HCFA tries to ease CLIA pain; but medicine continues to fight for relief from lab regulation

Article Abstract:

Physician groups that have office laboratories are not likely to accept the administrative tips for simplifying regulatory compliance that are being compiled by the Health Care Financing Administration (HCFA). Many of the 89,000 CLIA-registered physician office labs in the US are hoping that the regulations imposed by the Clinical Laboratory Improvement Amendment of 1988 will be eased by the new Republican Congress. Since CLIA regulations were established, at least 4,000 physicians have withdrawn from the office lab business because compliance was so difficult.

Medical Laboratories, Medical and Diagnostic Laboratories, Product Safety-Foods & Additives, Standards, Food additives, United States. Centers for Medicare and Medicaid Services, Food safety

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Will Congress let White House ease lab rules?

Article Abstract:

Both the White House and the Centers for Disease Control and Prevention are seeking to ease strict rules on clinical laboratories, but members of Congress are vowing to fight any changes. Currently, laboratories that perform simple tests are subject to little regulation, but laboratories that do routine but more sophisticated tests are subject to intense regulatory scrutiny. Physicians who operate their own laboratories object to what they perceive as excessive regulation.

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Some lab rules relaxed, but many doctors say 'enough' and close

Article Abstract:

A Health Care Financing Administration review claims that about 4,000 doctors have closed their in-house medical laboratories in response to new requirements under the Clinical Laboratory Improvement Act of 1988 (CLIA). The act, which went into effect on Sep 1, 1992, brings all laboratories under varying degrees of government regulation. Information on CLIA regulations governing medical lab operation is presented.

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