N.Y. Comp. Codes R. & Regs. tit. 10 § 19.1

Current through Register Vol. 46, No. 45, November 2, 2024

Section 19.1 - Definitions

(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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 19.1

Amended New York State Register June 12, 2019/Volume XLI, Issue 24, eff. 6/12/2019