Along with stipulating qualifications, the CLIA regulations specify the expected of duties for the laboratory director. The director has the responsibility for the overall administration and operation of the laboratory, including hiring personnel who are competent to perform laboratory testing and record/report test results promptly, accurately, and proficiently.
The director is also responsible for assuring compliance with the regulations. The regulations related to the director are contained in Subpart M, along with those for the technical consultant, clinical consultant, and testing personnel. The laboratory director must be accessible to the laboratory to provide on-site, telephone, or electronic consultation as needed.
A person may direct no more than five laboratories. If qualified, the laboratory director may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the appropriate qualifications. If the laboratory director reassigns performance of his/her responsibilities, he/she remains responsible for ensuring all duties are properly performed. Duties for directing a moderate level laboratory include:
Source: 42 CFR 493 (Subpart M, 493.1407)
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Clinical Laboratory Improvement Amendments (CLIA)
Physician Office Laboratory Director Duties