EQC: Whats the Story Today! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MADISON, WI

Embed Size (px)

Text of EQC: Whats the Story Today! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MADISON, WI

  • Slide 1

EQC: Whats the Story Today! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MADISON, WI Slide 2 Quality Results for Quality Healthcare!! Ultimate Goal of Regulations Slide 3 Quality 2006 Test Sites View Meeting the Regulations and Passing Inspection CLIA (CMS) the feds JCAHO CAP etc. Slide 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 Slide 5 Error SourceRoss and Boone 1 Plebani et al. 2 Pre-analytical 46%68% Analytical7%13% Post-analytical 47% 19% Total Analytical error distribution 1 Ross and Boone, Inst. of Critical Issues in Health Lab Pract, DuPont Press, 1991 2 Plebani and Carraro, Clin Chem 43:1348, 1997 Slide 6 CLIA - 24 January 2003 NEW http://www.phppo.cdc.gov/clia/pdf/CMS-2226-F.pdf Slide 7 Quality Systems Approach Now CLIA03 is organized and has quality requirements that emphasize quality for the entire testing process Pre-analytical Analytical Post-analytical Slide 8 Quality Systems Approach CLIAs 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 Slide 9 Quality Systems Approach Governments Philosophy: Following the CLIA regulations should yield higher quality results Slide 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 Slide 11 CLIA03 -- Analytical Phase CLIAs answer to analytical quality equivalent quality testing Slide 12 Minimum Quality and Minimum QC? Equivalent Quality Control (EQC)??? Slide 13 January 2004 -- CLIA Appendix C (SOM) Survey Procedure & Interpretive Guidelines for Laboratories and Laboratory Services Governments 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 Slide 14 EQC does not mean Electronic QC EQC = Electronic Quality Control Slide 15 CLIA03 and Quality Control Acceptable, minimum quality control: At least 2 external, liquid quality control materials analyzed per test per day Slide 16 CLIA03 and EQC All other quality control approaches From electronic to sophisticated internal quality checks All must be qualified under EQC Slide 17 CLIA03 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) Slide 18 EQC Qualification Process Each test site must prove that the instruments built-in controls are equivalent to the traditional mandated, minimum, external (liquid) QC procedures Slide 19 CLIA and EQC The Devil is in the Details Slide 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 Slide 21 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 Slide 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 Slide 23 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 Slide 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 Slide 25 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 Slide 26 EQC Qualification Process Just so you dont 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! Slide 27 EQC Qualification Process The key word in the CLIA regulations is acceptable, Unfortunately CLIA offers NO insight into what is acceptable Slide 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? Slide 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 http://www.westgard.com Slide 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 Slide 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. Slide 32 Look for changes with EQC! As the world turns so does CLIA! EQC CLSI (NCCLS) Meeting March 18, 2005 Judy Yost We blew it Judy Yost until resolved, citations on new QC will continue to be educational Slide 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 Slide 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. Slide 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 manufacturers 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. Slide 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 Slide 37 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! Slide 38 Bottom line with EQC for now! Follow Manufacturers Instructions As the world turns so does CLIA! Slide 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 Slide 40 CLIA Information http://www.cms.hhs.gov/clia/ Note: web address for links have changed on CMS new website Slide 41 Bottom Line continually aim for: Right test Right result Right patient Right time Right record Slide 42 Thanks for you attention! Now it is your turn Questions and Answers