New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter C - Access To Records › Part 52 - Tissue Banks And Nontransplant Anatomic Banks › Subpart 52-2 - Tissue Banks And Nontransplant Anatomic Banks-licensure › Section 52-2.5 - License issuance and denial

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A tissue bank, other than a tissue
					 transplantation facility, tissue storage facility or a limited procurement
					 service, shall be issued a license for one or more tissue categories, provided
					 that:
(1) the owner(s) and/or an authorized
					 representative have submitted a license application pursuant to this
					 Subpart;
(2) a tissue bank director
					 has been appointed who:
(i) is a physician
					 licensed and currently registered to practice medicine in New York State or in
					 the state in which he or she practices, and has at least two years' training or
					 experience in the category or categories of tissue, or in a related field, as
					 determined by the department; or
(ii) is a person with a doctoral degree in an
					 appropriate biological science, and has a minimum of two years' tissue banking
					 experience in the category or categories of tissue, or in a closely related
					 field, as determined by the department; or
(iii) is a person with a master's degree in
					 an appropriate biological science, and has a minimum of four years' tissue
					 banking experience in the category or categories of tissue, or in a closely
					 related field, as determined by the department; or
(iv) is a person with a bachelor's degree in
					 an appropriate biological science, and has a minimum of six years' tissue
					 banking experience in the category or categories of tissue, or in a closely
					 related field, as determined by the department; and
(v) holds a current certificate of
					 qualification from the department, in the category or categories of testing, if
					 laboratory testing is performed by the tissue bank;
(3) the medical director is a physician
					 licensed and currently registered to practice medicine in New York State or in
					 the state in which he or she practices. The tissue bank director may serve as
					 the medical director if he or she is a physician licensed and currently
					 registered to practice medicine in New York State or in the state in which he
					 or she practices;
(4) for tissue
					 banks other than insemination/implantation sites, the medical advisory
					 committee is found acceptable by the department;
(5) the department has found that the tissue
					 bank owners any parties with a controlling interest, medical director and
					 tissue bank director have the character and competence to ensure that the
					 tissue bank is competently staffed, properly equipped, and operated in
					 accordance with the law, and that such tissue bank will be so operated. In
					 making such a determination, the department shall consider the factors listed
					 in subdivision (e) of this section with respect to the tissue bank, the
					 director, medical director, and owner(s) of the tissue bank, and any affiliated
					 person, including parties with a controlling interest; and
(6) the tissue bank has corrected
					 deficiencies found on any inspection conducted by the department and any
					 deficiencies noted by the department in the standard operating procedures
					 manual submitted with the application.