Notice of Intent to Sole Source Nucleic Acid Testing (NAT) Analyzers

Solicitation / RFP / RFQ

This document is a Justification and Approval (J&A) for a sole-source acquisition of three (3) Nucleic Acid Testing (NAT) analyzers (molecular diagnostic instruments) for the Defense Health Agency (DHA), specifically for the Armed Services Blood Bank Center-San Antonio (ASBBC-SA). The purpose is to screen blood and plasma donations for infectious diseases, including West Nile Virus (WNV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficient Virus (HIV), and Babesia. The acquisition is necessary to support the medical processing of approximately 30,000 Basic Military Trainees annually and the collection of 10,000 blood units.

• Lease of 3 Nucleic Acid Testing (NAT) analyzers.

• Continuous sample loading capability for flexible workflow and rapid turnaround.

• Simultaneous testing for WNV, HBV, HCV, HIV, and Babesia.

• Throughput of 275 results in an 8-hour shift.

• Compact physical footprint (238 sq. ft. available laboratory space).

• 24/7 live telephone hotline with a 24-hour technical service response time.

• Compatibility with existing laboratory utilities and Government-owned Pipettor system.

• Contract Type: Firm-Fixed Price (FFP).

• Period of Performance: 12 months (Base Period: 29 May 2026 – 28 May 2027).

• Estimated Value: Not explicitly stated, but a total estimated ceiling is mentioned.

• Funding Type: Operations & Maintenance (O&M).

• This is a sole-source justification, indicating no open competition at this time. A "Notice of Intent to Sole Source" was published on SAM.gov, yielding zero interested parties.

• Future competition is planned by synchronizing this contract with a reagent procurement vehicle and conducting market research (RFI, Industry Day).

• This is a sole-source acquisition, not subject to set-aside requirements.

• The Grifols Procleix Panther system is identified as the only source meeting all requirements, particularly due to its compact footprint and compatibility with existing Government-owned equipment, avoiding significant cost duplication and mission delays. Alternative systems (Roche Cobas, Hologic Panther) were evaluated and rejected due to space limitations, utility incompatibility, or inability to perform the full panel of required assays.

• The contract will include ongoing maintenance, service, and technical support.

Statement of Work (SOW)

To provide Nucleic Acid Testing Analyzers and associated support services for the Medical Treatment Facility (MTF) and Blood Donor center at JBSA Lackland, Texas. The analyzers are intended for screening blood and plasma donations for infectious diseases.

• Lease of three (3) Nucleic Acid Testing Analyzers for the Blood Donor Center.

• Provision of continuous equipment lease and support services.

• Support for medical processing of approximately 30,000 Basic Military Trainees and collection of 10,000 blood units.

• Services include preventative maintenance, unscheduled repairs, and software revisions.

• Equipment must be capable of testing for West Nile Virus, Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, and Babesia using nucleic acid detection methods.

• Equipment must be new, not refurbished.

• The analyzer system must fit within a 238 sq ft space, with capacity for two analyzers for redundancy.

• The system must not require a water treatment system.

• Analyzer basic requirements include specific ambient operating conditions, automated workflow, noise limits, reporting capabilities, continuous load/unload capacity, LIS connectivity, and a defined assay portfolio.

• Throughput requirement: 275 results in 8 hours or 500 results in 24 hours.

• Standard of care must align with College of American Pathologists (CAP), Association for the Advancement of Blood and Biotherapies, and FDA guidelines.

• Equipment performance will be evaluated by the Chief of Clinical Laboratory Services.

• Location: JBSA Lackland, Texas.

• Specific contract period of performance is not detailed in this SOW excerpt, but installation must be completed by a specified date.

• Installation by company engineers and product specialists, including initial validation and calibration.

• A minimum thirty-day overlap with the previous performance period for validation studies.

• Provision of a full uninterruptable power supply (UPS).

• Training: Onsite and offsite training for MTF personnel.

• Maintenance: Seven (7) days a week, 24-hour hotline support with on-site service within 24 hours if phone support fails.

• Computer Interface: Bi-directional interface for the hospital Electronic Health Record (EHR) system.

• Environmental Site Visit required to assess cooling, space, and electrical feasibility.

• Contractor personnel must comply with MTF infection control and safety procedures.

• Strict adherence to HIPAA and Privacy Act regulations regarding Protected Health Information (PHI).

• Contractor is responsible for all parts, labor, and services for the analyzer system.

• Contractor must provide housekeeping during servicing.

• Government will not be responsible for damage to the analyzer system unless due to malicious destruction.