2. POC Leadership Forum Update on the Regulations CLIA, CAP, JCAHO and COLA Ronald H. Laessig, Ph.D. University of Wisconsin Madison, Wisconsin www.cms.hhs.gov/clia

3. Purpose of U.S. Lab Regulations … quality standards for all laboratory testing to ensure accuracy reliability timeliness of patient test results regardless of where the test is performed… www.cms.hhs.gov/clia

4. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #1 www.cms.hhs.gov/clia

5. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #2 www.cms.hhs.gov/clia

6. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #3 www.cms.hhs.gov/clia

7. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #4 www.cms.hhs.gov/clia

8. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #5 www.cms.hhs.gov/clia

9. Series of six slides from Glamour Magazine The latest information on test quality Believe it or not #6 www.cms.hhs.gov/clia

10. Quality POCT: What drives the system? According to Glamour Magazine: ….(we always go right to the source) If Regulations are not followed…......Human error follows J. Yost, the CLIA Lady

11. Manufacturers Point of View Evolution in Assured Quality Reduction in size Operator ID / Patient ID Reagent viability Lock-out quality control Connectivity Data management Roche Diagnostics

12. Regulators Point of View U.S. Regulations = CLIA C = Clinical L = Laboratory I = Improvement A = Amendments Regulates ~180,000 U.S. test sites http://www.cms.hhs.gov/clia/

13. Regulators Point of View CLIA88 (February 28, 1992) CLIA03 (January 24, 2003)

14. Linking Quality and Regulations CLIAs working premise: CLIAs mandated quality practices will improve quality of test results

15. CLIA Regulations and the Director The laboratory director is responsible for the overall operation and administration of the laboratory … [the] testing systems … used [must] provide quality laboratory services for all aspects of test performance … including the pre- analytic, analytic, and post-analytic phases of testing

16. Quality POCT Challenge – March 2004 Dilemma for today: With the manufacturer building- in/assuring quality, Where is the professional input from the laboratory director? Does the director just buy the technology and use it?

17. What do we know today about CLIA and Quality Requirements? CLIA03 takes a Quality Systems approach like ISO documents The quality requirements follow the route of the specimen pre-analytical analytical post-analytical issues

18. CLIA and Quality Requirements? The old CLIA covered the analytical requirements in one section and quality assurance in another. The new CLIA groups the quality requirements under a new term Quality Assessment Quality Assessment = Quality Control + Quality Assurance CLIA wants to consider the testing process start to finish-hence pre, post and analytical assessment

19. CLIA 03 and QC? Control procedures must (§493.1256): Monitor the accuracy and precision of the complete analytical process Detect immediate errors due to test system failure, adverse environmental conditions, and operator performance Monitor over time precision and accuracy that may be influenced by changes in test system, environment and operator performance

20. CLIA03 and QC? Control procedures must (§493.1256): Monitor complete analytical process Detect immediate errors Monitor over time precision and accuracy Conceptually, meeting the requirements sounds easy, But ---

21. CLIA03 and QC? Control procedures must (§493.1256): Monitor complete analytical process Detect immediate errors Monitor over time precision and accuracy Conceptually, meeting the requirements sounds easy, But ---

22. CLIA 03 and Q C The Devil is in the Details

23. CLIA03 – The details! What about Electronic QC? Process controls? Internal controls? Do these a) evaluate complete analytical process b) detect immediate errors c) monitor accuracy and precision over time d) none of the above

24. Details - 12 January 2004 http://www.cms.hhs.gov/clia/appendc.asp NEW and More Interpretive Guidelines for CLIA – 300+ pages

25. New Concept for QC? EQC Equivalent Quality Control

26. New Concept for QC? EQC = Electronic Quality Control

27. What is Equivalent QC (EQC)? For instruments with procedural/internal controls, test sites can choose to: Analyze 2 external, liquid controls per day OR Qualify the procedural/internal controls as one of three EQC options

28. EQC Option #1 Test Systems with internal/procedural control(s) that monitor the entire analytic process Test site may use EQC, if test systems stability is demonstrated

29. EQC #1 - Evaluation of Stability Along with internal/ process controls, run 2 external QC daily for 10 consecutive days (why 10?) If internal/process and external control results are acceptable (what is acceptable?) reduce external QC from daily to once / month unless manufacturer requires more Lab must perform/monitor the internal control(s) in accordance with manufacturer instructions

30. Option #1 Instrument with manufacturer supplied on board controls, run automatically.

31. EQC Option #2 Test Systems with internal/procedural control(s) that monitor a portion of the analytic process Test site may use EQC, if test systems stability is demonstrated

32. Option #2 - Evaluation of Stability Along with internal process controls, run 2 external QC daily for 30 consecutive days (why 30?) If internal and external control results are acceptable (what is acceptable?) reduce external QC from daily to once / week unless manufacturer requires more Lab must perform/monitor the internal control(s) in accordance with manufacturer instructions

33. Option #2 Hand held instrument currently advertized as having on board, electronic controls.

34. EQC #3 Test Systems without Internal/Procedural Control(s) Advancements in technology have produced systems –Capable of maintaining stable performance specifications over time –Minimally influenced by adverse environmental conditions and operator variance. Test site may use EQC, if test systems stability is demonstrated

35. Option #3 - Evaluation of Stability Along with internal process controls, run 2 external QC daily for 60 consecutive days (why 60?) If internal and external control results are acceptable (what is acceptable?) reduce testing external QC from daily to once / week unless manufacturer requires more Lab must perform/monitor the internal control(s) in accordance with manufacturer instructions

36. Option #3? What belongs in this picture?

37. Option #3? Prove stability for 60 days, run external QC once per week Every Instrument! Vitros Hitachi aca, SMAC, etc.

38. CLIA – Equivalent QC (EQC) The director must consider the laboratorys clinical and legal responsibility for providing accurate and reliable patient test results versus the cost implications of reducing the QC testing frequency. EQC is a choice!

39. Uncle Sam Has Uncle Sam gone Crazy?

40. Uncle Sam Has Uncle Sam gone Crazy? Maybe or Maybe Not!

41. March 2004 Does EQC and the U.S. regulations open a new era for new technologies or does EQC just cause confusion?

42. Quality POCT: What Drives the System? To me, CLIA QC regulations say – Continue the old way – 2 external QC/day Qualify the test system under EQC options and reduce frequency of external QC

43. Quality POCT: What Drives the System? To me, CLIA QC regulations say – Continue the old way – 2 external QC/day Qualify the test system under EQC options and reduce frequency of external QC EQC Option #3 ( for a test system with no internal/process controls) Do you want your testing done on a system that qualifies under this option?

44. The Devil is in the details EQC Qualified System – External QC analyzed once per month or once per week. EQC-1 EQC-2&3

45. The Devil is in the Details §493.1282 Standard: Corrective actions …[if] external QC [results]…fail to meet the laboratory's established criteria for acceptability, all patient test results obtained…since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected…

46. Quality POCT: Drivers? Manufacturers – Building the perfect instrument to meet the needs of the testing environment

47. CLIAs new QC/EQC Requirements Have a two-year phase in Inspection Citations NO punitive activities

48. Manufacturers have EQ Options #1, 2, & 3 To be competitive in the marketplace, options #2 and #3 DONT count

49. The bottom line…..the Regs We are in a two year phase in We are all trying to figure out what they mean At the end of the day, the laboratory director must make the call -- QC or EQC (1,2,or 3) We are after all in the patient care business Legally, Morally, ethically, technically, the patients (must) always come first.

50. CLIA Regulations and the Director The laboratory director is responsible for the overall operation and administration of the laboratory … [the] testing systems … used [must] provide quality laboratory services for all aspects of test performance … including the pre- analytic, analytic, and post-analytic phases of testing

51. …..and Speaking of Lab Directors, Heerrrrrs Fritz !!!!!