SOW Hologic Fluent System.docx

White River Junction VA Healthcare System Hologic Fluent System and Hysteroscopy Accessories 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, installation, and implementation of the Hologic Fluent System and hysteroscopy accessories. This document highlights the technical specifications and services being requested by the White River Junction VAMC for consideration towards the purchase of the Hologic Fluent System. 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 VAMC project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices.

The Contractor is responsible for the set-up of the equipment. VA Staff in Healthcare Technology Management, HTM, is responsible for connecting the equipment to the VA network with vendor guidance if the facility opts to network the device.

Equipment Specifications Equipment: The Fluent Fluid Management System must allow intrauterine pressure to be adjusted between 40 and 120 mmHg. The maximum inflow rate must be ~650 ml/min and reduced automatically by the pump once the pre-set intrauterine pressure setting has been reached. The system must be designed to provide both fluid and vacuum systems that maximize the performance of the MyoSureR Tissue Removal System.

The system must operate with a completely non-contact pressure measurement of the irrigation medium, with the pressure control circuit continuously comparing the desired preset intrauterine pressure with the actual intrauterine pressure. The function of this algorithm is to maintain the pre-set intrauterine pressure. 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. Vendor must support equipment for 10 years from point of purchase.

System Equipment

a. Set-up and configuration of the equipment including assembly, software configuration, calibration, and user management.

b. Other

i. (2) User Manuals

ii. (2) Service Manuals

iii. (2) Cleaning instructions

iv. Information on disposable procurement

2. Services

a. Training

b. Installation [If applicable] Training Provided / Training Materials

1. Vendor will be required to provide two user manuals for the Hologic Fluent System and hysteroscopy accessories.

2. Vendor will be required to provide two service manuals for the Hologic Fluent System and hysteroscopy accessories.

3. Vendor will be required to provide an on-station in-service on the proper use and setup of the system.

4. Vendor will be required to provide the cleaning methods/guidelines for Hologic Fluent System and hysteroscopy accessories.

5. All employees who will be utilizing Fluent System, including Providers, Technicians, Biomedical Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative by Hologic 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 VAMC

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

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 Biomed staff at least 24 hours in advance.

f. The vendor will provide all technical and clinical information needed to configure the software.

g. 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.

c. Assign additional clinical staff during the transitions.

d. Provide staff and clinical resources during initial testing and go-live.

e. Responsible for any structural changes (cabinets, desks, etc.).

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

· High risk clinical areas may require after hours 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 VAMC staff.

6. The WRJ VA will provide a staging area for the equipment to be staged before deployed.

Delivery Location Contractor shall deliver all equipment to the:

White River Junction VA Medical Center 163 Veterans Dr.

White River Junction, VT 05009

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 deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

6. Contractor shall 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. Contractor 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 requirements do not apply, and a Security Accreditation Package is not required.