The Centers for Disease Control and Prevention (CDC) wants to develop a national "sentinel" network to help detect and prevent HIV, hepatitis C virus and other diseases from being transmitted through the millions of organ and tissue transplants conducted each year.
CDC already developed and tested last December a basic prototype of the Transplantation Safety Network (TSN) to identify and track the source and distribution of organs and tissues and their potential risks for infections, according to a request for information published in the Sept. 21 Federal Register.
But the agency still needs to develop management of the network's technology infrastructure, its health information security and privacy requirement, system governance and standards for sharing data, according to the notice.
CDC also wants TSN to use data standards now being promoted by the Health and Human Service Department that would enable public health reports and alerts to be shared through electronic health records.
Each year, patients receive more than 28,000 solid organ and 2 million tissue transplants, but infections from donors are also a source of disease and death, CDC said.
The Food and Drug Administration has oversight over activities related to tissue manufacture and distribution. Another agency, the Health Resources and Services Administration, oversees organ transplant activities.
"However, healthcare providers are not required to report adverse events," according to the notice.
While the TSN needs to "avoid duplication" with these existing networks, "interfacing with these existing systems is critical," it said.
The TSN should provide a method for standardizing organ and tissue identifiers, tracking receipt of organs and tissues, sending out rapid notification of the transmission of potential disease and integrating it into a national bio-vigilance network.
All organizations involved in transplantation should be able to communicate when a possible disease transmission is identified, CDC said. "It could potentially result in fewer transmission events, incidents of disease and death," the notice said.
The Office of the National Coordinator for Health IT is making recommendations for incorporating public reporting criteria into certified electronic health records, which could help to identify and report potential public health cases and adverse events.
"Integrating these requirements into a national TSN system is vital to the long term viability of the program," the notice said.
The RFI is attributed to Tanja Popovic, CDC's chief science officer. Comments are due Dec. 11.
The Federal Register notice is online.
