EQC:What’s the Story Today!

Sharon S. Ehrmeyer, Ph.D.UNIVERSITY OF WISCONSIN

MADISON, WI

Quality Results

for

Quality Healthcare!!

Ultimate Goal of Regulations

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

CLIA - 24 January 2003

NEW

http://www.phppo.cdc.gov/clia/pdf/CMS-2226-F.pdf

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…

CLIA’03 -- Analytical Phase

CLIA’s answer to analytical quality–

“equivalent” quality testing…

Minimum Quality and Minimum QC?

Equivalent Quality Control (EQC)???

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

EQC does not mean Electronic QC

EQC =

Electronic Quality Control

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

CLIA and EQC

The “Devil is in the Details”

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!

Bottom line with EQC for now!

Follow Manufacturers’ Instructions

As the world turns so does CLIA!

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

Bottom Line – continually aim for:

Right testRight result

Right patientRight time

Right record

Thanks for you attention!

Now it is your turn

Questions and Answers