CDC to develop network to detect, prevent diseases transmitted by deceased organ, tissue donors.

As the number of organs and tissues transplanted in the US have grown steadily over the last 20 years, so have the number of new life threatening infectious diseases and malignancies transmitted by the life saving, life enhancing transplants. Today, there are more than a dozen viruses, bacteria and parasites which are resulting morbidity and mortality in the 28,000 organ and 2 million tissue recipients transplanted annually.

With this backdrop, the US Centers for Disease Control and Prevention (CDC) has announced plans to develop and operate a Transplantation Sentinel Network (TSN) with a charge to detect and prevent diseases transmitted by organ and tissues into transplant recipients.

The CDC is seeking input from the transplant community on this ambitious undertaking. A notice in the September 29 Federal Register provided a complete overview of the agency's plans for developing a TSN and a request for the organ and tissue transplant community to comment on the Request for Information (RFI) by December 11, 2009.

The purpose of the network is to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation from deceased donors. Respondents are asked to describe experiences, plans or opinions regarding aspects of designing, building, testing and operating a TSN; system governance, security, and marketing; user training; and operational and infrastructure management. Content areas include:

*Transition of TSN Prototype to Full Production; *Standardization and Compability Issues; *Reporting Criteria; *Interoperability and Interfacing with Existing Data Sources; *System Operation and Infrastructure Management; *Analysis Plan including Feedback to Users; *Patient Health Information Privacy and Security; and *System Governance.

Respondents are also encouraged to address any critical, relevant issues that are not specifically mentioned in the TSN RFI.

CDC notes parties that have an interest in responding include organ procurement organizations, eye banks, tissue banks, transplant centers, healthcare providers, patients, software developers, IT specialists, consulting firms, trade associations, "think tanks", as well as institutions that may be interested in housing and operating a TSN system.

The US Centers for Disease Control and Prevention's (CDC) Office of Blood, Organ and Other Tissue Safety is seeking input from the organ and tissue procurement and transplantation community on the agency's plan to develop a Transplantation Sentinel Network with a mandate to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation. Supplementary Information:

"Each year in the US, more than 28,000 solid organs and 2 million tissues are transplanted, including heart, lung, liver, kidneys, pancreas, intestine, bone, skin, heart valves, tendons, fascia and corneas. Donor-derived infections have been identified as a source of morbidity and mortality among both solid organ and tissue transplant recipients.

Infections transmission identified in the past few years among solid organs have reflected a broad array of viruses, bacteria, and parasites, resulting in a high proportion of mortality amongst infected recipients; examples include HIV, hepatitis C virus (HCV), lymphocytic choriomeningitis virus, Mycobacterium tuberculosis, Pseudomonas aeruginosa, Strongyloides spp, and Trypanosoma cruzi, the etiologic agent of Chagas Disease.

Malignancies also have been transmitted by solid organs. The Health Resources and Services Administration (HRSA) oversees the transplantation of solid organs through the Organ Procurement and Transplantation Network (OPTN) administered by the United Network for Organ Sharing (UNOS). OPTN policy requires reporting of all potential donor-derived infections to UNOS and notification of institutions that recovered organs and tissues from that donor.

For tissues, disease transmission reports are less frequent but include transmission of HCV, Group A streptococcus, Clostridium spp, and Chryseobacterium. Unlike solid organs, risk of disease transmission depends on multiple factors related to the graft, including the feasibility and effectiveness of processing , which may vary according to tissue type and specific processing or manipulation procedures.

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), regulates articles containing or consisting of human cells or tissues intended for transplantation, infusion, or transfer into a human recipient such as human cells, tissues, or cellular or tissue-based products (HCT/Ps). HCT/P establishments are required to report to FDA all serious infections following graft transplantation. However, healthcare providers are not required to report adverse events, and healthcare facilities that do not perform any steps in tissue manufacture (recovery, processing, storage, labeling, packaging, distribution, or donor screening or testing) are not subject to any FDA regulation for HCT/Ps.

Because organs and tissues can come from the same donor, a TSN should provide the mechanism for standardizing allograft identifiers, tracking organ and tissue receipt, rapid notification of and response to potential disease transmissions, benchmarking of sentinel events and integration into a national biovigilance network. Specifically utilizing these system characteristics, all relevant recovery, processing, distributing and implanting institutions could rapidly communicate when a possible disease transmission is identified. This may prevent any further use of allografts with transmissible diseases in additional recipients after a problem is recognized and allow for earlier initiation of treatment or prophylaxis of recipients, potentially resulting in reduction of transmission events or resulting morbidity or mortality.

A national TSN needs to avoid duplication of the OPTN or of FDA reporting mechanisms; however, interfacing with these existing systems is critical. A national TSN could be coordinated by CDC in collaboration with other agencies of the Department of Health and Human Services (HHS) and external partners. In addition, HHS has recognized health information technology (IT) data and exchange standards to promote the exchange of health information across the healthcare landscape.

The National Health IT activities initiated by the HHS Office of the National Coordinator for Health IT (ONC) has examined incorporating reporting criteria into Electronic Health Records (EHRs) which could assist in the possible identification and reporting of public health cases and adverse events. Reporting criteria which are incorporated and utilized by EHRs may include: general and specific reporting considerations, as well as the identification of data and events that may trigger a report, additional questions that may need to be asked of reporters, and the identification of specific data that may need to be reported. Integrating these requirements into a national TSN system is vital to the long term viability of the program.

Dated: September 13, 2009 Tanja Popovic, Chief Science Officer, Centers for Disease Control and Prevention.