HT491026N0037 JA Other Than Full and Open Competition under FAR Part 6 for SAM_Redacted.pdf

CUI

Control Number: FY26-0644

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

efficiency and throughput. Market research was conducted to verify the unavailability of alternative sources. A notice of intent to sole source (HT941026N0037) was posted to the System for Award Management (SAM.gov) from 10 April 2026 through 25 April 2026. No responses or expressions of interest were received from industry during this period, confirming that no other vendor can meet the technical requirements of the TAMC Core Laboratory. The inability to procure Phadia reagents and equipment would have a direct, negative impact on mission readiness and patient safety. Without these specific products, TAMC would be forced to cease in-house allergy testing and instead utilize outside reference laboratories. This transition would result in substantial delays in test results and a major disruption to patient care. Additionally, the shift to external testing is estimated to increase laboratory operational costs by approximately 35%. Therefore, the use of Phadia ImmunoDiagnostic products is essential to maintain the standard of care and fiscal responsibility at TAMC.

6. Efforts to Obtain Competition: To date, no sources have expressed written interest in the requirement. A notice of intent to sole source (HT941026N0037) was posted to the System for Award Management (SAM.gov) from 10 April 2026 through 25 April 2026. No responses or expressions of interest were received from industry during this period, confirming that no other vendor can meet the technical requirements of the TAMC Core Laboratory.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: TAMC will continue to survey the market to identify any FDA approved immunoassay analyzers that may become available or other authorized distributors of Phadia Analyzers, Reagents, and accessories. In accordance with the basis for award procedures at RFO 6.104-2, the Contracting Officer will utilize a comparison of the proposed price with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable. Additionally, the Government has historical pricing information from similar contracts that provided similar services. The cumulative data available to the Contracting Officer provides for the ability to determine a fair and reasonable price in accordance with RFO 6.104-1(a)(7).

8. Market Research: Market research was conducted from January through April 2026. This research consisted of reviews of similar previous procurements, alignment with 42 Code of Federal Regulations (CFR) Part 493 and accrediting testing requirements, and searches of mandatory sources including FPDS- NG, ECAT-DLA, and GSA Advantage. Mandatory sources (AbilityOne, UNICOR, and ECAT) and the SBA Dynamic Small Business Search (DSBS) returned negative results regarding vendors able to meet the Government's requirement. The TAMC Core Laboratory relies heavily on Phadia ImmunoDiagnostic products for its ASAP, routine, and specialized applications for diagnostic and prognostic autoimmunity and allergy testing. Phadia is the manufacturer and sole source of reagents for testing specific allergens, including tilapia, sunflower seeds, bayberry, house dust, Hollister-Stier, and peanut components. Furthermore, Phadia provides the only assay that closely mimics skin prick testing.

Phadia reagents are proprietary and can only be used with the Phadia 250 Analyzer; the Phadia Laboratory System is the only FDA-cleared platform capable of fully automated allergy and autoimmune testing on a single, consolidated system. Without these specific reagents and analyzers, TAMC would be forced to cease in-house allergy testing and utilize outside reference laboratories. This would delay test results, disrupt patient care and safety, and increase costs to TAMC by approximately 35%. The requirement includes the provision of analyzers inclusive of all reagents, controls, supplies, consumables, equipment, parts, peripherals, accessories, preventive maintenance, and repairs. Therefore, the recommendation is to issue a sole-source purchase order to Phadia.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes

(2) If 9.a.(1) is No, was the action just prior to this one completed? N/A

(3) If 9.a.(2) is Yes, what has changed where this action cannot be completed? N/A

b. Additional Information: None.

10. Interested Sources: None.

11. Technical and 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.

12. Contracting Officer Determination of Fair and Reasonable Cost Determination: Consistent with historical data, I hereby determine the action described herein represents the best value to the Government. I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Approval Based on the foregoing justification, I hereby approve the procurement of supplies on a sole source basis pursuant to the authority of 41 United States Code 1901 and 1903, as implemented in Federal Acquisition Regulation 12.201-1, sole source (including Brand Name Only requirements) under the authority of the simplified procedures for certain commercial items, subject to availability of funds, and provided that the or acquisition.