DOCUMENT
65 -- CTXVAHCS Viral Analyzer - Attachment
- Notice Date
- 1/10/2018
- Notice Type
- Attachment
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- 00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
- ZIP Code
- 79106
- Solicitation Number
- 36C25718Q0344
- Response Due
- 2/2/2018
- Archive Date
- 5/3/2018
- Point of Contact
- Ronalda Ohio
- E-Mail Address
-
ronalda.ohio@va.gov
(ronalda.ohio@va.gov)
- Small Business Set-Aside
- N/A
- Description
- The Central Texas VA Health Care System (CTVHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 8. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. THE VENDOR MUST BE REGISTERED AS A SMALL BUSINESS UNDER NAICS CODE 325413 TO BE CONSIDERED FOR AWARD. The North American Industry Classification System (NAICS) is 325413. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, February 02, 2018. Notification shall be e-mailed to Ronalda Ohio, at ronalda.ohio@va.gov. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. PART A- SCOPE OF WORK GENERAL INFORMATION 1. Title of Project: HCV/HIV-1 Viral Load Molecular Analyzer 2. Scope of Work: The contractor shall provide a cost per test automated Molecular Analyzer System capable of simultaneously performing HIV-1 and HCV viral load testing. 3. Background: HCV and HIV-1 viral load testing using the Cobas AmpliPrep/Cobas TaqMan Analyzer test platform has been performed at the CTVHCS-Waco ICF Molecular Pathology Laboratory since 2009. The system fulfills the requirements for HIV-1 and HCV viral load testing for the Waco Molecular laboratory. 4. Performance Period: Contract shall have a base with four (4), one (1) year options to be exercised at the discretion of the Government. 5. Type of Contract: This is a Firm-Fixed Price Contract B. CONTRACT AWARD MEETING The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting, or has advised the contractor that a kick off meeting is waived. C. GENERAL REQUIREMENTS The Molecular Analyzer system shall have the capability of sampling, performing and reporting HIV-1 and HCV viral load tests. The system must be capable of automated transfer of patient samples from primary specimen tubes into the secondary testing tubes, maintaining positive ID sample tracking from the point of aliquotting to test results. The system must be able to simultaneously perform HIV-1 viral load and HCV viral load test profiles to 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 system must be capable of automatically transferring HIV and HCV viral load samples from extraction through amplification and detection allowing it to accommodate completion of testing after duty hours. The system must be able to perform a minimum of 24 samples per batch of HIV-1 or HCV tests. Other requirements of the system are a closed-tube format, clot detection, and must be able to be housed in one room for PCR process. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on instrumentation, software upgrades, and training. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW Task One: The contractor shall provide a detailed work plan and briefing for the VA project team, which presents the contractor's plan for completing the task order. The contractor's plan shall be responsive with this SOW and describe, in further detail, the approach to be used for each aspect of the task order as defined in the technical proposal. Deliverable One: A fully automated Molecular Analyzer System to include a pre-analytic sample handling module, amplification module, analyzer/detection module and data station. Deliverable Two: Reagents and Consumables to perform HIV-1 and HCV viral load testing. Deliverable Three: Service plan to include regular scheduled preventative maintenance conforming to the manufacturer s recommendations to keep the equipment in good operating condition. Emergency repair to be dispatched within 24 hours of notification of inoperability of system. Contractor shall provide all parts and labor needed for service and/or repair. Travel, per diem and other expenses associated with service/repair will be included in service plan. Service report shall be provided as documentation/warranty of service/repair. E. SCHEDULE FOR DELIVERABLES 1. The contractor shall complete the Delivery Date column in Attachment A for each deliverable specified. 2. Unless otherwise specified, the number of draft copies and the number of final copies shall be the same. 3. If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations. G. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with H. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access. Position Sensitivity The position sensitivity has been designated as Low Risk. Background Investigation The level of background investigation commensurate with the required level of access is N/A Contractor Responsibilities The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and are able to read, write, speak and understand the English language. The contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form 0710, Authority for Release of Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract. Failure to comply with contractor personnel security requirements may result in termination of the contract for default. 4. Government Responsibilities The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor, or to the contractor s employees, after receiving a list of names and addresses. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy, and forward the forms to the office of Personnel Management (OPM) to conduct background investigations. The VA Office of Security and Law Enforcement will notify the CO, and contractor, of adjudication results received from OMB. Upon being notified about a favorable determination, the CO may issue a notice to proceed to the contractor. Attachment A to the Statement of Work Schedule of Deliverables Deliverable No. One Item Pre-analytical, fully automated patient tube handling instrument Quantity 1 Delivery Date Within _90__ calendar days after award Two Amplification instrument for HIV-1 & HCV 1 Within _90__ calendar days after award Three Post amplification detection analyzer 1 Within _90__ calendar days after award Four Docking station to automate the amplification and post amplification modules 1 Within _90__ calendar days after award Five Data/Computer module 1 Within _90__ calendar days after award Six HCV reagents 46 boxes IDIQ Seven HIV-1 reagents 23 boxes IDIQ Eight Consumables/Wash for HIV-1/HCV testing IDIQ
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25718Q0344/listing.html)
- Document(s)
- Attachment
- File Name: 36C25718Q0344 36C25718Q0344.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4009787&FileName=36C25718Q0344-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4009787&FileName=36C25718Q0344-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: 36C25718Q0344 36C25718Q0344.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4009787&FileName=36C25718Q0344-000.docx)
- Place of Performance
- Address: Central Texas VA Health Care System;1901 Veterans Memorial Dr;Temple;TX
- Zip Code: 76504
- Zip Code: 76504
- Record
- SN04786388-W 20180112/180110231207-17dbcaa2f09e94f2b0fead518f5332d2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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