The FDA intends to issue a Request for Quotations (RFQ) for Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. Scope of Work: Provide continuous data resources on Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data. A single Contractor will furnish the required personnel, materials, services, databases, facilities to provide qualified support for: 1. Continuous access to data resources on inpatient and Emergency Department (ED) drug product usage in adult and pediatric patients throughout the length of the contract; these data shall meet the need of the FDA to access discharge-level and/or patient-level data describing adult and pediatric inpatient, and ED drug use in short-stay hospitals (average length of stay is 60 days or less). 2. FDA personnel with the ability to use these data to describe national patterns of drug utilization in the adult and pediatric inpatient settings, and emergency department settings through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel. 3. Access to information relating to the hospitalization episode and ED visits, for example operating room and radiology procedures, and drug data (anesthetics, contrast agents, etc.), microbiology data (cultures, sensitivities, antigen testing, etc.), information on admitting diagnosis, drugs at admission, and drugs at discharge. 4. Drug-related information, for all administered drugs: date of administration, treatment dose, and treatment duration. 5. Direct, unlimited Internet or network-based access via an interface tool to the entire data resource for adult and pediatric inpatient data and emergency department data in a multi-user environment and in real time. 6. Full disclosure of data collection, construction, coding and configuration to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology. 7. A complete data dictionary in an electronic format. An updated dictionary shall be provided within 30 days of changes which affect the data elements contained within tools or data streams accessed by the FDA. 8. FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies. 9. Ad-hoc technical support programming hours for additional data extraction services not readily available through the data tool in a timely manner. 10. Annual reports that will include: a. Size and characteristics of the population of hospitals from which the data are derived. b. Number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures. c. Description of the data acquisition status for all data streams for the adult and pediatric inpatient and ED drug utilization data resource. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, methods for coding data, percentage of missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates. 11. Two on-site training sessions per option year offered at FDA facilities (Silver Spring, MD). Training of FDA staff maybe required for any enhancements or upgrades to the data resource. Written documentation related to using the data shall be required. Training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users) shall also be required. 12. Options for additional "on-demand" sessions either in person or via live meeting/web-based methods shall be provided. The training shall be initiated within 30 days of award and continues throughout the duration of contract. 13. Ongoing technical, analytical, and clinical support shall be required throughout the length of the contract. Ongoing technical, analytical, and clinical support by phone or by e-mail shall be required for all certified users of the data during business hours (9:00-5:00) throughout the length of the contract in accordance with the service levels established in the contract. 14. On-site annual meetings for the purposes of discussing contract performance, product enhancements, annual updates (data characteristics, data elements) to the data source and FDA satisfaction with all deliverables 15. Monthly usage reports detailing use of the resource by individual FDA users and type of use. The anticipated award type is an IDIQ (Indefinite Delivery Indefinite Quantity) with firm fixed price task orders for a base year and four option years. This contract will be awarded on best value basis. The designated North American Industry Classification System (NAICS) code is 518210-Data Processing, Hosting and Related Services. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal contract. The website is http://www.ccr.gov. This announcement is not a RFQ. Interested parties shall submit an email to request the solicitation at
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