CMS SOM App. Y, Tag Z165

absence of a donor document, the individual(s) responsible for making the donation

decision are informed of their options to donate organs or tissues (when the OPO is

making a request for tissues) or to decline to donate. The OPO must provide to the

individual(s) responsible for making the donation decision, at a minimum, the

following:

(1) A list of the organs and/or tissues that may be recovered.

(2) The most likely uses for the donated organs or tissues.

(3) A description of the screening and recovery processes.

(4) Information about the organizations that will recover, process, and distribute the

tissue.

(5) Information regarding access to and release of the donor’s medical records.

(6) An explanation of the impact the donation process will have on burial

arrangements and the appearance of the donor’s body.

(7) Contact information for individual(s) with questions or concerns.

(8) A copy of the signed consent form if a donation is made.

Interpretive Guidelines §486.342(a)

In the absence of a donor document (e.g., living will, advance directive, driver’s license

declaration and State donor registries), the family or legally authorized representatives

must give informed consent for the donation of organs.

Review the donor record sample (for donors without first person consent) to verify that in

each case the family or legally authorized representatives was provide with the

information listed in §486.342 (1)-(8) above and indicated an understanding of the

information. The confirmation that the informer assessed the level of understanding by

the family or legally authorized representatives may be incorporated into the consent

form or may appear as a summary note by the informer in another part of the record.

Any documentation of the level of understanding should include what information was

provided, the method used to determine the level of understanding and the level of

understanding expressed. The documentation should also include any specifics that were

repeated for clarification.

At the time that informed consent is acquired, the OPO may not know definitively how

the organ will be used. In these cases, informed consent must provide the family or

legally authorized representatives with the range of most likely possibilities for usage

(transplant or research).

The OPO should list its contact information on the consent form to include a specific

point of contact at the OPO.

Copies of the consent are shared with the family or legally authorized representatives at

the time the consent is signed. In instances where the recovery does not ultimately go

forward, there would be no need to include a copy of the consent with any letter of

explanation sent to the family or legally authorized representatives.