P09 Final SOW - Qiagen EZ1 Advanced XL Nucleic Acid Processor and Analyzers.docx

?.## STATEMENT OF WORK

1. SCOPE: Vendor shall provide and facilitate all parts, labor, expenses, expertise, annual preventative maintenance, replacements, repairs, peripherals, and services on EZ1 Advanced XL Nucleic Acid Processor and Analyzer and QIAcube Connect MDx units listed below to service and maintain.

CONTRACT PERIOD: Vendor shall complete all work associated with EZ1 Advanced XL Nucleic Acid Processors and QIAcube Connet MDx upon coordinated schedule with Biomedical Engineering.

2. SERVICES TO BE PROVIDED:

A. Vendor will provide the necessary manpower and supervision to ensure preventative maintenance is up to date annually on equipment listed below via On-Site Technical Support.

B. Vendor will provide the necessary parts and manpower to properly maintain EZ1 Advanced XL Nucleic Acid Processor and Analyzers and peripherals on equipment listed below.

C. Vendor will respond to service calls within 48 hours/2 days of being called

D. Upon completion of any work on equipment including repairs and preventative maintenance, thorough testing shall be completed, and a Field Service Report shall be provided within fifteen (15) working days of completed labor.

3. SPECIAL INSTRUCTIONS:

A. Contractor Check-In: The vendor’s representative will contact Biomedical Engineering at prior to performing service at the Iowa City VA Health Care System.

B. Documentation: A documentation package acceptable for Joint Commission purposes will be maintained by the contractor and made available to the Iowa City VA Medical Center. 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 contractor will perform PM according to manufacturer’s specifications. The contractor will have written procedures to be followed and documented evidence that each piece of equipment has been inspected according to those procedures.

C. 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 maintenance or repair has been performed on it.

4. General Requirements

It shall be understood that, throughout performance of the contract, the Contractor’s personnel, while on VA property, shall adhere to all requirements and regulations that govern the VA Health Care System and its property.

The contractor shall not store equipment or materials on the VA facility property. Any damage to VA caused by the contractor shall be repaired to its previous condition, or better, by the contractor at no additional cost to the Government.

Among all other requirements, the VA Health Care System and its property is now entirely smoke-free.

Contractor and their personnel shall follow all U.S. Department of Veterans Affairs (VA) policies, standard operating procedures, applicable laws, and applicable regulations while on VA property. Violations of this may result in citation and disciplinary measures for persons violating the law.

Contractor and their personnel shall wear visible identification at all times while they are on premises.

VA does not provide parking spaces at the work site; the Contractor must obtain parking at the work site if needed. It is the responsibility of the Contractor to park in the appropriate designated parking areas. VA shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

Possession of weapons is prohibited.

Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

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.

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.

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.

EQUIPMENT TO BE MAINTAINED AND SERVICED

· Instrument: Qiagen EZ1 Advanced XL Nucleic Acid Processor, Serial Number: L125A0805

· Instrument: Qiagen EZ1 Advanced XL Nucleic Acid Processor, Serial Number: L132A1049

· Instrument: QIAcube Connect MDx, Serial Number: 30141