SOW - Illumina Nucleic Acid Processors 1.docx

STATEMENT OF WORK

ILLUMINA MISEQ NUCLEIC ACID PROCESSOR AND SEQUENCERS FULL SERVICE CONTRACT

1. SCOPE: Vendor shall provide and facilitate all parts, labor, software, reagent replacement, expertise, peripherals, services necessary to provide preventative maintenance and emergency repairs on the Illumina MiSeq Nucleic Acid Processor and sequencer units listed below to service and maintain.

CONTRACT PERIOD: Contract period shall be one year beginning 10/03/2025. The contract will also contain the provision for four (4) annual option year renewals.

2. SERVICES TO BE PROVIDED:

A. General:

1) Vendor will provide the necessary manpower, parts, travel, labor, reagents, software, supervision, and peripherals to properly execute the preventive maintenance and emergency repairs of the equipment listed in Attachment 1.

2) A “Field Service Report” (FSR) must be generated, and a copy given to the Iowa City VAHCS’s Contracting Officer’s Technical Representative (COTR) or designee after each episode of scheduled or unscheduled maintenance.

B. Preventive Maintenance:

1) Preventive Maintenance will be performed by the vendor at the intervals that are in accordance with the manufacturer’s recommendations, but no less than annually.

2) Vendor will furnish any required “PM kits” needed to perform Preventive Maintenance.

C. Documentation: A documentation package acceptable for Joint Commission purposes will be maintained by the contractor and made available to the Iowa City VA Healthcare System. Required features include, at a minimum:

1) Serial Number of equipment serviced.

2) Any and all work performed on a particular date.

3) Preventive Maintenance – The vendor will perform PM according to manufacturer’s specifications. The vendor will have written procedures to be followed and documented evidence that each piece of equipment has been inspected according to those procedures.

4) Vendor will have representative/technician/field service employee/ employee read and sign document TMS 20939

D. New Equipment: Equipment may be added or deleted from the service contract as needed upon notification by the Contracting Officer (to be documented in writing via contract amendment). Deleted equipment will be credited in the full amount if deleted before any scheduled maintenance has been performed on it.

3. SPECIAL INSTRUCTIONS:

A. Contractor Check-In: The vendor’s representative will contact Biomedical Engineering at (319) 338-0581, ext. 6881 or (319) 981-2399 or (319) 338-0581 ext. 3810, prior to performing service at the Iowa City VA Health Care System.

B. Documentation: At the conclusion of each scheduled or unscheduled maintenance visit, the contractor will provide a written service report indicating the date of service, the model, serial number, and location of equipment serviced; the name of the representative, and the services performed and parts replaced. The reports will be delivered to Biomedical Engineering, Building 1, Room BE12.

EQUIPMENT TO BE MAINTAINED AND SERVICED

· Instrument: MiSeq Nucleic Acid Processor, Serial Number: M07391

· Instrument: MiSeq Nucleic Acid Processor, Serial Number: M07368

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Iowa City VAHCS records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their Iowa City VAHCS contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

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.

1. 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.

1. 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.

1. Iowa City VA HCS 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 Iowa City VAHCS 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 Iowa City VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. 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 Iowa City VA HCS 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).

1. 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 Iowa City VA HCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Iowa City VAHCS policy.

1. The Contractor shall not create or maintain any records containing any non-public Iowa City VAHCS information that are not specifically tied to or authorized by the contract.

1. 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.

1. The Iowa City VA HCS 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 Iowa City VA HCS 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.

1. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

E. Security

1. Ensure that a Contractor Security Control Assessment (CSCA) is completed within 30 days of contract approval and yearly on the renewal date of the contract.

2. Ensure that the CSCA is sent to the ISO and the OCS Certification Program Office for review to ensure that appropriate security controls are being implemented in service contracts.

3. Ensure a copy of the CSCA is maintained in the Security Management and Reporting Tool (SMART) database. COTR will provide a copy of the completed CSCA to ISO for uploading into SMART database.