[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48088-48089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22658]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Request for Information Regarding Development and Operation of a
Transplantation Sentinel Network
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.
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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://wwwdev.cdc.gov/ncidod/dhqp/pdf/ttsn/RFI_TSN_FedRegDoc_9909.pdf. Electronic
responses are preferred and should be sent to [email protected].
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:
[email protected].
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.
[[Page 48089]]
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 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.
Dated: September 14, 2009.
Tanja Popovic,
Chief Science Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-22658 Filed 9-18-09; 8:45 am]
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