Sole Source Justification Cepheid_redacted.pdf

[Last updated 11/28/2025.]

Sole Source Justification (SSJ) RFO - FAR 6.103-1 & GSAM/R 538.7104-3(b)(1)

1. Acquisition Title: Cepheid GeneXpert Analyzer Service Contract

This requirement is for a service contract to provide routine and on-call maintenance, repair, inspection, and parts replacement services for existing Cepheid GeneXpert analyzers located at the Portland Area Office (PAO) Service Units at the following locations: Warm Springs Service Unit (GX 16-16 SN: 844972), Western Oregon Service Unit (GX 16-16 SN: 844156), Fort Hall Service Unit (GX 4-4 SN: 845950) and Yakama Service Units (GX 16-16 SN: 810066). This includes both scheduled preventive maintenance and unscheduled corrective repairs, to be performed during the base period and any exercised option years.

The requirement exists to ensure the Cepheid analyzers remain fully operational and minimize the risk of equipment failure or service lapses. Continuous, reliable operation of this equipment is critical to meeting patient care and safety standards, as any downtime could directly impact diagnostic testing capabilities and patient care.

Division: Portland Area Office, Health Facilities Engineering Contracting Activity: Purchase Order Author: Stella Nantale, COR

2. Nature and/or Description of the Action being Approved: Portland Area Office (PAO) requests a Purchase Order for a comprehensive manufacturer-authorized service and maintenance support with the contractor listed in the table below for the covered GeneXpert analyzers. These are used to perform rapid, point-of-care molecular diagnostic testing at the Service Units identified above. These analyzers provide time-sensitive, on-site diagnostic results that directly support clinical decision-making and patient treatment, consistent with IHS's mission to ensure the availability of quality, accessible healthcare services to American Indian and Alaska Native patients. Uninterrupted operability of this equipment is essential to maintaining diagnostic capacity and continuity of patient care for the Service Units. This acquisition is being conducted as a only Sole Source in accordance with FAR Part 6.103-1, only one responsible source. This requirement is being justified as a sole source acquisition under a Justification for Other Than Full and Open Competition (J&A), on the basis that Cepheid is the only source capable of providing OEM-certified maintenance, repair, and technical support for Cepheid GeneXpert analyzers, which require proprietary calibration software, manufacturer-controlled parts, and factory-trained technicians. The Government projects award for August 2026 for services to be performed with four (4) option years thereafter.

Contractor: Cepheid, 904 Caribbean Drive, Sunnyvale CA 94089 Schedule Contract Number: N/A Performance Period

Dates/Duration Unit Price/CLIN (3% Escalation rate used for illustration purposes only; actual

Multiplier Total escalation rates may vary)

Base Period 12 months $84,000 1 $84,000 Option Period 1 12 months $85,890 1 $85,890 Option Period 2 12 months $87,823 1 $87,823 Option Period 3 12 months $89,799 1 $89,799 Option Period 4 12 months $91,819 1 $91,819 Option to Extend Services per FAR Clause 52.217-8 Estimated Total Dollar Value: $439,331 Original Contract Value: $439,331 New Contract Value: $439,331

*Formulate a table for each awardee if more than one.

3. Description of Supplies and/or Services:

This is for comprehensive manufacturer-authorized service and maintenance support for the covered GeneXpert analyzers, including:

24x7 technical phone support for laboratory and biomedical/clinical engineering staff On-site corrective maintenance Monday–Friday, 8:00 a.m.–6:00 p.m. (excluding federal holidays) Annual preventive maintenance performed by a certified field service engineer All required parts, labor, travel, and replacement components necessary to maintain system functionality (excluding consumables unless otherwise specified) Software updates, firmware updates, security patches, and manufacturer-required system upgrades Remote diagnostics and LIS support, as applicable Minimum 98% system uptime guarantee

Period of Performance:

Base Year: 08/01/2026 – 07/31/2027 First Option Year: 08/01/2027 – 07/31/2028 Second Option Year: 08/01/2028 – 07/31/2029 Third Option Year: 08/01/2029 – 07/31/2030 Fourth Option Year: 08/01/2030 – 07/31/2031

Make and model:

Fort Hall Service Unit Cepheid GX 4-4 SN: 845950 Warm Springs Service Unit Cepheid GX 16-16 SN: 844972 Western Oregon Service Unit Cepheid GX 16-16 SN: 844156 Yakama Service Unit Cepheid GX 16-16 SN: 810066

4. Authority Cited and Rationale: This acquisition is being conducted on a sole source basis in accordance with FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented at FAR 6.303 and FAR 13.106-1(b) (for actions within the simplified acquisition threshold)

a. GSAM/R 538.7104-3(b)(1)(ii)- Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized.

A contract with Cepheid will provide continued Original Equipment Manufacturer (OEM) support and sustainment for existing GeneXpert analyzers which provide results for molecular patient testing in the clinical laboratory testing necessary for the diagnosis, prevention and treatment of disease or assessment of health, providing information for clinical decisions. The manufacturer, Cepheid is the only source capable of meeting the requirement because the GeneXpert platform relies on Cepheid proprietary components/software and manufacturer-controlled service specifications to maintain proper function, performance, and manufacturer requirements.

5. Market Research:

A Sole Source notice was publicized on SAM.gov and received no results, suggesting limited market response to the requirement as structured. The J&A further states that Cepheid is considered the only source capable of meeting the requirement because the GeneXpert platform relies on proprietary components, software, and manufacturer-controlled service specifications. Based on the package, the prior acquisition approach appears to have been vendor-specific OEM service support for installed analyzers, and this market research is intended to confirm whether that remains the most appropriate strategy for the upcoming base year and option periods.

6. Procurement history:

The GeneXpert analyzers were acquired in late 2020 as part of the federal COVID-19 molecular testing response and placed into service between November and December 2020.

Following expiration of the initial manufacturer warranty, IHS Portland Area awarded Purchase Order 75H71322P00047 to Cepheid (UEI: W6HQTMWB9Q28), Sunnyvale, CA, on March 30, 2022, for a 48-month Advantage Service Agreement covering six GeneXpert analyzers across six Service Units at a total value of $232,824.00. The award was supported by a Simplified Acquisition Single-Source Justification under FAR 13.106(b).

a. Contractor: Cepheid Contract or Order Number: 75H71322P00047 Award Date and Period of Performance: 48 months Value (including all options): $231,824 Competitive Status: NA Authority formerly relied upon if Not Competed: 6.103-1

7. Actions to Foster Competition for Future, Similar Requirements:

This requirement is non-competitive due to the proprietary nature of the equipment, GeneXpert analyzers. Because there is a continuing need for maintenance and repair support of this equipment across current and future option years, the Government has initiated advanced planning to address barriers to competition and will continue market research efforts to identify potential opportunities for increased competition, including:

1. Ongoing Market Research — The Government will continue to monitor the market through the GSA Federal Supply Schedule, internet research, and open market sources to identify whether additional vendors become authorized to provide OEM-certified maintenance and repair services for Cepheid GeneXpert analyzers.

2. Long-Term Alternatives Consideration — Should the continuing sole source condition impose significant cost or performance limitations, the Government will evaluate the feasibility and cost-benefit of alternative equipment platforms that may offer competitive service options, weighing potential replacement/transition costs against the benefits of increased competition.

8. Additional Information or Other Facts: NA

9. Technical or Requirements Program Management Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. [Always required.]

7/17/2026

X Stella Nantale Right-Click "Signature Setup"

Signed by: Stella Nantale -S

Typed Name: Stella Nantale Title: Project Manager Signature & Date:

10. Best Value Determination: As the contracting officer, I hereby determine that the anticipated price to the Government for this contract action represents the best value for the Government.

Base on facts provided and market research conducted, it is determined only one responsible source is available to provide requested services and support. And due to proprietary rights noted in file from Cepheid, requirement has limited competition resources. Contracting searched Native American Businesses in SAM.gov utilizing NAICS identified in market research Sources Sought Notice.

Stella Nantale -S

Digitally signed by Stella Nantale -S Date: 2026.07.20 07:32:49 -07'00'

11. Contracting Officer (CO) Certification and Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge. [Always required; CO approval authority is limited to $900 thousand.]

X Right-Click "Signature Setup"

Typed Name Sheila Sells Contracting Officer Signature & Date:

[This space intentionally left blank.]

Sheila D.

Sells -S

Digitally signed by Sheila D. Sells -S Date: 2026.07.20 09:33:21 -07'00'

(The following Reviews and Approvals will ordinarily begin on a separate page at the end of the justification to allow minor, administrative changes to be made during the review process;

delete any individual reviews/approvals not applicable.)

ELEVATED REVIEWS & APPROVALS

12. Insert Division Advocate for Competition (AfC) Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition. [Division AfC approval authority is limited to $20 million.]

X Right-Click "Signature Setup"

Typed Name Title Signature & Date:

13. Insert Division Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition. [HCA approval authority is limited to $90 million.]

Head of the Contracting Activity Signature & Date:

14. HHS Office of General Counsel Review and Concurrence: I reviewed this justification and concur that it adequately supports a sole source acquisition. [Mandatory when SPE approval is required, unless otherwise waived in writing by the SPE.]

Title Signature & Date:

15. HHS Advocate for Competition (AfC) Review and Concurrence: I reviewed this justification and concur that it adequately supports a sole source acquisition. [Mandatory when SPE approval is required.]

HHS Advocate for Competition Signature & Date:

FINAL APPROVAL

16. HHS Senior Procurement Executive Approval: Based on the foregoing, I hereby approve this sole source justification pursuant to the authority of 41 U.S.C. 251, et seq. and 40 U.S.C.

501. [Required if the total award value (including all options and FAR 52.217-8 value, as applicable) exceeds $90 million.]

HHS Senior Procurement Executive Signature & Date: