New York Codes, Rules and Regulations
Title 8 - EDUCATION DEPARTMENT
Chapter II - Regulations of the Commissioner
Subchapter B - Regulation of Professions
Part 79 - Regulation of Individual Professions
Subpart 79-13 - Clinical Laboratory Technologist
Section 79-13.5 - Restricted license
Universal Citation: 8 NY Comp Codes Rules and Regs ยง 79-13.5
Current through Register Vol. 46, No. 39, September 25, 2024
(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.
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