Clinical Laboratory Improvement Act

Summary

Clinical Laboratory Improvement Act - Amends the Public Health Service Act to require the licensing of clinical laboratories. Sets forth the standards that must be met to receive and maintain such a license. Directs the Secretary of Health, Education, and Welfare to publish, administer, and enforce national standards for clinical laboratories to assure consistent performance by the laboratories of accurate tests and other procedures. Authorizes the Secretary to delegate regulation and licensing authority to a State if the Secretary determines that such State: (1) has adopted standards for such laboratories and a system of licensure which are no less stringent than the national standards and licensing system; (2) has adopted and is implementing adequate enforcement procedures; (3) will keep records and make reports as the Secretary may require; (4) permits exemptions from the requirements which are no less stringent than exemptions from national standards; and (5) has adopted and can implement adequate procedures for the control of health hazards which may result from an activity of a clinical laboratory. Enumerates conditions under which the Secretary may suspend or revoke the license of a clinical laboratory. Authorizes anyone aggrieved by suspension or revocation of a clinical laboratory license to file a petition for review with the appropriate United States court of appeals. Makes all consequent judgments of such courts subject to review by the Supreme Court. Stipulates that any unlicensed person, requred to be licensed under this Act who solicits or accepts directly or indirectly any specimen for laboratory examination shall be fined not more than $10,000, imprisoned for not more than one year, or both. Stipulates that any owner, operator, or employee of a clinical laboratory who willfully engages in any false, fictitious, or fraudulent billing practice for the purpose of obtaining payment for laboratory services provided under specified Federal health assistance programs shall be fined not more than $10,000, imprisoned for not more than three years, or both. Stipulates that no unlicensed clinical laboratory required to be licensed by this Act may receive a grant, contract, or other form of financial assistance under the Public Health Service Act, or charge or collect for laboratory services for any entity which receives a grant, contract, or financial assistance under such Act. Prohibits discrimination by an employer against an employee who has commenced, participated in, or testified in any proceeding authorized by this Act. Allows employees so discriminated against to file a complaint with the Secretary. Directs the Secretary to investigate such complaints and provide relief or deny the complaint within 90 days of its receipt. Permits persons aggrieved by the Secretary's final action on such complaints to obtain review in the appropriate United States court of appeals. Authorizes agents of the Secretary to enter at reasonable times any clincial laboratory for inspection purposes. Authorizes the Secretary to make grants to States with primary enforcement responsibility to assist in meeting the cost of administering programs for the regulation of clinical laboratories, such grants not to exceed 75% of the State's cost. Authorizes the appropriation of specified amounts in fiscal years 1979 through 1981 for the purpose of making such grants. Establishes in the Department of Health, Education, and Welfare an advisory council on clinical laboratories to advise the Secretary with respect to: (1) regulations promulgated under this Act; and (2) coordination between the Federal and State laboratory regulatory programs to avoid duplicate enforcement. Directs the Secretary to establish within the Department an administrative unit to be responsible for the coordination of the regulatory functions authorized by this Act and for specified laboratory regulatory functions under the Social Security Act. Requires the Secretary to make an annual report to Congress on the accuracy of tests and procedures performed by clincial laboratores. Amends the Social Security Act to set forth procedures for determining costs and charges for clinical laboratory services and prohibits reimbursement to the extent that any cost or charge is found to be unreasonable. Directs the Secretary to conduct a study of: (1) existing voluntary certification standards and State licensure laws for clinical laboratory supervisors, technologists, and technicians; and (2) qualifications of entities that certify such personnel as qualified to perform clinical laboratory services. Requires the Secretary to submit to Congress a summary of information received through license exemption applications during the three-year period after national standards for clinical laboratories are promulagated. Directs the Secretary, on the basis of such information, to make recommendations on possible revision of clinical laboratory licensing exemptions.

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Documents

2 official files

• Reported to House with amendment(s)

  summary · EN · 8 September 1976

  Open at official source

• Introduced in House

  summary · EN · 10 June 1976

  Open at official source

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