(a) As used in this chapter, âlaboratory directorâ means any person who is any of the following: (1) A duly licensed physician and surgeon. (2) Only for purposes of a clinical laboratory test or examination classified as waived, except as provided in paragraph (G), is any of the following: (A) A duly licensed clinical laboratory scientist. (B) A duly licensed limited clinical laboratory scientist. (C) A duly licensed naturopathic doctor. (D) A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in clause (ii) of subparagraph (E) of paragraph (5) of subdivision (a) of Section 3041. (E) A duly licensed dentist serving as the director of a laboratory that performs only clinical laboratory tests authorized within the scope of practice of dentistry as delineated under Section 1625. (F) A pharmacist-in-charge of a pharmacy serving as the director of a laboratory that only performs tests waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), as authorized by the Pharmacy Law (Chapter 9 (commencing with Section 4000)). (G) A certified nurse-midwife serving as the director of a laboratory that only performs clinical laboratory tests classified as waived or provider-performed microscopy authorized within the scope of the certificate to practice nurse-midwifery as specified in Section 2746.5. (3) Licensed to direct a clinical laboratory under this chapter. (b) (1) A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory. (2) As used in this subdivision, âCLIA laboratory directorâ means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS). (c) The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, they shall remain responsible for ensuring that all those duties and responsibilities are properly performed. (d) (1) The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. They shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter. (2) Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which they have been found by the laboratory director to be competent to perform and report. (e) As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and exami
‹ Prev All California sections Next ›
Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.