A13- SAP-Sole-Source-Justification RFO Part 8 and 12- CO signed 08Jun2026.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $350,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 12.102 or 8.401 (GSAR 538.7104-3). At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

National Center for Emerging and Zoonotic Infectious Diseases Division of Foodborne, Waterborne, and Environmental Diseases Enteric Diseases Laboratory Branch 1600 Clifton Road (Roybal campus) Building 23 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Office of Acquisition Services

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Five-year Illumina MiSeq i100 Plus Silver Support Plan maintenance agreement for Illumina MiSeq i100 Plus Sequencer S/N: SH00687 (Base Year plus Four Option Years).

b. Procurement Request (PR) Number (if available): HCRBC-2026-98944

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Illumina, Inc

b. Estimated Procurement Amount: $68,862.65

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 6/2/26

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 12.102, “only one source is available” in accordance with 41

USC 1901:

Only one source available A brand-name product or service being required without allowing “equal” products The need for compatibility with existing systems, equipment, software, licenses, warranties, or support arrangements Unusual urgency Exclusive licensing or proprietary rights Continuity of operations Other: [briefly describe]

2. Market Research Conducted:

Extensive market research was conducted through review of commercial sources, SAM.gov, historical acquisitions, manufacturer information, publicly available vendor information, and available contract vehicles. Market research included evaluation of maintenance support providers for the Illumina MiSeq i100 Plus platform and review of OEM maintenance requirements associated with the equipment.

The market research determined that Illumina, Inc., as the Original Equipment Manufacturer (OEM), is the sole authorized provider of comprehensive maintenance and support services for the Illumina MiSeq i100 Plus Sequencer. Illumina retains exclusive rights to the system’s proprietary diagnostic software, firmware updates, factory calibration procedures, and certified OEM replacement parts. No authorized third-party maintenance providers capable of providing equivalent OEM-certified support were identified.

Additionally, a Notice of Intent will be posted to identify any additional sources capable of satisfying the Government’s requirement. Any responses received will be evaluated to determine whether additional qualified sources exist.

3. Facts supporting sole source procurement: What can this product/service do that other products/services cannot do? Include description of other products/services considered and why they did not meet the need.

The requirement is for a five-year maintenance service agreement for the Illumina MiSeq i100 Plus Sequencer S/N: SH00687. This instrument is a mission-critical component of CDC’s PulseNet foodborne disease surveillance network and supports whole-genome sequencing activities necessary for rapid identification and investigation of foodborne disease outbreaks.

The Illumina MiSeq i100 Plus is a highly specialized scientific instrument that utilizes proprietary complementary metal-oxide-semiconductor (CMOS) technology, Illumina sequencing by synthesis (SBS) chemistry, proprietary firmware, proprietary diagnostic software, and factory-specific calibration standards. Maintenance, repair, calibration, software support, and firmware updates require access to proprietary OEM resources that are not available to non-authorized service providers.

Rev. 6/2/26

Illumina is the only source that employs field service engineers specifically trained, certified, and authorized to maintain and repair the MiSeq i100 Plus platform. Illumina is also the only source with direct access to OEM diagnostic tools, firmware updates, software support resources, factory calibration procedures, and certified replacement parts necessary to ensure the instrument continues to perform in accordance with manufacturer specifications.

Market research did not identify any authorized third-party maintenance providers capable of providing OEM-certified maintenance, proprietary diagnostic software access, firmware updates, certified replacement parts, and manufacturer-authorized service support for the MiSeq i100 Plus platform. Use of non-OEM maintenance services would risk loss of warranty coverage, degraded instrument performance, extended downtime, interruption of mission-critical laboratory operations, and reduced reliability of sequencing results.

Because only Illumina can provide the required OEM-certified maintenance services while preserving system integrity, manufacturer support, and operational readiness, Illumina, Inc. is the only source reasonably available to satisfy the Government’s requirement.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name: André Hopkins, Public Health Analyst

Center/Institute/Office COR/Program Official Signature/Date

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Sheena Delaine, Contracting Officer

Contracting Officer Signature/Date