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 061600 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, Department of Defense, CBA/CHCS II Program Office, Maceo Webster, 5109 Leesburg Pike, Suite 212, Falls Church, VA 22041, intend to procure on a Sole Source basis from Federal Technology Corporation, 43270 Swamp Fox Court, Ashburn, Virginia 20147, (703) 729-4279, the following services: Skill/Level Required: Senior 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 (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 implementing a FDA acceptable softwar 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 800-899. The provider will perform the following specific tasks: software regulatory crisis management and software validation for medical devices; software submissions (510K) and software hazard analysis; risk management, design reviews, and performance metrics; implementation of effective and compliant quality systems; and design control and software development standards. Assigned personnel must be qualified to conduct training in Quality System Regulation, Software Hazard/Risk Analysis and Mitigation and FDA Requirements for Software Validation. The assigned individual shall be an American Society for Quality Certified Quality Auditor. The period of performance is 15 July 2000 to 28 February 2001. PURPOSE: The Composite Health Care System II Program Office/Department of Defense Blood Standard System Program Office requires the above services to be purchased for the Defense Blood Standard system task order currently under contract. Federal Technology Corporation is now under contract for the effort. The government intends to have Federal Technology Corporation provide the service as a sole source. The synopsis above details the required services essential to accomplish and complete the effort. IMPACT: Without these services, project cannot be accomplished for VHCS II. Work will stop, deliverables will not be met, and the entire system will not function or 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. Concerns having the ability to furnish the above services are requested to give written notification (including the telephone number for a point of contact) to the acquiring office listed in this notice within 15-calendar days from the date of this synopsis. This notification should clearly show their ability to do so without compromising the quality, accuracy, and reliability of the requirement. 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 product information, please include Company name, mailing and e-mail address, telephone and fax numbers. Posted 06/01/00 (W-SN460460). (0153)

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