CDC Update Lab Quality: Vision for the Future of CLIA May 11, 2010

1. CDC UpdateLab Quality: Vision for the Future of CLIAMay 11, 2010 MariBeth Gagnon, MS CT(ASCP)HTL Laboratory Science and Regulation Laboratory Science Policy and Practice Program Office (proposed) Centers for Disease Control and Prevention

2. Overview • Organizational Improvement • CDC’s Current Activities • CLIAC activities • Laboratory Medicine Best Practices project • Genetic testing quality improvement activities • Rapid influenza testing surveys • Laboratory Medicine Roadmap and Integrations Workgroups • Assessment of cytology practices

3. Organizational Improvement Based on Dr. Frieden′s five priorities: • Strengthen surveillance, epidemiology, laboratory services • Improve ability to support state, tribal, local, and territorial public health • Increase global health impact • Increase policy impact • Better prevent illness, injury, disability, and death

6. CLIAC Activities • Goal • Manage CLIAC and subcommittees/workgroups to meet the needs of the CLIA program and assure compliance with the Federal Advisory Committee Act (FACA) • Status • 2 meetings per year – February and September • Workgroups • Active – Proficiency Testing • Inactive – Molecular and Biochemical Genetic Testing • Inactive – Waived testing

7. Health Information Technology and Electronic Health Record • February 2010 CLIAC meeting presentations • Office on the National Coordinator • Agency Updates – CMS, CDC, and FDA • Engleberg Center for Healthcare Reform @ the Brooking Institute • Manufacturers perspective – Sunquest Information Systems

8. EHR Incentive Program • American Recovery and Reinvestment Act (ARRA) bills that apply to laboratories • ONC interim rule standards and certification criteria • CMS proposed rule on incentives program (meaningful use) • ONC proposed rule on certifying programs • CLIA Issues • Authorized user • Perceived impediments to exchange of information

9. Proficiency Testing Workgroup • Members • Chair: James Nichols, Ph.D. • Microbiology Co-Chair: Gerri Hall, Ph.D. • Members represent stakeholders with respect to proficiency testing and include: • Laboratory experts • Proficiency testing program experts • Accreditation/state licensure experts • Government ex officios

10. Proficiency Testing Workgroup • Charge • Provide input to CLIAC for consideration in making recommendations to HHS regarding revisions to the CLIA requirements for proficiency testing (PT) specified in subparts H and I of the regulations • Proficiency Testing Workgroup Schedule • Meeting dates: March 10-11, 2010 • Follow-up teleconferences are ongoing • CLIAC report: September 1-2, 2010

11. Proficiency Testing Workgroup • Topics to Address • Update list of CLIA-regulated analytes • Revise the criteria for acceptable performance for CLIA-regulated analytes (target values acceptable limits, current and proposed) • Changes to specialties or subspecialties that do not have regulated analytes (microbiology) • Clarification of the requirements for PT referral • Appropriate PT for evolving technology, such as telemedicine • Other changes needed to update and improve CLIA PT

12. Molecular Genetic Testing

13. Molecular Genetic Testing Activities • Published commentaries and articles • Created fact sheets for laboratorians and clinicians • Assist CLSI with guidance document (MM20) on quality management • Presented at professional conferences (AMP, ACMG, SIMD, AACC) • Developing training courses and workshops

14. Biochemical Genetic Testing • Workgroup – Carol Greene, chair • Workgroup report presented to CLIAC – February 9, 2010 • CLIAC made recommendations • Writing MMWR R&R Good Laboratory Practices Biochemical Genetic Testing

15. Waived Testing

16. Waived Testing Activities • Developed poster or postcard “Top Ten” good laboratory practices for waived testing • Publish educational booklet for those who perform waived testing (in clearance) • Developing booklet for directors and/or supervisors • Developing on-line training course for non-laboratorians

17. Waived Testing

18. Laboratory Medicine Best Practices Goal Make evidence-based recommendations for quality improvement in the practice of laboratory medicine Status Developed methods for evaluating quality improvement evidence of effectiveness Projects Systematic Reviews Quality/Performance Measures

19. Systematic Reviews • 3 pilot test topics & 7 practices • Improving specimen identification • Barcoding • POCT barcoding • Improving critical values reporting • Automated electronic notification • Call center • Reducing blood culture contamination • Venipuncture vs. Catheter • Phlebotomy team • Commercial prep kit 4/7 practices had sufficient evidence to recommend as a best practice

20. Plans for Systematic Reviews Manuscript on LMBP methodology used for conducting the systematic reviews Technical guide on transparent procedures for replication of the study methods Manuscripts for the topic-specific evidence reviews Web-based tutorial to increase awareness of LMBP methods and key components of providing evidence for reviews Scientific presentations

21. Evidence-Based Lab Medicine Quality/Performance Measures Cooperative agreements – 3rd and final year Kaiser Permanente -Laboratory tests for chronic kidney disease Texas Dept of State Health Services - Newborn screening timeliness of diagnosis/ treatment Univ. of Colorado (Denver) - Pre and postanalytic laboratory medicine indicators

22. Evidence-Based Lab Medicine Quality/Performance Measures • Standardized, evidence-based quality measures developed for diverse lab settings • Prepaid health plans - outpatient chronic disease - 4 measures • Public health labs – newborn screening - 16 pre- and 18 post-analytic measures • University hospitals – anatomic pathology -6 quality indicators

23. Evidence-Based Lab Medicine Quality/Performance Measures • Planned Activities • Pilot test identified measures • Collect data collection to verify QI outcome • Publish methods and findings peer-reviewed journals • Disseminate information at professional conferences

24. Genetic Testing Quality Improvement Genetic Testing in Clinical Practice: A Team Approach Interactive Multimedia Learning Focus: Learning about the use of genetic tests in clinical practice through simulation Users: Clinicians, Medical Schools http://iml.dartmouth.edu/education/cme/Genetics/index.html

25. Genetic Testing Quality Improvement Government Agencies Academic, Clinical Genetic Testing Labs Cell Repositories Patient Advocacy Groups IVD Manufacturers Professional Organizations A Collaborative CDC-based program to improve the availability of reference materials for genetic testing 25

26. GeT-RM Projects Completed Projects Fragile X Huntington Disease Cystic Fibrosis Ashkenazi Jewish Panel 9 disorders including Tay-Sachs and Canavan disease BRCA1/2 MTHFR Multiple endocrine neoplasia Type 2A Alpha1-antitrypsin deficiency • Ongoing Projects • Pharmacogenetic • (20 markers!) • Newborn Screening • Cytogenetics • Molecular oncology • Biochemical Genetics Over 200DNA RM characterized by GeT-RM

27. Rapid Influenza Testing Survey with the Joint Commission • Goal • To assess rapid influenza test usage in -Emergency Dept. (ED) Community health centers (CHC) Physician office laboratories (POLs) • Types of rapid influenza tests in use • Training and competency of personnel • Adherence to “Good Laboratory Practices” • Impact on treatment - antivirals and antibiotics • Perceived utility of test

28. Rapid Influenza Testing Survey with The Joint Commission • Second survey (2010) • Revised based on H1N1 outbreak • Sensitivity 40-70% for Influenza A H1N1 • Changes in testing practices since H1N1 • Impact of H1N1 on diagnosis and treatment of patients with Influenza Like Illness

29. Laboratory Medicine Roadmap Workgroup • Goal • Create an action plan to help the laboratory community move from the present state to optimized patient care (6 IOM domains) • Status • Paper to describe the actions that increase the value of laboratory medicine through research & innovation, information technology, outreach, incentives, prioritization and implementation of activities

30. Laboratory Medicine Integrations Workgroup • Goal • Develop systems to improve selection and interpretation of laboratory tests • Status • Develop algorithms for test selection • Define challenges in test ordering & result interpretation • Focus groups for clinicians • Survey of medical school curricula • Develop clinical vignettes for testing residents • Develop protocol for inspecting clinical pathology residency programs to assess consultation education provided

31. Assessment of Cytology Practices • Cooperative agreements • College of American Pathologists • Michigan Public Health Institute • Goals of two are complimentary • Funded for 2010-2011

32. Assessment of Cytology Practices • College of American Pathologists • Survey all cytology labs • Review current practices (specimen types/methods, QC, PT, problem solving) • Analyze responses • Post on CAP website for comment • Convene a consensus conference in 2011

33. Assessment of Cytology Practices • Michigan Public Health Institute • Survey pap smear providers • Review test request and report formats, lab role in clinical management • Partner with MI Cancer Consortium

34. CDC Contact Information • CDC CLIA website: http://wwwn.cdc.gov/clia/ • CLIA phone line: 404-498-2290 • MariBeth Gagnon: 404-498-2745 or mbg0@cdc.gov