CMS SOM App. Y, Tag Z061

tissue donors.

Interpretive Guidelines §486.322(c)(1)(ii)

The written agreement/MOU between the tissue banks and eye banks and the OPO for

securing informed consent from the family or the legally authorized representative of the

potential donor in the absence of a donor document (living will, advance directive,

driver’s license) must include the expectations for obtaining “informed consent.” The

arrangements should address the extent of information that should be shared with the

family or the legally authorized representative regarding:

a) What procedures will be performed;

b) Where the procedures will be performed;

c) Who will perform the procedures (generally);

d) When the procedures will be performed (generally);

e) What impact the procedures will have on the donor’s body (e.g., disruption of

funeral viewing); and

f) The associated documentation requirements including specific requirements for

telephone consents.

If the OPO utilizes the same informed consent form or procedure to obtain informed

consent for both organs and tissue/eye, the documentation on the consent form must

verify that the OPO provided information specific to tissue, eye or organ donation.

The OPO should have a written protocol in place with the tissue banks and eye banks

regarding telephone consent. The telephone consent protocol should require a witness to

all telephone consents unless the individual State law specifically allows a verbal record

of the informed consent over the telephone without the need for a witness. In these cases,

the consent recording should be maintained per medical record retention requirements.

The telephone protocol should also address the OPO staff who may take the consent,

persons who may provide consent, and how the OPO verifies the identity of the person

providing consent.