SPECIAL NOTICE
B -- Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data
- Notice Date
- 5/14/2010
- Notice Type
- Special Notice
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- HHS-FDA-RFI-1071143
- Archive Date
- 6/5/2010
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description: Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. This is an RFI NOTICE to determine the availability and capability of small businesses (i.e. certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) for Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. No telephone inquiries will be accepted. FDA may consider soliciting services for a five year contract. Draft 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. The objectives of the Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data program is to obtain the services of a single Contractor that 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. We may anticipate a firm fixed price IDIQ type contract for five years. Viable parties shall provide the following: Part A. Capabilities and Technical Experience - Provide a capability statement describing how your company would provide Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data as provided in the Draft Scope of Work. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm's status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. Part D. Cost Estimate- In accordance with FAR Part 10 Market Research Information; provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours for the Access to Inpatient and Emergency Department Adult and Pediatric Drug Utilization Data. Part E. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation on Subcontracting. Responses shall be:  RFI Sought number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-RFI-1071143/listing.html)
- Record
- SN02150477-W 20100516/100514235415-0ffc4c7728978cac6026e3513e4bfc95 (fbodaily.com)
- Source
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