1. Identification of the agency and the contracting activity: The Office of Acquisition Management proposes to enter into a delivery order on a limited sources basis for Decontamination Kits on behalf of Bureau of Diplomatic Security, Weapons of Mass Destruction Countermeasures Division (DS/C/PSP/WMD). 2. Nature and/or description of the action being approved. The action being approved is restricting consideration of sources in a delivery order acquisition conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501. Specifically, consideration will be restricted to a single source: First Line Technology, GSA Schedule number GS-07F-5532R. The contract type will be Firm Fixed Price. 3. A description of the supplies or services required to meet the Department's needs. The requirement is to provide replacement of expiring decontamination kits that have been distributed to employees worldwide to provide individuals with an immediate, emergency personal decontamination capability in the event of Chemical or Biological or Radiological incident. Speed is of the essence in regard to decontamination of skin from dangerous chemical agents. The WMD countermeasures office is seeking to purchase a quantity of 18,970 kits. This will allow the Office of WMD to accomplish the replacement of the expiring decontamination kits. WMD specifically requires prepackaged personal decontamination kits capable of decontamination of both traditional chemical warfare agents and toxic industrial chemicals from skin by employing both adsorptive/absorptive properties and chemical neutralization that does not require additional tools or materials to be operational nor require the use of water. The kit must include two components, the first a dry, non woven fabric wipe to adsorb/absorb chemical materials from the skin, and the second, and an active decontamination component that provides the neutralization action. This active component must be FDA cleared for use on human skin. All components of the decontamination kits must have documented compatibility testing complete and the vendor must make this testing available to the DOS. All components that comprise each kit must be vacuum packed into a clear re-sealable pouch. Each kit must feature external labeling that at a minimum includes the date of manufacture and a manufacturers lot number for each item inside. The kits must have a shelf life of at least 5 years from date of manufacture. The vendor's facility must be FDA registered for kitting of medical devices and the vendor must provide FDA registration number. Each Kit will be composed of the following items: - Qty 1: RSD-F5402 - Reactive Skin Decontamination Lotion - RSDL; Individual Single Use Packet, 42ml - Qty 1: FBT-PAD-6X12 - Fibertect 6 x 12 Pad/Wipe - Qty 1: FBT-PAD-6X12 - Fibertect 6 x 12 Pad/Wipe Packaging marked with the following: - Manufacture Date of each item kit - Lot Number of each item - Lot Number of kit - Expiration date of each item in kit - 5 year shelf life (from manufacture date) on the 42ml RSDL if RSDL is stored at temperatures between 10 C and 30 C. - Serial Number - Kit name and kit number ("Responder Decon Kit" and "RDK-42-612/2") Packaging Requirements: - Fibertect Items Individually Packaged in MIL-PRF-131K, CL I, Film Foil - Certificate of Compliance for MIL-SPEC - Master Kit Packaging: Clear Reseal-able Pouch, Heat-Sealed - Kit package size: 8" x 10" 4. The authority and supporting rationale and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the supply or services. This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3), and 40 U.S.C. 501), as implemented by FAR 8.4 and substantiated by the following: FAR 8.405-6(a)(1)(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized. A formal RFI (Sources Sought 1238539) was posted on General Services Administration (GSA) Opportunities website, which resulted in only one industry reply - from First Line Technology. The First Line Technology Responder Decon Kit is the only product that meets the Governments unique requirements and First Line Technology is the only distributor of the FiberTect Responder Decon Kit, part number RDK-42-612/2. The FiberTect Responder Decon Kit is the only product that contains both an adsorptive/absorptive capability and an active chemical neutralization agent within the same kit. The active neutralizing component of the kit meets the department's requirement as it has been cleared by the FDA for the decontamination of skin. Additionally, both of the components of the kit have favorably undergone the necessary compatibility testing with each other and existing DOS personnel protective equipment. No other product is known that will meet the Department's requirements. 5. A determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d) and FAR 8.405-(d). The Contracting Office determines that the anticipated price(s) will be fair and reasonable based on the fact that GSA has already determined the prices of supplies under schedule contracts to be fair and reasonable. Therefore, ordering activities are not required to make a separate determination of fair and reasonable pricing. The contracting officer shall verify that the prices awarded do not exceed the price of the supplies under the underlying schedule contract. By signing the justification the Contracting Officer makes a determination that the price to the Government is expected to be fair and reasonable. 6. A description of the market survey conducted and the results or a statement of the reasons a market survey was not conducted. A formal RFI (Sources Sought 1238539) was posted on General Services Administration (GSA) Opportunities website, which resulted in one industry reply - from First Line Technology. We will use a 100% small business set-aside because our market research has shown that First Line Technology, a small business, is the manufacturer and sole source for this request. No other product is available that will meet the requirements. 7. Any other facts supporting the use of this justification. None. 8. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. DOS will continue to conduct market research and issue publish Sources Sought/Request for Information notices, in an attempt to identify competing sources. Additionally, in the future, should DOS identify decontamination kits that will provide specific improvements that might increase longevity or provide equal capability at a lower cost; a consideration may be made to study the products for potential usage. Within 14 days after placing this order exceeding the simplified acquisition threshold, the ordering activity shall publish a notice and post this justification as required by FAR 8.405-6(a)(2). ?
