• Instructions_[1]
• Required - all facilities must submit the Application for Licensure - Form DOH-2973_[2].
  • Corporations must provide a copy of the certificate of incorporation.
  • Partnerships must provide a copy of the partnership agreement.

As applicable based on your Application for Licensure, page 1, submit the form(s) below and provide the additional documentation requested therein:

• Form A_[3] - Limited Tissue Procurement Services
• Form B_[4] - Comprehensive Tissue Procurement Services/Tissue Processing Facilities/Tissue Storage Facilities
• Form B-1_[5] - Reproductive Tissue Banks
• Form C_[6] - Tissue Transplantation Facilities
• Form D_[7] - Insemination/Implantation Sites
• Form E_[8] - Nontransplant Anatomic Bank
• Form G_[9] - Assisted Reproductive Technology Service Provider (ARTSP) Registration

Public Health Law Article 43-B, enacted in 1990, established the Commissioner's authority over tissue banks.  Part 52, Tissue Banks and Nontransplant Anatomic Banks_[10], covers such tissues as skin, eye, semen, embryos, and stem cells. Subpart 58-5, Hematopoietic Progenitor Cell Banks_[11], regulates activities involving hematopoietic progenitor cells (precursors of blood cells found in umbilical cord blood, peripheral blood, and bone marrow). Licensure is required for all tissue banking activities in New York, including collection, processing, storage, and distribution.

Regulations also include requirements for licensure of facilities that recover, process, store and/or distribute nontransplant anatomic parts for medical research or health professional education.

Statutes - Public Health Law

• Article 5, Title V: Clinical Laboratory and Blood Banking Services: Navigate to the NYS Legislature resource_[12] and enter CLINICAL LABORATORY AND BLOOD BANKING SERVICES in the search box, then click PUBLIC HEALTH LAW ARTICLE 5T5
• Article 43-B: Organ Tissue and Body Parts: Navigate to the NYS Legislature resource_[13] and enter ORGAN TISSUE AND BODY PARTS in the search box, then click PUBLIC HEALTH LAW ARTICLE 43-B

Regulations Title 10, NYCRR

• Part 52 Tissue Banks and Nontransplant Anatomic Banks_[14]
• Part 58-5 Hematopoietic Progenitor Cell Banks_[15]

• Exceptions for People Living with HIV (PLWH)_[16]
• Hepatitis B Positive Directed Donors_[17]
• Screening for Blood Transfusions in Living Allogeneic Donors_[18]
• Donation of Stored Embryos_[19]
• Tuberculosis (TB) Testing of Milk Donors_[20]
• Rubella Immunity Testing of Milk Donors_[21]
• HTLV-I Testing of Non-Leukocyte-Rich Tissues_[22]
• Distribution of Birth Tissues_[23]
• Importation of Client-Depositor (C-D) Reproductive Tissue_[24]
• Testing of Semen Donors - Timing_[25]
• Regulation of Pluripotent Stem Cell Products_[26]
• Acceptability of Birth Tissue Donors_[27] (up to 14 days after retrieval)
• Testing of Semen Donors For Gonorrhoeae_[28]

What is considered a reportable incident?

For purposes of reporting to the Tissue Resources Program, an incident is any:

• Error, accident, or non-conformance in tissue or hematopoietic progenitor cell donor screening, testing, qualification, and/or selection; or
• Error, accident, or non-conformance in the recovery, collection, processing, storage, distribution, insemination, implantation, and/or transplantation of tissue or hematopoietic progenitor cells that may affect the safety of the tissue or cells, including tissue or cells for autologous purposes.

What does not need to be reported?

Post-implantation or transplantation data unrelated to the condition of the donor tissue or hematopoietic progenitor cells as the result of post-operative infection following the transplantation or implantation procedure.

How do facilities file an incident report?

In order to report a Tissue or Hematopoietic Progenitor Cell related incident, please complete and submit the Transplantation/Tissue Bank-related Incident Report_[29] or Transplantation/HPC Bank-related Incident Report_[30] form to tissue@health.ny.gov_[31].

When do facilities have to report an incident?

All tissue and/or hematopoietic progenitor cell-related errors, accidents, or non-conformance events shall be reported to the Tissue Resources Program within seven calendar days of its discovery.

If the error, accident, or non-conformance is not detected prior to issuance of the tissue or cells, it shall also be reported to the receiving facility.

Tissue or hematopoietic progenitor cell banks seeking an exception (waiver) to a requirement in Part 52 or Part 58-5 must request the exception, and receive Department approval, prior to noncompliance with the standard. The form below is intended for exceptions related to importation and/or use of reproductive tissue only. Submit the exception request to tissue@health.ny.gov_[32]. For exceptions related to all other tissues, e-mail your request in writing to tissue@health.ny.gov_[33].

Exception Request form for Reproductive Tissues_[34]