P09 IVIS S5 SOW with NARA.docx
DOCX document 18 KB Posted
- Attached to
- J066--IVIS Lumina S5 Maintenance Services
- Solicitation number
- 36C26326Q0574
About this file
Statement of Work Summary
This is a Statement of Work (SOW) for maintenance and support services for an IVIS Lumina S5 Imaging System located at the Iowa City VA Health Care System in Iowa City, Iowa. The contract period of performance runs from July 1, 2026, through June 30, 2027, with two optional renewal periods. The contractor shall provide the Revvity "Signature" Service plan, which includes one annual preventative maintenance visit, priority remote support during normal business hours (8:00 AM to 4:30 PM CT, Monday through Friday), unlimited repairs, and emergency on-site repair services with a three-business-day response requirement. All repairs must utilize Original Equipment Manufacturer (OEM) new or refurbished parts exclusively, and the contractor's service representative must be factory-trained with a minimum of two years of experience on the contracted medical device. The contractor is responsible for furnishing all software updates and patches issued by the manufacturer and maintaining access to all necessary diagnostic software.
The SOW establishes specific service delivery requirements including notification to the Contracting Officer's Representative (COR) before commencing service calls during normal operating hours, hazard communication and OSHA lockout/tag-out compliance, and comprehensive documentation of all repair services via detailed service reports provided to the COR within five to ten days of service completion. Additionally, the SOW incorporates extensive records management obligations requiring full compliance with the Federal Records Act, NARA regulations, Privacy Act protections, and Freedom of Information Act requirements. All contractor employees handling federal records must complete VHA-provided records management training, and the contractor is prohibited from retaining, using, or disseminating any deliverables or non-public information beyond contract authorization. All data and records produced under the contract are owned by the U.S. Government.
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Statement of Work Requirement for existing equipment IVIS Lumina S5 Imaging System located at the Iowa City VA Health Care System, 601 Hwy 6 West, building 40 Rm B101, Iowa City, IA 52246. IAW the requirements of the Performance Work Statement (PWS). The period of performance shall be 7/1/26 – 6/30/27 with two options periods.
The support includes the following:
The Contractor shall provide the Revvity “Signature” Service plan, one annual Preventative Maintenance, priority remote support during normal business hours (8:00 AM – 4:30 PM CT), unlimited repairs.
The Contractor shall provide emergency on-site repair services within 3 business days to include all travel, labor and parts. The Contractor shall provide documentation (e.g., service report) detailing all repair services performed upon completion of services.
The Contractor shall respond within 2 business days (Monday through Friday) via phone or email for reports of service.
Prior to reporting to a service call, the contract’s services representation shall notify the COR (Contracting Officers Respresntative) via email or telephonically before commencing services during normal duty operating hours (0800 to 1630 CST). During other than normal operating hours, the Contractor's representative shall arrange for access with the COR.
The Government and the Contractor's service representative will exchange hazard communication information before the commencement of any repair.
When required, the Contractor's service representative will comply with the Occupational Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on Medical Devices/Medical Device Systems (MD/MDS).
Upon completion of services by the Contractor's service representative, a service report shall be provided to the COR. The service report shall provide detailed information regarding the cause of the MD/MDS malfunction and corrective action taken. It shall include, at a minimum, the time required to complete the work and a list of parts replaced with part numbers prior to leaving the facility.
In the event all information is not available to the Contractor's service representative when services are performed, the initial service report shall include all available information to close work order within five days. The Contractor shall provide the balance of the required information to the COR no later than ten days after services are completed.
The Contractor shall have access to all necessary diagnostic software (if applicable). The Contractor shall use only Original Equipment Manufacturer (OEM) new or OEM refurbished repair parts.
The Contractor's service representative will be factory trained and have desired to have a minimum of two years of experience working on the contracted MD/MDS The Contractor shall furnish all software updates/patches issued by the MD/MDS manufacturer.
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 [Agency] records.
2. Does not include personal materials.
3. Applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.
4. 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.
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.
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.
4. Iowa City VAHCS 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.
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 Iowa City VAHCS 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 Iowa City VAHCS guidance for protecting sensitive, proprietary information, 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 Iowa City VAHCS policy.
8. 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.
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.
10. The Iowa City VAHCS 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 VAHCS 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 #4192704, Records Management for Everyone. 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.
2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
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