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Clarify Requirements for Reporting a Potential Disease Transmission

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Background

Transplant programs are required to report any discoveries of potential disease transmissions from donor organs they have received for transplant. Yet the lack of a clear and precise definition of an unexpected disease transmission in OPTN policy has created confusion among transplant programs about when an event is considered unexpected. This confusion has led to over and under-reporting of disease transmission events. Additionally, reporting disease transmission is particularly difficult for lung recipients. This proposal will define unexpected disease transmission in OPTN policy and define and clarify reporting requirements for sick and non-sick lung recipients.

Supporting Media

Presentation

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Proposed changes

  • Creates a definition for an unexpected disease transmission
  • Defines a time period for when a donor-derived disease transmission is considered unexpected
  • Creates a definition of a “sick lung recipient”
  • Clarifies reporting requirements for both sick and non-sick lung recipients

Anticipated impact

  • What it's expected to do
    • Create consistency in reporting unexpected disease transmissions
    • Streamline communication for reporting unexpected disease transmissions to other recipients
    • Remove uncertainty in reporting practices
    • Establishes reporting requirements for lung recipients

Terms to know

  • Cross Clamp Time: The time when blood flow to an organ is stopped during a procurement.
  • Organism Colonization: When a microorganism or biological community grows and multiplies in or on a host or habitat without causing disease or an immune response in the host.
  • Pathogens of Special Interest: A list of specific disease-causing organisms that, if discovered post-procurement of a donor organ, must be reported to the OPTN Improving Safety Portal within 24 hours.
  • OPTN Improving Patient Safety Portal: Portal that is used to report patient safety concerns directly to the OPTN.

Click here to search the OPTN glossary

Read the full proposal (PDF)

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