College of American Pathologists
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With ’03 regulation, CLIA ’88 closes QC loop

New regulation at a glance

March 2003
Karen Lusky

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 Accreditation.

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 press time.

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 on laboratories.

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 PT samples.

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 failure."

Grade yourselves

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 testing personnel.

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.

Stressing safety

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 medical errors.

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 procedures."

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.