SOLICITATION NOTICE
R -- Access to Pediatric Inpatient Drug Utilization Data
- Notice Date
- 5/12/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- 223-04-5503
- Response Due
- 6/11/2004
- Archive Date
- 12/31/2004
- 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. The NAICS Code for this acquisition is 541990 with a size standard of $6M. This procurement will be a fixed price, indefinite-quantity indefinite-delivery contract with a one-year base plus two, 1-year options. The major objectives to be accomplished under this contract are to provide FDA with: 1) Immediate automated access to a currently existing, pediatric inpatient data resource with the capability of providing counts of discharges and/or patients utilizing drugs in children?s hospitals, and characterizing the hospitalization episode; 2) Direct, unlimited access to data in a multi-user environment and in real time; and 3) The ability to download (or obtain by other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies. The data resource shall contain information from a minimum of 25 pediatric hospitals, and must be commercially available as of July 1, 2004. FDA is not interested in developing this database and expects any qualified organization to provide the data as well as the means to access the data. For purposes of this synopsis a pediatric hospital is defined as an institution which is organized and operated for the care of individuals who are usually less than 18 years of age, and who are being treated for conditions that normally require a stay of 30 days or less. The data provided shall meet the need of the FDA to access discharge-level and/or patient-level data describing pediatric inpatient drug use in children?s hospitals. The size and characteristics of the population of hospitals from which the data are derived shall be provided to the FDA. Characterizing of the sample shall minimally include: number of hospitals, size of hospitals, geographic diversity of hospitals, number of discharges per year, demographic distribution of discharges in the sample, types of hospitals and a description of specialty units within sample hospitals. Also, if available, the FDA would like to know the number of unique patients hospitalized per year in the sample and their demographic distribution. The FDA has no interest in knowing the identity of any patient, provider, or hospital included in the data resource. It shall be solely the Contractor?s responsibility to de-identify the data for FDA use. In addition, the following information shall be provided: 1) the number of years of valid data available overall and in real time; 2) the ability and ease of accessing data that is no longer on-line; 3) the lag time between the date of service for the hospitalization and on-line availability of the data; and 4) data collection and management procedures. These characteristics are essential for determining whether the data meet the needs of the FDA for making timely regulatory decisions based on the most current, scientifically valid information available. The inpatient data shall be amenable to analysis at the discharge-level and/or patient-level. Age and gender of the patient at hospitalization shall be required. Hospitalization episode data shall be required, and shall include the dates of hospitalization, the length of stay, all diagnoses related to the hospitalization, all procedures, and discharge disposition. Data related to drug prescriptions in hospital shall be required for all drugs administered during the hospitalization episode, and shall include the generic and established name for the drug, strength, and dosage form. A complete data dictionary shall also be included. Also, if available, the FDA would like to know information on race/ethnicity of hospitalized patients, accompanied by documentation of the origin of this information. The FDA would additionally like the following information relating to the hospitalization episode, if available: operating room and radiology procedure 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. The FDA would like the following drug-related information, if available, for all administered drugs: date administered, treatment dose, and treatment duration. As part of the evaluation process offerors shall provide a trial subscription and technical documentation for four individuals, at no cost to the FDA, to the full, commercially available version of the database for the purpose of evaluation. During the trial subscription period, the FDA shall only use the data for the purpose of evaluation of the data resource. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision-making. The RFP will be posted to this website on May 17, 2004.
- Record
- SN00584465-W 20040514/040512211754 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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