EQC:
What’s the Story Today!
Sharon S. Ehrmeyer, Ph.D.
UNIVERSITY OF WISCONSIN
MADISON, WI
Ultimate Goal of Regulations
Quality Results
for
Quality Healthcare!!
Quality 2006 – Test Site’s View
Meeting “the” Regulations
and Passing Inspection
CLIA (CMS) “the feds”
JCAHO
CAP
etc.
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
Total Analytical error distribution
Error Source
Ross and Boone1
Plebani et al.2
Pre-analytical
46%
68%
Analytical
7%
13%
Post-analytical
47%
19%
1Ross
and Boone, Inst. of Critical Issues in Health Lab Pract, DuPont Press, 1991
2Plebani 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 “builtin” [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 preanalytic, 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….
As the world turns so does CLIA!
Look for changes with EQC!
CLSI (NCCLS) Meeting
EQC
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!
As the world turns so does CLIA!
Bottom line with EQC for now!
Follow Manufacturers’ Instructions
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
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 test
Right result
Right patient
Right time
Right record
Thanks for you attention!
Now it is your turn
Questions and Answers