New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter I - State Sanitary Code › Part 19 - Clinical Laboratory Directors › Section 19.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Director means
				the individual responsible for administration of the technical and scientific
				operation of a clinical laboratory or blood bank, including supervision of test
				procedures, the reporting of results, and the duties and responsibilities
				specified in section
				19.3 
				of this Part. If a clinical laboratory or blood bank employs more than one
				director, the laboratory owner(s) shall designate in writing one such
				individual as the director of record for the laboratory.
(b) Assistant director means a director who
				has been designated by the owner(s) of the laboratory as having shared
				responsibility with a director for the technical and scientific operation of
				the clinical laboratory or blood bank in one or more categories and/or
				subcategories.
(c) Acceptable
				laboratory means a facility, operating lawfully, that meets the definition of a
				clinical laboratory or blood bank as defined in Section 571  of the Public Health Law and which has a
				director who meets or would meet the requirements of this Part, including the
				anatomic and clinical pathology facilities of a hospital or health department,
				a clinical testing unit of a university or medical research institution, an
				independent clinical laboratory or blood bank, a privately operated forensic
				testing laboratory, or a facility providing training and/or experience in the
				testing of human specimens.
(d)
				Accredited means having the approval (accreditation) conferred on schools,
				institutions or programs by an accrediting agency or association recognized by
				the United States Secretary of Education and verified as such by the
				department.
(e) Physician means a
				physician who is licensed and currently registered to practice medicine in New
				York State or in the state or the country in which he or she practices and is
				not subject to any disciplinary or non-disciplinary order by the applicable
				state or country except as otherwise allowed by the department.
(f) Dentist means a dentist who is licensed
				and currently registered to practice dentistry in New York State or in the
				state or the country in which he or she practices and is not subject to any
				disciplinary or non-disciplinary order by the applicable state or country
				except as otherwise allowed by the department.
(g) Certificate of qualification means a
				credential issued by the department to applicants determined by the department
				to meet the requirements set forth in this Part.
(h) Grandfathered laboratory director means a
				laboratory director who qualified for and received a certificate of
				qualification in one or more categories of testing prior to the amendment of
				this regulation which became effective January 25, 1988.
(i) Category means an area, field, or
				discipline of laboratory medicine or laboratory science in which a certificate
				of qualification is issued. The department may issue certificates of
				qualification in a specified subpart of a category, including, but not limited
				to, a subcategory, technology, method, or specific procedure, based on the
				applicant's education, training, and experience and the applicant's ability to
				demonstrate that tests performed under their direction generate reliable
				results. The department shall make available a list of: categories and
				subcategories in which certificates of qualification are issued; minimum
				qualifications for each category; and the corresponding categories of testing
				authorized by a laboratory permit.
(j) Department means the New York State
				Department of Health.
(k) Board
				certified means having completed all requirements set forth by an accrediting
				board acceptable to the department, including a passing score on any qualifying
				examination and completion of all the requirements for recertification whenever
				the certifying board mandates recertification, provided such requirements are
				determined by the department to provide the applicant with the ability to
				effectively discharge the responsibilities described in Parts 10 and 58 of this
				title.
(l) Earned doctoral degree
				means a doctor of philosophy, doctor of science, or equivalent degree as
				determined by the department.
(m)
				Training includes participation in a residency, fellowship, or post-doctoral
				position, or participation in a training course approved by a board acceptable
				to the department.
(n) Experience
				includes post-doctoral employment or voluntary participation in an acceptable
				laboratory where the applicant performed, supervised or directed testing of
				human clinical specimens. Teaching experience directly related to a medical
				technology program, clinical laboratory sciences program, or a clinical
				laboratory section of a residency program is also considered acceptable
				experience.