N.Y. Comp. Codes R. & Regs. Tit. 8 §§ 79-13.5

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

Section 79-13.5 - Restricted license

(a) In accordance with section 8610 (1) of the Education Law, the department may issue a restricted clinical laboratory license to perform certain examinations and procedures within the definition of clinical laboratory technology as set forth in section 8601 (1) of the Education Law, provided that such a restricted licensee may only perform examinations and procedures in those of the following areas which are specifically listed in his or her certificate: histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, molecular testing, and toxicology as provided in paragraph (b)(1) of this section.

(b) Notwithstanding subdivision (a) of this section, restricted licensees employed at the National Cancer Institute designated cancer centers or at teaching hospitals that are eligible for distributions pursuant to section 2807-m (3)(c) of the Public Health Law may receive a certificate that also includes the practice of molecular testing including by not limited to genetic testing-molecular and molecular oncology, provided that such certificate holders may practice in such additional areas only at such centers, teaching hospitals or other sites as may be designated by the commissioner.

(1) Only individuals employed in a New York State Department of Health authorized toxicology laboratory, operating under the direction of a clinical laboratory director, may obtain a certificate in toxicology.

(c) In addition to the requirements set forth in section 8610 (1) of the Education Law, to qualify for a restricted license, an applicant shall satisfy the following requirements:

(1) Professional study. The applicant shall have successfully completed a baccalaureate or higher degree program in the major of biology, chemistry, the physical sciences, or mathematics from a program registered by the department or determined by the department to be the substantial equivalent.

(2) Training program. In accordance with section 8610 (1)(c)(iii) of the Education Law, the applicant shall have completed a training program that meets the following requirements:

(i) The training program shall have a planned sequence of supervised employment or engagement in activities appropriate for the area of certification, which training program is satisfactory to the department in quality, breadth, scope and nature and is provided by an entity that shall be responsible for the services provided.

(ii) The training program shall be described and attested to by the clinical director of the laboratory in which it is located prior to the beginning of the program.

(iii) The training program shall consist of not less than one year of full-time training in the specific areas in which the applicant is seeking certification, which shall consist of no less than 1,750 hours in a calendar year, in the specific area in which the applicant is seeking certification, or the part-time equivalent thereof, as determined by the department.

(iv) Successful completion of the program shall be certified by a laboratory director who is responsible for overseeing such program.

(v) The training program shall include the following curricula for certificates issued in each of the following areas:

(a) For a certificate in the area of histocompatibility, the training program shall include knowledge of clinical immunology, immunogenetics, basic molecular biology, and laboratory mathematics. The training program shall also include, but need not be limited to, general laboratory principles and skills, including infection control and aseptic technique; the practice of HLA typing and HLA antibody testing; specimen collection, processing and handling; instrumentation and equipment; reagent preparation and quality control; quality assurance, principles and techniques of histocompatibility assays, and crossmatching; antibody screening and identification; and determination of degree of HLA matching.

(b) For a certificate in the area of cytogenetics, the training program shall include knowledge of chromosome structure/behavior and its correlation with phenotype and recognition and interpretation of chromosomal abnormalities. It shall also include, but need not be limited to, general laboratory principles and skills; clinical cytogenetics; general knowledge of human genetics; infection control and aseptic technique, quality control, and quality assurance; laboratory mathematics; the collection, handling, preparation and processing of pertinent specimens; the use of appropriate cell culture techniques; the principles and techniques for harvesting specimens or cell cultures; and the principles and techniques of chromosome banding, staining, analysis, and instrumentation.

(c) For a certificate in the area of stem cell process, the training program shall include knowledge of stem cell biology. It shall also include, but need not be limited to, general laboratory principles and skills; infection control and aseptic technique methods; instrumentation and equipment; quality control and quality assurance; laboratory mathematics; the process of handling stem cell specimens in the laboratory; enumeration and characterization of stem cells; ABO/Rh confirmatory typing; and reagent preparation.

(d) For a certificate in the area of flow cytometry/cellular immunology, the training program shall include knowledge of the technique for counting, sorting, and characterization of cells suspended in a fluid stream based on their physical properties and expression of cell surface molecules. The training program shall also include, but need not be limited to, general laboratory principles and skills; infection control and aseptic technique; instrumentation and equipment; quality control and quality assurance; the basic principles of flow cytometry, including specimen preparation, fluidics and electronics; fluorochrome selection; antibody selection; the design of flow cytometry procedures, including routine standardization and quality management; and specific clinical applications.

(e) For a certificate in the area of molecular testing, the training program shall include:

(i) knowledge of nucleic acid chemistry, human molecular biology, molecular pathology, molecular diagnosis, molecular oncology (including the role of genetics in molecular diagnosis and molecularly targeted therapies), human and microbial molecular genetics, and molecular test result calculation, interpretation, and reporting;

(ii) practicum in molecular techniques, including but not limited to, nucleic acid isolation, separation, detection, amplification, sequencing, techniques to prevent specimen contamination, and additional molecular techniques as determined by the department;

(iii) laboratory operations relevant to molecular testing, including, but not limited to, quality control, quality assurance, safety, instrument operation and maintenance, and

(iv) knowledge of applications of molecular testing in the fields of infectious disease, oncology, genetics, genomics, transfusion medicine, pharmacogenomics, and other fields as determined by the department; and

(f) For a certificate in the area of molecular testing as provided in Education Law, section 8610 (1)(b), an applicant shall:

(1) be employed at a National Cancer Institute designated cancer center or at a teaching hospital that is eligible for distributions pursuant to Public Health Law § 2807m(3)(c); and

(2) have completed the training requirements for the restricted license in molecular testing pursuant to clause (e) of this subparagraph; and

(3) have completed additional training requirements for the restricted license in molecular testing acceptable to the department that would enable the applicant to practice competently in accordance with section 8610 (1)(b) of the Education Law.

(g) For a certificate in the area of toxicology, the training program shall include knowledge of laboratory methods in toxicology, including qualitative and quantitative determination of xenobiotics present in biological specimens. The training program shall also include, but need not be limited to, general laboratory principles and skills; basic principles of chemistry, biology, and the physical sciences; basic principles of pharmacology; basic principles of purification, separation, and extraction techniques; instrumentation and equipment; quality control and quality assurance; laboratory mathematics; the principles of immunoassay techniques; preparation and processing of biological specimens for toxicological analysis; the principles of analytical techniques; review and certification of toxicology results; aseptic technique and infection control and specific clinical applications.

N.Y. Comp. Codes R. & Regs. Tit. 8 §§ 79-13.5

Amended New York State Register April 22, 2020/Volume XLII, Issue 16, eff. 4/22/2020

Amended New York State Register December 27, 2023/Volume XLV, Issue 52, eff. 12/11/2023, exp. 2/8/2024 (Emergency)

Amended New York State Register January 24, 2024/Volume XLVI, Issue 4, eff. 1/24/2024