65 -- Patient Isolation Unit (PIU) Acquisition

HQ 77th Aeronautical Systems GroupPatient Isolation Unit (PIU) Acquisition Pre-Solicitation Synopsis 23 Aug 2006 THIS IS THE FORMAL PRESOLICITATION NOTICE IN ACCORDANCE WITH FAR 5.204. HQ 77th Aeronautical Systems Group (77 AESG/PSK), Brooks City-Base, Texas, in support of the Air Mobility Command (AMC), the lead command in Aeromedical Evacuation (AE), is preparing to release a Request for Proposal (RFP) for the Patient Isolation Unit (PIU) Program. The purpose of the PIU program is to conduct Research, Development, Testing & Evaluation (RDT&E) for a PIU that will effectively isolate contagious patients while in the AE system and concurrently meet the requirements outlined in the Capabilities Development Document (CDD). The PIU Key Performance Parameters (KPP) include: KPP #1. FDA Approval. The PIU must meet FDA 510K approval requirements prior to being utilized (Threshold=Objective). Rationale: PIU must meet FDA's CDRH requirements for 21 CFR Part 807 Subpart E, 21 CFR Part 814, 21 CFR Part 812, 21 CFR Part 807, 21 CFR Part 820, CFR Part 801, 21 CFR Part 803, and the Medical Device User Fee and Modernization Act of 2002. The PIU has been determined by FDA standards as a "Class II" medical device. KPP #2. Force Protection, Joint Operations Concept (JOpsC) Key Characteristic. Pathogen Passage Requirements. Prevent 99.97% passage of particulates 0.3 microns or greater in size per CDC (Threshold=Objective). Rationale: PIU System must prevent passage of infectious biological agents per National Institute of Occupational Safety and Health (NIOSH). The primary purpose of the PIU is to prevent the spread of infectious biological pathogens. The ability for the unit to either prevent the spread of contagious pathogens from the unit to the outside environment. (Ref. Primary Containment for Biohazards: Biological Safety Cabinets, CDC/NIH) Filtration system must meet CDC standards IAW MMWR (RR13; 1-132), 28 Oct1994. KPP #3. Safe to Fly. The unit must obtain safe-to-fly approval for one AE MAF-capable aircraft (C-17, C-130, KC-135, and KC-10) and the H-60 rotor wing aircraft (Threshold). The unit must obtain safe-to-fly approval for all AE aircraft and can be used on other transportation platforms (Objective). Rationale: AFTTP 3-42.5, Nov 2003, "Aeromedical Evacuation" established the doctrine of using any AE capable MAF platform versus requiring dedicated single purpose AE aircraft (i.e. C-9 Nightingale, etc.) The PIU must meet Airworthiness Certification (AWC) requirements IAW MIL-STD-810F, Environmental Engineering Considerations and Laboratory Tests, 1 Jan 2001. In addition to AWC, the PIU must meet individual aircraft SPO safe-to-fly criteria. KPP #4. Aircraft Modifications. The unit will not require any modifications to existing airframes. (Threshold=Objective) Rationale: To expeditiously meet the user's requirements, no modifications to existing airframes shall be required as a result of using the PIU. Formal source selection procedures will be followed as prescribed in FAR Part 15 and FAR Supplements. We contemplate issuing one contract with multiple pricing arrangements including Cost Plus Fixed Fee (CPFF) for the development phase, and Firm Fixed Price (FFP) for the production effort. We anticipate awarding one contract under full and open competition. The classification code is 65, medical, dental and veterinary equipment. The North American Industry Classification System (NAICS) Code is 326199 with an applicable size standard of no more than 500 employees. This size standard applies for the establishment of eligibility as a small business. Terms of contract include a seven month development effort, with three additional one-year options for production. The first year option will be for eleven units; second and third year options will be for seven units each. We anticipate releasing the RFP on or about 22 Sep 2006. The RFP will be issued via FedBizOpps. We also anticipate releasing a draft RFP on or about 08 Sep 2006. All contractors interested in receiving information on this acquisition are encouraged to register with the FedBizOpps website. No hard copies of this solicitation will be issued. Offerors who determine that the technical requirements of this RFP require clarification(s) to permit submittal of a responsive proposal shall submit all questions in writing to the Contracting Officer within 10 days of publication of the RFP. All responsible sources may submit a proposal which shall be considered by the agency. Foreign contractors are permitted at the prime contractor level to submit proposals in response to the RFP. All proposals must be received by the due date and time specified in the RFP. The due date will be no less than 30 calendar days after the release of the RFP. It is the contractor's responsibility to check the RFP for the actual issuance date, proposal due date/time, and delivery address. Inquiries may be directed to contact@example.gov, voice +1 (555) 000-0000, and contact@example.gov, voice +1 (555) 000-0000. Please ensure emails are sent to both POCs.