Beryllium Lymphocyte Proliferation Test (BeLPT) for Naval Health Clinic Hawaii

Justification and Approval (J&A) / Sole Source Justification

This document justifies a sole source contract action for Beryllium Lymphocyte Proliferation Test (BeLPT) services. The Defense Health Agency (DHA) Contracting Activity (DHACA) intends to award a firm-fixed-price contract to National Jewish Health for these services to meet the requirements of Naval Health Clinic Hawaii (NHCH).

• Annual BeLPT services for an estimated 250 blood samples.

• Testing to determine beryllium sensitivity by measuring lymphocyte proliferation.

• Services are required for medical surveillance of workers exposed to Beryllium, as mandated by OSHA.

• Costs for shipping, testing, and interpreting results are included.

• Contract Type: Firm Fixed Price

• Period of Performance: Starts 01 February 2026 to 31 January 2027, with four (4) option years extending through 31 January 2031.

• Estimated Amount: Not explicitly stated, but the document refers to a total estimated amount.

This document is a justification for a sole source award, not a solicitation. Therefore, there are no proposal submission or evaluation criteria detailed here.

This is a sole source justification. Market research was conducted, including a Notice of Intent posted on SAM.gov, which did not identify any other capable sources.

• The critical factor for this sole source justification is the strict 24-48 hour timeframe for blood sample viability after collection. National Jewish Health's location in Denver, Colorado, and established infrastructure are cited as essential for meeting this requirement.
• The previous contract for these services was also a sole source award.
• The statutory authority cited is FAR Subpart 13.5 in accordance with 41 U.S.C. 1901 (Simplified Acquisition Procedures).

Statement of Work (SOW) / Performance Work Statement (PWS)

To acquire Beryllium Lymphocyte Proliferation Test (BeLPT) services to support the Naval Health Clinic (NHC) Hawaii Makalapa Laboratory in fulfilling Occupational Safety and Health Administration (OSHA)-mandated medical surveillance for workers exposed to Beryllium.

• Performance of BeLPT testing services for blood samples submitted by NHC Hawaii Makalapa Laboratory.

• Includes sample processing, testing, result interpretation, and reporting.

• Ensures compliance with relevant shipping regulations and maintains patient data confidentiality.

• Results must be accurate, timely, and compliant with all applicable regulations.

• Reporting of BeLPT results within 14 calendar days of sample receipt.

• Comprehensive Quality Control Plan (QCP) to ensure accuracy, reliability, and timeliness.

• Period of Performance (PoP): Base (02/01/2026 - 01/31/2027) with four Option Periods extending to 01/31/2031.

• Place of Performance: Contractor Facility.

• Contractor must provide all personnel, equipment, supplies, facilities, transportation, tools, and materials.

• Must maintain a secure and confidential system for storage and transmission of patient data, complying with HIPAA and DHA security policies.

• Contractor must have a CLIA-certified laboratory space.

• Adherence to OSHA Standards for Beryllium Exposure, HIPAA Regulations, and IATA Shipping Regulations for Biological Specimens.

• TIER II: Non-critical sensitive position for personnel.

Notice of Intent to Sole Source

This document is a Notice of Intent to award a sole source service contract for Beryllium Lymphocyte Proliferation Test (BeLPT) services to National Jewish Health. The Defense Health Agency Contracting Activity (DHACA) intends to award a firm fixed price contract based on Federal Acquisition Regulation (FAR) 13.501(a) and 13.106-1(b)(1)(i), as only one source is available to meet the Government's needs.

• Procurement of Beryllium Lymphocyte Proliferation Test (BeLPT) services.

• Annual BeLPT services are required for an estimated 250 samples submitted by the Makalapa Laboratory for the Naval Health Clinic Hawaii (NHCH) Occupational Health Department.

• BeLPT is used to determine beryllium sensitivity by measuring lymphocyte proliferation, mandated by OSHA for medical surveillance of workers exposed to Beryllium.

• All costs for shipping, testing, and interpreting results are included.

• Contract Type: Firm Fixed Price

• Period of Performance: Base Year (01 February 2026 - 31 January 2027) plus four (4) Option Years (01 February 2027 - 31 January 2031).

• This is not a request for competitive quotes; no solicitation document currently exists.

• Interested sources must submit capability statements demonstrating their ability to provide the required services.

• Capability statements should include management, technical data, and cost information.

• Capability statements must not exceed six (8.5 x 11 inch) pages with a font size no smaller than 10-point.

• The closing date for challenges to this requirement is no later than 10:00 am Pacific Time, 04 December 2025.

• NAICS Code: 621511 - Medical Laboratories

• Business Size Standard: $41.5M

• PSC Code: Q301 - Medical- Laboratory Testing

• The government has determined National Jewish Health is the only source capable of meeting the requirements, particularly regarding the 24-48 hour sample viability timeframe.

• NHCH will ship samples via priority overnight courier. Samples must arrive at the testing facility within 24-48 hours of blood collection to maintain viability. Late arrivals or negative positive controls will result in sample rejection and require re-testing.

• The contractor's facility location relative to NHCH is a significant factor for timely sample delivery.

• Work will be performed at the contractor's facility.

• Information received will be used to determine whether to conduct a competitive procurement or proceed with a sole source purchase order.