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FBO DAILY ISSUE OF SEPTEMBER 24, 2009 FBO #2861
MODIFICATION

D -- Request for Information for National Transplantation Sentinel Network

Notice Date

9/22/2009
 

Notice Type

Modification/Amendment
 

NAICS

518210 — Data Processing, Hosting, and Related Services
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

2009-91509
 

Point of Contact

Maria S Shamburger, Phone: 770-488-2057
 

E-Mail Address

HEG9@cdc.gov
(HEG9@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

Request for Information National Transplantation Sentinel Network DESCRIPTION: This is a Request for Information (RFI). This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes. 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. For this Request for Information (RFI), 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. By submitting a response, the respondent agrees that the Government may copy the response information for purposes of facilitating review. Any and all respondents may be asked to further explain or clarify in writing areas of their response during the review process. All submitted information shall remain with the Government and will not be returned. BACKGROUND The goal of creating a national transplantation sentinel network is to improve allograft quality by reducing disease transmission, including infection and malignancy, from donors to recipients. 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 notification of institutions that recovered organs and tissues from that donor. Potential disease transmission cases are examined by the OPTN/UNOS Disease Transmission Advisory Committee, not under the Federal Advisory Committee Act (FACA), in an effort to evaluate the likelihood of transmission. 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. The ability to easily track tissue within a hospital is critical, particularly when tissues have been identified for recall. In past events, some healthcare facilities have been unable to locate all recalled tissues due to the lack of effective tracking systems within their institutions. The Joint Commission (JC), one of the three accrediting organizations recognized by Centers for Medicare and Medicaid (CMS), establishes operational guidelines and provides accreditation to hospitals and other healthcare facilities through surveys and inspections. In response to inefficiencies in tracking human tissue, hospitals were issued standards by JC in 2006 requiring maintenance of tissue tracking records upon receipt in the hospital through implantation. 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. 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. The cooperative agreement was awarded to UNOS which, along with other partners assembled through an Advisory Group, developed a Transplantation Transmission Sentinel Network (TTSN) prototype in response to the RFA. Development and field testing of the TTSN prototype was completed in 2008. INFORMATION REQUESTED To assist interested parties, this RFI describes specific areas in which information is being requested and solicits respondent experiences, plans or opinions, including viewpoints about the difficulty and or feasibility of the potential requirement, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. Respondents also are encouraged to address any critical issues that are not specifically mentioned below Additional information to guide responses is as follows: • Responses need not address every aspect of this RFI; responses may be limited to address specific components or portions of a section. • Respondents are encouraged to investigate current action of the ONC National Health IT and Health Information Technology Standards Panel (HITSP) Public Health Case Reporting Interoperability Specification. Suggested links are: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1204&parentname=CommunityPage&parentid=1&mode=2&in_hi_userid=10741&cached=true http://www.hitsp.org/InteroperabilitySet_Details.aspx?MasterIS=true&InteroperabilityId=364&PrefixAlpha=1&APrefix=IS&PrefixNumeric=11 • Respondents also are welcome to provide information regarding ideas on a TSN system that would be housed within the federal government, as an alternative approach to a platform operated by contracted organizations or others in the private sector. From this perspective, respondents could describe their supportive role of a government operated system, within the scope of the RFI, including any additional relevant information. • Solid organs of interest for this RFI include heart, lungs, liver, pancreas, intestines, and kidneys from deceased donors. Organs or organ segments where the primary source is from a living donor are currently not included, but could be considered for inclusion in the future. • Tissues of interest for this RFI include corneas, bone, skin, heart valves, tendons, ligaments and dura mater from deceased donors. Tissues where the primary source is a living donor, such as cellular and gene therapy products, reproductive tissue, and stem cells are currently not included, but could be considered for inclusion in the future. The specific sections requested for comments are as follows: I. Transition of TTSN Prototype to Full Production II. Standardization and Compatibility Issues III. Reporting Criteria IV. Interoperability and Interfacing with Existing Data Sources V. System Operation and Infrastructure Management VI. Analysis Plan including Feedback to Users VII. Patient Health Information Privacy and Security VIII. System Governance Further definition for each of these areas is provided below. Respondents may refer to the TTSN Pilot Functional Specifications Document http://www.cdc.gov/ncidod/dhqp/pdf/ttsn/TTSN_SpecificationsDocument.pdf and two Concept Documents http://www.cdc.gov/ncidod/dhqp/pdf/ttsn/TTSN_ConceptDocuments.pdf for background on work accomplished to date. The Functional Specifications Document comprises Parts A, B, and C of the TTSN prototype which outline the process and procedures for donor registration, graft implant registration and potential adverse event registration, respectively. TTSN Concept Document, Part D, describes potential applications of the system for data analysis and reporting, and Part E describes potential education and communication functions of the system. I. Transition of TTSN Prototype to Full Production Development and field testing of the TTSN prototype was completed in 2008. The current design of TTSN may be the best approach to move forward; however, new or modified designs would be considered. Respondents are asked to comment on the following: • Process to complete development and implementation of a national TSN (e.g., planning, developing, programming, testing, system evaluation, installation) based on transitioning the TTSN prototype to full production, modifying the design, or developing a new design • Schematics of data models for importing or entering data into a TSN system (prototype, modified design, or new design) and indicate data flow; how the model would function; and model benefits and challenges. • Consideration on how interconnectivity with other data collecting or reporting systems and alignment with the national health IT interoperability standards could be phased in to a basic model, such as regulatory and non-regulatory reporting requirements and public health case reporting interoperability standards • Proprietary relationship for use and ownership of developed software • General estimates on staffing, materials, financial, and other resources required to complete development and implementation of a national TSN system would be appreciated. II. Standardization and Compatibility Issues Systems and procedures for donor identification, labeling of allografts, and allograft tracking vary considerably between transplant institutions. When developing the TTSN prototype, the differences in systems and procedures created challenges for ensuring data integrity. Incorporation of bar coding software or other suitable technology into the process would likely reduce data entry errors. Additionally, coding and label-recognition software would facilitate donor confidentiality and ensure accurate and easy identification of allografts for tracking and implantation. The TTSN prototype made the assumption that all tissue institutions use the same format for labeling a graft. A second assumption was that the identification information (listed below) is printed on the allograft package by the tissue institution. Thus, when the hospital registers a tissue implant in TTSN, the "Graft ID" field is programmed to read 12 unique characters "xxx - xxxxx - xxxx" entered as "center code - unique donor ID - graft ID" creating a link between the graft and donor. Respondents are encouraged to provide information on the following issues and other challenges not presented. • Information regarding the feasibility of or alternatives to the above Graft ID and allograft labeling assumptions • Maturity of industry and commercial industry best practices related to using bar codes and/or radio frequency identification device tags to label, track and identify organs, tissues and ocular tissue • Cost estimates associated with purchase, installation, and use of bar coding software and/or radio frequency identification device tags • Models demonstrating how tracking systems could be phased into the TSN system Individual or aggregate donor and recipient information is communicated electronically among institutions and healthcare agencies locally, regionally, or globally. Broader sharing of data requires establishing standard data elements, descriptions and terminologies that are consistent to facilitate accurate reporting and compatibility between databases. For example, the European Union Standards and Training for the Inspection of Tissue Establishments (EUSTITE) uses a severity grading tool for classifying adverse reactions in tissue recipients and an imputability assessment tool to assess the causal relationship between the donor tissues/cells transplanted and the recipient adverse reaction. Respondents are asked to comment on the following: • Strategies addressing how to progress toward standardized terms and definitions for adverse events and any differences that might be acceptable or appropriate and the mapping of these to recognized standard terminologies • Any differences in data elements and definitions that currently exist between the TTSN prototype and other data systems that would affect accurate reporting or autopopulation of data fields, coupled with approaches to facilitate consistency or compatibility • Potential solutions for interoperability, compatibility, interconnectivity, and interface using recognized Health Information Technology (IT) standards with Electronic Health Records (EHR), Health Information Exchanges (HIE), National Health Information Network (NHIN) and other Health IT systems adopted by clinicians, health care facilities, public health systems, regulatory agencies, and government and private health plans III. Reporting Criteria The frequency in which tissue allografts may actually transmit infections with common organisms is unknown. Detection of recipient infections with the same organism and with tissue products from the same donor might be more easily recognized if high rates of post-implantation infections, versus only suspected transmissions, were collected. The TSN system would monitor these events and serve as the central analytical unit. In the absence of recognition criteria in the TSN prototype for graft-attributable infections, respondents are asked to comment on the following issues: • Request that hospitals or surgeons register all tissue post-implantation infections in TSN until more empirical information is available to develop clinical criteria, OR • Availability of published or draft criteria that might be employed to register post-implantation infections • Systems used by large healthcare organizations and related laboratories to capture automated clinical data on tissue transplantation and associated adverse events, (i.e., type of procedure, any infection following surgery, type of organism, interval after surgery) as a point of comparison for analysis IV. Interoperability and Interfacing with Existing Data Sources Electronic reporting systems are currently in place for organ, tissue and eye recovery institutions, such as MedWatch, OARS and UNet. In addition, CDC is piloting a transfusion adverse event surveillance system which has potential for expansion to other biologics, including organs and tissues, as a hemovigilance module through the National Healthcare Safety Network's biovigilance component. Many recovery, processing and distribution institutions have in-house data systems for collecting donor information and tracking allografts. The TTSN prototype was designed for manual data entry only. Benefits to interfacing with other data sources include a reduction in data entry redundancy and an increase in data integrity and timeliness. Challenges include maintaining a secure system, heterogeneity of data elements between databases, and variability among software platforms. Respondents are asked to provide information on the following issues: • Additional challenges in interfacing existing data sources with a national TSN system, if any • Systems used by recovery, processing, and distributing institutions for monitoring and tracking of donors and allografts • Systems used by hospitals for tracking tissue allografts, the department(s) that house the system, and procedures for who enters allograft implant information into the system • Systems used by hospitals to track, prior to transplantation, stored vessels recovered with organs • The potential to interface with other national donor and recipient surveillance systems to enhance safety of exported organs and tissue allografts, addressing legal, technical and logistical issues, and other critical considerations • Information on resources required to facilitate and maintain system to system connectivity would be appreciated. V. System Operation and Infrastructure Management This section addresses the ramp-up and daily management phases of a TSN once the system is approved for implementation. Respondents are encouraged to comment on the various aspects of managing a TSN and other management issues not mentioned below: • Strategies to engage stakeholders (e.g., recovery, processing and distributing institutions hospital administration; transplant surgeons) to participate in a TSN; methods to assess stakeholder awareness about the TSN system; and challenges (e.g., reporting burden) to participation and how they might be resolved • Process for training and educating system users, evaluating and revising instructions and materials, measuring user understanding and operation of a TSN system; and how training efforts might change after ramp-up phase. Consideration might be given to how user groups could be phased-in to the system to enhance donor/recipient linkage. • Process for providing system user ongoing support, including documenting, reporting and responding to feedback • Process for quality assurance such as auditing for data errors (e.g., duplicate donor or recipient entries), updating data and monitoring for quality improvement • Access issues such as auditing and updating user accounts; ease of user access (i.e., single user reporting portal); and maintaining access • Process for ongoing system upgrades and installing system security updates, as needed • Plan for system back-up and recovery, and prevention of downtime • Process for monitoring reported adverse events • Server requirements for a national TSN data repository • General estimates on staffing, materials, funding and other resources required for marketing and training efforts and for a TSN system operation and infrastructure management would be appreciated. VI. Analysis Plan including Feedback to Users The TSN system also will provide aggregate and anonymized data to TSN participants about potential adverse events. Additionally, TSN participants will have access to all reports and data specific to their institution. Respondents should refer to the Concept Plan for TTSN Part D as the basis for suggestions on the following issues and other relevant issues on data analysis and feedback not addressed here: • How individual aggregate data can be utilized by participants and public health partners using a confidential, non-punitive approach. • The denominators (actual or best estimate) of the potential users of the TSN system (e.g., number of recovery, distribution and implanting institutions) and annual number of organ, tissue and cornea/sclera donors and recipients • Data elements, if any, currently not in the TTSN prototype which would derive useful metrics or improve data quality • Process for providing constructive feedback and improving patient safety in response to ongoing analysis of data • Procedures for ongoing evaluation of validity and usefulness of data elements and system improvements • Providing identifiable data to public health authorities, as needed • General estimates of staffing, funding and other resources required for analyzing and reporting data, website maintenance, analyzing data quality, etc. would be appreciated. VII. Patient Health Information Privacy and Security The TTSN Functional Specifications Document <http://www.cdc.gov/ncidod/dhqp/pdf/ttsn/TTSN_SpecificationsDocument.pdf and two Concept Documents http://www.cdc.gov/ncidod/dhqp/pdf/ttsn/TTSN_ConceptDocuments.pdf identify a number of procedures and requirements for the TTSN prototype to protect patient health information and secure the TTSN system. Technological, policy and procedural safeguards are a high priority as the system evolves. Respondents should comment on the privacy and security issues germane to the TTSN prototype, or other health information network systems similar in structural design or purpose to a TSN system, including the following issues: • Existing entities, resources or documents that provide a sound method or structure to guide privacy and security policy development for health information networks • Regulations and requirements that govern public health information privacy and security issues in the context of health information networks for a national TSN system and that consider such issues as system access and data collection, sharing and use • Network safeguards and how they might be applied to further enhance system security of the TTSN prototype, including interfacing with existing data sources • General estimates of staffing, materials, financial and other resources required to construct and maintain system security would be appreciated. VIII. System Governance Governance of a TSN would take into account the relevant legal, health information privacy, system security, communications, operations and other issues when developing, implementing and providing oversight of policies and standards. Respondents are asked to provide a framework for a governance body appropriate for a national TSN, including, but not limited to: • Structure, composition and responsibilities • Process for developing and adopting policies and standards • Process for implementing policies and standards • Process for oversight of operations • Relationship between contract administrator, governance body and contractor INQUIRIES Potential respondents who have questions regarding this RFI may email them to Nancy Norton at Nnorton@cdc.gov. Respondents may only make inquires and request clarification concerning the RFI by submission of written questions via email. Include "National Transplantation Sentinel Network - Request for Information" in the subject line. Parties which may 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 potential TSN system. SUBMISSION OF RESPONSES All information submitted to CDC will be kept confidential as allowed by relevant federal law, including the Freedom of Information Act (5 USC 552) and the Trade Secrets Act (18 USC 1905). Responses should be provided in electronic (preferred) or hard copy format. Electronic responses should be submitted in Adobe PDF or Microsoft Word format. All responses should be on 8 x 11 inch paper in size-12 font with one-inch margins and single spaced. Pages should be consecutively numbered. The cover page should state "National Transplantation Sentinel Network, Response to Request for Information" and include the firm or entity submitting the response, and the name, title, address, telephone and fax number, and email address of at least one point of contact. Responses should be preceded by the TSN RFI section title and bulleted issue within that section, if appropriate and feasible. Responses should be sent to the attention of: Contracting Officer Nancy Norton, Address: 2920 Brandywine Road, Mailstop K-14, Atlanta, GA, 30341, Telephone Number: 770.488.2056, Email Address: Nnorton@cdc.gov. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Supporting estimated costs provided by respondents are encouraged, where appropriate. Any estimated cost information provided will be informational only and used to help formulate and refine the Government cost estimate for these requirements. If an estimated cost is submitted, the respondent shall state that is an estimation or approximation. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY Vendors are encouraged to avoid the inclusion of proprietary, classified, confidential, or sensitive information in your response. However, any information that the vendor considers proprietary should be clearly marked as proprietary and will be protected by the Government as allowed by relevant federal law, including the Freedom of Information Act (5 USC 552) and the Trade Secrets Act (18 USC 1905). The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2009-91509/listing.html)
 

Place of Performance

Address: 2920 Brandywine Road, Atlanta, Georgia, 30341, United States

Zip Code: 30341
 

Record

SN01966041-W 20090924/090923002720-5057e8cb55719f4b856d79f5add46c9a (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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