1 Clinical Quality Management Policy Notice Clarification Clarification Policy -02 Notice (PCN) #15 Related legislation: Title XXVI of the Public Health Service (PHS) Act §§ 2604(h) (5), 2618(b)(3)(E), 2664(g)(5), and 2671(f)(2) Scope of Coverage: (RWHAP) Parts A, B, Ryan White HIV/AIDS Program C, and D Purpose of PCN: The purpose of th is PCN is to clarify the Health Resources and Services Administration (HRSA) RWHAP expectations for clinical quality management program (CQM) s. Background: 1 Parts A – D Title XXVI of the Public Health Service Act RWHAP the requires establishment program to: of a clinical quality management (CQM) • Assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent Public Health Service guidelines , (otherwise known as the HHS guidelines ) for the treatment of HIV disease and related oppo s; and rtunistic infection • Develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to , and quality of HIV services. 1 See §§ 2604(h)(5), 2618(b)(3)(E), 2664(g)(5), and 2671(f)(2) of the PHS Act. 1

2 The CQM requirement ; it is the applies directly to Parts A – D recipients with their subrecipients to responsibility of the recipient to work directly , monitor and provide any needed data on the CQM program . implement Health care’s adaptation of continuous quality improvement and total quality management techniques from manufacturing began nearly 50 years ago 2,3,4 . Over the years since, a large body with much momentum in the 1980s of evidence has emerged suggesting a robust and effective CQM program contribute to overall improvements in healthcare quality delivery. CQM is a 5 updated July component in the National HIV/AIDS Strategy (NHAS), major for both optimizing health outcomes and ultimately reducing HIV 2015, Coordination of CQM program activities is encouraged across all incidence. RWHAP funded recipients and s ubrecipients within a service area or a service to support a reduction in data burden and alignment of performance area and to maximize the impact of improved health outcomes. measurement Components of a CQM Program A CQM program is the coordination of activities aimed at improving patient care, health outcomes, and patient satisfaction. To be effective, a CQM program requires: • Specific aims based in health outcomes; Support by identified leadership • ; • Accountability for CQM activities; • Dedicated resources; and 2 Donabedian A. Evaluating quality of medical care. Milbank Q. 1966;44:166– 206. 3 Donab edian A. Exploration of quality assessment and monitoring. Vols 1, 2, 3. Ann Arbor, Michigan: Health Administration Press, 1980. 4 Berwick DM. Continuous improvement as an ideal in health care. N Engl J Med 1989;320: 53- 6. 2 5 National HIV/AIDS Strategy. The White House. Accessed at - -strategy/overview/ reso urces/national -hiv -aids 2

3 • and make Use of data and measurable outcomes to determine progress to achieve the aims cited above improvements . CQM activities should be continuous and fit within and support the are strongly framework of grant administration functions. Recipients encouraged to use the NHAS to frame CQM activities and goals . In order to develop a CQM program that improves patient care, health outcomes , and patient satisfaction, certain components are necessary. Th e three necessary components are infrastructure, performance measurement , and , and e ach of these components have a distinct role quality improvement in the overall CQM program. All are important to implemen t a comprehensive CQM program that is able to meet established goals. Recipients may choose to have subcontracts for some or all of the CQM activities . Recipients may also work collaboratively with their stakeholders such as planning councils/planning bodies , governing bodies, and/or board of directors , as appropriate. Whatever mechanism is used, t he recipient is responsible for ensuring that the CQM program HRSA’s ultimately meets requirements for the RWHAP Parts . A. Infrastructure Appropriate and sufficient infrastructure is needed to make the CQM program a successful and sustainable endeavor. I nfrastructure is needed to plan, implement, and evaluate CQM program activities . Utilization of RWHAP grant funds to establish e for a CQM program is an appropriate infrastructur allowed . An ideal i nfrastructure consists of: • Leadership: Leadership to guide, endorse, and champion the CQM program • Committee : A CQM committee that develops the CQM program and corresponding activities 3

4 • : Staff who are responsible for CQM duties and Dedicated Staffing , as well as any contractors that may be funded to assist with resources CQM work • Dedicated Resources: Resources for building capacity in order to carry out (e.g. , training on collecting performance meas urement CQM activities ) data A quality management plan describes all • Quality Management Plan: aspects of the CQM program including infrastructure, priorities, performance plan with a measures, quality improvement activities, action timeline and responsible parties , and evaluation of the CQM program • Consumer Involvement : People living with HIV (PLWH) involvement that reflects the population that is being served and ensures that the needs of PLWH are being addressed by CQM activities nvolvement (e.g. : Stakeholder i • , subrecipient, Stakeholder Involvement recipients in region, planning body and/or its committees , other consumers ) that provide s input on CQM activities to be undertaken • Evaluation of CQM Program : Evaluating the effectiveness of the CQM program ensures that the CQM activities are making changes that positively affect outcomes. This evaluation includes assessing whether CQM program activities have been implemented as prescribed by the quality manage ment plan (including the action plan). Recipients should include regular evaluation of their CQM activities in order to maximize the impact of the program. Evaluation provides the opportunity to learn the processes and resources needed in implementing CQ M activities through the collection of detailed information. Part of the evaluation should include identifying factors (i.e., staff acceptance of change, improved clinical performance, etc.) that affect the quality improvement activities. Evaluation also identifies effective improvement strategies that can be scaled up or implemented in other facets within a system of care. 4

5 Additional elements of an evaluation include effectiveness of the team and its ability to meet timelines and deliverables as describ ed in the action plan in order to determine the success of the planned process. vary in scope among recipients, the inclusion Although the infrastructure will these elements creates a strong foundation for the CQM program. of all Performance Measurement B. Performance measurement is the process of collecting, analyzing, and reporting data regarding patient care, health outcomes on an individual or population level, and patient satisfaction . In or der to appropriately assess outcomes, measurement must occur. Measures should be selected that best assess the services the recipient is funding. A sound performance measure portfolio is reflective of RWHAP identified needs of PLWH . funded services, local HIV epidemiology, and 6 are strongly encouraged to include HRSA HIV/AIDS Bureau Recipients and 7 HHS that measures align with the National HIV/AIDS Strategy (updated July 2015) . Recipients should have an identified process to regularly collect which wou and analyze performance measure data ld occur more frequently than data collection for reporting (i.e., the annual Ryan White HIV/AIDS ). It is also important for recipients to collect and analyze Service Report and improvement of performance measure data that allows for inspection health disparities across different target populations . In order to optimally support quality improvement activities, data collection for the CQM 8,9, 10 performance measures should occur quarterly at a minimum as this 6 HIV/AIDS Bureau HIV Performance Measures. 2013. Accessed at 7 Department of Health and Human Services. Common Indicators for HHS -funded HIV Programs and Services. Accessed at -common -hiv -indicators.pdf 8 Institute for Healthcare Improvement. How to Improve. Accessed at 5

6 ation of the affords appropriate reevalu effects of improvements that have . All funded service categories need to have at least one been implemented and highly prioritized performance measure. F or each highly utilized -funded service category RWHAP recipients should identify two performance measures and collect the corresponding performance measure data. Quality Improvement C. Quality improvement entails the development and implementation of activities to make changes to the program in response to the performance To do this, recipients are required to implement quality data results. improvement activities aimed at improving patient care, health outcomes, 11 Recipients are expected to implement quality and patient satisfaction . improvement activities using a defined approach or methodology (e.g. , 12 13 , Lean model for improvement , etc.). Quality improvement activities should be implemented in an organized, systematic fashion. As a result, the recipient to understand if specific changes or improvements had a is able positive impact on patient health outcomes or were indicative of further necessary changes in RWHAP funded services. All quality improvement activities should be documented. Related Activities Quality Assurance 9 Joint Commission. Tools for Performance Measurement in Health Care: a Quick Reference Guide. Access at 10 The timing of data collection for performance measures should be dependent on the availability of the data element. However, t he HIV/AIDS Bureau recommends quarterly data collection for quality improvement projects. 11 See §§ 2604(h)(5), 2618(b)(3)(E), 26 64(g)(5), and 2671(f)(2) of the PHS Act. 12 Institute for Healthcare Improvement. Model for Improvement. Accessed at toImprove/ScienceofImprovementHowtoImprove.aspx 13 Lean Enterprise Institute. What is Lean? Accessed at 6

7 Quality assurance refers to a broad spectrum of activities aimed at ensuring compliance with minimum quality standards. Quality assurance activities include the retrospective process of measuring compliance with standards delines, service standards ). Site visits , professional gui HHS guidelines (e.g., and chart review quality assurance s are examples of commonly used , activities. Quality assurance is not the same as quality improvement he results of quality assurance activities can be used to develop although t quality improvement activities. is part of the larger administrative function of a recipient’s Quality assurance program or organization and informs the clinical quality management program , but q uality assurance activities by themselves do not constitute a CQM program . Data collected as part of quality assurance processes should feed back into the CQM program to ensure improvement in patient care, health outcomes, and patient satisfaction. Grant Administration Grant administration refers to the activities associated with administering a 14 These include contracting of RWHAP grant or cooperative agreement . services, receipt and disbursal of program funds, data collection and submission of reports, monitoring of subrecipients, and compliance with audit requirements. Although these functions are necessary to comply with the terms and conditions of the award, their intent is not on improving health outcomes. Therefore , they are not CQM activities. See Appendix . 14 -01 Treatment of Costs Under the 10% Administrative Cap for RWHAP Parts A, B, C, and D available See PCN #15 at 7

8 cability to Appli Subrecipients are to identify the specific CQM program activities for their service Recipients ) or network (Part C and D recipients ). Specific area (Part A and B recipients performance measure portfolio, frequency CQM program activities include a of performance measure data collection, and identification of quality improvement activities, among other items. Recipients need to ensure that that their subrecipients provide services have the capacity to contribute to the recipient’s CQM program , have the resources to conduct CQM activities , and implement a CQM program in their organizations , in their organizations in the written agreements between the re cipient and as identified subrecipient. Recipients are expected to provide guidance to subrecipients on prioritizing measures and collecting data. Recipients need to work with subrecipients to identify improvement opportunities and monitor quality improvement activitie s at the subrecipient locations. Prioritization of CQM should be coordinated across service activities RWHAP recipients within and areas funded through the recipient. subrecipients Resource s Department of Health and Human Services Guidelines: Each set of Guidelines (see examples below) is developed by Panels or working groups the National Institutes of Health’s Office of AIDS Research and Advisory from Council , Centers for Disease Control and Prevention, Health Resources and Services Administration, and other agencies . These g uidelines are meant to provide HIV care practitioners with recommendations based on current knowledge. The working group or Panel reviews new evidence and updates recommendations in the G uidelines , when needed. ntiretroviral Guidelines • Adult and Adolescent A 8

9 • pportunistic Infection (OI) Prevention and Adult and Adolescent O Treatment Guidelines Perinatal Guidelines • • Pediatric Guidelines • Pediatric OI Prevention and Treatment Guidelines • HIV Prevention with Adults and Adolescents with HIV in the United States Recommendations (Prevention With Positives) • Pre -exposure Prophylaxis Guidelines nes2014.pdf First released in 2010 by the White House National HIV/AIDS Strategy: Office of National AIDS Policy and updated in July 2015 , NHAS is a concise plan that will identify a set of priorities and strategic action steps tied to measurable outcome s. The objectives and recommendations of the HIV Care Continuum Initiative have been fully integrated into the updated NHAS . reso -hiv -aids - urces/national strategy/overview/ HIV Care Continuum: ( Included as part of the NHAS as of July 2015 ) The HIV care continuum —sometimes also referred to as the HIV treatment cascade —is a model that outlines the sequential steps or stages of HIV me dical care that PLWH go through, from initial diagnosis to achieving the goal of viral suppression (a very low level of HIV in the body). The HIV care continuum also shows the proportion of individuals living with HIV who are engaged at each stage. resources/policies/care -continuum/ 9

10 National Quality Center: The a cooperative HIV/AIDS Bureau funds technical assistance to the agreement that focuses on providing training and RWHAP understanding of recipients to improve quality of care through an quality improvement concepts; a s well as the use of tools, techniques and various approaches to implement quality management and quality improvement initia tives in their respective programs. Institute for Healthcare Improvement (IHI): IHI is a recognized innovator, convener, and generous leader, a trustworthy partner, and a place to turn for expertise, help, and encouragement for anyone, anywhere who wants to profoundly change health care for the better. 10

11 Appendix: Relationship between Grant Administrative Functions/Administrative Costs/Quality Assurance and : CQM Grant administration functions/administrative costs are capped pursuant to legislation and include those activities associated with RWHAP the administering a RWHAP grant or cooperative agreement. These include contracting of services, receipt and disbursal of program funds, data collection and submission of reports, monitoring of subrecipients, and compliance with audit requirements. Although these functions are necessary to comply with the terms and conditions of the award, their intent is not on improving health outcomes. Grant administrative activities may include components of qualit y assurance and may provide important information to the CQM program, but by themselves are not CQM activities nor constitute a CQM program. The chart below demonstrates the overlap between Quality Assurance activities and CQM activities. The following table illustrates relevant activities under CQM and QA: Quality Assurance Clinical Quality (Administrative Management Activity Costs) Performance measurement X prioritization and alignment RWHAP Parts in the with other service area Development of X Service Standards X Data extraction for clinical quality management purposes (collect, aggregate, analyze, and report on measurement data) 11

12 X X Chart audits/reviews X Monitoring site visits If the purpose for the site visit is to assess or monitor the CQM Program X Extracting data for reporting to internal and external stakeholders Electronic health records X interface with other providers; system operations X CQM committee in planning for quality improvement projects 12

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