P09 - DRAFT SOW.docx

B. 2 - Statement of Work

A. BACKGROUND

The Iowa City VA Healthcare System, here in after referred to as the Iowa City needs a one-time purchase of CardioLab BT21 HD, hardware and software. This procurement supports a system upgrade initiative enhancing the existing capabilities of Altix AI.i EP recording equipment.

This system upgrade includes the updated hardware and software package, the required Prucka 3 amplifier, the INW server upgrade, the Windows 10 LTSC hardened operating system, GE client workstations, all necessary interface cabling and accessories, integration licenses for DICOM and HL7 interoperability, and onsite applications training. This system is used in the Electrophysiology Laboratory to record, display, analyze, and document intracardiac electrograms, surface ECG, hemodynamic data, and ablation system parameters, supporting EP workflow and documentation while performing data acquisition only, not direct patient care or therapy.

B. SALIENT CHARACTERISTICS

Specifications – Brand Name Only CardioLab BT21 HD

Minimum Specific Requirements:

The current system AltiX AI.i operates on a proprietary engineering owned and maintained by GE Healthcare, the original manufacturer. BT21 HD hardware and software upgrade, is fully compatible with the existing equipment and licensing structures, without requiring system replacement or data migration.

Since Iowa City VA already uses GE EP/Cath systems, maintaining interoperability, workflow continuity, and system safety requires GE‑exclusive components, and GE is the only entity legally and technically able to perform this upgrade.

This upgrade is critical to maintain uninterrupted Cardio Laboratory operations and ensuring the system continues to meet performance and security requirements.

Warranty Requirements Manufacturer must offer a (1) one-year minimum warranty that product is free from defects in materials and workmanship. All defects will be replaced or repaired by the manufacturer at no cost to the buyer.

Installation Installation is required by the Contractor. Contractor shall contract the Point-of-Contact within ten (10) business days from issuance of award to schedule installation.

Training Clinical Education and On-Site Training is required. Contractor shall contact the Point-of-Contact within ten (10) business days from issuance of award to schedule the Clinical Education and On-Site Training.

C. PERIOD OF PERFORMANCE:

TBD

D. TYPE OF CONTRACT

This is a Firm-Fixed-Priced, one-time supply contract with no option year(s).

E. POINT-OF-CONTACT (POC)

This contract is assigned a POC and will provide general instructions for administrating the contract. The POC is not authorized to grant permission(s) to change the scope of the project. The POC that is assigned for this contract will ensure that the supplies/services provided by this company are received based on the contractual terms and conditions.

Phone:

e-mail:

F. CONTRACTOR RESPONSIBILITIES (DELETE IF SUPPLY)

· At the competition of the project the Contractor shall provide the Bio-Med Chief with:

i. All service-related documentation (etc. Manuals, CD’s)

ii. URL’s for service ticket review.

iii. Contact Phone Numbers for service requests.

iv. Information on Submitting Service tickets.

· No tools during deinstallation or installation will be supplied/provided by the VA.

G. DELIVERABLES OR DELIVERY SCHEDULE

The vendor shall deliver the equipment via standard delivery with F.O.B. destination as scheduled. See Section C for delivery schedule period-of-performance.

The equipment shall be delivered to the following address:

H. CHANGES TO CONTRACT

Before performing any action in a non-contractual nature or is considered out-of-scope, the Contractor shall contact the Point of Contact (POC) and the Contract Officer identifying the reason(s) for change. All changes shall have prior authorization from a VA Contract Officer in the form of a written modification.

I. POST-AWARD PERFORMANCE CONFERENCE

The POC, Contract Specialist, or Contract Officer may schedule a post-award performance conference with Contractor, if deemed necessary, for contract orientation purposes.

J. SECURITY

No security language required by the ISSO.

K. PRIVACY

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

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. VA Iowa City 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 Fargo 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 Fargo 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 this contract. 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 Iowa City 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 this contract. 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 Iowa CIty 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 Iowa City Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA Iowa City Health Care System 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 VA Iowa City 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 [FACILITY] 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 VA Iowa City Health Care System -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.

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.

End of Statement of Work