CMS SOM App. Y, Tag Z167

Potential Donors and Organ Placement and Recovery.

The OPO must have written protocols for donor evaluation and management and organ

placement and recovery that meet current standards of practice and are designed to

maximize organ quality and optimize the number of donors and the number of organs

recovered and transplanted per donor.

Interpretive Guidelines §486.344

The OPO should have written protocols for:

A. Donor Evaluation (per organ) which addresses;

• Chart review required;

• Laboratory testing required (standard and additional as indicated);

• Other testing as indicated (echocardiogram, chest x-ray, etc.);

• Required timeframes for donor protocol activities;

• Documentation required;

• OPO staff member interactions with family or legally authorized representatives

to collect information; and

• OPO staff roles.

(NOTE: The above protocol is not developed to determine organ suitability for a certain

recipient, but to determine the medical suitability of a potential donor.)

While the OPO may review the potential donor’s hospital record without consent, in the

absence of a donor document, consent from family or legally authorized representatives,

or specific State law which allows invasive testing prior to consent, the OPO shall not

conduct invasive testing prior to consent. Non-invasive testing would include procedures

that involve no break in the skin and no contact with the mucosa or internal body cavities

beyond natural body orifices.

B. Donor Management (per organ) to include:

• Testing (such as cardiac);

• Laboratory testing;

• Drug administration parameters;

• Ventilation management;

• Optimal vital signs; and

• Fluid levels;

C. Organ Placement to include:

• UNET match list review;

• Communication with transplant hospitals.

D. Organ Recovery to include:

• Scheduling;

• Qualified staff;

• Documentation of verification of blood type;

• Documentation required during recovery;

• Organ packaging;

• Organ transport; Documentation accompanying the organ; and

• Any subsequent follow-up with transplant hospital.

The above OPO protocols must be consistent with current standards of community

practice for organ procurement.

As current clinical practices continue to evolve at a fairly rapid pace, advances are made

in the science of organ procurement to improve the outcomes of transplantation.

Therefore, the individual OPO is ultimately responsible for updating its own clinical

policies and protocols as necessary but at least annually.