There are over 104,000 people on the national transplant waiting list. Sadly, 17 people die each day waiting for an organ transplant. Not only can hospitals help save the lives of individuals waiting for a transplant, but hospitals are required by CMS to work with an Organ Procurement Organization (OPO). Yes - that’s right! Even if your hospital does not perform organ transplantation, CMS Condition of Participation §482.45 still applies. Let’s look at what is required.
First, Get to Know your OPO
There are 11 regional OPO offices in the United States. If you don’t know your OPO, you can find your regional organ procurement office by visiting the Organ Procurement & Transplantation Network (OPTN) website at: https://optn.transplant.hrsa.gov/about/search-membership/ Written Agreement and Policies
There are 11 regional OPO offices in the United States. If you don’t know your OPO, you can find your regional organ procurement office by visiting the Organ Procurement & Transplantation Network (OPTN) website at: https://optn.transplant.hrsa.gov/about/search-membership/ Written Agreement and Policies
Hospitals are required to have a written agreement and establish policies with the OPO. Responsibilities and expectations of the hospital and the OPO need to be clearly defined and include a definition for imminent death, establish criteria for when the hospital is to notify the OPO of a potential candidate, define timely notification, outline how notification is to occur, interventions the hospital will take to maintain organ vitality, education and training of staff, and OPO medical record access. That’s a lot! So, let’s explore the details.
Key Responsibilities:
- The hospital must allow the OPO, tissue bank, and eye bank to access the hospital’s death records according to a designated schedule, e.g., monthly or quarterly.
- The hospital is not required to perform credentialing reviews for, or grant privileges to, members of organ recovery teams; however, the OPO must provide and send only qualified, trained individuals to perform organ recovery.
- The hospital must notify the OPO of each individual death in a timely manner as defined in the agreement. (Batch reporting patient deaths by providing the OPO with periodic lists is not permitted.)
- The agreement must define the interventions the hospital will take to maintain organ vitality of the potential donor. Typically, patients are maintained on a ventilator to provide respiratory support and pharmacological support is continued.
Imminent Death
Most potential organ candidates have suffered a devastating brain injury, e.g., stroke or motor vehicle accident. In collaboration with the OPO, the hospital’s medical staff and governing body must develop and approve a written policy that defines "imminent death.” Additionally, this policy should clearly define criteria for notifying the OPO of all individuals whose death is imminent or who have died, e.g., Glasgow Coma Score
Most potential organ candidates have suffered a devastating brain injury, e.g., stroke or motor vehicle accident. In collaboration with the OPO, the hospital’s medical staff and governing body must develop and approve a written policy that defines "imminent death.” Additionally, this policy should clearly define criteria for notifying the OPO of all individuals whose death is imminent or who have died, e.g., Glasgow Coma Score
Timely Notification
When death is imminent, the hospital must notify the OPO both before a potential donor is removed from a ventilator and while organs are still viable. Timely notification means a hospital must contact the OPO by telephone as soon as possible after an individual has died, been placed on a ventilator due to a severe brain injury or been declared brain dead (ideally within one hour and prior to the withdrawal of any life sustaining therapies.) Note - When a patient dies during a transfer from one hospital to another, it is the receiving hospital’s responsibility to notify the OPO.
When death is imminent, the hospital must notify the OPO both before a potential donor is removed from a ventilator and while organs are still viable. Timely notification means a hospital must contact the OPO by telephone as soon as possible after an individual has died, been placed on a ventilator due to a severe brain injury or been declared brain dead (ideally within one hour and prior to the withdrawal of any life sustaining therapies.) Note - When a patient dies during a transfer from one hospital to another, it is the receiving hospital’s responsibility to notify the OPO.
Approaching Family about Donation
After notification, the OPO evaluates the patient and determines medical suitability to become a donor. It is perfectly acceptable for the family to refuse consent or give consent for donation of all or only some organs and tissues. Only an OPO representative or the hospital’s designated requestor is permitted to discuss organ donation with the family of a potential candidate. It is crucial that staff never approach a family about organ donation. Keep in mind, this is a stressful time for the patient’s family. The family may find peace in knowing their loved one will be an organ donor, only to be heartbroken if the patient is determined not medically suited for donation.
After notification, the OPO evaluates the patient and determines medical suitability to become a donor. It is perfectly acceptable for the family to refuse consent or give consent for donation of all or only some organs and tissues. Only an OPO representative or the hospital’s designated requestor is permitted to discuss organ donation with the family of a potential candidate. It is crucial that staff never approach a family about organ donation. Keep in mind, this is a stressful time for the patient’s family. The family may find peace in knowing their loved one will be an organ donor, only to be heartbroken if the patient is determined not medically suited for donation.
In case you are wondering, “what is a designated requestor?” A “designated requestor” is a hospital-designated individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community. If the OPO and the hospital agree to have a designated requestor, the training and responsibilities of this individual should be addressed in the written agreement between the OPO and the hospital.
Staff Education
All patient care staff must be trained on donation issues at the time of hire, annually, whenever policy changes occur, and when performance problems are identified. Staff responsible for notifying and working directly with the OPO should have appropriate training to carry out those responsibilities.
All patient care staff must be trained on donation issues at the time of hire, annually, whenever policy changes occur, and when performance problems are identified. Staff responsible for notifying and working directly with the OPO should have appropriate training to carry out those responsibilities.
Monitoring Performance
In collaboration with the OPO, the hospital is expected to monitor the timeliness of notifying the OPO of each potential candidate, along with monitoring the conversion rate (number of potential donors that
In collaboration with the OPO, the hospital is expected to monitor the timeliness of notifying the OPO of each potential candidate, along with monitoring the conversion rate (number of potential donors that
became actual donors.) Note - Surveyors may review the hospital’s OPO data and request documentation of corrective action if indicated. Possibly in the time it took for you to read this article another person may have been added to the national transplant waiting list. A new person is added every 10 minutes! To comply with CMS Condition of Participation §482.45 and save lives, hospitals need to work with their regional OPO. One donor can save up to eight lives!
References:
1. Center for Medicare and Medicaid Services. (2020). State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.
1. Center for Medicare and Medicaid Services. (2020). State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.
2. Donate Life America. https://donatelife.net/
3. Health Resources and Service Administration. Organ Procurement and Transplantation Network (OPTN). (2023). Organ Donation Statistics: https://www.organdonor.gov/
4. United Network for Organ Sharing (UNOS). (2023). Frequently Asked Questions: https://transplantliving.org/before-the-transplant/frequently-asked-questions/