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Rules & Regulations
This section is meant as a reference for applicable rules, regulations, and guidelines for organ, tissue, and eye donation. Please always refer to primary sources.
Iowa Law: Pronouncing Death
According to Iowa law, death is determined when based on ordinary standards of medical practice, that person has experienced an irreversible cessation of spontaneous respiratory and circulatory functions.
In the event that artificial means of support preclude a determination that these functions have ceased, a person will be considered dead if in the announced opinion of two physicians, based on ordinary standards of medical practice, that person has experience an irreversible cessation of spontaneous brain functions. Death will have occurred at the time when the relevant functions ceased.
Uniform Anatomical Gift Act
The UAGA established first person consent that allows an individual to legally record his or her donation decision. In Iowa, any documentation of gift (i.e. “Donor – Y” on a driver’s license, registry on the Iowa Donor Registry, living will, etc.) is legally binding and does not require the consent of any other person.
Iowa Donor Network encourages individuals to share and discuss their donation decision with their family and loved ones.
Organ Procurement Organization Disclosure under HIPAA
Covered entities under the Health Insurance Portability and Accountability Act of 1996 may use or disclose protected health information to organ procurement organizations or other entities engaged in the procurement…of…organs, eyes, or tissue for the purpose of facilitating organ, eye or tissue donation and transplantation.
Organ Procurement Organization Disclosure under HIPAA
CMS Conditions of Participation: Organ, tissue, & eye donation
Center for Medicare and Medicaid Services Conditions of Participation standards state that hospitals must:
- Have and implement an agreement with the designated organ procurement organization under which it must notify, in a timely manner, the OPO of individuals whose death is imminent or who have died in the hospital.
- Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval of tissues and eyes.
- Ensure, in collaboration with the OPO, that the family of each potential donor is informed of its options to donate organ, 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 designated requestor (an individual who has completed a course offered or approved by the OPO).
- Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors.
- Work cooperatively with the OPO 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 Conditions of Participation: Organ, Tissue, and Eye Procurement
The Joint Commission
The Joint Commission has established standards for participating hospitals which include that:
- The hospital has a written agreement with an OPO and at least one tissue bank and at least one eye bank.
- The hospital must work with the OPO, tissue bank, and eye bank to (1) review death records, (2) maintain potential donors while necessary testing and placement of potential donated organs, tissues, and eyes takes place, (3) educate staff about issues surrounding donation, and (4) develop a written policy that addresses opportunities for asystolic recovery.
- Education includes training in use of discretion and sensitivity to families of potential donors.
- The individual designated by the hospital to notify the family regarding the option to donate or decline to donate is an organ procurement representative, or a designated requestor (an individual who has completed a course offered or approved by the organ procurement organization).
- The hospital notifies the OPO of patients who have died and of mechanically ventilated patients whose death is imminent.
- The OPO determines medically suitability of organs for organ donation.
- The hospital maintains records of potential organ, tissue, and eye donors whose names have been sent to the OPO and tissue and eye banks.
DNV GL NIAHO — National Integrated Accreditation for Healthcare Organization
The DNV has established standards for participating hospitals which include that:
- The organization shall have a process in place for the procurement of organs, tissues, and eyes. The organization shall have an agreement with at least one tissue bank and one eye bank.
- The written agreement should include (1) protocols to ensure timely notification to the OPO for all individuals whose death is imminent or who have died; (2) ensure communication of the policy to all appropriate areas of the organization; (3) acknowledge that it is the OPO’s responsibility for determination of medical suitability; (4) ensure that the family or each potential donor is informed of its options to donate organs, tissues, or eyes, or decline to donate; (5) ensure that the individual designated by the hospital to initiate the request to the family must be an organ procurement representative or designated requestor (individual must have competed a course offered or approved by the OPO); and (6) ensure that it works cooperatively to educate staff on donation issues, review death records, and maintain potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.
Guidelines for EMS Provider Initiating Organ & Tissue Donation
Appendix J of the Statewide EMS TREATMENT PROTOCOLS for ADULT & PEDIATRIC encourages medical examiners or a medical examiner’s designee, peace officers, fire fighters, and emergency medical care providers to contact Iowa Donor Network to initiate organ and tissue donation following the pronouncement of a death.