Statement of Work
Procurement of nCounter Pro Analysis System
1.0 Purpose
Requesting instrument upgrade to nCounter Pro Analysis System, plus reagent and consumables, and technical service and support contract for existing instrumentation to include GeoMx System (serial # 2106G0279). This instrument will enable the development of in-house robust tumor testing for actionable treatment decisions. This platform combined with the Digital Spatial profiler will provide in-house actionable tumor information to guide therapy management and potential clinical trial enrollment for our Veterans.
2.0 Scope
The Contractor will provide instrument and related components including printers and power supplies, all reagents, supplies, and consumables, technical and field support, service, and training for testing. The Contractor shall:
Deliver, install, and set up the instrument and components.
Provide test validation guidance.
Provide technical support and guidance.
Provide reagents, consumables, and supplies as requested by VANTHCS staff.
Provide instrument repairs and scheduled preventive maintenance for the instrument and system components.
Provide operator training.
3.0 Location
The Nanostring Instrumentation is in the Molecular Department, Pathology & Laboratory Medicine Service (P&LMS) at VA North Texas Health Care System (VANTHCS), 4500 S. Lancaster Rd, Dallas, TX 75216.
4.0 Performance
Product testing requirements include the following:
Single tube multiplexing Up to 800 genes or regions, quantitative analysis
Ease-of-use Fully automated, intuitive user interface
Flexible sample requirements small samples from a variety of sources, including FFPE Comprehensive Content Off-the-shelf gene expression panels for human, mouse, non-human primate, and canine available for a variety of research areas
Flexible Experimental Design Tailor assay content to meet individual project needs by adding up to 55 user-defined targets with Panel Plus
Expandable Throughput increase sample capacity by adding a second Prep Station and multiplex up to 96 samples in one cartridge with PlexSet reagent.
Maintenance agreement include the following:
Ensuring equipment components perform within designated parameters to ensure proper performance according to manufacturer s specifications.
Repairs and Support.
Technical Support: Support Personnel will be available by telephone during normal business hours Monday through Friday 8:00am-4:30pm local time, excluding holidays.Â
On-site Repairs: With respect to any technical support issue that the contractor determines to require on-site support at VANTHCS, contractor will dispatch one or more Service Personnel to VANTHCS, normally within 48 business hours after the complaint has been logged by Customer Support. Contractor supplies unlimited service visits Monday through Friday 8:00am 5:00pm local time, excluding federal holidays.
For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost the government.
Contractor shall remove all parts, equipment or materials replaced or upgraded by the contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.
Safety
Contractor shall immediately notify the service of any changes in reagent composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations.
Test Performance
All tests, procedures, and equipment must perform at manufacturer specifications; deviations from the performance specifications shall be corrected by the contractor.
5.0 Period of Performance
Service Agreement for the Bruker - Nanostring Instrumentation will be established after delivery and installation.
6.0 Deliverables/Supplies
This order is for the procurement of instrumentation, service, technical support, and maintenance of the Nanostring Instrumentation.
The contractor shall provide all necessary warranted repair parts and the travel and labor to install parts.
The contractor shall deliver all equipment necessary for instrument maintenance at no additional cost.
The contractor shall provide labor and preventive maintenance kits for preventive maintenance visits.
The contractor shall perform test verification according to manufacturer specification and CAP requirements.
The contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle.
All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.
Any equipment modifications shall be immediately disclosed by the contractor electronically as well as by postal mail with supporting documentation of the change and detailed guidance against implementation within twenty -four hours of its application.
Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation and or any other additional cost shall be covered by the contractor at no additional charge to the government.
NARA Records Management Language for Contracts (May 2017)
1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.Â
2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.Â
3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.Â
4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.
In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.
5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA North Texas Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).
6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA North Texas Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.
7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA North Texas Health Care System policy.Â
8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract.Â
9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.Â
10. The VA North Texas Health Care System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA North Texas Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.
11. Training.  All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.Â
