CMS SOM App. A, Tag A-0886

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 hospital-designated

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.