Statement of Work

Brand Name or Equal to HemoSphere Alta Advanced Monitoring System

VA North Texas Veterans Health Care System

1. Description: The Department of Veterans Affairs (VA) has a requirement to replace and purchase a new Edwards HemoSphere Alta Advanced Monitoring System or equal to equipment for the intensive care unit (ICU) at the VA North Texas Veterans Health Care System (VANTHCS), Dallas VA Medical Center, located at 4500 Lancaster, Building 2, Dallas, Texas 75216-7167.

2. Project Scope and Requirements: VANTHCS clinical teams require continuity of advanced hemodynamic monitoring, compatible with the Edwards sensors, and a platform that supports predictive analytics and expanded noninvasive monitoring. The HemoSphere Advanced Monitoring Platform offers enhanced visualization, predictive decision support capabilities and it is compatible with the existing sensors. The advanced hemodynamic monitoring platform is requested to replace the Edwards EV1000 platform.

Modular monitoring use is needed for the operating room (OR) and the ICU but requires separate modules for invasive and noninvasive measurements. The system must include updated software, expanded connectivity, and improved user interface.

Key modular monitoring system needs:

• Unified platform for invasive, minimally invasive, and noninvasive monitoring.

• Predictive analytics via Acumen Hypotension Prediction Index (HPI).

• Supports multiple sensors and catheters (FloTrac, ClearSight, Swan-Ganz, tissue oximetry).

• Enhanced Electronic Medical Record (ERM) connectivity and remote viewing through the Viewfinder application.

• Improved decision support for fluid management and perfusion.

• Scalable architecture for future upgrades.

At a minimum, the Contractor shall provide a one‑year full‑service maintenance agreement and a 24‑month warranty. The full‑service maintenance agreement shall include all parts, labor, travel, and shipping costs for maintenance, repairs, and all standard industry services. Performance must meet or exceed all diagnostic imaging industry safety standards. Prior to acceptance, the equipment must pass all required acceptance testing, including accrediting body standards, if applicable. Equipment will be considered received once it has been inspected and placed into operation or use.

The contractor shall provide an advanced hemodynamic monitoring platform that is fully compatible with the facility’s existing Edwards hemodynamic monitoring ecosystem, including Swan‑Ganz pulmonary artery catheters, Edwards ForeSight tissue oximetry, Acumen IQ sensors, ClearSight non‑invasive finger cuffs, and Truwave pressure transducers.

The system shall interface natively with all existing Edwards disposables and accessories without the need for adapters, converters, or third‑party interface devices. It shall maintain current clinical workflows, alarm logic, and monitoring parameters without requiring staff retraining or protocol changes.

The system shall be FDA‑cleared for advanced hemodynamic monitoring and be fully compatible with the facility’s biomedical safety and integration requirements.

Minimum Equipment Requirements:

Item Number Item Details Quantity Unit of Measure

ALTASRSV2 HemoSphere Alta Smart Recovery Bundle with Acumen IQ/ClearSight, Pressure Cable for Acumen IQ/FloTrac, and Alta 360.

Kit contains: ALTASR1, HEMPC2K, EVHRS, HEMAPSC200,50038354001.

Alta 360 Program 24-month Plan

12 EACH

PCCVR PRESSURE CONTROLLER COVER – PCCVR

Included with HemoSphere, HemoSphere Alta, and HemoSphere Vita bundles, as well as Acumen IQ cuff, ClearSight cuff, and VitaWave cuff module upgrade kits.

12 EACH

HEMRLSTD1000 HemoSphere Roll Stand Accessory

12 EACH

3. Technical Specifications:

Hemosphere Alta Advanced Monitor or equal to Weight: 21 +/- 0.57 lbs (9.7 +/- 0.1 kg) Height: 13.45 in (342 mm) Width: 15.26 in (388 mm) Depth: 8.20 in (208 mm)

Display/Resolution/OS/Speaker Count: Active Area 15.6 in diagonal (396 mm)/1920x1080/Windows 10/ 1 - Speaker

Electrical Rated Supply Voltage: 100 to 240 Vac, 50/60 Hz Rated input: 1.5 to 2.0 Amps

Input/Output Touch Screen: Projective capacitive touch RS-232 Serial Port: 2 Edwards proprietary protocol:Maximum data rate=57.6 kilo baud USB Ports: 3 USB 2.0 (rear) Ports: 1 RJ-45 Ethernet, 1 HDMI Hospital information system connectivity: Wifi integration services are subject to local availability

DPT Pressure: DPT Pressure out signal from ClearSight technology is compatible with monitors and accessories intended to interface with Edwards non-invasive pressure signal ECG monitor: Sync line conversion: 1V/mV; Input voltage range: +/- 10V full scale;

Resolution: = +/- 1 BPM; Accuracy = ±10% or 5 BPM of the input, whichever is greater Range: =30-200 BPM; 1/4 in. stereo jack: tip at postive polarity; analog cable

Key Modules and Capabilities ClearSight System: Noninvasive, continuous monitoring using a finger cuff; measures blood pressure (BP), cardiac output, systemic vascular resistance (SVR).

Compatibility: Swan-Ganz (pulmonary artery catheter), ForeSight (tissue oximetry), and Acumen IQ sensors.

Acumen HPI: Provides predictive insight into potential hypotension events (MAP < 65 mmHg).

Functionality Interface: 11 customizable monitoring views.

Screen Options: Trending, physiologic, and cardiovascular views.

Alarms: User-adjustable

HemoSphere Alta battery pack Cells: 8 x Li-ion (Lithium Ion)

4. Delivery/Installation:

Dallas VA Medical Center 4500 Lancaster, Building 44 Dallas, Texas 75216-7167

Equipment shall be delivered 30 days after award and all systems must be operational within 30 days of delivery. Installation and set-up shall be coordinated with the Facility Point of Contact (POC).

5. Service Maintenance ALTA360 Protection Service

• Failure of associated models will be replaced at no charge

• Includes software updates and technology expansion upgrades to the equipment’s software

• Covers physical and liquid damage to the equipment (limited)

• Guaranteed next day replacement of covered equipment

• All parts, labor and shipping costs covered

• 24/7/365 technical and product support

• Preventative maintenance service as specified in the Operations Manual for each

ClearSight subsystem pump that has reached its lifetime expiration under covered equipment

•Base warranty upgraded to Total Protection at no additional cost for one year.

6. Acceptance Testing (pass/fail):

Acceptance of equipment requires all of the following to be met and documented in an Acceptance Test Procedure (ATP) signed by Biomedical Engineering and the Facility

POC:

• Power‑on & self‑test: no faults; correct firmware versions recorded.

• Display & controls: touchscreen responsiveness, brightness, alarm volume within spec.

• Measurement verification: ClearSight BP values, cardiac output derived parameters, and pressure channel calibration verified with traceable test equipment; recorded tolerances.

• Connectivity: RJ‑45/USB/serial ports functional; data export where applicable.

• Battery runtime: meets original equipment manufacturer (OEM) specification; log runtime and charge cycle.

• Accessories: kit completeness check (per Section 4); roll stand stability; cable integrity.

• Documentation: delivery report, training completion report, device configuration sheets, and warranty registration.

• Safety & compliance: labeling, electrical leakage tests (per International Electrotechnical Commission requirements), and OEM safety checks passed.

7. Hours of Operation: All coordination will be with the Facility POC, before work begins.

All maintenance and repair services shall be scheduled in advance with the POC and shall occur Monday through Friday, excluding Federal holidays, during regular business hours between 8:00 AM - 5:00 PM. Work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). Federal Holidays observed by the VA North Texas Health Care System are:

New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

Also included would be any other day specifically declared by the President of the United States to be a National Holiday.

8. Training:

Contractor shall provide training to staff upon delivery and installation.

9. Operational Manual:

Contractor shall provide one physical and one digital owner’s manual.

10. Personnel Clearances and Privacy Consideration: The Vendor will ensure that their personnel and subcontractor personnel meet the privacy standards as set forth by HIPPA (Health Insurance Portability and Accountability Act of 1996) with respect to personal and confidential information that they may come upon, while servicing medical equipment.

11. Documentation: Contractor shall provide serial numbers, model numbers, and firmware/software versions for each unit delivered, organized by clinical unit and for EIL

(Equipment Item List) creation. Provide a packing list and configuration sheet per device at acceptance.

Contractor will provide the Facility POC, and/or the Patient Care Service designee with individual written reports which describe the maintenance and repair service performed on the equipment in sufficient detail so as to be acceptable by field inspectors of the Joint Commission of Accreditation of Healthcare Organizations. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per the manufacturer’s specifications after repair. The service report will be signed by the contractor’s service technician, and by designated VANTHCS personnel. A copy will be given to VANTHCS for their internal records.

12. Facility Point of Contact (Technical Representative):

The Facility POC will be Ramon C. Caisido from the Patient Care Service (Nursing).

When a service call has been placed, the contractor will contact the Facility POC at

(214) 857-1015, and the Biomedical Engineering Service at (214) 857-1020. All vendors will sign in & out with the Biomedical Engineering Service prior to reporting to the Patient Care Service.

13. End of Contract: The contractor shall ensure that all equipment covered under this contract meets or exceeds the manufacturer’s performance specifications at the contract expiration date. Within two weeks following award to the new Contractor, a final inspection of all equipment will be conducted with the outgoing Contractor, the incoming Contractor, and the Facility POC present. Any deficiencies identified during this inspection will be the responsibility of the outgoing Contractor and shall be corrected in accordance with the terms of this contract.

14. Security Statement Requirements:

1) No memory device will be removed from the VA Facility without the approval of the Facility Information Security Officer (ISO). Bio-Medical devices and other equipment or systems (workstations, copies, FAX, prints) containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor during off-site repairs, warranty period, at the end of lease, for trade-in, or other purposes. Vendors must accept the system without the drive.

2) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data General, FAR 52.227-14(d)(1). No VA information shall be transferred outside of the VA.

3) The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. In such an event, the contractor/subcontractor shall immediately notify the Facility POC and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

4) Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

5) Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $29.95 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a) Notification.

b) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.

c) Data breach analysis.

d) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.

e) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

f) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

6) Training

a) All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

i) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

ii) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

iii) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

iv) Successfully complete any additional cyber security or privacy training, as require VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document –e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b) The contractor shall provide the contracting officer and/or the POC a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

d) If a vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor’s designated representative. By signing the Rules of Behavior on behalf of the vendor the designated representative agrees to ensure that all such individual(s) review and understand the Contractor Rule of Behavior when accessing the VA’s information and information systems.

15. Records Management (NARA)

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 North Texas 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 North Texas 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 North Texas 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 the 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 North Texas 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 the 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 North Texas 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 North Texas Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas 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 North Texas 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 VA North Texas Health Care System 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 VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

At the conclusion of the service visit, and prior to leaving the site, the contractor shall provide a written service report indicating:

a. the date of service,

b. the model, serial number, and VA identifying number (which is always on a bar code with EE#),

c. the location of the equipment serviced

d. the name of the Contractor personnel performing the work,

e. the service(s) performed, and the parts replaced.

All written deliverables will be phrased in layperson’s language. Statistical and other technical terminology will not be used without providing a glossary of terms.

End of Statement of Work