N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.1

Current through Register Vol. 46, No. 50, December 11, 2024

Section 52-2.1 - Licensure

(a) Any person who plans to operate a tissue bank or nontransplant anatomic bank or distribute tissue or nontransplant anatomic parts in New York State shall submit a completed, signed application to the department and obtain a license from the department prior to the operation of such a tissue bank or nontransplant anatomic bank, or conduct of such activity, unless otherwise specified in this Part.

(b) The department shall provide, upon request, an application for licensure as a tissue bank which may require information including, but not limited to, the following:

(1) the name, address and telephone number of the bank;

(2) the days and hours of bank operation;

(3) the type of organization sponsoring the bank, i.e., proprietary, municipal or nonprofit;

(4) the type of ownership, i.e., individual, partnership, corporation or government;

(5) if ownership is individual, corporation or partnership: the name and principal office address of the entity, and the name, title, home address and Social Security number and Federal employer identification number, if any, of the owner, officers of the corporation or the partners;

(6) if government-operated: the name, principal office address of the government entity, and the name(s), title(s) and addresses of the administrator responsible for the operation of the bank in conjunction with the director;

(7) except for facilities established pursuant to Public Health Law article 28, for any person or entity with a direct or indirect ownership interest in the tissue bank of five percent or more, or any owner who is a licensed health professional and is authorized by law to prescribe tissue services and/or perform tissue transplantation services, or principal stockholder or any person or entity with a controlling interest:

(i) name, home address, and Social Security number and employer identification number, if any, of such persons, or for a corporation, the corporate name, principal place of business, corporate executive office address and employer identification number;

(ii) the manner in which the person or entity has an ownership interest or a controlling interest, and the percentage of such ownership interest;

(iii) any existing or prior direct or indirect ownership interest or status as a person or entity with a controlling interest in any other tissue bank, laboratory, funeral firm or health care facility holding a New York State or New York City license, permit or certificate of operation, and the name and address of such tissue bank, laboratory, firm or facility, and whether such bank, laboratory, firm or facility has had its permit or license denied, revoked, suspended, limited or annulled, or currently has an enforcement proceeding pending against it; and

(iv) whether the person or entity has been convicted of, or pled guilty to, a criminal offense related to the operation of a bank, laboratory or health care facility, or of any programs established pursuant to title XVIII, XIX or XX of the Federal Social Security Act; and

(8) the category or categories of tissue, and the type or types of tissue services to be provided;

(9) a description of the tissue bank premises and equipment;

(10) any other employment of the tissue bank director and/or medical director, including the position and number of hours worked;

(11) the name, position, qualifications, duties and work schedule of all technical personnel;

(12) a copy of all existing tissue acquisition and/or processing agreements;

(13) a description of the tissue bank's proposed or existing service area for acquisition and/ or distribution of tissue;

(14) a description of educational programs, including those programs designed to encourage tissue donation;

(15) donor and recipient selection and testing criteria;

(16) a copy of each protocol or procedure required in this Subpart and in the Subpart for each category of tissue;

(17) any information required in the Subpart for each category of tissue;

(18) for a corporation: a copy of the existing certificate of incorporation, by-laws and any certificates of doing business under an assumed name, or for a partnership: a copy of the partnership agreement and any certificates of doing business under an assumed name;

(19) for the tissue bank director and medical director, if applicable, the following information:

(i) name;

(ii) work and home addresses and work telephone number;

(iii) educational background; and

(iv) work experience, including all places of employment and positions held for the 10 years immediately preceding the date of the application; and

(20) the name, title, work address and telephone number of the tissue bank compliance officer and tissue transplantation service director(s), if such personnel are required pursuant to this Part.

(c) An application for licensure as a limited tissue procurement service shall require the information specified in paragraphs (b)(1)-(8) of this section; and

(1) a list of all tissue banks performing tissue acquisition activities on the premises of a limited tissue procurement service; and

(2) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law article 43-B.

(d) An application for licensure as a nontransplant anatomic bank shall require the information specified in paragraphs (b)(1)-(8) of this section, and:

(1) a list of all the types of nontransplant anatomic parts banked;

(2) a list of all facilities that provide nontransplant anatomic parts to the nontransplant anatomic bank;

(3) a list of all facilities in New York State to which nontransplant anatomic parts are distributed;

(4) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law, article 43-B; and

(5) an affirmation that the tissue will be distributed only to a legal donee as designated in Public Health Law, section 4302 and will only be used by the bank for the purposes authorized by Public Health Law, section 4302.

(e) Any dentist or physician whose use of tissue is limited to virally inactivated tissue shall not be required to be separately licensed pursuant to this Part, provided he or she is licensed by, and currently registered with, the State Education Department.

(f) Shipping of any tissue from an out-of-state facility shall constitute distribution and shall require a license, unless the tissue is:

(1) avascular eye tissue or hematopoietic progenitor cells shipped to a licensed comprehensive tissue procurement service, provided the licensed comprehensive tissue procurement service shall be responsible for:

(i) the safety and appropriateness of the imported tissue as specified in Subparts 52-3 and 52-7 of this Part, and Subpart 58-5 of this Title;

(ii) obtaining documentation that valuable consideration has not been paid to the out-of-state facility transferring the tissue. Documentation that the transferring out-of-state facility is a nonprofit organization shall create a presumption that valuable consideration has not been paid;

(2) subjected to viral inactivation by a process accepted by leading authorities in the field of transplantation medicine and a written exception to the requirements of this subdivision has been granted by the department on the basis of documentation submitted by the applicant, including a detailed description of the viral inactivation methodology and procedure, and data showing the amount of virus introduced and the effectiveness of the method in destroying the virus; or

(3) from fully screened and tested donors; has been extensively processed and altered by such means as culturing over many generations, and combined with nontissue components, so that the original human tissue constitutes a small percentage of the final product; and a written exception to the requirements of this section has been granted by the department on the basis of documentation submitted by the applicant. Such documentation shall include a detailed description of the processing and donor screening performed to ensure that the tissue is free of pathogens listed in sections 52-3.4(c)(4), 52-4.7(a), 52- 5.7(a), 52-6.7(a) and 52-7.7(a) of this Part, as applicable to the type of tissue procured.

(g) All changes in the tissue bank director, medical director, owner or persons with a controlling interest shall be reported as specified in section 52-2.3(a) and (b) of this Subpart.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.1