1. QAPI What Medicare Really Wants? Presented to: Region 7 Presented on: February 13, 2015 Presented by: Gwen McNatt

2. Getting to Yes-Where: CMS Quality Strategy

3. Overview of CMS Approach

4. CMS Requirements + Survey Findings Program Design + Management ABO Verification Multi-Disciplinary Planning Patient + Living Donor Care Informed Consent Patient Selection Data Submission to OPTN Quality Assessment + Performance Improvement (QAPI) Risk-Adjusted Outcomes ( Graft + Patient Survival) Deficiency is Cited if: 1. SMR: Observed/Expected Failures > 1.5 (One-Year Post-Tx) 2. P <.05 (one-sided value, same as OPTN) 3. Observed minus Expected > 3

5. Five Medicare QAPI Themes 5

6. Key QAPI Themes 1.Design and Scope 1. Design + Scope (a) Effective (b) On-Going (c) Data-driven (d) Hospital-wide (e) Reflects Complexity of Hospital + Services (f) Focus on Outcomes + Prevention of Medical Errors

7. Regulation: Key QAPI Themes 1.Design + Scope 2.Organizational Awareness - Feedback Systems, Quality Indicators, Culture of Safety (a) Adverse Events 1.Identified Systematically, 2.Tracked, 3.Investigated 4.Analyzed 5.Used (b) Quality Indicators 1.Problem Prone Areas 2.High Risk Areas 3.Tracked 4.Used for Quality Improvement 2. Organizational Awareness: (a) Adverse Events (b) Quality Indicators High Reliability Organizations Weick, K.E + Sutcliffe, K.M; 2007 Managing the Unexpected, 2d Ed. San Francisco; Jossey-Bass

8. 2. Awareness - Feedback + QI Systems Adverse Events 1.Identified! (e.g., internal incident reporting systems) 2.Tracked, 3.Investigated 4.Analyzed 5.Used to Improve Systems – Prevent Recurrence …“to effect changes in the transplant center’s policies and practices to prevent repeat incidents” (42 CFR 482.96(b)(2)) Systematic Analysis for Systemic Improvement

9. Case Examples: Challenges Evident in Many Programs Root Cause Analysis (RCA) Expertise: Expertise Low Quest Quotient, Low Level of Systems Thinking Culture of Blame Silos, professional autonomy Informatics Expertise : Lack of expertise in using available sources of data, such as the SRTR data set. Informational Infrastructure: Info systems, measures, data input, staffing, tracking… Beliefs, Attitudes We don’t need this… QI is just an added burden imposed on us.

10. Case Example: The Case of the Non-Compliant Patient 5x Why or 5x How 1.How did he Die? Succumbed to Aspergillus

11. Were technical issues (surgical or non-surgical) a factor in this event? If yes, describe. Recommendation: Were donor selection issues a factor in this event? If yes, describe. Recommendation: Were recipient selection issues a factor in this event If yes, describe. Recommendation: Management: Was post-transplant management a factor in this event? If yes, describe. Recommendation: Management: Was medication dosing or protocols a factor in this event? If yes, describe. Recommendation: Management: Was coagulopathy a factor in this event? If yes, describe. Recommendation: Management: Were policies, protocol, or guidelines a factor in this event? If yes, describe. Recommendation: Recipient factors: Was non-compliance or missed care a factor in this event? If yes, describe. Recommendation: Were human resources an issue in this event? If yes, describe. Recommendation: Was communication a factor in this event? If yes, describe. Recommendation: Was a lack or misinterpretation of information a factor in this event? If yes, describe. Recommendation: Was lack or inadequate training a factor in this event? If yes, describe. Recommendation: Was availability or use of equipment a factor in this event? If yes, describe. Recommendation: Was the physical environment a factor in the event?If yes, describe. Recommendation: Contributing Factors

12. Develop a Improvement Master Plan

13. Case Example - The Case of the Non-Compliant Patient 5x Why or 5x How 1.How did he Die? Succumbed to Aspergillus 2.How ? Hung out at a Construction Site Failed to Follow Instructions to Avoid Construction Sites, Gardening

14. Case Example - The Case of the Non-Compliant Patient 5x Why or 5x How 1.How did he Die? Succumbed to Aspergillus 2.How ? Hung out at a Construction Site Failed to Follow Instructions to Avoid Construction Sites, Gardening 3.How Could he Fail to Follow Instructions? Instructions were Clear!

15. Case Example # 3 - The Case of the Non-Compliant Patient 5x Why or 5x How 1.How did he Die? Succumbed to Aspergillus 2.How ? Hung out at a Construction Site Failed to Follow Instructions to Avoid Construction Sites, Gardening 3.How Could he Fail to Follow Instructions? Instructions were Clear! 4.How were the Instructions Given Clearly Written with Warnings in his Instruction Materials

16. Case Example - The Case of the Non-Compliant Patient 5x Why or 5x How 1.How did he Die? Succumbed to Aspergillus 2.How ? Hung out at a Construction Site Failed to Follow Instructions to Avoid Construction Sites, Gardening 3.How Could he Fail to Follow Instructions? Instructions were Clear! 4.How were the Instructions Given Clearly Written with Warnings in his Instruction Materials 5.How is it that Written Instructions are Always Adequate?

17. Mastering SRTR Data as a QI Tool Valuable Quality Improvement Tool Risk-Adjusted Outcomes Data Subgroup Analyses Team Performance SRTR Methodology: http://www.srtr.org/csr/current/programs-report.aspx CUSUM Tool – Added July 2013

18. SRTR Tools (continued) SRTR Worksheets: https://securesrtr.transplant.hrsa.gov

19. Existing SRTR Quality Improvement Tool Kidney program – 1-year post-transplant graft survival for deceased donors All SRTR risk factors in this row This row auto re- calculates Sub- group? (Y/N)

20. QAPI Theme: Performance Improvement Projects 1.Design + Scope 2.Feedback, QI Systems, Awareness (a) Adverse Events 1.Reported, 2.Tracked, 3.Investigated 4.Analyzed (b) Quality Indicators 1.Problem Prone Areas 2.High Risk Areas 3.Tracked 4.Used for Quality Improvement 3.Performance Improvement Processes 4.Systemic Improvement 5.Governing Body + Leadership 3. Performance Improvement Projects and Processes (a) Not Specified by CMS (b) Tailored + Determined by Transplant Program (c) Used to Improve Systems (d) Data-driven (e) Effective (at least sometimes!)

21. QAPI Theme: Governing Body + Leadership 1.Design + Scope 2.Feedback, QI Systems, Awareness (a) Adverse Events 1.Reported, 2.Tracked, 3.Investigated 4.Analyzed (b) Quality Indicators 1.Problem Prone Areas 2.High Risk Areas 3.Tracked 4.Used for Quality Improvement 3.Performance Improvement Processes 4.Systemic Improvement 5.Governing Body + Leadership 5. Governing Body and Leadership (482.21 + 482.96) QAPI is: (a) Resourced (b) Used to Improve Systems (c) On-going (d) Data-driven (e) Hospital-Wide (f) Effective Special Responsibility to: (g) Set Expectations (h) Ensure Staffing/Personnel

22. Concerns How is this in the regs? What are triggers for FQAPI? Where are published Igs? Cost issues

23. Questions?