CLIAC meeting recap - Clinical Laboratory Improvement Advisory Committee

Medical Laboratory Observer, Nov, 2000 by C. Anne Pontius

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.