P03 PG_Part808.405-6_Atch2_Limiting_Sources_Justification_OVER_SAT AMA Chemistry CPRR Bridge.docx

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C257-25-AP-2464 JOFOC Tracker Number: FY25-NCO 17-1122

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 17, located at 5441 Babcock Road, Suite 302, San Antonio, Texas 78240, in support of the Amarillo Veterans Affairs Health Care System (AVAHCS) at 6010 W Amarillo Blvd, Amarillo, Texas 79106.

2237 Number: [REDACTED]

(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).

Order against: |X| FSS Contract Number: V797D-70260

(3) Description of Supplies or Services:

The estimated value of the proposed action is $1,250,000.00.

The Chemistry Department of the Pathology and Laboratory Medicine Service (P&LMS), under the direction of the AVAHCS, requires a bridge contract to Beckman Coulter for chemistry and immunoassay testing in Amarillo, Texas and Lubbock, Texas. This will be for one year with the understanding that the Amarillo Laboratory is undergoing a remodel and will only be requesting the lease of chemistry equipment. The contract price will include all costs associated with instrumentation, reagents, consumables, calibrators, quality control materials, water filtration system, uninterrupted power supplies, service, parts, training, shipping, middleware, interfacing, installation, and validation studies. Additionally, the need for the bridge contract is due to delays in construction of the new laboratory at the AVAHCS.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

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

|X| FAR 8.405-6(a)(1)(B): 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:

Beckman Coulter is the only vendor capable of fulfilling this one year contract from July 1, 2025 through June 30, 2026 without disrupting Veteran patient care at the AVAHCS. Their analyzers and tests are currently validated to regulatory requirements and operational at the Amarillo and Lubbock labs, supporting approximately 1 million tests annually.

The Amarillo laboratory’s renovation project, driven by setbacks beyond the control of the P&LMS, was initially expected to conclude by December 31, 2024; however, the renovation remains incomplete, leaving the lab in temporary space with insufficient capacity to accommodate new equipment or perform side-by-side validations required by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and VA regulations. The current Cost per Reportable Result (CPRR) contract with Beckman Coulter, supporting all chemistry-based testing across Amarillo and Lubbock, expires June 30, 2025. Without this one-year contract, the lab cannot solicit, install, or validate a new vendor’s systems by the deadline, risking a complete halt in chemistry and immunoassay testing for months. Such a disruption would delay critical STAT results (required within one hour) and force outsourcing, increasing turnaround times and costs, directly jeopardizing Veteran patient care. Beckman Coulter’s mirrored platforms ensure seamless throughput and consistency across sites, a capability no other vendor can replicate by June 30, 2025.

A competitive solicitation will be issued once the construction of the new laboratory reaches a state of completion to where a new automation line is ready for installation, which at this time is anticipated to be later in Calendar Year (CY) 2025 to early CY 2026.

|_| FAR 8.405-6(a)(1)(C): 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.

|_| FAR 8.405-6(b): Items peculiar to one manufacturer:

|_| A patent, copyright, or proprietary data limits competition. The proprietary data is:

|_| These are “direct replacements” parts/components for existing equipment.

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

(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:

Per FAR 8.404(d), GSA has already determined the prices of supplies to be fair and reasonable. Therefore, the ordering activity is not required to make a separate determination of fair and reasonable pricing. Evaluation in accordance with FAR 8.405-2(d) does not apply as it has been determined that Beckman Coulter is the only source that can satisfy the Government’s requirement. Therefore, it has been determined that the order will represent the best value and results in the lowest overall cost alternative (considered price, special features, administrative costs, etc.) to meet the Government’s needs.

(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 from March – April 2025.

A search of the mandatory sources of supplies, Ability One, revealed they do not offer clinical chemistry analyzers.

A search of Federal Prison Industries at unicor.gov revealed they do not offer clinical chemistry analyzers.

A search of GSA eLibrary Schedule 66 III, Category 605-1A found seven (7) large business manufacturers of automation lines for immunoassay and chemistry testing on a CPRR basis. Two (2) small businesses have also entered this schedule and category since market research was last conducted. These potential sources will be examined further when market research is conducted for the new base plus four requirement.

(7) Any Other Facts Supporting the Justification:

Not applicable.

(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:

As stated in Section 6, a search of GSA eLibrary Schedule 66 III, Category 605-1A found seven (7) large business manufacturers of automation lines for immunoassay and chemistry testing on a CPRR basis. Two (2) small businesses have also entered this schedule and category since market research was last conducted. These potential sources will be examined further when market research is conducted for the new base plus four requirement.

Due to delays in the construction of the new laboratory at the AVAHCS, there is not currently room to install an automation line that is to be included in the new contract. Therefore, a bridge contract is needed for the lease of the analyzers currently in place and for consumables. Any delay in award of the bridge contract will negatively impact Veteran patient care. A competitive solicitation will be issued once the construction of the new laboratory reaches a state of completion to where a new automation line is ready for installation, which is anticipated to be later in CY 2025 to early CY 2026.

(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.

Laboratory Manager Amarillo Veteran Affairs Health Care System (AVAHCS)

(10) Approvals in accordance with the :

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 Laboratory Services Support (LSS) Network Contracting Office (NCO) 17

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.

Branch Chief Laboratory Services Support (LSS)

c. Director of Contracting: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

Director of Contracting

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

d. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C257-25-AP-2464