US · guidance
CMS SOM App. Y, Tag Z164
(Condition) §486.342 Condition: Requesting Consent
An OPO must encourage discretion and sensitivity with respect to the circumstances,
views, and beliefs of potential donor families.
Interpretive Guidelines §486.342
Before going on-site, review the Aspen Complaint/Incident Tracking System (ACTS) to
determine if any complaints have been filed against the OPO for inappropriate or
insensitive behavior during the process of obtaining consent. If so, determine if there is
any additional follow-up required or were the complaints resolved sufficiently?
In the absence of first person consent, while it may be assumed by the OPO that, in
general, all persons, regardless of religious or personal beliefs, may be approached for
organ donation, the OPO must be sensitive to any factors (from record review, hospital
staff information, their own knowledge regarding religious beliefs or information
received) which indicate that the OPO should not pursue consent. The OPO must respect
the decisions by the family or the legally authorized representative as determined by State
law. Declination must be respected if the family or legally authorized representative was
approached by a trained requestor and declined donation. Review the staff orientation
program for discussions on sensitivity with donor families and legally authorized
representatives.
Review the QAPI documentation to determine if the OPO program conducted analysis on
any complaints received from family members or legally authorized representatives
reporting insensitive behavior or lack of discretion on the part of the OPO staff. Review
OPO documentation of subsequent counseling and increased training that was provided
to any staff member involved in such a complaint.
History
Rev. 115, Issued: 05-23-14, Effective: 05-23-14, Implementation: 05-23-14
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
b951fbb0d4972aff3aaf80d6fbe3539a84500077176210bf41462a936c6338d7
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