With ’03 regulation, CLIA ’88 closes QC loop
New regulation at a glance
CLIA ’88 will be complete on April 24 when the final
revised quality control regulation goes into effect after
a decade of phase-ins and debate about needed changes.
The new regulation, published by the Centers for Medicare and Medicaid Services and
the Centers for Disease Control and Prevention in the Jan. 24 Federal
Register, imposes a common set of QC requirements on all nonwaived
testing. It also streamlines and reorganizes existing requirements
to parallel the flow of a specimen through the lab.
In recognition of more robust technology than existed when the CLIA program got
its legs in 1992, the CMS agreed to decrease the frequency
of QC in many of the specialties and subspecialties and offer more
flexibility for routine QC. At the same time, the regulation tightens
requirements for grading proficiency testing to ensure better accuracy
of laboratory testing overall.
Under the new rules, proficiency testing providers, including the CAP, must grade
a laboratory’s samples in cases where 80 percent—rather than
the current 90 percent—of participant or referee labs agree
on the test result (for analytes reported to CMS). "This change
should result in more PT episodes being graded by PT providers,"
says Ronald Lepoff, MD, chair of the College’s Commission on Laboratory
The regulation also puts the ball squarely in the laboratory’s court for reviewing
and validating ungraded samples, especially where the lab’s result does not agree with the intended response or other data supplied
by the PT provider.
The CMS predicts the revamped regulation will have the biggest impact on laboratories
performing unmodified moderate-complexity testing cleared or approved
by the Food and Drug Administration. Once the regulation goes into
effect, these labs—which performed only minimal QC under the
phase-in requirements—will have to validate a test system
once to see if it works accurately before introducing the service.
(The College already requires laboratories to do this for any test
system regardless of its complexity.)
CLIA will continue to base personnel standards on test complexity. Doctoral-degreed
directors of high-complexity testing have to be board certified,
effective Feb. 24, unless they are eligible to be grandfathered
under the phase-in requirements. The CMS and CDC had proposed experiential
alternatives to board certification for these directors, but the
College and the Clinical Laboratory Improvement Advisory Committee
opposed the change.
Clinical laboratories must comply with the new CLIA requirements (or other, more stringent
ones) as of April 24, though CMS won’t enforce compliance until
a laboratory completes its CLIA survey cycle.
"CAP-accredited laboratories should wait for the Lab Accreditation Program
to notify them of any changes to the LAP checklist as the result of the new
CLIA regulation," Dr. Lepoff says. The College will probably notify its accredited
labs by letter and a notice in the "Laboratory Accreditation News" section of
CAP TODAY, though the exact communication plan was still being formulated at
No ’smoking gun’
While CMS officials gave clinical laboratory and accrediting organizations
a preview of the regulation at a CAP-hosted briefing in November,
the PT change was not part of the CMS briefing. But even with the unforeseen
change, "the rule doesn’t appear to contain a major smoking gun,"
observes Phil Bongiorno, the CAP’s assistant director of public
health and scientific affairs.
Dr. Lepoff seconds that assessment: "The regulation is easier to read and eliminates
most of the distinction between moderate- and high-complexity testing,"
he says. But he doesn’t see the changes as having a major impact
The regulation does hold one disappointment, says James MacLowry, MD, chair of
the CAP Council on Scientific Affairs. And that’s CMS’ refusal to
give laboratories the discretion to use reagents that have retained
their potency beyond the expiration date.
"The pathology community has been trying hard to get the government to give clinical
laboratories more flexibility in this area," Dr. MacLowry reports.
He notes that some reagents—particularly antibodies used for
various purposes—are extraordinarily expensive and may be
good for several years past the expiration date. "Actually, most
expiration dates are arbitrary and assigned as part of the manufacturing
process," he adds.
Why the PT change
Since laboratories were aware of most of the other coming changes in the regulation,
the stricter PT requirement provided the focal point for discussion
about the new regulation, at least initially. Judy Yost, director
of CMS’ division of laboratory services, says CMS decided to make
the change because of the large number of ungraded specimens that
were passing by default under the 90 percent consensus agreement.
That’s important, in CMS’ view, considering that ungraded PT specimens
receive an automatic 100 percent passing score, which can create
a false sense of security about the accuracy of laboratory testing.
The CLIAC also recommended the lower consensus requirement for grading
Yet the change isn’t significant for the CAP Surveys program because the majority
of the CAP’s proficiency testing attains greater than 90 percent
consensus, which is expected to remain at that level. But it could
have an impact on other PT providers that have trouble maintaining
that level of consensus among participant or referee laboratories.
The lower threshold for grading samples will not affect the CAP Laboratory
Accreditation Program per se, adds Dr. Lepoff, although the LAP does
track each lab’s PT results, either from the College or approved alternative
PT providers. "So to the extent that more labs fail PT, and we don’t know that
more labs will fail," he adds, "they will hear more from us in terms
of requests for documentation of corrective action taken in the event of PT
The regulation also requires laboratories to verify the accuracy of testing for any
CLIA-regulated analyte, subspecialty, or specialty assigned a PT score
that does not reflect the laboratory’s actual PT performance, especially
where the PT program questions the laboratory’s results. In CMS’ view,
this requirement, coupled with fewer ungraded PT results, will result
in more labs identifying and correcting in a timely manner potential
sources of error that might otherwise have gone undetected.
This more aggressive stance forces a laboratory that receives a default
PT score to take a closer look at how it performed on the challenge,
says a CAP staff member. For example, if the peer group for the test had
a 75 percent consensus and the lab got a different result from that
majority, the lab should take a closer look at how it is doing that test. Or
if the PT evaluation form shows the lab it’s the only one that got
a certain result on an ANA titer, that’s a red flag to look at how staff is doing the
test or who’s reading it—or that something may be wrong with
the lab’s fluorescent microscope.
The College began addressing the issue of ungraded analytes in its EXCEL proficiency
testing program several years ago by providing a chapter in its manual explaining
how to conduct a self-evaluation. It now plans to add language to the front
page of every PT evaluation reminding laboratories that they are responsible
for assessing results that weren’t formally graded by the PT provider. The CAP
also encourages labs to document their efforts in that regard on the PT evaluation
form. That way, the documentation is accessible to any inspector, whether from
the state or the CMS, the CAP, or another accreditation organization.
What’s up with QC
CMS’ Yost agrees the new PT requirement is important but believes the changes to
quality control are "exciting and more comprehensive and
will have a greater impact on laboratories overall." A hallmark
of the new regulation, the CMS says, is the flexibility it affords
a laboratory to tailor QC to its own unique programs and to the expertise levels of its
To reflect improvements in technology and reagent stability, the regulation
reduces the frequency of QC testing in microbiology, hematology,
general immunology and syphilis serology, and blood gas. Dr. Lepoff
notes, for example, that "CMS proposes doing less QC in microbiology
for stains than previously required under CLIA." He believes this particular
change is warranted "based on our experience with these reagents." In hematology,
laboratories will be required to run two controls with different
concentrations each day of testing rather than two levels of control
for each eight hours of testing.
The College’s scientific resource committees are reviewing the less stringent
QC requirements and will make recommendations to the Commission
on Laboratory Accreditation about whether the LAP should adopt them
for CAP-accredited laboratories. Dr. MacLowry predicts that the
vast majority of the committees will agree that the changes are
reasonable in most cases.
"For many years, the sense has been that many of the QC requirements are regulatory,
rather than scientifically driven," Dr. MacLowry explains. "The
CLIA regulations started out being much more conservative, but as
time has passed—and particularly in light of concerns about
the cost of testing—people are starting to agree that the
decreased frequencies are consistent with good practice."
A number of the QC changes are actually stricter than existing CLIA
requirements and will require modifications or additions to the
LAP checklist. For example, laboratories that perform mycobacteriology
identification will have to use acid-fast organisms that produce
positive and negative results (quality control) each day of use.
The CMS previously required laboratories to check the iron uptake
test each day with a positive and negative control organism, but
required only a positive acid-fast control for all other procedures.
Laboratories that perform the same test using different methods or instruments
or at multiple test sites will be required to evaluate and define
the relationship between test results twice a year. And laboratories
must flag and assess patient results that are inconsistent with
the following when available: patient age, sex, diagnosis or pertinent
clinical data, distribution of patient test results, and relationship
with other test parameters. The laboratory must also document all
of its test result comparison activities.
The regulation also directs laboratories to rotate control testing over time among
all operators who perform the test. This requirement represents
standard practice, Dr. Lepoff says, but the LAP will probably make
it more explicit in its checklist.
The regulation includes a new emphasis on improving patient safety. According to
CMS administrator Tom Scully, the way in which CMS organized the
requirements to track a specimen through each phase of the test
process should help labs prevent and detect laboratory-associated
Yost notes, for example, that numerous studies have found that many lab errors
occur in the preanalytical phase. "[So] by breaking out each phase
of testing in the regulation, with the applicable requirements for
that phase of testing," Yost explains, "the lab has a better chance
to identify errors and prevent them based on its own processes and
The regulation contains measures aimed at improving patient identification and
reporting potentially life-threatening results. For example, the
report must include either the patient’s name with an identification
number or a unique patient identifier and ID number.
CAP to work with CMS
At press time, the College continued to dissect the finer points of the regulation
and its potential impact on accredited laboratories and pathology
practice—a task the CAP’s Bongiorno likens to analyzing the
HIPAA privacy rule before the government released guidance documents
that got the dialogue flowing on specific issues. The College will
be working with the CMS to develop surveyor guidelines that laboratories
can use to comply with the new regulations. These guidelines should
be ready by late summer.
"One of the positives of the way CMS wrote the regulation," Yost says, "is that
it won’t be outdated before the policies are ready in the guidelines."
Karen Lusky is a writer in Brentwood, Tenn.