Statement of Work - Draft.pdf

DRAFT

Attachment 1

STATEMENT OF WORK

Service Agreement for Agena Biosciences

MassARRAY Analyzer 4 and Chip Prep Module 96 (6/7/2024)

1. SCOPE

The contractor shall furnish all labor, materials, parts, equipment software, updates, skilled labor, transportation, and supervision required to provide preventative maintenance and repair services on Agena Biosciences MassARRAY Analyzer 4 and Chip Prep Module 96 (CPM) in accordance with the contract and all attachments thereto.

2. PLACE OF PERFORMANCE

Central Arkansas Veterans Healthcare System (CAVHS) John L. McClellan Memorial Veterans Hospital Pharmacogenomics Analysis Laboratory (GC128) 4300 West 7th Street Little Rock, AR 72205

3. SPECIFIC REQUIREMENTS

The contractor’s scope of services shall include, but not be limited to the following:

3.1. System Maintenance. The MassARRAY® System Service Plan shall cover the following:

3.1.1. Remedial Maintenance: The contractor shall provide provide remedial maintenance services in response to written notification by the Customer that the MassARRAY System is inoperative or malfunctioning.

3.1.2. Planned Maintenance: The contractor shall provide one (1) planned maintenance service visit per year with the Premier Service Plan to ensure proper operation of the MassARRAY System. Planned maintenance services include testing and adjusting the MassARRAY System to performance specifications.

3.1.3. The contractor shall furnish to the Government, by Internet remote connection or on location, as appropriate, preventive maintenance and remedial service on the MassARRAY System. When required, contractor employees or authorized agents will travel to the customer’s location to conduct maintenance.

3.1.4. Subject to the exclusions set forth in Section 3, during the service plan period all labor, travel expenses, and parts/materials deemed necessary by the contractor will be provided at no charge to the Government under the service plan. Replacement parts shall be new or refurbished and any replaced parts shall be the property of the contractor.

3.1.5. The service plan does not cover the costs for labor, travel expenses, and spare parts of service calls that have the sole purpose of replacing Instrument consumable parts including, but not limited to, dispense tips, dispense pins, laser/laser cartridge.

3.2. Response Time: The contractor shall will use reasonable commercial efforts to generally meet a response time, defined as the time between a customer request for service and a contact by a contractor authorized agent, of within four (4) business hours during standard contractorcbusiness hours.

3.3. Action Time: The contractor shall use reasonable commercial efforts to generally meet an on-site response time by a contractor authorized agent of within 72 hours after the determination is made by the contractor that a service call is necessary. Action times may be extended based upon on the availability of spare parts. The contractor will make reasonable commercial efforts to anticipate spare part requirements and to have inventories available.

3.4. Service: The contractor shall ensure that a service representative will provide service and repair. Repairs will be made at the Customer site with commercially reasonable efforts made to provide prompt service.

3.5. Replacement Parts. The contractor will use fully functional replacement parts, that, at its discretion, may be new or refurbished to effect repairs. In case of failure to repair an instrument or instrument component, the contractor may, at its discretion, replace the instrument or complete instrument module with a “like/same” fully functional item that is either new or refurbished and will provide at least the capability of the replaced instrument or complete instrument module. All replacement parts shall be shipped FCA (San Diego, CA, USA) Incoterms® 2010. The contractor shall not be responsible for the return to contractor of requested replaced parts. Shipping costs and expenses will be paid by the Government and the replaced parts shall be the property of the contractor.

3.6. Software Updates. The contractor agrees to notify the Government of all software Updates. The contractor will, at its expense, provide Customer with all software Updates as they become available. For avoidance of doubt, the term “Update” describes mandatory, critical software improvements and does not include any software deemed by the contractor to be a new product or revision of an existing product that adds new features and functionality for which the contractor charges a separate fee. All Update releases are the sole and exclusive proprietary technology of the contractor and shall be subject to any and all of the contractor’s standard terms and conditions of sale or license in connection with the purchase of the software.

3.7. Computer Hardware and IT Support: The Contractor shall be responsible for loading standard operating software, assisting with PC imaging where applicable, and configuring the PC with appointed hardware. The Contractor shall provide a reasonable amount of general troubleshooting of the MassARRAY Database, to resolve performance issues, network configuration errors, missing data, and database recovery from a valid database backup.

3.8. Summary of Services.

3.8.1. Applications support includes:

3.8.1.1. On Site Support Yearly Checkup

3.8.1.2. Technician Re-Training at list price

3.8.1.3. 50% discount on training reagents

3.8.1.4. Remote Troubleshooting

3.8.2. Service support includes:

3.8.2.1. 4-hour remote response time

3.8.2.2. 72-hour on-site response time

3.8.2.3. Planned maintenance once per year

3.8.2.4. IQ/OQ Once per year

3.8.2.5. Remote system optimization once per year

3.8.2.6. Parts included **

3.8.2.7. Travel & labor included

3.8.2.8. 10% discount on instrument moves

3.8.2.9. Software updates

3.8.2.10. Remote database support

3.8.2.11. 10% Discount on computer upgrades ** Limited laser replacement. For MassARRAY Analyzer 4 systems only, the contractor may waive fees and provide replacement of laser/laser cartridge in the event of decreased laser power (routine consumption); limited to one (1) laser in the first five (5) years of continuous coverage under the service plan, which commenced immediately after the warranty period.

3. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

The contractor shall perform the specific tasks, and provide the deliverables described below.

3.1. Task One: Perform 1 (one) Preventative Maintenance (PM) on Agena Biosciences MassARRAY Analyzer 4 per year.

3.2. Task Two: Perform 1 (one) 1 PM on Agena Biosciences Chip Prep Module per year.

3.3. Deliverables: Provide a report of service on each piece of equipment within 5 business days of performing a service in electronic format (I.e, MS Word or PDF format).

4. RECORDS MANAGEMENT

4.1. The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

4.2. The contractor will not have access to protected Patient Health Information

(PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

4.3. 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.

4.4. 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.

4.5. 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.

4.6. Central Arkansas Veterans Healthcare 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 Central Arkansas Veterans Healthcare 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 Central Arkansas Veterans Healthcare system. The agency must report promptly to NARA in accordance with 36 CFR 1230.

4.7. 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 Central Arkansas Veterans Healthcare 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).

4.8. 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 Central Arkansas Veterans Healthcare system guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

4.9. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Central Arkansas Veterans Healthcare system policy.

4.10. The Contractor shall not create or maintain any records containing any non-public Central Arkansas Veterans Healthcare system information that are not specifically tied to or authorized by the contract.

4.11. 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.

4.12. The Central Arkansas Veterans Healthcare 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 Central Arkansas Veterans Healthcare 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.

4.13. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.