N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-1.1

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

Section 52-1.1 - Definitions

For purposes of this Part, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Acquisition means any activity, including solicitation, retrieval, and donor selection and testing, which is necessary to obtain tissue for transplantation, transfer, artificial insemination or implantation, or to obtain nontransplant anatomic parts for research or education.

(b) Allogeneic tissue collection means the retrieval of tissue from a donor for the purpose of transplantation or transfer into another individual, including tissue provided by a donor for transplantation, artificial insemination, implantation or transfer into a designated recipient.

(c) Aseptic processing means the handling, preservation and packaging of tissue not intended for viral inactivation, using methods designed to prevent contamination with pathogenic organisms.

(d) Aseptic retrieval means the recovery of tissue in a clean surgical field, using standard operating room techniques.

(e) Autogeneic tissue collection means the retrieval of tissue from a donor for subsequent reimplantation into that same donor.

(f) Clinical laboratory means a laboratory operating under a permit issued pursuant to article V, title 5 of the Public Health Law and/or which meets the requirements of the state in which it is located and of the Federal government (see clinical laboratory improvement amendments of 1988), and is acceptable to the commissioner as specified herein.

(g) Clinical use means the use of tissue for allogeneic or autogeneic transplantation, transfer, artificial insemination or implantation.

(h) Commissioner means the Commissioner of the New York State Department of Health.

(i) Controlling interest means the ability to direct or control the operation or management of a tissue bank, tissue processing facility or tissue storage facility (herein referred to as a facility), including, but not limited to, the ability or authority, expressed or reserved, to:

(1) amend or change the corporate or operating identity (e.g., joint venture agreement or unincorporated business status) of the facility;

(2) approve operating and capital budgets of the facility;

(3) adopt, approve or direct facility fiscal operating policies and procedures;

(4) approve debt necessary to finance the facility's costs of compliance with operational or plant standards required by law;

(5) approve contracts for management of facility services;

(6) hire or dismiss the medical director or tissue bank director and nontechnical personnel;

(7) maintain and control the books and financial records of the facility;

(8) control any of the assets of the facility;

(9) encumber the assets of the facility by way of mortgage or other indebtedness; and

(10) dissolve the facility or arrange for the sale or transfer of the facility to new ownership or control.

(j) Department means the New York State Department of Health.

(k) Direct ownership interest means the possession of stock, equity in the capital, or any interest in the profits of the facility.

(l) Distribution means any activity necessary to distribute tissue for transplantation, transfer, artificial insemination or implantation from the tissue bank to the transplantation facility, or insemination/implantation site, including allocation and transportation, but shall not include transportation within the transplantation facility. Distribution shall also include distribution of nontransplant anatomic parts from the bank to the research or education facility.

(m) Donor means, except as otherwise defined in this Part, a human being, living or dead, who is the source of tissue or nontransplant anatomic parts, for transplantation, transfer, artificial insemination, implantation, education or research purposes.

(n) FDA means the Food and Drug Administration of the United States Department of Health and Human Services.

(o) Indirect ownership interest means the possession of stock, equity in the capital, or any interest in the profits of an entity with a direct or indirect ownership interest in the facility. For example, if an entity owns 10 percent of the stock in a corporation that owns 80 percent of the stock in a facility, that entity's interest equates to an eight percent indirect ownership interest.

(p) Medical advisory committee means a panel composed of at least five members with experience and expertise in the fields specified in the Subpart specific to the category or categories of tissue services provided, who are responsible for monitoring the medical efficacy of the tissue bank and setting operating policies and procedures. At least one member of the medical advisory committee shall possess expertise in microbiology, clinical pathology or infectious disease.

(q) Medical director means a physician who meets the requirements of section 52-2.5(a)(3) of this Part.

(r) Nontransplant anatomic bank means any person or facility that solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of nontransplant anatomic parts, including whole bodies, body segments, organs or tissues from living or deceased donors, for education and/or research purposes specifically authorized by Public Health Law, section 4302. T he following shall not constitute a nontransplant anatomic bank:

(1) any person or entity that stores nontransplant anatomic parts, except whole bodies and body segments, solely for purposes of research and/or education conducted by such person, provided the person or entity maintains on its premises a properly executed anatomical gift consent document consistent with section 52-11.3 of this Part; and

(i) such person or entity is a legal donee pursuant to Public Health Law, section 4302 and obtains all organs/tissues from a tissue bank or nontransplant anatomic bank licensed by the department; or

(ii) is a general hospital conducting pathology services or research on nontransplant anatomic parts including whole bodies, recovered from within the facility from a living or deceased source;

(2) any person or entity whose activities within the State of New York are limited to distribution of nontransplant anatomic parts to a tissue bank or nontransplant anatomic bank licensed by the department;

(3) any person or entity that uses prepared slides and/or human-derived cell lines for purposes of education and/or research; and

(4) an employee of the Federal government, provided an anatomical gift consent document has been executed in accordance with Public Health Law, section 4301 and section 52-11.3(d) of this Part.

(s) Owner means a person, persons, or an entity with direct or indirect ownership interest in a facility.

(t) Person means an individual, corporation, government or governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity, other than the Office of Mental Health.

(u) Principal stockholder means any person who owns (whether of record or as beneficiary), holds or has the power to vote, 10 percent or more of any class of securities issued by a corporation.

(v) Processing means any activity necessary to prepare, preserve for storage, remove from storage and/or conduct laboratory testing to assure the potency, quality or sterility of bodies, body parts, organs or tissue for research and/or education purposes, or tissue for transplantation, transfer, artificial insemination or implantation.

(w) Procure means to perform any activity which is necessary for the procurement of organs or tissue for transplantation, artificial insemination, implantation, research, education, therapy, fertilization, or autogeneic purposes, including solicitation, retrieval, donor selection and testing, clinical laboratory testing, including typing, preservation, transportation, allocation, distribution, storage, and payment activities.

(x) Recipient means a patient who receives tissue through transplantation, artificial insemination, transfer or implantation.

(y) Service area means a geographic area for acquisition and/or distribution services approved by the United States Secretary of Health and Human Services or, in the absence of such approval, by the department pursuant to the standards established in this Subpart.

(z) Storage means any activity necessary to store tissue for transplantation, transfer, artificial insemination or implantation, or nontransplant anatomic parts for research and/or education purposes.

(aa)

(1) Tissue bank means any person or facility which solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of human tissues for transplantation, transfer, therapy, artificial insemination or implantation, including autogeneic procedures. Tissue banks shall be issued a license in the specific category of tissue and type of tissue services provided as described in subdivision (ad) of this section, and shall be required to comply with the standards applicable to the category or categories of tissue acquired, processed, stored and/or distributed. Categories of tissue and their definitions are:

(i) Cardiovascular tissue means human heart valves, aorta, great vessels, pericardium, saphenous vein, umbilical vein, or any other cardiovascular tissue for transplantation.

(ii) Musculoskeletal tissue means human bone, tendon, ligament, muscle, fascia, cartilage, dura, or any other musculoskeletal tissue for transplantation.

(iii) Skin means any human skin tissue for transplantation.

(iv) Eye means a human cornea or any other ocular tissue for transplantation.

(v) Reproductive tissue means any tissue from the reproductive tract intended for use in artificial insemination or any other assisted reproductive procedure. This includes, but is not limited to, semen, oocytes, embryos, spermatozoa, spermatids, ovarian tissue, testicular tissue and epididymal aspirates.

(vi) Human milk means human milk for ingestion by a child other than the mother's own.

(vii) Hematopoietic progenitor cells means human precursor or progenitor hematopoietic cells derived from bone marrow, peripheral blood or other tissue sources (see Subpart 58-5 of this Title).

(2) The following exceptions shall apply to the definition of tissue bank in this subdivision:

(i) An organ procurement organization shall not constitute a tissue bank solely by virtue of storing or arranging for the storage of heart valves.

(ii) An entity that uses tissue or fluids exclusively for diagnostic purposes, after removal or withdrawal of these materials in the course of standard medical practice, shall not constitute a tissue bank.

(iii) A hospital whose tissue banking activities are limited to requesting organs and/or tissue donations, or referring potential donors or next of kin to licensed comprehensive tissue procurement services pursuant to Public Health Law, article 43-A, shall not constitute a tissue bank.

(ab) Tissue bank compliance officer means an employee of a tissue transplantation facility who is responsible for communicating all department requirements pertinent to transplantation services to each transplantation service director in the facility and for responding to inquiries from the department regarding compliance with this Part.

(ac) Tissue bank director means a person who is appointed by the owner of a tissue bank and meets the requirements of section 52-2.5(a)(2) of this Part, who may be the medical director, and has responsibility for the operation of the tissue bank.

(ad) Tissue services means the type and extent of services provided by tissue banks acquiring, processing, storing and/or distributing tissues for transplantation, transfer, artificial insemination or implantation. Types of tissue services sites and their definitions are:

(1) Comprehensive tissue procurement service means a facility or organization that engages in donor selection, solicitation and retrieval activities related to tissues from living and/or cadaveric donors.

(2) Limited tissue procurement service means a facility or organization whose tissue acquisition activities are limited to donor selection and solicitation by its own staff or the provision of staff, training or equipment for tissue acquisition activities to assist a comprehensive tissue procurement service in retrieving tissue. Retrieval of tissues on the premises of a limited tissue procurement service shall be performed by the staff or agents of a comprehensive tissue procurement service. Hospitals whose tissue banking activities are limited to requesting organ and/or tissue donations, or referring potential donors or next of kin to licensed comprehensive tissue procurement services are not subject to the licensure requirements in Subpart 52-2 of this Part.

(3) Tissue processing facility means a facility or organization that engages in any or all activities associated with processing, storage and/or distribution of human tissues for transplantation, transfer, artificial insemination or implantation.

(4) Tissue storage facility means a facility that engages in any or all activities associated with storage and distribution of human tissues for transplantation, transfer, artificial insemination, and/or implantation, except insemination/implantation sites storing, for less than six months, semen collected and processed by a semen bank appropriately licensed by the department.

(5) Tissue transplantation facility means a facility which temporarily stores and transplants tissue, except for tissue intended for autogeneic transplantation, provided such tissue does not leave the operating room for processing and/or storage.

(6) Tissue transplantation service means a unit within a tissue transplantation facility that is independently supervised and transplants one or more types of tissue.

(7) Insemination/implantation site means a location at which artificial insemination or other assisted reproductive procedures are performed, using reproductive tissues from anonymous donors, directed donors and/or client-depositors. Semen processing, limited to washing, concentrating and storing semen from patients of physicians associated with the licensed insemination/implantation site or from the patients' regular sexual partners, and limited storage (less than six months' duration) may be undertaken without additional licensure.

(ae) Transplantation service director means a physician who directs a tissue transplantation service.

(af) Viral inactivation means a process that subjects tissue to sterilization using ethylene oxide gas, gamma irradiation, or other sterilization method generally accepted by leading authorities in transplant medicine.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-1.1