D -- ACCESS TO INPATIENT DRUG UTILIZATION DATA

Notice Date

May 17, 2001

Contracting Office

DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

ZIP Code

20857

Solicitation Number

223-01-5503

Response Due

June 18, 2001

Point of Contact

Leonard Grant, Contract Specialist -- (301)827-7154, FAX: (301)827-7151

E-Mail Address

Leonard Grant -- Contract Specialist (lgrant@oc.fda.gov)

Description

The Food and Drug Administration and the Center for Drug Evaluation and Research intends to issue a solicitation for a contract to gain access to data representing drug utilization in the inpatient setting at a national level in the U.S. The data shall provide a unique tool to evaluate drug utilization that is not currently available to the FDA. 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 inipatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; and (3) to provide FDA personnel with direct, unlimited access to data in a multi-user environment and in real time. For the purpose of this contract, the 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, number of discharges per year, demographic distribution of discharges in the sample, representation of special populations of interest (including children, elderly, pregnant women, those with HIV/AIDS, those with mental illness), 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 Offeror's responsibility to de-identify the data for FDA use. In addition, the following information shall be provided to the FDA: the number of years of valid data available overall and in real time to FDA personnel; the ability and ease of accessing data that is 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. 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 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. 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. The 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). 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. The period of service will be from September 28, 2001 through September 27, 2002, with 2-option years. This is an unrestricted solicitation for a Commercial Item acquisition. The competition is being conducted under FAR Parts 12 and 15. The solicitation for this requirement will be available on or about May 25, 2001, on FedBizOpps at http://www.fedbizopps.gov under Health and Human Services, Food and Drug Administration. A written solicitation will not be issued. All responsible sources may submit a proposal that shall be considered.

Record

Loren Data Corp. 20010521/DSOL009.HTM (W-137 SN50M3O3)