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The Clinical Laboratory Improvement Advisory Committee met September 27-28, 2000 to orient new members; provide agency updates; and discuss CLIA waived criteria, workforce shortage issues, unregulated tests, and genetic testing.

Orientation for new members

Ten new members (see http://www.mlo-online.com/observ/1000/story4.html for list of new members) were oriented to the rules of government committee service. In regard to issues relevant to conflicts of interest, it was clearly stated that committee members must abstain from voting on any categorization of a test produced by entities with which the member has a current direct financial interest, or produced by competitors of such entities. Members must disclose:

* laboratory and medical positions

* laboratory-related employment (ie, work with professional associations)

* laboratory ownership

* laboratory-related positions that involve a fiduciary capacity

* names of all relevant entities providing honoraria for attendance at scientific meetings within the past 12 months

* financial interests involving specific laboratory tests under consideration at those meetings.

When questions arose concerning whether a situation constitutes a conflict of interest, Toby Merlin, MD, CLIAC chair responded, "It's hard to know and good to be sure, so when in question, always ask."

Rhonda Waylon, chief of the Laboratory Practice Standards Branch of CLIAC, gave an extensive history and summary of CLIA. This gave new members a good introduction to the CLIA regulations.

CDC update: Research efforts

The CDC is attempting to find data that backs the anecdotal information relating to the laboratory environment that has come from CLIAC members, the CDC, and the healthcare industry. Anecdotal information consisted of reports that: POLs can't do quality work, HMOs are killing the business; laboratories can't find good workers; and CLIA interferes with laboratory operations. Steven Steindel, PhD, CDC, who is in charge of the Laboratory Sentinel Monitoring Network, presented the CDC's laboratory industry research efforts.

The CDC started the Network in 1994 by requesting that nonprofit organizations participate in this program in order to gather data for the CDC. The CDC then awarded grant money to the participating organization that became part of the Network. Washington State was the first to be awarded a participation grant to gather laboratory data but was not given instructions or a template on how to gather the data. The methods were to be determined by the state. Over the past several years, the Network has generated more than 10 reports of laboratory-related information that is consistent with their state network of more than 200 participants. The reports may be viewed at: http://www.phppo.cdc.gov/DLS/mlp/pnimsmn.asp.

The Sentinel Network is growing, with awards given in 1999 to both Arkansas and New York. The diversity of healthcare in participating states should help paint a realistic picture of our national laboratory industry. The network is attempting to gather data that will prove or disprove the anecdotal information reported to the CDC. Washington's Network is a success story. Their grant has been renewed for 3 years. Both Arkansas and New York have also been awarded grants to participate in the network for 3 years. NY has a new certificate for a limited testing service laboratory that is a waived lab but not classified as a POL. NY will have direct oversight of this type of lab and will put them in their network. NY state plans include onsite proficiency testing in these labs.

Edward L. Baker, MD, director, Public Health Practice Program Office at the CDC, provided the following clarification on why the Sentinel Network is necessary: "Anecdotes plus data equals policy." This makes sense because the CDC is involved in writing public health policies

HCFA update

Judy Yost, director of CLIA's program at HCFA, prefaced her presentation of data gathered by HCFA by reminding CLIAC members that these data represent a snapshot in time. The marketplace itself is dynamic, with labs entering and leaving daily. The data specified by "laboratory type" are determined by the entity completing the HCFA 116 CLIA application. The entity chooses the type based on options listed on the application, and, therefore, there may be discrepancies with reality.

Ms. Yost presented an overview of the waived certificate and testing category. She reviewed the pilot study performed in Colorado and Ohio that showed that more than 50% of those laboratories were out of compliance because they were performing tests not listed as waived or were not adhering to the requirement that they must follow the manufacturer's instructions when performing a test. The pilot study has been expanded to 8 more states and was to start in October. HCFA plans to conclude the expanded study by the end of 2001, at which time they will begin comparing data.

The pilot study includes announced inspections with a focus on data collection. In the event that an entity is not in compliance, the inspectors will help them become compliant Ms. Yost stated that only under the worst conditions would the laboratory receive a citation.

For most of the waived laboratories m Colorado and Ohio that were out of compliance, when they were revisited the inspectors found they had corrected their deficiencies.

Over the past several years, because of the market forces of consolidations, mergers, and moderate complexity laboratories becoming waived, there has been a decrease of 20,000 labs that are surveyed by CLIA. Therefore, some states have lost surveyors. It stands to reason that the states where the expanded pilot study may take place will be those in which there is a surplus of surveyors.

FDA update

Joseph Hackett, PhD with the FDA, presented the proposed changes to the FDA that include expanding the branches from 3 to 6. The current branches would be split in half. In doing this, the goals are to improve leadership quality, improve responsiveness, and develop policy. Policy development is slated for genetics diseases, high information content microarrays, bioterrorism, CLIA waivers, and noninvasive glucose monitors. In the FDA's attempt to be more responsive to their public, they have established a new motto of adhering to the 5 "F's", which is to: be friendly, be fair, finalize decisions, follow-up, and be flexible. Clara Sliva, MT(ASCP), MPA, acting CLIA coordinator, Division of Lab- oratory Services for the FDA added a sixth: to be fast.

CLIAC discusses waived tests

Dr. Baker requested that CLIAC give the FDA a statement regarding the criteria to categorize a waived test CLIAC discussed options ranging from making suggestions for changes in the statute, which requires congressional involvement and is unlikely to happen, to finalizing the current proposed criteria published in the Federal Register in 1995.

One area everyone struggles with is CLIA's definition of the word "harm" because it is such a subjective word. CLIAC is also struggling with the term "accuracy." The biggest unanswered question is: will the FDA waive tests because they are simple and easy to use or will they waive them based on how the tests will be used. Ms. Kay Setzer, nonvoting industry liaison to CLIAC, informed the committee that the Food, Drug, and Cosmetics Act defines the performance characteristics of a test, and that CLIA defines the user and facilities.

Dr. Baker suggested the development of a workgroup to further explore the waiver Issue and come up with a definitive statement for the FDA concerning the waived criteria. The committee came up with a list of more than 20 charges for the workgroup, which is currently comprised of 8 individuals. Most of the charges dealt with clarifying the verbiage of the statute. A sidebar issue is how to develop an appeals process for manufacturers that have a test or method that was denied waived status.

Dr. Merlin sent a letter on behalf of CLIAC to Donna Shalala, Secretary HHS, requesting the FDA to continue to use the 1995 proposed criteria to waive procedures until the CLIAC workgroup finalizes their statement. They expect it to be complete by the next CLIAC meeting, which is scheduled for February or March of 2001.

Unregulated tests workgroup report

At the previous CLIAC meeting, there was difficulty grasping how broadly to define CLIA's language of "materials derived from the human body." Because of this, a workgroup was convened to study the issue. Dr. Edward W. Hook 111, professor of medicine, University of Alabama at Birmingham and CLIAC member, presented the summary of the workgroup's comments.