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 ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered / created by the contractor while performing the contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable to FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or date used by the contractor/subcontractor needs to be restored in an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under FAR Part 12. g. This contract will require a Business Associate Agreement between the Government and the contractor. If a VHA contract is terminated for cause, the associated BAA must also be terminated an appropriate action taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer to all requests for, demands for production of, or inquiries about VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism, or alcohol abuse, or…