EQC: Whats the Story Today! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MADISON, WI.
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Transcript of EQC: Whats the Story Today! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MADISON, WI.
Quality 2006 – Test Site’s View
Meeting “the” Regulations and Passing Inspection
CLIA (CMS) “the feds”JCAHOCAPetc.
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
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, 19912Plebani and Carraro, Clin Chem 43:1348, 1997
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
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
Quality Systems Approach
Government’s Philosophy:
Following the CLIA regulations should yield higher quality results
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…
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)
http://www.cms.hhs.gov/CLIA/03_Interpretive_Guidelines_for_Laboratories.asp#TopOfPage
CLIA’03 and Quality Control
Acceptable, minimum quality control:
At least 2 external,
liquid quality control materials
analyzed per test per day
CLIA’03 and EQC
All other quality control approaches –
From electronic to sophisticated internal quality checks
All must be qualified under EQC
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)
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
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
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
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
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
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
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
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!
EQC Qualification Process
The key word in the CLIA regulations is “acceptable,”
Unfortunately CLIA offers NO insight into what is acceptable
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?
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
http://www.westgard.com
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
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….
Look for changes with EQC!
As the world turns so does CLIA!
EQCEQC
CLSI (NCCLS) Meeting
March 18, 2005
Judy Yost – “We blew it”
Judy Yost – “until resolved, citations on new QC will continue to be educational”
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
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.
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.
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
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!
EQC and JCAHO, CAP & COLA
Do not recognize EQCNo changes in QC regulations
Follow manufacturers’ QC recommendations Include at least 2 levels of QC each day of testing
CLIA Information
http://www.cms.hhs.gov/clia/
Note: web address for links have changed on CMS’ new website