6515--PR Needed NEW Request / Tyroid Molecular Tests - THYROSEQ 5 year contract

Statement of Work/ Performance Work Statement 1. Contract Title. Thyroid Molecular Testing 2. Background. Thyroid nodules are common and require biopsy for diagnosis of a benign vs malignant process. Fine needle aspiration cytology (FNA) is the biopsy method most frequently used to determine if a thyroid nodule is benign or malignant. Once assigned to the correct diagnostic category, a treatment plan can be prepared. If malignant, the treatment shall include a surgical procedure. Approximately 10% of the time the FNA diagnosis for a thyroid nodule shall be indeterminate for malignancy. These lesions are diagnosed: Follicular Lesion of Uncertain Significance (FLUS) or Follicular Neoplasm (FN). Thyroid nodules diagnosed on FNA as FLUS or FN may go on to surgery to determine the true nature of the nodule. Most thyroid nodules diagnosed FLUS or FN on FNA biopsy shall be found to be benign when the nodule is surgically removed. Therefore, many surgeries for thyroid nodules may not be necessary. Molecular testing of thyroid nodule FNA specimens was developed to aid in the diagnosis of indeterminate thyroid nodules. Molecular testing can detect hundreds of genes expressed in thyroid tissues. Reviewing thyroid-specific gene profiles can stratify thyroid nodule FNA specimens into those at low-risk (benign) and those at high-risk for malignancy. 3. Scope. Molecular testing of thyroid nodule FNA specimens has been found to assist in the assessment of indeterminate thyroid nodules. Molecular testing can detect genetic alterations associated with thyroid malignancy. Molecular testing of an indeterminate thyroid nodule can stratify patients into those who may or may not need a surgical procedure. The Government has a requirement for molecular testing of indeterminate thyroid nodules at VA Puget Sound Health Care System (VAPSHCS) Seattle. This testing shall be performed at an outside laboratory. An FNA specimen from a thyroid nodule is placed into transport media provided by the contractor and shipped to the laboratory using their shipping materials. The volume of tests performed annually at VAPSHCS shall be approximately 120 molecular tests per year at the present biopsy rate and present rate of indeterminate nodules. 4. Specific Tasks. a. The molecular test used for evaluating indeterminate thyroid nodules shall have high specificity and sensitivity for malignancy, high predictive value, and shall employ an extensive panel of thyroid-related gene mutations for detection to include at a minimum: BRAF, RAS, TERT, RET, NTRK, and ALK. The test shall be able to use samples from fine needle aspirations and must accept frozen samples. A report shall be provided with each sample that shall include detected mutations/alterations with interpretation (including percentage/possibility of malignancy). b. The Contractor shall provide the VAPSHCS with transport media for the FNA thyroid specimen and must provide packaging and postage label for overnight shipment. The (TAT) turnaround time must be within seven (7) business days. c. The Contractor facility shall be a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, undergoing regular proficiency surveys of their testing. The Contractor shall provide customer service that includes expertise in thyroid testing panels, who shall be available Monday Friday between the hours of 8am 4:30pm, MST. The laboratory shall have an established and reputable history of performing thyroid molecular testing for other VA laboratories. 5. Performance Monitoring VAPSHCS Medical Center will follow patients whose thyroid nodules have undergone molecular testing to ascertain whether the nodules were assigned to the correct diagnostic category of benign vs malignant. 6. Security Requirements The C&A requirements do not apply, and a Security Accreditation Package is not required. Specimens will be labeled with patient s full name and SSN and be shipped according to Contractor instructions. Results are Faxed to VAPSHCS using a secure FAX. 7. Privacy/Custody of VA Information a. Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data General, FAR 52.227-14(d)(1). b. VA information should not be co-mingled, if possible, with any other data on the contractor/subcontractor's information systems or media storage systems to ensure VA requirements related to data protection and media sanitization can be met. If comingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to