Notice of Intent to Sole Source: Lab Chemistry Analyzer and Cost-Per-Test Agreement for Naval Health Clinic Charleston

Form / Attachment / Pricing Sheet

This document, "Attachment A - Test Menu Requirements," lists the required clinical chemistry reagents, immunoassay reagents, and consumables, along with their annual volumes. It serves as a specification for the types and quantities of laboratory supplies needed.

• Clinical Chemistry Reagents: Includes a list of specific tests (e.g., HbA1c, Albumin, Glucose, Potassium) and their corresponding annual volumes.
• Immunoassay Reagents: Lists tests such as Free T4 and TSH with their annual volumes.
• Consumables: Details various laboratory consumables like control materials, calibrators, diluents, tips, cuvettes, and reagents, along with their required quantities.

This attachment is crucial for bidders responding to an opportunity that involves the provision of laboratory testing services or supplies. It directly informs the scope of work, required inventory, and potential volume of products needed, impacting pricing, logistics, and operational planning for any vendor seeking to fulfill this requirement.

Form / Attachment / Pricing Sheet

This document, "Attachment B - Essential Characteristics & Specifications Lab Chemistry Analyzer," outlines the specific technical requirements and performance characteristics for a lab chemistry analyzer. It serves as a detailed specification for bidders to understand the capabilities and features the government requires.

• Analyzer Requirements: Must meet CLIA'88 and CLSI standards for accuracy and precision. Requires an Authority to Operate (ATO) certificate from DHA.
• Operational Capabilities: Must perform all testing (pre-analytical/post-analytical), operate within 18-25 degrees Celsius and <70% humidity, and function without plumbing or external water sources.
• Technical Features: Requires 10 user-defined chemistry channels, single-use tips, storage for >240,000 samples/2 years with CD-ROM archiving, on-board reagent storage (Appendix A), bi-directional interface with LIS, manual/STAT/automatic test processing, positive patient identification via barcode scanner, and utilization of Dry-Slide Technology (Direct ISE, Colorimetric/Rate, Immunorate methods).
• Performance: Must include auto dilution, auto repeat, auto reflex, self-monitoring, clot detection, bubble detection, liquid Level-Sensing, short-sample detection, and determination of hemolysis, icterus, and turbidity without affecting throughput.
• Compliance: Must comply with FDA regulations and OSHA requirements.
• Physical Specifications: Footprint not to exceed 65.0” W x 43.0” D x 84.0” H, with space for UPS. No benchtop required; cart to be provided by contractor if needed.
• Cost-Per-Test: Pricing must include analyzer, reagents, supplies, and maintenance for 12 months. Single ship-to/bill-to required.
• Ordering & Delivery: Annual test volumes to estimate needs. Shipments quarterly or biannually. Deliveries to Naval Health Clinic Charleston.
• System Interface: Bi-directional interface with MHS GENESIS and ability to receive HL7 order messages from LIS. Interface integration at no cost to the government.

This attachment is critical for bidders to understand the precise technical specifications, operational constraints, and performance expectations for the lab chemistry analyzer. It directly informs product selection, system integration planning, and cost proposals. Bidders must ensure their proposed analyzer meets all listed criteria, including specific technologies, compliance standards, and interface requirements.

Notice of Intent to Sole Source

This Notice of Intent (NOI) informs industry of the Defense Health Agency's intent to award a sole source contract for a VITROS® 5600 Lab Chemistry Analyzer. This is not a request for competitive quotes.

• Provision of a VITROS® 5600 Lab Chemistry Analyzer capable of performing Costs-Per-Tests.

• The analyzer must comply with specifications in Attachment A (Test Menu Requirements) and Attachment B (Essential Characteristics).

• Compatibility with the Military Health System (MHS) GENESIS electronic health record system is required.

• The Cost-Per-Tests agreement includes all reagents, calibrators, controls, supplies, and preventive maintenance.

• The contractor must provide all necessary personnel, equipment, supplies, facilities, transportation, materials, and supervision.

• All services must comply with federal, state, and local laws, regulations, manufacturer standards, and commercial requirements.

• The contractor must possess a current/approved Authority to Operate (ATO) certificate from the Defense Health Agency (DHA) for the specific model.

• The contract will be a Cost-Per-Test Agreement.

• The period of performance includes a Base Period plus four (4) Option Years, and one (1) six (6) month Option period.

• Place of delivery/service: Naval Health Clinic Charleston, 110 NNPTC Circle Bldg. 2418, Goose Creek, SC 29445.

• This NOI is for informational purposes only. No award will be made based on unsolicited quotations or offers.

• Interested parties who are responsible, certified, and capable may submit a Capabilities Statement by 10:00 AM EST on February 19, 2026.

• Responses must show clear, compelling, and convincing evidence that competition would be advantageous to the Government.

• NAICS Code: 334516

• PSC Code: 6630

• SBA Size Standard: 1,000 employees

• All inquiries and concerns must be addressed in writing via email to Min Aung (min.z.aung.civ@health.mil) and Lenore Y. Paseda (lenore.y.paseda.civ@health.mil) with "VITROS ® 5600 Lab Chemistry Analyzer, Naval Health Clinic Charleston" in the subject line.