SOW MAC 5 EKG - Sources Sought.pdf

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GE MAC 5 EKG Devices
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36C241-26-AP-0392
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This Statement of Work (SOW) details the White River Junction VA Healthcare System's procurement of GE MAC 5 EKG devices for Home Based Primary Care. The objective is to replace existing EKG equipment with new mobile units that operate on Windows 11, ensuring compliance with national regulations, improved data security, and enhanced clinical workflow. The procurement aims to support veteran cardiac health monitoring by providing state-of-the-art, new equipment with full vendor support.

Key requirements include delivering new EKG systems to the White River Junction VA Medical Center, with the vendor responsible for complete installation, training, and a minimum 1-year manufacturer warranty. The vendor must provide user and service manuals, cleaning instructions, and comprehensive training for all staff who will use the equipment. Installation will occur during specified hours (7:30 am to 3:00 pm ET) on weekends, with potential after-hours installation for high-risk clinical areas. The contract includes strict records management provisions and requires the vendor to comply with federal information protection guidelines.

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White River Junction VA Healthcare System

GE MAC 5 EKG

Statement of Work

Objective

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded Contractor in relation to the provision of GE MAC 5 EKG. This document highlights the technical specifications and services requested by the White River Junction VAMC for consideration regarding the purchase of the systems. Vendors under this proposal shall provide all equipment, accessories, applicable training, and manuals.

Project Management / Equipment Implementation

Product delivery will be the responsibility of the Vendors working with the White River Junction VAHCS project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices.

Background/Justification/

The objective of this project is to enhance the quality of clinical care by Home Based Primary Care provided to our veterans via the procurement of replacement devices that ensure the highest data security, the safest and quickest clinical workflow, and improved clinical and diagnostic results, all while complying with National regulations. This procurement aims to ensure continued excellence in the monitoring and diagnosis of veteran’s cardiac health, improving overall patient outcomes. The new GE MAC 5 EKGs are mobile units, offering ideal clinical flexibility and adaptability for Home Based Primary Care, operate on Windows 11, ensuring high data security for our veterans, and use improved software to enable more reliable, accurate, and quicker heartbeat rhythm diagnostics. This procurement of replacement GE MAC 5 EKGs facilitates the clinical team’s existing workflow, thus supporting the clinical team's efforts to deliver the highest standard of care to our veterans. All equipment procurement, installation, training, and necessary transition support will be conducted to ensure minimal disruption to ongoing medical services and seamless integration into the existing clinical workflow.

The requested GE MAC 5 EKGs maintains compliance with National regulations by operating on Windows 11, whereas current EKGs are incompatible with Windows 11 and operate on Windows 10, thus not being Nationally compliant. The procurement of GE MAC 5 EKGs will ensure facility standardization as current EKGs are also GE Healthcare devices. This will help minimize additional training for clinicians and Healthcare Technology Management staff. Space is already allocated for these EKGs, as it is a simple one-to-one replacement. The procurement of GE MAC 5 EKGs, along with all accessories and warranties, fits into the challenge of our Veteran population who require care at home.

Equipment Specifications

Equipment: All equipment must be new, state-of-the-art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements including vendor supported operating systems.

1. System Equipment

a. Set-up of System

b. Other

i. (1) User Manuals

ii. (1) Service Manuals

iii. (1) Cleaning instructions

2. Services

a. Training

b. Installation [See below]

Training Provided / Training Materials

1. Vendor will be required to provide 1 user manual.

2. Vendor will be required to provide 1 service manual.

3. Vendor will be required to provide an on-station in-service for proper use and set-up.

4. Vendor will be required to provide the cleaning methods/guidelines for equipment.

5. All employees who will be utilizing the equipment, including Providers, Technicians, Healthcare Technology Management (HTM) Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative prior to using the System.

6. No charge on a mutually agreeable date and time.

Installation

1. Contractor’s Responsibilities:

a. Based on approved deployment work schedule, the Contractor shall provide all labor necessary to install, deploy and configure the requirements of WRJ VAHCS

b. Contractor shall receive and place equipment in the pre-arranged designated area at WRJ VAHCS

c. The Contractor shall unpack and install all equipment in the designated area and dispose of all trash. Disposing of the trash is the responsibility of the Contractor.

d. Contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure product is fully operational in accordance with manufacture operating standards.

e. Vendor will coordinate all site visits with the HTM staff at least 24 hours in advance.

f. The vendor will provide at least a 1-year manufacturer warranty on the device from the date of installation.

2. Medical Center’s Responsibilities:

a. Providing access to patient care spaces, hallways, and equipment rooms during normal business hours for implementation of the general system installation requirements.

b. Providing a single point of contact to work with in planning and implementing the services described.

3. On-site assembly and installation of items and performance of services identified in this document will take place during hours defined as: 0730 to 1500 (i.e.: 7:30 am to 3:00 pm ET), Saturday or Sunday, excluding Federal Holidays o High risk clinical areas may require after-hour install.

4. The Contractor is required to provide all tools, labor, and materials to complete assembly and installation of the items detailed in this document.

5. The Contractor shall have an on-site representative for the duration of assembly and installation to serve as the primary interface with the WRJ VAHCS staff.

Delivery Location

Contractor shall deliver all equipment to the:

White River Junction VA Medical Center

163 Veterans Dr.

White River Junction, VT 05009

ATTN: HTM and Dr. Annice Mason (SPRS service)

Records Management

1. The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

2. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

3. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

4. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

5. Contractor shall not retain, use, sell, or disseminate copies of any delivery that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

6. Contractor should not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

7. The Government Agency owns the rights to all data/records produced as part of this contract.

8. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractors must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

9. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

10. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

11. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

12. The A&A (Assessment and Authorization) requirements do not apply, and a Security

Accreditation Package is not required.

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