FAR 8 Sole Source Justification - Redacted.pdf

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for Part 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C242-27-AP-0628

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 02, located at 130 W. Kingsbridge Road, Bronx, NY 10468-3904, in support of the East Orange VA Medical Center (385 Tremont Avenue, East Orange, NJ 07018-1023).

Procurement request: 561-27-1-040-0004.

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: FSS Contract Number: V797D-70260

Name of Proposed Contractor: Beckman Coulter, Inc. (UEI PU6HHX2R11C7) Street Address: 250 S. Kraemer Blvd.

City, State, Zip: Brea, CA 92821 Phone: 714.872.6271

3. Description of Supplies or Services:

The estimated value of the proposed action is

The Contractor shall provide fully automated Chemistry and Immunochemistry analyzers to each site on a Cost-Per-Reportable-Result (CPRR) basis on all the test menu functions covering the following categories: Cellular Morphometric Parameters (CMP), Drugs of Abuse Testing (DAT), Electrolytes (ELECT), Esoteric, General Chemistry, Immunochemistry (IMMUNO), Indices, Proteins, Specialty, and Therapeutic Drug Monitor (TDM). The CPRR pricing includes reagents, controls, calibrators, kits (for tests, controls, calibrators), repeats, dilutions, consumables (e.g., cups, tips), and all other items including parts, service, preventive maintenance, and labor. Cost per test is not acceptable. CPRR pricing includes the following features at East Orange VA Medical Center:

(2) P/N C52826 DxS Prod Monthly Prod, AU5810

(1) P/N C57006 REMISOL Advance V2.0 Server MSK SG

(1) P/N C57012 REMISOL Advance V2.0 Test Server Kit SG

(2) P/N B86069 Remisol Virtual Server Software DxS Protection Pro Service Package (8x7)

(1) P/N A62244 Chemistry Dictionary Services

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering Procedures

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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.

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

GSAM/R 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 current FSS Delivery Order V797D-70260 36C24226N0087 will expire on September 30, 2026. The proposed FSS Delivery Order is needed to provide continued coverage for Chemistry Cost-Per-Reportable-Result (CPRR) during the period 10/01/2026 through 9/30/2027 while the East Orange VAMC competes, awards, and transitions to new instruments. The current FSS Delivery Order was established for a period of one year with no option years, effective 10/01/2025 and ultimately ending 9/30/2026. The FSS Delivery Order was established under an approved limiting-sources justification as nly 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 because of the extensive delays in submitting a long-term procurement package due to staffing shortages.

This proposed action is for unique and highly specialized testing involving contractor-owned proprietary analyzers belonging to Beckman Coulter, Inc. As such only reagents provided by Beckman Counter are compatible with the analyzers currently in use at the VA Medical Centers under FSS V797D-70260.

The East Orange VAMC decided to go alone in their effort to establish an FSS BPA, but they have missed the anticipated for submitting a procurement package. The East Orange VAMC has submitted the long-term procurement package to contracting so that the requirement can be competed and awarded in FY27 with phase-in transition of new instruments (regardless if successful offer is the incumbent) and having these new instruments ready to use by 10/01/2027.

Furthermore, the Beckman Coulter analyzers under this FSS BPA have been specifically calibrated; the East Orange VAMC laboratory personnel trained, and lab procedures written and implemented to produce consistent results and required testing. This functionality is crucial to the effective operation of East Orange VAMC laboratory testing and the successful completion of thousands of tests annually at the East Orange VAMC on Beckman Coulter�s Chemistry equipment. he East Orange VAMC for a new FSS BPA action date

0/01/2027 This lead-time between the award date and the effective date is needed to prepare for the time-intensive process involved in the transition of equipment as well as the preparation of staff and procedures resulting from a new award. Failure to have adequate contractor support with the current instruments would result in critical mission failure in

Acquisition Plan Action ID: 36C242-27-AP-0628 Page 3 of 5 the VA medical professionals� ability to provide diagnostic and critical treatment to the Veteran patients.

In the interim, patient testing cannot be interrupted. These analyzers are used to provide urgent as well as routine testing. The introduction of a new contractor at this time in lieu of the sole source award to Beckman Coulter would result in a disruption of services in the Pathology and Laboratory Medicine departments and unacceptable delays in the VA�s care of Veteran patients. This interim FSS Delivery Order action will prevent a cessation of critical services for one year.

The installation and implementation phase are time-intensive processes that include the phase in/out of new/old equipment which involves both correlation and staff competency phases. In the correlation phase: the new equipment is installed; concurrent tests are run on both old and new equipment; reviews and analyses of the results are conducted;

calibration of new equipment to ensure continuity of results; and additional concurrent tests are run and evaluated until results are congruent. In the staff competency phase, revisions to guidelines are initiated to educate the staff and ensure proper use of the equipment in the collection of data as follows: policies are updated; procedure manuals are revised; and training of multiple shifts of personnel in East Orange VAMC.

GSAM/R 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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

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

FSS contract V797D-70260 is effective October 6, 2017 through October 5, 2027 with CPRR prices established. The unit prices for this proposed FSS Delivery Order are the same as the expiring FSS Delivery Order. In accordance with GSAR 538.7102-2(c)(2), price reductions will be sought before establishing the FSS Delivery Order.

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

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A search in the SBA�s Small Business Search with the keyword �Chemistry�, NAICS �334516�, and filtered to those firms with an active SAM registration, resulted in 12 small business firms; however, these firms are not one of the firms listed in mandatory GSA eLibrary Schedule 66 III, Category 605-1A for Chemistry CPRR requirements.

A search in the SBA�s Small Business Search with the keyword �Chemistry�, NAICS �334516�, SBA certified VOSB or SDVOSB, and filtered to those firms with an active SAM registration, resulted in two SDVOSB firms; however, these firms are not one of the firms listed in mandatory GSA eLibrary Schedule 66 III, Category 605-1A for Chemistry CPRR requirements.

A search in GSA eLibrary Schedule 66 III, Category 605-1A yields eight Large Business and 2 Small Business firms. Recent solicitation 36C24224Q0940 (GSA eBuy RFQ1728623), yielded four Large Business responses to the solicitation, one of which is the incumbent contractor for this proposed FSS Delivery Order.

Any Other Facts Supporting the Justification: A notice of intent to sole source was published in accordance with 5.101.

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 agency will continue to assess the upcoming requirements and gauge the marketplace to ensure timeliness of procurement requirements and to maximize advantageous terms, conditions, and pricing for the government.

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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by RFO 8.4.

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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.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900k): I certify the justification meets requirements for other than full and open competition.

HIGHER LEVEL APPROVAL (Required for orders over $900,000)

c. VHA RPO HCA Review and Approval (over $900,000 to $90 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 GSAM/R 538.71 ordering procedures as directed by RFO 8.4.

No additional signatures are required.