Attachment 1: Combined Synopsis-Solicitation for Commercial Services

Effective Date: 01/15/2026 Revision: 03

Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2026-01.

This solicitation 36C24226Q0875 is not set-aside for small business concerns.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511 Medical Laboratories, with a small business size standard of $41.5 million.

The FSC/PSC is Q301 Medical – Reference Laboratory Testing.

The Department of Veterans Affairs Network Contracting Office (NCO) 2 located at 113 Holland Ave Albany, NY 12208 is seeking to establish an Indefinite Delivery Indefinite Quantity (IDIQ) Contract to provide comprehensive, clinically validated molecular diagnostic testing using NGS to improve the evaluation and management of thyroid nodules with indeterminate FNA cytology, enhancing diagnostic accuracy, reducing unnecessary surgeries, and guiding timely intervention for patients at risk.

All interested companies must provide quotations as specified in the Performance Work Statement (PWS):

Services Price/Cost Schedule

Description: The Contractor must furnish all labor, materials, equipment, supplies, collection and shipping kits, courier services, cytopathology analysis, reflex molecular testing, reporting, consultation, quality management, and all other services necessary to perform Cytopathology and Next Generation Sequencing Testing Services as specified in the PWS for the Northport VA Medical Center.

The contract performance period is 10/01/2026 – 09/30/2031. The minimum quantity under this contract is 30 tests and the maximum quantity is 600 tests over the five-year ordering period.

Line Item Description Quantity Unit of

Measure Unit Price

Total Price https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-12#FAR_12_202

Revision: 03

0001 Cytopathology Evaluation Services Estimated Quantity: 600 tests

1 Each

0002 Molecular Diagnostic Testing Estimated Quantity: 600 tests

1 Each

*Any fees, charges, or costs not clearly identified and included in the Offeror’s quote at the time of submission will not be accepted or paid by the Government.

Performance Work Statement

See attached Performance Work Statement.

The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far.

The following solicitation provisions and clause apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial

Services” (SEP 2023) (DEVIATION OCT 2025)

(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include—

(1) The solicitation number 36C24226Q0875;

(2) Offerors must complete the Price Schedule above and submit documentation that addresses the evaluation criteria at 52.212-2 below. Offerors that fail to provide sufficient documentation may be determined to be incomplete and ineligible for award.

(2) The name, address, telephone number of the Offeror;

(3) The Offeror’s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator;

(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;

(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and

(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

Revision: 03

(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is “late” and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(4) Offerors may withdraw their offers by written notice to the Government received at any time before award.

(d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received.

(e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:

(1) The agency’s evaluation of the significant weak or deficient factors in the debriefed Offeror’s offer.

Revision: 03

(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award.

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.

(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities.

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. (SEP 2024) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. (JAN 2017) 52.204-7 System for Award Management—Registration (NOV 2024) (DEVIATION

NOV 2025)

52.216-1 Type of Contract (APR 1984) (DEVIATION NOV 2025) Fill-In: Firm-Fixed-Price IDIQ 52.219-1 Small Business Program Representations. (FEB 2024) (DEVIATION NOV 2025) 52.229-11 Tax on Certain Foreign Procurements – Notice and Representation (JUN

2020) (DEVIATION SEP 2025)

52.240-90 Security Prohibitions and Exclusions Representations and Certifications.

(DEVIATION NOV 2025)

52.252-5 Authorized Deviations in Provisions (NOV 2020) Fill-In: VA Acquisition Regulation (VAAR) and 48 CFR Chapter 8

852.215-72 Notice of Intent to Re-solicit (OCT 2019) 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

Fill-In: Contractor must complete: 52.219-1 Small Business Program Representations. (FEB 2024) (DEVIATION NOV 2025)

(End of provision)

All quoters shall submit the following and must read FAR 52.212-2 Evaluation- Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025)

Revision: 03

1. Technical Capability

a. Diagnostic Performance - sensitivity, specificity, NPV/PPV for

Bethesda III-V nodules; supported by peer‑reviewed clinical validation showing improved diagnostic accuracy/reduced unnecessary surgery.

b. Molecular Testing Capability - validated NGS or equivalent;

DNA/RNA; detects SNVs, indels, fusions, CNAs, gene expression and clinically significant biomarkers.

c. Clinical Utility - risk stratification, interpretation, surgical decision support, identification of aggressive biology, guideline‑consistent management.

d. Experience - The Government will consider the Offeror’s depth and breadth of experience performing thyroid molecular testing, including annual testing volume, years in operation, clinical studies published, assay development history, and experience supporting integrated healthcare systems. A minimum of three (3) references to include the following information:

a. Company name and address

b. Name, telephone number and e-mail address of Company

POC

c. Dates of contract performance, aggregate award amount, and Contract number.

e. Submit Exclusions and Limitations-The contractor must clearly state any services, features, or components of the requirements described in this PWS that will not be provided as part of their offering, including any exclusions or limitations in scope, process, or deliverables. These should be included in the contractor’s technical proposal and referenced in the transition, implementation, or ongoing service documentation.

2. Past Performance

a. Three Past Performances within the last five years.

3. Key Personnel/Staffing

a. Board‑certified molecular pathology oversight; qualified personnel for high‑complexity testing; documented training and competency.

b. Provide licensing and accreditations as indicated in PWS.

4. Quality Management

a. Laboratory Quality & Accreditation - current CLIA certification; CAP accreditation; validated methods; proficiency testing participation;

QA procedures.

b. Turnaround Time - consistent report delivery within required TAT;

specimen tracking; notification of issues; customer support.

Revision: 03

c. Reporting & Clinical Interpretation - clear cytology descriptions, molecular findings, interpretation, estimated malignancy risk and recommendations.

d. Specimen Compatibility & Logistics - FNA compatibility, minimal specimen needs, acceptance of standard prep methods, collection kits, shipping materials, technical support.

5. Price

6. Veterans Involvement

All quotes shall be sent to Mariangie Rivera at Mariangie.Rivera@va.gov, no later than 5:00 PM EST on August 21, 2026.

2. FAR 52.212-2 Evaluation-Commercial Products and Commercial Services

(NOV 2021) (DEVIATION OCT 2025)

(a) The following factors will be used to evaluate quotations:

Technical or Quality Capability Statement The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Past Performance Past Performance will be evaluated for recent and relevant experience. To demonstrate recency and relevancy, the Quoters shall submit at least three (3) past performances from projects worked on within the last five (5) years. The past performance must be for contracts that are similar in size, scope, and complexity. When submitting, the past performance information must meet the requirement’s size, scope, and complexity. Should the past performance information not be of similar stature the quoter will receive a Neutral rating.

Additionally, past performance information submitted that is not recent and relevant combined will also receive a Neutral rating. Recent past performance is defined as past performance completed within the last 5 years. Relevancy is defined as past performance that must align with the current requirement.

In the event a contractor uses past performance information owned by another contractor without providing a team agreement or joint venture the past performance information will also be considered Neutral. Past Performance /Experience gained by Key Personnel on government contracts with other companies will be considered Key Personnel’s individual Performance / experience and will not be recognized as a Quoters past performance experience, and will be given a Neutral rating.

The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as mailto:Mariangie.Rivera@va.gov

Revision: 03 indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis. Neutral Evaluation will be given to offerors without relevant past performance.

Key Personnel Identification Key Personnel must be identified to include Contract Manager, Laboratory Director technical qualifications and roles and responsibilities. Key Personnel must be employed or will be employed by the Prime Contractor. If employment of Key Personnel is contingent upon the award of the contract, it is crucial to ensure that the Prime Contractor has a firm commitment from these individuals to work on the required service. This commitment should be documented in the Quote.

Resumes and other support materials will be included for all key personnel. If key personnel become unavailable after Quote submission but before award, the Interested Quoters must notify the Contracting Officer and obtain written approval before making any changes to the personnel list in its Quote. This process is designed to maintain the continuity of key personnel and ensure that the contractor can fulfill its obligations under the contract. Failure to provide this information will result in the contractor being non-responsive.

Veterans’ Involvement In accordance with Veterans Affairs Acquisition Regulation (VAAR) 852.215-70 (DEVIATION), Service-Disabled Veteran-Owned and Veteran-Owned Small Business (VOSB) Evaluation Factors, the Government will assign evaluation credit for a Quoter (i.e., prime contractor) which is a Service-Disabled Veteran- Owned Small Business (SDVOSB) or a VOSB. To receive credit, an offeror must be registered and verified in Vendor Information Pages (VIP) database at time of quotation submission and at time of award (https://certifications.sba.gov/) and must meet federal small business size standards for the North American Industry Classification System (NAICS) code assigned to this solicitation. Non- SDVOSB/VOSB quotations that use SDVOSBs or VOSBs as subcontractors will receive some consideration under this evaluation Factor. Quoters must state in their quotations the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts. In addition, the proposed subcontractors must be registered and verified in the VetBiz.gov VIP database (https://certifications.sba.gov/) and must meet federal small business size standards for the NAICS code assigned to this solicitation at time of both quotation submission and at time of award.

*In addition, the Veteran Owned Business seeking evaluation preference under this subpart must complete, sign, and submit with their proposal 852.219-75 VA http://www.cpars.gov/ https://certifications.sba.gov/ https://certifications.sba.gov/

Revision: 03

Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction.

Price The Government will evaluate the price by adding the total of all line-item prices.

The Total Evaluated Price will be that sum.

The Government reserves the right to consider an award to other than the lowest priced Quoters or other than the highest technically rated Quoters. The anticipated benefit of a higher priced quote must merit the additional cost. In accordance with FAR 52.212-2, the Government will award an Indefinite Delivery/Indefinite Quantity (IDIQ) contract resulting from this solicitation to the responsible Quoters whose Quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Technical and Past Performance factors, when combined, are more important than price.

The Government may determine that a Quote is unacceptable if the prices are significantly unbalanced. Unbalanced refers to a situation where a Quoters places unreasonably high values on certain items and an unreasonable low value on others within a unit price contract. An unbalanced Quote may be rejected if it raises concerns about the overall cost effectiveness of the Quote, as it could lead to the Government paying unreasonably high prices for contract performance.

“Evaluations of Options" For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all proposals relative to each other, and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8.

*Quotes may be evaluated by performing a comparative evaluation of quotations in accordance with FAR Overhaul 12.203(C)(2). The evaluation will be based on how well the proposed services meet the Government’s requirements.

3. FAR 52.212-3 is RESERVED.

Revision: 03 www.sam.gov registration is required to be complete at time of submission of response. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://sam.gov/.

4. FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services” (NOV 2023) (DEVIATION OCT 2025)

52.252-2 Clauses Incorporated by Reference (FEB 1998) https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR)

52.203-6 ALT I. Restrictions on Subcontractor Sales to the Government. (NOV 2021) 52.203-17 Contractor Employee Whistleblower Rights. (NOV 2023) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. (JAN 2017) 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) 52.204-13 System for Award Management-Maintenance (OCT 2018) (DEVIATION

NOV 2025)

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (JAN 2025) (DEVIATION NOV 2025) 52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV

2015) (DEVIATION NOV 2025)

52.216-18 Ordering (AUG 2020)

Fill-In: 10/01/2026 through 09/30/2031 52.216-19 Order Limitations (OCT 1995)

Fill-In: (a) 30 tests; (b)(1) 600 tests, (2) 600 tests, (3) 30 days; (d) 10 days 52.216-22 Indefinite Quantity (OCT 1995) (DEVIATION NOV 2025)

Fill-In: 09/30/2031 52.217-8 Option to Extend Services (NOV 1999)

Fill-In: 15 Days 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. (OCT 2022) (DEVIATION NOV 2025) 52.219-28 Postaward Small Business Program Rerepresentation (JAN 2025)

(DEVIATION NOV 2025)

52.222-49 Service Contract Labor Standards – Place of Performance Unknown

(MAY 2014) (DEVIATION NOV 2025)

52.222-55 Minimum Wages for Contractor Workers Under Executive Order 14026

(JAN 2022) (DEVIATION NOV 2025)

52.219-8 Utilization of Small Business Concerns. (JAN 2025) (DEVIATION NOV 2025) 52.222-3 Convict Labor. (JUN 2003) (DEVIATION NOV 2025) http://www.sam.gov/ https://sam.gov/ https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 http://www.va.gov/oal/library/vaar/index.asp

Revision: 03

52.222-36 Equal Opportunity for Workers with Disabilities. (JUN 2020) (DEVIATION

NOV 2025)

52.222-41 Service Contract Labor Standards. (AUG 2018) (DEVIATION NOV 2025) 52.222-42 Statement of Equivalent Rates for Federal Hires. (MAY 2014)

Fill-In: See Wage Determination on SAM.GOV 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts). (AUG 2018) (DEVIATION NOV 2025) 52.222-50 Combating Trafficking in Persons. (NOV 2021) (DEVIATION NOV 2025) 52.222-54 Employment Eligibility Verification. (JAN 2025) (DEVIATION NOV 2025) 52.222-62 Paid Sick Leave Under Executive Order 13706. (JAN 2022) (DEVIATION

NOV 2025)

52.222-90 Addressing DEI Discrimination by Federal Contractors (APR 2026) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving.

(MAY 2024)

52.232-19 Availability of Funds for the Next Fiscal Year (APR 1984)

Fill-In: 09/30/2027 52.232-33 Payment by Electronic Funds Transfer-System for Award Management.

(OCT 2018)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(MAR 2023)

52.233-3 Protest after Award. (AUG 1996) (DEVIATION NOV 2025) 52.233-4 Applicable Law for Breach of Contract Claim. (OCT 2004) (DEVIATION

NOV 2025)

52.237-3 Continuity of Services (JAN 1991) 52.240-91 Security Prohibitions and Exclusions. (DEVIATION NOV 2025)

Fill-In: No DHS FASCSA Order Fill-In: No DoD FASCSA Order Fill-In: No DNI FASCSA Order

52.244-6 Subcontracts for Commercial Products and Commercial Services. (JAN

2025) (DEVIATION APR 2026)

52.252-6 Authorized Deviations in Clauses (NOV 2020)

Fill-In: VA Acquisition Regulation (VAAR) and 48 CFR Chapter 8.

852.201-70 Contracting Officer’s Representative (DEC 2022) 852.203-70 Commercial Advertising (MAY 2018) 852.204-70 Personal Identity Verification of Contractor Personnel (MAR 2026)

(DEVIATION FEB 2026)

852.211-72 Technical Industry Standards (NOV 2018) 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JAN 2023) (DEVIATION) 852.215-71 Evaluation Factor Commitments (OCT 2019) 852.219-75 VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction.

852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.237-75 Key Personnel (OCT 2019)

Revision: 03

852.242-71 Administrative Contracting Officer (OCT 2020)

(End of clauses)

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exceptions and rationale for the exception(s), if any.

Submission of your response shall be received not later than 5:00PM EST on August 21, 2026, at Mariangie.Rivera@va.gov. Subject Line should state Solicitation Number:

36C24227Q0003 and Title: Cytopathology and Next Generation Sequencing Testing.

Late submissions shall be treated in accordance with the solicitation provision at FAR Overhaul 52.212-1(c)(1)-(2) as stated above under FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services” (SEP 2023) (DEVIATION

OCT 2025).

Telephone inquiry will not be accepted – no exceptions. Any questions, clarifications, or concerns regarding this solicitation must be forwarded No later than 5:00 PM EST on August 13, 2026, in writing via e-mail to the Point of Contact listed below.

A complete package as indicated in Instructions to Offerors is due no later than 5:00 PM EST on August 21, 2026.

Point of Contact Mariangie Rivera, Contracting Officer, Mariangie.Rivera@va.gov mailto:Mariangie.Rivera@va.gov mailto:Mariangie.Rivera@va.gov

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

As prescribed in 819.7011(b), insert the following clause:

VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction (NOV 2022)

(a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Contracting Officer check the appropriate box below based on the predominant NAICS code assigned to the instant acquisition as set forth in FAR 19.102.]

(i) X Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73 or VOSBs as set forth in 852.219-74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6.

(ii) □ General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73or VOSBs as set forth in 852.219-74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(iii) □ Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs as set forth in 852.219-73 or VOSBs as set forth in 852.219-74. Any work that a similarly situated subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(2) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(3) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating section 1001 of title 18.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract.

https://www.govinfo.gov/link/uscode/38/8127 https://www.ecfr.gov/current/title-13/section-125.6 https://www.govinfo.gov/link/uscode/38/8127 https://www.govinfo.gov/link/uscode/15/645

Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror's bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification

I hereby certify that if awarded the contract, will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of .

Printed Name of Signee:

Printed Title of Signee:

Signature:

Date:

Company Name and Address:

(End of clause)

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

VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction (NOV 2022)

Certification ii: Off iii: Off

Offeror Name: Insert Offeror Name

Signee Name:

Signee Title:

Signature:

Text6:

Date7_af_date:

Company Name and Address:

NORTHPORT VA MEDICAL CENTER

PATHOLOGY & LABORATORY MEDICINE SERVICE

PERFORMANCE WORK STATEMENT (PWS)

CYTOPATHOLOGY AND NEXT GENERATION SEQUENCING TESTING SERVICES

1. BACKGROUND

The Northport Department of Veterans Affairs (VA) requires comprehensive molecular diagnostic testing services to support the evaluation and management of patients with thyroid nodules demonstrating indeterminate cytology following fine needle aspiration (FNA). Cytologically indeterminate thyroid nodules, including Bethesda Categories III, IV, and select Category V lesions, present a diagnostic challenge because conventional cytopathology alone cannot reliably distinguish benign from malignant disease.

Fine Needle Aspiration (FNA) cytology is a common approach to evaluate thyroid nodules. It offers definitive diagnosis of a benign or malignant nodule in the majority of cases. However, 10-25% of nodules yield one of three indeterminate cytological diagnoses leading to suboptimal management of these patients.

Atypia of undetermined significance (AUS) / follicular lesion of undetermined significance (FLUS) are a common indeterminate diagnosis with cancer risk ranging from 6% to 48%. Current guidelines recommend that most of these patients undergo diagnostic thyroid surgery to assess whether nodules are benign or malignant. Approximately 70% to 80% of the time, the nodules prove to be benign by surgical pathology.

Further, accurate molecular testing is essential to improve diagnostic certainty, guide evidence-based clinical decision-making, reduce unnecessary thyroid surgeries, and facilitate timely identification of patients requiring surgical intervention. The requested testing shall provide high diagnostic accuracy with demonstrated clinical validation and shall integrate molecular findings into a comprehensive clinical interpretation to support patient management. Testing shall provide The Next Generation sequencing (NGS) panel of molecular mutational markers providing both high sensitivity and high specificity for cancer detection in thyroid nodules with AUS / FLUS cytology, which should allow improved management of these patients by avoiding many of the diagnostic surgeries currently performed for benign nodules, with associated decreases in health costs and postsurgical complications.

2. OBJECTIVES

The objective of this requirement is to combine specialized cytopathology and Next Generation Sequencing methodologies to:

• Identify patients who may avoid surgery, improving patient outcomes.

• Enable confident and timely clinical decision-making during a single patient visit.

• Integrate diagnostic processes seamlessly into physicians’ practice workflows.

• Ensure quality and convenience in the collection and shipping of patient samples.

• Enhance patient care while reducing overall costs.

3. SCOPE OF WORK

Northport VAMC estimates approximately 96 tests per year. Patient samples obtained through fine needle aspirate (FNA) biopsies are initially submitted for cytopathology evaluation. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or non-diagnostic, the Cytopathology FNA Analysis is complete. Molecular testing shall be performed only when clinically indicated based on cytopathology diagnosis that is indeterminate including Follicular lesion of Undetermined Significance /Atypia of Undetermined Significance), suspicious for Hurthle/Follicular Neoplasm, and other indeterminate classifications when molecular testing is clinically appropriate. The molecular assay shall utilize a validated Next Generation Sequencing (NGS) platform capable of evaluating clinically significant genomic alternations associated with thyroid malignancy. The assays shall analyze both DNA and RNA to detect clinically relevant molecular alterations. Interpretation and reporting with clinical risk stratification to assist providers in determining the likelihood of benign versus malignant disease shall be made by qualified molecular pathologists.

4. PERIOD OF PERFORMANCE

The period of performance is for a five-year contract with an estimated performance period to commence 10/01/2026 through 09/30/2031, effective on date of award.

This contract will be awarded as a single-award, Indefinite Delivery, Indefinite Quantity (IDIQ), Firm- Fixed-Price (FFP) contract for a period of five (5) years, with no option periods. The minimum guaranteed quantity under this contract is 30 tests, and the maximum quantity is 600 tests over the five-year ordering period.

5. RECOGNIZED HOLIDAYS

No services will be provided on recognized Federal holidays, weekends (Saturday and Sunday), or on any other day specifically declared by the President of the United States to be a national holiday. These days include, but are not limited to:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth Day

Should the President of the United States declare any additional national holidays, services will not be provided on those days as well.

6. HOURS OF OPERATION

The contractor is responsible for conducting business between the hours of 8:00 AM to 4:30 PM Monday through Friday only. No Federal holidays, Weekends (Saturday and Sunday). or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor must keep in mind that the stability and continuity of the workforce are essential.

7. TASKS

The Contractor must conduct the following tasks:

• Must provide Collection and Shipping kits for cytology samples. Samples must be collected within 24 hours of biopsy.

• Must provide courier service all-inclusive for specimen pick up from the Cytology lab located VAMC,79 Middleville Rd, Building 200 room # B1-28A

• Must provide dedicated courier pick-up service number.

• Must provide Cytology reports by fax to the Pathology Office. The fax number is 631-544-5309.

• Must provide notification when Cytopathology is indeterminate and molecular testing must be conducted.

• Must reflexively perform molecular testing only when the cytopathology results are indeterminate.

Upon completion the results must be faxed to the pathology office and followed up with hard copy by mail.

8. PERFORMANCE REQUIREMENTS

The molecular assay must meet the following minimum requirements:

Diagnostic Performance:

The assay must demonstrate:

• High clinical sensitivity for detection of thyroid malignancy.

• High clinical specificity to minimize unnecessary surgical intervention.

• High negative predictive value (NPV) sufficient to support conservative management when appropriate.

• High positive predictive value (PPV) to assist clinicians in identifying patients who would benefit from surgical treatment.

Performance characteristics must be supported by peer-reviewed clinical validation studies.

Comprehensive Molecular Analysis:

The assay must be capable of detecting clinically relevant thyroid cancer biomarkers, including:

• Single nucleotide variants (SNVs)

• Insertions and deletions.

• Gene fusions

• Copy number alterations (CNAs)

• Gene expression alterations or other validated molecular classifiers

• Other clinically significant genomic alternations associated with thyroid malignancies

Testing must utilize validated next-generation sequencing (NGS), DNA, and RNA sequencing.

The Contractor’s assay must be compatible with routine thyroid FNA specimens and accept standard cytology preparation methods. Minimal specimen volume requirements should be clearly stated and as low as feasible. Preference will be given to assays and platforms that minimize the need for repeat patient procedures.

9. END RESULTS / DELIVERABLES - REPORTS

FNA Cytopathology reports are expected within four (4) days from the day of biopsy and molecular testing results are expected within 15 days from the day of biopsy.

10. TRANSMITTAL/DELIVERY/ACCESSIBILITY

The contractor must provide one faxed copy of the cytopathology result and followed by the hard copy mailed to the Northport VAMC Pathologist and with the option to send to Northport VAMC Endocrinologists upon request.

11. TEST REPORT

Each test report must, at minimum, include the following information:

• Patient's full name

• Patient’s identification number, e.g. social security number (SSN)

• Physician’s name (if supplied)

• Government laboratory accession number (if supplied)

• Submitting facility name

• Submitting facility account number

• Patient's location (clinic/ward) (if supplied)

• Test(s) ordered

• Date/time of specimen collection (when available)

• Date/time test completed

• Test result

• Molecular findings

• Interpretation of detected alterations

• Estimated risk of malignancy

• Clinical significance of identified biomarkers

• Evidence-based management considerations

• Laboratory director review and sign-out

• References to clinically validated evidence when appropriate

• Reference intervals (adjusted for age, sex or race, when appropriate)

• Reference laboratory accession number

• Name and address of testing laboratory

• Any other information the laboratory has that may indicate a questionable validity of test results.

• Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

12. SERVICE

The Contractor must provide:

• Telephone number(s) and contact person(s) to be used by the VAMC, Northport, NY to make specimen problem inquiries and problem solving at all times.

• Names and telephone number(s) of Technical Director(s) and Pathologist(s) available for consultation.

13. CONTRACTOR QUALIFICATIONS

The contractor must provide the following documentation:

• Extensive experience performing thyroid molecular diagnostics.

• Board-certified molecular pathology oversight.

• Published peer-reviewed clinical validation studies supporting assay performance.

• Proven clinical utilization within academic medical centers and integrated healthcare systems.

• Ongoing assay updates reflecting advances in thyroid molecular diagnostics.

• Clinical Laboratory Improvement Amendments (CLIA) Certification

• College of American Pathologists (CAP) Certification

• The Joint Commission (TJC) Certification

• New York State Department of Health (NYSDOH) clinical laboratory permit

14. CONTRACTING OFFICER REPRESENTATIVE (COR)

The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

15. KEY PERSONNEL

The following personnel are considered key personnel by the government: Contract Manager and Laboratory Director. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m., Monday through Friday except Federal holidays, Weekends, or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below: The Contract Manager qualifications would be bachelor's degree and a minimum of five (5) years of experience managing clinical laboratory contracts. The Laboratory Director qualifications must be CLIA Laboratory Director requirements for the testing performed.

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

16. IDENTIFICATION OF CONTRACTOR EMPLOYEES

All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. The contractor personnel must obtain and wear badges in the performance of this service.

17. CORRECTIVE ACTION

The Contractor will be notified any time a performance standard is missed or of any complaints related to services provided or personnel performance issues. The Contractor will be given an opportunity to correct any deficiency noted. The timeframe for correcting deficiencies will be determined on a case-by-case basis by the Contracting Officer depending on the circumstances.

18. VA INFORMATION SYSTEM AND VA NETWORK

The Contractor shall not and will not have access to VA Network or VA Systems.

19. PROTECTION OF HEALTH INFORMATION (PHI) AND COMPLIANCE WITH (HIPAA)

The Contractor mut comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all applicable laws and regulations regarding the protection, security, and privacy of Protected Health Information (PHI). The Contractor must ensure that all personnel handling PHI are appropriately trained in HIPAA requirements and shall implement safeguards i.e., administrative, technical, and physical to prevent unauthorized use or disclosure of PHI.

Any PHI collected, processed, transmitted, or stored in connection with this contract must be handled in accordance with VA policies and HIPAA standards. The Contractor must promptly report any actual or suspected breach of PHI to the Contracting Officer and the VA Privacy Officer.

Failure to comply with HIPAA and VA privacy requirements may result in remedial action, up to and including termination of the contract.

20. OTHER RELATED SERVICES (NOT INCLUDED IN THE SCOPE OF WORK)

Any services not expressly stated in this PWS are not authorized.

The following services, while related to the requirements of this contract, are not included in the scope of work and are not covered under this agreement:

• Any services not specifically described in the Performance Work Statement.

• Additional training or consulting services not expressly listed in the contract.

• Emergency response or after-hours support not explicitly detailed in the agreement.

• Laboratory or medical testing services outside those expressly listed in the PWS.

Any requests for these or other related services outside the contract’s defined scope shall require review and approval by the Contracting Officer through a supplemental agreement.

No other person, including the COR or any other VA personnel, is authorized to request additional work from the Contractor. Any services performed by the Contractor that are not expressly authorized in writing by the Contracting Officer shall be performed at no cost to the Government.

21. QUALITY ASSURANCE SURVEILLANCE PLAN

Purpose:

The purpose of this Quality Assurance Surveillance Plan (QASP) is to provide guidance on how the quality of services provided under this contract will be monitored.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis.

However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

Scope:

• The areas to be addressed under the QASP are as follows:

• Timeliness of sample collection

• Accurate Testing on Cytopathology FNA Analysis and molecular testing

• Timeliness of test reports

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