Center for Improvement in Healthcare Quality Newsletter
September 2021

News You Can Use

September Compliance Tip of the Month

September’s tip of the month is focused on the standard/requirements regarding organ, tissue & eye procurement. The regulations for both CIHQ and CMS are included below for your reference.
The most common finding for larger organization’s is around the need to document education provided to staff on the items described in OP-01 - Requirement G. Smaller organizations tend to struggle when it comes to the written agreement. Most standard agreements with OPO’s include language that requires the hospital to maintain surgical services in order to harvest donated organs/eyes. Hospitals are not required to provide surgical services as this is an optional service as defined by CMS and CIHQ and therefore the language should be changed to reflect the transport process of the deceased to another facility in order for harvesting to occur.

CIHQ

OP-1: Organ, Tissue & Eye Procurement
The organization must develop, implement, and maintain a policy(s) and process(s) to assure that organ, tissue and/or eye procurement is effectively managed.
  1. The organization must have a written agreement with a designated organ procurement organization (OPO).
  2. The organization must notify in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital.
  3. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the organization; the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the organization for this purpose.
  4. Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement.
  5. Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues or eyes, or to decline to donate. The individual designated by the organization to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation.
  6. Encourage discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors.
  7. Ensure that the organization works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors and maintaining potential donors while necessary testing and placement of potential donated organs, tissues and eyes take place.

CMS

§482.45 Condition of Participation: Organ, Tissue and Eye Procurement
§482.45(a) The hospital must have and implement written protocols that:
§482.45(a)(1) - Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose;
§482.45(a)(2) - Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;
§482.45(a)(3) - Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate.
  • The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;
§482.45(a)(4) - Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;
§482.45(a)(5) - Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues; reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.
§482.45(b) Standard: Organ Transplantation Responsibilities
(1) A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term “rules of the OPTN” means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act, or with the requirements of this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing.
(2) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas.
(3) If a hospital performs any type of transplants, it must provide organ transplant related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide such data directly to the Department when requested by the Secretary.
It is recommended that there be a mechanism put in place to ensure that a mechanism is in place to document education that is provided to staff on organ donation issues and also to perform a review the written agreement to assure that it the language is applicable to the organization.
ARS resources to assist with compliance:
Resource Library
  • 1046 Policy – Organ Donation
  • 1047 Policy – Organ Donation for Hospitals Without Capacity to Maintain Donor
Staff Training:
  • Organ & Tissue Donation – Power Point and Post Test