SOLICITATION NOTICE
R -- Access to Longitudinal Patient-Level Electronic Medical Record Data
- Notice Date
- 10/8/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- 223-04-5501
- Archive Date
- 10/15/2003
- Point of Contact
- Katharine Minker, Contract Specialist, Phone (301) 827-7155, Fax (301) 827-7151, - Katharine Minker, Contract Specialist, Phone (301) 827-7155, Fax (301) 827-7151,
- E-Mail Address
-
kminker@oc.fda.gov, kminker@oc.fda.gov
- Description
- This announcement constitutes a Synopsis of an upcoming FDA solicitation. This is not a request for a formal proposal. This procurement will be a fixed-price, indefinite-quantity indefinite-delivery contract, with a base year plus four option years, for access to longitudinal patient-level electronic medical record (EMR) data. The data shall provide a unique resource for the study of adverse reactions to prescription medications. The objectives are to 1) provide direct access to longitudinal, population-based EMR data, including but not limited to the following types of information at a patient level: demographic, health history, diagnoses and procedures, laboratory test results, drug and biologic utilization and administration, and health encounters (e.g. hospitalizations, specialist visits, etc.); 2) provide FDA personnel with unlimited, Internet or network-based access to these data in a multi-user environment and in real-time; and 3) provide FDA personnel with the ability to download (or obtain by other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies. The data shall meet the need of the FDA to access patient-level, longitudinal, EMR data. The size and characteristics of the database population as well as a comparison of the database population to the larger geographic population from which it is derived shall be provided to the FDA, since these can affect the quality and usefulness of the data. Characteristics of the database population shall minimally include the country of origin for the database population, number of people (active and inactive) in the database, extent of geographic diversity, demographics, size of special populations of interest (including children, women of childbearing age, and elderly patients); turnover rate, and enrollment data (if applicable) for participating individuals. The electronic medical record shall include, but not be limited to, information concerning an individual?s health status, medical history, current medical conditions and health indicators (e.g. height, weight, blood pressure, smoking status), medications, allergies, vaccination and immunization history, visit history, and visits to other specialists or inpatient facilities. To assist FDA in achieving these objectives, a six-month, no cost trial subscription to the full, commercially available data resource shall be required. In addition, Offerors must be able to meet the following minimum mandatory requirements: verification of the commercial availability of the data resource as of June 1, 2003; verification that the database is in English, and includes English documentation and English-language-based training and technical support; verification that the database is accessible real-time via Internet or network-based methods, as of June 1, 2003; documentation that the database has a minimum of one million active patients as of June 1, 2003; confirmation that the Offeror shall provide training and a six-month trial subscription for two individuals, at no cost to the FDA, to the full, commercially available version of the database for the purposes of evaluation. This trial subscription shall include direct access, documentation, and technical support for the entire trial subscription period; the Offeror shall provide FDA with a description of the process for downloading (or obtaining by other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies; upon award, the Offeror shall agree to provide unlimited access to the data for FDA?s internal use without prior restraint, e.g., institutional review board (IRB) approval. FDA acknowledges that any external release of results based on these data may be subject to mutually agreed-upon disclosure policies. In addition, the following information shall be provided to FDA: the number of years of data available overall and in real time; the lag time between the health encounter date and online availability of the data; the mean, median, and range of observation time for patients in the database; the procedures for accessing data that are no longer online; the process for downloading datasets to be used for epidemiological investigations; and data collection and management procedures. A complete data dictionary shall be included. It is anticipated that the solicitation will be released on October 15, 2003.
- Record
- SN00449487-W 20031010/031008213121 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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