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 52-2.1 - Licensure

Current through Register Vol. 46, No. 28, July 10, 2024
(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.