FAR 8 Limited Sources Justification - 36C242-26-AP-0421 - Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0421

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C242-26-AP-0421

(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 following VISN 02 Downstate facilities:

James J. Peters VA Medical Center (130 W. Kingsbridge Road, Bronx, NY 10468-3904);

East Orange VA Medical Center (385 Tremont Avenue, East Orange, NJ 07018-1023);

Castle Point VA Medical Center (41 Castle Point Road, Wappingers Falls, NY 12590-7004);

Franklin Delano Roosevelt Hospital (2094 Albany Post Road, Montrose, NY 10548-1454);

Margaret Cochran Corbin VA Campus (423 East 23rd Street, New York, NY 10010-5011);

Brooklyn VA Medical Center (800 Poly Place, Brooklyn, NY 11209-7104);

Northport VA Medical Center (79 Middleville Road, Building 200, Northport, NY 11768-2200).

Procurement requests: 526-26-1-109-0005; 620-26-1-124-0012; 630-26-1-456-0009; 630-26-1- 456-0010.

(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). This acquisition seeks to establish a Federal Supply Schedule Delivery Order for a period of one year, effective October 1, 2025 through September 30, 2026, with no option years.

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, VHAPG Part 808.405-6 Limiting Sources Page 2 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0421 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 each site:

James J. Peters VA Medical Center

(2) P/N C52823 DxS Prod Monthly Prod, DxC700AU

(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

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

Hudson Valley Healthcare System (Castle Point VAMC and FDR VA Hospital)

(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

Margaret Cochran Corbin VA Campus

(1) P/N C57008 REMISOL Advance V2.0 Client Kit SG

(1) P/N B85112 Remote Site Implementation

Brooklyn VA Medical Center:

(1) P/N C57008 REMISOL Advance V2.0 Client Kit SG

(1) P/N B85112 Remote Site Implementation

Northport VA Medical Center:

(2) P/N C52823 DxS Prod Monthly Prod, DxC800

(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

VHAPG Part 808.405-6 Limiting Sources Page 3 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0421

Package (8x7)

(1) P/N A62244 Chemistry Dictionary Services

(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:

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;

The current VISN 2 Downstate FSS BPA number V797D-70260 36C24224A0001 will expire on September 30, 2025. The proposed FSS Delivery Order is needed to provide continued coverage for Chemistry Cost-Per-Reportable-Result (CPRR) during the period 10/01/2025 through 9/30/2026 while the participating sites transition to new instruments. The current FSS BPA was established for a period of one year with one option year, effective 10/01/2023 and ultimately ending 9/30/2025. The FSS BPA was established under an approved limiting-sources justification as a logical follow-on requirement because of the extensive delays in implementing the instruments in the prior FSS BPA that was competitively awarded.

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 edical Centers identified in section 1 of this justification under FSS V797D-70260.

For all sites except the East Orange VAMC, award is imminent to establish a new FSS BPA with an estimated �Go Live� date of 4/01/2026. These sites require approximately six months of continued coverage under a new FSS Delivery Order while the new FSS BPA allows for implementation/phase-in of new instrumentation at these sites. The estimated value is reflected accordingly.

The East Orange VAMC decided to go alone in their effort to establish an FSS BPA, but they have missed the anticipated timeframe for submitting a procurement package. Going forward, the East Orange VAMC requirement will be included with VISN 2 Upstate facilities as a consolidated effort, namely with the Buffalo VAMC, Bath VAMC, Canandaigua VAMC, Syracuse VAMC, and the Albany Stratton VAMC, as all these sites are now on the same timeframe for periods of performance. Furthermore, the inclusion of the East Orange VAMC in that separate consolidated effort, with its large estimated annual volumes, will increase the purchasing power in a single, consolidated effort, resulting in larger discounts for all participating sites than if East Orange VAMC went alone. As such, the East Orange VAMC will need one-year of continued coverage under this FSS Delivery Order while a long-term effort is competed, and award established with a �Go Live� date anticipated for 10/01/2026.

Furthermore, the Beckman Coulter analyzers under this FSS BPA have been specifically calibrated; the VISN 2 South laboratory personnel trained, and lab procedures written and

VHAPG Part 808.405-6 Limiting Sources Page 4 of 6 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0421 implemented to produce consistent results and required testing. This functionality is crucial to the effective operation of VISN 2 laboratory testing and the successful completion of thousands of tests annually at the VISN 2 Downstate medical facilities on Beckman Coulter�s Chemistry equipment. As the VISN 2 Downstate medical facilities (except East Orange VAMC) prepare to finalize on a new FSS BPA action, the effective date is proposed for 4/01/2026 with the award date anticipated by late September or early October 2025. 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 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 approximately six months for all the VISN 2 Downstate VA medical centers, except for East Orange VAMC, which would be needed 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 five VISN 2 laboratory facilities.

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.

VHAPG Part 808.405-6 Limiting Sources Page 5 of 6 Revision: 01 Effective Date: 09/01/2024

(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:

The incumbent contractor has confirmed that the unit prices on all cost-per-reportable-result (CPRR) line items will remain unchanged from the pricing provided on the current FSS BPA for both years, which were already determined fair and reasonable. In accordance with FAR 8.405-4, 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.

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 one SDVOSB firm; however, this firm is 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 seven 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.

(7) Any Other Facts Supporting the Justification: An notice of intent to sole source was published in accordance with FAR 5.203.

(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 of 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.

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

VISN 2 Downstate Chemistry / Immunoassay Chair VA New York Harbor Healthcare System

VHAPG Part 808.405-6 Limiting Sources Page 6 of 6 Revision: 01 Effective Date: 09/01/2024

(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 Network Contracting Office 2

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.

Division Chief, Division 1 Network Contracting Office 2

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

c. 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 East VHA Head of Contracting Activity (HCA)

No additional signatures are required.