Clinical Guidance for Transplant Safety

Key points

  • Every organ donor can save as many as eight lives and enhance 75 more.
  • While rare, an infection can be transmitted through an organ transplant from a donor to a recipient. This occurs in <1% of all transplants.
  • Several safety measures are in place to lessen the risk of disease transmission to ensure that every usable organ is used safely.

Guiding principles

When a suspected (or confirmed) donor-derived disease transmission is identified in a transplant recipient, other recipients of organs and tissues from the same donor must be quickly identified and notified. Early notification and treatment improve the chance of patient survival and prevention of organ or tissue graft loss. Additionally, the ability to easily trace unused tissue to storage locations for immediate quarantine can prevent further transplantation of potentially infected tissue.

Multiple state/local health departments may be involved in a single investigation as the location of the donor hospital and healthcare facilities where donor organs or tissues were transplanted frequently encompasses multiple states.

Well-coordinated investigations among public health agencies, organ procurement organizations, transplant centers, clinicians, and laboratorians are strongly encouraged. Findings from investigations help inform regulatory decisions and guidance on reducing the risk of infectious transmissions through organ and tissue transplantation. Any of these entities can contact CDC regarding all aspects of diagnosing, treating, and investigating cases.

Hope Act

The HIV Organ Policy Equity (HOPE) Act was passed in 2013, enabling the transplantation of solid organs from HIV-positive donors to HIV-positive recipients when following specified protocols. Because the number of donor organs is not sufficient to meet the need, intentional transplantation of organs from HBV– and HCV–infected donors is accepted medical practice. These organs are typically offered to transplant patients known to have the same infection or, in many circumstances, to uninfected patients in cases of urgent medical need.

Policies for notification and investigation

The U.S. Congress established the Organ Procurement and Transplantation Network (OPTN) through the National Organ Transplant Act (NOTA) of 1984. NOTA called for a unified transplant network operated by a private, non-profit organization under federal contract. The United Network for Organ Sharing (UNOS) administers the OPTN under contract with the Health Resources and Services Administration (HRSA). Under federal law:

  • All U.S. transplant centers and organ procurement organizations (OPO) must be members of the OPTN to receive any funds through Medicare.
  • Healthcare workers and OPTN members must screen transplant donors, test transplant tissue and/or organs, and report all suspected, unexpected donor-derived disease transmission events to the OPTN for investigation.
  • Once notified, UNOS patient safety staff must notify transplant centers and request follow-up on potentially impacted recipients. The OPTN Disease Transmission Advisory Committee (DTAC) reviews the reports to determine the likelihood of transplant transmission, educate the transplant community, and inform policy.

The policies governing transplantation in the United States mean that transplant-transmitted infections are recognized and reported differently than standard public health protocols: through a working agreement with the Health Resources and Services Administration (HRSA), CDC may be alerted to a potential transmission before local or state public health authorities.

To ensure the inclusion of appropriate public health authorities, CDC and HRSA created a working agreement whereby UNOS directly notifies CDC of cases involving pathogens of special interest and the reporting transplant center or OPO notifies local public health authorities. CDC works first to establish recipient safety and determine the residency of all involved; relevant health departments are notified promptly should a donor or recipient be within their jurisdiction. At the investigation's conclusion, investigators provide a summary to UNOS so that DTAC can assign a case classification highlighting important aspects of the case for the transplant community.

If public health departments are the first to recognize potential transplant-transmitted diseases and initiate an investigation, they should also encourage the relevant transplant center or OPO to report to UNOS. This ensures timely notification of other organ recipients, tissue banks, and eye banks.

Donor screening and testing

Donor Screening

The OPTN policies (for organ procurement organizations [OPOs]) and FDA regulations and guidance (for tissue and eye banks) require providers to conduct a medical and social history screening interview with the deceased donor's next of kin or another well-informed person. These interviews gather information about:

  1. risk behaviors that may have exposed the donor to certain diseases.
  2. the donor's past medical history
  3. relevant travel history, which can be important for exposure to certain pathogens.

This interview is one of several ways to measure the donor's risk for having an infectious disease. Its usefulness depends on 1) how well the person being interviewed knew the donor; and 2) the interviewee's comprehension of the meaning of the questions.

Laboratory Testing for Infectious Diseases

OPTN policy requires OPOs and hospitals that recover living donor organs to perform the following tests for donors:

FDA regulations require tissue and eye banks to effectively and properly test donor specimens for risks associated with:

A donor with positive test results for any of these infectious pathogens, but not necessarily CMV, is not eligible.

The medical director or designated person of the tissue or eye bank performs a final review of available records (for example, communicable disease test results, an autopsy report, and tissue processing treatments when applicable) to determine donor eligibility before deciding if tissues from a particular donor are safe for transplantation.

Treatment options

When possible, providers should rid tissue of pathogens identified during screening and/or testing to make them safe for transplantation. For example:

  • Storing corneas in a solution containing antibiotics to reduce bacterial growth.
  • Cleaning, disinfecting, and possibly irradiating tissues.

However, providers should not sterilize some tissues, such as corneas, blood vessels, and heart valves because such treatment could damage the tissue.


PHS Guidelines

The U.S. Public Health Service (PHS) published the U.S. PHS Guideline. The PHS Guideline assesses Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection.

The OPTN developed policies for organ procurement organizations and transplant centers based on these recommendations. The policies were implemented in early 2021, with a subsequent revision of 1 recommendation published in 2022.

A list of previous guidelines and other publications by year is available.