CLIA: Yesterday, Today & Tomorrow!

1. CLIA: Yesterday, Today & Tomorrow! Judith Yost, M.A., M.T. Director Division of Laboratory Services CLIA

2. Topics for Discussion • Where did we begin? • Where are we today? • Technology • Personnel • Oversight/Quality • Where will we be? • Technology • Personnel • Oversight/Quality CLIA

3. 232, 548 LABS Enrolled in CLIA in 2011! • Compliance -----19, 319 • Waiver -------- 146,071 • PPM------------ 37, 767 • Accredited ------ 15,787 • Exempt (NY/WA) -----6,802 • Note: There were 150,000 labs in 1994! • Continued growth expected! • Source: CLIA Database June 2011 CLIA

4. CLIA Labs by Certificate Type CLIA

5. CLIA POLs by Certificate Type CLIA

6. CLIA Labs by Certificate Type 1995 vs 2011 1995 2011 • Compliance---37,578vs 19, 319 • Waiver---------56,031 vs 146, 071 • PPM------------23,089 vs 37,767 • Accredited-----19,426 vs 15,767 CLIA

7. Laboratories by Certificate Type Over Time CLIA

8. Accredited Labs by Accrediting Organization CLIA

9. Lab Facility Types CLIA

10. Lab Oversight • Past Oversight • CLIA ’67, AO’s & States • Not all-inclusive • Current Oversight • Mostly regulation via: • CMS • AO &/or States • Rigid, difficult to change, outdated standards • Future Oversight • Same, but use regs as an umbrella w/ guidance: • Public/private partnerships • Professional & International standards • Performance Measures • Flexible, easier to adjust, current standards CLIA

11. Pathology • Current Pathology • Review & interpretation of microscopic slides • Using a standard microscope • In a clinical laboratory • Future Pathology • Digital pathology—images transmitted to unlimited no. of locations via the Web • Telepathology; Virtual pathology • Excellent educational tool • Brings new compliance challenges • Now includes other specialties CLIA

12. Genetic Testing & CLIA • Est. number of labs—600-1000 • Est. number of tests---1000 & growing daily! • FDA approved----approx. 12; Remainder---LDTs • What are FDA’s plans for LDT oversight? • Limited PT challenges & QC materials available • 2 sides: More regulation vs. less; by whom? • Consider private/public partnerships • CMS utilizing enhanced oversight w/ existing standards • CDC MMWR Molecular “Best Practices” pub. 6/09 • State surveyors trained; Molecular experts hired • How many tests can you fit on a chip? • When does ‘information’ become a result? CLIA

13. Personnel Shortage • Growth of clinical labs is >27% (BLS) • 155,822 MTs now; will need 187,818 by 2014 • 146,626 MLTs now; will need 183,347 by 2014 • Median age is 48 yrs. • Skill set is mobile • Current shortfall 10,000/yr. • National recruitment & retention strategies underway NOTE: Information courtesy Elissa Passiment, Exec. VP, ASCLS CLIA

14. Personnel Shortage • Issues • Recognition • Power • Work environment • No opportunity for advancement • Risk of infectious disease • Work hours • Stress • Wages CLIA

15. Personnel Shortage • Multi-faceted Resolutions Underway • Send young MTs to recruit very young folks • Develop HS science lesson plans • Update MT curricula w/ today’s skills/needs • Establish re-training pgm. for former techs • Obtain Congressional funds • Brand labs as good workplace; offer creative opportunities • Employers emphasize value & recognize techs • Improve salaries & safety • Create career ladders, innovative schedules CLIA

16. Point of Care Testing • Provides efficient, convenient patient care • Continues to increase • 377 pharmacies in 1997; 6116 in 2011 • Technology is dynamic & robust • 8 waived tests in 1992 ; >100 analytes now • 1,000’s of test systems!! • What will the future bring? Sensors? in vivo? • Explosion in waived tests & sites comes w/ issues • Turnover; TP less-trained; may not ID problems • No routine oversight; no CMS funding • Minimal QC required =quality issues • Pre & post analytical issues identified CLIA

17. CMS Certificate of Waiver (CW) Project • CMS suspected & found problems in CW labs • Conducted pilot studies: • Approx. 50% didn’t follow mfgr’s. instr. • Received support from CLIAC & CMS • Initiated 2% annual on site educational visits • Congress never anticipated 67% labs w/ o oversight! • 2-4% CW labs/yr. have immediate jeopardy to patients’ health & safety! • Turnover, lack of training, etc. • Intervention yields significant improvement CLIA

18. CMS Certificate of Waiver (CW) Project • 2004 • 39% not following instructions—initial visit • 2006 & Beyond • 34% not following instructions—initial visit • 70% improved conformance after educational intervention!! • 2011 - Address quality concerns w/ multifaceted plan in coordination w/ Partners; including A-19 CLIA

19. CLIA & EHRs • CLIA requires results to authorized person • Or individual who will use them • Or to lab that ordered the test (referral) • Authorized person can designate ‘agent’(EHR) on their behalf • CLIA requires certain data elements on lab repts. • CLIA requires accurate, reliable, timely & confidential result transmission regardless of mechanism • New CMS guidance is available Mar. 2010! • Clarifies standard interpretations re EHRs. • Patient access reg pub. 9/12/11;Comments due 11/17/11 • More efforts underway w/ ONC CLIA

20. Most Frequent CMS Deficiencies--1995 Citation % Labs Cited • Perform 2 levels of QC-----------------29%* • Establish/follow QA plan--------------26%* • Follow mfgr’s. instructions------------25%* • LD responsibilities----------------------17% • Alt. Assessment for PT------------------6%* *Similar problems in 2011 CLIA

21. Most Frequent CMS Deficiencies--2011 Citation % Labs Cited • Policy for proper reagent storage-------—5.8% • Analytic Systems’ QA----------------------5.5%* • Verify accuracy non-PT’d tests---------—5.5%* • Follow mfgr’s. instructions-----------------4.9%* • Procedure manual----------------------------4.6% *Similar problems as initial surveys Source CMS CLIA database 12/2010 CLIA

22. Most Frequent Partners’ Deficiencies—2007-9 CLIA

23. Partners Performance Measures • Performance measures serve as an adjunct to validation protocol to identify what AO’s (and CMS) actually do! • Have identified weaknesses & facilitated improved & standardized oversight practices for all • Most frequent deficiencies for AO’s & CMS are similar • Provides focus for training, lab education; better requirements • Enhanced level of oversight achieved by Partners’ improved communication, coordination & collaboration CLIA

24. 2003 QC Regulation Each laboratory that performs non-waived testing must meet the applicable analytic systems requirements, unless HHS approves a procedure, specified in the Interpretive Guidelines, that provides equivalent quality. CLIA

25. CMS Interpretive Guidelines (IG)- Published 2004 • Provides regulatory interpretations, policies for labs & surveyors • Located on CMS/CLIA web site • Introduces “Equivalent QC” (EQC) • CMS will make adjustments w/ experience &/or data or new policies CLIA

26. “QC for the Future” • ‘05 CLSI meeting w/ lab prof. orgs., gov’t, industry & AOs: • Labs need more info from manufacturers. • One-size-fits-all QC won’t work for all test systems, different patient pop. & lab types. • CLSI Evaluation Protocol (EP) doc completed • Alternative QC for labs using ISO risk management • Interpretive Guidelines will be revised accordingly CLIA

27. EP-23: Laboratory QC Based on Risk Management • CMS working w/ CLSI to develop new guidance “Evaluation Protocol” documents • Includes experts from labs, industry & gov’t. • Utilizing a consensus process • Exciting, groundbreaking efforts • Utilizes much of what the lab already does • Laboratories’ guidance to design custom alternative QC w/ manufacturer’s information—EP-23 • Chaired by James Nichols, Baystate Health CLIA

28. EP-23: Laboratory QC Based on Risk Management • Intended for laboratory & POC users • Uses mfgrs.’ risk mgmt. info about test limitations • Reduces negative impact of test limits on QC • Enables lab to develop cost-efficient, effective QC protocols • While ensuring compliance with applicable regulations • Considers labs’ unique environmental factors: • Technology, personnel competency, temperature, • Storage conditions • Clinical use of test results (if known) CLIA

29. PT Regulation Update • Plan w/ milestones developed; No firm ETA • Includes target values, grading system, PT pgms., labs, PT referral, alt. assessment; analyte selection • Requires a proposed rule w/ comment & final • PT providers’ meeting held Nov. ’08 • Utilize CLIAC process w/ SME WG • Medicare & other data reviewed for test frequency • Evaluating methods for analyte selection & grading • WG mtg. March 2010; rept. to CLIAC Sept. ‘10 & Mar. ‘11 • Ongoing mtgs. & data analysis w/ CDC • Stay tuned…. CLIA

30. Goals for the Future • Publish standards/performance measures reflective of current technology & state of lab medicine • Improve consistency among AOs, CMS regions, State surveyors, where possible • Use professional standards in lieu of regulations for flexibility, where appropriate • Engage in public/private partnerships to garner expertise • Collaborate w/ FDA on LDT oversight • Ensure quality in CW labs via education & other approaches • Assume waived lab oversight if A-19 passes: develop quality standards based on data from CW visits CLIA

31. Goals for the Future • Become more data driven to enhance program management & lab oversight • Increase CMS involvement in personnel shortages • Maintain solvency of CLIA program • Finalize strategy for oversight of international labs • Address digitized/virtual testing in multiple sites • Update personnel, certificate, etc. regulations • Determine oversight of non-invasive tests • Help to enhance patient-centric care • Augment relationships betw. providers & labs CLIA

32. CLIA Retrospective Thoughts….. • Balance of extremes to craft quality standards- • Assure access; minimize cost/burden • Maintain integrity of quality oversight • Work w/ AOs, exempt States to improve the level & consistency of oversight-Partner’s • Use an educational, not punitive, QA focus to survey labs & monitor outcomes (test results) CLIA

33. Where to find more info • CMS CLIA web site • www.cms.hhs.gov/clia • Brochures, lab look-up; guidelines; data, etc. • CMS Central office in Baltimore • 410-786-3531 • Judy Yost’s email • Judith.yost@cms.hhs.gov CLIA

34. THE END! The future is now! Thank you!! CLIA