Q301--Thyroid Molecular Testing

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. Solicitation 36C24723Q0287 is issued as a request for quotation. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01. This solicitation is issued as unrestricted, the associated NAICS code is 621511 and small business size standard is $41.5 Million. This solicitation includes Wage Determination 2015-4427, attached.

DESCRIPTION: The Department of Veterans Affairs, Network Contracting Office 7 is looking to award a single firm-fixed price purchase order for a period of one base year with four, one-year option periods for reference laboratory services. The Contractor shall provide thyroid molecular genomic sequencing diagnostics as needed and requested by Ralph H. Johnson VA Medical Center physicians. The tests must be brand name or equal to Afirma Genomic Sequencing Classifier (GSC), CPT code 81546, and the Afirma Xpression Atlas (XA) CPT code 0204U, allowing the facility to align its diagnostics capability with those offered by the Local Affiliate Institution, the Medical University of South Carolina. The salient physical, functional, or performance characteristics that equal products must meet are specified in the solicitation.

The result of the test must include a benign/negative or suspicious/positive result and provide a risk of malignancy. Thyroid nodules classified by the genomic test as suspicious must be further classified by specific gene alterations/variants specifically related to surgical management decisions and any available FDA-approved targeted therapies. The Comprehensive Tissue Gene testing can mean the difference to a patient with an initial inconclusive tissue FNA diagnosis, to now have surgical procedure, to a patient that can avoid potentially costly and invasive diagnostic surgery.

TERMS: This requirement incorporates one or more clauses/provisions by reference, with the same force and effect as if they were given in full text. The full text of a clause or provision may be accessed at http:///www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/. Offerors are encouraged to, and responsible for, reviewing the full solicitation (attached) for detailed requirement description, applicable terms and conditions, provisions, submittal instructions to offerors, and evaluation procedures prior to submitting their quotes. All Offerors must have an active registration in the System for Award Management (SAM), www.sam.gov, at the time of submittal.

QUESTIONS: Any questions pertaining to this requirement must be emailed to lasonja.harvey@va.gov no later than 1:00 PM ET, January 26, 2023 and include Solicitation 36C24723Q0287 in the subject line of the email to ensure timely review and response. No questions will be accepted nor answered after this date and time. Response to questions will be posted as an amendment to the solicitation once the question period has expired. Offerors are responsible for monitoring Contracting Opportunities at www.sam.gov for any amendments to the solicitation as the government will not send notice of amendments. Representatives from potential Offerors or on behalf of potential Offerors shall not contact any VA Medical Center representative to discuss nor inquire about this solicitation.

DEADLINE: All offers/quotes must be submitted in a single email to lasonja.harvey@va.gov and received no later than 11:00 AM ET, January 30, 2023 and include Solicitation 36C24723Q0287 in the subject line of the email to be considered for this requirement.