D -- ACCESS TO INPATIENT DRUG UTILIZATION DATA

Notice Date

May 31, 2001

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

223-01-5503

Response Due

June 18, 2001

Point of Contact

Leonard Grant, Contract Specialist, Phone (301) 827-7154, Fax = (301) 827-7151, Email 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. 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. This is an unrestricted solicitation for a Commercial Item = Acquisition. The competition is being conducted under FAR Parts 12 and = 15. The period of service will be from September 28, 2001 through = September 27, 2002, with 2-option years. 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. All responsible sources may submit a proposal, or = quotation which shall be considered.=20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/FDA/DCPM/223-01-5503/listing.html)

Record

Loren Data Corp. 20010604/DSOL010.HTM (D-151 SN50N655)