Limited Sources Justification Emergency - Blood Gas Analyzers_Redacted.pdf

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6550--Emergency Blood Gas Analyzers
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36C24825Q0337
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This is a Limited Sources Justification document for the Department of Veterans Affairs (VA) James A. Haley Veterans' Hospital in Tampa, FL to procure seven GEM Premier 5000 blood gas analyzers and associated supplies from Werfen USA LLC. The procurement is justified as urgent and compelling due to the critical need for blood gas analysis capabilities in the Intensive Care Units, Pulmonary Outpatient Clinics, and Emergency Department.

The contract (GS-07F-128DA) was awarded to Werfen USA LLC for $263,571.28 with a performance period of February 1, 2025 to January 31, 2026. The scope includes seven analyzers and supplies to support approximately 14,400 tests per year across the machines. Specific supplies include IL PVP units, test paks, and printer paper. The justification cites Werfen's proprietary equipment that is already integrated with the hospital's Laboratory Information System as the basis for the sole-source award. Limited market research was conducted due to the urgent nature and proprietary requirements of the equipment.

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Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405 6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248 25 AP 1509

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405 6

Acquisition Plan Action ID: 36C248 25 AP 1509

(1) Contracting Activity: Department of Veterans Affairs, VISN 8, James A. Haley Veterans’ Hospital (JAHVH), 13000 Bruce B. Downs Blvd., Tampa, FL, 33612.

(2) Description of Action: The JAHVH has an urgent and compelling need for emergency 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: MAS Contract # GS 07F 128DA

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

City, State, Zip: Bedford, MA 01730 2443 Phone: 402 709 7774 (Paul Descheneaux)

(3) Description of Supplies or Services:

The estimated value of the proposed action is .

The Period of Performance is 2/1/2025 – 1/31/2026.

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.

The estimated annual testing volume is 1,200 tests per month across 7 machines for a total estimate of 14,400 tests per year. The estimated equipment and supplies necessary to support the testing volume is:

Part Number Name QTY

GEM 5000 GEM 5000 7

00024001515 IL PVP 14

00055407510 5K BG/ISE/GL/COOX 75 Test Pak 31d 54

VHAPG Part 808.405 6 Limiting Sources Page 2 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248 25 AP 1509

00055415010 5K BG/ISE/GL/COOX 150 Pak 31d 72

0002500050 PAPER PRINTER 5/BOX GEM 5000/4000 24

(4) Identify the Authority and Supporting Rationale:

FAR 8.405 6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

IMMEDIATE IMPACT TO OPERATIONS: This request is paramount to the care of veterans.

Failure to implement this critical support in the most expeditious manner would cause significant health care operations at JAHVH to stop. The result would be an unacceptably high risk of devastating effect to patient care at JAHVH directly affecting the ability for diagnosis and treatment of veterans.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: JAHVH currently has Werfen USA LLC equipment in place and operating. Werfen is immediately capable of meeting the needs of the Government in accordance with their GSA Schedule and any delay would cause unacceptable risks as outlined above. The expected outcome of this requirement is a sole source to Werfen USA LLC which provides the greatest overall benefit in response to this urgent requirement.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Limited market research was conducted due to the urgency and proprietary (sole source) nature of the requirement. This agency is committed to the competitive spirit of all procurement regulations. It is our policy to seek full and open competition to the largest extent possible while fulfilling the necessary requirements. The proprietary nature of this requirement restricts other vendors from being able to provide support.

(7) Any Other Facts Supporting the Justification: N/A

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

The VHA is committed to the competitive spirit of all procurement regulations. It is our policy to seek full and open competition to the largest extent possible while fulfilling the necessary requirements. Currently there is no anticipated competition for the requested equipment and supplies due to the urgent and compelling need and proprietary nature of the stated requirement. The Government will continue market research efforts to best support future needs.

VHAPG Part 808.405 6 Limiting Sources Page 3 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248 25 AP 1509

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE

Supervisory Program Specialist ACOS Medicine and Specialty Care

NAME TITLE SERVICE LINE/SECTION

James A. Haley VA Hospital

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

CONTRACTING OFFICER SIGNATURE

James A. Haley Veterans Hospital / NCO 8__ NCO 8 Contracting Officer FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

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

SIGNATURE

NCO 8 Contracting Officer

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