1. Charles E. Chambers, MD, FSCAI President Elect, Society for Cardiovascular Angiography & Interventions Professor of Medicine and Radiology Pennsylvania State University College of Medicine Director Cardiac Catheterization Laboratories, Hershey Medical Ctr, PA

2. 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. Society for Cardiovascular Angiography and Intervention Melvin Judkins and Mason Sones SCAI Founders

3. SCAI Publications 1978-1998

4. …and the work continues

5. 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

6. 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

7. Develop QI programs in catheterization laboratories Maintain existing QI programs Allow labs to tailor QI programs to local environments Christopher White, MD, FSCAI Past President, SCAI

8.  Initiated late 2010 to bolster quality efforts in the cardiac cath lab environment  SCAI Quality Committee oversight  SCAI-QIT Physician Champions: currently more than 300 worldwide  Series of SCAI-QIT Modules/Webinars: total of seven to date mid-2013

9. Defining Quality in the Cath Lab Operator and Staff Requirements Procedural Quality ◦ Benchmarking ◦ Key conferences Cath Lab Best Practices Facility and Environmental Issues Care Coordination with Referring Physicians

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

11.  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

12. Catheterization Laboratory RN Critical Knowledge Assessment 1.What is the standard dilution for nitroglycerine? 2.Which of the following drugs do not need to be adjusted for renal dosing? a)Bivalirudin b)Heparin c)Low Molecular Weight Heparin d)Tirofiban 3.A patient is overly sedated and by physician assessment needs reversal of versed. What is the preferred agent and what is the initial dose? Yearly skills review, defined standards, remedial process Requirements for annual continuing education Performance of mock patient care scenarios Valuable for low volume facilities and for skills specific to unstable patients RCIS certification Knowledge Assessment Example

13.  Benchmark—“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: ◦ Absolute standards  Joint Commission Sentinel Events:  Wrong patient; wrong body part  Fluoroscopy dose >1,500 rads to a single field ◦ Other cath labs: region, nation, and worldwide

14.  CathPCI Registry Definition: ◦ Bleeding event - Access site (hematomas, retroperitoneal bleed) and/or Major access site related injury (access site occlusion, peripheral embolization, dissection, psuedoaneurysm, AV fistulas) ◦ Requiring treatment ◦ Developing within 72 hours of the procedure ◦ Must be associated with a hemoglobin drop of >3 g/dL; transfusion of whole or packed red blood cells, or a procedural intervention/surgery at the bleeding site to reverse/stop or correct the bleeding  Current Benchmark rates: ◦ Diagnostic cath (with or without PCI) Median: 0.2% 10th percentile: 0.8% 90th percentile: 0.0% 25th percentile: 0.5% 75th percentile: 0.0% ◦ PCI Median: 1.2% 10th percentile: 3.3% 90th percentile: 0.0% 25th percentile: 1.9% 75th percentile: 0.6%

15.  Invasive Cardiology Morbidity and Mortality (Cath Lab M&M) ◦ Separate from clinical cardiology M&M ◦ Open review and assessment of cath lab complications and in- hospital events following invasive cardiovascular procedures  Invasive Case Review Conference (Angio Review) ◦ Open review of random sample of cases ◦ Diagnostic and interventional cases  Catheterization Laboratory Educational Conference (Cath Conf) ◦ Regular, frequent, formal educational events ◦ Focus on cath lab practice and issues 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

16.  Review adverse events, learn from others’ mistakes  Identify cath lab structure and process problems  Improve communication among cath team members  Educate staff, trainees, and operators.  The purpose is NOT punitive. Avoid blame!!  How to Identify Cases for Review: ◦ Develop system for unbiased incident reporting ◦ All major complications, defined by ACCF/SCAI 1,2  Attendance: all cath lab physicians, trainees, cath lab advanced practitioners are requested to attend  Rules of Conduct:  Declare the conference to be a peer review session  Responsible MD should be present when case reviewed.  QI problems needing action should be referred to the QI Committee.  1 Bashore TM, et al. 2012 ACCF/ SCAI: Expert Consensus n Cardiac Catheterization Laboratory Standards Update. J Am Coll Cardiol 2012;59:2221-2308. 2 Levine GN et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the ACCF/AHA/SCAI. Cathet Cardiovasc Intervent 2011;73;453-495.

17.  Assure indications for invasive procedures and intra-procedure decision- making conform to guidelines.  Permits learning from others’ routine cases, not just complication cases  Independent criteria provide objective quality measures ◦ ACCF/SCAI Cath Indications 1 and PCI Appropriateness Criteria 2  For less clear case selection or procedures this is the venue for open discussion.  Non-punitive: the aim is process improvement  Designate responsible MD (Cath Lab Director) or cath lab manager, Quality Officer to select random cases for review.  Avoid reviewing a case when responsible MD away  Keep track of progress (e.g., appropriate indication, number of “normal coronary” cases, use of FFR) and update the group on progress. 1 Patel MR et al. ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 Appropriate Use Criteria for Diagnostic Catheterization. J Am Coll Cardiol 2012;59:1-33. 2 P atel MR, et al. ACCF/SCAI/STS/AATS/AHA/ ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the ACCF Appropriate Use Criteria Task Force, SCAI, STS, AATS, AHA, ASNC, SCCT. J Am Coll Cardiol 2012;59:857-881.

18.  Professional development/education Required by JCAHO and ACGME  Introduces new technologies  Cath Lab Director/Fellowship Director in charge of conference  Regular event: weekly, same location  Use core curriculum to structure topics  Encourage attendance by non-cath lab MDs – especially cardiac surgeons, to stimulate discussions  Sign-in sheets; Obtain CME credit 1 For information, contact Accreditation Council for Continuing Medical Education: www.accme.orgwww.accme.org CME credit !

19.  Pre-Procedure ◦ Informed Consent ◦ Sedation, Anesthesia and Analgesia Evaluation  Procedure Patient Preparation in Procedure Room Sedation, Anesthesia Administration and Documentation Optimal Catheterization Laboratory Team Post Procedure ◦ Physician to Patient Communication ◦ Access Site Management ◦ Monitoring and Length of Stay

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

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

23. Radiation Safety Program Personnel: Physician, Staff, & Physicist “Radiation Conscious” ◦ Training and CME ◦ Film Badge Compliance ◦ Justification/ALARA ◦ Consent Forms ◦ Chart Documentation ◦ Patient Follow-up ◦ CQI program for PCI Chambers CE, Fetterly K, Holzer R, Lin PJP, Blankenship JC, Balter S, Laskey WK. Radiation Safety Program for the Cardiac Catheterization Laboratory. Cath and Card Interv. 2011 77: 510-514.

24.  To provide education to the referring physician on common pre- and post-procedural issues in patients undergoing invasive/interventional cardiac procedures  To heighten awareness among referring physicians of Guidelines and Appropriate Use  To foster a collaborative effort of our mutual patients for post procedure care  To highlight awareness in the quality arena: SCAI-QIT Quality Champions

25. Early “data” on SCAI-QIT are impressive, especially considering the program is less than three 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 Rational:

26. The Uptake of QIT Webinars Diagnostic Cath AUC Revascularization AUC Cath Lab Standards Revised PCI Guidelines QIT: Operator & Staff Requirements QIT: Procedural Quality & Cath Lab Best Practices QIT: Defining Quality in the Cath Lab, Environmental/Radiation Program, and ACE 1428 Cath Labs Participated

27.  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: ‒ 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

28. Initiative #1: SCAI-QIT Quantifying Impact ◦ Christopher J. White, MD, FSCAI, Past President SCAI Initiative #2: Personal Commitment to Quality ◦ Theodore A. Bass, MD, FSCAI, SCAI President ◦ James C. Blankenship, MD, FSCAI, SCAI Vice-President Initiative #3: Cath Lab Director Boot Camp ◦ Charles E. Chambers, MD, FSCAI, SCAI President Elect

29. Where To Start? Every successful Cath Lab Quality program has one Physician Champion SCAI Tool Kit Creates an electronic community of many cath lab Champions All dedicated to improve processes in the cath lab and boost the quality of patient care All Interacting through a webinars on topics related to quality care and education

30. Every successful Cath Lab Quality program has one PHYSICIAN CHAMPION!! It is Individual Interventional Cardiologist Champions that create and maintain QUALITY in their OWN cath labs doing the right thing, for the right patient, at the right time, …. even when nobody is watching Wants to Work with Each of You, and SACIS to Help Establish Quality Champions Throughout Saudi Arabia Using the SCAI-QIT

31. 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.

32. There is Help!