P09- SOW - Ensite.pdf

B.2 STATEMENT OF WORK (SOW)

Description of Services. Delivery of one (1 The EnSite™ X EP System is a catheter navigation and mapping system capable of displaying the 3-dimensional (3-D) position of conventional and Sensor-Enabled™ electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these 3-D maps are based on the anatomy of the patient’s own cardiac chamber. I can help hospitals performing these procedures to better focus on operational efficiency, patient safety and an improved workflow for the Cath Lab in the Heart Center Services located at Audie L. Murphy VA Medical Center.

01. Scope of Work (SOW).

a. Contractor shall deliver one (1) EnSite to the Cath Lab to Audie L. Murphy VA

Medical Center.

i. Contractor shall contact the Contracting Officer Representative (COR) noted within paragraph sixteen (16) of this statement of work for an installation date and time that would avoid disruptions to patient care within the nursing services department.

ii. On-site installation shall be provided at the place of performance listed within this statement of work.

iii. On-site installation shall occur during the hours of operation (excluding federal holidays) listed within this statement of work, unless written consent is agreed upon by the Contractor, COR, and Contracting Officer (CO) as to avoid disruptions to patient care.

02. Equipment Listing. The following equipment shall be delivered and installed as agreed upon within this statement of work:

Item# Description Original MFG Part Number Qty 1 Ensite X EP System ENSITE X-SYS 1 2 EnSite™ Contact Force Module CFK3000 1 3 Ampere™ Generator Kit H700494-CQM 1

Ampere™ Remote Control (includes 15m fiber cord)

H700490-CQM 2

5 Cool Point Irrigation Pump 89003 1 6 ViewMate Multi Ultrasound system VMM-ICE-02 3

7 BASE YEAR EX913-1 2

1001 OPTIONAL YEAR 1 EX913-1 2

1002 OPTIONAL YEAR 2 EX913-1 2

04. Place of Performance.

South Texas Veterans Health Care System Heart Center Services Department Audie L. Murphy VA Medical Center 7400 Merton Minter Blvd San Antonio, TX 78229.

05. Hours of Operation. Services provided under this contract shall be performed during normal business hours of 7:00 a.m. to 4:30 p.m., Monday through Friday excluding Federal holidays. (Services required outside of normal duty hours, or weekdays requires approval by the COR prior to scheduling.)

06. Federal Holidays. The federal government hereby provides notice, and Contractor hereby acknowledges receipt that government personnel observe the following federal holidays:

New Year’s Day January 1st Birthday of Martin Luther King, Jr. Third Monday in January Washington’s Birthday (Presidents Day) Third Monday in February Memorial Day Last Monday in May Juneteenth National Independence Day June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday.

When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the President’s Proclamation

It is understood and agreed upon between the federal government and the Contractor that observance of such days by government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor's personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

07. Period of Performance. Installation shall not exceed ten (10) business days thereafter delivery of equipment listed within paragraph three (3) of this statement of work.

08. Type of Contract: Firm-Fixed

09. Check In Requirements. Contractor personnel shall check-in with COR, Herbert A Baldwin if any onsite work is needed.

10. Safety Requirements. In the performance of this contract the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the Contractor or his representative at the work sit shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default.

11. Information Systems Officer, Information Protections. The Contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services.

12. Privacy Officer. The Contractor will not have access to Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the

VA.

13. Records Manager. There will be no federal records created, maintained, used or disposition with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]

14. Additional Requirements.

14.1 Smoking. Smoking is only authorized in designated smoking areas and is strictly prohibited in and around all facilities near flammable liquids and highly combustible materials.

14.2 Security. All Contractor personnel must report to the designated individuals at each VAMC and sign in prior to performing work and sign out after completion of work each day. All Non-VA personnel shall wear security badge in plain sight above the waist during the entire time he/she is on Government property. I.D. badges must have an identification picture and shall state the name of the individual and the company he/she represents. The Contractor is to coordinate with the COR to obtain the I.D. badge from the PIV Office. The Contractor is to provide a list of all Contractor personnel who shall be performing service on this project. Contractors found on government property without an I.D. badge will be immediately removed from VA property by VA Police.

14.3 Parking. It is the responsibility of the Contractor’s personnel to park only in designated parking areas. The STVHCS shall not waive or make reimbursement for parking violations of the Contractor’s personnel under any circumstances. Contractor vehicles found parked in VA parking lots will be issued a United States District Court Violation Notice and immediately removed and banned from VA property if parking violations are repeated.

15. General Requirements.

15.1 Contract Administration. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the

Contracting Officer is authorized to make commitments or issue changes that will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. All changes to the contract will be issued via an amendment and/or modification in writing from the Contracting Officer to the Contractor.

15.2 Invoices. Invoices are to be submitted electronically; either monthly or quarterly, in arrears of the start of the services that were performed. Electronic invoices can be submitted at no additional cost at the VA Vendor Information System (VIS) The COR is responsible for acceptance of services and/or the processing of receiving reports for the services provided to the government.

15.3 Payments. Payments for services rendered will only be processed after the COR has verified and approved the invoice for services performed and accepted.

15.4 Contracting Officer Representative (COR). The COR will be identified by a separate letter.

The COR monitors all technical aspects of the contract and assists in contract administration. A letter of designation issued to the COR, a copy of which will be provided to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

15.5 Contractor Responsibilities. The Contractor shall exercise extreme care to avoid damaging Government property such as buildings, equipment, trees, shrubs, or turf. Any damage to Government property by the Contractor shall be repaired by the Contractor to its original condition at no additional cost to the Government. The Contractor shall restore ALL disturbed grounds to existing conditions. The Contractor shall ensure that all materials are new, free from defects, imperfections.

15.5.1 The Contractor shall be responsible for obtaining and coordinating the services of any and all third-party Contractors/entities performing other services on site as part of the contract to ensure the expected quality, timely delivery, and documented final product.

15.5.2 The Contractor shall provide all necessary equipment and materials to protect personnel, furnishings, equipment, piping, and building from damage; Contractor shall move, remove, and/or replace movable items as necessary and shall replace any item damaged due to work performed under this contract, equal to its original installation, and/or finish.

15.5.3 The Contractor shall be responsible for safeguarding all government equipment, information and property provided to Contractor personnel while performing the services described herein.

15.5.4 The Contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.

15.6 Work Stoppage/Delays. The Contracting Officer shall be notified at the earliest time available, but no later than the next business day, via email of the Contractor's knowledge of any conditions which may adversely affect the Contractor's ability to perform under the terms and conditions as stated in the specifications of this requirement. For example, union strikes, vehicle problems, licenses, or anything that might jeopardize the terms and conditions of this contract should be reported to the Contracting Officer.

16.Information Systems Officer, Information Protection:

The contractor will/will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

16.1 Privacy Officer:

The contractor will/will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

16.2 Records Manager:

The NARA Records Management language (Attached) only need to be added if records could be created, maintained or dispositioned by the contract/contractor.

Otherwise, this “no records” statement can be used:

Records Officer: There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].

So short version for no records – long version for records will be created, maintained,etc.

16.2.1. 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.

16.2.2. 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.

16.2.3. 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.

16.2.4. STVHCS 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 STVHCS 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 STVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

16.2.5. 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 STVHCS 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).

16.2.6. 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 STVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

16.2.7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

16.2.8. The Contractor shall not create or maintain any records containing any non-public STVHCS information that are not specifically tied to or authorized by the contract.

16.2.9. 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.

16.2.10. The STVHCS 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 STVHCS 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.

16.2.11. 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 #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

(End of Statement of Work)

B.2 STATEMENT OF WORK (SOW)