Changes to requirements for donor information shipped with organs

Changes to requirements for donor information shipped with organs

Audience

All OPO staff

Background

In December 2015, the Board of Directors approved a proposal to change the requirements for sending “the complete donor record” in the container with each organ. The proposal reduced the documentation to only blood type source documentation and infectious disease testing results. While the OPTN policy change went into effect on March 1, 2016, CMS regulations still required OPOs to provide the complete donor record with each organ.

CMS recently published regulatory changes in the Federal Register[1] to reduce the paper documentation requirements to align with OPTN requirements. §486.346(b) has been revised “to no longer require paper documentation, with the exception of blood typing and infectious disease information, be sent with the organ to the receiving transplant center.” This change becomes effective on January 1, 2017.

What OPOs need to do

OPOs must report all required information to the OPTN Contractor upon receipt by uploading the information to DonorNet®. Transplant hospitals will need to be aware that donor information is available in DonorNet® and OPOs will only include the blood type and infectious disease source documentation in the shipping container with each organ. If paper copies of donor information are required, transplant hospitals will need to print the information.

[1] https://www.federalregister.gov/documents/2016/11/14

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