1. Quality Initiatives SCAI Quality Symposium 24 th Great Wall International Congress of Cardiology Asia Pacific Heart Congress 2013 October 12, 2013 Beijing, China Charles E. Chambers, MD, FSCAI President Elect, Society for Cardiovascular Angiography & Interventions Chairman, SCAI Laboratory Survey Committee Professor of Medicine and Radiology Pennsylvania State University College of Medicine Director Cardiac Catheterization Laboratories, Hershey Medical Center, PA Charles E. Chambers, MD, FSCAI President Elect, Society for Cardiovascular Angiography & Interventions Chairman, SCAI Laboratory Survey Committee Professor of Medicine and Radiology Pennsylvania State University College of Medicine Director Cardiac Catheterization Laboratories, Hershey Medical Center, PA

2. Advances in Cardiovascular Disease Diagnosis and Therapy in the US CV Mortality Correction: 1950 to 2007 There has been a dramatic reduction in CV disease death rates over the past 57 years There has been a dramatic reduction in CV disease death rates over the past 57 years 586 CV deaths per 100,000 in 1950 586 CV deaths per 100,000 in 1950 188 CV deaths per 100,000 in 2007 188 CV deaths per 100,000 in 2007 Considering the current US population of 300 million, 1.2 million fewer CV deaths/yr than if it were 1950 Considering the current US population of 300 million, 1.2 million fewer CV deaths/yr than if it were 1950 The number of lives saved annually is greater than all American deaths in all our wars combined The number of lives saved annually is greater than all American deaths in all our wars combined

3. Mission Statement SCAI promotes excellence in invasive and interventional cardiovascular medicine through physician education and representation, and the advancement of quality standards to enhance patient care. SCAI promotes excellence in invasive and interventional cardiovascular medicine through physician education and representation, and the advancement of quality standards to enhance patient care. Society for Cardiovascular Angiography and Intervention

4. SCAI Publications 1978-1998

5. …and the work continues

6. A Quality Improvement Program for all Cath Laboratories A Quality Improvement Program for all Cath Laboratories RecommendationCORLOE Every PCI program must have a quality improvement program that routinely: a) reviews quality and outcomes of the entire program; b) reviews results of individual operators; c) includes risk adjustment; d) provides peer review of difficult or complicated cases, and; e) performs random case reviews IC Participation by every PCI program in a regional or national PCI registry for the purpose of benchmarking its outcomes against current national norms IC Participation by all physicians that perform PCI in the American Board of Internal Medicine interventional cardiology board certification and maintenance of certification program IIaC ACC/SCAI 2011 PCI Guidelines Update

7. How to Implement a Cath Lab Quality Program STEP 1: SCAI position paper on cath lab quality cited below STEP 2: Assemble Cath Lab QI Committee STEP 3: Determine Which Quality Measures to Follow STEP 4: Identify a database or method to capture data STEP 5: Develop Plan to Capture Data STEP 6: Analyze Data STEP 7: Using Benchmark Comparisons, Identify Quality Concerns STEP 8: Implement Plan- Do-Check-Act Cycle STEP 1: SCAI position paper on cath lab quality (www.scai.org, under header bar “guidelines and quality” select “guidelines”, access link to article under “2011, May”)www.scai.org

8. STEP 2: Assemble Cath Lab QI Committee a. Chairperson: a physician trusted by all e.g., Director of Cath Lab or Interventional the Physician Champion b. Lab Staff Champion (Staff QA Coordinator) c. Physician Support (Invasive cardiologists) d. Physician Extenders e. Laboratory Support Staff Cath Lab technical director or chief technologist f. Cath Lab/Recovery Area g. Cath Lab Administrator/Hospital Administrator h. Consider cardiac surgeons, other cardiologists, internists, ER physicians & other representative from hospital QA department, and IT support. Team work is essential

9. Responsibilities of the Cath Lab Quality Committee 1. Regular Meetings (monthly) 2. Identify metrics of care to be monitored (from NCDR reports) 3. Review all serious adverse events (e.g., death, emergency CABG) 4. Perform random film audits (e.g., 1 case per MD for appropriateness, adequate imaging, outcome) 5. Review data on process and outcome metrics. 6. Identify quality issues. (e.g., any complication with frequency > 90 th ile of peer hospitals). (e.g., any physician with outlier incidence of complications) 7. Develop remediation plans, oversee implementation, check results. (i.e., plan/do/check/act cycle) 8. Refer larger issues for appropriate intervention. (e.g., disruptive physician behavior referred to department director) Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers CE, et al.: American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards. Update 2012. J. Am. Coll. Cardiol. May 8, 2012 as doi: 10.1016/j.jacc.j.jacc.2012.02.010.

10. STEP 3: Determine Which Quality Measures to Follow Structural Domain Structural Domain Hospital and cath lab structure, Credentialing, Educational Efforts Hospital and cath lab structure, Credentialing, Educational Efforts Process Domain Process Domain Monitoring patient, System related, Guidelines related, Cost/Utilization Monitoring patient, System related, Guidelines related, Cost/Utilization Outcomes Domain Outcomes Domain Monitoring of outcomes on a regular basis including risk adjusted mortality, procedure related LOS, fluoro time, etc., complications (30 days) with data sharing and reporting. Monitoring of outcomes on a regular basis including risk adjusted mortality, procedure related LOS, fluoro time, etc., complications (30 days) with data sharing and reporting.

11. In the US, NCDR’s Cath/PCI Data Registry is easiest solution: In the US, NCDR’s Cath/PCI Data Registry is easiest solution: 1. 85% of cath labs use cath PCI Registry 1. 85% of cath labs use cath PCI Registry 2. Quarterly reports summarize institution’s data 2. Quarterly reports summarize institution’s data 3. Results are compared to all hospitals 3. Results are compared to all hospitals 4. Trends are evident over time 4. Trends are evident over time 5. Problem areas are easily identified (e.g., >90 th %’tile complication rate) 5. Problem areas are easily identified (e.g., >90 th %’tile complication rate) 6. Mortality data is risk adjusted 6. Mortality data is risk adjusted STEP 4: Identify a Database or Method to Capture Data

12. 1. Requires dedicated personnel (e.g., nurses) a. Data from untrained personnel is unreliable (e.g., floor nurses) a. Data from untrained personnel is unreliable (e.g., floor nurses) 2. Docs must provide some technical data (e.g., coronary anatomy details) 3. Docs can’t be relied on for all data (they won’t do it all) 4. Auto-population of database from in-lab system is ideal 5. Identifying post-PCI complications is most difficult part a. Confirm complications with interventionist before entry into database. a. Confirm complications with interventionist before entry into database. 6. Work with other hospital departments to obtain data a. Health Physics/Rad Safety can provide data on radiation exposure a. Health Physics/Rad Safety can provide data on radiation exposure b. Hospital QI committee can provide data on readmissions w/in 30 days b. Hospital QI committee can provide data on readmissions w/in 30 days STEP 5: Develop Plan to Capture Data

13. STEP 6: Analyze Data For Individual Adverse Events 1. Review data, records, cine images, etc. a. Benchmark—“something that serves as a standard by which others may be measured or judged 2. QI Committee evaluates quality of care surrounding the adverse event a. relationship of event to procedure: direct, indirect, not related b. relationship of event to sub-optimal care: direct, indirect, not related c. quality of care: sub- optimal, optimal, any opportunity for improvement Klein LW et al. Quality assessment and improvement in interventional cardiology: a position statement of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Intervent 2011;77:927-935

14. STEP 7: Using Benchmark Comparisons, Identify Quality Concerns

15. 1. Develop strategy to address problem 2. Implement strategy 3. Measure results 4. If not satisfactory, repeat cycle Example for US: D2B is > 90 minutes routinely --- Plan: Evaluate opportunities for improvement --- Plan: Evaluate opportunities for improvement --- Do: Implement pre-hospital EKG-based cath lab activation --- Do: Implement pre-hospital EKG-based cath lab activation --- Check: Measure D2B after new system implemented --- Check: Measure D2B after new system implemented --- Act: If D2B still > 90 minutes, repeat the cycle. --- Act: If D2B still > 90 minutes, repeat the cycle. STEP 8: Implement Plan-Do- Check-Act Cycle: Close the Loop Klein LW et al. Quality assessment and improvement in interventional cardiology: a position statement of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Intervent 2011;77:927-935

16. Now, How Can This Functioning Quality Assurance/ Quality Improvement Program Be Effective? Now, How Can This Functioning Quality Assurance/ Quality Improvement Program Be Effective? ■ QA/CQI Committee ■ Data collection process ■ Direct patient-care related indicators ■ System-specific indicators ■ Guidelines-driven indicators ■ Cost-related indicators ■ Outcome-related indicators ■ Physical/Service ■ SCAI QI Toolkit QA/QI Components Clinical Proficiency Review Peer Review Equipment Performance

17. The Society for Cardiovascular Angiography and Intervention Quality Improvement Toolkit (SCAI-QIT) There is Help!

18. SCAI QIT Outline Defining Quality in the Cath Lab Defining Quality in the Cath Lab Operator Requirements Operator Requirements Staff Requirements Staff Requirements Procedural Quality Procedural Quality Benchmarking Benchmarking Key conferences Key conferences Cath Lab Best Practices Cath Lab Best Practices Facility and Environmental Issues Facility and Environmental Issues

19. Defining Quality in the Cath Lab Structural Domain Structural Domain Hospital/Cath lab structure, Credentialing, Education Efforts Hospital/Cath lab structure, Credentialing, Education Efforts Process Domain Process Domain Monitoring pt., System/Guidelines related, Cost/Utilization Monitoring pt., System/Guidelines related, Cost/Utilization Outcomes Domain Outcomes Domain Monitoring of outcomes on a regular basis Monitoring of outcomes on a regular basis Risk adjusted mortality, procedure related LOS, fluoro time, etc., complications (30 days) with data sharing and reporting Risk adjusted mortality, procedure related LOS, fluoro time, etc., complications (30 days) with data sharing and reporting

20. Operator and Staff Requirements ACLS certification should be completed yearly. All staff should have one of the following: Nursing RN license. Radiation Technologist certification. Cardiovascular technologist professional training certificate.

21. Procedural Quality Benchmark—“something that serves as a standard by which others may be measured or judged” Benchmark—“something that serves as a standard by which others may be measured or judged” Using external benchmarks allows you to see how your cath lab performs relative to: Using external benchmarks allows you to see how your cath lab performs relative to: Absolute standards, for example, Absolute standards, for example, Joint Commission Sentinel Events: Joint Commission Sentinel Events: Wrong patient; wrong body part Wrong patient; wrong body part Fluoroscopy dose >1,500 rads to a single field Fluoroscopy dose >1,500 rads to a single field Other cath labs in your region, nation, and worldwide Other cath labs in your region, nation, and worldwide

22. Cath Lab Best Practices Pre-procedure Pre-procedure Informed Consent Informed Consent Sedation, Anesthesia and Analgesia Evaluation Sedation, Anesthesia and Analgesia Evaluation Procedure Procedure Patient Preparation in Procedure Room Patient Preparation in Procedure Room Sedation, Anesthesia Administration and Documentation Sedation, Anesthesia Administration and Documentation Optimal Catheterization Laboratory Team Optimal Catheterization Laboratory Team Post Procedure Post Procedure Physician to Patient Communication Physician to Patient Communication Access Site Management Access Site Management Monitoring and Length of Stay Monitoring and Length of Stay

23. Invasive Cardiology Morbidity and Mortality (Cath Lab M&M) Invasive Cardiology Morbidity and Mortality (Cath Lab M&M) Separate from clinical cardiology M&M Separate from clinical cardiology M&M Open review and assessment of cath lab complications and in- hospital events following invasive cardiovascular procedures Open review and assessment of cath lab complications and in- hospital events following invasive cardiovascular procedures Invasive Case Review Conference (Angio Review) Invasive Case Review Conference (Angio Review) Open review of random sample of cases Open review of random sample of cases Diagnostic and interventional cases Diagnostic and interventional cases Catheterization Laboratory Educational Conference (Cath Conf) Catheterization Laboratory Educational Conference (Cath Conf) Regular, frequent, formal educational events Regular, frequent, formal educational events Focus on cath lab practice and issues Focus on cath lab practice and issues QA and Cath Lab Conferences 1 http://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFaqId=311&ProgramId=1; accessed February 28, 2011 2 http://www.acgme.org/outcome/implement/complete_PBLIBooklet.pdf2 http://www.acgme.org/outcome/implement/complete_PBLIBooklet.pdf; accessed March 1, 2011

24. Facility and Environmental Issues Infection control Infection control Radiation safety Radiation safety Operator and staff health – ergonomics (back pain, neck pain, etc.) Operator and staff health – ergonomics (back pain, neck pain, etc.) Information Storage and Inventory Information Storage and Inventory Equipment maintenance Equipment maintenance Worst Best

25. Core Measure Information Accountability Measures Accountability Measures Evolution of Performance Measurement at The Joint Evolution of Performance Measurement at The Joint Commission Key Historical Activities Key Historical Activities Future Goals and Objectives Future Goals and Objectives Ongoing Activities Ongoing Activities Performance Measurement Initiatives Development Initiatives Development Initiatives Core Measure Sets Core Measure Sets Disease-Specific Care Certification Measures Disease-Specific Care Certification Measures Staffing Certification Measures Staffing Certification Measures Library of Other Measures Library of Other Measures Specifications Manuals Specifications Manual for National Hospital Inpatient Quality Measures Specifications Manual for National Hospital Inpatient Quality Measures Specifications Manual for Joint Commission National Quality Core Measures Specifications Manual for Joint Commission National Quality Core Measures Performance Measurement Systems Performance Measurement System Information Performance Measurement System Information Core Systems List Core Systems List Core eMeasure Pilot Project Systems List Core eMeasure Pilot Project Systems List Non-Core Systems List Non-Core Systems List Candidate Systems List Candidate Systems List Facts About ORYX Performance Measurement Systems Facts About ORYX Performance Measurement Systems However, at the end of the day… Someone is always watching.

26. doing the Haka War Dance

27. Public Reporting

28. Peer Review Internal Peer Review Internal Peer Review Large enough MD Pool Large enough MD Pool Rotate Membership Rotate Membership Unbiased/No secondary agendas Unbiased/No secondary agendas External Peer Review External Peer Review Considered the best assurance for an unbiased and accurate review Considered the best assurance for an unbiased and accurate review No established data for this No established data for this The specifics of peer review should be individualized to the lab, health system, and/or state The specifics of peer review should be individualized to the lab, health system, and/or state

29. Cath Lab Accreditation

30. What is ACE ? Accreditation for Cardiovascular Excellence is an independent, not for profit organization initially established by SCAI in 2009 with subsequent partnership from ACC. The mission of ACE is to ensure high- quality patient care and promote patient safety in facilities performing invasive cardiac and endovascular procedures. ACE achieves this mission by setting standards for quality care, establishing requirements for accreditation, and providing peer review. ACE, the only cath lab accrediting organization, also provides tools and resources to support self-evaluation and quality improvement. Visit http://www.cvexcel.org.http://www.cvexcel.org 30 Cath Lab Accreditation

31. Background Standards based on guidelines, current literature Including this ECD Revised yearly, o r more frequently if science demands Current Accreditation Programs Carotid Artery Stenting Cath/PCI Other Review Programs Data Integrity “Low Volume” Operator External Peer Review Appropriate Use Reviews Customized Programs Pathway to Accreditation Initial Application – Review by Nurse and Physician Reviewers Policies and Procedures Demographics, Appropriate Use, Outcome Measures, Standard Quality Metrics Internal Peer Review Process Nurse Site Visit – Validation of NCDR reported data – Process and Facility Review Physician Data and Angiographic Review – Report Deficiencies and Corrective Action Plans Recommendation for Accreditation, Provisional Accreditation or Denial – Physician Site Visit for cause ACE Board Approval Ongoing support to implement corrective action plans Shared experiences Best Practices

32. Continuing the Work… SCAI Think Tank on Quality, 2013 Initiative #1: SCAI-QIT Impact Christopher J. White, MD, FSCAI, Past President SCAI Christopher J. White, MD, FSCAI, Past President SCAI Initiative #2: Personal Commitment to Quality Theodore A. Bass, MD, FSCAI, SCAI President Theodore A. Bass, MD, FSCAI, SCAI President Initiative #3: Cath Lab Director Boot Camp Charles E. Chambers, MD, FSCAI, SCAI President Elect Charles E. Chambers, MD, FSCAI, SCAI President Elect

33. SCAI-QIT Impact Since its launch in May 2011, SCAI’s Quality Improvement Toolkit (SCAI- QIT) has provided the Society and the field of interventional cardiology with a proactive message about QUALITY. Since its launch in May 2011, SCAI’s Quality Improvement Toolkit (SCAI- QIT) has provided the Society and the field of interventional cardiology with a proactive message about QUALITY. SCAI-QIT has been funded by SCAI’s industry partners and has generated significant media coverage, portrayed as both a forward-looking effort to enhance quality and help the profession improve care: SCAI-QIT has been funded by SCAI’s industry partners and has generated significant media coverage, portrayed as both a forward-looking effort to enhance quality and help the profession improve care: ‒ Incorporate Appropriate Use Criteria (AUC) into clinical decision making. ‒ A response to queries related to allegations of inappropriate/unnecessary procedures. SCAI-QIT CHAMPIONS US States Represented42 Countries Represented31 N = 390 Total US316 (81%) Total OUS74 (19%) Year 3: Measuring SCAI-QIT’s IMPACT: Process improvement: ie. Peer-review conferences Outcome improvement: ie. Improved bleeding rate

34. Appropriate Use Criteria AUC APP Early “data” on SCAI-QIT are impressive, especially considering the program is two years old, with data to date focused almost exclusively on “uptake” and demographics who is using the various tools, how many cath lab personnel attended each webinar, the number of times the AUC Calculator was accessed 2,245 Rational:

35. Implementation An efficient and cost-effective approach to measuring the impact of SCAI-QIT is to establish a “Research Steering Committee” – to select metrics, develop one or more hypotheses on the impact of SCAI-QIT tools on either cath lab processes (e.g., benchmarking, check lists, or best practices) or patient outcomes (e.g., reduction of complications). An efficient and cost-effective approach to measuring the impact of SCAI-QIT is to establish a “Research Steering Committee” – to select metrics, develop one or more hypotheses on the impact of SCAI-QIT tools on either cath lab processes (e.g., benchmarking, check lists, or best practices) or patient outcomes (e.g., reduction of complications). Once these core components of the initial research project are established, the study group will expanded to include other active Quality Improvement Committee members and selected research “sites”. Once these core components of the initial research project are established, the study group will expanded to include other active Quality Improvement Committee members and selected research “sites”.

36. Personal Commitment to Quality: A Plan to Support Interventional Cardiology by Supporting Individual Interventionalists Personal Commitment to Quality: A Plan to Support Interventional Cardiology by Supporting Individual Interventionalists Theodore A. Bass, MD, SCAI President SCAI-QIT SCAI-QIT: our commitment to supporting quality one cath lab at a time. Now … SCAI commits to supporting quality one Fellow at a time.

37. Overview: Long-Term Goal: To make “FSCAI” synonymous with quality To make “FSCAI” synonymous with quality To grow awareness of the value of FSCAI to external audiences (public, referring providers, etc.), so they will learn to seek FSCAI doctors To grow awareness of the value of FSCAI to external audiences (public, referring providers, etc.), so they will learn to seek FSCAI doctors To demonstrate the profession’s (and the Society’s) commitment to Quality To demonstrate the profession’s (and the Society’s) commitment to Quality Paradigm Shift Requires Phased-in Approach: Natural progression from guidelines & AUC to SCAI-QIT to expectations for individual members Natural progression from guidelines & AUC to SCAI-QIT to expectations for individual members Trickle down, starting with leaders & volunteers; then Quality Champions and committee members; new FSCAI applicants; eventually to all Fellows Trickle down, starting with leaders & volunteers; then Quality Champions and committee members; new FSCAI applicants; eventually to all Fellows

38. Personal Commitment to Quality Phase 1 Assemble a cross-disciplinary task force of SCAI leaders to develop a Menu of “tasks” with a pathway to completion and a plan for incentivizing participation. Test to see if meaningful, reasonable, measurable, valuable? Phase 2 valuate and adjust. Create a pilot program work in defined geographic area then evaluate and adjust. Phase 3 Roll-out to all Members with an invitation to participate and explanations of pathway, process, tools, resources, etc. Also make an announcement to External Audiences that SCAI takes commitment to Quality to a new level. This will provide a reassurance that interventional cardiologists are leading the way in quality care and why to look for FSCAI when choosing your cardiologist.

39. Cath Lab Director’s Boot Camp Rationale Cath Lab Directors serve as influential decision makers and leaders with no job description or special training provided. SCAI can provide structured guidance and tools for improved, quality-based decision making. Assess/Understand Need Define Cath Lab Director Population Conduct Focus Groups during SCAI 2013 Conduct Online Survey Interview Thought Leaders

40. Cath Lab Directors Survey 280 Surveys sent out 80% of responders were cath lab directors with 50% 10 80% felt appointed as the most qualified 95% receiving OJT (on Job Training) 75% felt there should be a national job description for medical directors 63% felt there should be a certification Program 92% interested in attending educational program Majority felt combination of meeting format, such as with annual SCAI meeting, and separate on-line offerings, were the best option

41. Plan – Realize Synergies, Create Dynamic Opportunities Leverage Existing Resources SCAI Quality Improvement Toolkit (QIT) SCAI Quality Improvement Toolkit (QIT) SCAI live programming/Annual Meeting SCAI live programming/Annual Meeting MySCAI (eSCAI) Community MySCAI (eSCAI) Community Determine Optimal Formats Define “Boot Camp” Concept – credential process vs. road map? Define “Boot Camp” Concept – credential process vs. road map? Develop Online Resource Develop Online Resource Static & dynamic presentations and videos Static & dynamic presentations and videos Inclusion of QIT components Inclusion of QIT components Develop Live Programming Develop Live Programming Stand alone program for Cath Lab Directors? Stand alone program for Cath Lab Directors? Sessions incorporated into existing programs? Sessions incorporated into existing programs? Cath Lab Director’s Boot Camp?

42. Final Thoughts and Questions SCAI is thankful for the opportunity to attend and present our quality initiatives. We as a society are dedicated to this effort and enthusiastic in partnering with all societies, countries, etc., to promote universal application of quality standards for the best possible patient care.