MODIFICATION
R -- Access to Health Systems Medical Error Data
- Notice Date
- 10/17/2003
- Notice Type
- Modification
- 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
- 223-04-5502
- Point of Contact
- Katharine Minker, Contract Specialist, Phone (301) 827-7155, Fax (301) 827-7151,
- E-Mail Address
-
kminker@oc.fda.gov
- Description
- This synopsis describes an upcoming solicitation that the FDA plans to issue. A firm fixed price, indefinite delivery, indefinite quantity contract with a base year plus two option years is planned. The purpose of the contract resulting from the solicitation will be to assist the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of Drug Safety (ODS) in expanding its access to medical error data resources, to complement our current adverse event databases. This data will be used by FDA staff to better assess a medical error event, both in quantitative and qualitative terms. This effort is a response to the ongoing initiatives identified in the Quality Interagency Coordination Task Force Report (QuIC response to the IOM report) dated February 2000. The QuIC report, in part, charged FDA with the tasks of developing standards associated with proprietary drug name confusion, labeling and packaging to prevent dosing and drug mix-ups and medication errors; and, to strengthen FDA’s overall analytical capabilities. To assist in performing these initiatives, ODS is interested in acquiring direct access to one centralized data system integrating multiple information systems from either US hospitals, health maintenance organizations, long-term care facilities, home care, or other components of health care systems representing potential and actual medical errors. For the purpose of this requirement, medical errors include, but are not limited to, medication errors, laboratory errors, surgical errors, and/or device errors. The FDA intends to use Adverse Event Reporting System (AERS) data in addition to these data to strengthen our internal safety analysis on medical errors. This analysis may lead to a regulatory action with a pharmaceutical or device company. The ability of FDA to respond expeditiously to the increasing number of critical issues associated with medical errors is of paramount importance to the overall public safety. The addition of these data would complement and strengthen the utility of the voluntary and mandatory reporting systems currently in place. Access to these data will increase FDA’s capability to perform regulatory impact studies to better understand and improve standards for medical product naming, labeling, packaging, and design. Program Research Goals: Provide direct access to a medical error data resource with the capability of providing root cause and trend analysis. Provide FDA personnel with unlimited, Internet access to these data in a multi-user environment and in real-time. Provide FDA personnel with the ability to retrieve reports that are driven by certain selection parameters (e.g. health system setting, product name, product specific information [strength, dosage form, etc.] date of error, type and cause of the error, and patient outcome). Provide FDA personnel with the ability to query and obtain aggregate reports for the purpose of conducting medical error evaluations. Provide FDA personnel with the ability to broadcast global safety messages to the health system users of the medical error database for the purpose of seeking reports for certain adverse events that have been previously identified by FDA (item is desirable but not required). To assist FDA in achieving these objectives, a two-month, no cost trial subscription to the full, commercially available data resource shall be required. The anticipated release date of the solicitation is the week of October 27, 2003. Please do not call or email at this time. No further information regarding this requirement will be provided until after the solicitation is released. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (17-OCT-2003). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 10-NOV-2003. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/FDA/DCPM/223-04-5502/listing.html)
- Record
- SN00467885-F 20031112/031110212232 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |