N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.5

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

Section 52-2.5 - License issuance and denial

(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.

(b) A tissue transplantation facility shall be issued a license for one or more tissue categories, provided that:

(1) the owner(s) and/or authorized representative have submitted a license application pursuant to this Subpart;

(2) a tissue bank compliance officer has been appointed;

(3) a director who is a physician licensed and currently registered to practice medicine in New York State is appointed for each tissue transplantation service within the tissue transplantation facility;

(4) the tissue transplantation facility is established pursuant to Public Health Law, article 28, or is the private office of a physician licensed and currently registered to practice medicine in New York State;

(5) the department has found no evidence that the tissue bank compliance officer and director of each tissue transplantation service within the tissue transplantation facility lack the character and competence to ensure that the tissue transplantation facility is competently staffed, properly equipped and operated in accordance with the law, and that such tissue transplantation facility 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 transplantation facility, the tissue bank compliance officer and the director of each tissue transplantation service within the tissue transplantation facility; and

(6) the tissue transplantation facility has corrected any deficiencies noted by the department in the written standard operating procedure manual or records of tissue issuance and, if inspected, the tissue transplantation facility has corrected any deficiencies found.

(c) A tissue storage facility shall be issued a license provided:

(1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart;

(2) a director has been appointed who has at least two years' experience in the storage of tissue or in a related field, as determined by the department;

(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 storage facility director may serve as the medical director only 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) if inspected, the facility has corrected any deficiencies found; and

(5) the department has found that the tissue bank owners and any parties with a controlling interest, medical director and tissue bank director have the character and competence to ensure that the facility 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 facility, the director(s) and owner(s) of the facility, and any affiliated person, including parties with a controlling interest.

(d) A nontransplant anatomic bank or limited tissue procurement service shall be issued a license provided:

(1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart;

(2) if inspected, the bank has corrected any deficiencies found; and

(3) the bank is competently staffed, properly equipped and operated in accordance with the law. In making such a determination, the department may consider the factors listed in subdivision (e) of this section with respect to the bank, the director(s) and owner(s) of the bank, and any affiliated person, including parties with a controlling interest.

(e) In determining whether to deny a license, the department may consider the following factors with respect to the tissue bank or nontransplant anatomic bank director(s) and owner(s), and any affiliated person, including parties with a controlling interest:

(1) false representation or omission of a material fact in filing the license application or during inspection;

(2) failure to supply further information necessary to process the license application, within three months of the department's written request, without satisfactory explanation;

(3) conviction of any crime or sustained charges of administrative violations of State or Federal laws, rules and regulations, related to the operation of a site performing health care services or a funeral directing firm, including, but not limited to, the Public Health Law or related statutes;

(4) the employment of unqualified technical personnel or an insufficient number of such personnel or support personnel;

(5) a pattern of deficiencies on on-site inspection, especially in areas of quality assurance, management, and handling of regulated medical waste and radioactive materials, including:

(i) refusal or inability to produce records or reports as requested by department employees;

(ii) failure to correct deficiencies from inspection to inspection;

(iii) deviation from regulations and/or accepted standards so as to jeopardize the quality of tissue services provided or pose a hazard to employees, donors, recipients or the public; and

(iv) refusal to provide department employees with access to the premises;

(6) knowing acceptance of tissue requisitions from or provision of tissue services or tissue to a person or persons not authorized by law to provide such services, or possess or use such tissue;

(7) failure of the director to be on the premises for an adequate amount of time and adequately supervise technical personnel to ensure the proper performance of all tissue services provided;

(8) failure to establish and follow procedures for disposal or handling of tissue or infectious or radioactive medical waste, as determined by the governing State and Federal agencies, or disposal in a manner which endangers the public, the employees, or the environment; and

(9) whether the bank is in compliance with the technical requirements specified in this Subpart, Subpart 52-3 of this Part and/or the Subpart specific to each category of tissue.

(f) License denial.

(1) If the department proposes to deny a license to a tissue bank or nontransplant anatomic bank, the bank shall be given written notice of the proposed denial, stating the reason or reasons for the denial. Such notice shall be sent by certified mail and shall be a final determination to be effective 30 days from the date of the notice unless reconsideration is requested pursuant to paragraphs (3), (4) and (5) of this subdivision.

(2) Denial of a license shall preclude the applicant from operating a tissue bank or nontransplant anatomic bank in New York State, either directly or indirectly through any other person.

(3) If the department gives notice of proposed denial of a license, the applicant may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within 30 days of the date of the notice. Submission of a request for reconsideration within 30 days shall stay any action to deny a license, pending the department's decision regarding such reconsideration.

(4) The written request for reconsideration shall include all information the applicant wishes to be considered, including any written documentation which would controvert the reason for the denial or disclose that the denial was based upon a mistake of fact.

(5) Within 90 days of receipt of the request for reconsideration, the department shall review its initial determination to deny a license and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke, or modify the proposed denial, allow issuance of a license conditional on maintenance of corrective action, or require that the applicant take corrective action. Such determination shall be the final decision of the department.

(6) No license application shall be considered for any applicant who is substantially the same as an applicant who has been denied a license within six months of the final determination of the department denying such application. In the event an applicant has received two successive license denials, no license application shall be considered for that applicant within two years of the last final determination of the department denying a previous application.

(7) In addition to any penalties provided under the Public Health Law and Penal Law, falsification or failure to make full disclosure on a license application shall be deemed to constitute, in itself, a bar to obtaining a tissue bank or nontransplant anatomic bank license in New York State.

(g) A tissue bank license shall list the categories of tissue and types of tissue services offered, as defined in section 52-1.1(aa) and (ad) of this Subpart, respectively. Such license shall be conspicuously posted on the premises of the bank.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.5