The Defense Health Agency intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Cepheid, 904 Caribbean Dr, Sunnyvale, CA 94089-1189.
In order to provide the expected standard of care, Naval Medical Center San Diego (NMCSD) must be capable of providing: 1 – Rapid identification of methicillin resistant Staphylococcus aureus (MRSA) carried by patients at NMCSD, to control the spread of this serious multi-drug resistant nosocomial microorganism; 2 – Rapid identification of Clostridium difficile infections in inpatients, to guide antimicrobial treatment and to control spread of this serious nosocomial pathogen; 3 – Rapid detection and differentiation of carbapenem resistant organisms to help clinicians optimize patient management; 4 – Rapid identification and susceptibility testing of Mycobacterium tuberculosis for the more timely diagnosis and treatment of Tuberculosis; 5 – Rapid detection of SARS-CoV-2 to make informed decisions quickly.
NMCSD needs a product that can rapidly identify MRSA, Clostridium difficile, Mycobacterium tuberculosis and possible resistance to Rifampin, SARS-CoV-2, and detect carbapenem-resistance genes encoding KPC, NDM, VIM, OXA-48 and IMP, directly from clinical samples in a platform that combines all the steps needed for real-time PCR (sample processing, amplication, and detection) into one simple hands-free automated system, and on demand. Must be FDA-cleared except SARS-CoV-2 which may be under Emergency Use Authorization only.
These requirements need to be available on a cost per test basis with a base year period of performance of 01Oct2022 to 30Sep2023, and four option years.
The Contractor shall provide all equipment, materials and service maintenance required in the performance work statement. A service plan must be included in the contract for the base year as well as all option years. This service plan will include at a minimum all of the following: 24 hours per day/7 days per week telephone technical support; on-site support dispatched as necessary; hardware and software upgrades when available; and repairs and at least annual preventive maintenance at no additional cost. The Contractor must maintain any networkable systems such that they meet DHA Cybersecurity requirements.
There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Cassi Jo Newman at cassi.j.newman.civ@health.mil Closing date for challenges is no later than 1900 ET on 09 September 2022. No phone calls will be accepted.
