NOTICE OF INTENT TO SOLE SOURCE_Final 5 June 2026.pdf

NOTICE OF INTENT TO SOLE SOURCE:

This Notice of Intent is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored. Only one responsible source, and no other supplies or services will satisfy agency requirements.

The Defense Health Agency Contracting Activity Healthcare Contracting Division, Southeast (DHACA-HCD-SE) provides notice of its intent to award a firm-fixed-price, sole-source contract to Roche Diagnostics. This notice is not a request for competitive proposals; no solicitation package is available, and telephone requests will not be honored. The acquisition is conducted under the authority of Federal Acquisition Regulation (FAR) 6.302-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."

This sole-source requirement is based on the fact that Roche Diagnostics is the only source capable of providing the necessary proprietary equipment and support for the existing infrastructure at the 20th Medical Group, Shaw Air Force Base. Market research confirms that the Cobas® Liat® PCR System, including its analyzers, reagents, and software, is proprietary.

The Original Equipment Manufacturer (OEM), Roche Diagnostics, has provided written confirmation that there are no authorized resellers or third-party service providers for the required maintenance, upgrades, and support. Furthermore, this system is mission-essential due to its superior Turnaround Time (TAT) and unique multiplex assay capabilities. Utilizing an alternative would require procuring entirely new equipment, resulting in unacceptable operational delays and a duplication of costs for the Government.

Under the proposed contract, the contractor shall provide one (1) new Cobas Liat Assays Analyzer, all necessary PCR test kits, and comprehensive maintenance support for both new and existing units. The contractor will be required to provide all personnel, equipment, supplies, and services necessary to deliver a complete molecular real-time polymerase chain reaction service as defined in the Performance Work Statement (PWS).

The Contractor will provide the clinical laboratory with a molecular real-time polymerase chain reaction service. The molecular real-time polymerase chain reaction service includes equipment, equipment service/support, test assays, and equipment support products. Real-time polymerase chain reaction system that is classified by the Clinical Laboratory Improvement Amendments (CLIA) as waived testing for Influenza A/B, RSV, SARS Cov 2, and Streptococcus A assays.

Test Estimate SARS-Cov-2 Approximately 700 Influenza A Approximately 700 Influenza B Approximately 700 Respiratory Syncytial Virus Approximately 700 Beta Streptococcus Group A 700

Testing Range : 3,300 – 3,800 Tests Per Year

Material Number Material Description Unit Ship

Qty Requested

Delivery Date

09731261190 KIT COBAS LIAT SARS-COV-

2/FLU/RSV PC 15 Quarterly 07341911190 KIT COBAS LIAT STREP A PC 36 Quarterly

093731270190

KIT COBAS LIAT SARS-COV-

2/FLU/RSV CTL

PC 3 Annual

07402678190 KIT COBAS LIAT STREP A CTL PC 2 Annual 07402759190 CLEANING TOOL KIT PC 1 Annual

Market research was conducted on the Cobas® Liat® PCR System, which is a service that includes equipment rental of the Roche Diagnostics Liat 1 and 3 analyzers on a cost-per-reportable-result basis. This service also covers all necessary reagents, controls, maintenance, service, any required correlation or start-up studies for the analyzers, and on-site training for personnel.

The system offers the best Turnaround Time (TAT), specificity, and sensitivity. The testing time is 20 minutes from a single nasal sample in a single test. Additionally, the vendor offers a Cobas® Liat® multiplex assay for SARS-CoV-2, Influenza A/B, and RSV, which can test all four viruses in one go.

Period of Performance

• Base Delivery Period - 1 September 2026 to 31 August 2027

• Option Item Period 1 - 1 September 2027 – 31 August 2028

• Option Item Period 2 - 1 September 2028 – 31 August 2029

• Option Item Period 3 - 1 September 2029 – 31 August 2030

• Option Item Period 4 - 1 September 2030 – 31 August 2031

The intended procurement will be classified under North American Industry Classification System (NAICS) 621511 (Medical Laboratories) with a Small Business Size Standard of $41.5 Million.

Materials and Equipment. The Contractor must provide full contract support and full maintenance support. Must provide qualified, certified technicians, test equipment, tools, and materials to perform troubleshooting, repair, preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational and within manufacturer specifications between the duty hours of 8:00am-5:00pm (EST).

There are no set-aside restrictions for this requirement.

Capability Statement: Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10 points. "All capability statements received by the closing date of this synopsis will be considered by the government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response.

A determination by the government is 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 competitive procurement.

Capability statements are due by 12:00 PM, EST, June 19, 2026.

Capability statements shall be submitted by email only as a Microsoft Word or Adobe PDF attachment to the Contracting Officer, Lenore Paseda, lenore.y.paseda.civ@health.mil; and Contract Specialist, Rebecca Brashears, rebecca.a.brashears.civ@health.mil.