Presentation on theme: "EQC: What’s the Story Today!"— Presentation transcript:
1EQC: What’s the Story Today! Sharon S. Ehrmeyer, Ph.D.UNIVERSITY OF WISCONSINMADISON, WI
2Quality Results for Quality Healthcare!! Ultimate Goal of RegulationsQuality Results for Quality Healthcare!!
3Quality 2006 – Test Site’s View Meeting “the” Regulationsand Passing InspectionCLIA (CMS) “the feds”JCAHOCAPetc.
4Quality 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
5Total Analytical error distribution Error SourceRoss and Boone1Plebani et al.2Pre-analytical46%68%Analytical7%13%Post-analytical47%19%Total Analytical error distribution1Ross and Boone, Inst. of Critical Issues in Health Lab Pract, DuPont Press, 19912Plebani and Carraro, Clin Chem 43:1348, 1997
7Quality Systems Approach Now CLIA’03 is organized and has quality requirements that emphasize quality for the entire testing processPre-analyticalAnalyticalPost-analytical
8Quality Systems Approach CLIA’s pre- and post-analytical process requirements:Policies/procedures to ensure RIGHTpatienttestsampleprocessingpatient recordQuality assessment (assurance) practices to assess effectiveness of all these policies/procedures
9Quality Systems Approach Government’s Philosophy:Following the CLIA regulationsshould yield higher quality results
10CLIA –Analytical Phase QC procedures must monitor the complete analytical processTake into account:performance specifications of the methoddetect immediate errorsmonitor long-term precision and accuracyUnless CMS approves a procedure in Appendix C of the SOM that provides “equivalent” quality testing…
12Minimum Quality and Minimum QC? Equivalent Quality Control (EQC)???
13January 2004 -- CLIA Appendix C (SOM) “Survey Procedure & Interpretive Guidelines for Laboratories and Laboratory Services”Government’s way to introduce new conceptsInterprets the regs for both surveyor and labProvides probes to ascertain complianceD-tags associated with reg used to cite deficienciesExplains equivalent quality testing (control)for_Laboratories.asp#TopOfPage
14EQC does not mean Electronic QC Electronic Quality Control
15CLIA’03 and Quality Control Acceptable, minimum quality control:At least 2 external,liquid quality control materialsanalyzed per test per day
16CLIA’03 and EQC All other quality control approaches – From electronic to sophisticated internal quality checksAll must be qualified under EQC
17CLIA’03 and EQCTo use instruments with “built-in” electronic/procedural/internal controls, labs must either:Analyze at least 2 external liquid controls per test per dayORQualify the “built-in” controls as equivalent (to external liquid QC)
18EQC 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
19The “Devil is in the Details” CLIA and EQCThe “Devil is in the Details”
20EQC 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
21daily to once every 30 days EQC Option 1If test site judges “built-in” and external QC results as “acceptable,” thenTest site reduces external QC analysis fromdaily to once every 30 days
22EQC 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
23daily to once every 7 days EQC Option 2If test site judges “built-in” and external QC results as “acceptable,” thenTest site reduces external QC analysis fromdaily to once every 7 days
24EQC 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
25daily to once every 7 days EQC Option 3If test site judges external QC results as “acceptable,” thenTest site reduces external QC analysis fromdaily to once every 7 days
26EQC 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!
27EQC Qualification Process The key word in the CLIA regulations is “acceptable,”Unfortunately CLIA offers NO insight into what is acceptable
28EQC 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?
29EQC and Quality -- circa 2006 Comments from an “authority” on ways to protect the laboratory using just electronic EQC:Call EQC Equivocal not Equivalent QCAdd “in god we trust” on all lab resultsAdd “in George W Bush we trust” on all test resultsDefinitely do not suggest adding “in Westgard we trust” on all test results
30A 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
31A 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….
32As the world turns so does CLIA! Look for changes with EQC!CLSI (NCCLS) MeetingMarch 18, 2005Judy Yost – “We blew it”EQCJudy Yost – “until resolved, citations on new QC will continue to be educational”
33Excerpt from J. Yost Presentation CMS Survey Policy for CMS Surveyed labsreceive 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 statementExisting requirements [prior to January 24, 2003] must be met or are cited on a deficiency statementCAP, JCAHO, inspected sites continue to meet the AOs standards
34Excerpt 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.
35Excerpt 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.
36Latest QC Information from the Government (CLIA [CMS]) CLIA 2003 QC recommendations “new to the lab” are considered educational and will not be citedCMS is seeking additional information, data and scientific input from CLSI through guidelinesLab directors are in chargeFollow manufacturers’ QC recommendationsInclude at least 2 levels of QC each day of testingBefore 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.
37CLIA – “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!
38As the world turns so does CLIA! Bottom line with EQC for now!Follow Manufacturers’ Instructions
39EQC and JCAHO, CAP & COLA Do not recognize EQC No changes in QC regulationsFollow manufacturers’ QC recommendationsInclude at least 2 levels of QC each day of testingCAP 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.
40CLIA Information http://www.cms.hhs.gov/clia/ Note: web address for links have changed on CMS’ new website
41Bottom Line – continually aim for: Right testRight resultRight patientRight timeRight record
42Thanks for you attention! Now it is your turnQuestions and Answers