SOURCES SOUGHT
R -- Access to Data on Prescribing Practices of Health Care Practitioners
- Notice Date
- 10/26/2005
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-1009829
- Response Due
- 11/10/2005
- Archive Date
- 11/25/2005
- Description
- This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. This is not a request for a formal proposal. The anticipated NAICS Code for this acquisition is 541990 with a size standard of $6M. This synopsis seeks to identify contractors that can provide access to data on health care practitioner prescribing practices including, but not limited to, patient demographics and indications for treatment in the outpatient setting. FDA requires access to such data to obtain national estimates or counts. The overall data characteristics provided shall include: the number of health care practitioners (e.g., physicians, physician?s assistants, nurse practitioners, dentists), visits, and patients; characterization of individual health care practitioners in terms of number, specialty, practice setting, age, gender, geographic region and U.S. Census region. Additionally, potential offerors shall provide a characterization of the practice setting of health care practitioners in terms of type of facility (e.g., surgi-centers, staff model HMOs, clinics), geographic region and U.S. Census region (desired, but not required). Where possible, potential offerors shall provide a comparison to national figures. The data resource shall be accessible via a secure Internet or network-based method. Potential offerors shall provide the following: a method of access for examining visit-level prescribing data for products linked to clinical or medical data on indication shall be specified in detail; a method of access for examining data on visits for specified diseases or medical conditions, and associated treatments, if any; the ability to capture all drugs prescribed to treat the same diagnosis as well as all drugs mentioned during the visit regardless of diagnosis; interface documentation (e.g., white paper, training manual) the ability to receive e-mail confirmation when reports are complete, if applicable; a method and frequency for updating interface; a method of simultaneous, multi-user access; a past history of scheduled and unscheduled downtime of data; and the number and nature of limits to access, including numbers of users, numbers and types of data elements. Technical Requirements and Capabilities A. The patient-level and/or visit-level data shall be a currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access with the capability of providing characterization of health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting. B. The data shall be a currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access with the capability of providing both current and historical national-level prescribing practice information. C. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to software and data. D. Access shall be via secure Internet or network-based methods and shall be in a multi-user environment. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. FDA shall not support modem-based or dial-up access. Additionally, FDA shall not support or maintain potential offerors?s equipment or personnel on premises. E. Potential offerors shall provide documentation addressing the stability of their business contracts or agreements with their data suppliers over the course of this proposed contract with the FDA. F. In the event of changes to the potential offerors? business contracts or agreements with their data suppliers, FDA shall be notified within 5 business days of the potential offerors becoming aware of such changes, detailing the impact of these changes on data quality, data quantity, and overall data characteristics. G. Access shall be through an interface and this interface shall be user-friendly, transparent and flexible enough to meet the FDA?s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports. H. FDA requires the ability to make national estimates of visit-based and/or patient-based outpatient health care practitioner prescribing practices using a mutually agreed upon projection or other appropriate methodologies, which shall be valid, reliable, and robust with regard to prescribing practices specifically, and the methods fully disclosed. If such methodology has not been developed, a commitment in the form of a detailed development plan, strategic outline and timeline to collaborate with FDA investigators to develop and implement a mutually acceptable method for making national estimates within 6 months shall be provided as part of the written technical proposal. I. Full disclosure of data collection and projection methodology and a complete, up-to-date data dictionary shall be required as part of the technical proposal to allow FDA staff to appropriately evaluate and interpret the data and its source. All proprietary information provided as part of the technical proposal shall be kept confidential. J. The FDA shall have the ability to archive and analyze historical data in a timely manner. K. The FDA shall have the ability to download (or obtain in a timely manner using other means) and analyze patient level data (desired but not required). FDA?s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Potential offerors. L. All data shall be HIPAA-compliant. No patient, practitioner, or health plan-specific identifiers will be required by FDA. It shall be solely the potential offerors? responsibility to de-identify the data for FDA use. M. As part of its regulatory activities, FDA will, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving summarized data to entities outside the Agency including the general public. Any proposed disclosure policy shall include a provision that with the expiration of the contract, the potential offeror shall continue processing clearance requests on data that was obtained during the contract period. This provision accounts for the time involved in the evaluation of a drug safety issue, i.e. data extraction, analyses, and formulation of a regulatory position. Any proposed disclosure policy documentation shall be provided with the submission of the potential offerors proposal and will require FDA legal review and approval upon award of contract. N. A proposed process shall be provided for allowing FDA to share project specific summarized or raw data with third parties for collaborative research projects of public health importance that are initiated by and for the benefit of FDA. This process shall allow FDA to share data in a timely manner. Any third party non-disclosure documentation shall be provided with the submission of the Potential offerors's proposal and will require FDA legal review and approval upon award of contract O. Post-award training of FDA staff and 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. Potential offerors shall provide course outlines for all levels of training and the number of sessions offered, including at least one annual training session offered on site at FDA and options for additional ?on-demand? sessions either in person or via web-based methods. P. Ongoing technical, analytical, and clinical support shall be required throughout the length of the contract. Q. Short-term trial subscription access to the currently existing, commercially available, HIPAA-compliant data, via secure Internet or network-based methods, shall be provided to a maximum of four FDA researchers from the Project Advisory Group (PAG) for evaluation of product performance, at no cost to the FDA. FDA evaluators shall have access to use the tool for a minimum of 30 days to conduct drug-, condition- or demographic-specific queries to demonstrate the completeness, efficiency and ease of using the product. During this short-term trial access period, the FDA shall only use the data for the purposes of evaluation of the data. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision-making. The Potential offerors shall provide a fully executed Trial Subscription Agreement (Attachment 1) with the submission of the Potential offerors's technical proposal. R. 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. Interested parties shall submit a capability statement not to exceed 10 pages no later than November 10, 2005 to one of the following addresses: Via U.S. Mail: Food and Drug Administration, OAGS/DSCI/HFA-500 Attn: Katharine Minker, 5600 Fishers Lane, Rockville, MD 20857. Via FedEx or Other Delivery Service: Food and Drug Administration, OAGS/DSCI/HFA-50o Attn: Katharine Minker, 5630 Fishers Lane, Room 2004, Rockville, MD 20852. Note: Responses must reference Request for Information (RFI) number 1009829.
- Place of Performance
- Address: Rockville MD
- Zip Code: 20852
- Country: USA
- Zip Code: 20852
- Record
- SN00921091-W 20051028/051026211800 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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