JA SS - BeLPT - Redacted.pdf
PDF 330 KB Posted
- Solicitation number
- HT941026N0006
- Issued by
-
Defense Health Agency
About this file
This is a Justification and Approval (J&A) for a sole source contract award under FAR 13.501 (Simplified Acquisition Procedures).
The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division West in San Diego, is seeking to award a firm fixed price sole source contract to National Jewish Health, located at 1400 Jackson Street, Denver, Colorado 80206, for Beryllium Lymphocyte Proliferation Test (BeLPT) services. The requirement is for Naval Health Clinic Hawaii (NHCH), which needs approximately 250 blood samples tested annually for beryllium sensitivity through BeLPT testing. The contract period runs from February 1, 2026, through January 31, 2027, with four one-year option periods extending through January 31, 2031. BeLPT is a critical occupational health surveillance test mandated by the Occupational Safety and Health Administration (OSHA) for workers exposed to beryllium. Blood samples must arrive at the testing facility within 24–48 hours of collection to maintain cell viability; samples received after this timeframe or with negative positive control tests are rejected and must be redrawn.
National Jewish Health is justified as the sole source because it is the only vendor of three identified BeLPT providers capable of meeting the strict 24–48 hour delivery requirement due to its proximity to Hawaii and its decades of experience performing the assay at scale with dedicated facilities, cell-culture operations, quality assurance systems, and demonstrated long-term proficiency in federal beryllium health surveillance programs. Cleveland Clinic was determined to lack specialized beryllium immunology experience and operates at smaller test volumes, while Oak Ridge Institute for Science and Education focuses on program management and research rather than high-volume clinical laboratory services. National Jewish Health is the incumbent contractor on current contract HT941023P0009, with only two samples received outside the viability window in the past three years due to inclement weather. A Notice of Intent to Sole Source was posted on SAM.gov from November 20, 2025, through December 4, 2025, with no competing proposals or capability statements received. The contracting officer has determined the anticipated cost to be fair and reasonable based on comparison to previous purchases and the Independent Government Cost Estimate.
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Text version
CUI
Source Selection Information - See FAR 2.101 and 3.104-4
2 NOV 2024
5. Rationale Justifying Use of Authority Cited:
This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR Subpart 13.5 in accordance with 41 U.S.C. 1901.
Blood samples must arrive at the testing facility within 24 - 48 hours after blood collection to maintain viability. If blood samples are received past 48 hours after the sample is drawn, or the positive controls’ test is negative, the sample is rejected, and a new blood test must be re-drawn and re-submitted by NHCH. The contractor’s place of performance location is a major factor in ensuring test samples are delivered within this time frame. There are three (3) potential vendors that perform BeLPT in the United States.
National Jewish Health (NJH) is located in Denver, Colorado. Due to its proximity to NHCH, National Jewish Health has the ability to accommodate this strict time frame. Their BeLPT program is built around decades of performing the assay at scale with dedicated facilities, cell-culture operations, and quality assurance systems. NJH is uniquely positioned to ensure test method uniformity, a critical mitigation factor for known BeLPT variability. To provide living cells capable of mounting a response to antigenic stimulus, the first 24 – 30 hours after the blood is drawn is determined excellency for cell viability. NJH has found cells are able to survive up to the 48-hour timepoint and can mount a response to positive controls and the beryllium antigen.
NJH is the incumbent on current contract HT941023P0009, and for the past three years, only two samples were received after viability due to inclement weather.
Cleveland Clinic does not specialize in beryllium immunology or operates as a national BeLPT reference laboratory. Its experience is significantly more limited compared to NJH, with smaller test volumes and lest historical involvement in national-scale programs, with no demonstrated, long-term proficiency testing history comparable to NJH’s involvement in federal beryllium health surveillance programs.
Oak Ridge Institute for Science and Education is primarily a program management, research, and workforce development under Department of Energy, not a high-volume clinical laboratory service provider. ORISE’s focus is not full-scall medical surveillance laboratory operations and does not maintain the same level of immunologic testing specialization or long-term continuous BeLPT program infrastructure
National Jewish Health is the only vendor capable of meeting the government’s requirement and meeting the 24 - 48 hours’ time frame.
6. Efforts to Obtain Competition:
Contract specialist conducted a mandatory search throughout November 2025 and determined via internet searches that this requirement is customarily available in the commercial marketplace. BeLPT services are not available from the following mandatory sources:
AbilityOne, UNICOR, ECAT, MMC, VA, and GSA Advantage. A small business dynamic search for small business firms meeting the requirement resulted in negative results under
3 NOV 2024
NAICS code 621511 and search terms beryllium lymphocyte proliferation test. Historical contract HT941023P0009 was not previously competed and was solicited as sole source.
A Notice of Intent (NOI) to Sole Source under solicitation number HT941026N0006 was issued on 20 November 2025 and closed 04 December 2025, allowing potential vendors to provide capability statements meeting the Government's minimum requirements. No responses were received, and no additional sources submitted capabilities statements for the Government consideration.
7. Actions to overcome barriers:
Naval Health Clinic Hawaii and the DHA Healthcare Contracting Division West will continue to survey and engage the market of any potential vendors that can provide BeLPT services and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for BeLPT services.
8. Market Research:
As stated above, several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online search engines reviewed by Naval Health Clinic Hawaii and DHA Healthcare Contracting Division West in November 2025.
A Notice of Intent to Sole Source was posted on SAM.gov under solicitation number HT941026N0006 from 20 November 2025 and closed 04 December 2025, resulting in the identification of no additional sources capable of meeting the Government's minimal requirement.
9. Other Facts:
a. Procurement History:
(1) Is this a new requirement? No.
(2) If 9.a.(1) is No, was the action just prior to this one competed? No.
10. Interested Sources:
National Jewish Health is the only source identified that can meet the Government's minimum requirements. Additional market research and the posting of a Notice of Intent to Sole Source did not identify any additional interested parties.
11. Technical Certification:
I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.
4 NOV 2024
12. Requirements Certification:
I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.
13. Fair and Reasonable Cost Determination:
I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.
Basis for Determination: In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer utilized FAR 13.106-3(a)(2)(ii), a comparison of the proposed price found reasonable on previous purchases and FAR 13.106-3(a)(2)(vi), a comparison of the price to the Independent Government Cost Estimate (IGCE) to determine fair and reasonable.
14. Legal Review:
I have reviewed this justification and have found it to be legally sufficient.
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