Title: Section 58-1.2 - Laboratory director
58-1.2 Laboratory director.
(a) Each laboratory or blood bank shall have a laboratory director who shall serve the clinical laboratory or blood bank full-time, or on a regular part-time basis, to perform the duties listed in this Part and in Part 19 of this Title. Regular part-time basis shall mean assumption of full responsibility for direction and technical operation of the laboratory, including adherence to the Department’s clinical laboratory standards of practice, which shall be publicly available on the Department’s website. Every laboratory director shall possess a certificate of qualification issued by the Department pursuant to Part 19 of this Title, in at least one category of testing offered by the clinical laboratory or blood bank. Individuals holding a certificate of qualification can be designated by the laboratory director as assistant directors; however, if an individual holds the sole certificate of qualification for a category or categories of testing at that facility, that individual is considered a sole assistant director, and will be held responsible for the duties listed in Part 19 for that category or those categories of testing conducted by the clinical laboratory or blood bank.
(b) An individual shall not serve as laboratory director or sole assistant director of more than five clinical laboratories or blood banks or any combination thereof, within or outside New York State either permitted by New York or registered in accordance with federal regulations.
(c) Commensurate with the workload, scope and complexity of the testing procedures carried out, qualifications of onsite personnel, proximity to another clinical laboratory or blood bank under identical directorship, and availability of alternate monitoring and communications capabilities, the laboratory director and any sole assistant directors shall be on-site on at least on a regular part-time basis in the clinical laboratory or blood bank to direct and supervise the technical performance of the staff and shall be readily available at all other times by telephone and/or through synchronous two-way electronic audio-visual communication to the laboratory’s staff and clients. Attendance records may be required to document the adequacy of the laboratory director's or sole assistant director's presence.
(1) For purposes of this section “regular part-time” is defined as at least eight hours per week.
(2) Requests for a laboratory director to be on-site less than eight hours per week will be considered pending a review of the number of permit categories for which they are responsible, the volume and complexity of testing at the clinical laboratory or blood bank, and the performance history of the clinical laboratory or blood bank during inspections and proficiency testing.
(3) The Department may require that a laboratory director be present on a more frequent basis than previously approved based upon concerns identified during inspection or proficiency testing, or if the Department has received more than one complaint against the clinical laboratory or blood bank.
(d) The laboratory director and any sole assistant director shall be responsible for performance of all tests or procedures carried out in the clinical laboratory or blood bank, adherence to the Department’s clinical laboratory standards of practice for such tests or procedures, accurate reporting of the test results and recording of required information.
(e) The laboratory director and owner shall be jointly and severally responsible for clinical laboratory or blood bank operations and shall exercise authority for the design, implementation, maintenance and improvement of a quality management system for the delivery of services that meet the needs of patients and all clinical personnel responsible for patient care.
(f) Failure to notify the Department of the resignation, termination, death, or physical or mental incapacitation of the laboratory director within sixty (60) calendar days of such event shall result in the voiding of the permit. Failure to notify the Department of the resignation, termination, death, or physical or mental incapacitation of a sole assistant director within sixty (60) calendar days of such event shall result in the voiding of the specific permit category under the sole assistant director’s direction.
(g) If the laboratory director or sole assistant director will be temporarily absent for more than sixty (60) consecutive calendar days, arrangements shall be made, with the prior approval of the Department, for a new laboratory director or sole assistant director who possesses a certificate of qualification in the appropriate categories. Failure to notify the Department of the absence of a laboratory director or sole assistant director of greater than sixty (60) calendar days shall result in the voiding of the permit.
VOLUME A-1 (Title 10)