Page:United States Statutes at Large Volume 102 Part 3.djvu/955

 PUBLIC LAW 100-578—OCT. 31, 1988

102 STAT. 2907

"(B) to maintain records, equipment, and facilities Records. necessary for the proper and effective operation of the laboratory, "(C) in performing and carrying out its laboratory examinations and other procedures, to use only personnel meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which qualifications shall, as appropriate, be different on the basis of the type of examinations and procedures being performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures, "(D) to qualify under a proficiency testing program meeting the standards established by the Secretary under paragraph (3), and "(E) to meet such other requirements as the Secretary determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures. "(2) CONSIDERATIONS.—In developing the standards to be issued under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration— "(A) the examinations and procedures performed and the methodologies employed, "(B) the degree of independent judgment involved, "(C) the amount of interpretation involved, "(D) the difficulty of the calculations involved, "(E) the calibration and quality control requirements of the instruments used, "(F) the type of training required to operate the instruments used in the methodology, and "(G) such other factors as the Secretary considers relevant. '(3) PROFICIENCY TESTING PROGRAM.—

"(A) IN GENERAL.—The Secretary shall establish standards for the proficiency testing programs for laboratories issued a certificate under this section which are conducted by the Secretary, conducted by an organization approved under subparagraph (C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the Secretary has determined that a proficiency test cannot reasonably be developed. The testing shall be conducted on a quarterly basis, except where the Secretary determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not less often than twice per year). "(B) CRITERIA—The standards established under subparagraph (A) shall include uniform criteria for acceptable performance under a proficiency testing program.

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