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``CORRECTED Version of Request for Information Regarding Development and Operation of a Transplantation Sentinel Network''

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Information about this document as published in the Federal Register.

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AGENCY:

Office of Blood, Organ and Other Tissue Safety, Division of Healthcare Quality Promotion, Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention, Department of Health and Human Services.

ACTION:

Request for information notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) is seeking information on development and operation of a national transplantation sentinel network (TSN) for the United States, including resources needed for management of such a system. The purpose of the network is to detect and prevent disease transmission from organ and tissue allografts recovered for transplantation.

In June 2005, the CDC announced a Request for Application (RFA) through a cooperative agreement for development of a TSN for organizations that recover, process, distribute, and implant organs and tissues. The overall goal of the system was to improve patient safety for organ and tissue recipients. The RFA objectives were to: (1) Identify and track organs and tissues to facilitate intervention following recognition of infections among recipients or donors; (2) improve communication among those in the transplant community, healthcare facilities and public health agencies concerning potential risks for transmission of infections; and (3) improve pathologic and microbiologic capabilities on cadaveric donor specimen samples through shared resources. Development and field testing of the prototype was completed in 2008.

For this RFI, respondents are asked to describe experiences, plans or opinions regarding aspects of completing and operating a TSN system; system governance, security, and marketing; user training; and operational and infrastructure management. Responses need not address every aspect of this RFI; responses may be limited to address specific components or portions of a section. The specific sections requested for comments are: (1) Transition of Transplantation Transmission Sentinel Network (TTSN) Prototype to Full Production; (2) Standardization and Compatibility Issues; (3) Reporting Criteria; (4) Interoperability and Interfacing with Existing Data Sources; (5) System Operation and Infrastructure Management; (6) Analysis Plan including Feedback to Users; (7) Patient Health Information Privacy and Security; and (8) System Governance.

DATES:

Comments must be submitted on or before December 11, 2009.

ADDRESSES:

The entire TSN RFI can be accessed at http://www.cdc.gov/​ncidod/​dhqp/​pdf/​ttsn/​RFI_​TSN_​FedRegDoc_​9909.pdf. Electronic responses are preferred and should be sent to TransplantRFI@cdc.gov. Responses sent in hard copy format must be securely bound and sent to Debbie Seem, Office of Blood, Organ and Other Tissue Safety, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Building 16, MS-A07, 1600 Clifton Road, NE., Atlanta, GA 30329-4018, Telephone number: 404-639-3234, E-mail Address: gqi4@cdc.gov.

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SUPPLEMENTARY INFORMATION:

Each year in the United States, 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.

Infectious 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 Start Printed Page 49882notification 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 meningosepticum. 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, regulates articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient 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 of 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 and 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.

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Tanja Popovic,

Chief Science Officer, Centers for Disease Control and Prevention.

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[FR Doc. E9-23427 Filed 9-28-09; 8:45 am]

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