CLIAC update.

The Clinical Laboratory Improvement Advisory Committee met for a one-day session February 3, 1999. The short agenda included the following topics: agencies' updates, inspections of cytology labs, research on Clinical Laboratory Improvement Amendment cytology proficiency testing requirements, and validation inspections of accredited laboratories. Not on the agenda but just as significant was the recognition of the outgoing CLIAC chairperson and members, as well as other distinguished individuals.

People

Morton K. Schwartz, PhD, Department of Clinical Laboratories, Memorial Sloan-Kettering Cancer Center, New York, NY, has served as the chair of the CLIAC since its inception in 1992. Schwartz said that over the years, serving as the CLIAC chair taught him that high quality care could be found in a wide spectrum of places, not just in the Ivy League facilities. At an emotional adjournment, he reminisced about the experiences he had with other healthcare providers doing proficiency testing.

Toby L. Merlin, MD, chief medical officer and senior vice president and pathologist, Lovelace Health Systems, Albuquerque, NM, who currently serves on the CLIAC, will be the new Committee chair. His first CLIAC meeting as chair is tentatively scheduled for May 1999.

Service recognition plaques were presented to the following outgoing Committee members:

Regina M. Benjamin, MD Aliza A. Lifshitz, MD Bernice M. Madison, PhD Deborah McHugh, CRNP Glenda D. Price, PhD Patricia E. Saigo, MD Elliott A. Segal, MPH Ulder J. Tillman, MD

Although these members have received their plaques, if their replacements are not appointed and ready to serve at the next meeting, these members may continue to serve. Some members of the last outgoing group stayed on for several meetings after their terms had ended.

Dr. Edward Baker, director, Public Health Practice Program Office, Centers of Disease Control and Prevention welcomed Robert Martin, DrPH, as the new directs, Division of Laboratory Systems, PHPPO. Dr. Martin has been with the Michigan Department of Community Health since 1991. He is a graduate of Michigan State University (BS '71), Michigan Technological University (MS '75), and the University of North Carolina (MPH '76 and DrPH '79). He is also an adjunct associate professor at Michigan State University where he has been teaching undergraduate medical microbiology for the past five years.

Dr. Baker also introduced Devery Howerton, PhD, as the new branch chief, Laboratory Practice Standards Branch, DLS. Dr. Howerton has been the national quality assurance manger for SmithKline Beechman Clinical Laboratories since 1993. She received a BS degree in medical technology from the Medical University of South Carolina, an MS degree in clinical immunology from Emory University, and a PhD in experimental pathology from Emory University.

On a sad note, Dr. Schwartz informed everyone of the death on Christmas day of CLIAC member Lemuel J. Bowie, PhD. He was the director of clinical laboratories at Evanston Hospital in Evanston, IL.

CDC, HCFA, and FDA updates

The CDC is still working on the process to move responsibility for determining CLIA test categorizations from the CDC to the FDA. Although it gave no time line, the CDC claimed that as soon as the process is complete, it will inform the CLIAC. CDC has not completed its evaluation of CLIAC's comments on the assisted reproductive technology (ART) topic (for more on ART, see POL Adviser in MLO's November 1998 issue, p. 14) and remains uncommitted with regard to a decision on bringing ART testing under CLIA regulation.

The Health Care Financing Administration continues to reshape CLIA to keep pace with changes in the clinical laboratory profession. Still to come are the "final, final, final" [sic] CLIA regulations that will address all of the original issues identified during the comment period back in the early '90s. HCFA is also working with the CDC to ensure the Administration's critical systems will be year 2000 compliant. HCFA pledged assurance that providers will continue to receive payments.

Although the total number of CLIA-registered laboratories has been stable over the last year, the number of physician office laboratories (POLs) has shown an increase of approximately 2,000 labs since January 1998. Surveyor's deficiency data from "all labs" (which includes POLs) versus that from POLs alone shows little difference for the three most cited deficiencies (see Table).

The FDA continues to update its processes to meet the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The Administration underwent leadership changes that hampered FDAMA's progress but is still on track to revamp the premarket approval application and 510(k) processes to be more efficient.

Validation survey process

The CLIA regulations specify that 5% of accredited laboratories must undergo a validation survey. A validation survey is a normal HCFA inspection performed in an accredited laboratory to validate an accrediting agency's survey or inspection process. The HCFA results are reviewed by a special task force that compares condition level deficiencies with findings from the accrediting agency. Validation surveys have been completed for fiscal years 1996 and 1997 (FY98 should be complete in March '99). Using a formula from the CLIA regulations, a disparity can be calculated for each accrediting agency. All of the following accrediting agencies were below the 20% disparity threshold that would require a reexamination of an agency's equivalency to CLIA. The accrediting agencies are the American Association of Blood Banks, the American Osteopathic Association, the American Society for Histocompatibility and Immunogenetics, the College of American Pathologists, Commission on Office Laboratory Accreditation, and the Joint Commission for the Accreditation of Healthcare Organizations.

Table

Most frequently cited deficiencies in all types of labs versus
physician office labs

Third round inspection deficiencies    All labs(*)    POLs

Failed to follow QC manufacturer's          9%        10%
instructions

Failed to perform 2 levels                  8%         8%
of QC per day of testing

No quality assurance program                7%         7%

* Including POLs

Currently validation surveys are performed in every state up to 60 days after the accreditation agency's inspection. Because circumstances can change in the testing environment and inspectors may not be doing apples-to-apples comparisons, HCFA and the accrediting agencies are considering performing validation and accreditation surveys simultaneously. This would reduce the inspector's on-site visit to the laboratory to one event per cycle. Currently, laboratories with dual inspections have to respond to both sets of deficiencies.

Cytology proficiency testing

HCFA has struggled with finding an acceptable national proficiency testing (PT) program for cytologists that meets the CLIA regulations. Glass slides and computer-based PT have been researched, but the findings resulted in more questions than answers. The public commenters and cytology-savvy CLIAC members felt strongly that cytologist work performance should not be solely judged by their PT performance.

Cytology laboratory reviews

In addition to a routine CLIA inspection, HCFA has a specialized review process specifically for cytology laboratories. HCFA's CLIA office may choose to review a cytology laboratory based on one of three accounts: random selection (announced survey 8-10 days), recommendation (announced survey 8-10 days), or complaint (unannounced survey). The cytology laboratory compliant rate is 22%, but few are substantiated. The inspection includes a retrospective rescreen of randomly selected negative test results or slides that were used in an internal quality control program. This program helps ensure high quality testing.

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C. Anne Pontius is a member of MLO's Advisory Board and president of Laboratory Compliance Consultants in Raleigh, NC. She can be reached by e-mail at: [e-mail].