meropenem or ≥2 mcg/mL for ertapenem) OR by production of a carbapenemase ( specifically , KPC, NDM, VIM, IMP, OXA-48) polymerase chain reaction, demonstrated using a recognized test ( examples: - 7 12 January 2019

222 MDRO and CDI Module metallo -Hodge test, Carba- NP). Note -lactamase test, modified - - β : For in plan CRE surveillance, facilities must conduct surveillance for all three E.coli - Enterobacter , and organisms CRE CRE - Klebsiella (Klebsiella - , CRE and Klebsiella pneumoniae ). oxytoca Any Acinetobacter spp. testing non- susceptible (specifically , either resistant MDR- or intermediate) to at least one agent in at least 3 antimicrobial classes of the Acinetobacter: following 6 antimicrobial classes : Class Antimicrobial Class Antimicrobial Amikacin Piperacillin Aminoglycosides lactam/β - : -lactam β Gentamicin Piperacillin/tazobactam β -lactamase Tobramycin inhibitor : combination Cefepime Imipenem : Cephalosporins : Carbapenems Ceftazidime Meropenem Doripenem Ampicillin/sulbactam Ciprofloxacin : : Fluoroquinolones Sulbactam Levofloxacin Settings: MDRO LabID Event reporting can occur in any location: inpatient or outpatient. Requirements : Facilities choose at least one of the reporting methods listed below and report data accordingly: Facilities must indicate each reporting choice chosen f or the calendar month on the Note : Patient Safety Monthly Reporting Plan ( CDC 57.106). For each MDRO being monitored, all MDRO test results are evaluated using either the algorithm in Figure 1 ( All Specimens ) or Figure 2 ( Blood Specimens only ) to determine reportable LabID events for each calendar month, and for each facility location as determined by the reporting method chosen. If monitoring all specimens , a ll first MDRO isolates (chronologically) per patient, per month, per location are reported as a LabID event regardless of specimen source [ ] (Figure 1) ; if a EXCLUDES tests related to active surveillance testing duplicate MDRO isolate is from blood, or if monitoring blood specimens only, it is reported as a LabID event only if it represents a unique blood source [ specifically , no prior isolation of the MDRO in blood from the same patient and location in ≤2 weeks, even across calendar months] (Figures 1 & 2). As a general rule, at a maximum, there should be no more than 3 blood isolates reported, which would be very rare. If monitoring all specimens and a blood isolate is entered specimens can be entered that month for non-blood as the first specimen of the month, then no LabID Event individually on a separate form. that patient and location. Report each - 8 12 January 2019

223 MDRO and CD I Module Laboratory -Identified (LabID) Events Figure 1. MDRO Test Result Algorithm for All Spe cimens MDRO isolate from any specimen (except AST specimens) per patient and location st 1 in calendar month per patient, per location, per MDRO No Yes Source No Not a - Duplicate MDRO LabID Event (Non = Blood LabID duplicate isolate) isolate for Event patient Yes ame Prior (+) s MDRO from Yes Not a blood in ≤14 days LabID from same Event location (including across months ) calendar No LabID Event (Unique blood source MDRO) ** NOTE : If the first MDRO isolate for calendar month is a blood isolate, the specimen is reported as a LabID event, even if a previous MDRO blood isolate was reported in the previous 14 days (across calendar months). - 9 12 January 2019

224 CDI Module MDRO and Figure 2. MDRO Test Result Algorithm for Blood Specimens Only Laboratory-Identified (LabID) Events MDRO isolate from blood per patient and location r (+) same Prio MDRO from blood from in ≤ 14 days same patient and location (including across calendar months) No Yes Duplicate Not a LabID LabID Event Event O test MDR - 10 12 January 2019

225 MDRO and CDI Module orting Options for the MDRO Module (non- Table 2: Rep CDI) Numerator Data Reporting by Method Denominator Data Reporting Location Facility -wide by location Report separate denominators for each LabID Event Enter each MDRO location in the facility as specified in the All t monitor Mus Note: reported by location NHSN Monthly Reporting Plan Specimen sources Selected locations All t monitor Report separate denominators for each Note: Mus Enter each MDRO LabID Event sources with the Specimen Selected location(s) monitored as specified reported by selected locations - exception of IRF units, 24 in the NHSN Monthly Reporti ng Plan hour observation, and emergency department denominator data for all Report total physically located in inpatient locations the hospital (for example, total number of admissions and total number of patient Enter each MDRO LabID days), as well as denominators for all Specimen Event from all inpatient minus inpatient locations inpatient Overall Facility -wide separately for AND locations rehabilitation facility and inpatient Inpatient (FacWideIN), outpatient emergency department, psychiatric facility locations with separate All Specimen hour observation and 24- CCNs location(s) • Separate denominators should be entered for each mapped outpatient emergency department and 24 -hour observation location(s) all denominator data for Report total (for example, total outpatient locations Overall Facility -wide Enter each MDRO LabID Event Outpatient (FacWideOUT), number of encounters, including ED and affiliated outpatient from all All Specimen OBS encounters in addition to other locations separately outpatient locations) Report total denominator data for all inpatient locations physica lly located in the hospital (for example, total number of admissions and total number of patient Enter each MDRO LabID Blood days), as well as denominators for all Specimen Event from all inpatient Overall Facility -wide locations minus inpatient rehabilitation separately for locations AND Inpatient (Fa cWideIN), facility and inpatient psychiatric facility outpatient emergency department, Blood Specimen Only locations with separate CCNs hour observation and 24- location(s) Separa te denominators should be entered • for each mapped outpatient emergency department and 24 -hour observation location(s) -wide Overall Facility Total Blood denominator data for Each MDR O LabID all outpatient Outpatient (FacWideOUT), (for example, total number of locations Event from all affiliated Specimen Blood Specimen Only encounters) outpatient locations by location - 11 12 January 2019

226 MDRO and CDI Module Definitions: n MDRO Isolate : Any specimen , obtained for clinical decision making , testing positive for a MDRO (as defined above). Note : Excludes tests related to active surveillance testing. MDRO isolate from the Duplicate MDRO Isolate : If monitoring all specimens , any subsequent same patient and location after the first isolate of the specific MDRO during a calendar month, regardless of specimen source, except unique blood source (Figure 1). EXAMPLE: On January 2, a newly admitted ICU patient has a positive MRSA urine culture. The following week, while still in the ICU, the same patient has MRSA cultured from an infected decubitus ulcer. The MRSA wound culture is considered a duplicate MDRO isolate , since it is the second non -blood MRSA isolate collected from the same patient and location during the same calendar month. Unique Blood Source: A MDRO isolate from blood in a patient with no prior positive blood culture for the same MDRO and location in ≤ 14 days , even across calendar months and different facility admissions ( Figure 2). There should be 14 days with no positive blood culture result for the patient, MDRO, and location before another Blood LabID Event is entered into NHSN for the patient, MDRO, and location. Additionally, i f following all specimens, the first MDRO for the patient, month, and location should be reported. The date of specimen collection is considered Day 1. internal line listing log of all positive isolates Note: NHSN recommends that facilities keep an cision making around the for reference in LabID event reporting which will assist is de 14-day reporting rule which is location specific. - 12 12 January 2019

227 CDI Module MDRO and On January 1, an ICU patient has a positive MRSA urine culture which is EXAMPLE: into NHSN because blood specimens only are being Monitoring Blood not entered monitored. On January 2, while in the same location (ICU), the same Specimens only into NHSN. is entered patient has a positive MRSA blood culture which with multiple This starts the 14 day count. On January 5, while in the same location isolates from (ICU), the same patient has another positive MRSA blood culture which is same location not entered into NHSN because it has not been 14 days since the original positive MRSA blood culture while in the same location. The January 5 positive blood culture starts a new 14 day count. On January 19, while in the same location (ICU), the same patient has another positive MRSA into NHSN blood culture. The January 19 MRSA blood culture is entered because it has been > 14 days since the patient’s most recent positive blood same culture (January 5) while in the location (January 19 is day 15). - 13 12 January 2019

228 MDRO and CDI Module is On January 1, an ICU patient has positive MRSA urine culture which EXAMPLE: into NHSN because it is the first MDRO isolate of the month for Monitoring All entered with Specimens this patient. On January 2, while in the same location (ICU), the same multiple isolates patient has a positive MRSA blood culture which is entered into NHSN No other from same because it is the first positive MRSA blood isolate for the month. location non-blood MRSA isolates should be reported for the month for this patient and location as these would represent duplicate isolates. Any additional MRSA positive blood isolates for the month should be reported following Subsequent -day rule as when reporting Blood Specimens only. the same 14 months should be reported in the same manner. - 14 12 January 2019

229 MDRO and CDI Module duplicate MDRO isolates from any specimen Laboratory -Identified (LabID) Event : All non- EXCLUDES tests related to active source and unique blood source MDRO isolates. [ ]. Even if reporting at the Fac surveillance testing or ility Wide level (FacWideIN FacWideOUT ), all reporting must follow rules by location for reporting. is available on the NHSN website to help with data entry Note: A LabID Event calculator , which is location specific. decision making around the 14- day rule If monitoring blood specimens for FacWideIN (which requires EXAMPLE #1: Blood -hour observation surveillance in the emergency department and 24 Moni toring locations), a patient has a positive MRSA laboratory isolate while in the Specimens only emergen cy department (ED) . This specimen represents a MRSA LabID with isolates from Event and should be entered for the outpatient emergency department. ED & inpatient The next calendar day, the same patient is admitted to ICU and three days location later, has a second positive MRSA blood specimen. This specimen also represents a unique LabID Event, because it is the first positive blood specimen in this location (ICU). Note : while this patient has two LabID Events, the second specimen taken from the ICU will be removed from most analysis reports. If monitoring all specimens , on January 2, a newly admitted ICU patient #2: EXAMPLE Monitoring All with no previous positive laboratory isolates during this admission has a positive MRSA urine culture. This specimen represents a LabID Event Specimens since it is the first MRSA isolate for the patient, the location, and the calendar month. all specimens If monitoring for FacWideIN surveillance, on January 2, a EXAMPLE #3: All Monitoring VRE wound culture is collected from the facility’s own ED. The patient with Specimens is then admitted to 4W the next calendar day. The ED culture result must isolates from ED be entered as an outpatient LabID event for the ED location for January 2, & inpatient as the ED location is included in FacWideIN surveillance and r eporting. location blood specimens only , on January 26, a newly admitted ICU If monitoring #4: EXAMPLE Blood Monitoring patient with no previous positive laboratory isolates during this admission has a positive MRSA urine culture which is not entered as a LabID Event Specimens only with multiple only are being monitored. The following day, since blood specimens blood isolates while in the same location, the same patient has a positive MRSA b lood culture. This specimen represents a LabID Event since it is a unique blood source (the first MRSA blood isolate for the same patient and same location). While remaining in ICU, the same patient has another positive blood culture on February 5. This does not represent a new LabID Event been >14 days since the most recent MRSA positive blood not since it has isolate for this patient and location. - 15 12 January 2019

230 MDRO and CDI Module : Reporting Instructions • All LabID Events must be reported by location • LabID event reporting is separate and independent of events reported through MDRO reporting and/or HAIs reported through the Device-a ssociated Infection Surveillance and/or Procedure-associated Modules. • For instructions on unique reporting scenarios, s ee Guidance for Handling Appendix 1. MDRO and CDI Module Infection Surveillance and LabID Event Reporting When Also Following Other NHSN Modules For additional reporting information, s ee Appendix 3. Differentiating Between LabID • Event and Infection Surveillance Numerator Data: Data will be reported using the Laboratory- identified MDRO or CDI Event form ( CDC 57.128). for Denomin ator Data: Patient days and admissions (for inpatient locations), and encounters ( ) are reported using the MDRO and CDI outpatient locations (CDC Monthly Denominator Form 57.127). FacWideIN Denominators: Reporting Row 1: F acilities will enter total patient days and total patient admissions to reflect all inpatient locations physically located in the hospital. Row 2: The s econd row of denominator data entry should reflect all inpatient locations minus inpatient rehabilitation units (IRF units) and inpatient psychiatric units (IPF units) with a separate CCN. hird row of denominator data entry should reflect all inpatient locations minus Row 3: The t units (IRF units) and inpatient psychiatric inpatient rehabilitation units (IPF units) with a separate CCN minus baby-based locations (for example, NICU, well baby nursery, etc.). The totals should not include other facility types within the hospital that are enrolled and reporting separately ( for example, LTAC). See Table of Instruction s for completion instructions. Note: For Acute Care Hospitals completing FacWideIN surveillance, additional guidance on denominator reporting is available here: https://www.cdc.gov/nhsn/pdfs/cms/acutecare- mrsa - cdi-labiddenominator-reporting.pdf FacWideO UT , Emergency Departments, 24 hour observation units, and other outpatient units: patient encounters. An encounter is defined as any monthly denominator data are reported as outpatient location. visit to an - 16 12 January 2019

231 MDRO and CDI Module Note For NHSN reporting purposes, the ‘date admitted to the facility’ is HD 1. When : determining a patient’s admission dates to both the facility and specific inpatient location, the NHSN user must take into account any days spent in an inpatient location as an “observation” patient before being officially admitted as an inpatient to the facility, as these days contribute to exposure risk. Therefore, all days spent in an inpatient unit, regardless of and/or billing local admission status status are included in the counts of admissions and in patient days for the facility and specific location ; for NHSN reporting purposes, the date admitted to the facility is the calendar date that the patient physically locates to an inpatient location . For further information on counting patient days and admissions, see Appendix 2: Determining Patient Days for Summary Data Collection: Observation vs. Inpatients. Data Analysis: Based on data provided on the LabID Event form, each event will be categorized by NHSN to populate different measures. By classifying positive specimens obtained on day 1 (admission date), day 2, and day 3 of admission as community-onset (CO) LabID Events and positive specimen s obtained on or after day 4 as healthcare facility -onset (HO) LabID Events, all HO LabID Events will have occurred more than 48 hours after admission . The following categorizations and prevalence and incidence calculations are built into the analysis capabilities of NHSN, and are based on timing of admission to a facility and/or , and monthly location, specimen collection, location where specimen was collected denominators. Descriptions are provided to explain how the categories and metrics are defined in NHSN. Note: For FacWideIN analysis reports, the denominator values entered on “Row 2” of the res used for MDRO analyses. FacWideIN denominator form a Categorizing MDRO LabID Events Note: See “Onset” variable in the NHSN Line List. This is b ased on the location of specimen collection, the date admitted to f acility , and date s pecimen c ollected , as applicable Community -Onset (CO) : LabID Event specimen collected in an outpatient location or an inpatient location ≤3 days after admission to the facility (specifically , days 1, 2, or 3 of admission). LabID Event specimen collected >3 days after admission to Healthcare Facility -Onset (HO) : , on or after day 4). ( specifically the facility - 17 12 January 2019

232 MDRO and CDI Module The following section describes the various measures calculated for MDRO LabID event surveillance . Note : FacWi deIN MDRO rate and SIR calculations utilize the FacWideIN denominators (patient days and admissions) reported for the facility minus admissions and patient days from rehabilitation facility (IRF) inpatient y (IPF) locations with and inpatient psychiatric facilit unique CCNs . For NHSN reporting purposes, IRF/IPFs located within an acute care hospital (ACH ) are recognized as an inpatient location for the ACH ; therefore, admissions/ discharges from AC H to IRF/IPF and vice versa are considered ‘transfers’, specifically , the hospitalization is considered a ‘continuous’ stay for event reporting. ures for Exposure Burden of MDROs – All specimens : Proxy Meas Inpatient Reporting: st Admi ssion Prevalence Rate = Number of 1 • LabID Events per patient per month identified ≤3 days after admission to the location (if monitoring by inpatient location), or the facility (if monitoring by overall facility -wide inpatient=FacWideIN) / Number of patient admissions to the location or facility x 100 Location • = Percent Admission Prevalence that is Community -Onset Number of Admission Prevalent LabID Events to a location that are CO / Total number Admission Prevalent LabID Events x 100 Location P -Onset = Number of • ercent Admission Prevalence that is Healthcare Facility Admission Prevalent LabID Events to a location that are HO / Total number of Admission Prevalent LabID Events x 100 st • = Number of 1 Overall P LabID Events per patient per month atient Prevalence Rate regardless of time spent in location ( specifically prevalent + incident, if monitoring by inpatient location), or facility ( specifically , CO + HO, if monitoring by overall facility- wide inpatient=FacWideIN) / Number of patient admissions to the location or facility x 100 Outpatient R eporting: st LabID Events per patient per month for the • Outpatient Prevalence Rate = Number of 1 location (if monitoring by outpatient location), or the facility (if monitoring by overall facility -wide outpatient = FacWideOUT) / Number of patient encounters for the location or facility x 100 loodstream Infection: Calculated when monitoring either all Measures for MD RO B except for certain locations (specifically Note : inpatient specimens or blood specimens only. - 18 12 January 2019

233 MDRO and CDI Module , emergency departmen hour observation locations), the Blood rehabilitation facilities t, and 24- specimens only option can only be used at the FacWideIN and FacWideOUT levels. MRSA Blo odstream Infection Standardized Infection Ratio (SIR): The SIR is calculated by dividing the number of observed events by the number of predicted events. The number of predicted events is calculated using LabID probabilities estimated from negative binomial models constructed from 2015 NHSN data , which represents a standard population. For most settings, MRSA Bloodstream Infection SIRs are calculated for FacWideIN survei llance only. Note : In th e NHSN application, the number of predicted events is referred to as “numPred”. The SIR will be calculated only if the number of predicted events (num ) is ≥1 to help Pred enforce a minimum precision criterion. Inpatient Reporting : • MRSA Blo odstream Infection SIR = Number of all unique blood source MRSA LabID IRF/IPF inpatient location >3 days after admission to the Events identified in a non- facility (specifically with no prior MRSA blood event for that , HO MRSA blood events patient in the previous 14 days) / Number of predicted HO MRSA blood LabID Events o : This SIR is only available for FacWideIN reporting. More information Note about which events are counted in the FacWideIN SIR can be found here: https://www.cdc.gov/nhsn/pdfs/ps- -resources/mrsacdi_tips.pdf analysis MDRO Blo • odstream Infection Admission Prevalence Rate Number of all unique = blood source LabID Events per patien t per month identified ≤3 days after admission to the location (if monitoring by inpatient location), or facility (if monitoring by overall FacWideIN) / Number of patient admissions to the location or facility x 100 o Note : For MRSA Bacteremia FacWideIN surveillance, this is the CO rate that is used in the risk adjustment calculations of the MRSA bacteremia SIR. The numerator excludes any event in which the patient had a prior positive event in the previous 14 days. • MDRO Blood stream Infection Incidence Rate = Number of all unique blood source LabID Events per patient per month identified >3 days after admission to the location (if monitoring by inpatient location), or facility (if monitoring by overall facility -wide inpati ent=FacWideIN) / Number of patient admissions to the location or facility x 100 = Number of all unique blood Rate • MDRO Blo odstream Infection Incidence Density source LabID Events per patient per month identified >3 days after admission to the location (if monitoring by inpatient location), or facility (if monitoring by overall - 19 12 January 2019

234 MDRO and CDI Module -wide inpatient=FacWideIN) / Number of patient days facility for the location or facility x 1,000 st odstream Infection Overall Patient Prevalence Rate = • MDRO Blo Blood Number of 1 LabID Events per patient per month regardless of time spent in location ( specifically , prevalent + incident, if monitoring by inpatient location), or facility (specifically , CO + HO, if monitoring by overall facility -wide inpatient=FacWideIN) / Number of patient admissions to the location or facility x 100 MRSA Blo odstream Reporting for CMS -certified Inpatient Rehabilitation Facilities (IRFs) mapped as units within a hospital: tic reports and metrics are available for analyzing MRSA bacteremia LabID Two analy event data reported from IRF units located within a hospital: odstream Infection SIR for IRF units = Number of all unique blood • MRSA Blo source MRSA LabID Events identified >3 days after location admission to the IRF unit and where the patient had no positive MRSA bacteremia LabID E vent in the prior -certified IRF unit / Number of predicted HO 14 days in any CMS MRSA blood LabID Events in the IRF unit Inpatient MRSA Bacteremia Incidence Density Rate for IRF units: Number of • all incident blood source MRSA LabID events identified > 3 days after location admission to an IRF unit and where the patient had no positive MRSA bacteremia LabID Events in the prior 14 days in any CMS- certified IRF unit / Total number of patient days for IRF unit (s) x 1,000 Outpatient R eporting: Combined MRSA Bloodstream Infectio n Outpatient Prevalence Rate for ED and • f unique blood source MRSA LabID 24 hour Observation Locations = Number o events identified in an ED or 24 hour observation location / Total patient encounters in ED and 24 hour observation location(s) x 100 o Note : For MRSA Bacteremia FacWideIN surveillance, this outpatient rate is used in the risk adjustment calculations of the MRSA bacteremia SIR. The numerator excludes any event in which the patient had a prior positive event in the previous 14 days in an ED or 24-hour observation location. MDRO Blo odstream Infection Outpatient Prevalence Rate = Number of all • unique blood source LabID Events per patient per month for the location (if monitoring by outpatient location), or the facility (if monitoring by overall -wide outpatient=FacWideOUT) / Number of patient encounters for the ity facil location or facility x 100 - 20 12 January 2019

235 CDI Module MDRO and Measures for MDR O-CRE surveillance : T he above incidence and prevalence rates are oli, specifically , Klebsiella, E.c and calculated separately for each species of CRE ( Enterobacter) as well as for all species combined. The following additional metric is available for CRE LabID event reporting: Percent Po sitive for Carbapenemase: number CRE positive for carbapenemase / numb er CRE tested for carbapenemase x 100 : Proxy Meas ures for MDRO Healthcare Acquisition st • LabID Events Number of 1 Overall MDRO Infection/Colonization Incidence Rate = per patient per month among those with no documented prior evidence of previous infection or colonization with this specific organism type from a previously reported LabID Event, and identified >3 days after admission to the location (if monitoring by inpatient location), or facility (if monitoring by overall facility -wide inpatient=FacWideIN) / Number of patient admissions to the location or facility x 100 st Overall MD • LabID RO Infection/Colonization Incidence Density Rate = Number of 1 ts per patient per month among those with no documented prior evidence of Even previous infection or colonization with this specific organism type from a previously reported LabID Event, and identified >3 days after admission to the location (if -wide npatient location), or facility (if monitoring by overall facility monitoring by i inpatient=FacWideIN) / Number of patient days for the location or facility x 1,000 - 21 12 January 2019

236 CDI Module MDRO and Clostridioides difficile (C. difficile ) LabID Event Reporting Facilities may choose to monitor ogy: C Methodol . difficile where C . difficile testing in the , conforming to the shape of laboratory is performed routinely only on unformed ( specifically C. difficile LabID events may be monitored from all a vailable the container) stool samples. , emergency departments and 24 hour observation locations as well as all inpatient locations available affiliated outpatient locations where care is provided to patients post discharge or prior to admission ( for example, outpatient clinics and/or physician offices using the same medical record number for the patient as the admitting facility). LabID Event reporting can occur in any location: inpatient or outpatient. C . difficile Settings: Surveillance will NOT be performed in NICU, SCN, babies in LDRP, well-baby nurseries, or well -baby clinics. If LDRP locations are being monitored, baby counts must be removed. Requireme test results are evaluated using the algorithm in Figure 3. . difficile All C nts: e reporting choices Facilities must choose one or more of th listed in Table 3 below and report data accordingly. - 22 12 January 2019

237 MDRO and CDI Module Test Result Algorithm for Laboratory Identified (LabID) Events Figure 3. C. difficile test result (+) C. difficile per patient and location Prior (+) in ≤14 days from same patient and location (including across calendar months) No Yes Not a LabID Duplicate C. LabID Event Event difficile test - 23 12 January 2019

238 CDI Module MDRO and Table 3: Reporting Options for C . difficile LabID Event Numerator Data Reporting Method Denominator Data Reporting by Location each eparate denominators for Report s Enter each CDiff -wide by Facility LabID Event location in the facility as specified in the reported by location location NHSN Monthly Reporting Plan Report separate denominators for selected LabID Event Enter each CDiff locations Selected locations monitored as specified in the selected locations reported by NHSN Monthly Reporting Plan all denominator data for Report total inpatient locations ly located in the physical hospital (for example , total number of admissions and total number of patient days), LabID Event Enter each CDiff inpatient rehabilitation facility and minus Overall Facility from all inpatient locations -wide inpatient psychiatric facility locations with AND separately for outpatient Inpatient CCNs unique (FacWideIN) emergency department and 24- hour observation location(s) • Separate denominators should be entered to capture encounters for each mapped - outpatient emergency department and 24 (s) hour observation location all for total denominator data Report , total -wide Overall Facility outpatient locations (for example Enter each CDiff LabID Event from all affiliated outpatient number of encounters including ED and OBS Outpatient encounters in addition to other outpatient locations separately (FacWideOUT) locations) Note: lities must indicate each reporting choice chosen for the calendar month on the Faci Patient Safety Monthly Reporting Plan (CDC 57.106). Definitions: CD-positi ve laboratory assay: A positive laboratory test result for C. difficile toxin A and/or B, (includes molecular assays [PCR] and/or toxin assays) tested on an unformed stool specimen (must conform to the container) OR A toxin-producing organism detected by culture or other laboratory means C. difficile performed on an unformed stool sample (must conform to the container). Note : • When us ing a multi- I on the same unformed stool specimen, step testing algorithm for CD test performed on the specimen that is documented in the patient the finding of the last medical record will determine if the CDI positive laboratory assay definition is met. - 24 12 January 2019

239 MDRO and CDI Module of Multi- step Testing Interpretations (does not consider prior positives) : Examples -step Eligible Testing Documented Multi Testing Step Method Findings sting Te LabID Event? Same Specimen Test 1 NAAT Negative Example A Positive Test 2 GDH Yes Last test Test 3 EIA Positive Positive Test 1 NAAT B Example Test 2 Positive GDH No Last test Test 3 EIA Negative Test 1 Positive GDH C Example Test 2 EIA Negative Yes Last test Test 3 NAAT Positive GDH Positive Test 1 Example D EIA Test 2 Positive No Last test Test 3 Negative NAAT Duplicat -positive test: difficile e C. Any positive laboratory result from the same patient and location, C. difficile • toxin- toxin-positive laboratory result within 14 days even across C. difficile following a previous location . calendar months and readmissions to the same facility C. difficile toxin- positive laboratory result for the patient There should be 14 days with no • C. difficile and specific location before another LabID Event is entered into NHSN for the patient and location. The date of specimen collection is considered Day 1. • : NH Note SN recommends each facility keep an internal line listing log of all positive to ensure the 14-day rule is applied specimens as a reference in LabID event reporting . The 14-day rule for LabID events reporting is specific to the location and resets each correctly patient transfers to a new inpatient location. time a EXAMPLE : On Jan positive laboratory result toxin- C. difficile uary 1, an ICU patient has a which is entered into NHSN. On January 4, while in the same location (ICU), the same patient not entered into NHSN which is positive laboratory result toxin- C. difficile has another positive is a duplicate for the patient and location ( has not been because it C. >14 days since the original difficile toxin- positive laboratory result while in the same location ). On January 16, while in the . positive laboratory result toxin- C. difficile same location (ICU), the same patient has another - 25 12 January 2019

240 MDRO and CDI Module C. difficile toxin-positive While it has been more than 14 days since the initial positive was entered into NHSN (January 1) for the same patient and same location , it laboratory result n >14 days since the patient’s most recent C. difficile toxin- has not bee positive laboratory result (January 4) while in the same location . Therefore, the C. difficile toxin -positive laboratory result for January 16 is not entered into NHSN. On January 31, the patient has another C. difficile toxin- positive laboratory result while in the same location (ICU). Since it has been >14 (January 16) days since the patient’s most recent C. difficile toxin- positive laboratory result while in the same location, this event entered into NHSN. is positive laboratory : All non- duplicate C. difficile toxin- ry-Identified (LabID) Event Laborato results. Even if reporting at the f acility -w ide level (FacWideIN or FacWideOUT ), all reporting must follow rules by location for reporting. Notes: • A La bID Event calculator is available on the NHSN website to help with data entry decision making around the location specific 14-day rule. • If a facility is participating in F acWideIN surveillance and reporting, the facility must also conduct separate location -specific surveillance in all outpatient emergency department and 24-hour observation locations. This means LabID Events for the same organism and LabID Event type must be reported from these locations even if the patient is not subsequently admitted to an inpatient location during the same encounter. All emergency department and 24-hour observation locations must be identified and • mapped as outpatient locations within NHSN. For more information about mapping in the NHSN manual. locations, see Chapter 15 - 26 12 January 2019

241 MDRO and CDI Module Reporting Instructions: All C . difficile LabID Events must be reported by location and ly of Events reported using the . difficile Infection Surveillance separately and independent C reporting option and/or HAI reporting . Data will be reported using the Laboratory- Identified MDRO or CDI Event form Numerator: (CDC 57.128). Denominator Data: and admissions (for inpatient locations), and encounters ( for Patient days ) are reported using the MDRO and CDI outpatient locations Monthly Denominator Form (CDC 57.127). Reporting FacWideIN Denominators : Row 1: Facilities will enter total patient days and total patient admissions to reflect all inpatient locations physically located in the hospital. Row 2: The second row of denominator data entry should reflect all inpatient locations minus inpatient rehabilita tion units (IRF units) and inpatient psychiatric units (IPF units) with a separate CCN. Row 3: The third row of denominator data entry should reflect all inpatient locations minus inpatient rehabilitation units (IRF units) and inpatient psychiatric units (IPF units) with a separate CCN minus baby- based locations (for example, NICU, well baby nursery, etc.). The totals should not include other facility types within the hospital that are enrolled and reporting for example, LTAC). See separately ( of Instructions for completion instructions. Table Note: For Acute Care Hospitals completing FacWideIN surveillance, additional guidance on denominator reporting is available here: https://www.cdc.gov/nhsn/pdfs/cms/acutecare- mrsa - cdi-labiddenominator-reporting.pdf FacWideOUT and ED/24 Denominator data is -hour Observation locations reporting: provided using encounters. An encounter is defined as a patient visit to an outpatient location for care. When determining a patient’s admission dates to both the facility and specific inpatient location, the NHSN user must take into account all days, including any days spent in an inpatient location as an “observation” patient before being officially admitted as an inpatient to the facility, as these days contribute to exposure risk. Therefore, all days spent in an inpatient unit, regardless o f admission and/or billing status are included in the counts of admissions and inpatient days for the facility and specific location . For NHSN reporting purposes, the facility and specific location admission date is the first day spent in the inpatient lo cation . For further information on counting patient days and admissions, see Appendix 2: Determining Patient Days for Summary Data Collection: Observation vs. Inpatients - 27 12 January 2019

242 MDRO and CDI Module ifficile C. D Data Analysis: The foll owing categorizations and prevalence and incidence calculations are built into the analysis capabilities of NHSN, and are based on timing of admission to a facility and/or date , location where specimen was collected location, specimen collection , and monthly denominators . Descriptions are provided to explain how the categories and metrics are defined in NHSN. Note: For FacWideIN analysis reports, the denominator values entered on “Row 3” of the FacWideIN denominator form as used for CDI analyses. CDI Even t Categorization Note: This is based on c pecimen collection and prior date of specimen urrent date of s collection of a previous CDI LabID Event. R efer to the “cdiAssay” variable in NHSN Line List . • Inciden t CDI LabID Event : Any CDI LabID Event from a specimen obtained > 56 days after the most recent CDI LabID Event (or with no previous CDI LabID Event documented) for that patient. Note: the date of first specimen collection is considered day 1. Recurren : Any • LabID Event from a specimen obtained > 14 t CDI LabID Event CDI days 56 days after the most recent CDI LabID Event for that patient. Not e:the and ≤ date of first specimen collection is considered day 1. • CdiAssa y will be unassigned, or “blank”, for any CDI LabID event that was collected ≤ 14 days after the most recent CDI LabID event for that patient. ning in 2015, for FacWideIN surveillance, cdiAssay is assigned based on Events Note : Begin , emergency departments from inpatient locations , and 24-hour observation locations. For data reported prior to 2015, cdi assigned based on events from within the same setting Assay was only. For example, in 2014, if performing both FacWideIN and FacWideOUT surveillance, cdiAssay of inpatient CDI LabID Events was determined by a review of previously-entered CDI LabID Events from inpatient locations only. categorization, CDI LabID Events are further categorized within o the cdiA ssay In addition t NHSN using the ‘onset’ variable. The following categorizat ions, as well as prevalence and incidence calculations that are built into the analysis capabilities of NHSN, are based on timing of admission to facility and/or location, specimen collection date , location where specimen was rge. Descriptions are provided to explain how the categories and collected, and previous discha metrics are defined in NHSN. Onset” variable in NHSN Line List. Note: See “ - 28 12 January 2019

243 MDRO and CDI Module Communit : LabID Event meeting one of the following criteria: • y-Onset (CO) o A) collected in an outpatient location in which the patient was not previously ≤ discharged from an inpatient location within the same facility 28 days prior to current date of specimen collection o B) collected in an inpatient location ≤3 days after admission to the facility (specifically , days 1, 2, or 3 of admission). • Communit y-Onset Healthcare Facility -Associated (CO -HCFA): CO LabID Event collected from a from a patient who was discharged n inpatient or an outpatient location from the facility ≤ 28 days prior to current date of stool specimen collection. The previous discharge must have been from an inpatient location within the same facility (in other words, an outpatient visit does not qualify as “admitted”, and therefore is not used to set the timeline for CO- HCFA). • Healthcar e Facility -Onset (HO) : LabID Event collected from an inpatient location >3 specifically days after admission to the facility ( , on or after day 4). The foll owing section describes the various measures calculated for CDI LabID event surveillance. Note nning with 2015 data, the number of FacWideIN admissions and number of : Begi FacWideIN patient days used in the various CDI rate and SIR calculations will represent those reported for the facility minus admissions and patient days from the following: IRF a nd IPF locations with unique CCNs separate from the reporting facility, neonatal ICUs, special care -baby locations. nurseries, and well The CDI rate and SIR calculations use the denominators entered on Row 3 of the FacWideIN denominator form. I Prevalence: Measures of CD • Inpatient Admission Prevalence Rate = Number of non-duplicate CDI LabID Events per patient per month identified ≤3 days after admission to the location (if monitoring by inpatient location), or facility (if monitoring by overall facility ide -w inpatient=FacWideIN) (includes CO and CO- HCFA events) / Number of patient admissions to the location or facility x 100 o Note : See “CDIF_admPrevRate” in the NHSN Rate Tables. • Communit y-Onset Admission Prevalence Rate = Number of inpatient CDI LabID events that are CO, per month, in the facility / Number of patient admissions to the facility x 100 Note : See “CDI_COprevRate” in the NHSN Rate Tables. T his calculation is FacWideIN verall FacWideIN reporting. For CDI only accurate for o - 29 12 January 2019

244 MDRO and CDI Module surveillance, this is the CO rate that is used in the risk adjustment calculations of the CDI SIR . Inpatient Percent Admission Prevalence that is Community -Onset = Number of • CO / Total number Admission Admission Prevalent LabID Events to a location that are Prevalent LabID Events x 100 o Note : See “CDIF_pctAdmPrevCO” in the NHSN Rate Tables. This percentage is available for unit -specific CDI surveillance and is calculated separately for each applicable unit. The numerator in this formula does not include CDI LabID events labeled as HCF A. CO- Percent Admission Prevalence that is Community -Onset Healthcare Facility - • Inpatient Associated = Number of Admission Prevalent LabID Events to a location that are CO - HCFA / Total number Admission Prevalent LabID Events x 10 o Note : See “CDIF_pctAdmPrevCOHCFA”. This percentage is available for unit - specific CDI surveillance and is calculated separately for each applicable unit. Percent Admission Prevalence that is Healthcare Facility -Onset • Inpatient Number of = Admission Prevalent LabID Events to a location that are HO / Total number of Admission Prevalent LabID Events x 100 o Note : See “CDIF_pctAdmPrevHO” in the NHSN Rate Tables. This percentage is available for unit -specific CDI surveillance and is calculated separately for each applicable unit. st Inpatient Overall Patient Prevalence Rate = Number of 1 • CDI LabID Events per patient per month regardless of time spent in location ( specifically , prevalent + incident, if monitoring by inpatient location), or facility (specifically , CO + CO- HCFA + HO, if monitoring by FacWideIN) / Number of patient admissions to the location or facility x 100 o Note : See “CDIF_prevRate” in the NHSN Rate Tables. • Outpati ent Prevalence Rate = Number of all non-duplicate CDI LabID Events per patient per month for the location (if monitoring by outpatient location), or the facility (if monitoring by overall facility -wide outpatient=FacWideOUT) / Number of patient encounters for the location or facility x 100 I Incidence : Measures of CD ardized Infection Ratio (SIR): • CDI Stand The SIR is calculated by dividing the number of observed events by the number of predicted events. The number of predicted events is calculated using LabID probabilities estimated from - 30 12 January 2019

245 MDRO and CDI Module models constructed from 2015 NHSN data, which represents a standard negative binomial For most settings, CDI SIRs are calculated for FacWideIN surveillance only. population. In t he NHSN application, the number of predicted events is r Note: ”. eferred to as “numPred The SIR will be calculated only if the number of predicted events (num Pred ) is ≥1, to help enforce a minimum precision criterion. The CDI SIRs are only calculated at the quarter level or higher in order to account for the quarterly- reporting of CDI test type. Note that SIRs will not be calculated for a quarter until est type has been reported. When the FacWideIN the CDI t MDRO denominator form is completed for the last month of each quarter, users are asked to report the primary type of test that was used to identify CDI in the hospital for that quarter. That test type is then used in the calculation of the FacWideIN CDI SIR for that quarter. The test type selected should reflect the testing methodology used for clinical decision making. • Facility CDI Incidence SIR = Number of all Incident CDI LabID Events identified in a non- IRF/IPF location >3 days after admission to the facility (specificall y, HO events with no prior positive events for that patient in the previous 14 days) / Number of predicted Incident HO CDI LabID Events o : This SIR is only available for FacWideIN reporting. More information Note about which events are counted in the FacWideIN CDI SIR can be found here: analysis -resources/mrsacdi_tips.pdf https://www.cdc.gov/nhsn/pdfs/ps- • Inpatient Location CDI Incidence Rate = Number of Incident CDI LabID Events per month identified >3 days after admission to the location / Number of patient days for the location x 10,000 o Note : See “CDIF_incRate” in the NHSN Rate Tables. This rate is only available for location- specific CDI surveillance. Facility CDI Healthcare Facility • Inpatient -Onset Incidence Rate = Number of all Incident HO CDI LabID Events per month in the facility / Number of patient days for the facility x 10,000 o Note: See “CDIF_HOIncRate” in the NHSN Rate Tables. (T his calculation is only available for FacWideIN reporting.) Facility CDI Combined Incidence Rate = Number of all Incident HO and CO- • Inpatient HCFA CDI LabID Events per month in the facility / Number of patient days for the facility x 10,000 (T : See “CDIF_facIncRate” in the NHSN Rate Tables. his calculation is o Note only available for FacWideIN reporting.) - 31 12 January 2019

246 MDRO and CDI Module difficile Reporting for CMS -certified Inpatient Rehabilitation Facilities (IRFs) C. mapped as units within a hospital: IRF units within a hospital that participate in the CMS Inpatient Rehabilitation Facility Quality Reporting Program will be given a CDI SIR separate from the FacWideIN SIR for the acute care hospital. The SIR will be sent to CMS on behalf of IRF units participating in the CMS IRF Quality Reporting Program. In addition, a CDI LabID Event i ncidence rate is available for IRF units. • Inpatien t CDI SIR for IRF units: Number of all incident CDI LabID events identified > 3 days after location admission to an IRF unit and where the patient had no positive CDI LabID eve nts in the prior 14 days in any CMS- certified IRF unit / Number of predicted inciden t CDI LabID events in the IRF unit(s) -certified IRF units located within an o Note : This SIR is only available for CMS is only acute care or critical access hospital. T IRF Units he CDI SIR for calculated at the quarter level or higher in order to account for the quarterly - reporting of CDI test type. Note that SIRs will not be calculated for a quarter until the CDI test type has been reported. When the IRF Unit’s MDRO denominat or form is completed for the last month of each quarter, users are asked to report the primary type of test that was used to identify CDI for that quarter. That test type is then used in the calculation of the IRF Unit’s CDI SIR More in formation about which events are counted in the IRF for that quarter. Unit’s CDI SIR can be found here: - https://www.cdc.gov/nhsn/pdfs/ps- analysis resources/mrsacdi_tips.pdf • Inpatien t CDI Incidence Density Rate for IRF units: Number of all incident CDI LabID events identified > 3 days after location admission to an IRF unit and where the patient had no positive CDI LabID events in the prior 14 days in any CMS- certified IRF unit / Total number of patient days for IRF units x 10,000 : See “CDIF_IRFIncRate” in the NHSN Rate Tables. This rate is only o Note -certified IRF units located within an acute care or critical available for CMS access hospital - 32 12 January 2019

247 CDI Module MDRO and Table 4. Me asures Delivered to CMS For Facilities Participating in Quality Reporting Programs: MRSA Bloodstream Infection and C. difficile LabID Events y Type LabID CMS Quali ty difficile MRSA Bloodstream C. Facilit Infection LabID Event Reporting Program Event Measure Sent Measure Sent to CMS to CMS MRSA Bloodstream Inpatient Quality CDI Incidence SIR General Acute Care Hospitals Infection SIR (FacWideIN) Reporting Program (FacWideIN) Long Term Care Hospitals Long Term Care (referred to as Long Term CDI Incidence SIR Hospital Quality NONE * Acute Care Hospitals in (FacWideIN) Reporting Program NHSN) IRF units within a IRF units within a l: CDI Incidence hospita * : NONE hospital SIR for IRF Units Inpatient Rehabilitation Inpatien t Rehabilitation Facility Quality Facilities (IRFs) Reporting Program : Free-standing IRFs Free-standing IRFs : CDI Incidence SIR * NONE (FacWideIN) ing with 2018 Q4 data, CMS removed the requirement for IRFs and LTACs to report MRSA Start * bacteremia LabID Events as part of the CMS Quality Reporting Program. However, MRSA bacteremia LabID Event analysis reports, including the SIR, are still available to all facilities. - 33 12 January 2019

248 MDRO and CDI Module Option 2: Infection Surveillance Reporting The Infection Surveillance reporting option for enables C . difficile infections Introduction: MDRO and -associated infections definitions for identifying and reporting users to utilize the CDC/NHSN healthcare infections associated with MDROs and/or C . difficile . Surveillance must occur from at least one patient care area and requires a ctive, patient -based, prospective surveillance of the chosen MDRO (s) and/or C. difficile infections . This means that the IP shall seek to confirm and (CDIs) by a trained Infection Preventionist (IP) classify infections caused by the chosen MDRO(s) and/or C . difficile for monitoring during a patient’s stay in at least one patient care location during the surveillance period. These data will enhance the ability of NHSN to ag gregate national data on MDROs and CDIs. A. MDRO Infection Surveillance Reporting Methodology: Facilities may choose to monitor one or more of the following MDROs: MRSA, MRSA and Ent MSSA, VRE, CephR- Klebsiella , CRE (CRE - Klebsiella , CRE - E. coli , and CRE - erobacter) , and multidrug -resistant spp. (See definitions in Section I, Option 1A). For S. aureus , both the Acinetobacter resistant (MRSA) and the susceptible (MSSA) phenotypes can be tracked to provide concurrent measures of the susceptible pathogens as a comparison to those of the resistant pathogens in a setting of active MRSA Note: No Active Surveillance Culture/Testing (ASC/AST) results are to be included in prevention efforts. this reporting of individual results. Infection Surveillance can occur in any inpatient location Settings: where such infections may be identified and where denominator data can be collected, which may include critical/intensive care units (ICU), specialty care areas (SCA), neonatal units, step-down units, wards, and chronic care units. In Labor, Delivery, Recovery, & Post-partum (LDRP) locations, where mom and babies are housed toget her, users must count both mom and baby in the denominator. If moms only are being counted, then multiply moms times two to include both mom and baby in denominators. Requirements: Surveillance for all types of NHSN- defined healthcare -associated infection s (HAIs) , regardless if HAI is included in “in -plan” or “off - plan” surveillance, of the MDRO selected for monitoring Patient Safety Monthly Reporting Plan in at least one location in the healthcare facility as indicated in the (CDC 57.106) . Definitions: MDROs included in this module are defined in Section I, Option 1A . Refer to CDC/NHSN Surveillance Definitions for Specific Types of Infections for infection site criteria. Location of Attribution and Transfer Rule applies – See Identifying HAIs in NHSN chapter (Chapter 2). Reporting Instructions : If participating in MDRO/CDI Infection Surveillance and/or LabID Event Reporting, along with the reporting of HAIs through the Device-Associated and/or Procedure- Associated Modules, see Appendix 1: Guidance for Handling MDRO/CDI Module Infection Surveillance and LabID for instructions on unique reporting scenarios. , Event Reporting When Also Following Other NHSN Modules - 34 12 January 2019

249 MDRO and CDI Module Numerat or Data: Number of healthcare -associated infections, by MDRO type. Infections are reported on -Associated Event Primary Bloodstream Infection, Pneumonia, Ventilator , the appropriate NHSN forms: Urinary Tract Infection, Surgical Site Infection, or MDRO or CDI Infection Event (CDC 57.108, 57.111, 57.112, 57.114, 57.120, and 57.126, respectively.). Table of Instructions , located in each of the See the applicable chapters, for completion instructions. Denomin Number of patient days and admissions. Patien t days and admissions are reported by ator Data: MDRO and CDI Monthly Denominator Form location using the Table of Instructions (CDC 57.127). See for completion instructions. Data Analys is: Data are stratified by time ( for example, month, quarter, etc.) and patient care location. MDRO Infection Incidence Rate / Number of patient days x 1000 = Number of HAIs by MDRO type B. Clostridiu m difficile Infection Surveillance Reporting Methodol ogy: C . difficile Infection (CDI) Surveillance, reporting on all NHSN -defined healthcare - associated CDIs from at least one patient care area, is one reporting C . difficile (part of your option for facility’s Monthly Reporting Plan). These data will enhance the ability of NHSN to aggregate national data on CDIs. Settings: Infection Surveillance will occur in any inpatient location where denominator data can be collected, which may include critical/intensive care units (ICU), specialty care areas (SCA), step -down units, wards, and chronic care units. Surveillance will NOT be performed in Neonatal Intensive Care Units (NICU), Specialty Care Nurseries (SCN), babies in LDRP , or well-baby nurseries. If LDRP locations are being monitored, baby counts must be removed. Requireme Surveillance for CDI must nts: be performed in at least one location in the healthcare institution (CDC 57.106). as indicated in the Patient Safety Monthly Reporting Plan -associated infections where C . s: , identi fied by a positive toxin Report all healthcare Definition difficile ted pathogen, according to the Repeat Infection result including toxin producing gene [PCR]), is the associa Identifying HAIs in NHSN chapter Timeframe (RIT) rule for HAIs (See ). Refer to specific definitions in chapter for C. difficile s for Specific Types of Infections CDC/NHSN Surveillance Definition gastrointestinal system infection (GI -CDI ). that meet criteria f or a healthcare -associated infection should be reported as ases of CDI HAI c Clostridioides gastro intestinal system infection (GI -CDI ). Report the pathogen as C. difficile on the difficile MD RO or CDI Infection Event form (CDC 57.126). If the patient develops GI -CDI, and GI -GE or GI -GIT , report the GI -CDI and the GI- GE or GI -GIT only if additional enteric organisms are identified and identified event (LabID Event) categorizations (for applicable criteria are met . Note: CDI laboratory- , recurrent CDI assay, incident CDI assay, healthcare facility example -onset, community-onset, community- - 35 12 January 2019

250 MDRO and CDI Module -associated) do apply to HAIs including C. difficile associated gastrointestinal onset healthcare facility not infections (GI -CDI). Each new GI -CDI must be reported according to the HAI rules outlined in system Identifying HAIs in NHSN chapter. CDI Complic ations : CDI in a case patient within 30 days after CDI symptom onset with at least one of the following: 1. Admissio for example : for shock n to an intensive care unit for complications associated with CDI ( that requires vasopressor therapy); 2. Surgery (f or example, colectomy) for toxic megacolon, perforation, or refractory colitis AND/OR 3. Death ca used by CDI within 30 days after symptom onset and occurring during the hospital admission. Location of Attribution and Transfer Rule apply to Infection Surve illance – See Identifying HAI s in NHSN chapter. r Data: Numerato Number of healthcare -associated C. difficile infections. Infections are reported on the MDRO or CDI Infection form (CDC 57.126). See Tables of Instructions for completion instructions. Event Denomin ator Data: s by location are reported using the MDRO and Number of patient days and admission CDI Monthly Denominator Form Tables of Instructio ns for completion instr uctions. (CDC 57.127). See C . difficile Inf ections: Numerato for a r: The total number of HAI CDI cases identified during the surveillance month location. Denomina tor: The total number of patient days and admissions during the surveillance month for a location. Data Analys is: Data are stratified by time ( for example, month, quarter, etc.) and by patient care location. C. difficile = Number of HAI CDI cases / Number of patient days x ate 10,000 Incidence R Infection - 36 12 January 2019

251 MDRO and CDI Module Supplemental II. Reporting ntion Process Measures Surveillance 1. Preve ng Adherence to Hand Hygiene a. Monitori ion: This option will allow facilities to monitor adherence to hand hygiene after a healthcare Introduct worker (HCW) has contact with a patient or inanimate objects in the immediate vicinity of the patient. Research studies have reported data suggesting that improved after-contact hand hygiene is associated with reduced MDRO transmission. While there are multiple opportunities for hand hygiene during patient care, after contact with a patient or inanimate objects in the for the purpose of this option, only hand hygiene immediate vicinity of the patient will be observed and reported. ( http://www.cdc.gov/handhygiene/ ) Settings: Surveillance will occur in any location: inpatient or outpatient. Requireme nts: Surveillance for adherence to hand hygiene in at least one location in the healthcare institution for at least one calendar month as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106). This should be done in patient care locations also selected for Infection Surveillance or LabID Event reporting. In particip contact ations, perform at least 30 different unannounced observations after ating patient care loc with patients for as many individual HCWs as possible. For example, try to observe all types of HCWs performing a variety of patient care tasks during the course of the month, not only nurses, or not only during catheter or wound care. No personal identifiers will be collected or reported. Definitions: ic handwash: Washing hands with water and soap or other detergents containing an antiseptic Antisept agent. ic hand -rub: Applying an antiseptic hand-rub product to all surfaces of the hands to reduce the Antisept number of microorganisms present. A general term that applies to either: handwashing, antiseptic hand wash, antiseptic hand Hand hygiene: rub, or surgical hand anti sepsis. Handwashi ng: Washing hands with plain ( specifically , non- antimicrobial) soap and water. Numerato Hand Hygiene Performed = Total number of observed contacts during which a HCW touched r: either the patient or inanimate objects in the immediate vicinity of the patient and appropriate hand hygiene . was performed - 37 12 January 2019

252 MDRO and CDI Module Hand Hygiene Indicated = Total number of observed contacts during which a HCW touched Denominator: either the patient or inanimate objects in the immediate vicinity of the patient and therefore, appropriate hand hygiene was indicated . MDRO and CDI Monthly Denominator Form Hand hygiene process measure data are reported using the 127). See Tables of Instructions for completion instructions. (CDC 57. for example is: Data are stratified by time ( , month, quarter, etc.) and patient care location. Data Analys Hand Hyg iene Percent Adherence = Number of contacts for which hand hygiene was performed / Number of contacts for which hand hygiene was indicated x 100 b. Monit oring Adherence to Gown and Gloves Use as Part of Contact Precautions onitor adherence to gown and gloves use when a HCW ion: This option will allow facilities to m Introduct has contact with a patient or inanimate objects in the immediate vicinity of the patient, when that patient is on Transmission- based Contact Precautions. While numerous aspects of adherence to Contact Precautions could be monitored, this surveillance option is only focused on the use of gown and gloves. ) (http://www.cdc.gov/ncidod/dhqp/gl_isolation_contact.html Settings: Surveillance can occur in any of 4 types of inpatient locations: (1) intensive care units (ICU), (2) specialty care areas, (3) neonatal intensive care units (NICU), and (4) any other inpatient care location in the ). institution (for example, surgical wards Requireme nts: Surveillance for adherence to gown and gloves use in at least one location in the healthcare Patien t Safety Monthly Reporting Plan ( CDC institution for at least 1 calendar month as indicated in the 57.106). Ideally, this should be done in patient care locations also selected for Infection Surveillance or LabID Event reporting. nts on Transmission- based Contact Precautions in participating patient ca re locations, perform Among patie at least 30 unannounced observations. A total of thirty different contacts must be observed monthly among HCWs of varied occupation types. For example, try to observe all types of HCWs performing a variety of patient care tasks duri ng the course of the month, not only nurses, or not only during catheter or wound care. Both gown and gloves must be donned appropriately prior to contact for compliance. No personal identifiers will be collected or reported. Definition s: Gown and glove s use : In the context of Transmission- based Contact Precautions, the donning of both a gown and gloves prior to contact with a patient or inanimate objects in the immediate vicinity of the patient. Both a gown and gloves must be donned appropriately prior to contact for compliance. r: Gown and Gloves Used = Total number of observed contacts between a HCW and a patient or Numerato - 38 12 January 2019

253 MDRO and CDI Module on Transmission- inanimate objects in the immediate vicinity of a patient based Contact Precautions for which gown and gloves had been donned appropriately prior to the contact. ator: Denomin Gown and Gloves Indicated = Total number of observed contacts between a HCW and a patient on Transmission -based Contact Precautions or inanimate objects in the imm ediate vicinity of the patient and therefore, gown and gloves were indicated. Gown and gloves use process measure data are reported using the MDRO and CDI Monthly Denominator Form (CDC 57.127). See Tables of Instructions for completion instructions. is: Data are stratified by time (for example, month, quarter, etc.) and patient care location. Data Analys Gown and Glove Use Percent Adherence = Number of contacts for which gown and gloves were used appropriately / Number of contacts for which gown and gloves were indicated x 100 c. Monitor ing Adherence to Active Surveillance Testing Introduct ion: This option will allow facilities to monitor adherence to active surveillance testing (AST) of MRSA and/or VRE, using culturing or other methods. Settings: ), Surveillance will occur in any of 4 types of inpatient locations: (1) intensive care units (ICU (2) specialty care areas, (3) neonatal intensive care units (NICU), and (4) any other inpatient care location in , surgical wards). the institution (for example nts: Surveillance of AST adherence in at least one location in the healthcare faci lity for at least Requireme one calendar month as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106). A facility may choose to report AST for MRSA and/or VRE in one or mult iple patient care locations, as the facility deems appropriate. Ideally, this should be done in patient care locations also selected for Infection Surveillance or LabID Event reporting. To improve standardization of timing rules for AST specimen collectio n, classify specifically admission specimens as those obtained on day 1 (admission date), day 2, or day 3 ( , ≤3 days). Classify discharge/transfer AST specimens as those collected on or after day 4 (specifically , >3 days). Definition s: Choose one of two methods for identifying patients that are eligible for AST: le Patie nts : AST Eligib All = All patients in the selected patient care area regardless of history of MRSA or VRE infection or colonization. OR NHx = All patients in the selected patient care area who have NO documented positive MRSA or VRE infection or colonization during the previous 12 months (as ascertained by either a facility’s laboratory records or information provided by referring facilities); and no evidence of MRSA or , they are not in Contact Precautions). VRE during stay in the patient care location (specifically : Choose one of two methods for reporting the timing of AST: AST Timing of - 39 12 January 2019

254 MDRO and CDI Module Adm = Specimens for AST obtained ≤3 days after admission, OR Both = Specimens for AST obtained ≤3 days after admission and, for patients’ stays of >3 days, at the time of discharge/transfer. Discharge/transfer AST should include all discharges (including discharges from the facility or to other wards or deaths) and can include the most recent weekly AST if performed >3 days after admission to the patient care location. Discharge/transfer AST should not be performed on patients who tested positive on AST admission. Numerat : Use the MDRO and CDI Monthly Denominator Form (CDC 57.127) or and Denominator Data to indicate: 1) AST was performed during the month for MRSA and/or VRE, 2) AST-eligible patients, and 3) the timing of AST. No per sonal identifiers will be collected or reported. See Tables of Instructions for completion instructions. Numerato r: For each month during which AST is performed: = Number of patients eligible for admission AST who had a specimen Admission AST Performed obtained for testing ≤3 days after admission, AND/OR Discharge/Transfer AST Performed = For patients’ stays >3 days, the number of discharged or transferred patients eligible for AST who had a specimen obtained for testing prior to discharge, not including the admission AST. For each month during which AST is performed: nator: Denomi Admission AST Eligible = Number of patients eligible for admission AST (All or NHx), AND/OR Discharge/Transfer AST Eligible = Number of patients eligible for discharge/transfer AST (All or NHx) AND in the facility location >3 days AND negative if tested on admission. is: Data are stratified by patient care location and time ( for example , month, quarter, etc.), Data Analys according to AST-eligible patients monitored and the timing of AST. Admissio n AST Percent Adherence = Number of patients with admission AST Performed / Number of patients admission AST eligible x 100 = Number of patients with discharge/transfer AST performed / /transfer AST Percent Adherence Discharge Number of patients discharge/transfer AST eligible x 100 - 40 12 January 2019

255 MDRO and CDI Module Active Surveillance Testing Outcome Measures 2. Introduct ion: This option will allow facilities to use the results of AST to monitor the prevalent and incident rates of MRSA and/or VRE colonization or infection. This information will assist facilities in assessing the impact of intervention programs on MRSA or VRE transmission. Surveillance will occur in any of 4 types of inpat Settings: ient locations: (1) intensive care units (ICU), (2) specialty care, (3) neonatal intensive care units (NICU), and (4) any other inpatient care location in the institution (for example, surgical wards). Requireme nts: Surveillance for prevalent and/or inci dent MRSA or VRE cases in at least one location in the healthcare facility for at least one calendar month as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106). This can be done ONLY in locations where AST adherence is being performed. A minimum AST adherence level will be required for the system to calculate prevalence and incidence. A facility may choose to report AST for MRSA and/or VRE in one or multiple pa tient care locations, as the facility deems appropriate. Ideally, this should be done in patient care locations also selected for Infection Surveillance or LabID Event reporting. To improve standardization of timing rules for AST specimen collection, clas sify admission specimens as those obtained on day 1 (admission date), day 2, or day 3 (specifically , ≤3 days). Classify discharge/transfer AST specimens as those collected on or after day 4 , >3 days). Only the first specimen positive for MRSA or VRE from a given patient in the (specifically patient care location is counted, whether obtained for AST or as part of clinical care. If an Admission AST specimen is not collected from an eligible patient, assume the patient has no MRSA or VRE colonization . Definition s: AST Adm ission Prevalent case : Known Positive = A patient with documentation on admission of MRSA or VRE colonization or infection in the previous 12 months ( specifically , patient is known to be colonized or infected as ascertained by either a facility’s laboratory records or information provided by referring facilities). (All MRSA or VRE colonized patients currently in a location during the month of surveillance should be considered “Known Positive”), OR Admission AST or Clinical Positive = A patient with MRSA or VRE isolated from a specimen collected for AST ≤3 days after admission or from clinical specimen obtained ≤3 days after specifically , MRSA or VRE cann ot be attributed to this patient care location). admission ( AST Inci dent case : A patient with a stay >3 days: With no documentation on admission of MRSA or VRE colonization or infection during the previous 12 months (as ascertained either by the facility’s laborato ry records or information provided by referring facilities); including admission AST or clinical culture obtained ≤3 days after , patient without positive specimen), admission ( specifically AND - 41 12 January 2019

256 MDRO and CDI Module With MRSA or VRE isolated from a specimen collected for AST or clinical reasons > 3 days after admission to the patient care location or at the time of discharge/transfer from the patient care location (including discharges from the facility or to other locations or deaths). MRSA col onization: Carriage of MRSA without evidence of infection (for example , nasal swab test positive for MRSA, without signs or symptoms of infection). AST Eligib : Choose one of two methods for identifying patients’ eligible for AST: le Patients All = All patients in the selected patient care area regardless of history of MRSA or VRE infection or colonization, OR NHx = All patients in the selected patient care area who have NO documented positive MRSA or VRE infection or colonization during the previous 12 months (as a scertained either by the facility’s laboratory records or information provided by referring facilities); and no evidence of MRSA or VRE during stay in the patient care location . Timing of AST: Choose one of two methods for reporting the timing of AST: Adm = Specimens for AST obtained ≤3 days after admission, OR = Specimens for AST obtained ≤3 days after admission and, for patients’ stays of >3 days, at Both the time of discharge/transfer. Discharge/transfer AST should include all discharges (including discharges from the facility or to other wards or deaths) and can include the most recent weekly AST if performed >3 days after admission to the patient care location. Discharge/transfer AST should not be performed on patients who tested positive on AST admission. Numerat or and Denominator Data: Use the MDRO and CDI Monthly Denominator Form (CDC 57.127) to indicate: 1) AST outcomes monitoring and adherence was performed during the month for MRSA and/or VRE, 2) AST eligible patients, and 3) the timing of AST. No personal identifiers will be collected or reported. See Tables of Instructions for completion instructions. If only admi ssion AST is performed, only prevalent cases of MRSA or VRE can be detected in that patient care location. If both admission and discharge/transfer AST are performed, both prevalent and incident entifiers will be collected or reported. cases can be detected. No personal id n Prevalent Case: Admissio Numerator Sources : (1) Known Positive; (2) Admission AST or Clinical Positive = Cases ≤3 days after admission Denominator Source: Total number of admissions Case: Incident and without Discharge/transfer AST or Clinical Positive = Cases >3 days after admission Numerator: on admission positive test result(s) - 42 12 January 2019

257 MDRO and CDI Module Denominator: Total number of patient days Note For : -days at risk (specifical research purposes calculating patient -days in which ly, excluding patient patients were known to be MRSA or VRE colonized or infected) may be a preferable denominator, but for surveillance purposes and ease of aggregating, total number of patient days is required for this module. Data Analys is: Data are stratified by patient care location and time ( for example , month, quarter, etc.) according to the eligible patients monitored and timing of AST. AST Adm ission Prevalence rate = For Eligible patients = All : Number of admission AST or clinical p ositive / Number of admissions x 100 For Eligible patients = NHx : Number of admission AST or clinical positive + Number of known positive / Number of admissions x 100 AST Inci dence rate = / Number of patient days x 1000 Number of discharge/transfer AST or clinical positive 1 -Resistant Organisms in Healthcare Settings. HICPAC, Management of Multidrug . 2 Cohen AL, et al. Infection Control and Hospital Epidemiology . Oct 2008; 29:901 -913. 3 McDonald LC, Coignard B, Dubberke E, Song X. Horan T, Kutty PK. Recommendations for surveillance of Clostridium difficile -associated disease. Infection Control Hospital Epidemiology 2007; 28:140- 5. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious 4 Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA); L Clifford McDonal d, Dale N Gerding,Stuart Johnson, Johan S Bakken, Karen C Carroll,Susan E Coffin, Erik R Dubberke, Kevin W Garey, Carolyn V Gould , Ciaran Kelly, Vivian Loo, Julia Shaklee Sammons, Thomas J Sandora, Mark H Wilcox ; Clinical Infectious Diseases, –994, Volume 66, Issue 7, 19 March 2018, Pages 987 - 43 12 January 2019

258 MDRO and CDI Module Module Infection Surveillance and LabID Guidance for Handling MDRO and CDI Appendix 1. Event Reporting When Also Following Other NHSN Modules If a facili ty is monitoring CLABSIs, CAUTIs, VAPs , or VAEs within the Device-Associated Module and/or -Associated Module and is also monitoring MDROs (for example, MRSA) in the SSIs within the Procedure Module, then there are a few situations where reporting the infection or LabID event may MDRO and CDI be confusing. The following scenarios provide guidance to keep the counts and rates consistent throughout your facility and between all of the NHSN Modules. These rules apply to the reporting of “Big 5 ” ) caused by an MDRO selected for monitoring. infections (BSI, UTI, PNEU, VAE, and SSI ociated Module with MDRO and CDI Module Device- Ass Scenario 1 : Facility is following CLABSI, CAUTI, VAP , or VAE along with MDRO Infection Surveillance and possibly LabID Event Reporting in the same location : Healthcare- associated Infection identified for this location. 1. Report the infection (BSI, UTI, PNEU , or VAE ). . 2. Answer “Yes” t o the MDRO infection question This fulfills the infection reporting requirements of both modules in one entry and lets the NHSN reporting tool know that this infection should be included in both the Device-Associated and the MDRO infection datasets and rates. If follow ing LabID event reporting in the same location , report also (separately) as a LabID E vent (if 3. meets the MDRO protocol criteria for LabID eve nt). Scenario 2: Facility is following BSI (CLABSI), UTI (CAUTI) , PNEU/VAP, or VAE along with MDRO Infection Surveillance and possibly LabID Event Reporting in multiple locations : The event date for the infection is the day of patient transfer from one location (the transferring location) to another location (the new location), or the next day. 1. , if Report t he i nfection (BSI, UTI, PNEU and VAE ) and attribute to the transferring location VAE ) on the day of Event, transferring location was following that Event Type (BSI, UTI, PNEU, which occurred on the date of transfer , or the following day. o the MDRO infection question , if the transferring location was following that 2. Answer “Yes” t MDRO on the day of Event, which occurred on the date of transfer, or the following day. If, on the date of , report also culture collection, the new location is following LabID event reporting 3. (separately) as a LabID Event and attribute to the new location (if meets the MDRO protocol criteria for LabID event). - 44 12 January 2019

259 MDRO and CDI Module As ciated Module with MDRO and CDI Module Procedure- so Is are associated with a procedure and not a patient location, but MDROs are connected with the SS Note: patient location. Scenario 3: Facility is following SSI along with MDRO Infection Surveillance and possibly LabID Event Reporting: Patient has surgery, is transferred to a single unit for the remainder of the stay, and during the current stay acquires an SSI . 1. ) and attribute to the post-op location. he infection (SSI Report t 2. Answer “Yes” t o the MDRO infection question , if the post-op location is following that MDRO during the month of the date of event. Event ing LabID event reporting in the post-op location, report also (separately) as a LabID 3. If follow (if meets the MDRO protocol criteria for LabID event). acility is following SSI along with MDRO Infection Surveillance and possibly LabID Event ario 4 : F Scen Reporting: Patient has surgery, is either discharged immediately (outpatient) or transferred to a unit (inpatient), is discharged, and subsequently is readmitted with an SSI. 1. Report the infection (SSI) and attribute to the discharging (post -op) loc ation (not the readmission location). Answer “Yes” t o the MDRO infection question , if the discharging (post-op) location was following 2. that MDRO during the Date of Ev ent. If follow 3. ing LabID event reporting in the readmitting location or outpatient clinic where the vent (if meets the MDRO protocol a LabID E specimen was collected , report also (separately) as criteria for LabID event) . - 45 12 January 2019

260 MDRO and CDI Module Observation Patients Appendix 2: Counts Involving In response to questions regarding counting “observation” patient s, the following guidance is offered. For the purp ose of NHSN surveillance and reporting, an “observation” location (for example, 24-hour observation area) is considered an outpatient unit, and time spent in this type of unit does not ever contribute specifically , patient days, device days, admissions). Stays in such outpatient units to any inpatient counts ( represent “encounters” for the purposes of outpatient surveillance for LabID Event monitoring in the MDRO/CDI module. The NHSN instructions for recording the number of patients in an inpatient unit state that for each day of the month selected, at the same time each day, the n umber of patients on the unit should be recorded. This procedure should be followed regardless of the patient’s admission status as an observation patient or an inpatient. Key point -- i t is the patient’s physical location and NOT the patient’s admission status as an “observation” patient that determines whether the patient counts for an inpatient location or the 24 hour observation location 1. Observat : ion patient in observation location n patient is housed in -hr Observation area , they When an observatio a location that is mapped as a 24 These areas are considered outpatient locations. should not be included in any inpatient counts. inpatient location: 2. Observat ion patient in a. If an observation patient is transferred to an inpatient location : are to be included in patient • LabID event reporting -- Only patient days in the inpatient location day counts for the location or FacWideIN. These counts should be inclusive of all patients housed patient. in the inpatient location, regardless of their status as an observation • Device- associ ated surveillance -- Device -day d enominator data accrue beginning when the patient arrives in any inpatient location where surveillance is occurring, in accordance with the location’s device-count methods. If an obser b. vation patient is admitted to an inpatient location, the patient must be included in all surveillance events designated in the monthly reporting plan and included in patient and device day counts. The patient is being housed, monitored, and cared for in an inpatient location and therefore is at risk for acquisition of an HAI. The facility assignment of the patient as an observation patient or an inpatient has no bearing for the purpose of counting. Below is a n example of attributing patient days to a patient admitte d to an inpatient location, regardless of whether the facility considers the patient an observation patient or an inpatient. - 46 12 January 2019

261 MDRO and CDI Module les show counts taken at: A) 12:00 am and B) 11:00 pm. The examp A. Count at 12: 00 am (midnight): Mr X Pt Day Mr Y Pt Day Date 01/01 Mr X admitted at 8:00 pm itted at 12:00 am Mr Y adm unted because the count for Mr X not co Mr Y is c ounted because the count for 01/01 01/01/10 was taken at 12:00 am on 01/01 10 was taken at 12:00 am and that is when he was admitted and he was not yet admitted X 1 01/02 2 1 2 3 01/03 01/04 3 4 Mr X discharged at 5:00 pm 01/05 Mr Y discharged at 12:01 am 4 5 Counted for 01/05 because he was in the Counted for 01/05 because he was in the hospital at 12:00 am on 01/05 when the hospital at 12:00 am on 01/05 when the count for that day was taken count for that day was taken Total 4 patient days 5 patient days If we use th . X, but a different time is selected for the patient day e same admission dates and times for Mr count, say 11:00 pm, the total number of days in the count will be the same; they will simply be coming from different dates. - 47 12 January 2019

262 MDRO and CDI Module B. Count at 11:00 pm: Date Mr X Pt Day Mr X admitted at 8:00 am Counted because the count for 01/01 is taken 01/01 at 11:00 pm on 01/01 and he is in the hospital at that time 1 01/02 - 2 01/03 3 - 01/04 - 4 01/05 MR X discharged at 5:00 pm Not counted for 01/05 because he was not in the hospital at 11:00 pm on 01/05 when the count for that day was taken X - Total 4 patient days Determin ing Admission Counts for Summary Data Collection: In response to questions regarding how to count number of admissions, the following guidance is offered. How you operationalize this guidance will depend on how you are obtaining the data for your counts. Recognizi ng that there are a variety of ways in which patient day and admission counts are obtained for a facility and for specific locations, this guidance is offered to assist with standardization within and across facilities. It is most important that whatever method is used by a facility , it should be used each and every month for consistency of data and metrics. If admissi ons are calculated electronically , the data must be checked to ensure that all appropriate patients are included or excluded from those counts and that, for three consecutive months, your electronic data are within +/- 5% of the number obtained by manual counts. If these counts are more than 5% discrepant, then you will need to evaluate and discuss with your IT staff to determine the cause of the discrepancies and methods to address them. The main goal is to accurately count patients in the denominators that may contribute to the numerator. See below f or specific examples: 1. Facility -W ide Inpatient Admission Count: Include any new patients that are assigned to a bed in any inpatient location within the facility regardless of billing status. Qualification as a new patient means that the patient was n ot present on the previous calendar day . The daily admission counts are summed at the end of the calendar month for a monthly facility-wide inpatient admission count. -Specific Admission Count: Include any new patients that are assigned to a bed in the t Location 2. Inpatien . Qualification as a new patient means that the patient was not present in the specific inpatient location - 48 12 January 2019

263 CDI Module MDRO and specific inpatient location on the previous calendar day. The daily admission counts are summed at the end of the calendar month for a monthly inpatient location -specific admission count. Any patient who meets criteria for new inclusion should be counted, regardless of whether they are coded by the facility as an inpatient or as an observation patient. Below is an example of manually counting location- specific and f acility -wide admission counts related to a patient admitted to an inpatient location and transferred to multiple patient locations during his hospital stay. The example show counts taken at 11:00 pm. Example: Counts at 11:00 pm: Inpatient Facility Unit Date/Time Mr. X - Date/Time Mr. X Inpatient Transferred Out Location- Specific Placed on Wide Admission Count Inpatient Unit Admission Count of Inpatient Unit SICU 10/13 – 9:00am 1 Adm for SICU 10/08 – 10:00am 1 Adm for FacWideIN (facility admission) Not present and so 10/13 – 9:15am 10/13 – 11:00am Same Adm, and MICU not counted also not present so not counted Surgical Ward 10/13 – 11:30am 10/25 – 1:00pm 1 Adm for Surgical Same Adm so not Ward counted Same Adm so not Medical Ward 10/25 – 1:30pm 10/26 – 10:00am for Medical 1 Adm counted Ward (facility discharge) - 49 12 January 2019

264 MDRO and CDI Module Surveillance Appendix 3: Differentiating Between LabID Event and Infection Topic Infection Surveillance (using HAI LabID Event surveillance definitions) LabID Event protocol in Chapter 12 of Infection Surveillance protocol in Chapter 12 of Protocol NHSN manual NHSN manual and HAI site-specif ic definitions for example , BSI, UTI, SSI, in NHSN manual ( PNEU, VAE , and GI -CDI and other HAI definitions ) NONE. Laboratory and admission data, Combination of laboratory data and clinical Signs & evaluation of patient (signs/symptoms) without clinical evaluation of patient Symptoms Surveillance • HAI and POA do NOT apply do and POA HAI • apply Transfer Rule does apply Rule NOT • s ies Transfer Rule appl • Location = location of patient at time • • regarding See NHSN protocol for details specimen collection of location and date of event • Event date = specimen collection date m Device days and patient days Denominator ust be • • Number of patient days and admissions collected separately for each monitored Reporting location Can be reported by specific location • -wide, depending on or facility • Inpatient reporting only reporting option(s) selected • Inpatient and/or outpatient • Categorization Events categorized based on • HAI protocols used of Infections inpatient or outpatient and admission or not, therefore Events are either HAI • and specimen collection dates apply LabID Event categorizations do not • -Onset Healthcare Facility Only HAIs are reported to NHSN • (HO) -Onset (CO) Community • -Onset Community • Healthcare Facility - Associated (CO-HCFA) for C. difficile only , and CO • -HCFA (if HO,CO applicable) LabID Events must be reported to NHSN Additional categorizations are • applied to C. difficile , which include and Recurrent Incident CDI event event. Both must be reported to CDI NHSN. - 50 12 January 2019

265 Antimicrobial Use and Resistance Module AUR Antimicrobial Use and Resistance (AUR) Module Table of Contents Introduction 1 2 1. Antimicrobial Use (AU) Option Introduction 2 Requirements 3 Data Analyses 7 Appendix A. Table of Instructions : Antimicrobial Use 12 Appendix 13 B. List of Antimicrobials Appendix C. Example Calculations of Antimicrobial Days 17 Appendix D. List of SAARs 21 Appendix E. Antimicrobial groupings for SAAR & Rate Table 23 calculations 28 2. Antimicrobial Resistance (AR) Option Introduction 28 Requirements 29 Data Analyses 36 Appendix F. Lis t of Eligible Organisms for the NHSN AR Option 43 Appendix G. Technical and Isolate Based Report Variables 49 Appendix H. Denominator Data Variables 51 Appendix I. NHSN AR Option Phenotype Definitions 52 Introduction module contains two options, one focused on antimicrobial use and the second on This antimicrobial resistance. To participate in either option, facility personnel responsible for reporting antimicrobial use (AU) or resistance (AR) data to the National Healthcare Safety Network (NHSN) must coordinate with their laboratory and/or pharmacy information software providers to configure their system to enable the generation of standard formatted file(s) to be imported into NHSN. The format provided for data submission follows the Health Level (HL7) 7 Clinical Document Architecture (CDA ) standard. Manual data entry is not available for the AUR Module. Facilities can participate in one (AU or AR) or both (AU and AR) options at any given time. Purpose NHSN AUR Module provides a mechanism for facilities to report and analyze antimicrobial The use and/or resistance as part of local or regional efforts to reduce antimicrobial resistant infections through antimicrobial stewardship efforts or interruption of transmission of resistant 6 pathogens at their facility. -1 14 January 2019

266 Antimicrobial Use and Resistance Module AUR 1. Antimicrobial Use (AU) Option : Rates of resistan ce to antimicrobial agents continue to increase at hospitals in the Introduction 1 One of the four CDC core initiatives to combat the spread of antimicrobial United States. 2 resistance is improving the use of antimicrobials. Previous studies have shown that feedback of reliable reports of rates of antimicrobial use and resistance to clinicians can improve the 3-5 appropriateness of antimicrobial usage. Objectives: The Option is to facilitate risk- primary objective of the Antimicrobial Use (AU) adjusted inter- A secondary objective is and intra-facility benchmarking of antimicrobial usage. to evaluate trends of antimicrobial usage over time at the facility and national levels. Methodology: The primary antimicrobial usage metric reported to this module is antimicrobial days per 1,000 days present. An antimicrobial day (also known as day of therapy) is defined by any amount of a specific antimicrobial agent administered in a calendar day to a particular patient as document ed in the electronic medication administration record (eMAR) and/or bar coding medication record (BCMA) (refer to Numerator Data section starting on page 14-3); all antimicrobial days for a specific agent administered across a population are summed in 8-11 in a patient Days present are defined as the aggregate number of patients housed aggregate. (refer to Denominator care location or facility anytime throughout a day during a calendar month starting on page 14-6 ). For each facility, the numerator (antimicrobial days) is Data section aggregated by month for each patient t areas facility-wide care location and overall for inpatien (specifically, facility-wide inpatient or FacWideIN). Similarly, the denominator (days present) is calculated for the corresponding patient care-location-month or facility-wide inpatient-month. A secondary antimicrobial usage metric for facility-wide inpatient also reported to this module is antimicrobial days per 100 admissions. The numerator and denominators are further defined must adhere to the data format prescribed by the HL7 CDA Implementation Guide below and 7 developed by the CDC and HL7. Manual data entry is not available for the NHSN AU Option. inpatient facilities Settings: All (for example, general acute care hospitals, critical access hospitals, children’s hospitals, oncology hospitals, long term acute care hospitals, and inpatient can rehabilitation facilities) enrolled in NHSN and using the Patient Safety Component participate in the AU Option. Facilities must have the ability to collect the numerator and denominator data electronically and upload those data into NHSN using the required CDA the AU Option from specifications. NHSN does not currently support the submission of data into skilled nursing facilities, nursing homes) or outpatient long term care facilities (specifically, dialysis facilities. strongly encourages the submission of data from all NHSN -defined inpatient locations NHSN inpatient (FacWideIN), and (including procedural areas like operating rooms), facility-wide select outpatient acute care settings (specifically, outpatient emergency department, pediatric emergency department, and 24-hour observation area) from which the numerator and contain data from denominator data can be accurately captured. The FacWideIN record should all inpatient locations and inpatient procedural areas from which the numerator and denominator -2 14 January 2019

267 Antimicrobial Use and Resistance Module AUR A comprehensive submission will enable a facility to optimize inter can be accurately captured. - and/or int ra-facility comparisons among specific wards, combined wards, and facility-wide data. Within NHSN, a CDC-defined designation is given to each patient care area/location where similar disease conditions or are receiving care for similar medical or surgical patients have specialties. Each facility location is “mapped” to one CDC Location within the NHSN facility. The specific CDC Location code is determined by the type of patients cared for in that area according to the NHSN location mapping algorithm for acuity level and service type. The patient care areas include adult, pediatric, and neonatal units as defined by NHSN Codes. See the NHSN Loc ations chapte r for more information regarding location mapping. Note that the same patient care locations should be used throughout NHSN for both AUR and HAI reporting. Facilities should not map separate locations only for AUR reporting. Requirements: An acceptable minimal month of data includes: 1. The facility must indicate the specific locations from which they plan to submit antimicrobial use data on the Patient Safety Monthly Reporting Plan (CDC 57.106). a. When reporting AU Option data from inpatient and outpatient locations, list FacWideIN, each individual inpatient location, and each individual outpatient location as separate rows in the plan. (Appendix A ) Table of Instructions The CDA files contain all data fields outlined in the 2. for each location of data submitted. Data are uploaded via CDA files 3. for all locations indicated on the Monthly Reporting Plan. NHSN recommends that data be entered into NHSN for a given calendar month by the end of the subsequent calendar month. Numerator Data (Antimicrobial Days): Defined as the aggregate sum of days for which any (Days of Therapy): Antimicrobial Days amount of a specific antimicrobial agent was administered to individual patients as document ed 8-11 in the eMAR and/or BCMA. B provides the full list of antimicrobial agents Appendix Aggregate antimicrobial days are reported monthly for collected in the NHSN AU Option. inpatient locations, facility-wide inpatient (FacWideIN), and three select outpatient acute care outpatient emergency department, pediatric emergency department, and settings (spe cifically, 24-hour observation area) for select antimicrobial agents and stratified by route of administration (specifically, intravenous, intramuscular, digestive, and respiratory). for definitions of drug-specific antimicrobial days and stratification Table 2 and Table 1 Refer to based on route of administration. For example, a patient to whom 1 gram Vancomycin is administered intravenously twice daily for three days will be attributed three “Vancomycin Day s (total)” and three “Vancomycin Days (IV)” when stratified by intravenous route of administration. Please note that antimicrobials that have an extended half-life such as Dalbavancin and Oritavancin are only counted as an antimicrobial day on the day of administration. Similarly, in the setting of renal impairment, antimicrobials such as Vancomycin -3 14 January 2019

268 Antimicrobial Use and Resistance Module AUR Table 3 summarizes the are only counted as an antimicrobial day on the day of administration. data elements for numerator calculation. provides additional examples for the Appendix C calculation of antimicrobial days. Please note that “zero” should be reported when no aggregate usage occurred during a given reporting period for a specific antimicrobial agent/route (for example, Zanamivir via the respiratory route) that agent/route can be at a facility in which the agent/route is used and accurately captured in the eMAR or BCMA system. Further , “NA” (N ot Applicable) should be reported when data are not available for a specific antimicrobial agent/route at a facility (specifically , the agent can’t be electronically captured at that facility). A value (specifically, a must be reported for every antimicrobial agent and route of ”) specific number, “zero”, or “ NA administration for every location record for each month. Appendix B listed in n and Definitions of Routes of Administration for Antimicrobial Days Classificatio Table 1. b Definition Classification: a Route of Administration Intravenous (IV) An intravascular route that begins with a vein. Intramuscular (IM) A route that begins within a muscle. Digestive Tract A route that begins anywhere in the digestive tract extending c from the mouth through rectum. Respiratory Tract A route that begins within the respiratory tract, including the oropharynx and nasopharynx. a the AU Option reporting (for example, antibiotic locks, m Other routes of administration are excluded fro intraperitoneal, intrapleural, intraventricular, irrigation, topical) and should not be included in either the . total antimicrobial days nor the sub-stratification of the routes of administration b CDA Antimicrobial Use Definitions were drawn from SNOMED qualifier value hierarchy. Refer to the (AU) Toolkit for specific codes corresponding to each route of administration. c For example, rectal administration of Vancomycin. Example Stratification of Antimicrobial Days by Route of Administration Table 2. Month/ Drug-specific Antimicrobial Days Year- Antimicrobial b a Digestive IV IM Respiratory Total Agent Location Tobramycin Mont h/ Tobramycin Tobramycin Tobramycin Tobramycin Days Tobramycin Days Days Days Year Days Location (IM) (Respiratory) (IV) (Digestive) (Total) 01/2016 1 1 1 0 0 Med Ward a Drug-specific antimicrobial days (total) attributes one antimicrobial day for any route of administration. For example, a patient to whom Tobramycin was administered intravenously and via a respiratory route on the same day would be attributed “one Tobramycin Day (Total)”; the stratification by route of administration would be “one Tobramycin Day (IV)” and “one Tobramycin Day (Respiratory)”. b is not FDA approved for For purposes of example of route stratification only (Tobramycin administration via the digestive route). -4 14 January 2019

269 Antimicrobial Use and Resistance Module AUR Data Elements for Antimicrobial Days Table 3 . Data Element Details Defined as select antimicrobial agents and stratified by route of administration Antimicrobial (specifically, intravenous, intramuscular, digestive, and respiratory). Refer to Agents for a complete list of antimicrobials. The list of select antimicrobials Appendix B will evolve with time as new agents become commercially available. Topical antimicrobial agents are not included in the NHSN AU Option. Antimicrobial days are derived from administered data documented in the eMAR Data source and/or BCMA only. Usage derived from other data sources (for example, pharmacy orders, doses dispensed, doses billed) cannot be submitted. Antimicrobial days are aggregated for each inpatient location, facility-wide Location inpatient, and three select outpatient acute-care settings (specifically, outpatient emergency department, pediatric emergency department, and 24-hour observation area) per NHSN location definitions. Antimicrobial days for a specific antimicrobial agent and stratification by route of Time Unit administration are aggregated monthly per location. Denominator Data (Days Present and Admissions): The numerator will be analyzed against [FacWideIN] only). inpatient of days present and admissions (for facility-wide the denominators The denominators are further defined below. Days present : Days present are defined as time period during which a given patient is at risk for antimicrobial exposure in a given patient location. The definition of days present differs from conventional definition of patient days used in other NHSN modules. Days present is further defined below in context of calculation for patient care location-specific analyses and facility- wide inpatient analyses. Please note that a separate calculation for days present is required for inpatient. patient care location compared to facility-wide For patient care location-specific analyses, days present is calculated as the number of patients who were present, regardless of patient status (for example, inpatient, for any portion of each day of a calendar month for a patient care location. observation), The aggregate measure is calculated by summing up all of the days present for that location and month. The day of admission, discharge, and transfer to and from locations in the will be included days present count. Below are examples that illustrate appropriate counting of days present: A patient admitted to the medical ward on Monday and discharged two days later on  because the Wednesday will be attributed three days present on that medical ward patient was in that specific location at some point during each of the three calendar days (specifically, Monday, Tuesday, and Wednesday).  On the day a patient is transferred from a medical critical care unit to a medical ward the patient will be attributed one day present on the medical critical care unit as well because the patient was in both locations at as one day present on the medical ward some point during that . Similarly, a patient’s the operating room time in calendar day -5 14 January 2019

270 Antimicrobial Use and Resistance Module AUR or emergency department will be included in days present for these types of units (if data are submitted from these locations).  One patient can only account for one day present for a specific location per calendar day (specifically, one patient cannot contribute more than one day present to any one unique location on the same day, but can contribute a day present to two different locations on the same day). For example, a patient transferred from the surgical ward to the operating room and back to the surgical ward in a calendar day contributes one day present to the surgical ward and one day present to the operating room. For facility-wide (FacWideIN) analyses, days present is calculated as the inpatient number of patients who were present in an inpatient location within the facility for any portion of each day of a calendar month. The aggregate measure is calculated by summing up all of the days present for facility-wide inpatient for a given month. Thus, a sum of days present from location-specific analyses would be higher than days present for the facility (FacWideIN), because transfers between wards can account for multiple “ days present ” for a given patient on a single calendar day. Therefore, it is not location permissible to sum the individual days present for location-specific analyses to achieve the facility-wide inpatient (FacWideIN) days present count. The calculation must be a separate summation for facility-wide inpatient analyses. : Admissions are defined as the aggregate number of patients admitted to an inpatient Admissions location within the facility (facility-wide inpatient) starting on first day of each calendar month through the last day of the calendar month. This is the same definition for admissions u sed in the NHSN MDRO/CDI Module . In the AU Option, admissions are reported only for facility-wide inpatient (FacWideIN). Location-specific and Facility-wide Inpatient Metrics Table 4. Metric Collected Metric Definition Comments Patient Care Location-Specific Analyses Antimicrobial Drug -specific antimicrobial days per One patient can contribute only one Days/Days patient care location per month/Days day present per calendar day for present per patient care location per present each specific location. Summed month total may be higher when compared to facility-wide count (reflecting transfers between locations). -6 14 January 2019

271 Antimicrobial Use and Resistance Module AUR Metric Collected Metric Definition Comments Facility-wide Inpatient Analyses Drug One patient can contribute only one Antimicrobial -specific antimicrobial days for day Days/Days inpatient units in a facility per present per calendar day for a month/Days present per facility- present is facility. Thus, one denominator obtained wide inpatient per month for all inpatient locations in an entire facility. The day present measure for facility-wide inpatient should be lower when compared to sum total from location-specific comparison. Drug Antimicrobial Only calculated for facility-wide -specific antimicrobial days for inpatient units in a facility per Days/Admissions inpatient for the AU Option. month/Admissions per facility-wide inpatient per month Data Analyses : (SAAR) Standardized Antimicrobial Administration Ratio The Standardized Antimicrobial Administration Ratio (SAAR) is a metric developed by CDC to analyze and report antimicrobial use data in summary form. The SAAR is calculated by dividing observed antimicrobial use by predicted antimicrobial use. SAAR = Observed (O) Antimicrobial Use Predicted (P) Antimicrobial Use The observed antimicrobial use is the number of days of therapy, or antimicrobial days, reported patient care by a facility for a specified category of antimicrobial agents in a specified group of locations. The predicted antimicrobial use is calculated using predictive models developed by CDC and applied to nationally aggregated 2017 AU data reported to NHSN from the same group of patient care location types. Separate predictive models are developed for each specific antimicrobial agent category. for 13 The SAARs are generated for 15 antimicrobial agent categories, 7 adult and 8 pediatric, for a total of 40 possible SAARs (see specific NHSN location types, 8 adult and 5 pediatric, ), each of which can serve as a high value target or high-level indicator for Appendix D antimicrobial stewardship programs. The antimicrobial agent categories were determined by CDC with input from external adult and pediatric infectious disease physicians and pharmacists. The adult and pediatric SAAR agent categories are listed below. The specific antimicrobial agents in each category can be found in Appendix E.  Adult SAAR antimicrobial agent categories o All antibacterial agents o Broad spectrum antibacterial agents predominantly used for hospital-onset infections -7 14 January 2019

272 Antimicrobial Use and Resistance Module AUR Broad spectrum antibacterial agents predominantly used for community-acquired o infections o Antibacterial agents predominantly used for resistant Gram-positive infections (e.g., MRSA) o Narrow spectrum beta-lactam agents o Antibacterial agents posing the highest risk for CDI (not mutually exclusive, agents may overlap with other categories) o Antifungal agents predominantly used for invasive candidiasis Pediatric SAAR antimicrobial agent categories  o All antibacterial agents Broad spectrum antibacterial agents predominantly used for hospital-onset o infections o Broad spectrum antibacterial agents predominantly used for community-acquired infections Ant ibacterial agents predominantly used for resistant Gram-positive infections o (e.g., MRSA) o Narrow spectrum beta-lactam agents o Azithromycin Antibacterial agents posing the highest risk for CDI (not mutually exclusive, o agents may overlap with other categories) Antifungal agents predominantly used for invasive candidiasis o At present, SAARs are available to facilities that have submitted AU data from one of the 13 eligible adult and pediatric Table 5 . Future iterations of the SAAR location types mapped in SAAR can extend its use as a metric to additional patient care locations when aggregate data are sufficient for those purposes. Location types able to generate SAARs Table 5. NSHN Healthcare Service Location CDC Location Type (HL7) Code CDC Location Code Adult Locations Medical Critical Care IN:ACUTE:CC:M 1027 -2 Surgical Critical Care IN:ACUTE:CC:S 1030 -6 Medical-Surgical Critical Care 1029 -8 IN:ACUTE:CC:MS Medical Ward IN:ACUTE:WARD:M 1060 -3 Surgical Ward IN:ACUTE:WARD:S 1072 -8 Medical-Surgical Ward IN:ACUTE:WARD:MS 1061 -1 Oncology General Hematology- IN:ACUTE:WARD:ONC_HONC 1232 -8 Oncology Ward -1 1099 IN:ACUTE:STEP Adult Step Down Unit -8 January 2019 14

273 Antimicrobial Use and Resistance Module AUR NSHN Healthcare Service Location CDC Location Type CDC Location Code (HL7) Code Pediatric Locations Pediatric Medical Critical Care IN:ACUTE:CC:M:PED 1044 -7 Pediatric Medical-Surgical Critical Care IN:ACUTE:CC:MS_PED 1045 -4 -9 Pediatric Medical Ward 1076 IN:ACUTE:WARD:M_PED IN:ACUTE:WARD:S_PED 1086 -8 Pediatric Surgical Ward -9 Pediatric Medical-Surgical Ward IN:ACUTE:WARD:MS_PED 1081 A high SAAR that achieves statistical significance (specifically, different from 1.0) may indicate excessive antibacterial use. A SAAR that is not statistically different from 1.0 indicates A low SAAR that antibacterial use is equivalent to the referent population’s antib acterial use. Note: A SAAR alone is not achieves statistical significance may indicate antibacterial under use. a definitive measure of the appropriateness or judiciousness of antibacterial use, and any SAAR may warrant further investigation. For example, a SAAR above 1.0 that does not achieve statistical significance may be associated with meaningful excess of antimicrobial use and further investigation may be needed. Also, a SAAR that is statistically different from 1.0 does not mean that further investigation will be productive. or cumulative time periods. The SAARs can be produced by month, quarter, half year, or year SAAR report can be modified to show SAARs by a specific location or a subset of location types. However, keep in mind that SAARs can only be generated and/or modified to show data for the 13 select location types Table 5 . listed above in As a supplement to the SAARs, a rate table showing antibacterials predominantly used for extensively antibiotic resistant bacteria can be generated for adult and pediatric SAAR location types. This rate table shows the antimicrobial days per 1,000 days present for a grouping of five E) along with the pooled mean rate and percentile distributions for the specific drugs ( Appendix th th th th , 50 , 75 , and 90 25 percentiles based on the 2017 baseline AU data. Option Analyses Additional AU Uploaded AU data can also be displayed in numerous types of other reports: line lists, rates and bar charts. tables, pie charts Line Lists: Line lists are the most customizable type of AU Option analysis report. The default line lists show the total antimicrobial days and the sub-stratification of routes of administration for each antimicrobial as well as the days present and admissions for each month and location of data submitted. Default line lists can be generated for the most recent month of data submitted or all months of data submitted for FacWideIN or each individual location. Modifications can be made to any line list to show specific months, locations, antimicrobials, and/or routes of administration. The line lists are the most helpful AU Option report when validating the data. -9 14 January 2019

274 Antimicrobial Use and Resistance Module AUR Rate Tables: Rate tables are generated as incidence density rates of antimicrobial days per 1,000 days present stratified by patient care location and facility-wide inpatient. A rate of antimicrobial days per 100 admissions can also be generated for facility-wide inpatient only. Default rate tables can be generated by antimicrobial category (specifically, antibacterial, antifungal, anti-influenza) and class (for example, aminoglycosides, carbapenems, cephalosporins) for the most recent month of data submitted or all months of data submitted for FacWideIN or each individual location. Modifications can be made to any rate table to show specific months or locations. The rate tables can also be modified to produce a rate per individual antimicrobial, select antimicrobials within the same class, and select antimicrobials within different classes. Pie Charts & Bar Charts: Pie charts and bar charts provide visualizations of the antimicrobial use within a facility. Default pie charts and bar charts can be generated for the most recent month of data submitted or all months of data submitted for FacWideIN or each individual location. There is also a bar chart that shows selected agent distribution by month. All AU Option data can also be exported from NHSN in various formats (for example, CSV, SAS, and Microsoft Access). -10 January 2019 14

275 Antimicrobial Use and Resistance Module AUR References 1. Weiner LM, Webb AK, Limbago B, et al. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2011- 2014 6;37:1288-1301 . . Infect Control Hosp Epidemiol 201 2. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013. Available at: https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar- threats-2013-508.pdf . 3. Davey P, Marwick CA, Scott CL, et al. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev 2017:2;CD003543. 4. Ansari F, Gray K, Nathwani D, et al. Outcomes of an intervention to improve hospital antibiotic prescribing; interrupted time series with segmented regression analysis. J Antimicrob Chemother 2003;52:842-8. 5. Solomon DH, Van Houten L, Glynn RJ. Academic detailing to improve use of broad- spectrum antibiotics at an academic medical center. Arch Inter Med 2001;161:1897-902. 6. Infectious Diseases Society of America and Dellit TH, Owens RC, McGowan JE, et al. the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship. Clin Infect Dis 2007;44:159-77. 7. National Healthcare Safety Network (NHSN) Patient Safety Component: Clinical Document Architecture. http://www .cdc.gov/nhsn/cdaportal/index.html 8. Schwartz DN, Evans RS, Camins B, et al. Deriving measures of intensive care unit antimicrobial use from computerized pharmacy data: methods, validation, and overcoming barriers. Infect Control Hosp Epidemiol 2011;32:472-80. 9. adult Polk RE, Fox C, Mahoney A, Letcavage J, MacDougall C. Measurement of Antibacterial Drug Use in 130 US Hospitals: Comparison of Defined Daily Dose and Days of Therapy. Clin Infect Dis 2007;44:664-70. 10. Kuster SP, Ledergerber B, Hintermann A, et al. Quantitative antibiotic use in hospitals: comparison of measurements, literature review, and recommendations for standards of reporting. Infection 2008; 6:549-59. Berrington A. Antimicrobial prescribing in hospitals: be careful what you measure. J 11. Antimicrob Chemother 2010:65:163-168. 12. CLSI. Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Fourth Edition. CLSI document M39-A4. Wayne, PA: Clinical — Approved Guideline and Laboratory Standards Institute; 2014. -11 January 2019 14

276 Antimicrobial Use and Resistance Module AUR Appendix A. Table of Instructions: Antimicrobial Use Option Data Field Data Field Description a Facility OID Required. Must be assigned to facility and included in the importation file prior to submission to NHSN. Month Required. Record the 2-digit month during which the data were collected for this location. Required. Record the 4-digit year during which the data were collected for Year this location. Location Required. The patient care location for which the data are being uploaded. Required. Antimicrobial days are defined as the aggregate sum of the days of Numerator: a specific antimicrobial was administered. These are exposure for which Antimicrobial days per month required to be extracted from electronic medication administration record per location (eMAR) and/or bar coding medication record (BCMA). Antimicrobials days Appendix B will be collected for select antimicrobial agents (refer to ) and stratified by route of administration. Denominator(s): Required. is defined as risk for antimicrobial exposure per time unit of Days present Days present care location-specific analyses, analysis stratified by location. For patient days present is calculated as the number of patients who were present for any care location. For portion of each day of a calendar month for a patient inpatient analyses, days present is calculated as the number of facility-wide patients who were present in an inpatient location within the facility for any portion of each day of a calendar month. Admissions are defined as the aggregate number of patients admitted to an Admissions inpatient location within the facility (facility-wide inpatient) starting on first day of each calendar month through the last day of the calendar month. In the AU Option, admissions are only reported for facility-wide inpatient. a Facilities interested in submitting data to NHSN via CDA must obtain a Facility OID (object identifier). CDA Submission More information on how to obtain an OID for your facility can be found on the Support Portal . -12 January 2019 14

277 Antimicrobial Use and Resistance Module AUR Appendix B. List of Antimicrobials Please note that mapping of standardized terminology (RXNORM) are provided in the timicrobial Use Toolkit . The list of NHSN drug An Information Data Model (IDM) found in the codes as well as the drug values used for the development of the CDA files can be found here: Eligible Antimicrobials . Antimicrobial Antimicrobial Antimicrobial Antimicrobial Agent a a Category Subclass Class Anti-influenza M2 ion channel AMANTADINE inhibitors AMIKACIN Antibacterial Aminoglycosides AMOXICILLIN Antibacterial Penicillins Aminopenicillin AMOXICILLIN/ Antibacterial Β - lactam/ Β -lactamase inhibitor combination CLAVULANATE Polyenes Antifungal AMPHOTERICIN B AMPHOTERICIN B Antifungal Polyenes LIPOSOMAL Antibacterial Penicillins Aminopenicillin AMPICILLIN AMPICILLIN/ Antibacterial Β - lactam/ Β -lactamase inhibitor combination SULBACTAM ANIDULAFUNGIN Antifungal Echinocandins AZITHROMYCIN Antibacterial Macrolides Antibacterial AZTREONAM Monobactams CASPOFUNGIN Echinocandins Antifungal rd Cephalosporins Cephalosporin 2 generation CEFACLOR Antibacterial st Antibacterial Cephalosporins Cephalosporin 1 generation CEFADROXIL st Antibacterial Cephalosporins Cephalosporin 1 CEFAZOLIN generation rd CEFDINIR Cephalosporins Cephalosporin 3 generation Antibacterial rd Antibacterial Cephalosporins Cephalosporin 3 generation CEFDITOREN th Cephalosporin 4 CEFEPIME Antibacterial Cephalosporins generation rd CEFIXIME Cephalosporin 3 Antibacterial generation Cephalosporins rd Antibacterial Cephalosporins CEFOTAXIME generation Cephalosporin 3 CEFOTETAN Antibacterial Cephalosporins Cephamycin CEFOXITIN Antibacterial Cephalosporins Cephamycin rd CEFPODOXIME Cephalosporins Cephalosporin 3 generation Antibacterial rd Antibacterial Cephalosporins Cephalosporin 2 CEFPROZIL generation CEFTAROLINE Antibacterial Cephalosporins Cephalosporins with anti- MRSA activity rd generation Cephalosporins Cephalosporin 3 CEFTAZIDIME Antibacterial -13 14 January 2019

278 Antimicrobial Use and Resistance Module AUR Antimicrobial Antimicrobial Antimicrobial Agent Antimicrobial a a Subclass Class Category / Antibacterial Β - CEFTAZIDIME -lactamase lactam/ Β inhibitor combination AVIBACTAM rd Antibacterial Cephalosporin 3 generation CEFTIBUTEN Cephalosporins rd CEFTIZOXIME Cephalosporins Cephalosporin 3 generation Antibacterial CEFTOLOZANE/ Antibacterial Β - lactam/ Β -lactamase inhibitor combination TAZOBACTAM rd Antibacterial Cephalosporin 3 generation CEFTRIAXONE Cephalosporins rd Cephalosporins Cephalosporin 2 CEFUROXIME generation Antibacterial st Antibacterial Cephalosporin 1 CEPHALEXIN generation Cephalosporins CHLORAMPHENICOL Antibacterial Phenicols CIPROFLOXACIN Antibacterial Fluoroquinolones CLARITHROMYCIN Antibacterial Macrolides CLINDAMYCIN Antibacterial Lincosamides Polymyxins Antibacterial COLISTIMETHATE DALBAVANCIN Antibacterial Lipoglycopeptide Glycopeptides Antibacterial DAPTOMYCIN Lipopeptides Antibacterial Fluoroquinolones DELAFLOXACIN DICLOXACILLIN Antibacterial Penicillins Penicillinase-stable penicillins DORIPENEM Antibacterial Carbapenems DOXYCYCLINE Tetracyclines Antibacterial ERTAPENEM Antibacterial Carbapenems ERYTHROMYCIN Antibacterial Macrolides ERYTHROMYCIN/ Antibacterial Folate pathway SULFISOXAZOLE inhibitors FIDAXOMICIN Antibacterial Macrocyclic Antifungal FLUCONAZOLE Azoles Antibacterial Fosfomycins FOSFOMYCIN GEMIFLOXACIN Antibacterial Fluoroquinolones GENTAMICIN Antibacterial Aminoglycosides IMIPENEM/ Antibacterial Carbapenems CILASTATIN ISAVUCONAZONIUM Antifungal Azoles ITRACONAZOLE Antifungal Azoles LEVOFLOXACIN Antibacterial Fluoroquinolones Oxazolidinones LINEZOLID Antibacterial -14 14 January 2019

279 Antimicrobial Use and Resistance Module AUR Antimicrobial Antimicrobial Agent Antimicrobial Antimicrobial a a Subclass Class Category MEROPENEM Antibacterial Carbapenems - - MEROPENEM/ Β - lactam/ Β -lactamase Antibacterial inhibitor combination VABORBACTAM Antibacterial Nitroimidazoles METRONIDAZOLE - MICAFUNGIN Antifungal Echinocandins - MINOCYCLINE Antibacterial Tetracyclines - MOXIFLOXACIN Antibacterial - Fluoroquinolones Antibacterial Penicillins NAFCILLIN Penicillinase-stable penicillins NITROFURANTOIN Antibacterial Nitrofurans - ORITAVANCIN Antibacterial Glycopeptides Lipoglycopeptide OSELTAMIVIR Neuraminidase - Anti-influenza inhibitors OXACILLIN Antibacterial Penicillins Penicillinase-stable penicillins PENICILLIN G Antibacterial Penicillins Penicillin Penicillins Antibacterial PENICILLIN V Penicillin PERAMIVIR - Anti-influenza Neuraminidase inhibitors PIPERACILLIN Antibacterial Penicillins Ureidopenicillin - Antibacterial Β - lactam/ Β -lactamase PIPERACILLIN/ TAZOBACTAM inhibitor combination Antibacterial - POLYMYXIN B Polymyxins Antifungal Azoles POSACONAZOLE - QUINUPRISTIN/ Antibacterial Streptogramins - DALFOPRISTIN RIFAMPIN Antibacterial Rifampin - Anti-influenza RIMANTADINE M2 ion channel - inhibitors SULFAMETHOXAZOLE/ Antibacterial Folate pathway - inhibitors TRIMETHOPRIM Antibacterial Folate pathway - SULFISOXAZOLE inhibitors TEDIZOLID Antibacterial Oxazolidinones - TELAVANCIN Glycopeptides Lipoglycopeptides Antibacterial TELITHROMYCIN Antibacterial Ketolides - TETRACYCLINE Antibacterial Tetracyclines - lactam/ Β - - -lactamase Β Antibacterial TICARCILLIN/ CLAVULANATE inhibitor combination -15 January 2019 14

280 Antimicrobial Use and Resistance Module AUR Antimicrobial Agent Antimicrobial Antimicrobial Antimicrobial a a Class Subclass Category TIGECYCLINE Antibacterial Glycylcyclines - Nitroimidazoles Antibacterial TINIDAZOLE - TOBRAMYCIN Antibacterial Aminoglycosides - VANCOMYCIN Antibacterial Glycopeptides Glycopeptide Antifungal Azoles VORICONAZOLE - ZANAMIVIR Anti-influenza Neuraminidase - inhibitors 12 a Adapted from CLSI January 2014 -16 January 2019 14

281 Antimicrobial Use and Resistance Module AUR Appendix C. Example Calculations of Antimicrobial Days Example 1. Example eMAR and Calculation of Antimicrobial Days This example illustrates the calculation of antimicrobial days from a patient receiving Meropenem 1gram intravenously every 8 hours and Amikacin 1000mg intravenously every 24 hours in the medical ward. Table 1 provides an example of administered doses for this patient documented in eMAR. Table 2 illustrates the calculation of Meropenem and Amikacin days by antimicrobial (total) and stratified by route of administration based upon the administered doses of Meropenem and Amikacin documented in eMAR. Despite receiving three administrations of Meropenem on December 29, the patient only attributes one total Meropenem antimicrobial day per calendar day. Table 3 illustrates the contribution of this patient’s antimicrobial days to the aggregate monthly report per patient care location. Table 1. Example eMAR for p atient housed in Medical Ward Wednesday Medical Ward Tuesday Monday December 28 December 29 December 30 Given: 0700 Meropenem 1gram Given: 2300 Given: 0700 intravenously every 8 hours Given: 1500 Given: 2300 Given: 2300 -- Amikacin 1000mg Given: 2300 intravenously every 24 hours Table 2. Example of calculation of antimicrobial days Tuesday Wednesday Calculation Monday December 30 December 29 December 28 Meropenem Days = 1 Meropenem Days = 1 Meropenem Days = 1 Drug-specific Antimicrobial Amikacin Days = 0 Amikacin Days = 1 Amikacin Days = 1 Days (total) Drug-specific Antimicrobial Meropenem Days Meropenem Days Meropenem Days Days by Stratification of (IV) = 1 (IV) = 1 (IV) = 1 Route of Administration Amikacin Days Amikacin Days Amikacin Days (IV) = 1 (IV) = 1 (IV) = 0 Table 3. Example of antimicrobial days per month per patient care location Month/ Antimicrobial Drug-specific Antimicrobial Days Agent Year- Location Total IV IM Digestive Respiratory December Meropenem 3 3 0 0 0 Medical Ward 0 2 0 0 December 2 Amikacin Medical Ward -17 January 2019 14

282 Antimicrobial Use and Resistance Module AUR Example 2. Differences in Calculations for Patient Care Location and Facility -Wide Inpatient for a Patient Transferred Between Patient s Care Location This example illustrates the calculation of antimicrobial days from a patient receiving Vancomycin 1gram every 8 hours that was transferred from the MICU to a medical ward on December 1. Table 1 provides an example of doses documented in eMAR administered to this patient in the MICU and medical ward. Table 2 illustrates the calculation of Vancomycin days by antimicrobial (total) and stratified by route of administration based upon the administered doses of Vancomycin documented in eMAR. One Vancomycin day both the MICU and is attributed to the Medical Ward locations since administrations took place in both locations during the calendar day. Further, despite receiving two administrations of Vancomycin in the Medical Ward, the patient only attributes one total Vancomycin antimicrobial day for Medical Ward per calendar day. Table 3 illustrates t he contribution of this patient’s Vancomycin days to the aggregate monthly report per patient care location and facility-wide inpatient. Note that while the patient attributes one total Vancomycin day for both the MICU and the Medical Ward on December 1, only one total Vancomycin day can be attributed to the Facility-wide Inpatient (FacWideIN) count that calendar day. atient transferred from MICU to Medical Ward on December 1 Example eMAR for p Table 1. eMAR Tuesday Tuesday December 1 Decemb er 1 Location: Medical Ward Location: MICU Vancomycin 1gram Given: 0700 Given: 1500 intravenously every 8 hours Given: 2300 Table 2. Example of calculation of antimicrobial days for December 1 Tuesday Calculation Tuesday December 1 December 1 Location: Medical Ward Location: MICU Vancomycin Days = 1 Drug-specific Antimicrobial Vancomycin Days = 1 Days (total) Vancomycin Days Drug-specific Antimicrobial Vancomycin Days (IV) = 1 (IV) = 1 Days by Stratification of Route of Administration -18 14 January 2019

283 Antimicrobial Use and Resistance Module AUR Example of antimicrobial days per month per patient care location and facility-wide Table 3. inpatient contributed from December 1 Month/ Antimicrobial Drug-specific Antimicrobial Days Agent Year- Location Total IV IM Digestive Respiratory December Vancomycin 1 1 0 0 0 MICU 0 0 Vancomycin 1 1 0 December Medical Ward 0 0 1 0 1 Vancomycin December Facility-wide inpatient Calculation of Antimicrobial Days for a Patient Care Location when a Patient Example 3 . Admission extends over Two Different Months This example illustrates the calculation of antimicrobial days from a patient receiving Ceftriaxone 1gram intravenously every 24 hours for two days in the Surgical Ward (but spanning different months). Table 1 provides an example of administered doses for this patient documented in eMAR. Table 2 illustrates the calculation of Ceftriaxone days by antimicrobial (total) and stratification of route of administration based upon the administered doses of Ceftriaxone documented in eMAR. Table 3 illustrates the co ntribution of this patient’s Ceftriaxone days to the aggregate monthly report per patient care location. (denominator) would be attributed to the month the patient was he patient’s admission Note: T first admitted to an inpatient location within the facility. In the scenario highlighted here, the patient would attribute 1 admission to December and no admission to January (specifically, the patient would not be counted in the total January admissions count). The patient would continue to attribute one day present for each day the patient was in the location/facility. Example eMAR for p atient housed in Surgical Ward Table 1. eMAR Thursday Friday December 31 January 1 Location: Surgical Ward Location: Surgical Ward Given: 0800 Given: 0800 Ceftriaxone gram intravenously every 24 hours -19 January 2019 14

284 Antimicrobial Use and Resistance Module AUR Table 2. Example of calculation of antimicrobial days Calculation Thursday Friday December 31 January 1 Location: Surgical Ward Location: Surgical Ward Ceftriaxone Day = 1 Drug-specific Antimicrobial Ceftriaxone Day = 1 Days (total) Ceftriaxone Day Ceftriaxone Day Drug-specific Antimicrobial (IV) = 1 (IV) = 1 Days by Stratification of Route of Administration Table 3. Example of antimicrobial days per month per patient care location Month/ Antimicrobial Drug-specific Antimicrobial Days Year- Agent Location Digestive Respiratory IM Total IV 0 December/ Ceftriaxone 1 1 0 0 Surgical Ward 0 0 0 January/ 1 Ceftriaxone 1 Surgical Ward -20 14 January 2019

285 Antimicrobial Use and Resistance Module AUR Appendix D: List of SAARs Table 1. Adult SAARs SAAR Antimicrobial Agent Category Locations SAAR Type in NHSN All antibacterial agents All Adult SAAR Locations Adult_All-Antibacterial_2017 Adult_BSHO_ICU_2017 Adult Medical, Medical-Surgical, Broad spectrum antibacterial agents Surgical ICUs predominantly used for Adult_BSHO_Ward_2017 Adult Medical, Medical-Surgical, hospital-onset infections Surgical Wards Adult Step Down Units Adult_BSHO_Step_2017 Adult_BSHO_ONC_2017 Adult General Hematology-Oncology Wards Broad spectrum Adult_BSCA_ICU_2017 Adult Medical, Medical-Surgical, antibacterial agents Surgical ICUs predominantly used for Adult Medical, Medical-Surgical, Adult_BSCA_Ward_2017 community-acquired Surgical Wards infections Adult Step Down Units Adult_BSCA_Step_2017 Adult General Hematology-Oncology Adult_BSCA_ONC_2017 Wards Antibacterial agents Adult Medical, Medical-Surgical, Adult_GramPos_ICU_2017 predominantly used for rgical ICUs Su resistant Gram-positive Adult Medical, Medical-Surgical, Adult_GramPos_Ward_2017 infections (e.g., MRSA) Surgical Wards Adult Step Down Units Adult_GramPos_Step_2017 Adult General Hematology-Oncology Adult_GramPos_ONC_2017 Wards Narrow spectrum beta- Adult Medical, Medical-Surgical, Adult_NSBL_ICU_2017 lactam agents Surgical ICUs Adult Medical, Medical-Surgical, Adult_NSBL_Ward_2017 Surgical Wards Adult Step Down Units Adult_NSBL_Step_2017 Adult_NSBL_ONC_2017 Adult General Hematology-Oncology Wards Adult Medical, Medical-Surgical, Adult_CDI_ICU_2017 Antibacterial agents posing the highest risk for Surgical ICUs CDI Adult_CDI_Ward_2017 Adult Medical, Medical-Surgical, Surgical Wards Adult_CDI_Step_2017 Adult Step Down Units Adult General Hematology-Oncology Adult_CDI_ONC_2017 Wards Antifungal agents Adult Medical, Medical-Surgical, Adult_Antifungal_ICU_2017 predominantly used for Surgical ICUs invasive candidiasis Adult Medical, Medical-Surgical, Adult_Antifungal_Ward_2017 Surgical Wards Adult Step Down Units Adult_Antifungal_Step_2017 Adult_Antifungal_ONC_2017 Adult General Hematology-Oncology Wards -21 14 January 2019

286 Antimicrobial Use and Resistance Module AUR Pediatric SAARs Table 2: SAAR Antimicrobial Agent Category Locations SAAR Type in NHSN All antibacterial agents All Pediatric locations Ped_All-Antibacterial_2017 Pediatric Medical and Medical-Surgical Ped_BSHO_ICU_2017 Broad spectrum ICUs antibacterial agents predominantly used for Ped_BSHO_Ward_2017 Pediatric Medical, Medical-Surgical, hospital-onset infections Surgical Wards Ped_BSCA_ICU_2017 Pediatric Medical and Medical-Surgical Broad spectrum ICUs antibacterial agents predominantly used for Pediatric Medical, Medical-Surgical, Ped_BSCA_Ward_2017 community-acquired Surgical Wards infections Antibacterial agents Ped_GramPos_ICU_2017 Pediatric Medical and Medical-Surgical predominantly used for ICUs resistant Gram-positive Pediatric Medical, Medical-Surgical, Ped_GramPos_Ward_2017 infections (e.g., MRSA) Surgical Wards Pediatric Medical and Medical-Surgical Ped_NSBL_ICU_2017 Narrow spectrum beta- lactam agents ICUs Pediatric Medical, Medical-Surgical, Ped_NSBL_Ward_2017 Surgical Wards Azithromycin Pediatric Medical and Medical-Surgical Ped_Azith_ICU_2017 ICUs Ped_Azith_Ward_2017 Pediatric Medical, Medical-Surgical, Surgical Wards Pediatric Medical and Medical-Surgical Ped_CDI_ICU_2017 Antibacterial agents posing the highest risk for CDI ICUs Pediatric Medical, Medical-Surgical, Ped_CDI_Ward_2017 Surgical Wards Antifungal agents Ped_Antifungal_ICU_2017 Pediatric Medical and Medical-Surgical predominantly used for ICUs invasive candidiasis Ped_Antifungal_Ward_2017 Pediatric Medical, Medical-Surgical, Surgical Wards -22 14 January 2019

287 Antimicrobial Use and Resistance Module AUR for SAAR & Rate Table calculations Appendix E: Antimicrobial groupings Adult SAAR Antimicrobial Agent Categories Adult All antibacterial agents All antibacterial agents in the AUR protocol except :  DELAFLOXACIN  MEROPENEM/VABORBACTAM  PIPERACILLIN TICARCILLIN/CLAVULANATE  Adult Broad spectrum antibacterial agents predominantly used for hospital-onset infections AMIKACIN (IV only)  AZTREONAM (IV only)   CEFEPIME  CEFTAZIDIME  DORIPENEM  GENTAMICIN (IV only)  IMIPENEM/CILASTATIN MEROPENEM   PIPERACILLIN/TAZOBACTAM  TOBRAMYCIN (IV only) Adult Broad spectrum antibacterial agents predominantly used for community-acquired infections  CEFACLOR  CEFDINIR  CEFIXIME  CEFOTAXIME  CEFPODOXIME  CEFPROZIL  CEFTRIAXONE  CIPROFLOXACIN  CEFUROXIME ERTAPENEM   GEMIFLOXACIN  LEVOFLOXACIN  MOXIFLOXACIN Adult Antibacterial agents predominantly used for resistant Gram-positive infections (e.g., MRSA)  CEFTAROLINE  DALBAVANCIN DAPTOMYCIN   LINEZOLID -23 14 January 2019

288 Antimicrobial Use and Resistance Module AUR ORITAVANCIN   QUINUPRISTIN/DALFOPRISTIN  TEDIZOLID  TELAVANCIN  VANCOMYCIN (IV only) Adult Narrow spectrum beta-lactam agents  AMOXICILLIN  AMOXICILLIN/CLAVULANATE AMPICILLIN   AMPICILLIN/SULBACTAM  CEFADROXIL CEFAZOLIN  CEFOTETAN  CEFOXITIN   CEPHALEXIN  DICLOXACILLIN  NAFCILLIN  OXACILLIN PENICILLIN G   PENICILLIN V Adult Antibacterial agents posing the highest risk for CDI This category contains antimicrobials that are part of other SAAR categories.  CEFDINIR  CEFEPIME  CEFIXIME CEFOTAXIME   CEFPODOXIME CEFTAZIDIME   CEFTRIAXONE  CIPROFLOXACIN  CLINDAMYCIN  GEMIFLOXACIN LEVOFLOXACIN   MOXIFLOXACIN Adult Antifungal agents predominantly used for invasive candidiasis  ANIDULAFUNGIN  CASPOFUNGIN  FLUCONAZOLE  MICAFUNGIN Rate Table: Adult Antibacterial agents predominantly used for extensively antibiotic resistant bacteria CEFTAZIDIME/AVIBACTAM  -24 January 2019 14

289 Antimicrobial Use and Resistance Module AUR CEFTOLOZANE/TAZOBACTAM   COLISTIMETHATE (IV only)  POLYMYXIN B (IV only)  TIGECYCLINE Pediatric SAAR Antimicrobial Agent Categories Pediatric All antibacterial agents All antibacterial agents in the AUR protocol except :  DELAFLOXACIN  MEROPENEM/VABORBACTAM  PIPERACILLIN  TICARCILLIN/CLAVULANATE Pediatric Broad spectrum antibacterial agents predominantly used for hospital-onset infections AMIKACIN (IV only)   AZTREONAM (IV only)  CEFEPIME  CEFTAZIDIME  CIPROFLOXACIN DORIPENEM   ERTAPENEM  GEMIFLOXACIN IMIPENEM/CILASTATIN   LEVOFLOXACIN  MEROPENEM  MOXIFLOXACIN  PIPERACILLIN/TAZOBACTAM  TOBRAMYCIN (IV only) Pediatric Broad spectrum antibacterial agents predominantly used for community-acquired infections  AMOXICILLIN/CLAVULANATE  AMPICILLIN/SULBACTAM  CEFACLOR CEFDINIR   CEFIXIME  CEFOTAXIME  CEFPODOXIME  CEFPROZIL  CEFTRIAXONE  CEFUROXIME Pediatric Antibacterial agents predominantly used for resistant Gram-positive infections (e.g., MRSA)  CEFTAROLINE -25 January 2019 14

290 Antimicrobial Use and Resistance Module AUR CLINDAMYCIN   DALBAVANCIN  DAPTOMYCIN  LINEZOLID  ORITAVANCIN  QUINUPRISTIN/DALFOPRISTIN  TEDIZOLID  TELAVANCIN  VANCOMYCIN (IV only) Pediatric Narrow spectrum beta-lactam agents AMOXICILLIN   AMPICILLIN  CEFADROXIL  CEFAZOLIN  CEFOTETAN  CEFOXITIN  CEPHALEXIN  DICLOXACILLIN NAFCILLIN  OXACILLIN   PENICILLIN G PENICILLIN V  Pediatric Azithromycin AZITHROMYCIN  Pediatric Antibacterial agents posing the highest risk for CDI This category contains antimicrobials that are part of other SAAR categories.  CEFDINIR  CEFEPIME  CEFIXIME  CEFOTAXIME  CEFPODOXIME  CEFTAZIDIME CEFTRIAXONE   CLINDAMYCIN  CIPROFLOXACIN  GEMIFLOXACIN  LEVOFLOXACIN  MOXIFLOXACIN Pediatric Antifungal agents predominantly used for invasive candidiasis  ANIDULAFUNGIN CASPOFUNGIN   FLUCONAZOLE -26 14 January 2019

291 Antimicrobial Use and Resistance Module AUR  MICAFUNGIN Rate Tables: Pediatric Antibacterial agents predominantly used for extensively antibiotic resistant bacteria  CEFTAZIDIME/AVIBACTAM  CEFTOLOZANE/TAZOBACTAM  COLISTIMETHATE (IV only) POLYMYXIN B (IV only)   TIGECYCLINE -27 14 January 2019

292 Antimicrobial Use and Resistance Module AUR 2. Antimicrobial Resistance (AR) Option Introduction Common measures of antimicrobial resistance include the proportion of isolates resistant to specific antimicrobial agents. This proportion resistant (%R) is used to aid in clinical decision making (hospital antibiograms) as well as for assessing impact of cross transmission prevention success or antimicrobial stewardship success, although the measure may not be very sensitive to measuring success of efforts in the short term. An additional value of measuring the proportion resistant includes a local or regional assessment of progression or improvement of a particular resistance problem, to guide local or regional cross-transmission prevention efforts. By using standard methodology of aggregating proportion resistant, local and regional assessments of the magnitude of a particular resistance phenotype will be more valid. Objectives: 1. Facilitate evaluation of antimicrobial resistance data using a standardized approach to: a. Provide local practitioners with an improved awareness of a variety of antimicrobial re sistance problems to both aid in clinical decision making and prioritize transmission prevention efforts. Provide facility-specific measures in context of a regional and national b. perspective (specifically, benchmarking) which can inform decisions to accelerate transmission prevention efforts and reverse propagation of emerging or established problematic resistant pathogens. Regional and national assessment of resistance of antimicrobial resistant organisms of 2. public health importance including ecologic assessments and infection burden. Methodology: 1 Antimicrobial resistance data are reported as a proportion. The proportion resistant is defined as the number of resistant isolates divided by the number of isolates tested for the specific antimicrobial agent being evaluated. For each facility, the numerator (specifically, number of resistant isolates) is derived from isolate-level reports submitted. The ultimate source of the isolate data included in these reports is the laboratory information system (LIS). In healthcare settings where the LIS is directly connected to the electronic health record system (EHRs), Option numerator records laboratory results data from the EHRs can be used to populate the AR submitted to NHSN. The denominators of patient days and admissions can be obtained from the (or similar system that allows for electronic access of required data elements). The ADT system numerator and denominator are further defined below and must adhere to the data format 2 prescribed by the HL7 CDA Implementation Guide developed by the CDC and HL7. Manual data entry is not available for the NHSN AR Option. Settings: All inpatient facilities (for example, general acute care hospitals, critical access hospitals, children’s hospitals, oncology hospitals, long term acute care hospitals, and inpatient rehabilitation facilities) enrolled in NHSN and using the Patient Safety Component can participate in the AR Option. Facilities must have the ability to collect the numerator and -28 January 2019 14

293 Antimicrobial Use and Resistance Module AUR denominator data electronically and upload those data into NHSN using the required CDA specifications. NHSN does not currently support the submission of data into the AR Option from long term care facilities (specifically, skilled nursing facilities, nursing homes) nor outpatient dialysis facilities. NHSN strongly encourages reporting specimens from all NHSN defined inpatient locations (including inpatient procedural areas like operating rooms) and three select outpatient locations: Emergency Department (ED), Pediatric Emergency Department, and 24-hour Observation Area at each facility. Implementation experience with the AR Option provides evidence that reporting from all NHSN patient care locations is technically easier than reporting from selected locations. The denominators of patient days and admissions are only reported at the facility-wide inpatient level (FacWideIN). Requirements: Each month: Patient Safety 1. The facility must indicate they plan to submit AR Option data on the Monthly Reporting Plan (CDC 57.106).  For reporting AR Option data from inpatient locations, FacWideIN is added to the plan. Individual inpatient locations do not need to be listed in the AR Option plan. For reporting AR Option data from the three select outpatient locations, each  outpatient location must be listed separately. Two record types must be reported for each month of surveillance. 2.  One file for each isolate-based report o Isolate is defined as a population of a single organism observed in a culture obtained from a patient specimen. Each AR Option event file contains the specific location of specimen collection. o  One file for the denominator data report (facility-wide inpatient[FacWideIN]) NHSN recommends that AR Option data be submitted to NHSN for a given calendar month by the end of the subsequent calendar month. Isolate-based report Appendix F ). Report all required data each month for each eligible isolate-based report (See Only specimens collected in an inpatient or select outpatient location (ED, pediatric ED, and 24 - for eligibility. hour observation) of the reporting facility should be considered that meet the reporting guidelines outlined in this protocol should be reported All eligible isolates to NHSN regardless of the antimicrobial resistance of the isolated organism. This means that even isolates that are susceptible to all required antimicrobials should be considered eligible to be reported to the AR Option. Additionally, isolates in which all of the NHSN required antimicrobials were not tested, but at least one non-required drugs was tested, should be isolate considered eligible to be Staphlococcus aureus reported into NHSN. For example, if a -29 January 2019 14

294 Antimicrobial Use and Resistance Module AUR NHSN required was tested for the non-required drug, Telithromycin, and none of the other 26 antimicrobials were tested, that isolate would still be considered eligible for reporting to the AR Option. This should be consistent with CLSI M39 Guidance on reporting cumulative susceptibility test results. Further, non-culture based organism identification results should not be submitted. Two distinct events should be reported on the basis of specimens obtained in inpatient and select outpatient locations with susceptibility testing performed: 1. Each eligible organism isolated from an invasive source (blood or cerebrospinal fluid [CSF]) per patient, per 14 day period even across calendar months: There should be 14 days with no positive culture result from the laboratory for the a. patient and before another invasive source Antimicrobial specific organism Resistance (AR) Event is entered into NHSN for the patient and specific organism. NOTE: The date of specimen collection is considered Day 1. After >14 days have passed with no positive culture results for that specific b. organism, another positive culture from an invasive source with that specific organism can be reported as an AR Event. For example, if a positive blood culture was obtained from the patient on January 1, the earliest another invasive specimen would be January could be reported to NHSN for that same patient and organism 15 (assuming there were no positive blood or CSF cultures in the interim). 2. First eligible organism isolated from any eligible non-invasive culture source (lower respiratory or urine), per patient, per month. a. ne AR event is allowed per calendar month for the same patient/organism Only o for lower respiratory or urine specimens. to Note: The AR Option 14 day rule starts with the day of specimen collection and applies only those specimens collected in an inpatient location or select outpatient location (ED, pediatric ED, or 24-hour observation area) in Outpatient locations other than the ED, the reporting facility. pediatric ED, and 24-hour observation area (for example, wound clinic, outpatient laboratory) should not be included in the 14 day rule. Further, cultures obtained while the patient was at healthcare facility should not be included in the 14 day calculations. another A. Eligible organisms include:  All Acinetobacter species  Candida albicans  Candida auris  Candida glabrata  Candida parapsilosis  Candida tropicalis  Citrobacter amalonaticus  Citrobacter freundi i  Citrobacter koseri (Citrobacter diversus)  All Enterobacter species  Enterococcus faecalis -30 January 2019 14

295 Antimicrobial Use and Resistance Module AUR  Enterococcus faecium  Enterococcus spp. (when not specified to the species level)  Escherichia coli  Group B Streptococcus Klebsiella oxytoca   Klebsiella pneumoniae  Morganella morganii  Proteus mirabilis  Proteus penneri  Proteus vulgaris  Pseudomonas aeruginosa Serratia marcescens   Staphylococcus aureus  Stenotrophomonas maltophilia Streptococcus pneumoniae  Facilities and vendors should refer to the Information Data Model (IDM) found in the for the complete list of eligible Antimicrobial Resistance Toolkit organisms for AR Option th an “X” in reporting and their associated SNOMED codes. Only those organisms listed wi the ARO Pathogen column of the Pathogen Codes tab should be reported. B. Specimen Sources for in the Antimicrobial Resistance Toolkit Facilities and vendors should refer to the IDM found the complete list of eligible specimens and their associated SNOMED codes. Only those SNOMED codes listed in the AR Specimen Source value set on the Specimen Source tab in the should be reported (specifically, do not include SNOMED children specimen types unless IDM specifically listed). Eligible invasive specimen sources include cerebrospinal fluid (CSF) and blood 1. specimens. Note: Report blood or CSF cultures growing the same eligible specific organism (genus ) only if the patient had no and species or genus only if the species has not been identified positive blood or CSF culture result with that specific organism (genus and species or genus only if the species has not been identified) within the last 14 days, even across calendar months. -31 January 2019 14

296 Antimicrobial Use and Resistance Module AUR Table 1: Example of 14 day rule for a specific organism from a single patient in an inpatient location Reported to NHSN? Date Justification Lab Result January 1 Yes Patient’s first blood culture of Staphylococcus aureus Staphylococcus inpatient admission; isolated from aureus is isolated; AR Event is blood culture reported into NHSN. January 4 It has been less than 14 days since the No Staphylococcus aureus last positive culture (January 1) from isolated from Staphylococcus the patient isolating blood culture aureus. January 16 It has been less than 14 days since the No Staphylococcus ) from isolated from last positive culture (January 4 aureus Staphylococcus the patient isolating CSF culture aureus . It has more than 14 days since the last January 31 Yes Staphylococcus positive culture (January 16) from the aureus isolated from blood culture patient isolating Staphylococcus aureus ; AR Event is reported into NHSN. 2. Eligible non-invasive specimen source s include lower respiratory (for example, sputum, endotracheal, bronchoalveolar lavage) and urine specimens. All isolate test results are evaluated using either the algorithm in Figure 1 (Invasive specimens ) or Figure 2 (Non-invasive specimens) to determine reportable AR events for each calendar month.  For eligible invasive specimens, there should be 14 days with no positive culture result specific organism the laboratory for the patient and from before another invasive source AR Event is entered into NHSN for the patient and specific organism ( Figure 1 ). Based on the 14 day rule, at a maximum, there would be no more than three invasive isolates per patient per month. per specific organism reported  For eligible non-invasive specimens, all first non-invasive isolates (chronologically) per ). AR Event (Figure 2 patient, per month, per organism are reported as an Required Data C. Required data include data available from the laboratory information system, electronic health record, and administrative data systems. The set of variables for each isolate consists of a variable to identify the NHSN facility, specimen/patient related data, and antimicrobial susceptibility data as outlined below. For additional information on each variable please see Appendix G. -32 January 2019 14

297 Antimicrobial Use and Resistance Module AUR  Facility identifier o Unique NHSN Facility ID (Object Identifier [OID] is used in the CDA) Specimen / Patient related data  o Patient identifier Date of b o irth o Gender o Date admitted to facility (use the encounter date if event occurred in outpatient location) o Specimen collection d ate Specimen source o Location code (mapped to CDC location codes) o o Isolate identifier (unique isolate ID in the electronic laboratory report) o Organism ( Appendix F )  Antimicrobial susceptibility data o Antimicrobial ( Appendix F ) PBP2a ) Staphylococcus aureus -agglutination (required only if o ) PCR mec-gene (required only if Staphylococcus aureus o E-test sign o E-test value & unit of measure o o Interpretation of E-test o MIC sign MIC value & unit of measure o Interpretation of MIC test o Disk diffusion (KB) test sign o Disk diffusion (KB) test value & unit of measure o o Interpretation of disk diffusion (KB) test o Final interpretation result of these fields are required to be included in the CDA report, facilities unable Note: While many to electronically obtain the results of the individual laboratory tests (specifically , E-test, MIC, Disk diffusion [KB]) may still report AR Option by using ‘Unknown’ or ‘Not Tested’ for data these specific tests as long as the final interpretation result can be provided for each antimicrobial tested. Facilities should not employ manual means of data collection to report AR Option data to NHSN. Reporting Guidelines Interpretation of test results (E-test, MIC test, Disk diffusion [KB] test) includes the  following results: o S = Susceptible o S-DD = Susceptible-Dose Dependent o I = Intermediate o R = Resistant -33 January 2019 14

298 Antimicrobial Use and Resistance Module AUR o NS = Non-Susceptible o N = Not Tested o Specific to Gentamicin and Streptomycin results for Enterococcus testing :  S = Susceptible/Synergistic R = Resistant/Not Synergistic  Only final or corrected susceptibility testing should be reported to NHSN. No preliminary  laboratory results should be used for NHSN AR Option reporting.  In circumstances where different breakpoints are required, rely on the specimen source to determine which susceptibility results to report. If the specimen source is CSF report the meningitis breakpoint susceptibility. If the specimen source is blood, urine, or lower respiratory report the non-meningitis breakpoint susceptibility. D. Removal of Same Day Duplicates Multiple isolates of the same organism from the same specimen may be processed and reported to NHSN, retaining the conflicting results. Only one isolate should be produce unique nature of the test results. Rules must be in place to ensure duplicate isolate reports are are defined as same specific species or same genus, when identification removed. Duplicates Isolates must be of the same to species level is not provided, from same patient on same day. source type (specifically, invasive or non -invasive) to be considered duplicates. Select the isolate to report to NHSN based on these rules (see Figure 3 ):  For invasive source isolate selection, CSF isolates should be selected over blood isolates. For non -invasive source isolate selection, lower respiratory isolates should be  selected over urine isolates.  Eliminate isolates on same day without susceptibility test results as only isolates with complete/final laboratory testing should be reported to NHSN.  Do not merge test results across multiple isolates (specifically , don’t summarize results across different isolates tested on same day).  If two isolates from the same day have conflicting susceptibilities to the panel of antimicrobials tested, report the isolate with the most resistant final interpretation (NS > R > I > S -DD > S > NT). If a final interpretation was not provided by the lab, report the isolate with the higher amount of drug resistance based on the number If it cannot be determined which isolate is the antimicrobials testing “NS” or “R”. most resistant, report the isolate that was the first entered into the LIS. was isolated from two blood specimens For example, Candida albicans o collected from the same patient on the same calendar day and no final interpretation was provided by the lab. The first isolate tested “R” to three of the eight antimicrobials tested and the second isolate tested “R” to four of the eight antimicrobials tested. Report the second isolate to NHSN since it showed the higher amount of resistance. specific test is performed on the same isolate but they produce conflicting If the same  results, report the final interpretation provided by the laboratory. If no final -34 January 2019 14

299 Antimicrobial Use and Resistance Module AUR interpretation is provided by the laboratory, then report the most resistant interpretation (NS > R > I > S-DD > S > NT) for that specific antimicrobial. o For example, if two E-tests are performed for the same drug on the same isolate and one produces “Intermediate” and the other produces “Susceptible”, report “Intermediate” as the final interpretation for that specific drug susceptibility. If specific antimicrobial tests are performed on the same isolate and produce  conflicting susceptibility interpretations, and the laboratory did not provide a final summary interpretation, report the most resistant specific test interpretation as the final interpretation (NS > R > I > S-DD > S > NT) for that specific antimicrobial. o For example, if drug susceptibility results produced MIC = Resistant and E- Test = Intermediate but no final interpretation was provided, report “Resistant” as the final interpretation for that specific antimicrobial susceptibility. Denominator Data For each month, report combined denominator data for all inpatient locations within the facility (facility-wide inpatient [FacWideIN]): (See Appendix H for details) at the same time on each day of Patient Days: Number of patients present in the facility 1. the month, summed across all days in the month. 2. Admissions: Number of patients admitted to an inpatient location in the facility each month. Note: Neither the patient day nor admissions denominators will include the counts from outpatient locations (ED, pediatric ED, and 24 -hour observation area). No denominator record is required for the three outpatient locations. Since the same definitions are used for the NHSN Multidrug-Resistant Organism & Clostridium nformation on counting patient days and difficile Infection (MDRO/CDI) Module, further i admissions can be found in Appendix 2 of the NHSN MDRO & CDI Module Protocol: NHSN MDRO & CDI Module Protocol . Minimizing Bias & Bypassing Suppression The ultimate source of antimicrobial susceptibility test results should be the hospital laboratory information system (LIS), but in some healthcare facilities not all susceptibility results acquired for reporting to NHSN. Concerted efforts may be needed or stored in a LIS are readily available to obtain antim icrobial resistance data for purposes of reporting to NHSN that might be clinical end users, a practice referred to as suppression. This practice can serve suppressed from to control costs or to prevent overuse of some antimicrobial agents, but it also can exert an adverse impact on antimicrobial resistance reporting to public health surveillance systems and 4 Suppression can lead to significant biases in the antimicrobial infection control programs. resistance data available for surveillance or infection control. As a result, every effort should be made to report all antimicrobial resistance data that meets the NHSN protocol requirements, regardless of whether those data are suppressed from clinical end users. -35 14 January 2019

300 Antimicrobial Use and Resistance Module AUR : Data Analyses AR Option data are expressed using several metrics at the monthly, quarterly, semi-annual, or how rare the isolates occurred. annual time frame depending on Facility-wide Antibiogram A facility-wide antibiogram table is available in NHSN that displays the calculated percent non- susceptible (see Table 2 ) for each organism-antimicrobial combination. The antibiogram table can be stratified by specimen source, time period, and/or by specific antimicrobial or organism. Note: at least 30 isolates must have been tested and reported for a specific organism/antimicrobial combination in the given time period for results to appear in the NHSN antibiogram report. Table 2. Facility-wide Antibiogram Definition Metric Facility-wide: standard report for facility and group user Calculated for each* organism-antimicrobial pairing: % non-susceptible (Total # of organisms that tested resistant or intermediate for a pathogen / Total # of organisms tested for that pathogen) *exceptions Staphylococcus aureus test results for Oxacillin or Cefoxitin: non- 1. susceptible isolates are only those that tested resistant. Enterococcus spp. 2. Enterococcus faecalis , Enterococcus faecium , and tested for Vancomycin: non-susceptible isolates for this pairing are only those that tested resistant. Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae , 3. Enterobacter spp. test results for Cefepime: non-susceptible isolates for these pairings include those isolates that tested resistant, susceptible -DD) [Note S-DD may be reported as intermediate], dose-dependent (S or non-susceptible (NS). Antimicrobial Resistance Events Two reports list the Antimicrobial Resistance events that have been reported into the NHSN AR Option. Line List: A line list can be generated to show all AR Events reported into NHSN for a given time period. The line list is the most customizable type of AR Option analysis the most helpful AR Option report when validating the data. report. The line list is also Bar Chart: A bar chart can also be generated to show all AR Events reported into NHSN for a given time period. By default the bar chart will show the number of AR Events by -36 January 2019 14

301 Antimicrobial Use and Resistance Module AUR organism over the most recent 12 month time period. Modifications can also be made to show the number of Antimicrobial Resistant Organisms based on the AR Option Appendix I phenotype definitions ( ). Antimicrobial Resistant Organisms Three reports use the AR Option phenotype definitions ( Appendix I ) to determine Antimicrobial Resistant Organisms. Line List: A line list can be generated to show all AR Organisms that meet the AR Option p henotype definitions for a given time period. The default line list shows each AR Organism reported to NHSN, patient information, specimen collection date and the location where the specimen was collected. Frequency Table: A frequency table can also be generated to show the number of AR Events meeting the AR Option phenotype definitions in a given time period. While the table default is to display events by month, modifications can be made to display the data by quarter, half year, year or cumulative time periods. Rate Table: A rate table can be generated to display the percent of isolates that were resistant by AR Option phenotype. The percent resistant is calculated by dividing the number of isolates reported as resistant over the number of isolates tested multiplied by 100. All AR Option data can also be exported from NHSN in various formats (for example, CSV, SAS, and Microsoft Access). Additional analysis reports will be available in future releases. Requests for additional reports [email protected] . can be sent to: NH -37 January 2019 14

302 Antimicrobial Use and Resistance Module AUR Figure 1. Test Result Algorithm for Invasive Specimen Reporting Eligible organism isolated from invasive source (blood or CSF) per patient Prior (+) isolate with same organism from invasive in ≤ 14 days, source per patient (Including across calendar months) Yes No Should Should AR Event Additional not be be AR isolate reported reported -38 January 2019 14

303 Antimicrobial Use and Resistance Module AUR Test Result Algorithm for Non-Invasive Specimen Reporting Figure 2. non-invasive Eligible organism isolated from source (lower respiratory or urine) per patient st in calendar 1 month per patient, per organism No Yes Should Should AR Additional AR Event be be not isolate reported reported -39 January 2019 14

304 Antimicrobial Use and Resistance Module AUR Figure 3. Reporting Algorithm for Same Day Duplicates -40 January 2019 14

305 Antimicrobial Use and Resistance Module AUR -41 January 2019 14

306 Antimicrobial Use and Resistance Module AUR References 1. Schwaber MJ, De -Medina T, and Carmeli Y. Epidemiological interpretation on what are we missing? Nat Rev Microbiol 2004;2:979- antibiotic resistance studies – 83. 2. National Healthcare Safety Network (NHSN) Patient Safety Component: Clinical Document Architecture. http://www.cdc.gov/nhsn/cdaportal/index.html 3. CLSI. Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline Third Edition. CLSI document M39-A3. Wayne, PA: – Clinical and Laboratory Standards; 2009. 4. Council of State and Territorial Epidemiologists (CSTE). Recommendations for strengthening public health surveillance of antimicrobial resistance in the United . SI-01.pdf http://c.ymcdn.com/sites/www.cste.org/resource/resmgr/PS/13- States. Accessed October 1, 2015. -42 January 2019 14

307 Antimicrobial Use and Resistance Module AUR 3 Appendix F. List of Eligible Organisms for the NHSN AR Option Please note that mapping of standardized terminology (SNOMED) are provided in the . Antimicrobial Resistance Toolkit Information Data Model (IDM) found in the Testing methods should follow most recent CLSI guidance as appropriate. Organism Specimen Type Antimicrobial Agents Blood, Urine, Lower Amikacin Acinetobacter (All species Acinetobacter Ampicillin-sulbactam Respiratory, CSF noted in the IDM/Pathogen Cefepime Codes tab listed in the Cefotaxime ARO Pathogen column) Ceftazidime Ceftriaxone Ciprofloxacin Colistin Doripenem cycline Doxy Gentamicin Imipenem with Cilastatin Levofloxacin Meropenem Minocycline Piperacillin-tazobactam Polymyxin B Tobramycin Trimethoprim-sulfamethoxazole Additional Agents for Urine Tetracycline CSF Blood, Urine, Anidulafungin Candida albicans Note: Lower respiratory will Caspofungin auris Candida not be collected for Candida Fluconazole Candida glabrata spp. Flucytosine Candida parapsilosis Itraconazole Candida tropicalis Micafungin Posaconazole Voriconazole Additional Agents for Urine None -43 January 2019 14

308 Antimicrobial Use and Resistance Module AUR Organism Antimicrobial Agents Specimen Type Amikacin Blood, Urine, Lower Citrobacter amalonaticus Amoxicillin-clavulanic acid Respiratory, CSF Citrobacter freundii Ampicillin Citrobacter koseri Ampicillin-sulbactam (Citrobacter diversus) Aztreonam Enterobacter Enterobacter All ( species Cefazolin (urine or non-urine a noted in the IDM/Pathogen breakpoints) Codes tab listed in the Cefepime ARO Pathogen column) Cefotaxime Escherichia coli Cefotetan Klebsiella oxytoca Cefoxitin Klebsiella pneumoniae Ceftazidime Morganella morganii Ceftazidime-avibactam Proteus mirabilis Ceftolozane-tazobactam Proteus penneri Ceftriaxone Proteus vulgaris Cefuroxime Serratia marcescens Chloramphenicol Ciprofloxacin Colistin Doripenem Ertapenem Gentamicin with Cilastatin Imipenem Levofloxacin Meropenem Piperacillin-tazobactam Polymyxin B Tetracycline Trimethoprim-sulfamethoxazole Tobramycin Additional Agents for Urine Fosfomycin Nitrofurantoin Sulfisoxazole Trimethoprim -44 14 January 2019

309 Antimicrobial Use and Resistance Module AUR Organism Specimen Type Antimicrobial Agents Ampicillin Blood, Urine, Lower Enterococcus faecalis Respiratory, CSF Dalbavancin Enterococcus faecium Daptomycin spp. Enterococcus (When not otherwise Gentamicin ; excluding specified E. Linezolid , E. faecium, and faecalis Oritavancin b other identified species) Penicillin Streptomycin Tedizolid Telavancin Vancomycin Note: For Gentamicin and Streptomycin only: Susceptible Synergistic = Non -synergistic = Resistant Additional Agents for Urine Ciprofloxacin Fosfomycin Note: Exclude Gentamicin Levofloxacin and Streptomycin Nitrofurantoin Tetracycline Blood, Urine, Lower Amikacin Pseudomonas aeruginosa Respiratory, CSF Aztreonam Cefepime Ceftazidime Ceftazidime-avibactam Ceftolozane-tazobactam Ciprofloxacin Colistin Doripenem Gentamicin with Cilastatin Imipenem Levofloxacin Meropenem Piperacillin-tazobactam Polymyxin B Tobramycin None Additional Agents for Urine -45 January 2019 14

310 Antimicrobial Use and Resistance Module AUR Antimicrobial Agents Organism Specimen Type Blood, Urine, Lower Azithromycin Staphylococcus aureus Respiratory, CSF Cefoxitin Ceftaroline Chloramphenicol Ciprofloxacin Clarithromycin Clindamycin Dalbavancin Daptomycin Doxycycline Erythromycin Gentamicin Levofloxacin Linezolid Minocycline Moxifloxacin Oritavancin c Oxacillin or Nafcillin b Penicillin Rifampin Tedizolid Telavancin Tetracycline Trimethoprim-sulfamethoxazole Vancomycin Nitrofurantoin Additional Agents for Urine Sulfisoxazole Trimethoprim Ceftazidime Blood, Urine, Lower Stenotrophomonas Chloramphenicol Respiratory, CSF maltophilia Levofloxacin Minocycline Trimethoprim-sulfamethoxazole Additional Agents for Urine None -46 January 2019 14

311 Antimicrobial Use and Resistance Module AUR Specimen Type Organism Antimicrobial Agents Blood, Urine, Lower Amoxicillin Streptococcus pneumoniae Amoxicillin-clavulanic acid Respiratory, CSF Cefepime (meningitis or non- d meningitis breakpoints) Cefotaxime (meningitis or non- d meningitis breakpoint) Ceftaroline Ceftriaxone (meningitis or non- d meningitis breakpoint) Cefuroxime (parental breakpoint) Chloramphenicol Clindamycin Doxycycline Ertapenem Erythromycin Gemifloxacin Imipenem with Cilastatin Levofloxacin Linezolid Meropenem Moxifloxacin b (meningitis or non- Penicillin d meningitis breakpoint) b Penicillin V (oral breakpoint) Rifampin Tetracycline Trimethoprim-sulfamethoxazole Vancomycin None Additional Agents for Urine -47 January 2019 14

312 Antimicrobial Use and Resistance Module AUR Organism Specimen Type Antimicrobial Agents Ampicillin Group B Streptococcus Blood, Urine, Lower Cefepime Respiratory, CSF Cefotaxime Ceftaroline Ceftriaxone Chloramphenicol Clindamycin Dalbavancin Daptomycin Erythromycin Levofloxacin Linezolid Oritavancin b Penicillin Ted izolid Telavancin Vancomycin Additional Agents for Urine None a If the LIS produces urine and non-urine breakpoint results, rely on the specimen source to determine which susceptibility results to report. If the specimen source is urine, report the urine breakpoint susceptibility. If the specimen source is blood, CSF, or lower respiratory, report the non- urine breakpoint susceptibility. b If the LIS does not differentiate between Penicillin G and Penicillin V, list susceptibility results under Penicillin G and indicate that Penicillin V was not tested (N). c For Staphylococcus aureus susceptibility testing, if the LIS tests Nafcillin instead of Oxacillin, report Nafcillin susceptibility results as Oxacillin. d If the LIS produces meningitis and non-meningitis breakpoint results, rely on the specimen source to determine which susceptibility results to report. If the specimen source is CSF report the meningitis breakpoint susceptibility. If the specimen source is blood, urine, or lower respiratory report the non-meningitis breakpoint susceptibility. -48 January 2019 14

313 Antimicrobial Use and Resistance Module AUR Appendix G. Technical and Isolate Based Report Variables NAME LEVEL OF DESCRIPTION OF FIELD CODE VALUE LIST REQUIREMENT a Required - Facility OID Must be assigned to facility and included in the importation file prior to submission to NHSN. - Required Patient ID Alphanumeric patient ID assigned by the hospital and may consist of any combination of numbers and/or letters. This should be an ID that remains the same for the patient across all visits and admissions. The date of the patient’s birth including - Required Date of Birth month, day, and year. Gender M (Male), F (Female), O (Other) to indicate Required - the gender of the patient. Date admitted to Date patient was admitted to the inpatient Required - facility including month, day, and year. facility – use the encounter date if event Note occurred in an outpatient location. Required Specimen Date the specimen was collected including - collection date month, day, and year. Specimen Specimen source from which the isolate was SNOMED Required source recovered (urine, lower respiratory, blood, CSF). Location Patient care area where patient was located CDC Location Required when the laboratory specimen was collected. Codes Use patient location obtained from administrative data system (ADT). - Isolate identifier unique for each isolate Required Isolate identifier within laboratory. Required Organism identified from specimen collected Organism SNOMED ). (Appendix F b Antimicrobial Antimicrobial(s) tested for susceptibility Norm Required Rx will define agents by organism (Appendix F and specimen source) Conditional (for PBP2a- Result for PBP2a-agglutination (only if SA) - Pos/Neg/Unk agglutination Staph aureus) PCR mec-gene Result for PCR mec-gene (only if SA) Conditional (for - Staph aureus) Pos/Neg/Unk c - E-test sign E-test sign Optionally Required - Optionally E-test E-test (Value in micrograms/liter). Use '.' as Required value/units of decimal delimiter, for example, 0.25 measure -49 14 January 2019

314 Antimicrobial Use and Resistance Module AUR NAME DESCRIPTION OF FIELD CODE LEVEL OF REQUIREMENT VALUE LIST Interpretation of Interpretation result of the E-test susceptibility - Required E-test test performed c Optionally MIC sign - MIC sign Required - MIC value/units MIC (Value in micrograms /liter). Use '.' as Optionally decimal delimiter, for example, 0.25 of measure Required Interpretation of Interpretation result of the MIC susceptibility - Required MIC test test performed - Optionally Disk diffusion Disk diffusion (KB) sign c (KB) sign Required Disk diffusion Disk diffusion (KB) value in millimeters - Optionally Required (KB) value/units of measure Interpretation of Interpretation result of the disk diffusion (KB) - Required Disk diffusion susceptibility test performed (KB) test Final - Required Final interpretation result of all different Interpretation susceptibility tests performed result a Facilities interested in submitting data to NHSN via CDA must obtain a Facility OID (object identifier). More information on how to obtain an OID for your facility can be found on the CDA Submission Support Portal . b At this time, the R1 Norm Implementation Guide uses RxNorm codes to report antimicrobials for the AR Option. NHSN plans to move to antimicrobial/test expressed as LOINC codes in a future version of the Implementation Guide used for the AR Option. c Refer to the HL7 Implementation Guide for specifics on how to code these values in the CDA report. Note: While many of these specific test results (specifically , E-test, MIC, Disk diffusion [KB] ) are se results required to be included in the CDA report, facilities unable to electronically obtain the . Facilities should not employ manual may still participate by using ‘Unknown’ or ‘Not Tested’ means of data collection. -50 14 January 2019

315 Antimicrobial Use and Resistance Module AUR Appendix H. Denominator Data Variables - LEVEL OF REQUIREMENT DESCRIPTION OF FIELD Facility Wide Inpatient Denominator Facility Must be assigned to facility and included in the importation Required a OID file prior to submission to NHSN. Required Location FacWideIN Month Required 2-Digit month Year Required 4-Digit year Patient For facility wide inpatient locations enter the total number Required Days of patient days collected at the same time each day combined for the month. All of the facility’s inpatient locations with an overnight stay should be included where denominators can be accurately collected. Admission Enter the total number of admissions for all facility Required inpatient locations combined for the month. All the Count ations with an overnight stay where facility’s inpatient loc denominators can be accurately collected should be included. a Facilities interested in submitting data to NHSN via CDA must obtain a Facility OID (object identifier). More information on how to obtain an OID for your facility can be found on the CDA . Submission Support Portal -51 January 2019 14

316 Antimicrobial Use and Resistance Module AUR I. NHSN AR Option Appendix Phenotype Definitions Phenotype Code Phenotype Name Phenotype Definition Methicillin-resistant MRSA_AR Staphylococcus aureus that has tested Resistant (R) of the following: oxacillin or cefoxitin one to at least Staphylococcus aureus , Citrobacter freundii CREexpanded_AR Any Citrobacter amalonaticus , Carbapenem-resistant Citrobacter koseri , Enterobacter spp., E. coli , Enterobacteriaceae Klebsiella pneumoniae , , and Klebsiella oxytoca (expanded) that has tested Resistant (R) to Serratia marcescens at least one of the following: imipenem, meropenem, doripenem, or ertapenem OR Any Proteus mirabilis , Proteus penneri , Proteus Morganella morganii and that has tested vulgaris, Resistant (R) to at least one of the following: meropenem, doripenem, or ertapenem Carbapenem-resistant CREall_AR Any Escherichia coli, Klebsiella oxytoca, Klebsiella E. Enterobacteriaceae ( pneumoniae, or Enterobacter spp. that has tested coli, Klebsiella, or one Resistant (R) to at least of the following: ) Enterobacter imipenem, meropenem, doripenem, or ertapenem that has tested Resistant (R) to Carbapenem-resistant CREecoli_AR Any Escherichia coli at least one of the following: imipenem, E.coli meropenem, doripenem, or ertapenem Any spp. that has tested Resistant (R) Enterobacter CREenterobacter_AR Carbapenem-resistant spp. one of the following: imipenem, to at least Enterobacter meropenem, doripenem, or ertapenem Carbapenem-resistant or CREklebsiella_AR Any Klebsiella oxytoca Klebsiella pneumoniae that has tested Resistant (R) to at least one of the Klebsiella following: imipenem, meropenem, doripenem, or pneumoniae/oxytoca ertapenem that has tested either Carbapenem- Pseudomonas aeruginosa non- carbNS_PA_AR susceptible Intermediate (I) or Resistant (R) to at least one of the following: imipenem, meropenem, or doripenem Pseudomonas aeruginosa Any that has tested Resistant (R) to Extended-spectrum Escherichia coli ESCecoli_AR cephalosporin-resistant at least one of the following: cefepime, ceftriaxone, cefotaxime, or ceftazidime. E.coli Klebsiella oxytoca Klebsiella pneumoniae or Any ESCklebsiella_AR Extended-spectrum one that has tested Resistant (R) to at least cephalosporin-resistant of the following: cefepime, ceftriaxone, cefotaxime, or Klebsiella ceftazidime. pneumoniae/oxytoca -52 January 2019 14

317 Antimicrobial Use and Resistance Module AUR Phenotype Name Phenotype Code Phenotype Definition MDR_PA_AR that has tested either Multidrug-resistant Pseudomonas aeruginosa Intermediate (I) or Resistant (R) to at least one drug Pseudomonas in at least three of the following five categories: aeruginosa 1. Extended-spectrum cephalosporin (cefepime, ceftazidime) 2. Fluoroquinolones (ciprofloxacin, levofloxacin) Aminoglycosides (amikacin, gentamicin, 3. tobramycin) Carbapenems (imipenem, meropenem, 4. doripenem) 5. Piperacillin/tazobactam non- Carbapenem- Any carbNS_Acine_AR Acinetobacter spp. that has tested either susceptible Intermediate (I) or Resistant (R) to at least one of Acinetobacter spp. the following: imipenem, meropenem, or doripenem Acinetobacter spp. that has tested either Any Multidrug-resistant MDR_Acine_AR spp. Acinetobacter one drug Intermediate (I) or Resistant (R) to at least in at least three of the following six categories: Extended-spectrum cephalosporin 1. (cefepime, ceftazidime, ceftriaxone, cefotaxime) 2. Fluoroquinolones (ciprofloxacin, levofloxacin) 3. Aminoglycosides (amikacin, gentamicin, tobramycin) Carbapenems (imipenem, meropenem, 4. doripenem) 5. Piperacillin/tazobactam 6. Ampicillin/sulbactam Enterococcus faecalis that has tested Resistant (R) Vancomycin-resistant VREfaecalis_AR to vancomycin Enterococcus faecalis Vancomycin-resistant VREfaecium_AR Enterococcus faecium that has tested Resistant (R) to vancomycin Enterococcus faecium Any FR_Candi_AR Candida albicans, Candida auris, Candida Fluconazole-resistant Candida glabrata, Candida parapsilosis , or Candida albicans/auris/glabrata/ that has tested Resistant (R) to tropicalis fluconazole parapsilosis/tropicalis Drug-resistant DR_SP_AR Streptococcus pneumoniae that has tested either one of the antimicrobials Resistant (R) to at least Streptococcus listed in the NHSN AR Option defined drug panel pneumoniae -53 January 2019 14

318 CDC Locations and Descriptions and Instructions for Mapping Patient Care Locations Table of Contents Instructions for Mapping Patient Care Locations in NHSN ... 2 ... 7 Appendix: Creation and Management of Locations in NHSN Master CDC Locations and Descriptions ... 9 Inpatient locations ... 9 Acute care facilities general ... 9 Adult critical care units ... 9 ... 11 Pediatric critical care units Neonatal units ... 12 Specialty care areas (SCA ) ... 16 Adult wards ... 16 ... 20 Pediatric wards Step down units ... 22 Mixed acuity units ... 23 Operating Rooms 25 ... Chronic care units (previously named long-term care ) ... 26 Long term care facilities ... 27 Long term acute care facilities 29 ... Inpatient rehabilitation facilities ... 30 ... 30 Oncology facilities Psychiatric facilities ... 34 Outpatient locations ... 36 Ambulatory Surgery Centers ... 37 Acute care facilities general ... 38 Acute settings 38 ... Clinic (non-acute) settings 39 ... Miscellaneous outpatient settings ... 48 Outpatient dialysis facilities ... 48 Miscellaneous areas 49 ... Facility-wide locations ... 49 Community locations... 50 51 ... ions Non-patient care locat 15-1 January 2019

319 Instructions for Mapping Patient Care Locations in NHSN Instructions for Mapping Patient Care Locations in NHSN NHSN requires that facilities map each patient care area in their facility to one or more locations as defined by NHSN in order to report surveillance data collected from these areas. This document functions as a decision-making tool when determining the appropriate CDC location for NHSN surveillance, as defined in the NHSN Manual. This process should be followed when adding any new unit to NHSN for surveillance and should be repeated for any unit when there has been a significant change in patient mix (e.g., merging of units, taking on a new service). Step 1: Define the acuity level for the location Is this patient care area comprised of at least 80% of 1 patients that are of the same acuity level? YES NO and map to a location type Proceed to Step 2 Ca n this patient care area be split into 2 or of that acuity level using the NHSN 80% Rule more locations in NHSN for the purposes of 2 for that specific type. surveillance – also referred to as “virtual 3 locations”? YES NO and create Proceed to Step 2 Map to a CDC Mixed locations in NHSN for each of 4 Acuity location. the acuity levels, using the 2 NHSN 80% Rule. List of Acuity Levels: Mixed Acuity Units Adult Critical Care Units Pediatric Critical Care Units Operating Rooms Neonatal Critical Care Units Chronic Care Specialty Care Areas (SCA)/Oncology Long Term Acute Care Adult Wards Rehabilitation Pediatric Wards Outpatient (ACUTE) Locations Neonatal Wards Clinic (Nonacute) Settings Step Down Units 15-2 January 2019

320 Instructions for Mapping Patient Care Locations in NHSN Define the type of service for the location Step 2: medical, Is this patient care area a general surgical, or medical/surgical unit? Or is it comprised of patients from a specific service 1 type (e.g., burn, cardiac)? Specific General If general medical or surgical, are If the unit is comprised of more than 60% of patients either patients of a specific service type, medical or surgical? does this unit meet the NHSN 2 ? 80% Rule for locations YES NO The mix of Create a Create a location Can this single unit be patients should location in in NHSN that is split into 2 or more then be a 50/50 NHSN that is mapped to that units in NHSN for the to 60/40 mix of mapped to the CDC location purposes of surveillance medical and majority type type also referred to – as surgical patients 3 (i.e., medical or ”? “virtual locations surgical) Create a YES location in NO NHSN that i s mapped to a Is the mix of patients in Create locations combined this unit approximately in NHSN for medical/surgical a 50/50 to 60/40 mix of each of these CDC location combined medical and specific service surgical? virtual locations NO YES Create a location in NHSN that is mapped to Create a location in NHSN the location of the that is mapped to a combined majority type (i.e., medical/surgical unit greater than 60%) - either medical or surgical January 2019 15-3

321 Instructions for Mapping Patient Care Locations in NHSN Please see the CDC Location descriptions for definitions of each CDC Location used for NHSN surveillance in this chapter. 1. Patient mix: When determining the appropriate CDC Location mapping for a unit, facilities should review the patient mix in that unit for the last full calendar year. If a full year is not available, facilities should review patient mix based on the data they have available for that unit. When determining the acuity level, as well as the specific service type of a location, the admission/transfer diagnosis should be used when determining the appropriate location mapping. The admission diagnosis is considered the most accurate depiction of the patient’s illness and reason for being adm itted to a particular unit. 2. NHSN 80% Rule : Each patient care area in a facility that is monitored in NHSN is “mapped” to one CDC Locations. The specific CDC Location code is determined by the type of patients cared for in that area according to the 80% Rule. That is, if 80% of patients are of a certain type (e.g., pediatric patients with orthopedic problems) then that area is designated as that type of location (in this case, an Inpatient Pediatric Orthopedic Ward). 3. Virtual locations : Virtual locations are created in NHSN when a facility is unable to meet the 80% rule for location designation in a single physical unit but would like to report their NHSN surveillance data for each of the major, specific patient types in that unit. The use of virtual locations is recommended only for those physical units that are geographically split by patient service or those in which beds are designated that is comprised of approximately 50% by service. For example, a facility has an ICU – called 5 West – neurology patients and 50% neurosurgery patients. Additionally, the neurology patients are housed in beds 1 thru 10 and the neurosurgery patients are housed in beds 11 thru 20. Rather than map as a medical/surgical critical care unit, the facility decides to create 2 new locations in NHSN: 5WEST_N: Neurologic Critical Care (10 beds) 5WEST_NS: Neurosurgical Critical Care (10 beds) This facility will collect and enter data for 5WEST_N and 5WEST_NS separately. The facility will also be able to obtain rates and standardized infection ratios (SIRs) for each location separately. Note that the data collected and reported for each virtual location will be limited to the designated 10 beds assigned (i.e., 5WEST_ overflow from 5WEST_N into 5WEST_NS will be counted with ). For those facilities that NS use an electronic source for collecting their data, we recommend that you discuss compatibility of virtual locations in NHSN with your facility’s EHR contact prior to reporting data for these locations. 4. Mixed Acuity Unit : This location is intended for those units comprised of patients with varying levels of acuity. NOTE: Mapping a location in NHSN to the CDC “Mixed Acuity” designation may have implications on data that your facility reports for the CMS Hospital Inpatient Quality Reporting Program and/or your state’s reporting mandate(s). Although a Mixed Acuity location may have ICU beds and ICU patients, it is not considered an ICU location type for the purposes of NHSN reporting and therefore, would not be included in any ICU-specific reporting requirements. Mixed Acuity units are also excluded from ward- specific reporting requirements. For information about how this location designation may impact your facility’s compliance with CMS HAI reporting measures, please contac t your Quality Improvement Organization (QIO). For information about how this location designation may impact your facility’s compliance with your state mandate (if applicable), please contact your state HAI coordinator: . www.cdc.gov/HAI/state-based/index.html January 2019 15-4

322 Instructions for Mapping Patient Care Locations in NHSN Examples Example 1: An ICU that is 85% Burn patients, 15% Trauma CDC Location: Burn Critical Care (IN:ACUTE:CC:B) Why? Meets 80% rule for critical care acuity level and 80% rule for specific service (burn) Example 2: An ICU that is 55% medical and 45% surgical CDC Location: Medical/Surgical Critical Care (IN:ACUTE:CC:MS) Why? Meets 80% rule for critical care acuity level and does not meet the 60% rule for designation as either medical or surgical service level alone, therefore, use combined medical/surgical designation Example 3: A unit that is comprised of 60% medical inpatients and 40% general observation patients CDC Location: Medical Ward (IN:ACUTE:WARD:M) This is a special scenario due to the mix of inpatients and outpatients in this unit. A Why? location where at least 51% of the patients have been formally admitted to the facility should be mapped as in inpatient unit, rather than an outpatient observation unit. The 60% rule for general service and the 80% rule for specific service still apply when deciding on the specific type of inpatient location to use; this location met the 60% rule for medical service. All patients housed in this unit should be included in the surveillance efforts for this location. Example 4: An ICU that is 40% Neurosurgical, 40% Surgical, and 20% Medical Option 1 - Single CDC Location: Surgical Critical Care Meets 80% rule for critical care acuity level and does not meet the 80% rule for a Why? specific service level alone, but when surgical patients are combined, that total does equal 80%. Option 2 - Multiple CDC Virtual Locations: Neurosurgical Critical Care and Surgical Critical Care, with the medical patients reported with the Surgical Critical Care location since the general surgical designation is the least specific of the t wo Why? By splitting this unit into 2 virtual locations, each meets the 80% rule for critical care acuity level and one meets the 80% rule for designation as Neurosurgical Critical Care, while the other meets the 60% rule as general surgical service (when combining surgical and medical patients). Example 5: A unit that is comprised of 60% Medical ICU and 40% Step Down patients Option 1 - Single CDC Location: Mixed Acuity Unit Why? not comprised of at least 80% of the patients of the same acuity This location is level and therefore meets the single location definition of a mixed acuity unit. Note that this location is not considered an ICU location type for the purposes of NHSN reporting and therefore, would not be included in any ICU-specific reporting requirements. Option 2 - Multiple CDC Virtual Locations: Medical Critical Care and Step Down Unit By splitting this unit into 2 virtual locations, each meets the 80% rule for the Why? appropriate acuity level and each meets the 80% rule for type of service. 15-5 January 2019

323 Instructions for Mapping Patient Care Locations in NHSN Example 6: A pediatric ward that is comprised of 70% neurosurgical patients and 30% orthopedic patients Option 1 - Single CDC Location: Pediatric Surgical Ward Meets 80% rule for ward-level acuity and does not meet the 80% rule for a specific Why? service level alone, but meets the 60% rule for general surgical service. Option 2 - Multiple CDC Virtual Locations: Pediatric Neurosurgical Ward and Pediatric Orthopedic Ward Why? By splitting this unit into 2 virtual locations, each meets the 80% rule for the appropriate acuity level and each meets the 80% rule for type of service. 15-6 January 2019

324 Instructions for Mapping Patient Care Locations in NHSN Appendix: Creation and Management of Locations in NHSN Create New Locations: If there are any operational locations in your hospital that are not already set-up in NHSN, you will need to create these locations for the purposes of NHSN surveillance and reporting. Locations can be set up by following these steps: 1. Go to Facility > Locations. 2. On the Locations screen, enter a location code (“Your Code”) and location label (“Your Label”). 3. Select a CDC Location Description from the drop-down menu. NOTE: When selecting a CDC Location Description, your location must meet the 80% Rule in order to be assigned as that CDC Location Description. 4. Make sure the Status is set to “Active” and then enter the number of beds that are set up and staffed in that location. 5. Once all information for this new location is entered, click ‘Add’. Manage Existing Locations: Facilities should make sure that the only locations with an “ Active ” status in NHSN are those that are operational units within the facility. The number of beds indicated for each location should also be checked for accuracy and, if necessary, updated to reflect the current number of beds set up and staffed. Location information can be updated by following these steps: 1. Go to Facility > Locations. On the Locations screen, click ‘Find’. 2. 3. Review the information that appears in the Location Table at the bottom of the screen. Review the Status of each location, as well as Bed size. 4. If a location’s information needs to be updated, click the location code under the “Your Code” column; the location’s information will auto -fill in the fields above the Location Table. 5. Make any modifications to the Status and/or Bed size, then click ‘Save’. Manage Physically Moved Locations Units within a facility may physically move to another area of the same facility, and be given a different name. If the staff are moving with these locations, and the type of patients remains the same (i.e., the only difference is the geographical location and/or Bed size), then it's recommended to change “Your Code” and "Your Label" (and Bed size, if appropriate) on the existing location records. These fields can be updated by following the instructions for “Manage Existing Locations” above. Updating the value of “ Y our Code” will also update all previously-entered records for these locations, allowing for continuous analysis and reporting. Inaccurate CDC Location Description Please note that the CDC Location Description cannot be edited after a location is mapped in NHSN . If you believe that the CDC Location Description assigned to your existing location is incorrect, there are additional steps you will need to follow, depending on the scenario: Scenario 1: The patient population in this unit has changed such that the current CDC Location Description, using the 80% rule, is inaccurate. Solution: Because the patient population has changed, a new location should be created in NHSN and should be mapped to a CDC Location Description that most accurately reflects the type of patients receiving care in that location, using the 80% rule. The old location should be put into “Inactive” status. When creating a new location, you will need to use a different “Your Code” and January 2019 15-7

325 Instructions for Mapping Patient Care Locations in NHSN “Your Label” value. Note that data that have been reported from inactive locations can continue to be analyzed within NHSN for the months during which they appear in the Monthly Reporting Plans. Please note that these inactive locations will not be linked to new, active locations. Scenario 2: The CDC Location Description initially assigned has been inaccurate for much, if not all, of the reporting to NHSN, based on the updated location guidance for 2016 . Solution: Users cannot change the CDC Location Description on existing locations within NHSN. Facilities should ensure that the locations set up in NHSN are accurate for 2016 reporting per the updated guidance. If a new CDC Location Description is needed, users must create a new location in NHSN and inactivate the old location, per the instructions above. Note that data for the old location can still be analyzed, but these data will not be connected to data reported under the new location. To connect data to the new location, facility administrators must edit the older location event and summary records to the newly created locations. This must be done before the old change their location is put into “Inactive” status. Once the new location is active, facilities need to monthly reporting plan to record the change and capture the new location data. January 2019 15-8

326 Master CDC Locations and Descriptions Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code INPATIENT LOCATIONS ACUTE CARE FACILITIES GENERAL Adult Critical Care Units IN:ACUTE:CC:B Burn Critical Care 1026-4 Critical care area for the care of patients with significant/major burns. Critical care area for the care of patients with serious Medical Cardiac Critical Care 1028-0 IN:ACUTE:CC:C heart problems that do not require heart surgery. IN:ACUTE:CC:M Critical care area for the care of patients who are being 1027-2 Medical Critical Care treated for nonsurgical conditions. Critical care area for the care of patients with medical Medical-Surgical Critical Care 1029-8 IN:ACUTE:CC:MS and/or surgical conditions. Neurologic Critical Care Critical care area for the care of patients with life- IN:ACUTE:CC:N 1035-5 threatening neurologic diseases. Critical care area for the surgical management of patients Neurosurgical Critical Care 1031-4 IN:ACUTE:CC:NS with severe neurologic diseases or those at risk for neurologic injury as a result of surgery. January 2019 15-9

327 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code ONC Medical Critical Care 1223-7 IN:ACUTE:CC:ONC_M Critical care area for the care of oncology patients who are being treated for nonsurgical conditions related to their malignancy. ONC Surgical Critical Care 1224-5 IN:ACUTE:CC:ONC_S Critical care area for the evaluation and management of oncology patients with serious illness before and/or after cancer-related surgery. 1225-2 IN:ACUTE:CC:ONC_MS Critical care area for the care of oncology patients with ONC Medical-Surgical Critical Care medical and/or surgical conditions related to their malignancy. Prenatal Critical Care 1034-8 IN:ACUTE:CC:PNATL Critical care area for the care of pregnant patients with complex medical or obstetric problems requiring a high level of care to prevent the loss of the fetus and to protect the life of the mother. 1033-0 Critical care area for the evaluation and treatment of IN:ACUTE:CC:R Respiratory Critical Care patients with severe respiratory conditions. 1032-2 IN:ACUTE:CC:CT Surgical Cardiothoracic Critical care area for the care of patients following Critical Care cardiac and/or thoracic surgery. Critical care area for the evaluation and management of IN:ACUTE:CC:S Surgical Critical Care 1030-6 patients with serious illness before and/or after surgery. 15-10 January 2019

328 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code IN:ACUTE:CC:T Critical care area for the care of patients who require a Trauma Critical Care 1025-6 high level of monitoring and/or intervention following trauma or during critical illness related to trauma. Pediatric Critical Care Units IN:ACUTE:CC:ONC_PED ONC Pediatric Critical Care 1233-6 Critical care area for the care of oncology patients ≤18 years old who are being treated for surgical or nonsurgical conditions related to their malignancy. Critical care area for the care of patients ≤18 years old IN:ACUTE:CC:B_PED Pediatric Burn Critical Care 1042-1 with significant/major burns. Critical care area for the care of patients ≤18 years old 1043-9 IN:ACUTE:CC:CT_PED Pediatric Surgical Cardiothoracic Critical Care following cardiac and thoracic surgery. Critical care area for the care of patients ≤18 years old Pediatric Medical Critical Care 1044-7 IN:ACUTE:CC:M_PED who are being treated for nonsurgical conditions. Pediatric Medical-Surgical Critical care area for the care of patients ≤18 years old IN:ACUTE:CC:MS_PED 1045-4 Critical Care with medical and/or surgical conditions. Critical care area for the surgical management of patients Pediatric Neurosurgical 1046-2 IN:ACUTE: CC: NS_PED ≤18 years old with severe neurologic diseases or those at Critical Care risk for neurologic injury as a result of surgery. 15-11 January 2019

329 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Pediatric Respiratory Critical 1047-0 IN:ACUTE:CC:R_PED Critical care area for the evaluation and treatment of patients ≤18 years old with severe respiratory conditions. Care IN:ACUTE:CC:S_PED Critical care area for the evaluation and management of 1048-8 Pediatric Surgical Critical Care patients ≤ 18 years old with serious illness before and/or after surgery. Critical care area for the care of patients ≤18 years old Pediatric Trauma Critical Care 1049-6 IN:ACUTE:CC:T_PED who require a high level of monitoring and/or intervention following trauma or during critical illness related to trauma. Neonatal Units Well Baby Nursery (Level I) 1038-9 IN:ACUTE:WARD:NURS Hospital area for evaluation and postnatal care of healthy newborns. May include neonatal resuscitation and stabilization of ill newborns until transfer to a facility at which specialty neonatal care is provided. January 2019 15-12

330 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code IN:ACUTE:STEP:NURS 1041-3 Step down Neonatal Nursery The capabilities of Level II, listed below, are from the (Level II) American Academy of Pediatrics definitions of levels of 1 neonatal care. Level II special care nursery Level I capabilities plus: s. Provide care for infants born ≥32 wk  gestation and weighing ≥1500 g who have physiologic immaturity or who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis Provide care for infants convalescing after  intensive care  Provide mechanical ventilation for brief duration (<24 h) or continuous positive airway pressure or both Stabilize infants born before 32 wk s.  gestation and weighing less than 1500 g until transfer to a neonatal intensive care facility 15-13 January 2019

331 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Combined nursery housing both Level II and III 1039-7 IN:ACUTE:CC_STEP: NURS Neonatal Critical Care II/III) (Level newborns and infants, as per the NHSN level definitions above and below. This is analogous to a mixed acuity unit specifically for Neonatal Critical Care patients. IN:ACUTE:CC:NU 1040-5 Neonatal Critical Care A hospital neonatal intensive care unit (NICU) organized RS (Level III) with personnel and equipment to provide continuous life support and comprehensive care for extremely high-risk newborn infants and those with complex and critical illness. The capabilities of Level III and Level IV, listed below, are from the American Academy of Pediatrics definitions 1 of levels of neonatal care. NOTE: These classifications are all considered Level III NICUs in NHSN. Level III NICU Level II capabilities plus: Provide sustained life support  Provide comprehensive care for infants born < 32  wks. gestation and weighing <1500 g and infants born at all gestational ages and birth weights with critical illness January 2019 15-14

332 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code - - -  Provide prompt and readily available access to a full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists, and pediatric ophthalmologists Provide a full range of respiratory support that  may include conventional and/or high-frequency ventilation and inhaled nitric oxide  Perform advanced imaging, with interpretation on an urgent basis, including computed tomography, MRI, and echocardiography Level IV Regional NICU Level III capabilities plus: Located within an institution with the  capability to provide surgical repair of complex congenital or acquired conditions  Maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists, and pediatric subspecialists at the site Facilitate transport and provide outreach  education 15-15 January 2019

333 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Specialty Care Areas (SCA) Dialysis Specialty Care Area 1198-1 IN:ACUTE:SCA:DIAL Specialty care area for the care of patients who require acute dialysis as a temporary measure. Pediatric Dialysis Specialty 1091-8 IN:ACUTE:SCA:DIAL_PED Specialty care area for the care of patients ≤18 years old Care Area who require acute dialysis as a temporary measure. Hospital specialty area for the postoperative care of IN:ACUTE:SCA:SOTP_PED 1093-4 Pediatric Solid Organ 18 years old who have had a solid organ ≤ patients Transplant Specialty Care transplant (e.g., heart/lung, kidney, liver, pancreas). Area Solid Organ Transplant s IN:ACUTE:SCA:SOTP 1092-6 Specialty care area for the postoperative care of patient Specialty Care Area ≤18 years old who have had a solid organ transplant (e.g., heart/lung, kidney, liver, pancreas). Adult Wards Antenatal Care Ward 1205-4 IN:ACUTE:WARD: Hospital area for observation, evaluation, treatment or surgery of high risk pregnancy patients. ANTENAT Behavioral Health/Psych Ward Area for the evaluation and treatment of patients with IN:ACUTE:WARD:BHV 1051-2 acute psychiatric or behavioral disorders. IN:ACUTE:WARD:B Area for the evaluation and treatment of patients who Burn Ward 1052-0 have burns. 15-16 January 2019

334 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Ear, Nose, Throat Ward 1053-8 IN:ACUTE:WARD:ENT Area for the evaluation, treatment, or surgery of patients with ear, nose, or throat disorders. 1054-6 IN:ACUTE:WARD:GI Area for the evaluation, treatment, or surgery of patients Gastrointestinal Ward with disorders of the gastrointestinal tract. Genitourinary Ward 1055-3 IN:ACUTE:WARD:GU Area for the evaluation, treatment, or surgery of patients with disorders of the genitourinary system. 1056-1 IN:ACUTE:WARD:GNT Area for the evaluation, treatment, or surgery of patients Gerontology Ward with age-related diseases. Gynecology Ward 1057-9 IN:ACUTE:WARD:GYN Area for the evaluation, treatment, or surgery of female patients with reproductive tract disorders. Jail Unit 1171-8 IN:ACUTE:WARD:JAL Overnight stay patient care area of a hospital or correctional facility used only for those who are in custody of law enforcement during their treatment. Labor and Delivery Ward Area where women labor and give birth. IN:ACUTE:WARD:LD 1058-7 IN:ACUTE:WARD:LD_PP Labor, Delivery, Recovery, 1059-5 Suite used for labor, delivery, recovery and postpartum Postpartum Suite care -- all within the same suite. Area for the evaluation and treatment of patients with IN:ACUTE:WARD:M Medical Ward 1060-3 medical conditions or disorders. January 2019 15-17

335 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Medical-Surgical Ward 1061-1 IN:ACUTE:WARD:MS Area for the evaluation of patients with medical and/or surgical conditions. 1062-9 IN:ACUTE:WARD:N Area for the evaluation and treatment of patients with Neurology Ward neurologic disorders. Neurosurgical Ward 1063-7 IN:ACUTE:WARD:NS Area for the care of patients whose primary reason for admission is to have neurosurgery or to be cared for by a neurosurgeon after head or spinal trauma. 1226-0 Area for the evaluation and treatment of patients with IN:ACUTE:WARD: ONC Leukemia Ward ONC_LEUK leukemia. ONC Lymphoma Ward 1228-6 IN:ACUTE:WARD:ONC_ Area for the evaluation and treatment of patients with LYMPH lymphoma. IN:ACUTE:WARD: ONC_LL Area for the evaluation and treatment of patients with ONC Leukemia/Lymphoma 1229-4 Ward leukemia and/or lymphoma. IN:ACUTE:WARD:ONC_ST Area for the evaluation and treatment of oncology ONC Solid Tumor Ward 1230-2 patients with solid tumors. Area for the care of patients who undergo stem cell ONC Hematopoietic Stem Cell 1231-0 IN:ACUTE:WARD: transplant for the treatment of cancers and/or blood or Transplant Ward ONC_HSCT immune system disorders. 15-18 January 2019

336 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code ONC General Area for the evaluation and treatment of patients with 1232-8 IN:ACUTE:WARD: ONC_HONC Hematology/Oncology Ward cancer and/or blood disorders. Ophthalmology Ward 1064-5 IN:ACUTE:WARD:OPH Area for the care of patients whose primary reason for admission is to have eye surgery or to be cared for by an ophthalmologist after eye trauma. Area for the evaluation, treatment, or surgery on bones, IN:ACUTE:WARD:ORT Orthopedic Ward 1065-2 joints, and associated structures by an orthopedist. Area for the evaluation and treatment of patients with 1066-0 IN:ACUTE:WARD:T _ORT Orthopedic Trauma Ward orthopedic injuries or disorders. Plastic Surgery Ward 1067-8 IN:ACUTE:WARD:PLS Area for the care of patients who have reconstructive surgery performed by a plastic surgeon. Postpartum Ward 1068-6 Area for the care of patients recovering from childbirth. IN:ACUTE:WARD:PP Pulmonary Ward 1069-4 IN:ACUTE:WARD:PULM Area for the evaluation and treatment of patients with respiratory system conditions or disorders. Area for the evaluation and restoration of function to IN:ACUTE:WARD:REHAB Rehabilitation Ward (within 1070-2 Acute Care Hospital) patients who have lost function due to acute or chronic pain, musculoskeletal problems, stroke, or catastrophic events resulting in complete or partial paralysis. 15-19 January 2019

337 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code School Infirmary 1172-6 IN:ACUTE:WARD:IFM Overnight stay patient care area of a school infirmary or health center (e.g., private residential school or college campus). Stroke (Acute) Ward 1071-0 IN:ACUTE:WARD:STRK Area for the evaluation, stabilization, and treatment of patients who have experienced an acute stroke. Surgical Ward 1072-8 IN:ACUTE:WARD:S Area for the evaluation and treatment of patients who have undergone a surgical procedure. Telemetry Ward Hospital area dedicated to providing evaluation and IN:ACUTE:WARD:TEL 1208-8 treatment of patients requiring continuous cardiac monitoring Area for the evaluation and treatment of patients who Vascular Surgery Ward 1073-6 IN:ACUTE:WARD:VS have undergone vascular surgery. Pediatric Wards 1075-1 Adolescent Behavioral Health 18 IN:ACUTE:WARD: Area for the evaluation and treatment of patients 13- years old with acute psychiatric or behavioral disorders. BHV_ADOL Ward Area for the care of patients ≤18 years old who undergo ONC Pediatric Hematopoietic 1234-4 IN:ACUTE:WARD: stem cell transplant for the treatment of cancers and/or Stem Cell Transplant Ward ONC_HSCT_PED blood or immune system disorders. 15-20 January 2019

338 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code ONC Pediatric General 1235-1 IN:ACUTE:WARD: Area for the evaluation and treatment of patients ≤18 ONC_HONC_PED years old with cancer and/or blood disorders. Hematology/Oncology Ward Pediatric Behavioral Health Area for the evaluation and treatment of patients ≤18 1077-7 IN:ACUTE:WARD:BHV_PED years old with acute psychiatric or behavioral disorders. Ward Pediatric Burn Ward 1078-5 IN:ACUTE:WARD:B_PED Area for the evaluation and treatment of patients ≤18 years old who have tissue injury caused by burns. Area for the evaluation and treatment of patients ≤18 Pediatric Ear, Nose, Throat 1079-3 IN:ACUTE:WARD: ENT_PED years old with disorders of the ear, nose, and/or throat. Ward 1080-1 Area for the evaluation and treatment of patients ≤18 Pediatric Genitourinary Ward IN:ACUTE:WARD: GU_PED years old with disorders of the genitourinary system. 18 Pediatric Medical Ward 1076-9 IN:ACUTE:WARD:M_PED Area for the evaluation and treatment of patients ≤ years old with medical conditions or disorders. Pediatric Medical-Surgical 1081-9 Area for the evaluation and treatment of patients ≤18 IN:ACUTE:WARD: MS_PED Ward years old with medical and/or surgical conditions. 18 ≤ Pediatric Neurology Ward 1082-7 IN:ACUTE:WARD:N_PED Area for the evaluation and treatment of patients years old with neurologic disorders. 15-21 January 2019

339 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Pediatric Neurosurgical Ward 1083-5 Area for care of patients ≤18 years old whose primary IN:ACUTE:WARD:NS_PED reason for admission is to have neurosurgery or to be cared for by a neurosurgeon after head or spinal trauma. Pediatric Orthopedic Ward 1084-3 Area for the evaluation and treatment of patients ≤18 IN:ACUTE:WARD: ORT_PED years old with orthopedic injuries or disorders. Pediatric Rehabilitation Ward Area for the evaluation and restoration of function to IN:ACUTE:WARD: 1085-0 (within Acute Care Hospital) REHAB_PED patients ≤18 years old who have lost function due to acute or chronic pain, musculoskeletal problems, stroke, or catastrophic events resulting in complete or partial paralysis. IN:ACUTE:WARD:S_PED Area for the evaluation and treatment of patients ≤18 Pediatric Surgical Ward 1086-8 years old who have undergone a surgical procedure. Step Down Units Adult Step Down Unit 1099-1 IN:ACUTE:STEP Area for adult patients who are hemodynamically stable and can benefit from close supervision and monitoring, such as frequent pulmonary toilet, vital signs, and/or neurologic and neurovascular checks. January 2019 15-22

340 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Area for oncology patients who are hemodynamically IN:ACUTE:STEP:ONC 1227-8 ONC Step Down Unit stable and can benefit from close supervision and (all ages) (e.g., post-critical monitoring, such as frequent pulmonary toilet, vital care) signs, and/or neurologic and neurovascular checks. 1100-7 Area for patients ≤18 years old who are Pediatric Step Down Unit IN:ACUTE:STEP:PED hemodynamically stable and can benefit from close supervision and monitoring, such as frequent pulmonary toilet, vital signs, and/or neurologic and neurovascular checks. Mixed Acuity Units IN:ACUTE:MIXED: Adult Mixed Acuity Unit 1210-4 Hospital area for the evaluation and treatment of adult patients whose conditions are of varying levels of acuity ALL_ADULT (e.g., critical care, ward-level care, step-down type care, etc.). Such a care area may be comprised of patients followed by different hospital services(e.g., coronary, medical, surgical, etc.). This care area may or may not include ''acuity adaptable'' or ''universal'' beds (i.e., this model of patient care allows a patient to stay in same bed during all phases of his care, from critical care through lower levels of care). 15-23 January 2019

341 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Area for the evaluation and treatment of a mixture of IN:ACUTE:MIXED: Pediatric Mixed Acuity Unit 1211-2 ALL_PEDS adult and pediatric oncology patients whose conditions are of varying levels of acuity (e.g., critical care, ward- level care, step-down type care, etc.). This care area may or may not include "acuity adaptable" or universal beds (i.e. this model of patient care allows a patient to stay in the same bed during all phases of care, from critical care through lower levels of care. Mixed Age Mixed Acuity Unit 1212-0 Hospital area for the evaluation and treatment of a IN:ACUTE:MIXED:ALL mixture of adult and pediatric patients whose conditions are of varying levels of acuity (e.g., critical care, ward- level care, step-down type care, etc.). Such a care area may be comprised of patients followed by different hospital services (e.g., coronary, medical, surgical, etc.). This care area may or may not include ''acuity adaptable'' or ''universal'' beds (i.e., this model of patient care allows a patient to stay in same bed during all phases of his care, from critical care through lower levels of care). - IN:ACUTE:MIXED:ONC 1236-9 ONC Mixed Acuity Unit (all ages) 15-24 January 2019

342 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Operating Rooms Cardiac Catheterization 1005-8 IN:ACUTE:OR:CATH A room or rooms in a hospital equipped for the Room/Suite performance of heart catheterizations for diagnostic or therapeutic purposes. Operating Room requirements for air changes, temperature, humidity and surfaces must be met. Cesarean Section Room/Suite A room or suite in a hospital equipped for the 1095-9 IN:ACUTE:OR:LD performance of obstetric and gynecologic surgeries and for the care of the neonate immediately after birth. Operating Room requirements for air changes, temperature, humidity and surfaces must be met. 1203-9 A room where diagnostic or therapeutic radiology Interventional Radiology IN:ACUTE:OR:RAD procedures are done on outpatients or inpatients. Operating room requirements for air changes, temperature, humidity, and surfaces must be met. Operating Room/Suite 1096-7 A room or suite in a hospital equipped for the IN:ACUTE:OR performance of surgical operations. Requirements for air changes, temperature, humidity, and surfaces must be met. 15-25 January 2019

343 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Post Anesthesia Care 1097-5 Area designated for monitoring patients for immediate IN:ACUTE:OR_STEP effects of anesthesia before either going home or on to an Unit/Recovery Room in-patient care area. Chronic Care Units (Previously named Long Term Care) NOTE: These location descriptions should only be used to define chronic care units that share a CCN with the affiliated acute care hospital. NHSN does not specifically define “extended periods of time”, which is used to describe many of the chronic care units. NHSN leaves this to the facility’s discretion. Chronic care units are traditionally non-medical wards where dedicated care is given towards those patients with pre-existing or long term illness, as opposed to acute care which is concerned with short term or severe illness. Skilled nursing facility (SNF) units located within a hospital that have a CCN that is different from the acute care hospital should be enrolled as a separate NHSN facility within the NHSN Long Term Care Facility Component, and use the long term care locations defined on pages 28-29. Inpatient Hospice 1165-0 IN:NONACUTE:LTC:HSP Area where palliative care is provided to the dying patient. Chronic Alzheimer's Unit 1103-1 Area where care is provided to persons diagnosed with IN:NONACUTE:LTC:ALZ Alzheimer's syndrome for extended periods of time. Area where care is provided to patients with psychiatric Chronic Behavioral 1104-9 IN:NONACUTE:LTC:BHV or behavioral-disorder diagnoses for extended periods of Health/Psych Unit time. January 2019 15-26

344 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Chronic Rehabilitation Unit Area where evaluation and restoration of function is 1105-6 IN:NONACUTE:LTC: REHAB provided to patients who have lost function due to acute or chronic pain, musculoskeletal problems, stroke, or catastrophic events resulting in complete or partial paralysis. Chronic Care Unit IN:NONACUTE:LTC 1102-3 Area where care provided for patients with chronic disease or disabilities for extended periods of time. Ventilator Dependent Unit 1164-3 IN:NONACUTE:LTC:R Area where care is provided to patients whose respirations depend on the use of a ventilator for extended periods of time. LONG TERM CARE FACILITIES Long Term Care Facility IN:NONACUTE:LTCF:HSP A unit or designated area which provides palliative and 1254-2 Inpatient Hospice Unit supportive care services to individuals diagnosed with life limiting (terminal) conditions. A unit or designated area which provides specialized care Long Term Care Facility 1255-9 IN:NONACUTE:LTCF:DEM for individuals diagnosed with dementia or related Dementia Unit conditions, including Alzheimer's disease. January 2019 15-27

345 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Long Term Care Facility Unit or designated area which provides specialized care IN:NONACUTE:LTCF:PSY 1256-7 Psychiatric Unit for individuals diagnosed with psychiatric or behavioral disorders. A unit or designated area which primarily provides short IN:NONACUTE:LTCF: 1257-5 Long Term Care Facility REHAB dical, skilled nursing or rehabilitation term (˂90 days), me Skilled Nursing-Short Term services to individuals requiring restorative care Rehabilitation following recent hospitalization. A unit or designated area which primarily provides Long Term Care Facility IN:NONACUTE:LTCF:GEN 1258-3 General Nursing Unit nursing, rehabilitative or custodial services to individuals with varying levels of chronic conditions or disability requiring long term (˃90 days) support. A unit or designated area which provides nursing and Long Term Care Facility 1259-1 IN:NONACUTE:LTCF:VEN respiratory care to individuals who require mechanical Ventilator Dependent Unit ventilation. A unit or designated area which provides specialized care Long Term Care Facility 1260-9 IN:NONACUTE:LTCF:BAR for individuals who are preparing for or have undergone Bariatric Unit bariatric surgery. January 2019 15-28

346 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code LONG TERM ACUTE CARE FACILITIES Long Term Acute Care 1220-3 IN:ACUTE:CC:LTAC Critical care area specializing in the evaluation, Intensive Care Unit treatment, and management of patients that require high observance/acuity and/or special care that are suffering medically complex conditions or who have suffered recent catastrophic illness or injury and require and extended stay in an acute care environment. Long Term Acute Care Ward 1221-1 IN:ACUTE:WARD:LTAC Hospital area for the evaluation and treatment of patients suffering medically complex conditions or who have suffered recent catastrophic illness or injury, and require an extended stay in an acute care environment. Long Term Acute Care Critical care area specializing in the evaluation, IN:ACUTE:CC:LTAC_PED 1222-9 Intensive Care Unit treatment, and management of patients ≤ 18 years old, that require high observation/acuity and/or special care that are suffering medically complex conditions or who have suffered recent catastrophic illness or injury, and require an extended stay in an acute care environment. 15-29 January 2019

347 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Long Term Acute Care 1214-6 IN:ACUTE:WARD:LTAC_PE Hospital area for the evaluation and treatment of patients D Pediatric Ward <= 18 years old, suffering medically complex conditions or who have suffered recent catastrophic illness or injury, and require an extended stay in an acute care environment INPATIENT REHABILITATION FACILITIES Hospital area for evaluation, treatment, and restoration of IN:ACUTE:IRF 1217-9 Rehabilitation Ward – (freestanding Inpatient function to patients have lost function due to acute or Rehabilitation Facility) chronic pain, musculoskeletal problems, stroke, brain or spinal cord dysfunction, or catastrophic events resulting in complete or partial paralysis. Rehabilitation Pediatric Ward PED Hospital area for evaluation, treatment, and restoration of IN:ACUTE:IRF: 1218-7 (freestanding Inpatient 18 years old who have lost function function to patients ≤ Rehabilitation Facility) due to acute or chronic pain, musculoskeletal problems, stroke, brain or spinal cord dysfunction, or catastrophic events results in complete or partial paralysis. ONCOLOGY FACILITIES Critical care area for the care of oncology patients who Oncology Medical Critical 1223-7 IN:ACUTE:CC:ONC_M Care are being treated for nonsurgical conditions related to their malignancy. 15-30 January 2019

348 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Critical care area for the evaluation and management of 1224-5 Oncology Surgical Critical IN:ACUTE:CC:ONC_S Care oncology patients with serious illness before and/or after cancer-related surgery. Oncology Medical-Surgical Critical care area for the care of oncology patients with 1225-2 IN:ACUTE:CC:ONC_MS Critical Care medical and/or surgical conditions related to their malignancy. Critical care area for the care of oncology patients ≤18 IN:ACUTE:CC:ONC_PED 1233-6 Oncology Pediatric Critical Care years old who are being treated for surgical or nonsurgical conditions related to their malignancy. Oncology Leukemia Ward IN:ACUTE:WARD: Area for the evaluation and treatment of patients with 1226-0 ONC_LEUK leukemia. Oncology Lymphoma Ward IN:ACUTE:WARD:ONC_ Area for the evaluation and treatment of patients with 1228-6 LYMPH lymphoma. 1229-4 Oncology Leukemia- Area for the evaluation and treatment of patients with IN:ACUTE:WARD: ONC_LL leukemia and/or lymphoma. Lymphoma Ward Area for the evaluation and treatment of oncology IN:ACUTE:WARD:ONC_ST Oncology Solid Tumor Ward 1230-2 patients with solid tumors. January 2019 15-31

349 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Oncology Hematopoietic Stem Area for the care of patients who undergo stem cell IN:ACUTE:WARD: 1231-0 Cell Transplant Ward ONC_HSCT transplant for the treatment of cancers and/or blood or immune system disorders. Area for the evaluation and treatment of patients with Oncology General IN:ACUTE:WARD: 1232-8 Hematology-Oncology Ward ONC_HONC cancer and/or blood disorders. Area for the care of patients ≤18 years old who und IN:ACUTE:WARD: ergo Oncology Pediatric 1234-4 ONC_HSCT_PED stem cell transplant for the treatment of cancers and/or Hematopoietic Stem Cell blood or immune system disorders. Transplant Ward Oncology Pediatric General ≤18 IN:ACUTE:WARD: Area for the evaluation and treatment of patients 1235-1 Hematology-Oncology Ward ONC_HONC_PED years old with cancer and/or blood disorders. Oncology Step Down Unit IN:ACUTE:STEP:ONC Area for oncology patients who are hemodynamically 1227-8 stable and can benefit from close supervision and monitoring, such as frequent pulmonary toilet, vital signs, and/or neurologic and neurovascular checks. 15-32 January 2019

350 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Oncology Mixed Acuity Unit Area for the evaluation and treatment of a mixture of IN:ACUTE:MIXED:ONC 1236-9 adult and pediatric oncology patients whose conditions (all ages) are of varying levels of acuity (e.g., critical care, ward- level care, step down type care, etc.). This care area may or may not include ''acuity adaptable'' or ''universal'' beds (i.e., this model of patient care allows a patient to stay in same bed during all phases of care, from critical care through lower levels of care). In addition to the 14 ONC specific locations, HOSP-ONC facilities can also use the following locations within NHSN (Location codes and descriptions can be found in the appropriate section of the master location table): Inpatient Locations  Operating Rooms: Cardiac Catheterization Room/Suite   Interventional Radiology  Inpatient Operating Room/Suite  Post-Anesthesia Care Unit/Recovery Room  Facility-wide Areas:  FACWIDEIN Miscellaneous Areas:   Pulmonary Function Testing  Treatment Room  Transport Service  Float January 2019 15-33

351 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Outpatient Locations Acute Care   24 -Hour Observation Area  Ambulatory Surgery Center  Emergency Department  Outpatient Pediatric Surgery Center  Outpatient Plastic Surgery Center  Outpatient Surgery Recovery Room/Post-Anesthesia Care Unit  Pediatric Emergency Department  Clinic (Nonacute) Settings Infusion Center  Oc cupational Health Clinic  Outpatient Hematology/Oncology Clinic   Pediatric Hematology/Oncology Clinic  Radiology (includes Nuclear Medicine) Specimen Collection Area (Healthcare)  Community Locations  Home Care   Home-based Hospice  Location outside facility 51  All N on -Patient Care Locations as designated on page in the location table INPATIENT PSYCHIATRIC FACILITIES HOSP-PSYCH facilities can use the following locations within NHSN (Location codes and descriptions can be found in the appropriate section of the master location table): Inpatient Locations 15-34 January 2019

352 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code  Adult Wards  Behavioral Health /Psych Ward  Jail Unit  Medical Ward  Medical/Surgical Ward  Pediatric Wards  Adolescent Behavioral Health/Psych Ward  Pediatric Behavioral Health/Psych Ward  Mixed Acuity Locations  Adult Mixed Acuity  Pediatric Mixed Acuity  Chronic Care Units  Chronic Alzheimer’s Unit  Chronic Behavioral Health/Psych Unit  Facility-wide Areas:  FACWIDEIN  FACWIDEOUT 15-35 January 2019

353 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code OUTPATIENT LOCATIONS OUTPATIENT AMBULATORY SURGERY CENTERS Ambulatory Surgery Center Area that is equipped for the performance of surgical OUT:ASC:OR 1243-5 operations; can be attached to an ACH or free-standing and has a separate ASC CCN. Operating Room requirements for air changes, temperature, humidity and surfaces must be met. Area designated in an ASC for monitoring patients for OUT:ASC:OR_STEP Ambulatory Surgery Recovery 1245-0 Room the immediate effects of anesthesia. 1246- 8 Outpatient Ambulatory Area, in an ASC, that is equipped for the performance of OUT:ASC:OR:PED Pediatric Surgery Center surg ical operations for persons ≤18 years old; may be free-standing or part of a hospital. Operating Room requirements for air changes, temperature, humidity, and surfaces must be met. Patients do not stay overnight. 15-36 January 2019

354 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Outpatient Ambulatory Plastic Area, in an ASC, that is equipped for the performance of 1247-6 OUT:ASC:OR:P LS Surgery Center plastic surgery operations; may be free-standing or part of a hospital. Operating Room requirements for air changes, temperature, humidity and surfaces must be met. Patients do not stay overnight. A room or suite equipped for the performance of OUT:ACUTE:OR:HOPD_A_P 1248-4 Pediatric Outpatient Operating Room/Suite (Attached) ED pediatric surgical operations that is physically within the walls of the affiliated ACH. It is considered a hospital outpatient department used for outpatient pediatric surgical procedures. Requirements for air changes, temperature, humidity, and surfaces must be met. A room or suite equipped for the performance of Pediatric Outpatient Operating 1249-2 OUT:ACUTE:OR:HOPD_D_P Room/Suite (Detached) pediatric surgical operations that is not physically ED attached to the affiliated ACH (could be on the same campus or miles away). It is considered a hospital outpatient department used for outpatient pediatric surgical procedures. Requirements for air changes, temperature, humidity, and surfaces must be met. An outpatient setting where Acute Kidney Injury patients Outpatient Hemodialysis 1268-2 OUT:NONACUTE:CLINIC:DI are evaluated and receive dialysis several times weekly. Clinic - Acute Kidney Injury AL_AKI January 2019 15-37

355 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code ACUTE CARE FACILITIES GENERAL Acute Settings ARD 24-Hour Observation Area 1162-7 OUT:ACUTE:W Area where patients are monitored for suspected or non- life threatening conditions for 24 hours or less. More than 50% of patients in this location must be outpatients who are not expected to be admitted to an inpatient unit. OUT:ACUTE:ED Area that provides emergency medical services; top Emergency Department 1108-0 priority is given to those with life-threatening illness or injury. Mobile Emergency 1174-2 OUT:ACUTE:MOBILE:UE Mobile unit that provides clinical and emergency medical Services/EMS services to patients who require them in the pre-hospital setting. OUT:ACUTE:OR_STEP Area designated for monitoring patients for the Post-Anesthesia Care Unit 1169-2 immediate effects of anesthesia before being sent home. OUT:ACUTE:OR:HOPD_A Outpatient Operating 1242-7 A room or suite equipped for the performance of surgical Room/Suite_(Attached) operations that is physically within the walls of the It is considered a hospital outpatient affiliated ACH. department used for outpatient surgical procedures. Requirements for air changes, temperature, humidity, and surfaces must be met. 15-38 January 2019

356 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Outpatient Operating A room or suite equipped for the performance of surgical 1244-3 OUT:ACUTE:OR:HOPD_D Room/Suite(Detached) operations that is not physically attached to the affiliated ACH (could be on the same campus or miles away). It is considered a hospital outpatient department used for outpatient surgical procedures. Requirements for air changes, temperature, humidity, and surfaces must be met. Pediatric Emergency 1109-8 OUT:ACUTE:ED:PED Area that provides emergency medical services to Department ≤ patients 18 years old; top priority is given to those with -threatening illness or injury. life Urgent Care Center 1160-1 OUT:ACUTE:CLINIC:UE Area that provides medical care services for illnesses and injuries that are not life-threatening. Clinic (n on -acute) Settings An outpatient setting for the purpose of providing Allergy Clinic 1110-6 OUT:NONACUTE:CLINIC: ALRG services to patients with allergies. An outpatient setting for the purpose of providing Behavioral Health Clinic 1145-2 OUT:NONACUTE:CLINIC: BHV services to patients with psychiatric or behavior disorders. An outpatient setting where blood is collected from OUT:NONACUTE:CLINIC: Blood Collection Center 1147-8 BLOOD donors. This does not include donation centers temporarily set up in non-clinical settings (e.g., schools, churches) or mobile blood collection centers. 15-39 January 2019

357 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Cardiac Rehabilitation Center 1112-2 OUT:NONACUTE:CLINIC: An outpatient setting where patients with cardiac disease, in partnership with a multidisciplinary team of health C_REHAB professionals, are encouraged and supported to achieve and maintain optimal physical health through exercise, nutritional and psychological counseling. OUT:NONACUTE:CLINIC:C Cardiology Clinic 1113-0 An outpatient setting for the evaluation and treatment of patients with cardiac problems. An outpatient setting for the evaluation and treatment of Continence Clinic 1148-6 OUT:NONACUTE:CLINIC: patients with incontinence problems. CON Dermatology Clinic OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of 1115-5 DERM patients with dermatologic conditions by a dermatologist. Diabetes-Endocrinology Clinic 1116-3 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation, education, and DIAB treatment of persons with diabetes. Ear, Nose, Throat Clinic 1126-2 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of ENT conditions related to the ear, nose, and/or throat. Endoscopy Suite 1007-4 OUT:NONACUTE:DIAG:GI An area where endoscopic procedures (e.g., upper gastrointestinal, lower gastrointestinal endoscopies, bronchoscopy) are performed on outpatients and/or inpatients. Patient care and processing of equipment may on. take place in this locati 15-40 January 2019

358 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Family Medicine Clinic 1117-1 OUT:NONACUTE:CLINIC: An outpatient setting for patients who are managed by a family practice physician or group of physicians. Does FAM not include private physician practice. Genetics Clinic 1122-1 OUT:NONACUTE:CLINIC: An outpatient setting for testing and counseling of GEN patients with genetic or hereditary disorders. An outpatient setting for the evaluation and treatment of Gynecology Clinic 1121-3 OUT:NONACUTE:CLINIC: women with reproductive tract conditions. GYN An outpatient setting where alternative healthcare 1161-9 OUT:NONACUTE:CLINIC: Holistic Medicine Center HOL practices are used, focusing on the physical, mental, emotional, social and spiritual aspects of health. An outpatient setting where therapeutic hyperbaric Hyperbaric Oxygen Center 1017-3 OUT:NONACUTE:CLINIC: HBO oxygen is administered. Infusion Center 1018-1 OUT:NONACUTE:CLINIC: An outpatient setting for the administration of fluids, blood products and medications. FUS A self-contained mobile unit such as a bus or trailer that OUT:NONACUTE:MOBILE: Mobile Blood Collection 1176-7 Center BLOOD is specifically designed and equipped for the collection of blood and blood products from public donors. This unit typically moves from location to location. 15-41 January 2019

359 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Mobile MRI/CT 1175-9 OUT:NONACUTE: A self-contained mobile unit such as a bus or trailer that MOBILE_DIAG:RAD is equipped with MRI or CT radiologic equipment and that may be moved between healthcare locations (e.g., hospitals, clinics). Neurology Clinic 1123-9 OUT:NONACUTE:CLINIC:N An outpatient setting for the diagnosis, evaluation, and treatment of persons with neurologic disorders. An outpatient setting where workplace physicals, OUT:NONACUTE:CLINIC: 1151-0 Occupational Health Clinic OCC workplace injury management and immunological evaluations take place 1152-8 OUT:NONACUTE:CLINIC: Occupational Therapy Clinic An outpatient setting where persons with injury or disability are helped to resume activities of daily living OT_REHAB with exercise, massage, and other therapies. Ophthalmology Clinic 1124-7 OUT:NONACUTE:CLINIC: An outpatient setting for the diagnosis, evaluation and treatment of ophthalmologic disorders. OPH An outpatient setting for the diagnosis, evaluation and Orthopedic Clinic 1125-4 OUT:NONACUTE:CLINIC: ORT treatment of orthopedic disorders. OUT:NONACUTE:CLINIC: An outpatient setting for the management of persons who Ostomy Clinic 1149-4 OST have had surgical procedure for removing normal bodily wastes through a surgical opening (stoma) on the abdominal wall. 15-42 January 2019

360 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Dental Clinic 1150-2 OUT:NONACUTE:CLINIC: An outpatient setting that provides dental services, DENT including preventive teeth cleaning, emergency treatment, and comprehensive oral care. This may be a private or group practice or a teaching facility for dentists and/or dental hygienists. Gastrointestinal Clinic 1118-9 OUT:NONACUTE:CLINIC:GI An outpatient setting for the diagnosis, evaluation, and treatment of conditions related to the gastrointestinal tract. Usually includes an endoscopy suite. OUT:NONACUTE:CLINIC: 1200-5 An outpatient setting for the diagnosis, evaluation, and Hematology-Oncology Clinic treatment of persons with hematologic and/or oncologic HONC disorders. This may include chemotherapy or blood/blood products infusion services. An outpatient setting where chronic hemodialysis Outpatient Hemodialysis 1219-5 OUT:NONACUTE:CLINIC: HD (in inpatient facility) patients are evaluated and receive dialysis several times Clinic weekly. - IP facilities *BV Component USE ONLY An outpatient setting for the diagnosis, evaluation, and OUT:NONACUTE:CLINIC: HIV Clinic 1154-4 HIV treatment of persons who are HIV positive or who have AIDS. OUT:NONACUTE:CLINIC:M An outpatient setting for the diagnosis, evaluation and Medical Clinic 1120-5 treatment of medical disorders. 15-43 January 2019

361 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Rehabilitation Clinic 1155-1 OUT:NONACUTE:CLINIC: An outpatient setting where persons with injury or REHAB disability are evaluated and treated to resume activities of daily living, speech and language skills, and maximum physical function. This may include social and psychological evaluation and treatment Pain Clinic 1127-0 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of PAIN persons with chronic or intractable pain. 1146-0 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and management Pediatric Behavioral Health Clinic of persons ≤18 years old with psychiatric or behavior BHV_PED disorders. Pediatric Cardiology Center 1129-6 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and management PED_C of persons ≤18 years old with cardiac disorders. An outpatient setting for the evaluation and treatment of OUT:NONACUTE:CLINIC: 1128-8 Pediatric Clinic persons ≤18 years old. PED Pediatric Dental Clinic An outpatient setting that provides dental services, 1130-4 OUT:NONACUTE:CLINIC: DENT_PED including preventive teeth cleaning, emergency ≤18 treatment, and comprehensive oral care to persons years old. This may be a private or group practice or a teaching facility for dentists and/or dental hygienists. January 2019 15-44

362 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Pediatric Dermatology Clinic 1131-2 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and management DERM_PED of persons ≤18 years old with dermatologic disorders. Pediatric Diabetes- 1132-0 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and management Endocrinology Clinic DIAB_PED of persons ≤18 years old with diabetes or other endocrine disorders. 1119-7 An outpatient setting for the evaluation and treatment of OUT:NONACUTE:CLINIC: Pediatric Gastrointestinal Clinic persons ≤18 years old with gastrointestinal disorders. GI_PED Pediatric Hematology- 1136-1 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of HONC_PED Oncology Clinic persons ≤18 years old with cancer and/or blood disorders. Pediatric Nephrology Clinic 1137-9 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of persons ≤18 years old with disorders of the genitourinary PGU_PED tract. An outpatient setting for the evaluation and treatment of Pediatric Orthopedic Clinic 1133-8 OUT:NONACUTE:CLINIC: ORT_PED persons ≤18 years old with fractures or other orthopedic disorders. An outpatient setting for the evaluation and treatment of Pediatric Rheumatology Clinic 1138-7 OUT:NONACUTE:CLINIC: persons ≤18 years old with rheumatology disorders. RHEUM_PED January 2019 15-45

363 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Pediatric Scoliosis Clinic 1134-6 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of SCOL_PED persons ≤18 years old with scoliosis or other growth disorders of the spine. Physical Therapy Clinic 1202-1 OUT:NONACUTE:CLINIC: An outpatient setting where persons with injury or PT_REHAB disability are helped to obtain maximum physical function. A physician's office practice. OUT:NONACUTE:CLINIC 1141-1 Physician's Office Podiatry Clinic 1140-3 An outpatient setting for the evaluation and treatment of OUT:NONACUTE:CLINIC: POD patients with conditions or disorders of the feet. An outpatient setting for the evaluation and treatment of Prenatal Clinic 1156-9 OUT:NONACUTE:CLINIC: PNATL pregnant women. Pulmonary Clinic 1157-7 An outpatient setting for the evaluation and treatment of OUT:NONACUTE:CLINIC: PULM persons with disorders of the respiratory tract. Area where the evaluation of a patient's respiratory status 1009-0 Pulmonary Function Testing OUT:NONACUTE:DIAG: PULM takes place. 15-46 January 2019

364 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code 1008-2 An area where diagnostic or therapeutic radiologic Radiology OUT:NONACUTE:DIAG: RAD procedures are done on outpatients and/or inpatients. Operating room requirements for air changes, temperature, humidity, and surfaces are NOT met. (includes Nuclear Medicine) An outpatient setting for the evaluation and treatment of Rheumatology Clinic 1142-9 OUT:NONACUTE:CLINIC: RHEUM persons with autoimmune disorders, primarily rheumatoid arthritis. 1170-0 Area in a school or correctional facility that provides School or Prison Infirmary OUT:NONACUTE:CLINIC: IFM medical care to students/inmates. This area is not staffed or equipped for overnight stay patients. An outpatient setting for the evaluation and treatment of Speech Therapy Clinic 1158-5 OUT:NONACUTE:CLINIC: ST_REHAB persons with brain injury to maximize their speech, swallow, and language functions. An outpatient setting for the preoperative evaluation and Surgical Services Clinic 1143-7 OUT:NONACUTE:CLINIC:S the postoperative management of patients undergoing a surgical procedure. An outpatient setting for the examination and treatment Well Baby Clinic 1139-5 OUT:NONACUTE:CLINC: of normal newborns. NURS 15-47 January 2019

365 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code Wound Center 1144-5 OUT:NONACUTE:CLINIC: An outpatient setting for the evaluation and treatment of WND persons with acute or chronic wounds. Wound Ostomy Continence 1159-3 OUT:NONACUTE:CLINIC: An outpatient area that provides acute and rehabilitative Clinic WND_OST_CONT care for people with selective disorders of the gastrointestinal, genitourinary, and integumentary (skin) systems. 1207-0 Outpatient setting where blood is collected from patients OUT:NONACUTE:CLINIC: Therapeutic Apheresis Clinic and therapeutic apheresis procedures are performed. THERAPHERSIS Miscellaneous Outpatient Settings An area within a healthcare facility where procedures are Specimen Collection Area 1019-9 OUT:NA:LAB:SPEC (Healthcare) performed to collect blood, tissue, and other specimens for diagnostic purposes. Transport Service 1178-3 OUT:NONACUTE:MOBILE Mobile unit used to transport patients to their home or from one healthcare setting to another non-emergently. OUTPATIENT DIALYSIS FACILITIES (Available for u se in outpatient ambulatory hemodialysis facilities only) An outpatient setting for maintenance hemodialysis Outpatient Hemodialysis 1153-6 OUT:NONACUTE:CLINIC: patients where they are evaluated and dialyzed in-center. Clinic DIAL 15-48 January 2019

366 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code COMM:NONACUTE: Hemodialysis performed by an appropriately trained Home Hemodialysis 1262-1 patient (and the patient’s caregiver) and at home. HOME:DIAL MISCELLANEOUS AREAS (Mainly used for Healthcare Personnel Safety component) Float 1206-2 IN:ACUTE:FLOAT VALID IN HPS COMPONENT ONLY An area within a facility that is used for the storage Morgue/Autopsy Room 1189-0 NONPTC:NA:LAB: PATH_MORG and/or postmortem examination of deceased persons. Sleep Study Unit 1020-7 IN:NONACUTE:CLINIC: Area where patients stay overnight and are evaluated for SLEEP sleep disorders. (for inpatients and outpatients) IN:ACUTE:SUPPORT: Treatment Room 1209-6 A room in a patient care unit, in which various treatments TREAT or procedures requiring special equipment are performed, such as removing sutures, draining a hematoma, packing a wound, or performing an examination. FACILITY-WIDE LOCATIONS (Available only for Laboratory Identified Event Reporting [LABID] and Antimicrobial Use and Resistance [AUR] Module) Facility-wide Inpatient 1250-0 FACWIDEIN Facility-wide Inpatient (FacWIDEIn) (FacWideIN) FACWIDEOUT 1251-8 Facility-wide Outpatient (FacWIDEOut) Facility-wide Outpatient (FacWideOUT) January 2019 15-49

367 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code COMMUNITY LOCATIONS Blood Collection (Blood Drive 1195-7 COMM:NONACUTE:CLINIC: A location not designed or equipped to perform Campaign) BLOOD healthcare functions (e.g., school gym or shopping mall) that has been set up specifically to collect donations of blood and blood products from the public. Home Care A patient's home location where medical services COMM:NONACUTE: HOME 1192-4 including routine noninvasive and other invasive procedures (e.g., insertion of indwelling urinary catheter, insertion of IV line) are performed by healthcare workers and family members under the supervision of a licensed independent practitioner (e.g., MD, CNP,PA). COMM:NONACUTE:HOME: Home-based Hospice 1194-0 -life services are A patient’s home location where end -of performed by healthcare workers, family members, and HSP volunteers. COMM:NOTFAC A location outside this facility, including unknown Location outside facility 1204-7 outside location. 15-50 January 2019

368 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code A location not designed or equipped to perform Specimen Collection Area 1196-5 COMM:NA:LAB:SPEC healthcare functions (e.g., school gym or shopping mall) (Community) that has been set up specifically to collect body fluids for healthcare testing. Examples would be blood sugar or cholesterol screening clinics. NON-PATIENT CARE LOCATIONS (Non-Patient Care Areas available for use in Biovigilance or Healthcare Personnel Safety Components only) Administrative Areas 1184-1 NONPTC:NA:SUPPORT: Areas within a healthcare facility where administrative ADMIN functions take place. No patient care takes place in these areas. 1106-4 NONPTC:NA:HOME Assisted Living Area A location where persons live and have available to them housekeeping, meal preparation, transportation, and other non-medical services. Patient care is not done in this area. Blood Bank 1185-8 NONPTC:NA:LAB:BLOOD An area within a healthcare facility that may collect, store, and distribute blood and blood products, and performs diagnostic tests on blood/components to determine compatibilities. 15-51 January 2019

369 Master CDC Locations and Descriptions CDC Location Label Location Description CDC Location Code NHSN Healthcare Service Location Code An area within a healthcare facility where durable Central Sterile Supply 1186-6 NONPTC:NA:SUPPORT: CSS medical equipment is cleaned/decontaminated, wrapped, sterilized, and stored in preparation for patient use. An area adjacent to a healthcare facility where Central Trash Area 1187-4 NONPTC:NA:SUPPORT: biohazardous and non-biohazardous wastes are collected TRASH in preparation for transport to a landfill or incineration. Centralized Transfusion 1261-7 NONPTC:NA:LAB:CTS A location outside the facility that stores, manipulates, Service issues, and/or performs compatibility testing on blood and blood products (e.g., a contracted transfusion service or a separate hospital that provides transfusion services for your facility). 1011-6 An area within a diagnostic laboratory that performs NONPTC:NA:LAB:CHEM Clinical Chemistry Laboratory general clinical chemistry analysis (clinical biochemistry), endocrinology, therapeutic substance monitoring, toxicology, blood pH and blood gas analysis, urinalysis and urine pregnancy testing. Facility Grounds NONPTC:NA:SUPPORT: Any outdoor area adjacent to a healthcare facility that 1188-2 belongs to the facility (e.g., sidewalks, parking ramps, GRNDS lawns). January 2019 15-52

370 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code General Laboratory 1010-8 NONPTC:NA:LAB An area that encompasses all clinical divisions within a diagnostic laboratory. Hematology Laboratory 1012-4 NONPTC:NA:LAB:H An area within a diagnostic laboratory that determines the specific properties of blood (e.g., CBC, white blood count). NONPTC:NA:LAB: 1013-2 An area within a diagnostic laboratory that uses high- Histology-Surgical Pathology Laboratory power microscopy to evaluate cells and tissues for the HIST_PATH presence or absence of disease. Housekeeping/Environmental An area within a healthcare facility where the activities 1182-5 NONPTC:NA:SUPPORT: HSKP Services of housekeeping/environmental services staff are coordinated and supplies are stored. 1183-3 Laundry Room An area within a healthcare facility where laundry is NONPTC:NA:SUPPORT: LAUN sorted, washed, dried, and prepared for transport and use. 1014-0 An area within a laboratory that performs diagnostic tests Microbiology Laboratory NONPTC:NA:LAB:MICRO to determine the presence or absence of bacteria and their related properties. An area within a healthcare facility where medications Pharmacy 1179-1 NONPTC:NA:SUPPORT: PHARM are prepared and labeled for patient use. 15-53 January 2019

371 Master CDC Locations and Descriptions CDC Location Label CDC Location Code Location Description NHSN Healthcare Service Location Code Physical Plant Operations An area within a healthcare facility where construction, NONPTC:NA:SUPPORT: 1181-7 Center ENG renovation, and maintenance staff activities and supplies are coordinated. They may also include areas of machinery and equipment. Any indoor area within a healthcare facility that is not NONPTC:NA:SUPPORT: PUB Public Area in Facility 1180-9 used for patient care and that is available to the public (e.g., waiting rooms, cafeterias, hallways). An area within a diagnostic laboratory that performs Serology Laboratory 1015-7 NONPTC:NA:LAB:SER blood tests to determine the presence or absence of certain diseases or the levels of immunity. NONPTC:NA:SUPPORT:SOIL Soiled Utility Area 1190-8 Area where used and/or soiled disposable or durable medical equipment is stored and/or cleaned in ED preparation for disposal or reprocessing/reuse. Virology Laboratory 1016-5 NONPTC:NA:LAB:VIR An area within a diagnostic laboratory that performs tests and/or culturing to determine the presence or absence of specific viruses. 15-54 January 2019

372 Master CDC Locations and Descriptions References ; 130 597. - (3): 587 Pediatrics 2012 American Academy of Pediatrics. Policy Statement Levels of Neonatal Care . 1. January 2019 55 - 15

373 General Key Terms General Key Terms Definitions specific to individual protocols are found in the respective protocol. Term Definition For purposes of NHSN surveillance, Active Surveillance Culture/Testing Active Surveillance (ASC/AST) refers to testing that is intended to identify the Culture/Testing presence/carriage of microorganisms for the purpose of instituting or (ASC/AST) discontinuing isolation precautions (for example, nasal swab for MRSA, rectal swab for VRE), or monitoring for eradication of a carrier state. ASC/AST does NOT include identification of microorganisms with cultures or tests performed for diagnosis and treatment purposes (for example, specimens collected from sterile body sites including blood specimens). Also, see Surveillance cultures . See Vital Signs. Apnea Specimen obtained in a manner to prevent introduction of organisms from Aseptically the surrounding tissues. obtained Weight of the infant at the time of birth. Birthweight should not be changed Birthweight as the infant gains weight. The NHSN birthweight categories are as follows: g; E = -1000 g; C = 1001-1500 g; D = 1501-2500 A = ≤750 g; B = 751 >2500 g. A CDC-defined designation given to a patient care area housing patients CDC location care for similar who have similar disease conditions or who are receiving medical or surgical specialties. Each facility location that is monitored is “mapped” to one CDC Location. The specific CDC Location code is determined by the type of patients cared for in that area according to the patients in a location 80% Rule. The 80% Rule requires that 80% of the are of a certain acuity level and service type (for example, if 80% of the patients in a ward level area are pediatric patients receiving orthopedic care, this area should be designated as an Inpatient Pediatric Orthopedic Ward). When mapping facility locations to CDC locations, use the following points:  Acuity billing data (if available) is the most reliable and objective method of determining appropriate location mapping.  Admission/transfer diagnosis can also be used to determine location mapping if billing data is not available. s worth of data to make ’  When possible, facilities should use one year this determination. If that is not available, a shorter period of at least January 2019 16-1

374 General Key Terms Term Definition 3 months is acceptable, but every effort should be made to collect and analyze greater periods of time consistently in the future, using the same method. Also, see Virtual Location in the Locations and Descriptions chapter . For detailed instructions on how to map locations, see “Instructions for Mapping Patient Care Locations in NHSN” in the Locations and Descriptions chapter . Physician documentation of antimicrobial treatment for site-specific Clinical correlation infection related to equivocal findings (not clearly identified) of infection on imaging test. For example, when applying intraabdominal infection (IAB) criterion 3b, the finding of ‘fluid collection seen in the lower abdominal cavity’ on an imaging test, may or may not represent an infection. This finding is not clearly identified as an infection and should be confirmed with clinical evidence that an infection is present. In the case of IAB criterion 3b, the clinical evidence required is physician documentation of antimicrobial therapy for treating the intraabdominal infection. The date the first element used to meet an NHSN site-specific infection Date of event criterion occurs for the first time within the seven-day infection window (DOE) Synonyms: infection date, date of or SSI surveillance period. period infection, event date. In the case of a process measure, the date the process or intervention was performed (for example, the day a central line was inserted is the date of CLIP event). This definition does not apply to LabID event, or VAE. See Date of event for VAE , SSI , and LabID Event in respective protocols. The d used in the AUR Module. See only enominator days present is Days present Antimicrobial Use and Resistance (AUR) Module . An infection meeting the HAI definition is considered a device-associated Device-associated HAI (for example, associated with the use of a ventilator, central line, or infection indwelling urinary catheter) if the device was in place for >2 calendar days on the date of event and was also in place on the date of event or the day before. If the device was in place for >2 calendar days and then removed, the date of event must be the day of discontinuation or the next day to be device associated. For a patient who has a central line in place on hospital January 2019 16-2

375 General Key Terms Term Definition admission, day of first inpatient access is considered Device Day 1. For a patient who has a ventilator or urinary catheter in place on the day of admission, Device Day 1 is day of admission. A count of the number of patients with a specific device in a patient care Device days location during a time period. This count can be determined electronically or manually by a daily count or weekly sampling. See Denominator Data section within individual protocols. facility admission. The patient died during the current Died The event either directly caused death or exacerbated an existing disease Event contributed condition that then led to death as evidenced by available documentation to death (for example, death/discharge note, autopsy report, etc.). See Date of event. Event date See Vital signs. Fever Evidence of infection elicited or visualized on physical examination or Gross anatomical observed during an invasive procedure. This includes physical examination exam of a patient during admission and subsequent assessments of the patient. Additionally, it may include findings noted during a medical/invasive procedure and is dependent on the location of the infection as well as the infection criterion. NHSN of acceptable findings: Examples An invasive procedure to visualize an intraabdominal abscess.   Visualization of pus or purulent drainage from drains within an abscess.  Abdominal pain elicited on physical exam (without an invasive procedure) post-CSEC or hysterectomy, is sufficient evidence of infection detected. An infection is considered a HAI if the date of event of the NHSN site- Healthcare- specific infection criterion occurs on or after the 3rd calendar day of associated infection to an inpatient admission to an inpatient location where day of admission (HAI) location is calendar day 1. See Identifying HAIs chapter . Note: Rules for HAI do not apply to SSI, VAE, or LabID Events. See Vital signs. Hypotension January 2019 16-3

376 General Key Terms Term Definition A patient who is ≤ 1 year (≤ 365 days) of age. Infant See Date of Event. Infection date The 7 days during which all site-specific infection criteria must be met. It Infection window includes the date the first positive diagnostic test that is used as an element period (IWP) of the site-specific infection criterion was obtained, the 3 calendar days before, and the 3 calendar days after. See Location. Inpatient location Facility has indicated in their NHSN Monthly Reporting Plan that the In-plan NHSN surveillance protocol(s) will be used, in its entirety, for that surveillance type. Only in-plan data are submitted to CMS in particular HAI event and are included in accordance with CMS’s Quality Reporting Programs NHSN annual reports or other NHSN publications. as a Critical Care Unit, the ICU is a nursing care area that Also known Intensive care unit provides intensive observation, diagnostic and therapeutic procedures for (ICU) adults and/or children who are critically ill. An ICU excludes nursing areas that provide step-down, intermediate care or telemetry only. Specialty care areas are also excluded (see definition). The type of ICU is determined by the type of patients cared for in that unit – which means 80% of the patients in a location according to the 80% Rule are of a certain type. For example, if 80% of the patients in an area are patients receiving critical care for trauma, this area should be designated as Unit. When an ICU houses roughly equal an Inpatient Trauma Critical Care populations of medical and surgical patients (a 50/50 to 60/40 mix), it is called a medical/surgical ICU. The patient care area to which a patient is assigned while receiving care in Location the healthcare facility. Only mapped inpatient locations where denominator data are Note: collected can be used for attribution and reporting infection events via the Device-associated Module. Operating rooms (including cardiac catheter labs, C-section rooms, and interventional radiology), emergency attribution departments and outpatient locations are not valid locations for of device-associated infection events (see Location of Attribution). Also, see CDC Location . January 2019 16-4

377 General Key Terms Term Definition The inpatient location where the patient was assigned on the date of event Location of terms). Non-bedded patient (see also Date of Event and Transfer Rule attribution locations, (for example, are not eligible for assignment of PACU or OR) (LOA) location of attribution for HAI events. Location of attribution must be a location where denominator data can be collected. See individual HAI for additional details. protocol(s) A patient who is ≤ 30 days of age. Neonate Non-culture based Identification of microorganisms using a method of testing other than a microbiologic based testing require inoculation of a specimen to culture culture. Culture testing media, incubation and observation for actual growth of microorganisms. Depending on the organism identified, culturing can take several days to weeks for a final report. In contrast, non-culture based testing methods generally provide faster results, which can assist with early diagnosis and tailoring of antimicrobial therapy. Examples of non-culture based testing include but are not limited to PCR (polymerase chain reaction) and ELISA (Enzyme-linked immunosorbent assay). With the exception of Active Surveillance Culture/Testing (ASC/AST), any test methodology (culture or non-culture based) that provides a final identifies an organism, is and laboratory report in the medical record eligible for use in meeting an NHSN infection definition. not indicated in their NHSN Monthly Reporting Plan that the Facility has Off -plan NHSN surveillance protocol(s) will be used, in its entirety, for that surveillance particular HAI event type. Off-plan data are not submitted to CMS in accordance with CMS’s Quality Reporting Programs and are not included in NHSN annual reports or other NHSN publications. A count of the number of patients in a patient care location during a defined Patient days time period. This count can be determined electronically or manually by a daily count or, depending on the location type, weekly sampling. See Denominator Data section within individual protocols. NHSN site-specific infection criterion] with a meeting an An infection with Present on date of event that occurs on the day of admission to an inpatient location admission (POA) (calendar day 1), the 2 days before admission, or the calendar day after period). See Identifying HAIs chapter . admission (POA time not apply to SSI, VAE, or LabID Events. Note: Rules for POA do January 2019 16-5

378 General Key Terms Term Definition 14-day timeframe during which no new infections of the same type are The Repeat infection reported. timeframe (RIT) Rules for applying RIT: event determinations.  Applies to both POA and HAI  The date of event is Day 1 of the 14-day RIT. and the date of event  If criteria for the same type of infection are met is within the 14-day RIT, a new event is not identified or reported. Additional pathogens recovered during the RIT from the same type  of infection are added to the event and the original date of event is maintained as is the original 14-day RIT.  Device association determination and location of attribution are not amended.  Do not appl y to SSI, VAE, or LabID Events. See Identifying HAIs chapt er. The period in which a blood specimen must be collected for a secondary Secondary BSI bloodstream infection to be attributed to a primary site infection. This attribution period period includes the Infection Window Period (IWP) combined with the (SBAP) for the primary type of infection. It is Repeat Infection Timeframe (RIT) 14-17 days in length depending upon the date of event. Notes:  Secondary BSI Attribution Period does not apply to VAE or LabID Events.  a 17-day period that The Secondary BSI Attribution Period for SSI is of the SSI , 3 days prior to the date of event, includes the date of event and 13 days after the SSI date of event. Summary measure used to track HAIs over time. It compares the number of Standardized reported HAIs to the number of predicted HAIs, based on NHSN baseline Infection Ratio data. The SIR adjusts for several factors that may impact the risk of (SIR) acquiring an HAI. See the for more information. SIR Guide Those cultures reported as part of a facility’s infection prevention and Surveillance and treatment. in patient diagnosis control surveillance are not used cultures Surveillance cultures include but not limited to stool cultures for (VRE) and/or nasal swabs for vancomycin-resistant Enterococci methicillin-resistant Staphylococcus aureus (MRSA) surveillance. These cultures are also called active surveillance cultures or testing (ASC/AST). January 2019 16-6

379 General Key Terms Term Definition Note: Positive cultures collected from sterile body sites including blood specimens are not surveillance cultures and are eligible for use in meeting NHSN HAI , LabID , VAE, and SSI event criteria. Also, see Active Surveillance Culture/Testing (ASC/AST). NHSN defines three types of teaching hospitals: Teaching hospital  Major: Facility has a program for medical students and post-graduate medical training.  Graduate: Facility has a program for post-graduate medical training (residency and/or fellowships).  Undergraduate: Facility has a program for medical / nursing students only. Vital signs. See Temperature See Vital signs. Temperature instability The process of assigning location of attribution when the date of event is on Transfer rule the date of transfer or discharge, or the next day ; the infection is attributed to the transferring/discharging location. If the patient was housed in multiple locations within the transfer rule time frame, attribute the infection to the first location in which the patient was housed the day before the infection’s date of event . Clinical measurements used to assess a patient's essential body functions. If Vital signs a specific vital sign parameter is not stated in a CDC/NHSN HAI definition or criterion (for example, hypotension and temperature instability) the facility should use the vital sign parameter(s) as stated in its policies and procedures for clinical practices. Notes: does have a stated value; the facility should use the For fever, NHSN  temperature documented in the patient’s medical record. There is no conversion of temperature based on route of collection. be cannot For apnea in ventilated patients < 1 year of age, apnea  determined by changes /adjustments in ventilator settings or by worsening oxygenation. January 2019 16-7

380 Surveillance Definitions CDC/NHSN Surveillance Definitions for Specific Types of Infections INTRODUCTION This chapter contains the CDC/NHSN surveillance definitions and criteria for all specific types of infections. This chapter also provides additional required criteria for the specific infection types that SSI ) (for example, mediastinitis [MED] that may follow constitute organ space surgical site infections ( a coronary artery bypass graft, intra-abdominal abscess [IAB] after colon surgery, etc. ). Comments and reporting instructions that follow the site-specific criteria provide further explanation and are integral to the correct application of the criteria . Refer to Chapter 2 (Identifying HAIs in NHSN) for specific guidance for making HAI determinations. Infection criteria contained in this chapter may be necessary for determining whether a positive blood specimen represents a primary bloodstream infection (BSI) or is secondary to a different type of infection (see Appendix B Secondary Bloodstream Infection (BSI) Guide ). A BSI that is identified as secondary to another site of infection must meet one of the infection criteria detailed in this chapter and meet other requirements. Secondary BSIs are not reported as Laboratory Confirmed Bloodstream Infections in NHSN, nor can they be associated with the use of a central line. NOTES:  See individual protocol chapters for infection criteria for urinary tract infections (UTI) , , pneumonia , and (VAE) , ventilator-associated infections (PNEU) bloodstream infections (BSI) surgical site infections . (SSI)  Organisms belonging to the following genera cannot be used to meet any NHSN definition: Blastomyces, Histoplasma, Coccidioides, Paracoccidioides, Cryptococcus and Pneumocystis . These organisms are typically causes of community-associated infections and are rarely known to cause healthcare-associated infections, and therefore are excluded.  Antibiograms of the blood and isolates from potential primary sites of infection do not have to match for purposes of determining the source of BSIs (see “matching organisms” below) . A matching organism is defined as one of the following:  1. If genus and species are identified in both specimens, they must be the same. A a. Example: n intraabdominal specimen is used as an element to meet IAB definition and is growing Enterobacter cloacae. A blood specimen with a collection date in the IAB secondary BSI attribution period is reported to be growing Enterobacter cloacae. These are considered matching organisms. An intraabdominal specimen is used as an element to meet IAB b. Example: A blood specimen with Enterobacter aerogenes. definition and is growing a collection date in the IAB secondary BSI attribution period is reported to January 2019 17- 1

381 Surveillance Definitions be growing Enterobacter cloacae. These are NOT considered matching organisms as the species are different. 2. If the organism is less definitively identified in one specimen than the other, the lesser i dentified organism must be identified to at least the genus level and at that level the organisms must be the same. A surgical species is used to Pseudomonas wound growing a. Example: meet deep incisional SSI criteria and a blood specimen growing Pseudomonas aeruginosa is collected in the SSI secondary BSI attribution period. The organisms are considered matching at the genus level and therefore the BSI is secondary to the SSI. ying in CSF meets the MEN Enterococcus faecalis b. PCR identif Example: definition. A subsequent blood culture collected in the MEN secondary Enterococcus BSI attribution period is identified as species. The organisms idered to be matching and therefore the BSI is secondary to MEN are cons 3. There are two exceptions to the definition: criteria with Staphylococcus or Streptococcus: meeting LCBI 2 Infections a. A patient has a fever and a previous chest Example-(Staphylococcus): tube site is reddened, swollen and a culture is collected from the soft tissue. The chest tube site culture is reported positive for Staphylococcus species. SST/ST definition is met. The next day 2 blood culture sets are collected. The blood cultures are both positive for coagulase negative Staphylococcus. The organisms are NOT considered matching, because Staphylococcus species could represent a coagulase negative or a gulase positive Staphylococcus . Therefore the BSI would not be coa considered secondary to SST/ST. A patient has a fever and a previous chest tube Example-(Streptococcus): swollen and a culture is collected from the soft tissue. The is reddened chest tube site culture is reported positive for Streptococcus species. SST/ST definition is met. The next day 2 blood culture sets are collected. The blood cultures are both positive for Streptococcus , viridans group. The organisms are NOT considered matching, because Streptococcus species could represent a Streptococcus , viridans group or non- Streptococcus , viridans group. Therefore the BSI would not be considered secondary to SST/ST. b. In cases where an organism is identified only as “yeast” or “yeast not otherwise sp ecified”, the organism can be considered a match to other yeasts, when collected during the required timeframe, whether more fully identified or not. A culture of tissue from ulcer margin of a decubiti reported Example: positive for yeast is used as an element to meet DECU definition. A blood specimen collected in the secondary BSI attribution period of the DECU is reported as . In this example the two organisms are Candida albicans January 2019 17- 2

382 Surveillance Definitions as the organisms are complementary considered matching organisms Candida is a type of yeast) and because yeasts isolated from (specifically, non-sterile sites are commonly not identified to the genus or genus and species level. NOTE: This exception is limited to yeast. It does not apply to identification of organisms as Gram positive cocci, Gram negative rods, etc. Example : A culture of tissue from ulcer margin of a decubiti reported positive for Gram negative rod is used as an element to meet DECU definition. A blood specimen collected in the secondary BSI attribution period of the DECU is reported as E.coli . In this example the two organisms are NOT considered matching organisms. Examples for Determining Matching Organisms (correct selection for NHSN reporting is bolded) Identification # 1 Matching Identification # 2 Organisms Yes or No Enterobacter aerogenes Enterobacter cloacae No Yes Enterococcus faecalis Enterococcus Enterococcus faecium Enterococcus faecalis No Pseudomonas species Yes Pseudomonas aeruginosa aureus Staphylococcus Coagulase-negative Staphylococcus No Staphylococcus Yes Coagulase-negative Staphylococcus epidermidis species us Coagulase-positive Staphylococc Staphylococcus No No Streptococcus species Streptococcus Viridans Group Yeast Yes ecies Candida sp CRITERIA FOR SPECIFIC TYPES OF INFECTION Infection criteria used for NHSN healthcare-associated infection surveillance have been grouped into For example, there are three 14 major types with some further categorized into specific infection types. specific types of central nervous system infections (intracranial infection, meningitis or ventriculitis, Central Nervous System. CNS – and spinal abscess/infection ) that are grouped under the major type of s, and the Infection criteria are listed in alphabetical order, according to their (abbreviated) major code criteria for each of the specific types of infection follow it. January 2019 17- 3

383 Surveillance Definitions le 1: CDC/NHSN Major and Specific Types of Infections Tab Page Typ e 6 BJ Bone and Joint Infection – – Osteomyelitis 6 BONE – Disc space infection 6 DISC JNT – 7 Joint or bursa infection – 7 PJI Periprosthetic joint infection 8 CNS – Central Nervous System IC – Intracranial infection 8 Meningitis or ventriculitis MEN – 9 SA Spinal abscess/infection 10 – 11 Cardiovascular System Infection – CVS – Myocarditis or pericarditis 11 CARD – Endocarditis ENDO 11 MED – Mediastinitis 14 VASC Arterial or venous infection 15 – 16 – Eye, Ear, Nose, Throat, or Mouth Infection EENT CONJ – Conjunctivitis 16 17 EAR – Ear, mastoid infection – EYE 17 Eye infection, other than conjunctivitis ORAL Oral cavity infection (mouth, tongue, or gums) 18 – SINU – Sinusitis 18 UR – Upper respiratory tract infection, pharyngitis, laryngitis, epiglottitis 19 19 GI – Gastrointestinal System Infection CDI- Clostridioides difficile Infection 19 GE Gastroenteritis 20 – GIT – Gastrointestinal (GI) tract infection 20 IAB – Intraabdominal infection, not specified elsewhere 21 22 Necrotizing enterocolitis – NEC 23 LRI Lower Respiratory System Infection, Other Than Pneumonia – LUNG – Other infection of the lower respiratory tract 23 24 REPR – Reproductive Tract Infection Endometritis EMET – 24 EPIS Episiotomy infection 24 – OREP – eep pe lvic tissue infection or other infection of the male or female 24 D oduc tiv e tract repr – 25 Vaginal cuff infection VCUF January 2019 17- 4

384 Surveillance Definitions 25 -Skin and Soft Tissue Infection SST BRST – Breast abscess or mastitis 25 Burn Infection 26 BURN – 26 Newborn circumcision infection – CIRC 26 DECU – Decubitus ulcer infection (also known as pressure injury infection) SKIN 27 Skin infection – 28 Soft tissue infection ST – 28 – UMB Omphalitis 29 Urinary System Infection – USI January 2019 17- 5

385 Surveillance Definitions BJ -BONE AND JOINT INFECTION BONE-Osteomyelitis of the following criteria: Osteomyelitis must meet at least one 1. Patient has organism(s) identified from bone by culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis and treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has evidence of osteomyelitis on gross anatomic or histopathologic exam. 2. 3. Patient has at least two of t he following localized signs or symptoms: fever (>38.0 °C), swelling*, pain or tenderness*, heat*, or drainage* And at least of the following: one a. organism(s) identified from blood by culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis and treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) AND imaging test evidence suggestive of infection (for example, x-ray, CT scan, MRI, radiolabel scan [gallium, technetium, etc.]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for osteomyelitis. b. imaging test evidence suggestive of infection (for example, x-ray, CT scan, MRI, radiolabel scan [gallium, technetium, etc.]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for osteomyelitis. * With no other recognized cause Reporting instructions Report mediastinitis following cardiac surgery that is accompanied by osteomyelitis as SSI-  ONE MED rather than SSI-B .  If a patient meets both organ space JNT and BONE report the SSI as BONE.  After an HPRO or a KPRO if a patient meets both organ space PJI and BONE report the SSI as BONE. DISC-Disc space infection of the following criteria: Vertebral disc space infection must meet at least one 1. Patient has organism(s) identified from vertebral disc space by culture or non-culture based performed for purposes of clinical diagnosis and treatment, microbiologic testing method, which is for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has evidence of vertebral disc space infection on gross anatomic or histopathologic exam. Patient has at least 3. one of the fol lowing: fever (> 38.0°C ) or pain* at the involved vertebral disc space And at least one of the following: organism(s) identified from blood by culture or non-culture based microbiologic testing a. method which is performed for purposes of clinical diagnosis and treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) AND January 2019 17- 6

386 Surveillance Definitions imaging test evidence suggestive of infection (for example, x-ray, CT scan, MRI, radiolabel scan [gallium, technetium, etc.]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for vertebral disc space infection. b. im aging test evidence suggestive of infection (for example, x-ray, CT scan, MRI, radiolabel scan [gallium, technetium, etc.]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for vertebral disc space infection. * With no other recognized cause JNT-Joint or bursa infection (not for use as Organ/Space SSI after HPRO or KPRO procedures) Joint or bursa infections must meet at least one of the following criteria: 1. Patient has organism(s) identified from joint fluid or synovial biopsy by culture or non-culture based testing method which is performed for purposes of clinical diagnosis and treatment, microbiologic for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has evidence of joint or bursa infection on gross anatomic or histopathologic exam. 3. Patient has at least two of the following: swelling*, pain* or tenderness*, heat*, evidence of effusion*, or limitation of motion*. And at least one of the following: white blood cell count (per reporting laboratory’s reference range) elevated joint fluid OR a. positive leukocyte esterase test strip of joint fluid organism(s) and white blood cells seen on Gram stain of joint fluid b. c. organism(s) identified from blood by culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis and treatment ,for example, not Active Surveillance Culture/Testing (ASC/AST) d. imaging test evidence suggestive of infection (for example, x-ray, CT scan, MRI, radiolabel um, technetium, etc.]), which if equivocal is supported by clinical correlation, scan [galli specifical ly, physician documentation of antimicrobial treatment for joint or bursa infection. * With no other recognized cause Reporting instruction  If a patient meets both organ space JNT and BONE report the SSI as BONE. PJI – Periprosthetic Joint Infection (for use as Organ/Space SSI following HPRO and KPRO only) Joint or bursa infections must meet at least one of the following criteria: ) with at least one matching organism, 1. Two positive periprosthetic specimens ( tissue or fluid identified by culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis and treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). A sinus tract* communicating with the joint identified on gross anatomic exam. 2. January 2019 17- 7

387 Surveillance Definitions 3. Having three of the following minor criteria: a. elevated serum C-reactive protein (CRP; >100 mg/L) and erythrocyte sedimentation rate (ESR; >30 mm/hr.) or ( b. elevated synovial fluid white blood cell (WBC; >10,000 cells/μL) count OR “ ++ ” change on leukocyte esterase test strip of synovial fluid greater) c. elevated synovial fluid polymorphonuclear neutrophil percentage (PMN% >90%) positive histological analysis of periprosthetic tissue (>5 neutrophils (PMNs) per high power d. field) e. or ganism(s) identified from a single positive periprosthetic specimen ( tissue or fluid ) by culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis and treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) * A sinus tract is defined as a narrow opening or passageway that can extend in any direction through nd results in dead space with potential for abscess formation. soft tissue a Comments: . Organism(s) identified from hip or knee  A matching organism is defined on page 17-1 hardware can be used to meet criterion 1. The NHSN definition of PJI is closely adapted from the Musculoskeletal Infection Society’s  (MSIS’s) definition of PJI ( Proceedings of the International Consensus Meeting on Periprosthetic Joint Infection, 2013 ).  The standard laboratory cutoff values in criteria 3a - 3d are provided by NHSN for HPRO and KPRO SSI surveillance purposes only. The NHSN laboratory cutoffs are not intended to guide clinicians in the actual clinical diagnosis and management of acute or chronic PJI. Clinicians should refer to the MSIS consensus definition for clinical use. Reporting Instruction  After an HPRO or a KPRO if a patient meets both organ space PJI and BONE report the SSI as BONE. CNS -CENTRAL NERVOUS SYSTEM INFECTION IC -Intracranial infection (brain abscess, subdural or epidural infection, encephalitis) Intracranial infection must meet at least one of the following criteria: Patient has organism(s) identified from brain tissue or dura by a culture or non-culture based 1. microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has an abscess or evidence of intracranial infection on gross anatomic or histopathologic exam. of the following signs or symptoms: headache*, dizziness*, fever two 3. Patient has at least (>38.0°C), localizing neurologic signs*, changing level of consciousness*, or confusion* one And at least of the following: January 2019 17- 8

388 Surveillance Definitions organism(s) seen on microscopic examination of brain or abscess tissue obtained by needle a. aspiration or during an invasive procedure or autopsy. imaging test evidence suggestive of infection (for example, ultrasound, CT scan MRI, b. radionuclide brain scan, or arteriogram), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for intracranial infection. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism c. 4. Patient ≤1 year of age has at least two of the following signs or symptoms: fever (>38.0°C), hypothermia (<36.0°C), apnea*, bradycardia*, localizing neurologic signs*, or changing level of consciousness* ,for example, irritability, poor feeding, lethargy And at least of the following: one a. organism(s) seen on microscopic examination of brain or abscess tissue obtained by needle aspiration or during an invasive procedure or autopsy b. imaging test evidence suggestive of infection, (for example, ultrasound, CT scan, MRI, radionuclide brain scan, or arteriogram), which if equivocal is supported by clinical correlation ,specifically, physician documentation of antimicrobial treatment for intracranial infection. iagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism c. d * With no other recognized cause Reporting instructions  Report as MEN if meningitis (MEN) and encephalitis (IC) are present together. Report as IC if meningitis (MEN) and a brain abscess (IC) are present together after operation.   Report as SA if meningitis (MEN) and spinal abscess/infection (SA) are present together. MEN-Meningitis or ventriculitis Meningitis or ventriculitis must meet at least of the following criteria: one Patient has organism(s) identified from cerebrospinal fluid (CSF) by a culture or non-culture based 1. microbiologic testing method which is performed for purposes of clinical diagnosis or treatment for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has at least two of the following: 2. i. fever (>38.0°C) or headache (Note: Elements of “i” alone may not be used to meet the two required elements) ii. meningeal sign(s)* iii. cranial nerve sign(s)* And at least one of the following: increased white cells, elevated protein, and decreased glucose in CSF (per reporting a. laboratory’s reference range) b. organism(s) seen on Gram stain of CSF c. organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) d. d iagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism two : the following elements of 3. Patient ≤1 year of age has at least January 2019 17- 9

389 Surveillance Definitions ± ), apnea*, bradycardia*, or irritability* (Note: i. fever (>38.0°C), hypothermia (<36.0°C Elements of “ i ” alone may not be used to meet the required two elements). ii. meningeal signs* iii. cranial nerve signs* And at least one of the following: a. increased white cells, elevated protein, and decreased glucose in CSF (per reporting laboratory’s reference range) b. organism(s) seen on Gram stain of CSF ntified from blood by a culture or non-culture based microbiologic testing organism(s) c. ide method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) d. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism. * With no other recognized cause Reporting instructions  Report CSF shunt infection as SSI-MEN if it occurs within 90 days of placement; if later or after manipulation/access, it is considered CNS-MEN but is not reportable as an SSI  ) are present together (IC Report as MEN if meningitis (MEN) and encephalitis Report as IC if meningitis (MEN) and a brain abscess (IC) are present together after operation  Report as SA if meningitis (MEN) and spinal abscess/infection (SA) are present together SA -Spinal abscess/infection (spinal abscess, spinal subdural or epidural infection) Spinal ab scess/infection must meet at least one of the following criteria: 1. Patient has organism(s) identified from abscess or from purulent material found in the spinal epidural or subdural space by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has an abscess or other evidence of spinal infection on gross anatomic or histopathologic 2. exam. of the following localized signs or symptoms: fever (>38.0°C), back pain* one 3. Patient has at least or tenderness*, radiculitis*, paraparesis*, or paraplegia* And at least one of the following: organism(s) a. identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) AND imaging test evidence of spinal abscess/infection, which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for spinal abscess/infection. b. imaging test evidence of a spinal abscess/infection (for example, myelography, ultrasound, CT scan, MRI, or other scans [gallium, technetium, etc.]) which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for spinal abscess/infection. January 2019 17- 10

390 Surveillance Definitions * With no other recognized cause Reporting instruction  Report as SA if meningitis (MEN) and spinal abscess/infection (SA) are present together after operation. CVS -CARDIOVASCULAR SYSTEM INFECTION CARD-Myocarditis or pericarditis of the following criteria: Myocarditis or pericarditis must meet at least one 1. Patient has organism(s) identified from pericardial tissue or fluid by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) two 2. Patient has at least of the following signs or symptoms: fever (>38.0°C), chest pain*, paradoxical pulse*, or increased heart size* And at least one of the following: a. abnormal EKG consistent with myocarditis or pericarditis b. evidence of myocarditis or pericarditis on histologic exam of heart tissue 4-fold rise in paired sera from IgG antibody titer c. pericardial effusion identified by echocardiogram, CT scan, MRI, or angiography. d. of the following signs or symptoms: fever (>38.0°C), Patient ≤1 year of age has at least two 3. hypothermia (<36.0°C ), apnea*, bradycardia*, paradoxical pulse*, or increased heart size* And at least one of the following: a. abnormal EKG consistent with myocarditis or pericarditis b. histologic examination of heart tissue shows evidence of myocarditis or pericarditis. c. 4-fold rise in paired sera from IgG antibody titer pericardial effusion identified by echocardiogram, CT scan, MRI, or angiography d. With no other recognized cause * ENDO -Endocarditis When meeting the Endocarditis (ENDO) definition:  The ENDO Infection Window Period is defined as the 21 days during which all site-specific infection criteria must be met. It includes the date the first positive diagnostic test that is used as an element of the ENDO criterion was obtained, the 10 calendars days before and the 10 calendar days after. The Infection Window Period is lengthened for this event to accommodate the extended diagnostic timeframe that is frequently required to reach a clinical determination of endocarditis. extended to include the remainder of the patient’s current The RIT for Endocarditis (ENDO) is  admission. January 2019 17- 11

391 Surveillance Definitions When meeting the Endocarditis (ENDO) definition, the secondary BSI attribution period  includes and all subsequent days of the patient’s current the 21-day infection window period admission. o As a result of this lengthy secondary BSI attribution period, secondary BSI pathogen assignment for ENDO, is limited to organism(s) identified in blood specimen that match the organism(s) used to meet the ENDO definition. Example : If the ENDO definition was met using a site-specific specimen (for example, cardiac vegetation) or using a blood specimen with S.aureus as the identified organism, if a blood specimen collected during the ENDO secondary BSI attribution ive for S. aureus and E.coli, while the S. aureus can be assigned to the period is posit ENDO event, it cannot be assumed the E.coli can be assigned as a secondary BSI pathogen. The blood organism (E.coli) does not match the organism (S.aureus) used to meet the ENDO definition. If the blood specimen can be used to meet an ENDO definition criterion both organisms can be assigned. Otherwise the E.coli will need to be investigated as a separate BSI and identified as a secondary BSI to another site- specific infection or determined to be a primary BSI. one of the following criteria: Endocarditis of a natural or prosthetic heart valve must meet at least 1. Organism(s) identified from cardiac vegetation*, embolized vegetation ( for example, solid-organ abscess) documented as originating from cardiac source, or intracardiac abscess by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Organism(s) seen on histopathologic examination of cardiac vegetation, embolized vegetation, for example, solid organ abscess, documented as originating from cardiac source, or intracardiac abscess. Endocarditis seen on histopathologic examination of cardiac vegetation or intracardiac abscess. 3. † of the following echocardiographic evidence of endocarditis* one : At least 4. i. vegetation on cardiac valve or supporting structures ii. intracardiac abscess ew partial dehiscence of prosthetic valve iii. n And at least one of the following: a. typical infectious endocarditis organism(s) (specifically, Viridans group streptococci, Streptococcus bovis , Haemophilus spp., Actinobacillus actinomycetemcomitans , Cardiobacterium hominis , Eikenella corrodens , Kingella spp., Staphylococcus aureus, Enterococcus spp.) from ≥2 blood collections drawn on separate occasions identified with no more than 1 calendar day between specimens by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) b. Coxiella burnetii identified by anti-phase I IgG antibody titer >1:800 or identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment ,for example, not Active Surveillance Culture/Testing (ASC/AST). 5. of the following: three At least January 2019 17- 12

392 Surveillance Definitions i. prior endocarditis, prosthetic valve, uncorrected congenital heart disease, history of rheumatic heart disease, hypertrophic obstructive cardiomyopathy, or known IV drug use ‡ fever (>38.0°C) ii. iii. vascular phenomena: major arterial emboli ( specifically, embolic stroke, renal infarct, splenic infarct or abscess, digital ischemic/gangrene from embolic source), septic pulmonary infarcts, mycotic aneurysm (documented by imaging, seen in surgery, or described in gross pathological specimen), intracranial hemorrhage, conjunctival hemorrhages, or Janeway’s lesions documented chart, or white cell or red immunologic phenomena: glomuleronephritis (documented on iv. blood cell casts on urinalysis), Osler’s nodes, Roth’s spots, or positive rheumatoid factor And at least one of the following: a. typical infectious endocarditis organism(s) (specifically, Viridans group streptococci, spp., Actinobacillus actinomycetemcomitans Streptococcus bovis , Haemophilus , , Cardiobacterium hominis , Eikenella corrodens Kingella spp., Staphylococcus aureus, collections drawn on separate occasions from ≥2 blood Enterococcus spp. ) identified with no more than 1 calendar day between specimens by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) ied by anti-phase I IgG antibody titer >1:800 or identified from b. identif Coxiella burnetii blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment,,for example, not Active Surveillance Culture/Testing (ASC/AST). † of the following* 6. At least : one i. vegetation on cardiac valve or supporting structures seen on echocardiogram ii. intracardiac abscess seen on echocardiogram ew partial dehiscence of prosthetic valve seen on echocardiogram iii. n And at least three of the following: a. prior endocarditis, prosthetic valve, uncorrected congenital heart disease, history of rheumatic heart disease, hypertrophic obstructive cardiomyopathy, or known IV drug ‡ use b. fever (>38.0°C) r phenomena: major arterial emboli ( specifically, embolic stroke, renal infarct, c. vascula splenic infarct or abscess, digital ischemic/gangrene from embolic source), septic pulmonary infarcts, mycotic aneurysm (documented by imaging, seen in surgery, or described in gross pathological specimen), intracranial hemorrhage, conjunctival hemorrhages, or Janeway’s lesions documented d. immunologic phenomena: glomuleronephritis (documented in chart, or white cell or red blood cell casts on urinalysis), Osler’s nodes, Roth’s spots, or positive rheumatoid factor identification of organism(s) from the blood by at least one of the following methods: e.  recognized pathogen(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment ,for example, not Active Surveillance Culture/Testing (ASC/AST) identified from ≥2 blood collections drawn same common commensal organism(s)  on separate occasions on the same or consecutive days by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical January 2019 17- 13

393 Surveillance Definitions diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) 7. All of the following criteria: rior endocarditis, prosthetic valve, uncorrected congenital heart disease, history of p a. rheumatic heart disease, hypertrophic obstructive cardiomyopathy, or known IV drug use ‡ b. fever (>38.0°C) c. omena: major arterial emboli ( specifically, embolic stroke, renal infarct, vascular phen splenic infarct or abscess, digital ischemic/gangrene from embolic source), septic pulmonary infarcts, mycotic aneurysm (documented by imaging, seen in surgery, or described in gross pathological specimen), intracranial hemorrhage, conjunctival hemorrhages, or Janeway’s lesions documented immunologic phenomena: glomuleronephritis (documented or chart, or white cell or d. ’s nodes, Roth’s spots, or positive rheumatoid red blood cell casts on urinalysis), Osler factor e. identification of organism(s) from the blood by at least one of the following methods: recognized pathogen(s) identified from blood by a culture or non-culture based  microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). tified from ≥2 blood collections drawn same common commensal organism(s) iden  on separate occasions on the same or consecutive days by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). *“Cardiac vegetation” includes vegetation on a pacemaker/ defibrillator lead or ventricular assist device (VAD) components within the heart. † Which if equivocal is supported by clinical correlation (specifically, physician documentation of antimicrobial treatment for endocarditis). of 5i, 6a and 7a documented during the current admission: ‡Elements  May be documented outside of the ENDO infection window period or SSI surveillance period.  Should not be used to set the ENDO date of event. MED-Mediastinitis Mediastinitis must meet at least one of the following criteria: Patient has organism(s) identified from mediastinal tissue or fluid by a culture or non-culture based 1. microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) 2. Patient has evidence of mediastinitis on gross anatomic or histopathologic exam. 3. Patient has at least one of the following signs or symptoms: fever (>38.0°C), chest pain*, or sternal instability* And at least one of the following: al area a. purulent drainage from mediastin b. stinal widening on imaging test media January 2019 17- 14

394 Surveillance Definitions one Patient ≤1 year of age has at least of the following signs or symptoms: fever (>38.0°C), 4. hypothermia (<36.0°C ), apnea*, bradycardia*, or sternal instability* one And at least of the following: a. purulent drainage from mediastinal area mediastinal widening on imaging test b. * With no other recognized cause Comment: The mediastinal space is the area under the sternum and in front of the vertebral column,  containing the heart and its large vessels, trachea, esophagus, thymus, lymph nodes, and other structures and tissues. It is divided into anterior, middle, posterior, and superior regions. Reporting instruction  Report mediastinitis (MED) following cardiac surgery that is accompanied by osteomyelitis as SSI- . MED rather than SSI-B ONE VASC-Arterial or venous infection excluding infections involving vascular access devices with organisms identified in the blood Note: If a patient meets the criteria for an LCBI in the presence of an arterial or vascular infection (VASC) report as an LCBI not as a VASC. ** Arterial or venous infection must meet at least one of the following criteria: 1. Patient has organism(s) from extracted arteries or veins identified by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has evidence of arterial or venous infection on gross anatomic or histopathologic exam. r (>38.0°C), pain*, erythema*, or of the following signs or symptoms: feve 3. Patient has at least one heat at involved vascular site* AND More than 15 colonies cultured from intravascular cannula tip using semi-quantitative culture method. 4. Patient has purulent drainage at involved vascular site 1 year of age has at least of the following signs or symptoms: fever (>38.0°C), 5. one Patient ≤ hypothermia (<36.0°C), apnea*, bradycardia*, lethargy*, pain*, erythema*, or heat at involved vascular site* AND More than 15 colonies cultured from intravascular cannula tip using semi-quantitative culture method With no other recognized cause * Reporting instructions Report infections of an arteriovenous graft, shunt, fistula or intravascular cannulation site without  organism(s) identified from blood as CVS-VASC. January 2019 17- 15

395 Surveillance Definitions  Report Organ Space VASC infections as an SSI and not an LCBI when you have an SSI with secondary BSI.  Report intravascular infections with organism(s) identified from the blood and meeting the LCBI criteria, as BSI-LCBI. ** Occasionally, a patient with both a central line and another vascular access device will have pus at If the BSI meets the CLABSI criteria and the other access site. BOTH of the following are present within the infection window period, mark the data fiel d for risk factor “Central line” as “No”:  Pus at the site AND  Specimen collected from the site of one of the following, has at least one matching organism to organism(s) identified in a blood specimen: o Arterial catheters o Arteriovenous fistula o Arteriovenous graft Atrial catheters (also known as transthoracic intra-cardiac catheters, those catheters o inserted directly into the right or left atrium via the heart wall ) o Hemodialysis reliable outflow (HERO) dialysis catheters o Intra-aortic balloon pump (IABP) devices o accessed central line (not accessed nor inserted during the hospitalization) Non- o Peripheral IV or Midlines -E YE , EAR, NOSE, THROAT, OR MOUTH INFECTION EENT CONJ-Conjunctivitis Conjunctivitis must meet at least one of the following criteria: 1. Patient has organism(s) identified from conjunctival scraping or purulent exudate obtained from the conjunctiva or contiguous tissues, ( for example, eyelid, cornea, meibomian glands, or lacrimal glands ) by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has pain or redness of conjunctiva or around eye 2. And at least one of the following: WBCs and organism(s) seen on Gram stain of exudate a. b. purulent exudate c. multinucleated giant cells seen on microscopic examination of conjunctival exudate or scrapings d. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism Reporting instructions  Report other infections of the eye as EYE. – ), as a healthcare  Do not report chemical conjunctivitis, caused by silver nitrate (AgNO 3 associated infection. Do not report a separate case of conjunctivitis (CONJ) that occurs as a part of another viral  illness (for example, UR) . January 2019 17- 16

396 Surveillance Definitions EAR -Ear, mastoid infection Ear and mastoid infections must meet at least one of the following criteria: Otitis externa must meet at least one of the following criteria: Patient has organism(s) identified from purulent drainage from ear canal by a culture or non- 1. culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has at least one of the following: fever (>38.0°C), pain*, or erythema* AND organism(s) seen on Gram stain of purulent drainage from ear canal. Otitis media must meet at least one of the following criteria: 3. Patient has organism(s) identified from fluid from middle ear obtained during an invasive procedure ( for example, tympanocentesis ) by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has at least two of the following: fever (>38.0°C), pain *, inflammation*, retraction* or 4. decreased mobility of eardrum*, or fluid behind eardrum*. one of the following criteria: Otitis interna must meet at least 5. Patient has organism(s) identified from fluid from inner ear obtained during an invasive procedure by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 6. Patient has a physician diagnosis of inner ear infection. of the following criteria: Mastoiditis must meet at least one 7. Patient has organism(s) identified from fluid or tissue from mastoid by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment,for example not Active Surveillance Culture/Testing (ASC/AST). of the following: fever (>38.0°C), pain or tenderness*, post auricular two 8. Patient has at least swelling*, erythema*, headache*, or facial paralysis* And at least one of the following: organism(s) seen on Gram stain of fluid or tissue from mastoid a. b. imaging test evidence suggestive of infection ( for example, CT scan), which if equivocal is s upported by clinical correlation, specifically, physician documentation of antimicrobial treatment for mastoid infection. * With no other recognized cause EYE-Eye infection, other than conjunctivitis of the following criteria: one An infection of the eye, other than conjunctivitis, must meet at least January 2019 17- 17

397 Surveillance Definitions 1. Patient has organism(s) identified from anterior or posterior chamber or vitreous fluid by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). of the following signs or symptoms with no other recognized cause : eye at least 2. Patient has two pain, visual disturbance, or hypopyon AND two physician initiates antimicrobial therapy within days of onset or worsening of symptoms ORAL-Oral cavity infection (mouth, tongue, or gums) Oral cavity infections must meet at least one of the following criteria: 1. Patient has organism(s) identified from abscess or purulent material from tissues of oral cavity by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has an abscess or other evidence of oral cavity infection found on invasive procedure, gross anatomic exam, or histopathologic exam. Patient has at least of the following signs or symptoms with no other recognized cause: 3. one ulceration, raised white patches on inflamed mucosa, or plaques on oral mucosa. of the following: one And at least a. virus identified from mucosal scrapings or exudate by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) b. multinucleated giant cells seen on microscopic examination of mucosal scrapings or exudate c. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism. d. fungal elements seen on microscopic exam of mucosal scrapings or exudate (for example, Gram stain, KOH ) e. physician initiates antimicrobial therapy within 2 days of onset or worsening of symptoms. Reporting instruction Report healthcare associated primary herpes simplex infections of the oral cavity as ORAL; –  recurrent herpes infections are not healthcare associated. SINU-Sinusitis Sinusitis must meet at least one of the following criteria: 1. identified from fluid or tissue from the sinus cavity obtained during an Patient has organism(s) invasive procedure by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has at least one 2. of the following signs or symptoms: fever (>38.0°C), pain or tenderness over the involved sinus*, headache*, purulent exudate*, or nasal obstruction* AND Imaging test evidence of sinusitis (for example, x-ray, CT scan) January 2019 17- 18

398 Surveillance Definitions * With no other recognized cause UR-Upper respiratory tract infection, pharyngitis, laryngitis, epiglottitis Upper respiratory tract infections must meet at least one of the following criteria: 1. two of the following signs or symptoms: fever (>38.0°C), erythema of pharynx*, Patient has at least sore throat*, cough*, hoarseness*, or purulent exudate in throat* And at least one of the following: a. organism(s) identified from upper respiratory site [specifically: larynx, pharynx, and epiglottis ] by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Note: excludes sputum and tracheal aspirate because these are not upper respiratory specimens b. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism c. physician diagnosis of an upper respiratory infection or histopathologic exam or imaging test. Patient has an abscess on gross anatomical 2. he following signs or symptoms: fever (>38.0°C), 3. Patient ≤1 year of age has at least two of t hypothermia (<36.0°C ), apnea*, bradycardia*, nasal discharge*, or purulent exudate in throat* And at least one of the following: a. identified from upper respiratory site [specifically larynx, pharynx, and organism(s) epiglottis] by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Note: excludes sputum and tracheal aspirate because they are not upper respiratory specimens b. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism c. physician diagnosis of an upper respiratory infection * With no other recognized cause GI -GASTROINTESTINAL SYSTEM INFECTION Clostridioides difficile Infection CDI - of the following criteria: one Clostridioides difficile infection must meet at least 1. Positive test for toxin-producing C. difficile on an unformed stool specimen (conforms to the shape of the container). 2. Patient has evidence of pseudomembranous colitis on gross anatomic (includes endoscopic exams) or histopathologic exam. Note :  When using a multi-testing methodology for CD identification, the result of the last test finding, -CDI criterion 1 is met. which is placed onto the patient medical record, will determine if GI Comments: January 2019 17- 19

399 Surveillance Definitions  The date of event for CDI criterion 1, will always be the specimen collection date of the unformed stool, specifically, not the date of onset of unformed stool. and an unformed stool specimen is a single C. difficile t for toxin-producing A positive tes  elem ent and both are required to meet criterion. Reporting instructions  Report the CDI and the GE or GIT if additional enteric organism(s) are identified and criteria are met for GE or GIT. Report each new GI-CDI according to the Repeat Infection Timeframe (RIT) rule for HAIs  (see NHSN HAI for further details and guidance). definitions in Chapter 2  CDI laboratory-identified event (LabID Event) categorizations (for example, recurrent CDI assay, incid ent CDI assay, healthcare facility-onset, community-onset, community-onset healthcare facility-associated) do associated not apply to HAIs; including C. di fficile g astrointestinal infections (GI-CDI). infections) ile GE -Gastroenteritis (excluding C. diffic of the following criteria: one Gastroenteritis must meet at least 1. Patient has an acute onset of diarrhea (liquid stools for > 12 hours) and no likely noninfectious cause (for example, diagnostic tests, therapeutic regimen other than antimicrobial agents, acute exacerbation of a chronic condition, or psychological stress information). 2. two of the following signs or symptoms: nausea*, vomiting*, abdominal pain*, Patient has at least fever (>38.0°C), or headache* one of the following: And at least an enteric pathogen is identified from stool or rectal swab by a culture or non-culture based a. microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). b. an enteric pathogen is detected by microscopy on stool c. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism * With no other recognized cause Comment:  l The reference to “enteric pathogens” describes pathogens that are not considered to be norma flora of the intestinal tract. Enteric pathogens identified on culture or with the use of other diagnostic laboratory tests include Salmonella, Shigella, Yersinia, Campylobacter, Listeria, Vibrio, Enteropathogenic or Enterohemorrhagic E.coli or Giardia. Reporting instruction  Report only GI-GIT using the event date as that of GI-GIT if the patient meets criteria for both GI -GE and GI -G IT. - GIT Gastrointestinal tract infection (esophagus, stomach, small and large bowel, and rectum) excluding gastroenteritis, appendicitis, and infection C. difficile January 2019 17- 20

400 Surveillance Definitions Gastrointestinal tract infections, excluding, one of gastroenteritis and appendicitis, must meet at least the following criteria: 1. Patient has one of the following: a. an abscess or other evidence of gastrointestinal tract infection on gross anatomic or histopathologic exam. b. abscess or other evidence of gastrointestinal tract infection on gross anatomic or histopathologic exam AND organism(s) identified from blood by a culture or non-culture based microbiologic testing method, which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). The organism(s) identified in the blood must contain at least one MBI organism. (See Appendix A of the BSI protocol) ollowing signs or symptoms compatible with infection of the organ Patient has at least two of the f 2. or tissue involved: fever (>38.0°C), nausea*, vomiting*, pain*or tenderness*, odynophagia*, or dysphagia* And at least one of the following: a. identified from drainage or tissue obtained during an invasive procedure organism(s) or from drainage from an aseptically-placed drain by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). fungal elements seen on KOH stain or multinucleated b. organism(s) seen on Gram stain or giant cells s een on microscopic examination of drainage or tissue obtained during an invasive procedure or from drainage from an aseptically-placed drain. c. organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). The organism(s) identified in the blood must contain at least one MBI organism (See Appendix A of the BSI protocol) AND maging test evidence suggestive of gastrointestinal infection (for example, endoscopic i scan exam, MRI, CT ), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for gastrointestinal tract infection. d. imaging test evidence suggestive of infection (for example, endoscopic exam, MRI, CT ), which if equivocal is supported by clinical correlation, specifically, physician scan documentation of antimicrobial treatment for gastrointestinal tract infection. * With no other recognized cause Reporting instruction  Report only GI-GIT using the event date as that of GI-GIT if the patient meets criteria for both -GE and GI-GIT. GI IAB-Intraabdominal infection, not specified elsewhere, including gallbladder, bile ducts, liver (excluding viral hepatitis), spleen, pancreas, peritoneum, retroperitoneal, subphrenic or subdiaphragmatic space, or other intraabdominal tissue or area not specified elsewhere January 2019 17- 21

401 Surveillance Definitions Intraabdominal infections must meet at least one of the following criteria: 1. Patient has organism(s) identified from an abscess or from purulent material from intraabdominal space by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has at least one of the following: abscess or other evidence of intraabdominal infection on gross anatomic or histopathologic a. exam. r other evidence of intraabdominal infection on gross anatomic or histopathologic b. abscess o exam AND organism(s) identified from blood by a culture or non-culture based microbiologic testing method, which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). The organism(s) identified in the blood must contain at least one MBI organism. (See Appendix A of the BSI protocol) ollowing: fever (>38.0°C), hypotension, nausea*, vomiting*, ent has at least two of the f 3. Pati abdominal pain or tenderness*, elevated transaminase level(s)*, or jaundice* of the following: And at least one organism(s) seen on Gram stain and/or identified from intraabdominal fluid or tissue a. or from an aseptically-placed drain in the intraabdominal invasive procedure obtained during space (for example, closed suction drainage system, open drain, T-tube drain, CT guided drainage) by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). organism(s) identified from blood by a culture or non-culture based microbiologic testing b. s performed for purposes of clinical diagnosis or treatment, for example, not method which i Active Surveillance Culture/Testing (ASC/AST). The organism(s) identified in the blood must contain at least one MBI organism (See Appendix A of the BSI protocol) AND imaging test evidence suggestive of infection ( for example, ultrasound, CT scan, MRI, ERCP, radiolabel scans [gallium, technetium, etc.] or on abdominal x-ray), which if equivocal is supported by clinical correlation, specifically, physician documentation of † antimicrobial treatment for intraabdominal infection. * With no other recognized cause Reporting instructions †  Biliary ductal dilatation is considered an equivocal finding for cholangitis.  Do not report pancreatitis (an inflammatory syndrome characterized by abdominal pain, nausea, and vomiting associated with high serum levels of pancreatic enzymes) unless it is determined to be infectious in origin.  Eligible laboratory results that represent transaminase levels include: serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) or aspartate transaminase (AST). Consider the requirement for elevated inase level(s) met if at least one is elevated as per the normal range provided by the transam laboratory. January 2019 17- 22

402 Surveillance Definitions NEC-Necrotizing enterocolitis Necrotizing enterocolitis in infants ( ≤1 year of age ) must meet one of the following criteria: 1. Infant has at least one of the clinical and one of the imaging test findings from the lists below: At least one clinical sign: (see ** ) Note a. bilious aspirate b. vomiting stention c. abdominal di occult or gross blood in stools (with no rectal fissure) d. And at least one imaging test finding which if equivocal is supported by clinical correlation NEC) (specifically, physician documentation of antimicrobial treatment for : a. Pneumatosis intestinalis Portal venous gas (Hepatobiliary gas) b. Pneumoperitoneum c. Bilious aspirate from a transpyloric feeding tube should be excluded **Note: of the f EC: Infant has at least one ollowing surgical findings: Surgical N 2. a. surgical evidence of extensive bowel necrosis (>2 cm of bowel affected) b. surgical evidence of pneumatosis intestinalis with or without intestinal perforation Reporting instruction  Necrotizing enterocolitis (NEC) criteria include neither a site-specific specimen nor organism identified from blood specimen, however an exception for assigning a BSI secondary to NEC is provided. A BSI is considered secondary to NEC if the patient meets one of the two NEC criteria AND an organism identified from blood specimen collected during the secondary BSI attribution period is an LCBI pathogen, or the same common commensal is identified from two or more blood specimens drawn on separate occasions collected on the same or consecutive days. SPIRATORY INFECTION, OTHER THAN PNEUMONIA LRI - LOWER RE LUNG -Other infection of the lower respiratory tract one Other infections of the lower respiratory tract must meet at least of the following criteria: Patient has organism(s) seen on Gram stain of lung tissue or pleural fluid or identified from lung 1. tissue or pleural fluid (when pleural fluid was obtained during thoracentesis or initial placement of chest tube and NOT from an indwelling chest tube) by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has a lung abscess or other evidence of infection (for example, empyema) on gross 2. anatomic or histopathologic exam. 3. Patient has imaging test evidence of abscess or infection (excludes imaging test evidence of pneumonia) which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for lung infection). January 2019 17- 23

403 Surveillance Definitions Reporting instruction  If patient meets LUNG and PNEU report as PNEU only, unless the LUNG is a surgical site organ/space infection, in which case, report both PNEU and SSI-LUNG. REPR-REPRODUCTIVE TRACT INFECTION EMET-Endometritis of the following criteria: Endometritis must meet at least one Patient has organism(s) identified from endometrial fluid or tissue by a culture or non-culture based 1. microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has at least two of the following signs or symptoms: fever (>38.0°C), pain or tenderness (uterine or abdominal)*, or purulent drainage from uterus. * With no other recognized cause Reporting instructions Do not report an HAI chorioamnionitis as EMET (see OREP).   if a Do not report subsequent postpartum endometritis after a vaginal delivery as an HAI patient is admitted with POA chorioamnionitis (OREP). (See next bullet for endometritis following a C-section). f a C-section was performed on a patient with  Report as an organ space SSI-EMET i chorioamnionitis, and the patient later develops endometritis. EPIS-Episiotomy infection of the following criteria: Episiotomy infections must meet at least one Postvaginal delivery patient has purulent drainage from the episiotomy 1. 2. Postvaginal delivery patient has an episiotomy abscess Comment: Episiotomy is not considered an operative procedure in NHSN. OREP- Deep pelvic tissue infection or other infection of the male or female reproductive tract ) including chorioamnionitis, but (for example, epididymis, testes, prostate, vagina, ovaries, uterus excluding vaginitis, endometritis or vaginal cuff infections one of the following Other infections of the male or female reproductive tract must meet at least criteria: January 2019 17- 24

404 Surveillance Definitions identified from tissue or fluid from affected site (excludes urine and 1. Patient has organism(s) ) by a culture or non-culture based microbiologic testing method which is performed vaginal swabs for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has an abscess or other evidence of infection of affected site on gross anatomic or histopathologic exam. two of the following localized 3. Patient has suspected infection of one of the listed OREP sites and signs or symptoms: fever (>38.0°C), nausea*, vomiting*, pain or tenderness*, or dysuria* And at least one of the following: a. organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). b. physician initiates antimicrobial therapy within two days of onset or worsening of symptoms * With no other recognized cause Reporting instructions Report endometritis as EMET.  Report vaginal cuff infections as VCUF.  If patient has epididymitis, prostatitis, or orchitis and meets OREP criteria, and they also meet  UTI criteria, report UTI only, unless the OREP is a surgical site organ/space infection, in which case, only OREP should be reported. VCUF -Vaginal cuff infection one of the following criteria: Vaginal cuff infections must meet at least 1. Post hysterectomy patient has purulent drainage from the vaginal cuff on gross anatomic exam. Post hysterectomy patient has an abscess or other evidence of infection at the vaginal cuff on gross 2. anatomic exam. identified from fluid or tissue obtained from the vaginal Post hysterectomy patient has organism(s) 3. cuff by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). on Reporting instructi Report vaginal cuff infections as SSI-VCUF  SST -SKIN AND SOFT TISSUE INFECTION BRST-Breast infection or mastitis A breast abscess or mastitis must meet at least of the following criteria: one Patient has organism(s) identified from affected breast tissue or fluid obtained by invasive 1. procedure by a culture or non-culture based microbiologic testing method which is performed for January 2019 17- 25

405 Surveillance Definitions purposes of clinical diagnosis or treatment for example, not Active Surveillance Culture/Testing (ASC/AST). Patient has a breast abscess or other evidence of infection on gross anatomic or histopathologic 2. exam. and local inflammation of the breast, 3. Patient has fever (>38.0°C) AND Physician initiates antimicrobial therapy within 2 days of onset or worsening of symptoms Reporting instruction  For SSI after a BRST procedure : if the infection is in the subcutaneous region report as a superficial incisional SSI, and if the infection involves the muscle/fascial level report as a deep incisional SSI. BRST Criterion 3, above, cannot meet organ/space Surgical Site Infections.  infection BURN-Burn Burn infections must meet the following criteria: Patient has a change in burn wound appearance or character, such as rapid eschar separation, or dark 1. brown, black, or violaceous discoloration of the eschar, AND Organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active ture/Testing (ASC/AST). Surveillance Cul CIRC-Newborn circumcision infection Circumcision one infection in a newborn (≤30 days old) must meet at least of the following criteria: 1. Newborn has purulent drainage from circumcision site. of the following signs or symptoms at circumcision site: erythema*, one 2. Newborn has at least swelling*, or tenderness*, AND Pathogen identified from circumcision site by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Cult ure/Testing (ASC/AST). one 3. Newborn has at least of th e following signs or symptoms at circumcision site: erythema*, swelling*, or tenderness*, AND Common commensal is identified from circumcision site by a culture or non-culture based ic testing method which is performed for purposes of clinical diagnosis or treatment, for microbiolog example, not Active Surveillance Culture/Testing (ASC/AST), AND days on onset or worsening of symptoms. two Physician initiates antimicrobial therapy within * With no other recognized cause January 2019 17- 26

406 Surveillance Definitions DECU-Decubitus ulcer infection (also known as pressure injury infection), including both superficial and deep infections Decubitus ulcer infections must meet the following criterion: of the following signs or symptoms: erythema*, tenderness*, or swelling of 1. Patient has at least two decubitus wound edges*, AND Organism(s) identified from needle aspiration of fluid or biopsy of tissue from ulcer margin by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). * With no other recognized cause SKIN-Skin infection (skin and /or subcutaneous) excluding decubitus ulcers, burns, and infections at vascular access sites (See VASC ). Skin infections must meet at least one of the following criteria: 1. Patient has at least one of the following:  purulent drainage pustules  vesicles   boils (excluding acne) 2. Patient has at least two of the following localized signs or symptoms: pain* or tenderness*, swelling*, erythema*, or heat* And at least one of the following : a. organism(s) identified from aspirate or drainage from affected site by a culture or non-culture based testing method which is performed for purposes of clinical diagnosis and treatment for example, not Active Surveillance Culture/Testing (ASC/AST). Identification of 2 or more common commensal organisms without a recognized pathogen is not eligible for use. Common Commensal organisms include, but not are not limited to, diphtheroids (Corynebacterium spp. not C. diphtheria), Bacillus spp. (not B. anthracis), Propionibacterium spp., coagulase-negative staphylococci (including S. epidermidis), viridans group streptococci, Aerococcus spp., Micrococcus spp, and Rhodococcus spp. For a full list of Common Commensals see the Common Commensal tab of the NHSN organisms list. b. multinucleated giant cells seen on microscopic examination of affected tissue ngle antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism c. diagnostic si * With no other recognized cause Reporting instructions  Do not report acne as a skin/soft tissue HAI.  Apply the site specific definition (not SKIN) for the following:  Report omphalitis in infants as UMB Report infections of the circumcision site in newborns as CIRC   For decubitus ulcers, apply the DECU infection. January 2019 17- 27

407 Surveillance Definitions  Report infected burns as BURN  Report breast abscesses or mastitis as BRST  Report localized infection at a vascular access site as a VASC unless there is an organism identified from blood, meeting LCBI criteria, which should instead be an LCBI (see VASC definition) reported as ST -Soft tissue infection (muscle and/or fascia [for example, necrotizing fasciitis, infectious gangrene, necrotizing cellulitis, infectious myositis, lymphadenitis, lymphangitis, or parotitis]) excluding decubitus ulcers, burns, and infections at vascular access sites (See VASC ). Soft tissue infections must meet at least one of the following criteria: 1. Patient has organism(s) identified from tissue or drainage from affected site by a culture or non- culture based mi crobiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) 2. Patient has purulent drainage at affected site. ient has an abscess or other evidence of infection on gross anatomic or histopathologic exam Pat 3. Reporting instructions  Apply the site-specific definitions identified below (not ST) for the following:  Report infected decubitus ulcers as DECU.  . BURN Report infected burns as  Report infection of deep pelvic tissues as OREP.  Report localized infection at a vascular access site as a VASC unless there is an VASC organism identified from blood, then it should be reported as an LCBI (see definition). UMB-Omphalitis Omphalitis in a newborn (≤ 30 days old) must meet at least one of the following criteria: 1. Patient has erythema or drainage from umbilicus one And at least of the following: a. organism(s) identified from drainage or needle aspirate by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) b. organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST). 2. Patient has erythema and purulence at the umbilicus Reporting instructions  Report infection of the umbilical artery or vein related to umbilical catheterization as VASC if there is no accompanying organism identified from blood specimen. VASC If the patient meets criteria for LCBI, report as a LCBI (see ).  January 2019 17- 28

408 Surveillance Definitions USI – Urinary System Infection [formerly OUTI] (kidney, ureter, bladder, urethra, or perinephric space ) of the following criteria: Urinary system infections must meet at least one 1. Patient has microorganism(s) identified from fluid (not urine) or tissue from affected site by a culture or non -culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) Patient has an abscess or other evidence of infection on gross anatomical exam, during invasive 2. ocedure, or on histopathologic exam. pr of the following signs or symptoms: Patient has one 3.  fever (>38.0°C)  localized pain or tenderness* of the following: An d at least one a. purulent drainage from affected site organism(s) identified from blood by a culture or non-culture based microbiologic testing b. s performed for purposes of clinical diagnosis or treatment, for example, not method which i Active Surveillance Culture/Testing (ASC/AST). AND imaging test evidence suggestive of infection, for example, ultrasound, CT scan, magnetic resonance imaging [MRI], or radiolabel scan [gallium, technetium]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for urinary system infection. following signs or symptoms: Patient <1 year of age has at least one of the 4.  fever (>38.0°C)  hypothermia (<36.0°C)  apnea*  bradycardia* lethargy*  vomiting*  An one of the following: d at least a. purulent drainage from affected site b. organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, for example, not Active Surveillance Culture/Testing (ASC/AST) AND imaging test evidence suggestive of infection, for example, ultrasound, CT scans, magnetic resonance imaging [MRI], or radiolabel scan [gallium, technetium]), which if equivocal is supported by clinical correlation, specifically, physician documentation of antimicrobial treatment for urinary system infection. * With no other recognized cause Reporting instructions Report infections following circumcision in newborns as SST-CIRC.  If patient meets USI criteria and they also meet UTI criteria, report UTI only, unless the USI is  a surgical site organ/space infection, in which case, only USI should be reported. January 2019 17- 29

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