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This entry was published on 2023-07-07
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SECTION 8610
Restricted clinical laboratory licenses
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 165
§ 8610. Restricted clinical laboratory licenses. 1. Restricted
clinical laboratory license.

(a) The department may issue a restricted license pursuant to which
the restricted licensee may receive a certificate to perform certain
examinations and procedures within the definition of clinical laboratory
technology set forth in subdivision one of section eighty-six hundred
one of this article, provided that such a restricted licensee may
perform examinations and procedures only 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 (under
paragraph (b-1) of this subdivision).

(b) Notwithstanding paragraph (a) of this subdivision, restricted
licensees employed at National Cancer Institute designated cancer
centers or at teaching hospitals that are eligible for distributions
pursuant to paragraph (c) of subdivision three of section twenty-eight
hundred seven-m of the public health law may receive a certificate that
also includes the practice of molecular testing including but not
limited to genetic testing-molecular and molecular oncology, and
restricted licensees employed at national cancer institute designated
cancer centers may receive a certificate that includes the use of mass
spectrometry or any tests and procedures acceptable to the commissioner
of health, in consultation with the commissioner, in the field of
proteomics, 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.

(b-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) To qualify for a restricted license, an applicant shall:

(i) file an application with the department;

(ii) have received an education, including a bachelor's degree in the
biological, chemical, or physical sciences or in mathematics from a
program registered by the department or determined by the department to
be the substantial equivalent;

(iii) have completed a training program with 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. 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. The duration of the training program shall be one year of
full-time training in the specific areas in which the applicant is
seeking certification or the part-time equivalent thereof, as determined
by the department, and the successful completion of such program shall
be certified by a laboratory director who is responsible for overseeing
such program;

(iv) be at least eighteen years of age;

(v) be of good moral character as determined by the department; and

(vi) pay a fee of one hundred seventy-five dollars for an initial
restricted license and a fee of one hundred seventy dollars for each
triennial registration period.

(d) Each restricted licensee shall register with the department as
required of licensees pursuant to section sixty-five hundred two of this
title and shall be subject to the disciplinary provisions applicable to
licensees pursuant to subarticle three of article one hundred thirty of
this title.

2. The board of regents and the department are authorized to adopt
such rules and regulations as may be necessary to implement the
provisions of this section.

3. Nothing in this section shall restrict a clinical laboratory
practitioner, as defined in subdivision two of section eighty-six
hundred one of this article, from performing any of the examinations or
procedures which restricted clinical laboratory licensees are permitted
to perform under this section and which such clinical laboratory
practitioner is otherwise authorized to perform.