Directive 1103 Prevention of Retained Surgical Items

Transcript

1 Department of Veterans Affairs VHA Directive 1103 Transmittal Sheet Veterans Health Administration Washington, DC 20420 March 5, 2016 PREVENTION OF RETAINED SURGICAL ITEMS 1. REASON FOR ISSUE: T his Veterans Health Administration (VHA) Directive provides policy to prevent incidents of surgical items being retained in a patient following surgery. : C 2. SUMMARY OF MAJOR CHANGES ontent updated to include drains and guidewires The updated policy also describes the Critical as retained surgical items. Incident Tracking Notification (CITN) process for the field to document retained surg ical item events using a secure web -based intranet tool. The National Surgery Office (10A4E) to reconcile all (10NC2) works with the National Center for Patient Safety retained surgical items events to ensure complete capture and evaluate lessons learned. 3. RELATED ISSUES: None. he National Surgery Office (10NC2) in the Office of the 4. RESPONSIBLE O T FFICE : Assistant Deputy Under Secretary for Health for Operations and Management for . Questions may be Clinical Operations is responsible for the content of this Directive directed to the National Director of Surgery at 202- 461 -7130. 5. RESCISSIONS : V HA Directive 2010- 017, Prevention of Retained Surgical Items, is rescinded . 6. RECERTIFICATION : Th is VHA Directive is due for recertification on or before the last working day of March 2021. Da vid J. Shulkin, M.D. Under Secretary for Health Emailed to the VHA Publication Distribution List on 3/7/2016. DISTRIBUTION: T-1

2 March 5, 2016 VHA DIRECTIVE 1103 PREVENTION OF RETAINED SURGICAL ITEMS 1. PURPO SE This Veterans Health A dmi nistration (VHA) Directive provides policy to prevent s be ing retained in a patient following surgery. AUTHORITY: incidents of surgical item 38 USC 7301(b). 2. BACKGROUND a. Surgical ite ms are defined as instru ments, sharps, soft goods, drains, guidewires , or any m the surgical team to perform an operative procedure. Sharps aterials used by are surgical nee dles, aspirating needles, blunt needles, scalpel blades, or any item s with a sharp or pointed edge that pose a risk for skin puncture by me mbers of the surgical team . Soft goods include cotton gauze sponges of various sizes, laparotomy pads, surgical tow aterials not intended to re main in the patient’s els, or any absorbent m body after the surgical procedure is completed. b. A surgical item is considered to be retained if it is an item or parts thereof not intended to remain and is found in any part of the patient’s body after the patient has Drains are retained if placed been taken from the operating or procedure room. intentionally in the operating room (OR) for subsequent removal (example Penrose OR, all or a drain, chest tube, ureteral stent) but upon attempted removal outside the is unintentionally retained requiring an invasive procedure with portion of the drain informed consent for removal . The National Surgery Office (NSO) and the National Center for Patient Safety c. For Fiscal Year 2014, the VHA (NCPS) collect data for retained surgical items. incidence estimated rate of retained surgical items was determined to be 1 in 17,200 surgical procedures. This rate compares favorably to the national incidence rate for retained surgical items reported to range from 1 in every 8,000 to 18,000 procedures . is considered a senti urrence of a retai ned sur gical item nel event, d. The occ requires Root Cause Analysis (RCA), and The NCPS must be reported to the NCPS. ational Director of Surgery. aggregates RCA data and reports quarterly to the N NOTE: VHA Handbook 1050.01, VHA National Patient Safety Improvement , provides further guidance regar ding sentinel event reporting and requirements for patient disclosure . e. Beginning in August 2010, the NSO established the Critical Incident Tracking Notification process to collect retained surgical item events using a secure web -based intranet tool. On a quarterly basis, the NSO and NCPS reconcile all retained surgical item events to ensure complete capture, evaluation and determination of lessons . learned 1

3 March 5, 2016 VHA DIRECTIVE 1103 3. POLICY at the s urgi cal team m ust apply a standard approach to the It is V HA policy th ms when the operative procedure being perfor med is of retained s prevention urgical ite sibility one in which ther e is any pos for retention of a surgical item. 4. RESPONSIBILITIES Director. facility Director is responsible for ensuring a. The Facility at the lo cal le vel. compliance with this Directive Facility Chief of Surgery. The Chief of Sur gery is resp b. suring t hat onsible for en the surgical team perfo ing an operative procedure in which there is any possibility for rm cal it (including laparoscopic procedures) adheres to the followin g retention of a surgi em standar ds: Soft Goods . All soft goods that are placed in the surgical field mu (1) st be left in their original configuration must not be cut or altered in any way, or used for and dressings. (2) S urgical items intended for placement in the Radiopaque Surgical Items. heral to the op erating field and have the potential surgical wound or are placed perip to be placed in the surgical wound must be radiopaque (detectable by a radiograph). (3) Non Non -radiopaque surgical item s that are -Radiopaque Surgical Items. in the operating room, for exam ple, sponges used dur must used ing IV line insertion, ptacle de aste rece nated for that purpose a nd never in be disposed of in a separate w sig e space with counted surgical items. th e sam (4) Methodical Wound A methodical wound expl oration must be Exploration. med before closing the sur perfor ery case to ensure t hat all surg ical gical wound in ev ite ms are accounted for and extracted. (a) The space to be closed m ust be caref ully exa mined. Spe cial focus must be given to closure of a cavity within a cavity (e.g., heart, m ajor vessel, stom ach, bladder, uterus, and vagina). (b) A methodical wound explor must be perfor med before re moving stationary ation or table mounted retractors. (c) The surgeon m ust visually and m anually explore the o perative fiel d, making every effort to rem s left within a body cavity. ove any and all surgical item (d) A methodical visual inspection of the body cavity is required when performing a minimally invasive lap aroscopic , thoracoscopic , or arthroscopic procedure. (e) A methodical wound sweep is required for cataract procedures utilizing the microscope. 2

4 March 5, 2016 VHA DIRECTIVE 1103 me during wound closure, the s med of an inaccurate (f) If at any ti urgeon is infor count of surgical item s the surgeon m ust stop clos ing the wound and perform a methodical wound exam ination while O R sta ff continues to look repeat for the missing surgical ite m. Count of Surgical Items. All s urgical ite (5) unted in ms must be co every case. (a) A count of surgical ite ms must occur: 1. Before the procedure has begun or the incision is made to establish a baseline count; 2. When new soft goods and/or sharps are added to the field 3. When a drain or other miscellaneous item is cut, all pieces must be accounted for and counted. fore the cl osure of a cavity within a c avit y; 4. Be 5. Before wound closure begins; 6. At skin closure or end of procedure; and 7. At the ti me of pe rmanent relief of either the scrub person or the RN circulator . (b) OR staff must be allowed sufficient ti me for a count of surgical item s to be perfor med. 1. All surgical coun ts are performed using a standard two- person prac tice; the person and RN ite ms are counted audibly and viewed concurrently by the scrub circulator . ember of the surgical team regarding the 2. Any ti me there is a question by any m performed . must be count, an additional count ust never assum e that the count on prepackaged 3. Perioperative personnel m ms is accurate. The contents of each package must be cou nted sterilized ite individually by the scrub person and RN circulator using the standard two -person tice. If the package has an incorrect number of item s and the procedure has not prac begun, the entire pack must be re moved from the OR. If the procedure has begun, the pack must be bagged, properly labeled, and isolated from the other counted ite ms. 4. Counts must be perfor med in the sa me sequence each time. The cou nt needs to begin at the surgical site and the immed iate surrounding area, proceed to the instru ment stand and back table, and finally to the counted ite ms (soft goods , sharps, The use of assistive or instru ments) that have been discarded fr om the field. NOTE: 3

5 March 5, 2016 VHA DIRECTIVE 1103 technologies, including radiofrequency tags to detect technology –enabled soft goods to and radio frequency identification (RFID) systems, are adjunct technologies counting process but supplement manual the not replace the requirement to perform a count of surgical items in every case. ented in the Veterans Health Information 5. All relief personnel must be docum ) Surgery Pac Systems and Technology Architecture ( he VistA kage and will appear in t Operative Record. Nurse Intra- The surgeon m ust be infor med by OR staff at the ti me a discrepancy in a count (c) ms is d of surgical ite ve that a reasonable and appropriate iscovered. It is imperati search of the oper aken to recover the item ative field and surrounding area be undert in question and resolve the discrepancy. (d) When soft goods are used as therapeutic packing and the patient leaves the operating room with packing in place, the number and types of items placed must be documented in the VistA Surgery Package under nursing comments in the Nurse Intra -Operative Report. If and when the patient returns to the operating room for a subsequent procedure including the remove of the therapeutic packing, the number and type of radiopaque soft goods must be simi larly documented and excluded from subsequent counts of surgical items. Use of Intraoperative Radiograph. (6) (a) gical field is not requ ired if a methodical An intraoperative radiograph of the sur wound exploration is perfor count of all surgical ite ms is co rrect at the med and a completion of the procedure. must (b) A radi ograph of the entire surgical field to rule out a retained surgi cal item be perfor med mpletion of the surgical and interpreted by a physician at the co nt’s tr the OR, in the following circu mstan ces: from procedure, prior to the patie ansfer i.e., the preoperative surgical item 1. When the surgical count is “incorrect” ( s added during the procedure is grea count plus surgical item han the ter or less t post urgical item count) and the surgical item in question is not recovered operative s following a methodical wound exploration. ust interpret the radiograph and notify the surgical team by a. A radiologist m verbal or written communication when the missing surgical item is not found. The radiologist’s report must be made available to the sur gical team in a ti mely fashion recom mended to be less than 30 m the ti me the radiograph is inutes from ning a ew nal vi requested. Consideration should be given to obtai s, for dditio ple, an obl ique view of the ope rati ve site when initial radiographs do not exam reveal the missing item and the item still has not been found. NO TE: The surgeon has the discreti on to close t he surgic al wound prior to receiving a report from the radiologist regarding a missing s urgical item if delaying wound closure would substantially increase risk for the patient. 4

6 March 5, 2016 VHA DIRECTIVE 1103 ent for a gist to int erpr et the radiog raph if the b. There is no requirem radiolo cal team subsequently finds the missing object, thereby es tablishing t he surgi cal surgi co unt as correct. c. When the surgical wound does not involve a body cavity and the entirety of the wound is visible to the surgical team, the attending surgeon may determine that an intraoperative radiograph is not required when a count of surgical items is “incorrect.” All members of the surgical team must be in agreement. The attending surgeon must document the circumstances and reason for not obtaining an intraoperative radiograph in the patient’s electronic health record. 2. Radiography will be substituted for an instrument count when the surgeon, scrub person, and RN circulator unani mously agree that the number of surgical instru ments utilized during t he o perative procedure prohibits an expeditious and ti mely count. This sit uation is typically encountered with m ments. NOTE: ajor joint replace count of all sharps and soft goods A methodical wound exploration and must still be performed even t hough a radiograph is substituted for the surgical instrument count in such circumstances. 3. When the cli nical circu mstances dictate the patient requires em ergency care and the counting of surgical item be in the best interest of the patient. This s may not divergence or om ission from standard protocol (i.e., methodical wound explorat ion and com plete surgical item count) m ust be docu mented in the OR record in the following manner: a. The surgeon m ment in the operative report describing the ust include a state the patient, emergent nature of the procedure, the clinical condition of and the reasons for divergence from or o mission of standard protocol. b. The circulating nurse must enter a state ment in the “Nursing Care C omments” Sur gery Package, which will appear in the Nurse Intra -Operati ve section of the VistA Report describing the em ergent nature of the surgical pr clin ical co ndition ocedure, the patien t, and the asp of the ndard prot ocol was o mitted or modi fied. ects in which sta c. In such cases, a radiograph m ust be obtai ned in the Post -Anesthesia Recovery Unit or Intensive Care Unit and interpreted by a radiologist to rule out a ditio unless contr cated by the p atie nt’s cli retained surgical item aindi n. nical con 4. When the operative procedure being perfor me d is one deter mined by any member of the surgical team to be at high risk for retai ned surgical ite ms, even though a methodical wound exploration has been perfor he surgical item count is med and t correct. NO TE: The following operative procedures should be considered at high risk for retained surgical items: emergency procedures involving a body cavity; unexpected change in the conduct or scope of the operative procedure; operative procedures involving more than one surgical team; operative procedures of considerable duration shift change; unexpected transfusions particularly those that require a nursing staff 5

7 March 5, 2016 VHA DIRECTIVE 1103 defined as greater than 4 units of packed red blood cells; and high patient body mass index (BMI > 35) . 5. REFERENCES a. VHA Handbook 1050.01, VHA National Patient Safety Improvem ent Handbook. March 4, 2011. b. Cima, R.R., Kollengode , A., Garnatz, J., Storsveen, A., Weisbrod, C., Deschamps, C., “Incidence and Characteristics of Potential and Actual Retained Foreign Object Events in Surgical Patients,” Journal of the American College of Surgeons, July; 207 (1): 80- 87, 2008. c. The Joint Commission Sentinel Event Alert 51: Preventing unintended retained foreign objects. Published October 17, 2013, available at http://www.jointcommission.org/sea_issue_51/ d. Association of Perioper ative Registered Nurses. Guideline for Prevention of Retained Surgical Items . 2015, available at: http://www.aornstandards.org 6

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