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United States · Bill · S

S. 2477 (100th)

Medical Testing Improvement Act of 1988

Original

openUnited States· United States Congress· EN

Introduced

7 June 1988

Last action

Status

Indefinitely postponed by Senate by Unanimous Consent.

Sponsors

Subjects

Discovery layer

Source updated

21 April 2025

Summary

Medical Testing Improvement Act of 1988 - Amends title III (General Powers and Duties) of the Public Health Service Act to require an annual inspection of laboratories to insure compliance with standards issued by the Secretary of Health and Human Services. Requires laboratories to qualify under an annual or more frequent proficiency testing program established by the Secretary, including testing for each category of tests which the laboratory is authorized to perform under its license. Directs the Secretary to carry out a system of testing the proficiency of a laboratory and its employees with regard to gynecological smears. Sets forth recordkeeping and reporting requirements. Directs the Secretary to make the results of the proficiency testing and the information reported under these provisions available under specified Federal law relating to public information. Requires the Secretary to maintain a technical and staff capacity to provide training and technical assistance to laboratories requesting such service and to laboratories which do not qualify under the proficiency testing program. Allows the proficiency testing to be performed by a private entity only if the entity meets standards established by the Centers for Disease Control. Requires the Secretary to maintain the capacity to conduct the testing. Requires laboratories to provide for direct billing of patients. Makes laboratory licenses issued by the Secretary valid for one year instead of three years. Removes the cap on the fee for issuance or renewal of licenses. Removes provisions exempting from statutes regulating laboratories those laboratories operated by physicians, osteopaths, dentists, or podiatrists solely as an adjunct to the treatment of their own patients. Directs the Secretary to make grants to a State which enacts laws providing for standards equal to or more stringent than under the provisions amended by this Act to assist the State in implementing the laws.

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