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Title: Section 58-1.2 - Laboratory director

58-1.2 Laboratory director.

(a) The director shall serve the laboratory full-time, or on a regular part-time basis. Regular part-time basis shall mean assumption of full responsibility for direction and technical operation of the laboratory, including adherence to the department quality control standards and training of personnel performing the testing. If he serves on a regular part-time basis, he shall not serve as director of more than two clinical laboratories, within or outside New York State or more than one clinical laboratory and one blood bank or more than two blood banks. Where a laboratory and a blood bank are on the same premises and are under the supervision of the same director, such laboratory and blood bank shall be deemed one laboratory for the purpose of this subdivision. Notwithstanding the foregoing provisions of this subdivision, if the commissioner finds that more than two laboratories are required to serve the needs of an area and the total volume and the types of laboratory service provided by the several laboratories are not such as to require the services of more than one director, he may authorize an individual to direct more than two laboratories or blood banks or combinations thereof. Such authorization must be renewed at least every two years. The commissioner may also make an exception where the additional directorships involve only blood-holding facilities as defined in section 58-2.1(i) of this Part.

(b) Commensurate with the laboratory workload, scope and complexity of the testing procedures carried out, qualifications of onsite personnel, proximity to another laboratory under identical directorship, and availability of alternate monitoring and communications capabilities, the director shall spend an adequate amount of time in the laboratory to direct and supervise the technical performance of the staff and shall be readily available for personal or telephone consultation. The adequacy of the amount of time a laboratory director is present and in active direction shall be determined by the department based on the factors enumerated above, results of onsite inspections and proficiency testing and documentation of the director's full responsibility for direction and technical operation. Attendance records may be required to document the adequacy of the director's presence.

(c) The director shall be responsible for performance of all tests carried out in the laboratory, adherence to the department's quality assurance standards for such tests, and accurate reporting of the test results.

(d) The director shall be responsible for ensuring the employment of qualified laboratory personnel, evaluation of job performance of such personnel and their in-service training.

(e) If the director's employment terminates or he is temporarily absent, arrangements shall be made for a qualified temporary director, which arrangements must receive the prior approval of the department. An assistant director who holds a certificate of qualification to be a director of a clinical laboratory or blood bank in the appropriate category may act for the director in the director's absence, and at such time shall fully discharge the duties and responsibilities of the director.

When the director's employment terminates, for whatever reason, both the owner and the director of the laboratory, or the chief executive officer of the facility, shall notify the department in writing prior to the termination. In the case of death or physical and/or mental incapacitation of the director, the owner or the chief executive officer must notify the department within 72 hours of each event.


VOLUME A-1 (Title 10)