Page:United States Statutes at Large Volume 81.djvu/571

 81 STAT.]

PUBLIC LAW 9 0 - 1 7 4 - D E C. 5, 1967

of accurate laboratory procedures and services, and shall include, among others, standards to assure— " (i) maintenance of a quality control program adequate and appropriate for accuracy of the laboratory procedures and services; "(ii) maintenance of records, equipment, and facilities necessary to proper and effective operation of the laboratory; "(iii) qualifications of the director of the laboratory and other supervisory professional personnel necessary for adequate and effective professional supervision of the operation of the laboratory (which shall include criteria relating to the extent to which training and experience shall be substituted for education); and "(iv) participation in a proficiency testing program established by the Secretary. "(2) A license issued under this section shall be valid for a period of three years, or such shorter period as the Secretary may establish for any clinical laboratory or any class or classes thereof; and may be renewed in such manner as the Secretary may prescribe. The provisions of this section requiring licensing shall not apply to a clinical laboratory in a hospital accredited by the Joint Commission on the Accreditation of Hospitals or by the American Osteopathic Association, or a laboratory which has been inspected and accredited by such commission or association, by the Commission on Inspection and Accreditation of the College of American Pathologists, or by any other national accreditation body approved for the purpose by the Secretary, but only if the standards applied by such commission, association, or other body in determining whether or not to accredit such hospital or laboratory are equal to or more stringent than the provisions of this section and the rules and regulations issued under this section, and only if there is adequate provision for assuring that such standards continue to be met by such hospital or laboratory; provided that any such laboratory shall be treated as a licensed laboratory for all other purposes of this section. "(3) The Secretary may require payment of fees for the issuance and renewal of licenses, but the amount of any such fee shall not exceed $125 per annum. "(e) A laboratory license may be revoked, suspended, or limited if the Secretary finds, after reasonable notice and opport;unity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory— "(1) has been guilty of misrepresentation in obtaining the license; "(2) has engaged or attempted to engage or represented himself as entitled to perform a n j laboratory procedure or category of procedures not authorized in the license; "(3) has failed to comply with the standards with respect to laboratories and laboratory personnel prescribed by the Secretary pursuant to this section; "(4) has failed to comply with reasonable requests of the Secretary for any information or materials, or work on materials, he deems necessary to determine the laboratory's continued eligibility for its license hereunder or continued compliance with the Secretary's standards hereunder; "(5) has refused a request of the Secretary or any Federal officer or employee duly designated by him for permission to inspect the laboratory and its operations and pertinent records at any reasonable time; or "(6) has violated or aided and abetted in the violation of any provisions of this section or of any rule or regulation promulgated thereunder.

537

Period of validity.

License fees.

Revocation, etc.

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