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December 18, 1991

Information 'Leaking' About CLIA-Implementing Regulations to Be Published Early in 1992

JAMA. 1991;266(23):3257-3258. doi:10.1001/jama.1991.03470230015004

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PROPOSED REGULATIONS to implement the Clinical Laboratory Improvement Amendments (CLIA) of 1988 are nearing completion.

Publication is expected early in 1992, although even then there may be some provision for comments. The 1988 amendments require that all clinical laboratories meet quality standards and be certified by the federal government.

Even before they are published, however, the impact of the amendments soon will be brought home to physicians and others who operate clinical laboratories. This initial impact will be in the form of a detailed questionnaire from the Health Care Financing Administration (HCFA), the object of which is to give HCFA officials a better idea of the regulatory task that lies ahead of them.

Complex Questionnaire  The questionnaire is being sent to some 640 000 addresses, including physicians' office laboratories. The mailing even includes those who provide sidewalk cholesterol screening tests.Some who have seen the questionnaire estimate that it will