Synopsis: Please note that this is NOT a request for quotes or proposals. The Government is seeking information for market research purposes only. The Department of Veterans Affairs, VISN 3, Network Contracting Office 3 (10N3NCO) is currently conducting a market survey for firms capable of providing the following service: STATEMENT OF WORK Title: THYROSEQ V.2 Next Generation Sequencing Assay. 1. INTRODUCTION AND OVERVIEW: 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 the cases. However 10-25% of nodules yield one of three indeterminate cytological diagnoses leading to suboptimal management of these patients. Atypia of undetermined significance/follicular lesion of undetermined significance (AUS/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. The ThyroSeq v.2 multigene Next Generation sequencing (NGS) panel of molecular mutational markers conducted provides 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. Through ThyroSeq v.2 over 400 hotspots and fusion points on over 60 genes are tested to classify both benign and malignant nodules. By doing a Next Generation Sequencing of gene to determine whether the nodule is benign or malignant ThyroSeq v.2 we comply with VA's mission of providing exceptional care that improves the health and overall well-being of the Veteran. 1.1 Background: The ThyoSeq v.2 FNA Analysis is a diagnostic service provided for the assessment of thyroid nodules. The ThyroSeq v.2 Next Generation sequencing combines specialized cytopathology experts from incumbent vendor who properly identifies and categorizes biopsies allowing for further testing on only truly indeterminate FNAs. Physicians submit to incumbent vendor thyroid nodule FNA samples collected in a single patient visit. The combination of cytopathology screening with reflex to molecular testing is what makes ThyroSeq V.2 the most accurate diagnosis allowing patients to avoid unneeded surgeries and receive the right surgery. 1.2 Scope of Work Patient samples obtained through fine needle aspirate (FNA) biopsies are collected for both cytopathology assessment and ThyroSeq v.2. Initially cytopathology assessment is conducted. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or non-diagnostic, the Cytopathology FNA Analysis is complete. If the cytopathology diagnosis is indeterminate (includes Follicular lesion of Undetermined Significance (FLUS)/Atypia of Undetermined significance (AUS) and (suspicious for) Hurthle/Follicular Neoplasm), the thyroid nodule is greater than or equal to 1 cm and the patient is 21 or older, The ThyroSeq v.2 Next generation gene sequencing is performed. Thyroseq v.2 measures gene mutation which classifies both benign and malignant nodules by identifying actual mutations. Over 400 hotspot genes and fusion points on over 60 genes are tested. All results will be reported by the incumbent vendor. 1.3 Objectives: By combining specialized cytopathology and Thyroseq V.2 next generation sequencing 1.3.1 Enables physicians to identify patients who may avoid surgery 1.3.2 Empowers confident and timely clinical decisions from a single patient visit 1.3.3 Integrates seamlessly into a physician's practice workflow 1.3.4 Ensures quality and convenience in collecting and shipping patient samples 1.3.5 Allows patients to receive better care at a lower cost. 1.4 Period of Performance This Statement of Work (SOW) is submitted for the processing Cytopathology and ThyroSeq v.2 tests for Base plus four option years. 2. TASKS The contractor shall conduct the following tasks: 2.1 Provide Collection and Shipping kits for cytology samples. 2.2 Provide courier service for specimen pick up from the Cytology lab located VAMC,79 Middleville Rd, Building 200 room # B1-28A 2.3 Provide dedicated courier pick up service #. 2.4 Provide Cytology reports by fax to the Pathology Office. 2.5 Notification when Cytopathology is indeterminate and Thyroseq v.2 will be conducted. 2.6 Reflexively perform the Thyroseq v.2 test only when the cytopathology results are indeterminate. Upon completion the results will be faxed to the pathology office and to follow it up with hard copy by mail. 3. END RESULTS / DELIVERABLES FNA Cytopathology reports are expected within 4 days from the day of biopsy and ThyroSeq results expected within 15 days from the day of biopsy. 3.1 List of Deliverables by Task For large efforts, deliverables may be divided by subtask. The following table provides a complete listing of the required deliverables by task. The table includes, Task No. and Name, End Result/Deliverable, Tool for creating it, Acceptance Criteria, and Intended Use, as applicable. Task End Result/Deliverable Schedule/Milestone 1. FNA cytopathology report Up to 4 days from date of biopsy. 2. Thyroseq gene sequencing results Up to 15 business days from date of biopsy 4. TRANSMITTAL/DELIVERY/ACCESSIBILITY The contractor shall provide one faxed copy of the cytopathology result and followed by the hard copy to the Northport VAMC Pathologist with options to send to Northport VAMC Endocrinologists upon request. 4.1 Each test report shall, at minimum, include the following information: 4.1.1 Patient's full name 4.1.2 Patient's identification number, e.g. social security number (SSN) 4.1.3 Physician's name (if supplied) 4.1.4 Government laboratory accession number (if supplied) 4.1.5 Submitting facility name 4.1.6 Submitting facility account number 4.1.7 Patient's location (clinic/ward) (if supplied) 4.1.8 Test(s) ordered 4.1.9 Date/time of specimen collection (when available) 4.1.10 Date/time test completed 4.1.11 Test result 4.1.12 Reference intervals (adjusted for age, sex or race, when appropriate) 4.1.13 Reference laboratory accession number 4.1.14 Name and address of testing laboratory 4.1.15 Any other information the laboratory has that may indicate a questionable validity of test results. 4.1.16 Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. Responses to this notice must be submitted in writing via email and must be received not later than Friday, November 20, 2015, 1:00pm EST. No telephone inquiries will be accepted. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, HUB Zone, 8(a), small business or large business). Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses to this notice should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, proof of applicable certification. DUNS number, address, point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Contractor must be registered in System for Award Management (SAM), formerly CCR (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing, and received not later than Friday, November 20, 2015, 1:00 pm EST. All interested parties must respond to any related solicitation announcement separately from the responses to this announcement. Email: [email protected]. No telephone inquiries will be accepted. Interested parties MUST provide company/individual name, a capability statement, examples of same or similar work performed at other facilities, DUNS number and address, point of contact and social-economic.

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