CMS SOM App. Y, Tag Z125

The OPO’s medical director is a physician licensed in at least one of the States or

territories within the OPO’s service area and the medical director is responsible for

implementation of the OPO’s protocols for donor evaluation and management and organ

recovery and placement. The medical director is responsible for oversight of the clinical

management of potential donors, including providing assistance in managing a donor

case when the surgeon on call is unavailable.

Interpretive Guidelines §486.326(d)

Review the administrative file for the OPO medical director to verify that:

a) He/she is currently licensed as a physician in one of the States within the OPO

donation service area or as required by State law (State laws of other States in the

Donation Service Area may require that any physician practicing within that State

be licensed by that State); and

b) The position description for the medical director clearly delineates his/her role in

the implementation of protocols for donor evaluation and management,

determination of donor suitability for donation, organ recovery and placement in

increased risk cases.

Interview the medical director to determine:

a) His/her familiarity with the OPO protocols;

b) The extent of his/her involvement in the implementation of protocols (especially

protocols for the evaluation for suitability and donor management);

c) His/her role in donor management (either on-site or consultation);

d) His/her process for verifying whether the OPO is following its written protocols

and ensuring the protocols are consistent with current standards of practice;

e) Documentation of periodic evaluations of compliance with protocols (d above);

and

f) His/her role in the determination of donor suitability (e.g. donor of increased

risk).

Generally, the OPO organ procurement coordinator performs donor management per

protocols approved by the OPO medical director without his/her on-site participation.

However, the OPO medical director must be available for consultation on any case where

a procurement coordinator requires additional guidance. Verify through interview and

review of donor records that the medical director is available for consultation 24/7 or has

back-up coverage by another MD or DO.