Q301--Specialized Genetic Testing and Consultation Services

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Sources Sought Notice

THIS IS NOT A SOLICITATION; THIS IS A SOURCES SOUGHT NOTICE ONLY and is issued

in accordance with Federal Acquisition Regulation (FAR) 10 Market Research, to conduct

market research. Responses to this notice are not offers and cannot be accepted by the

Government to form a binding contract. This Sources Sought Notice is issued solely for

information and planning purposes and do not constitute a solicitation or guarantee to issue a

solicitation in the future. This Sources Sought Notice does not commit the Government to

contract for any supply or service. All information submitted in response to this announcement is

voluntary; the Government will not pay for information requested nor will it compensate any

respondent for any cost incurred in developing information provided to the Government. Not

responding to this Sources Sought Notice does not preclude participation in any future

solicitation, if issued. This announcement is based on the best information available at this time

and is subject to future modification.

The information provided in response to this notice may be used in developing an acquisition approach. Interested parties are responsible for adequately marking any proprietary or competitive sensitive information that is provided in a response. The information requested in this notice will be used to determine if there are sufficient small business socioeconomic concerns that are capable of performing the work described for the requirement.

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office (NCO) 17 is seeking sources for the following procurement:

Specialized Genetic Laboratory Testing Services with complementary studies that produce evidence to reduce variants of unknown significance (VUS) in accordance with the Statement of Work (SOW).

Place of Performance

South Texas Veterans Health Care System

Audie L. Murphy VA Hospital

7400 Merton Minter Blvd.

San Antonio, TX 78229

Description of Services

The South Texas Veterans Health Care System requires Specialized Genetic Laboratory Testing Services of patient specimens that the facilities do not have the capacity or capability to perform on-site. A laboratory test is an examination, diagnostic, or monitoring procedure on a human specimen removed from the body to determine specific information for diagnosis, treatment, or prevention of disease, and to detect the impairment of health status, or to assess the health of human beings. Laboratory testing must be provided in compliance with the requirements in VHA Handbook 1106.01 and 42 CFR Part 493.

The Contractor shall provide the following tests, in-house, with a 14 21 day Turn-Around-Time (TAT). Test must be equivalent to the test description described below.

Cancer Next - APC, ATM, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1

CDH1, CDKN2A, CHEK2, EPCAM, FH, FLCN, GREM1, HOXB13, MBD4, MET, MLH1, MSH2, MSH3, MSH6, MUTYH, NF1, NTHL1, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, RPS20, SMAD4, STK11, TP53, TSC1, TSC2, VHL

Colo Next+ RNA Insight - RNA Insight: AIP, ALK, APC, ATM, ATRIP, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDC73, CDH1, DK4, DKN1B, CDKN2A, CEBPA, CFTR, CHEK2, CPA1, CTNNA1, CTRC, DX4, DICER1, EGFR, EGLN1, EPCAM, ETV6, FH, FLCN, GATA2, GREM1, HOXB13, KIF1B, KIT, LZTR1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PALLD, PDGFRA, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PRSS1, PTCH1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, RUNX1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, MARCB1, MARCE1, SPINK1, STK11, UFU, TERT, TMEM127, TP53, TSC1, TSC2, VHL, WT1

The Contractor must provide complementary studies that produce evidence to reduce variants of unknown significance (VUS). The laboratory must be able to provide evidence of supporting variant classifications in the final results report sent to clinicians. The evidence summary must include any significant published literature references as well as internal laboratory data weighted towards the reported classification for full transparency.

The contractor must hold and maintain a certificate of accreditation from the Centers for Medicare & Medicaid Services (CMS), as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and must hold and maintain accreditation by the College of American Pathologists (CAP) to perform the services. See attached Performance Work Statement for the performance requirements.

The applicable NAICS Code is 621511 Medical Laboratories

Size Standard - $41.5 Million

Product Service Code is Q301 Medical Reference Laboratory Testing

Response Instructions.

Responses are due by 12/30/2025 at 1:00 pm EST. Responses shall be submitted via email to Kathryn.prose@va.gov

Name of Company

Point of Contact; name, phone number and email address

SAM Unique Entity Identification (UEI)

Business Size

Company socio-economic status (Woman Owned Small Business, Veteran Owned Small Business, Service-Disabled Veteran Owned Small Business)

Capability Statement The statement must fully describe the capability to meet all of the requirements of the Statement of Work (SOW) in order to be considered.

Small Businesses must submit verification that the Limitations of Subcontracting clauses described below can be met.

Failure to address all the requirements of the SOW to include certificates of accreditation for any laboratory identified to conduct the testing service will be considered as non-responsive and not considered.

All prospective Contractors are reminded that in accordance with FAR 4.11 they shall be registered in the System for Award Management (SAM) database and shall complete annual Representations and Certifications in SAM prior to any offer. SAM is located at http://www.sam.gov and consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. There is no cost to use SAM.

FOR SDVOSB/VOSB ONLY: Please note that if responding as an SDVOSB or VOSB, your company must be registered and certified in the Small Business Administration (SBA) Small Business database, which is available at: https://search.certifications.sba.gov/

Small Businesses are reminded to consider the Limitations of subcontracting and nonmanufacturing rule; The business is required to perform (1) For services (except construction), at least 50 percent of the cost incurred for personnel with its own employees;

FAR Clause 52.219-14 Limitations on Subcontracting

VAAR Clause 852.219-75 VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction.

See attached document: Statement of Work (SOW) Specialized Cancer Genetic Testing Services