Evaluation of Potential Data Sources for a National Network of Orthopedic Device Implant Registries

The FDA is issuing this Request for Quotations (RFQ) to identify, describe, and evaluate potential U.S. orthopedic implant registries that could participate to create a national network of such registries for the FDA in support of the Sentinel Initiative. The implants of interest would include, but are not limited to, total hip, total knee, hip resurfacing, intervertebral disk implants, and ankle devices Consistent with FDA's mission to protect and promote the public health, the Agency is embarking on the Sentinel Initiative to create a national, electronic distributed network, strengthening FDA's ability to monitor the post-market performance of a product. As currently envisioned, the Sentinel Initiative will enable FDA to capitalize on the capabilities of multiple, existing data systems (e.g. electronic registries, electronic health record systems, Medicare data, other medical claims databases) to augment the Agency's current surveillance capabilities. The System will enable queries of distributed data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Operations will adhere to strict privacy and security safeguards. The success of this Initiative will depend largely on the content, quality, searchability, and responsiveness of participating data sources and/or data environments. It is essential that FDA understand the strengths and limitations of potential data sources that might be included in the Sentinel Initiative. The Sentinel Initiative is intended to be created through a public-private partnership involving a broad spectrum of stakeholders, including government agencies, data holders, academia, patients, consumers, and healthcare professionals. The work requires the identification, description, and evaluation of potential U.S. orthopedic implant registries that could participate to create a national network of such registries as part of the Sentinel Initiative. The implants of interest would include, but are not limited to, total hip, total knee, hip resurfacing, intervertebral disk implants, and ankle devices. This work will require a thorough analysis of each registry's: (1) scope, content, structure, quality, and timeliness of data; (2) patient population(s), duration of follow-up and capture of care across all settings; (3) plans for further registry enhancements; (4) availability, experience and interest of investigators with knowledge of the data in using it for surveillance of post-market product performance; (5) availability, experience and interest of investigators with knowledge of the data in participating in a distributed data network; (6) potential privacy and security concerns related to the use of electronic health data; (7) view of working with professional societies in creating a distributed network; and (8) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising data sources and/or environments as the Sentinel Initiative moves forward. It should also include a value proposition and engagement strategy for registry owners and professional societies. The Period of Performance is Six Months from date of award. The award type will be Firm-Fixed-Price (FFP). There is no Set-Aside Designation. Competition is - Full and Open. The Procurement Procedures are those proscribed by FAR Part 13 for Simplified Acquisition Procedures. And, the anticipated Basis of Award will be - Best Value. The primary location of performance will be at the contractor's preferred location; however, the contractor will be required to travel to the Washington, DC/Maryland geographical area. The designated North American Industry Classification System (NAICS) code is: 541690 - Other Scientific and Technical Consulting Services. This industry comprises establishments primarily engaged in providing advice and assistance to businesses and other organizations on scientific and technical issues (except environmental). The Small Business Size Standard is $6.5 Million. This announcement is an active RFQ. The quotation due date is September 2, 2008, at 10:00 AM, ET. The anticipated award date is on or around September 18, 2008.