Guideline text:
(Rev. 37, Issued:  10-17-08; Effective/Implementation Date:  10-17-08)

§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;

## Interpretive Guidelines §482.45(a)(1)

The hospital must have a written agreement with an Organ Procurement Organization (OPO), designated under 42 CFR Part 486.  At a minimum, the written agreement must address the following:

- The criteria for referral, including the referral of all individuals whose death is imminent or who have died in the hospital;
- Includes a definition of 'imminent death';
- Includes a definition of 'timely notification';
- Addresses the OPO's responsibility to determine medical suitability for organ

donation;

- Specifies how the tissue and/or eye bank will be notified about potential donors using notification protocols developed by the OPO in consultation with the hospitaldesignated tissue and eye bank(s);
- Provides for notification of each individual death in a timely manner to the OPO (or designated third party) in accordance with the terms of the agreement;
- Ensures that the designated requestor training program offered by the OPO has been developed in cooperation with the tissue bank and eye bank designated by the hospital;
- Permits the OPO, tissue bank, and eye bank access to the hospital's death record information according to a designated schedule, e.g., monthly or quarterly;
- Includes that the hospital is not required to perform credentialing reviews for, or grant privileges to, members of organ recovery teams as long as the OPO sends only 'qualified, trained individuals' to perform organ recovery; and
- The interventions the hospital will utilize to maintain potential organ donor patients so that the patient organs remain viable.

Hospitals must notify the OPO of every death or imminent death in the hospital. When death is imminent, the hospital must notify the OPO both before a potential donor is removed from a ventilator and while the potential donor's organs are still viable.  The hospital should have a written policy, developed in coordination with the OPO and approved by the hospital's medical staff and governing body, to define 'imminent death.' The definition for 'imminent death' should strike a balance between the needs of the OPO and the needs of the hospital's care givers to continue treatment of a patient until brain death is declared or the patient's family has made the decision to withdraw supportive measures.  Collaboration between OPOs and hospitals will create a partnership that furthers donation, while respecting the perspective of hospital staff.

The definition for 'imminent death' might include a patient with severe, acute brain injury who:

- Requires mechanical ventilation;
- Is in an intensive care unit (ICU) or emergency department; AND
- Exhibits clinical findings consistent with a Glascow Coma Score that is less than or equal to a mutually-agreed-upon threshold; or
- MD/DOs are evaluating a diagnosis of brain death; or
- An MD/DO has ordered that life sustaining therapies be withdrawn, pursuant to the family's decision.

Hospitals and their OPO should develop a definition of 'imminent death' that includes specific triggers for notifying the OPO about an imminent death.

In determining the appropriate threshold for the Glascow Coma Score (GCS), it is important to remember that if the threshold is too low, there may be too many 'premature' deaths or situations where there is a loss of organ viability.  Standards for appropriate GCS thresholds may be obtained from the hospital's OPO or organizations such as The

Association of Organ Procurement Organizations.

Note that a patient with 'severe, acute brain injury' is not always a trauma patient.  For example, post myocardial infarction resuscitation may result in a patient with a beating heart and no brain activity.

The definition agreed to by the hospital and the OPO may include all of the elements listed above or just some of the elements.  The definition should be tailored to fit the particular circumstances in each hospital.

Hospitals may not use 'batch reporting' for deaths by providing the OPO with periodic lists of patient deaths, even if instructed to do so by the OPO.  If the patient dies during a transfer from one hospital to another, it is the receiving hospital's responsibility to notify the OPO.

' Timely notification ' means a hospital must contact the OPO by telephone as soon as possible after an individual has died, has been placed on a ventilator due to a severe brain injury, or who has been declared brain dead (ideally within 1 hour).  That is, a hospital must notify the OPO while a brain dead or severely brain-injured, ventilator-dependent individual is still attached to the ventilator and as soon as possible after the death of any other individual, including a potential non-heart-beating donor.  Even if the hospital does not consider an individual who is not on a ventilator to be a potential donor, the hospital must call the OPO as soon as possible after the death of that individual has occurred.

Referral by a hospital to an OPO is timely if it is made:

- As soon as it is anticipated that a patient will meet the criteria for imminent death agreed to by the OPO and hospital or as soon as possible after a patient meets the criteria for imminent death agreed to by the OPO and the hospital (ideally, within one hour); AND
- Prior to the withdrawal of any life sustaining therapies (i.e., medical or pharmacological support).

Whenever possible, referral should be made early enough to allow the OPO to assess the patient's suitability for organ donation before brain death is declared and before the option of organ donation is presented to the family of the potential donor.  Timely assessment of the patient's suitability for organ donation increases the likelihood that the patient's organs will be viable for transplantation (assuming there is no disease process identified by the OPO that would cause the organs to be unsuitable), assures that the family is approached only if the patient is medically suitable for organ donation, and assures that an OPO representative is available to collaborate with the hospital staff in discussing donation with the family.

It is the OPO's responsibility to determine 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.

## Survey Procedures §482.45(a)(1)

- Review the hospital's written agreement with the OPO to verify that it addresses all required information.
- Verify that the hospital's governing body has approved the hospital's organ procurement policies.
- Review a sample of death records to verify that the hospital has implemented its organ procurement policies.
- Interview the staff to verify that they are aware of the hospital's policies and procedures for organ, tissue and eye procurement.
- Verify that the organ, tissue and eye donation program is integrated into the hospital's QAPI program.

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