11/28/00

The Honorable Donna Shalala
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Shalala:

We, the undersigned organizations, are requesting your assistance in ensuring that the three federal agencies responsible for administering CLIA'88-the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Health Care Financing Administration (HCFA)-coordinate their efforts in developing and implementing a coherent clinical laboratory regulation. We are concerned that the FDA may have changed the criteria for placing tests in the waiver category without reaching an agreement with CDC and HCFA on how to proceed, nor seeking the advice and input from CLIAC-the agency advisory panel on laboratory issues

Although we share the FDA's desire to make the test categorization process more efficient and consistent, we believe that all three agencies first need to reach a compromise on how to move forward in this area given the implications of this change for the entire CLIA program. We are especially concerned, however, that this decision may "weaken" the waiver criteria standards at a time when preliminary government data indicates that there may be compliance problems in some of the lesser-regulated facilities. Therefore, we urge you to direct these agencies to meet and reach an agreement on this matter, which ensures both the quality of patient testing and maintains the integrity of the CLIA program.

Thank you for your consideration in this matter.

Sincerely,

American Association for Clinical Chemistry
American Association of Bioanalysts
American Clinical Laboratory Association
American Medical Technologists
American Society for Clinical Laboratory Science
American Society for Microbiology
American Society of Clinical Pathologists
Association of Public Health Laboratories
CLMA: Leadership in Clinical Systems Management
College of American Pathologists

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