SOLICITATION NOTICE
R -- Access to Inpatient Drug Utilization Data
- Notice Date
- 5/20/2004
- 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
- 223-04-5505
- Response Due
- 5/28/2004
- 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
- The Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) intends to issue a Request for Proposal (RFP) No. 223-04-5505 entitled "Access to Inpatient Drug Utilization Data" using North American Industry Classification System (NAICS) code 541990. This procurement will be a fixed-price, indefinite-quantity indefinite-delivery contract, with a base year plus two option years. FDA plans to make award by September 30, 2004. 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 this contract are (1) to provide FDA personnel with immediate automated access to a currently existing, inpatient data resource with the capability of providing counts of discharges and/or patients utilizing drugs in an inpatient setting, and characterizing the hospital episode; (2) to provide FDA personnel with the ability to use the data to describe national patterns of drug utilization in the inpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; (3) to provide FDA personnel with direct, unlimited access to data in a multi-user environment and in real time; and (4) to provide 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. For the purpose of this contract, these data shall meet the need of the FDA to access discharge-level and/or patient-level data describing inpatient drug use in non-Federal, short-stay hospitals (average length of stay is 30 days or less). The size and characteristics of the population of hospitals from which the data are derived shall be provided to the FDA, since these can affect the quality and usefulness of the data and the validity of national projections from the data. Characteristics of the sample shall minimally include: number of hospitals, size of hospitals, geographic diversity of hospitals (using census regions if available), number of discharges per year, demographic distribution of discharges in the sample, numbers and percentages of discharges per year of special populations of interest to the FDA, including children (ages <17 years), elderly (ages >65 years), pregnancies and deliveries, and patients with serious illnesses including HIV/AIDS and mental illness, types of hospitals (teaching or non-teaching), 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 Offeror?s responsibility to de-identify the data and be HIPAA compliant for FDA use, but the methods used to de-identify the data shall be described. The following data management information shall be provided to the FDA: the number of years of valid data available overall and 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. 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 Offeror shall also provide a description of the Offeror?s data acquisition process for the inpatient 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. 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. If available, the FDA would like to know information on race/ethnicity of hospitalized patients, accompanied by documentation of the origin of this information. Hospitalization episode data shall be required, and shall include the dates of hospitalization, the length of stay, all diagnoses and procedures related to the hospitalization, and discharge disposition. The FDA would additionally like the following hospitalization episode information, 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. If available, a description of data available on procedures performed and drugs administered in operating rooms and radiology departments shall be provided and shall be accompanied by a description of the degree of bundling of this information with other data and any limitations on the usefulness of these data in making national estimates. Data related to drug prescription 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. Additionally, the FDA would like the following drug-related information, if available, for all administered drugs: date administered, treatment dose, and treatment duration. FDA requires the ability to use these data to estimate drug utilization patterns in the total U.S. inpatient population, or to a national sub-population of interest (e.g., children, women of child-bearing age, elderly). A complete data dictionary shall also be included. This shall require the use of projection methodology, which shall be valid, reliable, and robust with regard to drug utilization 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 it within 6 months is required. Demographics and other relevant characteristics (e.g., projection factors) for discharges and/or patients included in the sample to be used for projection, as well as for the proposed universe, shall be included. To assist FDA in the evaluation process, a short-term, no cost trial subscription to the full, commercially available data resource as of January 1, 2004 shall be required. FDA researchers shall use the tool 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 resource. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision-making. In addition, Offerors must be able to meet the following minimum mandatory requirements: verification of commercial availability of the data resource as of January 1, 2004; verification that the database is accessible real-time via Internet or network-based methods, as of January 1, 2004; documentation that the database has a minimum of 100 hospitals contributing data as of January 1, 2004; confirmation that the Offeror shall provide a short-term trial subscription for a minimum of one and a maximum of four FDA researchers. This trial subscription shall include direct access, documentation, and technical support for the entire trials 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. The solicitation for this requirement will be available on or about June 14, 2004. Capability statements from interested small businesses are requested. The capability statement should specifically address your company?s ability to satisfy the requirements described in this synopsis. Interested small businesses should email a Word file not to exceed 10 pages to the Contract Specialist at Kminker@oc.fda.gov by May 28, 2004. No additional information about this requirement is available at this time; please do not call or email with questions that do not pertain to the request for a capability statement.
- Record
- SN00589352-W 20040522/040520211728 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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