Medical Testing Improvement Act of 1988

Summary

Medical Testing Improvement Act of 1988 - Amends title III (General Powers and Duties) of the Public Health Service Act to remove references to interstate commerce from provisions prohibiting operating a laboratory without a license issued by the Secretary of Health and Human Services. Repeals 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. Requires an annual inspection of laboratories to insure compliance with standards issued by the Secretary. Requires laboratories to qualify under a quarterly proficiency testing program established by the Secretary, including testing for each category of test which the laboratory is authorized to perform under its license. 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. 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. 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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1 official file

• Introduced in House

  summary · EN · 30 March 1988

  Open at official source

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