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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 08, 2015 FBO #5098
DOCUMENT

Q -- THYROSEQ V.2 Next Generation Sequencing Assay. - Attachment

Notice Date

11/6/2015
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;James J. Peters VA Medical Center;Network Contracting Office 3 (10N3NCO);130 West Kingsbridge Road;Bronx NY 10468-3904
 

ZIP Code

10468-3904
 

Solicitation Number

VA24316N0106
 

Response Due

11/20/2015
 

Archive Date

1/19/2016
 

Point of Contact

Delfo R. Saco-mizhquiri
 

Small Business Set-Aside

N/A
 

Description

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. 1.1Background: 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. 1.2Scope 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. 1.3Objectives: By combining specialized cytopathology and Thyroseq V.2 next generation sequencing 1.3.1Enables physicians to identify patients who may avoid surgery 1.3.2Empowers confident and timely clinical decisions from a single patient visit 1.3.3Integrates seamlessly into a physician's practice workflow 1.3.4Ensures quality and convenience in collecting and shipping patient samples 1.3.5Allows patients to receive better care at a lower cost. 1.4Period 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: 2.1Provide Collection and Shipping kits for cytology samples. 2.2Provide courier service for specimen pick up from the Cytology lab located VAMC,79 Middleville Rd, Building 200 room # B1-28A 2.3Provide dedicated courier pick up service #. 2.4Provide Cytology reports by fax to the Pathology Office. 2.5Notification when Cytopathology is indeterminate and Thyroseq v.2 will be conducted. 2.6Reflexively 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. 3.1List 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. TaskEnd Result/DeliverableSchedule/Milestone 1.FNA cytopathology reportUp to 4 days from date of biopsy. 2. Thyroseq gene sequencing resultsUp 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. 4.1Each test report shall, at minimum, include the following information: 4.1.1Patient's full name 4.1.2Patient's identification number, e.g. social security number (SSN) 4.1.3Physician's name (if supplied) 4.1.4Government laboratory accession number (if supplied) 4.1.5Submitting facility name 4.1.6Submitting facility account number 4.1.7Patient's location (clinic/ward) (if supplied) 4.1.8Test(s) ordered 4.1.9Date/time of specimen collection (when available) 4.1.10Date/time test completed 4.1.11Test result 4.1.12Reference intervals (adjusted for age, sex or race, when appropriate) 4.1.13Reference laboratory accession number 4.1.14Name and address of testing laboratory 4.1.15Any other information the laboratory has that may indicate a questionable validity of test results. 4.1.16Specimen 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: Delfo.Saco-mizhquiri@va.gov. 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/VA24316N0106/listing.html)
 

Document(s)

Attachment
 

File Name: VA243-16-N-0106 VA243-16-N-0106_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2409194&FileName=VA243-16-N-0106-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2409194&FileName=VA243-16-N-0106-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Northport VA Medical Center;79 Middleville Road

Zip Code: 11768
 

Record

SN03940357-W 20151108/151106233935-779524832fe42e2032dc34e2c3d1202a (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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