Denominator Data

Subject: Denominator Data. Solicitation Number: FDA1060796 Response Date: 21 August 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 541910 for full and open competition. The FDA intends to issue a firm fixed-price purchase order for the following data and service: Medical Device Exposure Dataset Identification and Evaluation Background: FDA routinely obtains reports of adverse events occurring throughout the life-cycle of medical devices. These reports come from the sponsor in the IDE prior to device marketing. Upon clearance/approval of the device, reports may come from a post-approval study (PAS) or through medical device reports (MDRs). As opposed to the well documented exposure information in the IDE study, post-marketing exposure to medical devices is difficult to ascertain. It is often limited to information from passive surveillance or from single-institution case series analysis. Knowing the number of individuals exposed to a medical device is key to many of FDA's post-marketing efforts to determine whether public safety is maintained throughout the device life-cycle. Use of exposure data would allow FDA to know the proportion of device users reporting adverse events via MDRs. It would also allow FDA to determine whether post approval studies have difficulty recruiting due to slow device uptake. In the event of potential safety signals for a medical device, exposure data would allow FDA to determine the number of people potentially affected by the adverse event as well as whether adequate substitutes for a medical device are present in the marketplace in the event of a recall. Representative, nationwide data for medical device utilization at the manufacturer and device-specific levels would offer the opportunity to derive more accurate rates of outcomes. To address this need for better information, FDA is asking for identification and evaluation of potential data sources for exposure to medical devices in the United States. For this initial assessment, data focused in on of three areas is requested. The areas of specific interest are gastroenterology/urology/renal, infection control/dental/general hospital/infusion pumps, or neurology/anesthesia/respiratory. Objectives: By the end of this evaluation of potential data sources, our objective is to identify the most appropriate medical device exposure dataset(s) available for purchase by or collaboration with FDA to assist with ongoing post-market device safety evaluation. Scope of Work: The scope of work of this project is the identification, description, and evaluation of potential U.S. data measuring exposure to commercial medical devices. Data evaluated in this project should be representative of the population exposed to the devices or able to be extrapolated to represent use in the U.S. population. This project shall require a thorough analysis of each set of identified data: (1) scope, content, structure, quality, and timeliness of data; (2) method of data collection and extrapolation to US population; (3) patient population(s), duration of follow-up (if any) and capture of care across all settings; (4) plans for further enhancements; (5) availability, experience and interest of data compilers or investigators with knowledge of the data in using it for surveillance of post-market product performance; (6) potential privacy and security concerns related to the use of data, including HIPAA and potential proprietary nature of data; (7) cost of data and updates; and (8) potential barriers that exist to government use of data. Medical Devices covered in this project shall include all of the products listed under at least one of the three headings below: Gastroenterology, Urology, and Renal Blood tubing sets for dialysis Hemodialysis catheters Home Dialysis machines Biliary catheters (stents) Intragastric implant for morbid obesity Injectable bulking agent for GU use Hyperthermia system, RF/Microwave, for BPH Mechanical/hydraulic impotence device (aka inflatable penile implants) Extracorporeal shock wave lithotripter Implanted electrical stimulator for incontinence Infection Control, Dental, General Hospital, and Infusion Pumps Infusion pumps Set, administration, intrasacular Hemodialysis Catheters Syringe, Piston Heparin, vascular access flush Disinfectant, medical devices Implant, Endosseous Bone grafting material with biologic Drill, bone, powered Alloy, Amalgam Neurology, Anesthesia, and Respiratory Ventilator Humidifier, Respiratory, Gas Tube, Tracheostomy Stimulator, Autonomic Nerve for Epilepsy, Parkinsons, or Depression Stimulator, spinal cord, pain relief Shunt, CNS Device, neurovascular embolization Stent, intracranial, neurovascular Device Monitoring, intracranial pressure Motor, Drill, pneumatic Dataset analyses shall lead to specific recommendations for further involvement of the most promising data sources and/or environments for purchase or collaboration. Detailed Requirements: 1. Identify, in consultation with FDA, potential data that could best describe medical device usage in the U.S. For each dataset, describe the primary purpose; the type of data (i.e., marketing research, registry, survey, etc.); the estimated proportion of device users captured; any follow-up or linked relevant electronic health care data source (e.g., claims data, medical records, radiology reports, etc.), if applicable; and cost of obtaining data. 2. For each dataset, describe: (a) Specificity of information to identify medical devices, including newly marketed products. Does the dataset include information by manufacturer, by device type, or by model number; (b) Size of population, degree of capture across geographic region, gender, age, and any other specified demographic factors; (e) Structure and coding, including consistency with widely recognized standards; (f) Completeness, timeliness, and accessibility of data, including frequency of data updates; (h) Potential limitations if used for estimating product uptake (i.e. using numbers as denominator counts for adverse events); (b) Information on surgical procedures including, but not limited to, indication for use of device, procedure volume, and technique; (c) Information regarding method of data collection and extrapolation to U.S. population. 3. For each dataset, describe prior and current uses of data, including (but not limited to): market research and forecasting, post-market safety surveillance, administrative purposes, quality assessment/improvement and/or benchmarking, academic/industry research. This shall include (but not be limited to): (a) Representative examples of presentations and/or publications that have been developed using these data; (b) Description of plans for future data source enhancement, if any; (c) Letters of support and curriculum vitae from internal and external users/researchers that describe both their experience and knowledge in working with the data and the strengths and potential limitations of working with data source and/or environment, as well as each reference's current and prior relationships (financial or otherwise) with this and other potential data sources. 4. For each dataset, research and analyze existing or proposed policies, rules, regulations, and other requirements related to the protection of privacy and safeguards related to HIPAA and potential proprietary nature of dataset. 5. Provide specific recommendations for next steps to engage the holders of the most promising datasets, including identification of potential liabilities. Reporting Requirements and Schedule: 1. Submit bimonthly progress reports addressing the detailed requirements, culminating in a final report to be submitted within 6 months of the date the contract is awarded. Draft final reports should be provided to the Agency for review and comment within 10 months of the date the award. All Agency comments shall be addressed in the final report. Multiple specific requirements may be combined in one or more reports, pending agreement of FDA and the awardee within 2 months of the award. 2. Schedule monthly progress meetings throughout this 12-month period with the Division of Epidemiology in the Office of Surveillance and Biometrics to report on progress to date, ability to meet stated deadlines, and any problems encountered. Refinements of requirements will be discussed and agreed upon, as necessary. Period of Performance: The base period of performance is September 1, 2009 to August 31, 2010, with the potential for an option year (September 1, 2010 to August 31, 2011) to expand into other device areas, subject to availability of funds. QUESTIONS DEADLINE: all questions must be received by email (contact@example.gov) before 4:30 pm (1630) EST on 27 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance, and 3) Price. Technical Capability and Past Performance when combined is significantly more important than price. Evaluation of Technical Capability shall be based on the information provided in the quotation. Quoters shall include their understanding of the requirement and any past performance that can support your quote or other literature which CLEARLY DOCUMENTS that the offered service meets or exceeds the specifications stated herein. This announcement constitutes the only solicitation and a written solicitation will not be issued for the development of information management processes as defined herein. The Government intends to award a firm fixed price purchase order under Simplified Acquisition Procedures. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541910; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 21 August 2009 to the attention of David Kordel, contact@example.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.