CDC's Transplant-Transmitted Infection Toolkit

Investigation Process Background

Transplant-Transmitted Infections are recognized in several manners and often differ from standard public health protocols, in that, the CDC, via a working agreement with the Health Resources and Services Administration (HRSA) may be alerted to a potential transmission prior to local or state public health authorities. This unusual notification process is linked to the policies that govern transplantation in the United States which are described below. Despite these notifications, there have been many cases in which local and state health authorities recognize a potential transplant-associated transmission and begin investigation. This form and the information provided for its’ use are meant to guide health departments that are participating in or leading investigations

The U.S. Congress established the Organ Procurement and Transplantation Network (OPTN) when it enacted the National Organ Transplant Act (NOTA) of 1984. The act called for a unified transplant network to be operated by a private, non-profit organization under federal contract. The United Network for Organ Sharing (UNOS) administers the OPTN under contract with 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. A member directory can be located at: http://optn.transplant.hrsa.gov/members/search.asp.

All OPTN Members are subject to review and evaluation for compliance with OPTN policies; (OPTN policy 4.5 [PDF – 5 pages]) requires reporting of suspected donor derived disease transmission in a recipient or new information regarding a donor that indicates risk of disease transmission to recipients. Once notified, UNOS patient safety staff begins notifying transplant centers and requesting follow up on potentially impacted recipients. These reports are reviewed by UNOS’s Disease Transmission Advisory Committee (DTAC) to determine the likelihood of transplant transmission, educate the transplant community, and inform policy. To ensure inclusion of appropriate public health authorities, CDC and HRSA created a working agreement. UNOS staff notifies CDC for cases that involve disease clusters, unknown diseases, or nationally notifiable diseases. Once public health begins investigation, UNOS will cease requests for information and recipient follow up. The agreement also requests that the reporting transplant center or OPO notify local public health authorities. CDC works first to establish recipient safety and then to determine residency of all involved; relevant health departments are notified promptly should a donor or recipient be within their jurisdiction. At completion of the investigation, a summary is provided to UNOS so that DTAC can assign a case classification and highlight important aspects of the case for the transplant community.

Public health departments have also recognized potential transplant-transmitted diseases. If such an investigation is initiated, encouragement should be given to the relevant organization (transplant center or OPO) to report to UNOS. This ensures timely notification of other organ recipients, tissue banks, and eye banks.

CDC developed this generic Transplant-Transmitted Infections form [PDF – 57K] and instructions [PDF – 82K] to assist state and local public health departments in the investigation and tracking of potential transplant-transmitted cases of infection. The form provides a broadly applicable framework for transplant investigations; for example, it includes tables for tracking and recording information about organ donors, organ recipients, diagnostic test results, and pertinent investigation contacts.

The form can be modified to suit the needs of the user and the particulars of the case at hand, and it can be used in combination with other applicable/available forms. For example, selected tables on the generic form could be used to supplement a disease-specific module.

Well-coordinated investigations among public health agencies, organ procurement organizations, transplant centers, clinicians, and laboratorians are strongly encouraged. CDC can be consulted regarding all aspects of diagnosing, treating, and investigating cases.