New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-1 - Clinical Laboratories › Section 58-1.2 - Laboratory director

Current through Register Vol. 46, No. 28, July 10, 2024
(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.