CMS SOM App. Y, Tag Z173

history.

Interpretive Guidelines §486.344(b)(3)

Due to the compressed time frame for deceased donor evaluation, there is a possibility

that certain infections, such as HIV, HBV, and or HCV, may be present at an early stage,

prior to the ability of an assay to detect the infection. Thus, considerable weight is

placed on the donor’s social and medical history in identifying potential risks that might

not be reflected in blood test results. The potential donor’s medical and social history

provides invaluable information that might clarify or explain ambiguous and/or

discordant diagnostic test results that could eliminate an otherwise suitable organ donor

or could include an otherwise unsuitable organ donor. It is crucial that the OPO closely

review the medical and social history for the potential donor, identify any factors which

may exclude the donor from donation or indicate extra restrictions on the type of

recipient who may be allowed to receive the organ. The OPO considers the reliability of

the informant for the social history and the likelihood the informant has sufficient

knowledge of the potential donor to provide a definitive response to questions, especially

questions associated with increased risk behavior.

In all instances on the social history where there are either questions answered in

the affirmative regarding increased risk behavior or there is inadequate information

to definitively respond on questions regarding increased risk behavior, confirm that

the OPO immediately documented this information in DonorNet to provide

sufficient information to transplant surgeons or transplant coordinators before

proceeding with the donation.

In any instance where a social history or medical history revealed a condition or

behavior that makes donation increased risk in most cases, there must be written

documentation in the donor record to verify that the conditions and behaviors were

completely discussed with the transplant surgeons at the time the organ offer was

made.

In the absence of a social or medical history, the OPO should elevate the potential donor

to an increased risk status and notify transplant surgeons of such evaluation.