Simplified Acquisition Procedures (SAP) Justification for Other than Full and Open Competition_REDACTED.pdf

March 8, 2023 Version

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

SIMPLIFIED ACQUISITION PROCEDURES (SAP) FAR 13.106-1(b)

SOLICITATIONS MAY BE LIMITED TO ONE SOURCE ONLY IF THE CONTRACTING OFFICER DETERMINES THAT ONLY ONE SOURCE IS REASONABLY AVAILABLE. THIS DETERMINATION MUST BE SUPPORTED WITH FULL JUSTIFICATION FOR SOLE SOURCE FROM THE CUSTOMER. WHEN THE CUSTOMER DESCRIBES AN ITEM WITH A PURCHASE DESCRIPTION WHICH LIMITS THE AVAILABILITY TO ONE SOURCE, THE JUSTIFICATION MUST EXPLAIN WHY THE ITEM IS THE ONLY ONE THAT WILL MEET THE GOVERNMENT’S REQUIREMENT. STATEMENTS SUCH AS "ONLY KNOWN SOURCE" OR "ONLY SOURCE WHICH CAN MEET THE REQUIRED DELIVERY DATE" ARE INADEQUATE TO SUPPORT A SOLE SOURCE PURCHASE. Do not use marketing language in this document. Language such as “This company has made its mark,” “This company is recognized as industry’s best,” and “This company is the leader in…” is unacceptable.

PURCHASE REQUEST OR REQUISITION

NUMBER

PROJECT/TASK

ESTIMATED AMOUNT (Over Micro- Purchase Threshold, but up to the SAT)

$247,000.00

CITE AUTHORITY & JUSTIFICATION TYPE – READ FAR 6.302 TO DETERMINE APPROPRIATE TYPE

10 U.S.C. § 3204(a)(1)

ONLY ONE RESPONSIBLE SOURCE AND NO OTHER SUPPLIES OR SERVICES WILL SATISFY

AGENCY REQUIREMENTS.

☐ 10 U.S.C. § 3204(a)(2) UNUSUAL AND COMPELLING URGENCY

10 U.S.C. § 3204(a)(3)

INDUSTRIAL MOBILIZATION; ENGINEERING, DEVELOPMENTAL, OR RESEARCH CAPABILITY; OR

EXPERT SERVICES

☐ 10 U.S.C. § 3204(a)(4) INTERNATIONAL AGREEMENT

☐ 10 U.S.C. § 3204(a)(5) AUTHORIZED OR REQUIRED BY STATUTE – MUST PROVIDE IT

☐ 10 U.S.C. § 3204(a)(6) NATIONAL SECURITY

☐ 10 U.S.C. § 3204(a)(7) PUBLIC INTEREST [SECRETARY OF HOMELAND SECURITY NEEDS TO APPROVE THIS DOC]

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED, AND THE INTENDED USE.

HSWL SC has 47 Cepheid GeneXpert systems deployed to CG ashore and afloat units. Cepheid requires a service contract to provide routine and emergency maintenance for the systems. GeneXpert systems are used to conduct COVID-19, FLU A/B, RSV, STREP and Vaginitis. This requirement is to provide annual on-site service visit by Field Service Engineer to conduct preventive maintenance inspections and 24/7 telephone support for 47 GeneXpert systems. Additionally, Cepheid will provide all personnel, parts, labor, and shipping costs associated with GeneXpert system repair incurred during the duration of established agreement. Routine parts replacement included any devices associated with the system.

UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER

SUPPLIES OR SERVICES CAN BE USED.

The Government has a current need in the HSWL SC Laboratories in order to provide maintenance services for a government owned Cepheid® GeneXpert® systems. Current market research has not revealed any other vendors than Cepheid® that could provide the particular maintenance services for this equipment. Failure to award a contract to Cepheid® would result in a lapse in testing, further resulting in potential mission failure in providing health care services to the CG clinics and cutters. Cepheid® is the only responsible source and no other vendor is capable of meeting the Government’s need. Currently Cepheid® is the only vendor that has the capability to provide maintenance, troubleshoot, provide any needed replacement equipment, or provide software support.

Currently Cepheid® has the proprietary rights of the firmware that is necessary to run the GeneXpert® system molecular analyzer and is unique to Cepheid®.

Currently it is in the best interest of the Government to acquire the maintenance services from Cepheid®, as they are the only vendor capable of meeting the Government’s requirement.The requirement is also based on Cepheid® equipment being proprietary in nature,. Proprietary in this sense is defined as any equipment or component of the system can only produced or repaired under exclusive rights to the manufacturer and that manufacturer has no legal obligation to disclose any information that may compromise the uniqueness or specialized nature of the system. Cepheid® required trained and factory authorized only technicians to perform service, maintenance, or repair tasks. any other outside agency are considered unauthorized therefore voiding any and all warranty or service agreements and are not in the best interest of the government.

March 8, 2023 Version

A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT QUOTATIONS OR OFFERS ARE SOLICITED FROM AS MANY

POTENTIAL SOURCES AS PRACTICABLE (INCLUDE YOUR MARKET RESEARCH EFFORTS HERE).

A sought notice was posted on July 16, 2024 under notice ID: CEPHEID_GENEXPERT_SYSTEM_RFI. The notice stated that all responsible sources may submit a capability statement or proposal, which shall be considered by the agency to determine if a comparable source is available, or more advantageous to the government. The notice closed on August 19, 2024, with one response from a GeneXpert Supplier from Iraq and no applicable response to the notice.

REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE WHICH CAN PROVIDE THE SUPPLIES OR SERVICES.

A search of the mandatory sources of procurement for supplies, UNICOR and Ability One, revealed that they do not offer the requested supplies and services. A search of GSA Advantage revealed that Cepheid has an FSS that offers the sale of their equipment; however, their FSS does not offer the requested services.

Previous market research efforts noted that large businesses McKesson and Thermo Scientific offer Cepheid reagents; however, Cepheid stated those businesses only distribute their equipments; however, they are not authorized to provide preventive maintenance services and repairs.

EXPLAIN WHY AN ADEQUATE PURCHASE DESCRIPTION OR OTHER INFORMATION SUITABLE TO SOLICIT BY FULL

AND OPEN COMPETITION HAS NOT BEEN DEVELOPED OR ARE NOT AVAILABLE.

Based on Market Research, COR anticipates that only one response will be received from Cepheid, and will based on a Far and Reasonable decision in comparison to Market Research (Historical Pricing) and comparison of the proposed price with prices found reasonable on previous purchases in accordance with FAR 13.106-3(a)(2)(1) and (11)

PROVIDE A STATEMENT OF ACTIONS, IF ANY, THE GOVERNMENT MAY TAKE TO REMOVE OR OVERCOME ANY

BARRIERS TO COMPETITION BEFORE FUTURE ACQUISITIONS ARE REQUIRED.

HSWL SC Lab Program Manager will conduct market research prior to any new purchase requirements to determine if there have been any changes in the marketplace.

SIGNATURE AND TITLE OF CUSTOMER CODE TELEPHONE

NUMBER

DATE

SIGNATURE OF CONTRACTING OFFICER

CODE TELEPHONE

DATE