Restricted Clinical Laboratory Licenses.

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§ 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 and molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology, 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 diagnosis 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.


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