Guidance on PHS increased risk donor organsView comments
Sponsoring Committee: Ad Hoc Disease Transmission Advisory (DTAC)
Strategic Goal: Increase the number of transplants
- DTAC board report (6/2017) PDF - 344 K
- Final version of guidance (6/2017)
In July 2013, the U.S. Public Health Service (PHS) published new guidelines for reducing human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) transmission through organ transplantation. These new guidelines, called "increased risk" guidelines, replaced earlier guidelines from 1994 called "high risk" criteria. The phrase "increased risk" refers to the donor characteristics that could place the potential recipient at increased risk of disease transmission. The phrase is not a reference to organ quality, nor should it be interpreted to be a predictor of graft survival.
A potential organ donor may be labeled as increased risk for a variety of different exposures, and these exposures carry different risks of transmitting recent infection with HIV, HBV, or HCV. Helping transplant patients understand the potential risks of disease transmission from increased risk organs versus refusing an organ for transplant is an important, but challenging topic. The transplant community has requested assistance explaining relative risk of disease transmission involving increased risk organ donors to potential organ recipients. The OPTN/UNOS Ad-hoc Disease Transmission Advisory Committee (DTAC), in collaboration with the Joint Society Steering Committee, developed this document to inform and facilitate conversations between transplant team members and their patients. The guidance profiles recent peer reviewed literature and OPTN data to describe the risk of undetected disease transmission from PHS increased risk organ donors.
This guidance document will help transplant clinicians in decision-making during organ offers from OPOs, and allow them to consider the risk of undetected HIV, HBV, or HCV infection in the donor. This guidance also provides speaking points to transplant program staff for patient education. This will guide the decision-making process whether the patient may want to consider an organ from an increased risk donor at the time of organ offer.
Read the proposal (PDF)
View a recording of a webinar held on April 4. It provides additional information about the project and the recommendations within the guidance document.
- What challenges has your organization experienced with PHS increased risk organ donors, e.g.: inconsistent acceptance practices with increased risk donors, lack of clarity regarding appropriate disclosure of donor risk behaviors?
- What practice changes have you made at your organization in response to these challenges?
Impact summaries (6/2017) PDF - 260 K
SMALL = UNOS project complexity for all departments
- 225 = Implementation hours all departments
- 105 = Ongoing (annual ) hours all departments
- No major financial impact to implement of maintain for hospitals, OPOs, Labs.
- Minimal Hospital staff time needed to update protocols recommended in guidance.
- Guidance documents do not contain new member requirements. However the assumption in estimating fiscal impact is the members will follow guidelines.
Hospital: Staff time to adjust protocols for patient discussion and to update any education materials is needed to implement the guidance. Staff time is variable dependent on size of program and existing protocol.
There is no substantial financial impact, as any changes can be completed within normal operations. Implementation is estimated at 1-2 months for most programs.
The number of transplants may go up if programs accept a greater number of increased risk organs, but costs are expected to be reimbursed by insurance.
OPO and Lab: Minimal or no impact.
A small instructional effort is required to implement this proposal.