1. EQC: What’s the Story Today!
Sharon S. Ehrmeyer, Ph.D.
UNIVERSITY OF WISCONSIN
MADISON, WI

2. Quality Results for Quality Healthcare!!
Ultimate Goal of Regulations
Quality Results for Quality Healthcare!!

3. Quality 2006 – Test Site’s View
Meeting “the” Regulations
and Passing Inspection
CLIA (CMS) “the feds”
JCAHO
CAP
etc.

4. Quality Patient Test Results?
In U.S., estimated 44,000 to 98,000 deaths / year due to “medical errors”*
May be as high as 198,000 deaths each year**
Lab provides ~70% of information for health care
~ 7 billion lab tests performed in U.S. each year
*To Err is Human, US Institute of Medicine Report – 2000
**Newsweek, 2004

5. Total Analytical error distribution
Error Source
Ross and Boone1
Plebani et al.2
Pre-analytical
46%
68%
Analytical 7%
13%
Post-analytical
47%
19%
Total Analytical error distribution
1Ross and Boone, Inst. of Critical Issues in Health Lab Pract, DuPont Press, 1991
2Plebani and Carraro, Clin Chem 43:1348, 1997

6. NEW Exciting! CLIA - 24 January 2003

7. Quality Systems Approach
Now CLIA’03 is organized and has quality requirements that emphasize quality for the entire testing process
Pre-analytical
Analytical
Post-analytical

8. Quality Systems Approach
CLIA’s pre- and post-analytical process requirements:
Policies/procedures to ensure RIGHT
patient
test
sample
processing
patient record
Quality assessment (assurance) practices to assess effectiveness of all these policies/procedures

9. Quality Systems Approach
Government’s Philosophy:
Following the CLIA regulations
should yield higher quality results

10. CLIA –Analytical Phase
QC procedures must monitor the complete analytical process
Take into account:
performance specifications of the method
detect immediate errors
monitor long-term precision and accuracy
Unless CMS approves a procedure in Appendix C of the SOM that provides “equivalent” quality testing…

11. CLIA’03 -- Analytical Phase
CLIA’s answer to analytical quality–
“equivalent” quality testing…

12. Minimum Quality and Minimum QC?
Equivalent Quality Control (EQC)???

13. January 2004 -- CLIA Appendix C (SOM)
“Survey Procedure & Interpretive Guidelines for Laboratories and Laboratory Services”
Government’s way to introduce new concepts
Interprets the regs for both surveyor and lab
Provides probes to ascertain compliance
D-tags associated with reg used to cite deficiencies
Explains equivalent quality testing (control)
for_Laboratories.asp#TopOfPage

14. EQC does not mean Electronic QC
Electronic Quality Control

15. CLIA’03 and Quality Control
Acceptable, minimum quality control:
At least 2 external,
liquid quality control materials
analyzed per test per day

16. CLIA’03 and EQC All other quality control approaches –
From electronic to sophisticated internal quality checks
All must be qualified under EQC

17. CLIA’03 and EQC
To use instruments with “built-in” electronic/procedural/internal controls, labs must either:
Analyze at least 2 external liquid controls per test per day OR
Qualify the “built-in” controls as equivalent (to external liquid QC)

18. EQC Qualification Process
Each test site must prove that the instrument’s “built-in” controls are equivalent to the traditional mandated, minimum, external (liquid) QC procedures

19. The “Devil is in the Details”
CLIA and EQC
The “Devil is in the Details”

20. EQC Option 1 Qualification Process
To qualify an instrument with “built-in” controls that evaluate the “entire” analytical process:
Test sites need to analyze 2 external QC materials daily for 10 consecutive days

21. daily to once every 30 days
EQC Option 1
If test site judges “built-in” and external QC results as “acceptable,” then
Test site reduces external QC analysis from
daily to once every 30 days

22. EQC Option 2 Qualification Process
To qualify an instrument with “built-in” controls that evaluate “part ” of analytical process:
Test sites need to analyze 2 external QC materials daily for 30 consecutive days

23. daily to once every 7 days
EQC Option 2
If test site judges “built-in” and external QC results as “acceptable,” then
Test site reduces external QC analysis from
daily to once every 7 days

24. EQC Option 3 Qualification Process
To qualify an instrument with NO “built-in” controls :
Test sites need to analyze 2 external QC materials daily for 60 consecutive days

25. daily to once every 7 days
EQC Option 3
If test site judges external QC results as “acceptable,” then
Test site reduces external QC analysis from
daily to once every 7 days

26. EQC Qualification Process
Just so you don’t miss the point – by adopting EQC after a comparison with external QC material for a short time, a test site can decide to reduce the frequency of “REAL” controls to once a month or once a week!

27. EQC Qualification Process
The key word in the CLIA regulations is “acceptable,”
Unfortunately CLIA offers NO insight into what is acceptable

28. EQC 2006 - Worst Case Scenario
During evaluation period, absence actual “built-in” [electronic] control failure(s), we learn nothing about the control capabilities!
If after 30 days, the mandated external QC fails, we --
Must reevaluate patient results for the previous 30 days.
What about the quality of reported patient results?

29. EQC and Quality -- circa 2006
Comments from an “authority” on ways to protect the laboratory using just electronic EQC:
Call EQC Equivocal not Equivalent QC
Add “in god we trust” on all lab results
Add “in George W Bush we trust” on all test results
Definitely do not suggest adding “in Westgard we trust” on all test results

30. A Discontinuity in Logic of CLIA and EQC
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-----BUT

31. A Discontinuity in Logic of CLIA and EQC
CLIA makes the Laboratory Director Responsible ---
Responsible for a whole host of things he/she can not control!
and EQC leads the list….

32. As the world turns so does CLIA!
Look for changes with EQC!
CLSI (NCCLS) Meeting
March 18, 2005
Judy Yost – “We blew it”
EQC
Judy Yost – “until resolved, citations on new QC will continue to be educational”

33. Excerpt from J. Yost Presentation
CMS Survey Policy for CMS Surveyed labs
receive educational surveys for requirements “ new to that lab”
Labs with problems meeting new QC standards receive a letter urging them to correct in lieu of a deficiency statement
Existing requirements [prior to January 24, 2003] must be met or are cited on a deficiency statement
CAP, JCAHO, inspected sites continue to meet the AOs standards

34. Excerpt from CMS Website
… since the publication of the 2003 final regulations and accompanying guidelines, CMS has identified innovations in technology and has received input from technical experts that may lead to further modifications of QC policies in our interpretative guidelines. CMS is also undertaking a number of processes to acquire additional information, data and scientific input relative to such QC and technological advances in order that our policies will reflect these innovations.

35. Excerpt from CMS Website, cont.
Therefore, so long as laboratory directors, at a minimum, review manufacturers’ QC instructions, find those instructions to reasonably monitor the accuracy of the analytic process and the laboratory then follows those manufacturers’ instructions [follow the manufacturer’s labeling], we plan to continue the educational process noted above until any merited changes are incorporated into our guidelines, for the QC requirements contained in the 2003 modifications of the CLIA regulations.

36. Latest QC Information from the Government (CLIA [CMS])
CLIA 2003 QC recommendations “new to the lab” are considered educational and will not be cited
CMS is seeking additional information, data and scientific input from CLSI through guidelines
Lab directors are in charge
Follow manufacturers’ QC recommendations
Include at least 2 levels of QC each day of testing
Before speaking to this slide:
The inspections are for the lab to view their quality policies and procedures.
Lab directors make the final decision as to what procedures will be performed in a lab.

37. CLIA – “Equivalent” QC (EQC)
“The director must consider the laboratory’s 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!

38. As the world turns so does CLIA!
Bottom line with EQC for now!
Follow Manufacturers’ Instructions

39. EQC and JCAHO, CAP & COLA Do not recognize EQC
No changes in QC regulations
Follow manufacturers’ QC recommendations
Include at least 2 levels of QC each day of testing
CAP and JCAHO both allow electronic controls and internal controls, following an initial analysis study. There is nothing specific as to what this study must be.

40. CLIA Information http://www.cms.hhs.gov/clia/
Note: web address for links have changed on CMS’ new website

41. Bottom Line – continually aim for:
Right test
Right result
Right patient
Right time
Right record

42. Thanks for you attention!
Now it is your turn
Questions and Answers