02/17/98

Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3745-P
P.O. Box 7517
Baltimore, Maryland 21207-0517

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on your December 19, 1997 proposed rule setting forth the Medicare and Medicaid hospital conditions of participation. In general, AACC supports the new conditions and, specifically, your attempts to encourage flexibility, eliminate unnecessary procedural requirements and place increased emphasis on patient outcomes.

AACC agrees that HCFA should maintain the current laboratory-related requirements, which mandate that hospitals furnish laboratory services, including 24 hour-a-day emergency laboratory services, and meet the CLIA ’88 requirements. We believe these stipulations are important mechanisms for ensuring that patients receive timely, quality care.

However, AACC also supports HCFA’s streamlining of the process by eliminating redundant provisions. Therefore, we agree that provisions requiring that a hospital laboratory secure the proper receipt and reporting of specimens, and that a written description of laboratory services be available to the medical staff, should be deleted. The first requirement is already required by CLIA ’88 and the second will be provided by hospitals regardless of whether it’s stipulated or not.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Manager, Government Affairs, at (202) 835-8721.

Sincerely,

  

Stephen Kahn, PhD, DABCC

President

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