P03 GSAR 538 Limiting_Sources_Justification_OVER_SAT 36C242-26-AP-3279.pdf

GSAR 538.7104-3 Sole Source Justifications Page 1 of 4 Acquisition ID#: 36C242-26-AP-3279

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C242-26-AP-3279

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 02, located at 3495 Bailey Avenue, Building 3, Second Floor, Buffalo NY 14215, in support of VISN 02 (Downstate) VA Healthcare Systems Laboratory & Pathology Medicine Departments at:

James J. Peters (Bronx) VAMC, VA New Jersey Healthcare System (East Orange and Lyons campuses), VA Hudson Valley Healthcare System (Montrose and Castle Point campuses) , VA New York Harbor Healthcare System (St. Albans, Brooklyn and Manhattan) and Northport VA Medical Centers, have submitted the following purchase request 2237’s:

# 526-26-4-108-0071: $85,000.00 # 561-26-4-040-0070: $200,000.00 # 620-26-4-124-0056: $30,000.00 # 630-26-4-456-0442: $275,000.00 # 632-26-4-107-0054: $102,500.00

Total funding: $692,500.00

(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 action being reviewed and approved is the establishment of a contract to provide comprehensive genetic and esoteric laboratory for VISN 2 South, including specimen pickup, transport, processing, analysis, result reporting, and associated support services as defined in the Performance Work Statement. This action will be awarded as a new requirement.

Order against: FSS Contract Number: V797D-70090

Name of Proposed Contractor: Quest Diagnostics Incorporated (Quest)

Street Address: 500 Plaza Drive

City, State, Zip: Secaucus, NJ 07094

Phone: 201-393-5424

(3) Description of Supplies or Services:

The estimated value of the proposed action is $692,500.00 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

GSAR 538.7104-3 Sole Source Justifications Page 2 of 4

The requirement is for Prognostics, Molecular Diagnostics, and Therapeutic referral laboratory services. Basic services include the transportation of clinical laboratory specimens to the Contractor’s laboratory(s), performance of analytical testing, reporting of analytical test results, and consultative services as required to provide the full scope of its laboratory operations for VISN 2 South. The service provides specialized testing, which is a test that is performed in low volume, but the technology, expense, or time-consuming nature of each test is such that some delay is expected. The delay usually occurs to allow tests received from different centers to be batched to make the operation cost effective. A type of reference lab dedicated to a particular type of 'esoteric' testing–e.g., allergy, and Esoteric testing, which are only preformed in a few laboratories throughout the country, which analysis of 'rare' substances or molecules that are not performed in a routine clinical lab.

(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.

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

There is an urgent and compelling need to establish a short-term, FSS BPA to ensure uninterrupted Prognostics, Molecular Diagnostics, and Therapeutic referral laboratory services for the VISN 2 Downstate New York and New Jersey facilities. The two existing contracts providing these essential services will expire on June 30, 2026, with no remaining option periods. The long-term competitively solicited contract to provide these services was protested at the pre-solicitation stage, and corrective action is being taken to move that solicitation forward. This corrective action will extend the timeline for releasing and awarding the new competitive requirement, creating an unavoidable gap in coverage.

These services are utilized heavily as the facilities do not have the laboratory space, specialized equipment or specialty personnel to perform these additional tests within their facilities.

Prognostics, Molecular Diagnostics, and Therapeutic referral laboratory services offer a high quality of care, provide quick and accurate diagnosis of disease and enable timely appropriate treatment of disease. The service is paramount to the Veteran Patients we serve. Any break in service would affect Veteran Patient care and delay the diagnosis and treatment of any diseases.

Additionally, onboarding a new vendor requires several months to establish specimen pickup schedules, delivery workflows, and reliable supply distribution to each facility. The incumbent contractor is fully operational and already integrated with established processes, enabling immediate continuation of services. Given the critical nature of these tests and the adverse impact a service lapse would have on Veteran care, this short-term BPA is required to maintain Veteran care while the long-term competitive action is solicited and awarded.

GSAR 538.7104-3 Sole Source Justifications Page 3 of 4

(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:

Awarding this short-term FSS BPA to Quest Diagnostics Incorporated (Quest) represents the best value to the Government. Quest is the incumbent contractor and is fully established with the required capabilities, which will allow these critical services to continue without interruption.

The required lab tests are available on Quest’s current FSS contract, V797D-70090, and have been determined to be fair and reasonable at the time of award. Utilizing this established pricing ensures cost-effectiveness and reduces administrative burden for the Government during this interim period.

Therefore, proceeding with Quest provides the lowest risk, most efficient, and most cost-effective solution and represents the overall best value to the Government while achieving Veterans Health Administration (VHA) mission.

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

Due to the urgent and compelling need limited market research has been conducted, and the findings indicated only the incumbent, Quest, can provide uninterrupted service across all participating facilities. Awarding a short-term BPA to Quest will mitigate the serious risks associated with a lapse in service, including delayed diagnoses, compromised clinical decision-making, specimen errors, and escalating backlogs as the long-term competitive requirement is solicited.

(7) Any Other Facts Supporting the Justification:

A gap in contracted laboratory services, for these facilities, would severely impact their ability to treat their Veteran Patients. These services are critical to maintain functioning hospital facilities.

(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:

Extensive market research has been conducted in the past, and we will continue to survey the market. However, based on previously gathered information and current findings, no small businesses can provide these services while complying with Limitations on Subcontracting.

Market research has identified other potential large businesses that appear capable of providing these services and are likely to respond to the long-term competitive solicitation that is being prepared concurrently.

GSAR 538.7104-3 Sole Source Justifications Page 4 of 4

(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 GSAR Subpart 538.71.

Laura Schriffen, Laboratory Manager Laboratory & Pathology Medicine Department, Northport VA Medical Center

(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.

Tracy Vega Contracting Officer, Services Team 1 RPO East/NCO 2 Contracting Office

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.

Joseph Cellino Branch Chief, Services Team 1 RPO East, NCO 2 Contracting Office https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx