JA FAR Part 12 Analyzer Lease and Reagents CRDAMC_Redacted.pdf

CUI//SP-PROCURE//FEDCON

Control Number: 26-MRCO-WEST-124

JUNE 2025

b. Operational and Technical Standardization: The reagents, assays, and consumable supplies required for existing Government-owned diagnostic equipment are proprietary to the Original Equipment Manufacturer (OEM), Cepheid. Carl R. Darnall Army Medical Center (CRDAMC) currently operates four (4) Government-owned Cepheid analyzers across the facility. To maintain clinical standardization, reduce operational risk, and ensure seamless system integration, the nine (9) leased analyzers must feature complete technical and consumable compatibility with this existing infrastructure. Procuring non-compatible platforms would disrupt established clinical workflows, necessitate duplicative staff training, and require the redundant stocking of mismatched consumables. Standardizing Cepheid-manufactured analyzers and accessories is therefore critical to maintaining clinical continuity and represents the most cost-effective, low-risk procurement strategy for the Government.

c. Clinical Standard and Performance: There are no other platforms that currently match performance, timeliness, and genetic target utilization. Cepheid is required to meet the current clinical standards implemented at this facility. The system’s ability to deliver these specific metrics is vital for maintaining the current level of patient care.

d. Proprietary System: The required reagents are essential consumables for the

Cepheid GeneXpert platform, which is a proprietary system manufactured by Cephid. These cartridges are specifically designed and optimized to function with the instrument’s hardware and software.

e. Compatibility: Only Cepheid GeneXpert cartridges are validated for use with the

Cepheid GeneXpert platform. Using third-party reagents would not fit the instrument and if tried would void the instrument's warranty, risk equipment damage, and lead to no diagnostic results.

f. Integrated Workflow: The GeneXpert cartridges are a core component of an integrated system that includes instruments, software, and reagents. Sourcing from the Original Equipment Manufacturer (OEM) is the only way to guarantee seamless operation and reliable technical support for the entire platform.

g. Diagnostic Quality and Consistency: Cepheid’s ready-to-use reagents ensure the highest level of molecular diagnostic quality, consistency, and reproducibility, which are critical for accurate infectious disease diagnosis. An alternative would require extensive in-house validation, delaying patient care.

h. Based on these factors, Cepheid is the only source that can provide the compatible and validated molecular diagnostics required for the Cepheid GeneXpert platform system. This is necessary to deliver timely, accurate and high-quality patient care.

Control Number: 26-MRCO-WEST-124

JUNE 2025

i. Alternatives: The only alternative is to entirely replace the Government-owned analyzers with another vendor, which would come at a significant duplication of cost and unacceptable delays for installation and to retrain staff. The Government has already invested significant capital in the current Cepheid analyzer equipment. Switching to a different vendor's analyzer and reagents would necessitate the purchase of entirely new analyzer platforms and compatible reagents, resulting in a duplication of costs, which would be cost-prohibitive and cause significant operational disruption up to six (6) months, including the need for retraining personnel and re-validating all diagnostic tests.

This acquisition of Cepheid analyzer lease and reagents is the only viable path to continuing the use of existing Government-owned, Cepheid-manufactured equipment. Therefore, there are no viable alternatives that are in the best interest of the Government due to the proprietary use of compatible Cepheid analyzers and reagents.

j. Impact if not approved: The laboratory would not have a compatible analyzer and reagents with the Government-owned equipment. Therefore, patients would be outsourced to the network at an increased cost to the Government indefinitely until a compatible analyzer and reagents were acquired.

7. Efforts to Obtain Competition: In accordance with RFO FAR 5.101, a notice of intent to award a sole-source contract will be published on the Government-wide Point of Entry (GPE). Any capability statements, bids, or proposals received will be evaluated. The Contracting Officer will publish the notices required by RFO FAR

5.101 and any bids or proposals received shall be considered.

a. Effective competition: Effective competition is not anticipated due to the proprietary nature of the requirement since Cepheid is the OEM and sole manufacturer of Xpert® reagents and GeneXpert® systems that are compatible with the four (4) Government-owned analyzers used throughout the medical center.

b. Subcontracting competition: Subcontracting competition is not applicable as the prime contractor is the sole manufacturer of the required analyzer and reagents/supplies. Therefore, there are no subcontracting possibilities in accordance with RFO FAR 19.109(c)(2).

8. Actions to Increase Competition: The Government will continue to monitor the laboratory analytical equipment and in-vitro diagnostics (IVD) markets for new entrants, technological changes, or other sources authorized to sell and service Cepheid-manufactured equipment. Prior to the exercise of each option period, the Contracting Officer will conduct market research to determine if any compatible, alternative products have become available. The findings will be documented in the contract file.