P03 SSJ - Phadia Reagents and Supplies mjc 1_BC signed.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 6 Revision: 04 Effective Date: 12/15/2025 Acquisition ID#: 36C241-26-AP-1382

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-26-AP-1382

1. Contracting Activity: Department of Veterans Affairs, VISN 01, NCO1 in support of VISN 1

Network Consolidated Laboratory

2. Nature and/or Description of the Action Being Processed:

This procurement is for a new firm-fixed priced BPA for Phadia Reagents and Supplies. These reagents and supplies are required for the operation of VA owned equipment. The reagents and supplies must be specific to the equipment already in place and must be brand name only. The testing equipment, reagents, and supplies have been extensively validated. Furthermore, the products must meet the regulated shelf-life expectancy for viability and storage. These supplies are for autoimmune and allergy diagnostic testing and are consistent with the VHA 1106 Directive for Pathology and Laboratory Medicine Services.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action is $ 406,036.65 over a five-year period.

10931602P ImmunoCAP Specific IgE Conjugate

14410201P T3 COMMON SILVER BIRCH

14410701P D1 DERMATOPH PTERONYSSINUS

14410901P E1 CAT DANDER

14432501P T70 MULBERRY

14439501P E72 MOUSE URINE PROTEINS

10954601P Maintenance Solution

14410001P G6 TIMOTHY

14410301P W6 MUGWORT

14410501P M2 CLADOSPORIUM HERBARUM

14410601P M6 ALTERNARIA ALTERNATA

14410801P D2 DERMATOPH FARINAE

14411001P E5 DOG DANDER

14411101P F1 EGG WHITE

14411201P F2 MILK

14411301P F4 WHEAT

14411501P F14 SOYBEAN

14411901P M3 ASPERGILLUS FUMIGATUS

14412601P F13 PEANUT

14413101P G2 BERMUDA GRASS

14414901P T7 OAK

VHAPG Part 806.3 OFOC Page 2 of 6

Acquisition ID#: 36C241-26-AP-1382

14415901P F3 FISH, COD

14416001P M1 PENICILLIUM CHRYSOGENUM

14416101P T1 BOX-ELDER

14417501P F10 SESAME SEED

14417901P F20 ALMOND

14418101P F24 SHRIMP

14421401P F40 TUNA

14421501P F41 SALMON

14422401P I6 COCKROACH

14422501P T6 MOUNTAIN JUNIPER

14422601P T8 ELM

14422701P T10 WALNUT

14422801P T11 MAPLE LEAF SYCAMORE

14422901P T14 COTTONWOOD

14423001P T15 WHITE ASH

14425201P W14 COMMON PIGWEED

14425601P W18 SHEEP SORREL

14452101P F256 WALNUT

14452801P F17 HAZELNUT

14453101P W1 COMMON RAGWEED

14450901P ImmunoCAP Total IgE Anti-IgE

14483501P F202 CASHEW NUT

14489501P F338 SCALLOP

14490501P E94 RFEL D 1 CAT IMMUNOCAP

14495501P E101, RCAN F 1, DOG

14495601P E102, RCAN F 2, DOG

14499801P E226, RCAN F 5, DOG

14524001P E220 NFEL D2 CAT SERUM ALBUMIN

14524101P E221, DOG SERUM ALBUMIN

14570201P E228 RFEL D 4 CAT

14575501P E229 RCAN F 4 DOG

14608101P E230 RCAN F 6 DOG

14608201P E231 RFEL D 7 CAT

14414301P I1 HONEYBEE VENOM

14422101P I2 WHITE-FACED HORNET VENOM

14422301P I5 YELLOW HORNET VENOM

14452501P I3 COMMON WASP VENOM

14452601P I4 PAPER WASP VENOM

10920201P Washing Solution 14441701P Specific IgE Anti-IgE ImmunoCAP 10944001P Development Solution-P250 (INCL.

10944101P Development Solution-P250 10944701P ImmunoCAP Total IgE Control (LMH

VHAPG Part 806.3 OFOC Page 3 of 6

Acquisition ID#: 36C241-26-AP-1382

10944501P ImmunoCAP Specific IgE Negative 10952802P ImmunoCAP Specific IgE Control L 10952902P ImmunoCAP Specific IgE Control M 10953002P ImmunoCAP Specific IgE Control H 10931902P ImmunoCAP Total IgE Conjugate 10931201P ImmunoCAP Specific IgE Curve Co 10932501P ImmunoCAP Total IgE Curve Contr 10938701P ImmunoCAP Total IgE Calibrator St 10945901P ImmunoCAP Specific IgE Calibrato

14567101P ELIA SYMPHONY S WELL

14564101P ELIA ANTI-TPO WELL

14564201P ELIA ANTI-TG WELL

14550101P ELIA U1RNP WELL

14550301P ELIA RO (SS-B) WELL

14550401P ELIA LA (SS-B) WELL

14551101P ELIA RNP70 WELL

14567201P ELIA SM DPS WELL

14551701P ELIA CELIKEY (tTG) IgA WELL 14560101P ELIA RF IgA WELL 14550001P ELIA dsDNA WELL 14551801P ELIA CELIKEY (tTG) IgG WELL 14553801P ELIA GLIADIN DP IgA WELL 14553901P ELIA GLIADIN DP IgG WELL

14550501P ELIA CENP (CENTROMERE) WELL

14550701P ELIA JO-1 WELL

14563701P ELIA SCL-70 WELL

14559901P ELIA RNA POL III WELL

14553601P ELIA PR3S WELL

14553701P ELIA MPOS WELL

14551501P ELIA CCP WELL

14551401P ELIA GBM WELL

14552801P ELIA CARDIOLIPIN IgA WELL 14552901P ELIA CARDIOLIPIN IgG WELL 14553001P ELIA CARDIOLIPIN IgM WELL 14553101P ELIA BETA 2 GLYCOPROTEIN I IgA WELL 14553201P ELIA B2-GLYCOPROTEIN I IgG WELL 14553301P ELIA B2-GLYCOPROTEIN I IgM WELL

83103701P ELIA NEGATIVE CONTROL

83103301P ELIA ANA POSITIVE CONTROL 250

83103401P ELIA ANCA/GBM POSITIVE CONTROL

83105501P ELIA APS POSITIVE CONTROL 250

83103601P ELIA CELIAC POSITIVE CONTROL 250

83111301P ELIA THYROID POSITIVE CONTROL

VHAPG Part 806.3 OFOC Page 4 of 6

Acquisition ID#: 36C241-26-AP-1382

83103501P ELIA CCP POSITIVE CONTROL

83107001P ELIA RF POSITIVE CONTROL 250

83101701P ELIA IgG CONJUGATE 50 83102101P ELIA IgA CONJUGATE 50 83105101P ELIA IgM CONJUGATE 50 14550901P ELIA IgA CALIBRATOR WELL 14550901P ELIA IgG CALIBRATOR WELL 14552701P ELIA IgM CALIBRATOR WELL

83118201P ELIA ANA 3 POSITIVE CONTROL

83102301P ELIA SAMPLE DILUENT

83101501P ELIA IgG CALIBRATOR STRIPS 83101601P ELIA IgG CURVE CONTROL STRIPS 83101901P ELIA IgA CALIBRATORS 83102001P ELIA IgA CURVE CONTROLS 83105201P ELIA IgM CALIBRATORS 83105301P ELIA IgM CURVE CONTROLS

12390708P ELIA DILUTION PLATES

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302- 2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302- 5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

VISN 1 VAMC Providence purchased the Thermo Fisher Phadia 250 Analyzer in September of 2025 for $139,590.00 under purchase order# 36C24125P0509, for which these reagents and supplies are being procured. The Thermo Fisher Phadia 250 Analyzer was chosen for the Providence VAMC as it is was the best analyzer for allergy and autoimmune testing, and the laboratory was looking to broaden its test menu to include autoimmunity. Compared to other immunoassay systems, the Thermo Fisher Phadia 250 Analyzer provided a more reliable and broader test options for facilities that are prioritizing immunology and allergy screening. It also has high sensitivity and specificity in allergy and autoimmune testing. Additionally, the Thermo Fisher Phadia 250 Analyzer offered a more user-friendly interface with minimal maintenance. The efficient reagent handling offered by the Thermo Fisher Phadia 250 Analyzer is ideal for small laboratories and has kits with only 14 tests, which are ideal for reducing the chances of kits

VHAPG Part 806.3 OFOC Page 5 of 6

Acquisition ID#: 36C241-26-AP-1382 expiring before use, and reducing operational costs. Replacing this instrumentation would be cost prohibitive. These reagents and supplies are highly specialized and are utilized for the detection of autoimmune and allergy disorders. These reagents also ensure accurate results and have been extensively optimized and validated to ensure high-quality diagnostic results. This testing is essential for Veteran care and will help dictate the appropriate treatment by the clinician. These specific reagents and supplies must be purchased by the manufacturer sole distributor, if not the warranty will be voided on the Thermo Fisher Phadia 250 Analyzer.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): These reagents must be specific to ensure compatibility with the existing VA owned Thermo Fisher Phadia 250 Analyzer.

These reagents are only available directly from the manufacturer sole distributer. A Sources Sought Notice was posted to SAM.gov on 1/20/2026 and closed on 2/4/2026. Received 3 responses; 2 from Service Disabled Veteran Owned Small Business’s (SDVOSB) however they were considered not acceptable, and 1 from the Large Business (LB) manufacturer and sole distributor of the items that are needed. A Notice of Intent to Sole Source was posted to SAM.gov on 2/6/2026, no responses have been received in response to the Intent to Sole Source.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The CO anticipates that the contract cost will be considered fair and reasonable based on comparisons of the proposed prices with the independent Government cost estimate and of the prices of similar items on the open market.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search was conducted utilizing GSS, FSS, SCMS, FPDS, SAM as well as an open market internet search. No suppliers were found other than the manufacturer, Fisher Scientifc Company LLC. These reagents must be specific to ensure compatibility with existing VA owned Thermo Fisher Phadia 250 Analyzer. The Thermo Fisher Phadia 250 Analyzer was purchased to perform allergy testing for all VISN1. The Thermo Fisher Phadia 250 Analyzer is a highly efficient and versatile instrument used for identifying allergies and autoimmune diseases. The Phadia allergy test utilizes ImmunoCAP technology, which is recognized as the gold standard in in-vitro allergy diagnostics. It allows for the testing of over 500 whole allergens and 100 allergen components, providing comprehensive results that help in diagnosing various allergic conditions. The tests can be performed on a small sample of serum or plasma, making it convenient for patients. The Phadia reagents and supplies are required to test using the VA owned Thermo Fisher Phadia 250 Analyzer. Fisher Scientific Company LLC is the sole provider of these reagents. A sources sought notice was posted to SAM.gov on 01/20/2026, looking to see if there are any vendors that could provide these items either domestically or non-domestically, 3 responses were received. Two of the responses were from SDVOSB’s, stating that they could potentially subcontract this requirement out. And the third respondent was a LB (the Manufacturer & sole distributor) with a sole source letter. With the results of the Sources Sought Notice and responses received the SDVOSB’s will not be capable of fulfilling this requirement.

VHAPG Part 806.3 OFOC Page 6 of 6 Revision: 04 Effective Date: 12/15/2025 Acquisition ID#: 36C241-26-AP-1382

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Fisher Scientific Company, LLC (LB)

BHPE, LLC (SDVOSB)

Northern Purchase Services LLC (SDVOSB)

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

While the items are specific to a manufacturer, continued market research will be conducted to allow any future distributors competition in subsequent acquisitions.

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Jacqueline Hite Date Manager, Pathology & Lab Service, West Haven VAMC

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date Manasés Cabrera

NCO1 - Contracting Officer, Bedford VAMC

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K):

I certify the justification meets requirements for other than full and open competition.

Sheryl Anthony Date NCO1 -Branch Chief, Bedford VAMC

JACQUELIN

E HITE

Digitally signed by

JACQUELINE HITE

Date: 2026.02.12 10:05:24 -05'00'

MANASES

CABRERA

Digitally signed by

MANASES CABRERA

Date: 2026.02.12 10:22:39 -05'00'

2/12/26

2/12/26