CMS SOM App. W, Tag C-1503

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 CAH. The OPO determines medical suitability for organ donation and,

in the absence of alternative arrangements by the CAH, 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 CAH for this purpose;

Interpretive Guidelines §485.643(a)

The CAH 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 CAH;

• 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 S notification protocols developed by the OPO in consultation with the

CAH-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 CAH;

• Permits the OPO, tissue bank, and eye bank access to the CAH’S death record

information according to a designated schedule, e.g., monthly or quarterly;

• Includes that the CAH 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 CAH will utilize to maintain potential organ donor patients

so that the patient organs remain viable.

CAHs must notify the OPO of every death or imminent death in the CAH. When death is

imminent, the CAH 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 CAH should have a

written policy, developed in coordination with the OPO and approved by the CAH’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 CAH’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 CAHs will create a partnership that furthers donation,

while respecting the perspective of CAH 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

• Has 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.

CAHs 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 Glasgow 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 CAH’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 CAH 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 CAH.

CAHs 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 CAH to another, it is the receiving CAH’S responsibility to notify the

OPO.

“Timely notification” means a CAH 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 CAH 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 CAH does

not consider an individual who is not on a ventilator to be a potential donor, the CAH

must call the OPO as soon as possible after the death of that individual has occurred.

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

• As soon as it is anticipated a patient will meet the criteria for imminent death

agreed to by the OPO and CAH or as soon as possible after a patient meets the

criteria for imminent death agreed to by the OPO and the CAH (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), ensures that the

family is approached only if the patient is medically suitable for organ donation, and

ensures that an OPO representative is available to collaborate with the CAH 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 CAH, 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 CAH for this purpose.

Survey Procedures §485.643(a)

• Review the CAH’S written agreement with the OPO to verify that it addresses all

required information.

• Verify that the CAH’S governing body has approved the CAH’S organ

procurement policies.

• Review a sample of death records to verify that the CAH has implemented its

organ procurement policies.

• Interview the staff to verify that they are aware of the CAH’S policies and

procedures for organ, tissue and eye procurement.

• Verify that the organ, tissue and eye donation program is integrated into the

CAH’S QA program.