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The “PHS Increased Risk” Label Is Associated With Nonutilization of Hundreds of Organs per Year

Volk, Michael L. MD, MSc1; Wilk, Amber R. PhD2; Wolfe, Cameron MD3; Kaul, Daniel R. MD4

doi: 10.1097/TP.0000000000001673
Original Clinical Science—General

Background The Public Health Service “Increased Risk” (PHS IR) designation identifies donors at increased risk of transmitting hepatitis B, C, and human immunodeficiency virus. Although the risk remains very low in the era of nucleic acid testing, we hypothesized that this label may result in decreased organ utilization.

Methods Organ Procurement and Transplantation Network data were used to compare utilization rates between PHS-IR and non–PHS-IR donors, as well as to compare export rates and variation in utilization.

Results Among adult standard criteria donors between 2010 and 2013 with a known PHS-IR status, covariate-adjusted utilization rates were lower among PHS-IR donors than non–PHS-IR donors for all organs. For example, 4073 (76.7%) of 5314 PHS-IR kidneys were used, compared with 25 490 (83.7%) of 30 456 non–PHS-IR kidneys—an absolute difference of 7%. Furthermore, all PHS-IR organs had higher export rates than non–PHS-IR organs. For example, 28.7% of PHS-IR kidneys were exported versus 19.7% of non–PHS-IR kidneys. Finally, the utilization rate of PHS-IR organs varied by Donation Service Area; utilization ranged from 20% to 100% among adult kidneys, suggesting significant variation in practices. Similar patterns were seen among pediatric donors. Based on the covariate-adjusted model, if the PHS-IR label did not exist, there could be an additional 313 transplants performed in the United States each year.

Conclusions The PHS “increased risk” label appears to be associated with nonutilization of hundreds of organs per year, despite the very low risk of disease transmission. Better tools are needed to communicate the magnitude of risk to patients and their families.

This OPTN data analysis indicates that the current definition of increased risk donors is associated with unacceptable discard rates of high quality organs despite very low risk of disease transmission, urging for a broader discussion of these risks with patients and healthcare professionals.

1 Transplantation Institute, Loma Linda University, Loma Linda, CA.

2 United Network for Organ Sharing, Richmond, VA.

3 Division of Infectious Diseases, Duke University, Durham, NC.

4 Division of Infectious Diseases, University of Michigan, Ann Arbor, MI.

Received 17 October 2016. Revision received 20 January 2017.

Accepted 26 January 2017.

This work was conducted under the auspices of the United Network for Organ Sharing (UNOS), contractor for OPTN, under Contract 234-2005-370011C (US Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation). The data reported here have been supplied by the United Network for Organ Sharing (UNOS) as the contractor for the Organ Procurement and Transplantation Network (OPTN). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy of or interpretation by the OPTN or the U.S. Government.

The authors declare no conflicts of interest.

M.V. participated in study design, interpretation of results, and writing the article. A.W. participated in study design, data analysis, and writing the article. C.W. participated in study design, interpretation of results, and editing the article. D.K. participated in study design, interpretation of results, and editing the article.

Correspondence: Michael L. Volk, MS, MSc, Division of Gastroenterology and Transplantation Institute, Loma Linda University Health, Loma Linda, CA. (

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