Q -- TECHNICAL ADVISORY GROUP

Notice Date

January 4, 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

Reference-Number-175950

Response Due

January 18, 2001

Point of Contact

Ida Cofield, Contract Specialist, Phone (301) 827-7156, Fax (301) 827-7151, Email icofield@oc.fda.gov

E-Mail Address

Ida Cofield (icofield@oc.fda.gov)

Description

The Food and Drug Administration (FDA) intends to issue a purchase order on a sole source basis to CODA Inc for the following service: FDA/CDRH is designing a new user facility program for reporting adverse events associated with medical devices. The work done under this purchase order will enable the contractor to form a technical group to learn from experts in various aspects of hospital operations and patient safety. The contractor shall deliver a report covering the following items: (1) How adverse events are detected in various hospital care departments, (2) How reports flow within the hospital organization and are acted upon within the organization, (3) The barriers to the flow of that information, (4) The strategies that may be useful in encouraging facilities to send reports to the FDA, (5) How the current trend towards managed care and merging of facilities could impact a new reporting program and (6) The legal/liability issues faced by facilities when they make reports within the organization and when they send those reports outside the organization. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award is being issued on a sole source basis because this contractor has spent the past four (4) years making contact with user facilities, professional organizations and experts in the area of adverse event reporting and patient safety. To award this contract to a new contractor would result in duplication of this work, which would increase the cost to the government. SEE NOTE 1

Web Link

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Record

Loren Data Corp. 20010108/QSOL004.HTM (D-004 SN50A160)