SSJ Cephid GeneXpert Services_03.16.26.pdf

Control Number: FY26-0547

Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold

1. Identification of the Agency and Contracting Activity: NMRTC Camp Pendleton, Directorate of Ancillary Support Services in the Laboratory Department (Customer) and Defense Health

Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division

(HCD) - West, supporting Naval Hospital Camp Pendleton (Acquisition Services).

2. Description of Action:

☐ New Requirement

☐ Purchase Order

☐ Blanket Purchase Agreement (BPA)

☐ Order against BPA #

☐ Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract

☐ Order against Single Award IDIQ Contract #

☐ Order against Federal Supply Schedule Contract #

X Follow-on Requirement to Contract/Order #

*NOTE: Vendor previously provided services under N6809422P6007 (expiring)

Modification against existing Contract/Order and Modification #

Contract Type:

X Fixed Price

☐ Time & Materials/Labor Hours

☐ Cost Reimbursable

☐ Hybrid

3. Description of Services or Supplies and Estimated Value:

The vendor shall provide full-service support for two (2) Cepheid GX16A1YGeneXpert analyzers under the

Cepheid Essential Care Plan. Equipment Service shall include: Description: The GX16A1Y refers to the Cepheid

GeneXpert XVI System, a high-throughput, automated PCR analyzer that processes 16 samples with 10-color multiplexing, featuring random access, touchscreen, and walk-away capability for fast, 24/7 diagnostic results from closed cartridges, ideal for centralized or decentralized lab testing. Key specs include its 16-module capacity, integration with lab systems, and power requirements.

Features:

Capacity: 16 modules for high throughput.

Automation: Fully automates sample prep, PCR, and detection, minimizing hands-on time.

Technology: Uses closed cartridge technology and 10-color multiplexing for broad test panels.

5. Reason for Authority Cited:

After completion of the market research, it was our desire to acquire the highly specialized

Cepheid GeneXpert Analyzers which satisfies the laboratory need for testing patient samples. We currently have an existing Cepheid GeneXpert system already established within our department.

Having other equipment sources will create unnecessary delays, increased risks in specimen degradation, validation tasks with change of instrumentation - creating potential challenges in isolation of organisms. This system supports the agency initiative in process improvement, manning and efficiency objectives while supporting current mission and vision of Camp

Pendleton Hospital. The support services provided for these systems are proprietary and must be provided by Cepheid or vendors authorized by Cepheid, otherwise the warranty would be voided.

6. Market Research:

The staff of the Laboratory Department performs regular and continuing market research with respect to GeneXpert GX16A1Y Systems available on the market today that is appropriate for all

NMRTC Camp Pendleton patients and beneficiaries. Our most recent market research was conducted online. GeneXpert Systems can supply products/equipment requested by the

Government. The support services provided for these systems are proprietary and must be provided by Cepheid or vendors authorized by Cepheid, otherwise the warranty would be voided.

7. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 7.a.(1) is No, was the action just prior to this one competed? No, sole source purchase.

(3) If 7.a.(2) is Yes, what has changed where this action cannot be competed?

Not applicable

b. Additional Information:

The proposed contractor, Cephid Inc., is the brand name that owns the GeneXpert Systems

(Cepheid GeneXpert Systems); therefore, they are the proprietary vendor for these support services. The support services provided for these systems are proprietary and must be provided by

Cepheid or vendors authorized by Cepheid, otherwise the warranty would be voided.

The GeneXpert GX16A1Y Systems enables our existing laboratory practices, support patient care and readiness. To maintain operational availability and accreditation requirements, the analyzers must be supported by a Cepheid service plan providing comprehensive maintenance and technical support. Our technicians are also trained with Cepheid Systems will require a lengthy validation protocol/process that will ultimately impact workload and potential delay in our Microbiology section to deliver quality patient results to help healthcare provider with diagnosis and care for their patients. If contract is changed, microbiology capability will be delayed, and services will be at risk.