Sunday, September 20, 2009

CDC Issues RFI

CDC issued a Request for Information (RFI) on September 15th to obtain information to use for project planning purposes to develop, operate, and manage a national Transplantation Sentinel Network (TSN). The goal for the network is to improve allograft quality by reducing disease transmission, including infection and malignancy from donors to recipients.

Each year in the U.S., 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.

The ability to easily track tissue within a hospital is critical particularly when tissues have been identified for recall. In the past, some healthcare facilities have been unable to locate all recalled tissues due to the lack of effective tracking systems within their institutions.

A national TSN will need to avoid duplication of the Organ Procurement and Transplantation Network and the FDA reporting mechanisms but at the same time, interfacing with these existing systems is critical and needs to be coordinated by CDC in collaboration with other agencies within HHS.

The TSN needs to be able to provide the mechanism for standardizing allograft identifiers, be able to track organ and tissue receipt, notify and respond to potential disease transmissions, and integrate sentinel events into a national biovigilance network. All implanting institutions must be able to rapidly communicate when a possible disease transmission is identified.

CDC is interested in hearing from organ procurement organizations, eye banks, tissue banks, transplant centers, healthcare providers, patients, software developers, IT specialists, consulting firms, trade association, “think tanks”, as well as institutions that may be interested in housing and operating a potential TSN system.

The response date for the RFI 2009-91509 is December 11, 2009. For further information, go to or email Maria Shamburger at