PWS 7.28.2026.pdf

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