Limited Sources Justification (LSJ) Ortho Reagents CO signed REDACTED.pdf

CUI

Control Number:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Limited Sources Justification (LSJ) Federal Acquisition Regulation (FAR) 8.401

1. Identification of the Agency and Contracting Activity:

Defense Health Agency (DHA), Healthcare Contracting Division - South

2. Nature and/or Description of Action being Approved:

This Limited Sources Justification is to establish a new four (4) month base plus four (4) option years, Firm Fixed Price contract with Quidel Ortho Sales Company, LLC (CAGE: 12B04) providing and delivering reagents, consumables, and maintenance compatible for two (2) Government owned Quidel Ortho, Vision Swift Analyzers in support of the 96th Medical Group (MDG) laboratory located at Eglin AFB, Florida. This action will be utilizing the vendor’s Veteran Affairs Federal Supply Schedule V797D-60637. The delivery order includes a base period from 1 June 2026 – 30 September 2026 and four (4) option years with a total estimated value of .

3. Description of Supplies or Services and Estimated Value:

96th Medical Group (MDG) laboratory is requesting a new requirement to provide and deliver a continuous and reliable supply of Food and Drug Administration (FDA) approved reagents and associated consumables specifically for the Quidel Ortho, Vision Swift Analyzers located within the Blood Bank located at 96th Medical Group (MDG), Eglin Air Force Base (AFB), Florida.

The statement of need below outlines the physical, functional and performance requirements, critical characteristics, required by the Government. The main objective within this requirement is to provide and deliver various reagents/consumables to include maintenance on two (2) Government own Quidel Ortho, Vision Swift Analyzers.

(1) All reagents must be FDA approved;

(2) All reagents and consumables must be compatible with the Government owned Quidel Ortho Vision Swift Analyzer(s);

(3) Must include technical support and maintenance to include routine software updates, and readily available field service engineers (FSE) for on-site repair as necessary;

(4) Must be able to provide all required reagents and consumables on a scheduled basis.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Continuous operation of the government-owned instruments is paramount to provide consistent instrument performance and optimal laboratory function for supporting patient care directives at the 96th MDG.

Period Period of Performance Estimated Value Type of Funding Base Period 01 JUN 2026 – 30 SEP 2026 O&M Option Period 1 01 OCT 2026 – 30 SEP 2027 O&M Option Period 2 01 OCT 2027 – 30 SEP 2028 O&M Option Period 3 01 OCT 2028 – 30 SEP 2029 O&M Option Period 4 01 OCT 2029 – 30 SEP 2030 O&M

FAR 52.217-8 N/A

Total

4. Authority Cited: FAR 8.401

5. Rationale Justifying Use of Authority Cited:

96th Medical Group (MDG) requests the use of a sole source justification IAW FAR 8.401, to provide and deliver reagents, consumables, and maintenance compatible for two (2) Government owned Quidel Ortho, Vision Swift Analyzers in support of the 96th Medical Group (MDG) laboratory located at Eglin AFB, Florida. The blood testing industry is highly regulated by the FDA and requires all reagents to be FDA 510k approved per Code of Federal Regulations (CFR) for the Government to be able to store and distribute blood products. FDA requirements for blood bank testing reagents mandate strict adherence to 21 CFR Part 606 and 21 CFR Part 660 standards. Reagents must be licensed by the FDA and properly labeled with the approved manufacturer instructions. The requirement necessitates an award to Ortho Clinical Diagnostics, the Original Equipment Manufacturer (OEM), as they are the sole vendor for FDA approved reagents, consumables and maintenance for the Quidel Ortho, Vision Swift Analyzers.

6. Market Research:

Market research was conducted utilizing Sam.gov, FPDS-NG.gov, GSA Advantage and other Government/commercial sources in order to locate alternative brands and/or sources to support the supplies required at the level and quality required by the Government. Due to the aforementioned critical characteristics, deviation from the FDA approved reagents and consumables for the Quidel Ortho, Vision Swift Analyzers would be detrimental to the Government's need.

Additionally, a Request for Information - Sources sought (RFI-SS) was posted on the Government Point of Entry, Sam.gov, on 27 March 2026 with a closing date of 06 April 2026 searching for businesses that are capable of providing the Government’s requirement. Reference RFI – SS identification number “HT9408-26-REAGENT.” The Government received one (1) industry response to the RFI – SS as follows:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Quidel Ortho Sales Company, LLC Solution met the Government’s minimum requirement.

7. Other Facts:

a. Procurement history.

(1) Is this a new requirement? Yes.

(2) If 7.a.(1) is No, was the action just prior to this one competed? N/A

(3) If 7.a.(2) is Yes, what has changed where this action cannot be competed? N/A

b. Additional Information. The Ortho reagents, consumables and maintenance were previously on an Air Force contract (FA2823-23-P-0055) with Quidel Ortho Sales Company, LLC

8. Actions to Remove or Overcome any Barrier to Competition:

The MTF located at Eglin AFB, Florida will continue to evaluate other products capabilities from other distributors through continuing market research. Additionally, if the Government's requirement changes in the future, the intent of the Government is to issue a full and open competitive solicitation in order to provide the greatest amount of competition as practicable. Continued efforts in this regard will ensure that Government is receiving the best value at a fair and reasonable price by ensuring the Government utilizes the most efficient and economical means possible. The Government will issue a notice of award to include the justification to sole source this action on the Government Point of Entry website, Contract Opportunities, to encourage small business participation and foster competition.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

9. 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.

Marcus Mattingly Contracting Officer Healthcare Contracting Division - South

Chief, Transfusion Service 96th Medical Group

10. 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.

Chief, Transfusion Service 96th Medical Group

11. Best Value Determination:

Consistent with FAR 8.401(b), DFARS 208.470(d), and supplemental Department of War requirements, I hereby determine the action described herein represents the best value to the Government.

Basis for Determination: FAR 8.401(b) and DFARS 208.470(d).

MATTINGLY.MARCU

S.HAY.1295235507

Digitally signed by

MATTINGLY.MARCUS.HAY.12952

35507 Date: 2026.04.22 10:20:53 -05'00'

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

12. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Marcus Mattingly Contracting Officer Healthcare Contracting Division - South

Attorney Office of General Counsel

13. Contracting Officer Certification:

I certify this justification pursuant to the authority of FAR 8.401 is accurate and complete to the best of my knowledge and belief.

MATTINGLY.MARCU

S.HAY.1295235507

Digitally signed by

MATTINGLY.MARCUS.HAY.12952

35507 Date: 2026.04.22 10:21:56 -05'00'