P09 SOW Molecular Thyroid Testing.docx

Rocky Mountain Regional VA Medical Center Statement of Work Molecular Testing for Thyroid Specimen

I. PURPOSE

Contractor will provide testing for the detection of unique genetic alterations (to include mutations, insertions, deletions, gene fusions, chromosomal copy alterations, and changes in gene expression) to help determine if a thyroid nodule is benign or malignant in fine needle aspirates (FNAs) that are read indeterminate (Bethesda III and IV) by a Rocky Mountain Regional VA Medical Center provider. Samples will be sent from the Rocky Mountain Regional VA Medical Center (RMRVAMC), located at 1700 North Wheeling Street, Aurora, CO, 80045.

II. SCOPE

a) The RMRVAMC requires access to a molecular assay which analyzes thyroid fine needle aspiration specimens from patients who have had a previous diagnosis of “atypical cells of undetermined significance” (Bethesda III) or “follicular neoplasm” (Bethesda IV). The purpose of the test is to detect genetic alterations which would predispose a patient to an increased risk of thyroid carcinoma, while negative testing would confer a low risk of malignancy. This test would decrease the need for repeat biopsies from the patient, which, in turn, reduces the risk of procedure-related complications and optimize patient follow-up.

b) An ideal molecular test to evaluate thyroid nodules with indeterminate cytology should have a negative predictive value that is comparable to that of benign thyroid cytology (< 3%). Thus, a negative test could allow for thyroid surgery to be safely avoided. The standard of care is to manage patients with cytologically indeterminate nodules and negative molecular testing in a similar fashion to patients with benign (Bethesda II) cytology nodules with clinical and ultrasound follow up.

c) The contractor shall be approved to provide clinical diagnostic laboratory testing under both Medicare and Medicaid regulations and all applicable federal and state laws.

PERIOD OF PERFORMANCE: Base plus four option years Base Year – September 1, 2026 through August 31, 2027 Option Year 1 - September 1, 2027 through August 31, 2028 Option Year 2 - September 1, 2028 through August 31, 2029 Option Year 3 - September 1, 2029 through August 31, 2030 Option Year 4 – September 1, 2030 through August 31, 2031

III. GENERAL REQUIREMENTS

A. The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The contract shall also provide any valid, in-date CLIA and College of American Pathologist (CAP) certifications, showing the address and CLIA or CAP number of the testing laboratory. The contractor shall be HIPAA compliant.

B. The test’s sensitivity, specificity, negative and positive predictive value should have been confirmed through a prospective multicenter clinical validation study with pathologist blinding. In addition, real world studies evaluating the performance of the test in different patient populations are needed to demonstrate clinical utility.

C. TESTING TO BE PERFORMED-Targeted mutation detection for thyroid samples, including:

a) Fine Needle Aspiration (FNA)

b) Cytology slide smears

c) FNA Cell Block

d) Resected Tissue (tumors)

e) Any other acceptable sample types

D. Contractor shall provide testing using tissue extracted during a fine needle aspiration. Contractor is requested to provide genomic sequencing to determine the expression profile of the mRNA. This test must use the expression profile to determine a “benign” or “suspicious for malignancy” interpretation for the submitted tissue. The Contractor is requested to offer BRAF and RET/PTC mutation testing in addition to the genomic sequencing classification to help determine the extent of surgery.

E. INFORMATION FOR ALL TEST

a) The contractor shall provide the following information to the Government on all tests.

i. Requisition form requirements

ii. Specimen collection and preservation requirements

iii. Test method employed (indicate if testing performed in duplicate) and interpretations

iv. Test reference intervals adjusted for age, sex or race, when required

v. Test-specific sensitivity, specificity and interferences, when required

vi. Test critical values, if any

vii. Policy for critical value notification

b) Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

F. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

G. Report turn-around time will be within 14 days from the date on which the Contractor receives the specimen.

H. Testing shall be performed Monday-Saturday

IV. SPECIMEN PREPARATION AND TRANSPORTATION

A. SPECIMEN PREPARATION

a) Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

b) Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the Contractor for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the Contractor.

c) Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

B. TRANSPORTATION FOR REFERENCE TESTING SPECIMEN:

a) Contractor shall provide transportation of primarily biomedical materials that include patient specimens.

b) Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

c) Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

i. Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

ii. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA), consistent with current regulatory updates.

iii. Test request forms preprinted with the appropriate Shipping Section details and account information.

iv. Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

V. REPORTING

Results may be called to the VA Anatomic Pathology Department at 720-723-6821 or faxed to 720-723-6037. Alternative methods of contact can be provided, if needed. Vendor must comply with posted turn-around times to ensure no delay in care.

VI. INVOICE REQUIREMENTS AND SUPPORTING DOCUMENTATION:

A. Supporting documentation and invoices must be submitted within 30 days of the end of each month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

a) Name and Address of Contractor

b) Contractor’s ID Number (Tax ID number)

c) Specimen ID (Patient name, patient ID number, order number)

d) Invoice Date and Invoice Number

e) Contract Number and Purchase/Task Order Number

f) Date of Service

g) Line Item Pricing, including test name

h) Total Price

B. VENDOR ELECTRONIC INVOICE SUBMISSION METHODS:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically per the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through Tungsten.

VII. CUSTOMER SERVICE

A. Contractor shall provide customer service that is accessible during Contractor’s business hours Monday-Friday 7:00am-5:00pm to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

C. Upon award, the Contractor shall provide the name(s) and telephone number(s) of Contractor employees who will address the following customer services throughout the contract performance period.

D. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

VIII. CONSULTATIVE SERVICES

Contractor shall provide consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.