I. Donating and Procuring Organs and Tissues (TS.01.01.01)
(EP1) The hospital has a written agreement with an organ procurement organization (OPO) and follows its rules and regulations.
(EP3) The hospital has a written agreement with at least one tissue bank and at least one eye bank to cooperate in retrieving, processing, preserving, storing, and distributing tissues and eyes.
Note 1: This process should not interfere with organ procurement.
Note 2: It is not necessary for a hospital to have a separate agreement with a tissue bank if it has an agreement with its organ procurement organization (OPO) to provide tissue procurement services, nor is it necessary for a hospital to have a separate agreement with an eye bank if its OPO provides eye procurement services. The hospital is not required to use the OPO for tissue or eye procurement, and is free to have an agreement with the
tissue bank or eye bank of its choice.
(EP4) The hospital works with the organ procurement organization (OPO) and tissue and eye banks to do the following:
- Review death records in order to improve identification of potential donors.
- Maintain potential donors while the necessary testing and placement of potential donated organs, tissues, and
eyes takes place in order to maximize the viability of donor organs for transplant.
- Educate staff about issues surrounding donation.
- Develop a written donation policy that addresses opportunities for asystolic recovery that is mutually agreed upon by the hospital, its medical staff, and the designated OPO. When the hospital and its medical staff agree not to provide for asystolic recovery and cannot achieve agreement with the designated OPO, the hospital documents its efforts to reach an agreement with its OPO, and the donation policy addresses the hospital’s justification for not providing for asystolic recovery.
(EP5) Staff education includes training in the use of discretion and sensitivity to the circumstances, beliefs, and desires of the families of potential organ, tissue, or eye donors.
(EP6) The hospital develops, in collaboration with the designated organ procurement organization, written procedures for notifying the family of each potential donor about the option to donate or decline to donate organs, tissues, or eyes.
(EP8) The individual designated by the hospital documents that the patient or family accepts or declines the opportunity for the patient to become an organ, tissue, or eye donor.
(EP9) The hospital notifies the organ procurement organization (OPO) of patients who have died and of mechanically ventilated patients whose death is imminent, according to the following:
- Clinical triggers defined jointly with its medical staff and the designated OPO
- Within the time frames (ideally, within one hour of death for patients who have expired) jointly agreed on by the hospital and the designated OPO
- For mechanically ventilated patients, prior to the withdrawal of life-sustaining therapies including medical or pharmacological support
Note: For additional information about criteria for the determination of brain death, please see the American Academy of Neurology guidelines available at http://www.neurology.org/content/74/23/1911 and the American
(EP10) In Department of Defense hospitals, Veterans Affairs medical centers, and other federally administered health care agencies, notification to the organ procurement organization of patients who have died or whose death is imminent is done according to procedures approved by the respective agency.
(EP11) The organ procurement organization determines medical suitability of organs for organ donation and, in the
absence of alternative arrangements by the hospital, it determines the medical suitability of tissue and eyes for donation.
II. Transplanting Organs (TS.02.01.01)
(EP1) The hospital performing organ transplants belongs to and abides by the rules of the Organ Procurement and Transplantation Network (OPTN) * established under section 372 of the Public Health Service (PHS) Act.
(EP2) If requested, the hospital provides all data related to organ transplant to the Organ Procurement and Transplantation Network (OPTN), the Scientific Registry, or the hospital’s designated organ procurement organization (OPO), and when requested by the Office of the Secretary, directly to the US Department of Health & Human Services.
III. Standized Procedures to Acquire, Receive, Store and Issue Tissue (TS.03.01.01)
(EP1) The hospital assigns responsibility to one or more individuals for overseeing the acquisition, receipt, storage, and issuance of tissues throughout the hospital.
(EP2) The hospital develops and maintains standardized written procedures for the acquisition, receipt, storage, and issuance of tissues. (See also TS.03.02.01, EP 5)
(EP3) The hospital confirms that tissue suppliers are registered with the US Food and Drug Administration (FDA) as a tissue establishment and maintain a state license when required.
(EP5) The hospital follows the tissue suppliers’ or manufacturers’ written directions for transporting, handling, storing, and using tissue.
(EP6) The hospital documents the receipt of all tissues. (See also TS.03.02.01, EPs 3 and 6).
(EP7) The hospital verifies at the time of receipt that package integrity is met and transport temperature range was controlled and acceptable for tissues requiring a controlled environment. This verification is documented. (See also TS.03.02.01, EP 6)
(EP8) The hospital maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. (See also TS.03.02.01, EP 5)
(EP9) The hospital continuously monitors the temperature of refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues.
(EP10) Refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues at a controlled temperature have functional alarms and an emergency back-up plan. Note: For tissue stored at room temperature, alarm systems are not required.
IV. Bi-directional Tracing of Tissues (TS.03.02..01)
(EP1) The hospital’s records allow any tissue to be traced from the donor or tissue supplier to the recipient(s) or other final disposition, including discard, and from the recipient(s) or other final disposition back to the donor or tissue supplier.
(EP2) The hospital identifies, in writing, the materials and related instructions used to prepare or process tissues.
(EP3) The hospital documents the dates, times, and staff involved when tissue is accepted, prepared, and issued. (See also TS.03.01.01, EP 6)
(EP4) The hospital documents in the recipient’s medical record the tissue type and its unique identifier.
(EP5)The hospital retains tissue records on storage temperatures, outdated procedures, manuals, and publications for a minimum of 10 years. If required by state and/or federal laws, hospitals may have to retain tissue records longer than 10 years. (See also TS.03.01.01, EPs 2 and 8)
(EP6) The hospital retains tissue records for a minimum of 10 years beyond the date of distribution, transplantation, disposition, or expiration of tissue (whichever is latest). If required by state and/or federal laws, hospitals may have to retain tissue records longer than 10 years. Records are kept on all of the following: The tissue supplier
(EP7) The hospital completes and returns tissue usage information cards requested by the tissue supplier. * Footnote *: According to the Health Insurance Portability and Accountability Act (HIPAA) regulations regarding protected health information, “A covered entity may disclose protected health information for public health activities or other purposes to a person subject to the jurisdiction of the Food and Drug Administration (FDA) for the following purposes: - To track products if the disclosure is made to a person required or directed by the FDA to track the product - To enable product recalls, repairs or replacement (including locating and notifying individuals who have received products of product recalls, withdrawals, or other problems” (Refer to 45 CFR 164.512(b)(1)(iii)(B) and (C))
V. Tissue and Adverse Events Investigation (TS.03.03.01)
(EP1) The hospital has a written procedure to investigate tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue.
(EP2) The hospital investigates tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue.
(EP3) As soon as the hospital becomes aware of a post-transplant infection or other adverse event related to the use of tissue, it reports the infection or adverse event to the tissue supplier.
(EP4) The hospital sequesters tissue whose integrity may have been compromised or that is reported by the tissue supplier as a suspected cause of infection.
(EP5) The hospital identifies and informs tissue recipients of infection risk when donors are subsequently found to have human immunodeficiency virus (HIV), human T-lymphotropic virus-I/II (HTLV-I/II), viral hepatitis, or other infectious agents known to be transmitted through tissue.