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This document is a Justification for Limiting Sources (LSJ) for the Department of Veterans Affairs, VISN 8, James A. Haley VA Hospital Medical Center. The acquisition involves purchasing seven GEM Premier 5000 blood gas analyzers and supplies from Werfen USA LLC under GSA Federal Supply Schedule (FSS) Contract Number GS-07F-128DA. The analyzers are critical for medical diagnostics, supporting analysis of co-oximetry, analytes, metabolites, glucose, ionized calcium, lactate, and plural pH in Intensive Care Units, Pulmonary Outpatient Clinics, and the Emergency Department.

The justification for sole-source procurement is based on the analyzers being already installed and fully compatible with the hospital's Laboratory Information Systems (LIS), VistA, and CPRS. Transitioning to a new vendor would require additional delivery, installation, configuration, and training, potentially risking patient care. The follow-on lease to Werfen USA LLC is deemed the most cost-effective approach, ensuring continuity of care, avoiding unnecessary effort duplication, and mitigating patient safety risks. The estimated purchase exceeds $25,000 and will be posted on e-Buy as required by federal acquisition regulations.

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Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 2 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248-25-AP-1509

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C248-25-AP-1509

1. Contracting Activity: Department of Veterans Affairs, VISN 8, James A. Haley VA Hospital Medical Center, 13000 Bruce B. Downs Blvd., Tampa, FL, 33612.

2. Description of Action: The JAHVH has a need for blood gas analyzers for analysis including co-oximetry, analytes, metabolites, glucose, ionize calcium, lactate, and plural ph to support diagnosis and treatment of Veterans. This is a critical need to ensure the efficient and accurate test results in the Intensive Care Units, Pulmonary Outpatient Clinics, and Emergency Department. This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against: FSS Contract Number: # GS-07F-128DA

Name of Proposed Contractor: Werfen USA LLC Street Address: 180 Hartwell Rd.

City, State, Zip: Bedford, MA 01730-2443 Phone: 781-861-4146

3. Description of Supplies or Services:

This request consists of seven (7) GEM Premier 5000 blood gas analyzers and supplies for use by the Respiratory Section, ACOS Medicine and Specialty Care Service, at JAHVH.

The GEM Premier 5000 analyzers are currently interconnected at JAHVH and fully compatible and configured with the existing Laboratory Information System (LIS). These devices and supplies are proprietary to Werfen USA LLC.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 2 of 2 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248-25-AP-1509

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: This acquisition is justified under FAR 8.405-6(a)(1)(i)(C), which permits a logical follow-on to an original Federal Supply Schedule order when it is in the interest of economy and efficiency, and the original order was not issued under sole-source or limited-source procedures. The GEM Premier 5000 analyzers are already installed and operational. They are fully compatible with the hospital’s Laboratory Information Systems (LIS), VistA, and CPRS. All necessary consumables are included and warranted under the current lease, ensuring rapid turnaround and minimal disruption. End users are trained and familiar with the equipment and processes.

Transitioning to a new vendor or device would require delivery, installation, configuration, and training, resulting in unacceptable delays and risks to patient care. The original order was placed using appropriate Federal Supply Schedule procedures and was not a sole-source or limited-source acquisition. Werfen USA LLC is immediately capable of meeting the Government’s needs under their GSA Schedule. Their contract includes maintenance, support, and all necessary supplies. Awarding this follow-on lease to Werfen USA LLC is the most cost-effective and operationally sound approach. It ensures continuity of care, avoids unnecessary duplication of effort, and mitigates risk to patient safety.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Contracting Officer Network Contracting Office (NCO) 8 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-6#FAR_6_303

2026-01-06T15:29:51-0500
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