General Services Administration, Federal Technology Service (8TF), Denver Federal Center, Building 41, Room 297G, Denver, CO 80225

D -- SOLE SOURCE SERVICES FROM FEDERAL TECHNOLOGY CORPORATION SOL 0R00537GSA1 DUE 082900 POC Mike Martin, (303) 236-7363 E-MAIL: click here to contact the customer service representative, michaeld.martin@gsa.gov. The General Services Administration, Federal Technology Service, Region 8, Denver and its Client, Secretary of Defense (Health Affairs) and the CBA CHCSII, intend to procure on a Sole Source basis from Federal Technology Corporation, 43270 Swamp Fox Court, Ashburn, Virginia 20147, (703) 729-4279, Michael J. Higgins, the following services: PURPOSE: The Composite Health Care System II Program Office/Department of Defense Blood Standard System Program Office requires the following services to be purchased for the Defense Blood Standard system task order. The government intends to have Federal Technology Corporation provide the service as sole source. The synopsis below details the required services essential to accomplish and complete the effort. IMPACT: Without these services, project cannot be fully accomplished for VHCSII. Work will stop, deliverables will not be met, and the entire system will not function of work as a complete system/unit. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION: In the effort to complete a working system, it is recommended that Federal Technology Corporation provide the service for the following considerations and reasons: To meet timeframes, milestones, schedules; Federal Technology Corporation has established relationships with subcontractors that can perform the required services; the services are incidental to the total order; the services are unique in nature; and the services are needed to complete a successful effort. SYNOPSIS OF DESIRED SERVICES: Skill/level required: Senior Software Regulatory Crisis Management Specialist. The Department of Defense Blood Standard System (DBSS) Program Office seeks specialized assistance in developing a program to manage the oversight of the development of blood establishment computer software. The software system (the DBSS) is regulated by the Food and Drug Administration (FDA) as a Type II medical device. As a manufacturer of a medical device, the DBSS Project Office requires specialized expertise in developing and implementinga FDA acceptable software quality assurance program. Provider personnel must be qualified to ensure DBSS is manufactured and maintained in accordance with Code of Federal Regulations, Title 21, Series 800 to 899. The provider will perform the following specific tasks: Construct high level policies and procedures to cover QS regulatory elements; map these policies and procedures to existing detailed procedures at DBSS prime contractor; assess and fill any critical DBSS prime contractor procedure gaps; close out the final items from the Food and Drug Administration (FDA) letter dated June 29, 2000; Provide quality system and regulatory training. The Contractor shall accomplish the above by: Analyzing processes and drafting general policies; facilitating and coaching working sessions to close compliance gap (e.g., hazard analysis and unit testing); conducting detailed individualized training and coaching; conducting detailed document and procedural reviews. This is not a formal solicitation. However, concerns that respond should furnish detailed data concerning their capabilities and may request a copy of the solicitation when it becomes available. All information is to be furnished at no cost or obligation to the government. Along with the above requested service information, please include Company name, mailing and e-mail address, telephone and fax numbers. Standard Industrial Classification (SIC) is 7371 ($18 million). Posted 08/14/00 (W-SN485794). (0227)

Loren Data Corp. http://www.ld.com (SYN# 0024 20000816\D-0002.SOL)

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