CLIA

1. CMS CLIA Update 2010For CAP Annual Policy MeetingMay 2010Harriet Walsh, Deputy Director, Division of Laboratory Services, Centers for Medicare & Medicaid Services CLIA

2. CLIA Update Topic Areas • General Status Update • Focus Areas • Activities for Immediate Future CLIA

3. CLIA Update General Status Update (Our numbers and on-going activities) • Current CMS CLIA Statistics • CMS Top Survey Deficiencies • CMS Enforcement Data • Cytology PT NPRM • CLIAC & Partners CLIA

4. Current Statistics Total Number of Laboratories: 214,875 • Compliance 19,178 • Accredited16,095 • Waived134,778 • Provider Performed Microscopy38,509 • Exempt6,315 • NY3,103 • WA 3,212 CMS data base 10/2009 CLIA

5. CLIA Update - General CLIA

6. CLIA Update - General CLIA

7. Current Statistics CLIA

8. Current Statistics CLIA

9. CLIA Update - General CLIA October 2009

10. CLIA Update - General CLIA October 2009

11. CMS’ Top 10 Condition Level Deficiencies Citation % Labs Cited Mod. complexity LD qual./resp.-----------------4.4% Successful PT participation-----------------------4.1% PT enrollment------------------------------------—1.9% Analytic Systems (QC)----------------------------1.9% Mod. complexity TP-------------------------------1.5% Source: CMS CLIA Database 10/09 CLIA

12. CMS’ Top 10 Condition Level Deficiencies Citation % Labs Cited High complexity director qual./resp.------------1.2% Technical consultant qual./resp.------------------0.9% Hematology-----------------------------------------0.6% Bacteriology----------------------------------------0.4% Gen. Lab Systems----------------------------------0.3% CMS CLIA Database 10/09 CLIA

13. CMS 2009 Enforcement Data 551 labs had sanctions proposed • Principal---372 sanctions • Certificate limitation, suspension, revocation • Alternative---806 sanctions • DPOC, on-site monitor, CMP, T&TA, cancel /suspend Medicare 141 labs had sanctions imposed • Principal---76 sanctions • Alternative---183 sanctions • 59 Immediate Jeopardy CLIA

14. 2008 Annual Lab Registry • CLIA requires public listing of all enforcement actions • >300 total listings for 2008 (some >1X) • 94 labs --certificate revoked &/or lost Medicare • IJ, Cond. Noncompliance, POC bad, PT referral • 63 labs -- certificate limited • Unsuccessful PT performance • 86 -- Directed POC • 14 -- CMP • 81 accredited labs rec’d. probation, cease testing/limitation, or were denied accreditation. • Lab types correspond to proportions of total lab pop. • POLs, independent, hospitals most entries CLIA

15. Cytology PT Cytology PT Proposed Regulation: • Proposed rule considered 17 CLIAC recommendations. • Pub. by CMS Jan. ‘09; comments closed Mar. ‘09 • Joint CDC/CMS collaboration. • Contains questions; solicits comments & suggestions • 5,193 comments received from 660 submissions • Comments are analyzed • Stay tuned! CLIA

16. Cytology PT Comparison of PT Performance, 1st Test 2005 91% passed 2006 95% passed • 96% passed • 97% passed • 97% passed Value of cytology PT: -Identifies those who shouldn’t screen. -Demonstrates high quality of those who do CLIA

17. Clinical Laboratory Improvement Advisory Committee (CLIAC) Scientific and technical advice & guidance to the Secretary on matters involving clinical laboratory standards • Needed revisions • Impact on medical and laboratory practice • Modifications for technological advances Meetings held twice per year, Atlanta • Announced through FRNs • Open to Public CLIA

18. CLIAC 20 members selected by the Secretary and deemed Special Government Employees • Professional authorities in laboratory medicine • Representatives from fields of Medical Technology, Public Health, and Clinical Practice • Consumer representatives • Three voting ex officio members or designees • Director of CDC • Commissioner of FDA • Administrator of CMS Serve overlapping terms of up to 4 years for continuity CLIA

19. CLIAC • Updates from all three agencies responsible for regulation of clinical laboratories • FDA • CDC • CMS • Workgroup and Subcommittee reports • Any current events or issues related to clinical laboratory testing • Meeting and committee information: http://wwwn.cdc.gov/cliac/default.aspx CLIA

20. Partners • CMS has been meeting with Partners in Laboratory Oversight since 2004 • Membership: • CMS CO&RO • AOs, Exempt States, and SAs with Licensure • DoD • VA • Meet approximately every 9 months CLIA

21. Partners • Common Goal: • Quality Laboratory Testing • Mutual Commitments: • Improved communication mechanisms • Enhanced information-sharing opportunities • Greater understanding of each entity’s relevant activities and policies • Establishment of more effective oversight programs CLIA

22. Partners Performance Measures Workgroup • Third Partners Meeting May 2005 • Volunteers from Partners • First meeting February 2006 • Open sharing and brainstorming • Agreement to develop performance indicators • Subsequent conference calls and meetings • Workgroup Purpose & Objective of Indicators • Final Plan developed May 2009 CLIA

23. Partners Performance Measures Workgroup Purpose and Objective • Joint development of performance indicators • Promote optimal & effective performance by all laboratory oversight entities • Strengthened oversight • Improved quality of laboratory testing • Common means of assessment • Joint initiatives CLIA

24. Partners Performance Measures Workgroup • Indicators Considered • Most Frequently Cited Deficiencies (in development) • PT Monitoring (evaluated) • Survey Timeliness (on-going) • Repeat Deficiencies (info-gathering) • Complaints (info-gathering) • Survey Validations (evaluated) CLIA

25. Quality System Essentials(Partners Data from 2007/2008) CLIA

26. Survey Category Deficiency Data2007 and 2008 CLIA

27. Survey Timeliness CLIA

28. CLIA Update Focus Areas • New Complaint Brochure & Complaint Data • Validation Surveys • Personnel • PT Referral CLIA

29. New Complaint Brochure • Hot off the press! • Result of GAO CLIA audit • Provides simple mechanisms for anyone to file a complaint • Will be distributed to all labs over next 2 yrs. • On CLIA web site • Will be available at professional meetings CLIA

30. CMS 2009 Complaint Data • 81 complaints received; 27% substantiated • 20 Compliance labs • 52 Accredited labs • 3 Waived labs • 6 PPM labs • All complaints investigated; most complaints generate an on site survey CLIA

31. Validation Surveys • CLIA Statute (after formal AO Approval) • Evaluation of AO Performance - annually • Report to Congress on Results – annually • Why? • Ensure equivalency (equal to or more stringent than) • How many? • Approximately 350 nationwide annually divided proportionately • AABB, AOA, ASHI – selected by CO • CAP, COLA, JC – selected by RO with SA input CLIA

32. Validation Surveys • CLIA Surveyor Role • Determine if the laboratory is in compliance with CLIA • Simultaneous surveys may require reassurance of AO surveyors • CLIA CO Role • Team reviews every condition-level deficiency on the CLIA survey report in comparison to the AO inspection report • Reaches consensus on each report CLIA

33. Validation Surveys • Question to be answered If the CLIA survey hadn’t occurred, would the laboratory have known from the AO inspection that the deficiency was present and needed correction? Yes = match No = disparity CLIA

34. Validation Surveys • Disparity rate calculation Total # disparities Total # validation surveys • Threshold 20% • Reports sent to each AO followed by a formal Report to Congress in the CMS Financial Report CLIA

35. Validation Surveys Recent Disparity Rates CLIA

36. Validation Surveys • What have we noticed? • Increased Mandatory Personnel Qualification Citation Discrepancies • Surveyor Training (10/2007 and 11/2009) • Policy Memo (S&C Letter 10-07) • Misunderstandings • Acceptance of ASCP certifications • Contracting out review of qualifications • This does NOT mean that we have an increase in unqualified personnel in laboratories! CLIA

37. Validation Surveys Outcomes Related to Personnel Policy Changes: • AOs have condition level citations on CMS validation surveys & increased disparity rates • 3 yrs. of data reflects personnel as high % of validation citations—20% of surveys • Impacts credibility & re-approval of AOs CLIA

38. Personnel Policies Applicable Regulations Subpart M-Covers mod., PPM & high complexity • §493.1351-§493.1495 • Laboratory Director (LD) • Clinical Consultant (CC) • Technical Consultant & Supervisor (TC/TS) • General Supervisor (GS) • Testing Personnel (TP) • Cytology General Supervisor (CGS) • Cytology Technologist (CT) CLIA

39. Personnel Policies • Use CMS Interpretive Guidelines (IG) & S & C Letter 10-07 as a guide • Qualification evaluations are done @ highest level of academic achievement for the position • All required positions & a sample of TP are reviewed once • Review additional TP on subsequent surveys along w/ any changes or new personnel • If a LD changes, qualifications are reviewed by the appropriate AO/SA upon notification prior to approval CLIA

40. Personnel Policies If education, training or experience requirements aren’t met by the individual, the position isn’t filled or position’s responsibilities not met, a condition level requirement must be cited CLIA

41. Personnel Policies Rationale: • Individuals downloaded qualifications from the Web, used them fraudulently to obtain CLIA certificates & billed Medicare for millions $$ • Number of false applications recorded so far: 70!! • ASCP discovered individuals who submitted false credentials for their certification • Surveyors must always evaluate credentials per policy to ensure consistency CLIA

42. Personnel Policies Rationale: • Mandatory citations also facilitate consistency—a fall out of GAO Report in 2006. Individuals are qualified or not; this isn’t considered educational. • There is great risk to CLIA & patients if an individual in a regulated position is ID as unqualified & quality issues are also found. • Lab w/ multiple, consecutive PT failures had TP w/ falsified HEW card. All lab results had to be reviewed. CLIA

43. Personnel Policies Rationale: • Offshore operation upgraded degrees for a fee; diploma mills; quickie degrees. • TP with 10th grade education was not following manufacturer’s instructions for intended use and was testing males for GC/Chlamydia with kit for endocervical specimens. • Lab w/ all personnel unqualified for high complexity micro testing it performed. • VA discovered falsified degrees. CLIA

44. Personnel Policies Rationale: • Many shell labs caught by pre-approval review of application credentials  • IJ in lab where GS had no foreign equivalency done • TP w/o HS or GED – test results impacted • POL w/ repeated deficiencies w/ MDs son without HS degree performing testing • Etc., etc., etc. CLIA

45. Personnel Policies Outcomes: • Increase in CMS condition level deficiencies cited for personnel • CMS’ policy now provides time frame to obtain documentation • Huge patient safety risk • Medicare/Medicaid defrauded of significant sums CLIA

46. Personnel Policies GOAL: All oversight agencies will have & enforce consistent personnel policies CLIA

47. PT Referral The “CLIA” Law (42 USC 263a) (i)(4) Improper referrals Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h) of this section. CLIA

48. PT Referral The Regulations 42 CFR 493 • Sec. 493.801 Condition: Enrollment and testing of samples. (b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. CLIA

49. PT Referral The Regulations 42 CFR 493 • Sec. 493.801 Condition: Enrollment and testing of samples. (b)(4) The laboratory must not send PT samples or portions of samples to another laboratory for any analysis which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certification revoked for at least one year. Any laboratory that receives proficiency testing samples from another laboratory for testing must notify CMS of the receipt of those samples. CLIA

50. PT Referral CMS Central Office Message: We want to be notified of anything that even looks like it could be considered PT Referral. We’re trying to develop enough case reviews to give full consideration to any changes we may need to make in how we approach determinations and enforcement. CLIA