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135230 1 (1988-02-29)

handle is hein.gao/gaobacvzy0001 and id is 1 raw text is: United States General Accounting Office Washington, D.C. 20548 Human Resources Division 135230 H8-0111 February 29, 1988 The Honorable Ron Wyden Chairman, Subcommittee on Regulation and Business Opportunities Committee on Small Business House of Representatives Dear Mr. Chairman: .In response to your January 5, 1988, request and later discussions with your office we are providing information on the states' regulation of clinical laboratories. There are three types of laboratories subject to state regulation. They are independent, hospital, and physician office laboratories. It is estimated there are at least 90,000 of these laboratories in operation in the United States. In doing our work we relied primarily on a review of the Laboratory Regulation Manual, published and updated periodically by Aspen Publishers, Inc. This manual covers all aspects of federal and state laboratory regulation. The infor- mation we analyzed was current as of January 1987 and does not reflect changes in state laws and regulations since then. We also contacted program offici4ls in 11 states to obtain further clarification concerning the extent of state regulatory requirements for the three types of laboratories. In analyzing state regulatory programs we considered five elements to be most important. These are licensure, proficiency testing programs, quality control programs, personnel requirements and standards, and inspection authority. We found that as of January 1987, the regulation of clinical laboratories varied among the 50 states for the 3 categories of laboratories. For example: -- Thirteen states did not regulate independent laboratories. -- Seventeen states issued licenses to hospital laboratories as separate entities while 23 additional states required licensed hospitals to have laboratories that met certain requirements. Oq1L/97 /f~3

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