LSJ Redacted_Redacted.pdf

GSAR 538.7104-3 Sole Source Justifications Page 1 of 6 Acquisition ID#: 36C263-27-AP-0120

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C263-27-AP-0120

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23, located at One Veterans Dr., Minneapolis, MN 55417, in support of VISN 23 VA Health Care System at Department of Veterans Affairs, Minneapolis, MN., One Veterans Dr., 55417.

2237: 618-27-1-106-0011.

(2) Description of Action: 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).

The proposed action is a new firm-fixed price requirement for Drugs of Abuse Reagents and Consumables under the identified GSA schedule contract. The requirement includes a base and four ordering periods to provide continued Federal Workplace Urine Drugs of Abuse Testing Program for all of the VA hospitals and their affiliated Community Based Outpatient Clinics (CBOCs).

Order against: FSS Contract Number: V797D-70260

Name of Proposed Contractor: Beckman Coulter, Inc.

Street Address: 250 S. Kraemer Blvd.

PO Box 8000

City, State, Zip: Brea, CA 92822-8000

Phone: 800-526-3821

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(3) Description of Supplies or Services:

The estimated value of the proposed action is

Base Ordering Period: 10/1/2026-9/30/2027 Ordering Period 1: 10/1/2027-9/30/2028 Ordering Period 2: 10/1/2028-9/30/2029 Ordering Period 3: 10/1/2029-9/30/2030 Ordering Period 4: 10/1/2030-9/30/2031

The Minneapolis VA Health Care System (MVAHCS) requires FDA approved Drugs of Abuse Reagents and proprietary Consumables that are specifically designed and validated for use on the Beckman Coulter AU480 chemistry analyzer. These items are used to perform federally regulated urine drug testing for Amphetamines/Methamphetamine, Cocaine Metabolites, Opiates (Morphine/Codeine), Cannabinoid Metabolites, and Phencyclidine. The MVAHCS Forensic Toxicology Laboratory is nationally certified under the Substance Abuse and Mental Health Services (SAMHSA) National Laboratory Certification Program (NLCP) program and is the sole provider for Federal Workplace Drug Testing.

The reagents being procured are unique and highly specialized to one manufacturer (Beckman Coulter) because only Beckman Coulter validated reagents meet the strict NLCP performance criteria, assay cutoffs, cross-reactivity requirements, QC parameters, and FDA cleared specifications needed to maintain federal accreditation. Although the AU480 analyzer is technically capable of using third party reagents, switching manufacturers would require full method revalidation and NLCP recertification, causing a nationwide disruption in VA employee drug testing. Consumables required to operate the AU480 instrument are also proprietary Beckman Coulter products, manufactured and sold exclusively by the OEM.

Estimated annual quantities include approximately 40,000 tests each for the five required assays, plus associated calibrators, controls, and instrument specific consumables.

The procurement will be a five-year contract with one base period (10/1/2026-9/30/2027) and four one-year ordering periods through 9/30/2031. All items will be ordered on an as-needed basis, with no guaranteed minimum quantities.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a supply or service.

GSAR 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAR 538.7104-3 Sole Source Justifications Page 3 of 6

GSAR 538.7104-3(b)(1)(ii): 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;

The Drugs of Abuse Reagents and analyzer Consumables required by the MVAHCS Forensic Toxicology Laboratory are unique, highly specialized products that can only be supplied by Beckman Coulter. These reagents and consumables must be fully compatible with the Beckman Coulter AU480 analyzer currently installed and must meet strict NLCP/SAMHSA mandated federal performance requirements, including specific assay cutoffs, cross-reactivity characteristics, QC acceptance ranges, and FDA cleared specifications.

r is the only manufacturer whose AU480 validated reagents meet these NLCP requirements.

NLCP validated methods and SAMHSA certification requirements can only be met with Beckman AU480 validated reagents; prior evaluations found no alternate reagents that satisfy the required cutoffs, QC ranges, and FDA cleared specifications. Switching reagent manufacturers would require full method revalidation and NLCP recertification, resulting in an estimated 2-3 month disruption to nationwide VA drug testing operations. Separately, the ufactured and sold exclusively by Beckman Coulter, and are not available from other sources.

GSAR 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAR 538.7104-4: Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: GSAR 538.7104-3(b)(3)(iii)(A)

These are for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

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(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7102-2(b)(4) to aid the contracting officer in making this best value determination:

The proposed order represents the best value to the government because it ensures uninterrupted delivery of FDA cleared, NLCP validated Drugs of Abuse Reagents and proprietary AU480 Consumables that are essential for legally defensible, federally regulated forensic toxicology testing. The MVAHCS is the sole national provider of Federal Workplace Drug Testing within VA and must maintain strict compliance with SAMHSA NLCP certification requirements, which specify exact assay cutoffs, QC ranges, and FDA cleared performance specifications. Only Beckman Coulter produces reagents and consumables that meet these mandatory federal standards and that are fully compatible with the Beckman AU480 analyzers currently in use.

Attempting to use alternative suppliers would require a complete 2-3 month nationwide shutdown of VA drug testing services.

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

Market research was conducted in accordance with FAR Part 10, VAAR 810.001-70, and VA policy under VAAM M810.002-70. The research included review of available GSA Schedule contracts, direct communication with the Original Equipment Manufacturer (OEM), a search of Veteran Small Business Certification (VetCert) firms, review of prior VA acquisition history, and analysis of publicly available contract databases.

A review of GSA Contract V797D-70260 identified only one schedule holder, Beckman Coulter, capable of supplying all required Drugs of Abuse reagents and Proprietary AU480 Consumables.

The OEM confirmed that all non-reagent consumables for the Beckman Coulter AU480 analyzer are proprietary, manufactured solely by Beckman Coulter, and not available through any other GSA contractor, SDVOSB, VOSB, or small business distributor. Although some reagents can be purchased through distributors, those distributors cannot provide the required consumables.

While some Beckman manufactured reagents are available through distributors, Beckman Coulter remains the only viable source capable of supplying both NLCP validated AU480 reagents and the proprietary consumables required to maintain federal certification. This distinction clarifies that Beckman is not only the sole manufacturer, but also the only source able to meet the complete requirement.

In accordance with VAAR 819.70001 (Veterans First Contracting Program), the Contracting Officer evaluated whether two or more VetCert listed SDVOSBs or VOSBs could meet the requirement. A VetCert search under NAICS 325413 identified zero SDVOSBs, VOSBs, and no small businesses capable of manufacturing, distributing, or supplying OEM validated AU480 reagents or proprietary consumables. Additionally, Beckman Coulter confirmed that all AU480 consumables are OEM only products, and no resellers exist who can meet NLCP certification requirements or provide authorized OEM product.