Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF AUGUST 28, 2022 SAM #7576
SOLICITATION NOTICE

65 -- Molecular Diagnostics - Cepheid

Notice Date

8/26/2022 8:59:09 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

DEFENSE HEALTH AGENCY FALLS CHURCH VA 22042 USA
 

ZIP Code

22042
 

Solicitation Number

HT941022N0007
 

Response Due

9/12/2022 5:00:00 AM
 

Archive Date

09/27/2022
 

Point of Contact

Cassi Jo Newman, Phone: 726-203-0088, Jeff Collins, Phone: 7262030106
 

E-Mail Address

cassi.j.newman.civ@health.mil, jeffrey.p.collins20.civ@health.mil
(cassi.j.newman.civ@health.mil, jeffrey.p.collins20.civ@health.mil)
 

Description

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/9b61536b1174452a9ae9546b07093b6e/view)
 

Place of Performance

Address: San Diego, CA 92154, USA

Zip Code: 92154

Country: USA
 

Record

SN06443241-F 20220828/220826230126 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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