EQC: Whats the Story Today

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EQCWhats the Story Today!

• Sharon S. Ehrmeyer, Ph.D.
• UNIVERSITY OF WISCONSIN
• MADISON, WI

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Quality Results forQuality Healthcare!!
Ultimate Goal of Regulations
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Quality 2006 Test Sites View

• Meeting the Regulations
• and Passing Inspection
• CLIA (CMS) the feds
• JCAHO
• CAP
• etc.

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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

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CLIA - 24 January 2003
NEW
Exciting!
http//www.phppo.cdc.gov/clia/pdf/CMS-2226-F.pdf
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Quality Systems Approach

• Now CLIA03 is organized and has quality
  requirements that emphasize quality for the
  entire testing process
• Pre-analytical
• Analytical
• Post-analytical

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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

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Quality Systems Approach

• Governments Philosophy
• Following the CLIA regulations
• should yield higher quality results

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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

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CLIA03 -- Analytical Phase

• CLIAs answer to analytical quality
• equivalent quality testing

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Minimum Quality and Minimum QC?

• Equivalent Quality Control (EQC)???

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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_Guidel
  ines_
• for_Laboratories.aspTopOfPage

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EQC does not mean Electronic QC
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CLIA03 and Quality Control

• Acceptable, minimum quality control
• At least 2 external,
• liquid quality control materials
• analyzed per test per day

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CLIA03 and EQC

• All other quality control approaches
• From electronic to sophisticated internal
  quality checks
• All must be qualified under EQC

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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)

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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

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CLIA and EQC

• The Devil is in the Details

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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

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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

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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

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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

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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

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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

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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!

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EQC Qualification Process

• The key word in the CLIA regulations is
  acceptable,
• Unfortunately CLIA offers NO insight into what is
  acceptable

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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?

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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
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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

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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.

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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
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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

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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.

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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.

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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

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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!

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

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CLIA Information

• http//www.cms.hhs.gov/clia/
• Note web address for links have changed on CMS
  new website

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Bottom Line continually aim for

• Right test
• Right result
• Right patient
• Right time
• Right record

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