Attachment I-Statement of Work 21 AUG 2020.pdf

STATEMENT OF WORK As of: 21 August 2020

1. Governments Minimum Requirements:

1.1. The scope of this requirement is for a complete turnkey solution for a patient monitoring system at RAF Lakenheath, United Kingdom. Contractor shall provide all equipment, installation, and training necessary to cover clinical application, user familiarization and Biomedical Engineer trouble shooting/maintenance/repair.

1.2. Deliveries shall be installed according to a customer/contractor coordinated installation plan.

Table 1 Departments that include patient monitoring are: Emergency Room (E.R) , Multi-Service Unit (MSU) , SCU, PACU - Post-Anesthesia Care Unit, and Operating Room (OR) See Attachment III pricing sheet for details.

2. System characteristics:

2.1. Refurbished equipment is not allowed.

2.2. All equipment and installation must comply with current Health Insurance Portability and Accountability Act (HIPAA requirements to ensure privacy of patient information.

2.3 All equipment and components must be FDA approved.

2.4 All networking equipment may be mounted in a communication closet for coverage area

2.5. Vendors must ship direct to site and the price must be included in the quotes.

Ship to the following location:

48MDSS/SGSM

Building 930 Boston Drive RAF Lakenheath Brandon Suffolk IP27 9PN

STATEMENT OF WORK As of: 21 August 2020

3. Patient Monitor Systems :

3.1 Must provide for continuous monitoring of cardiac telemetry through a facility-wide Med- COI based WIFI infrastructure set-up for 32 beds and offer the capability to increase capacity to allow for a future workload of 40 beds. Contractors can propose other wireless alternatives that meet the government overall requirement of having continuous cardiac telemetry throughout the facility. The government is not responsible for adding any additional network infrastructure to make a proposed solution feasible.

3.2 Required to be monitored and manipulated (this includes waveforms, SpO2, EtCO2, ECG 5 Lead, ECG 12 lead, core temperature, and 3 arterial line monitoring with cardiac output measurement/monitoring) from TWO (2) central stations (located: ER and MSU/SCU)

3.3 Must perform capnography, pulse oximetry, central line and core temperature monitoring, retrospective 12 lead ECG analyses, post-discharge full disclosure, advanced telemetry monitor tools; calipers, annotation/ ECG strip export capability.

3.4. Must communicate with electronic medical records (Essentris/AHLTA/MHS Genesis).

3.5. Must include a mobile wireless monitor that will transmit trends, events, and vitals to include: waveforms, SpO2, EtCO2, ECG 5 Lead, ECG 12 lead, core temperature, and arterial line monitoring with cardiac output measurement/monitoring , when ambulating patients and during intra-hospital transfers without the need for additional equipment. The mobile wireless monitor when docked to the bedside system will download recorded data to the closest Central Monitoring Stations.

3.6. Must be capable of utilizing 110-240v (50/60Hz).

3.7. Must include rechargeable batteries with charging stations.

3.8. Must interface with current government-held equipment: Anesthesia's Philips G7 Gas Analyzer

3.9. Required to be capable of capturing physiological data when a patient is connected to the system and having that patient information available to relevant providers wherever they may be in the facility.

3.10. Must include audible and visual alarms, and must be configurable to set a min and max parameter and be able to be silenced for no more than 60 seconds.

STATEMENT OF WORK As of: 21 August 2020

4. Monitors (Included with Patient Monitor System) – 32 each:

4.1. Display with dimensions no less than 18” at minimum: 4 waveforms (SpO2, eTCO2, 5-lead ECG, and Arterial BP/CCO), will also display NIBP with MAP

4.2. Must be within 5 feet of the bed (wall or bedside mounted), wall mounted units must be detachable. Include cost of mounts in quote.

4.3. Must include audible and visual alarms, and must be configurable to set a min and max parameter and be able to be silenced for no more than 60 seconds.

4.4. Must have Arterial line pressure monitoring/invasive BP measuring/monitoring.

4.5. Must be capable of whole wave (P, QRS & T) via an HL7 outbound interface to Essentris, CHCS, and MHS Genesis to capture into the patient record.

5. Accessories:

5.1. Must include an initial supply of:

SpO2 sensors (Qty 32) SpO2 extension cables (Qty 32) SpO2 glove sensors (Qty 32) ECG 5 Lead (Qty 32) ECG 12 Lead (Qty 32) Hemodynamic extensions with dual temp (Qty 4) NIBP hose (Qty 25)

5.2. Must include 3 remote telemetry units and 6 wearable WI-FI capable telemetry monitors or with transitional patient data readings: SPO2, EKG, 5 lead ECG (the readings must transmit simultaneously and independently from each other) and must be visible on the central monitor in the ICU, from any point in the MTF. Contractors can propose other wireless alternatives that meet the government overall requirement of having continuous cardiac telemetry throughout the facility. The government is not responsible for adding any additional network infrastruture to make a proposed solution feasible.

6. Central Monitor Stations- 2 each:

6.1. Must be interconnected to offer cross-coverage of monitoring capability by any Central Monitoring Station (located: ER, MSU/SCU).

6.2. Must include an UPS (Back-up Power Supply) for each station.

6.3. Must enable the use of 110-240v (50/60Hz).

of: 21 August 2020

6.5. Must include audible and visual alarms, and must be configurable to set a min and max parameter and be able to be silenced for no more than 60 seconds.

7. Interactive Review Stations- 1 each

7.1. Eight display stations with dimensions no less than 18” at minimum (ER qty 1)

8. Printer Compatibility:

8.1. Must enable printing of any patient’s data utilizing existing government owned printing sources compatible with Windows Embedded 8.1 or better

9. Maintainability/Maintenance Support:

9.1 Must provide a listing of each piece of equipment that requires an IP address.

9.2. Operating System (OS) shall at least be one of the following:

9.2.1. Windows embedded 8.1 OR

9.2.2 Windows Embedded 7.0 if there is a pathway to windows 10, and the contractor provides both of the following:

A) Copy of an extended service agreement with Microsoft and provide this service agreement at “no cost” to the government until the pathway to Windows 10 is achieved AND, B) Timeline for achieving the pathway to Windows 10.

9.3. All equipment must have seamless compatibility to interface with CliniComp, Intl.

Essentris® and MHS Genesis to update the Electronic Health Record (EHR). This also includes data from transport monitors and/or telemetry monitors to update the EMR via the monitoring system.

9.4. Operators, Maintenance and Training manuals must be provided for every type of equipment and must be in digital form (CD), with rights to reproduce and distribute within the United Kingdom.

9.5. Must provide a system schematic once the system is installed and a data workflow diagram.

9.6. Must provide cleaning instructions for the exterior of the system.

9.7. Bi-directional interface with the Cerner EHR (Electronic Health Record) must be included.

(In addition, the quote must provide all required interface needed; including software, hardware and licensing; to ensure system functionality for the life of the system.)

9.8. Networking equipment may be rack-mounted utilizing in-place rack system.

9.9. If the manufacturer has to install proprietary equipment, at a minimum, workstation

9.10 At minimum all equipment and components will come with a 2 year warranty, transferable from U.S. to U.K for manufacture defects.

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9.11. Unlimited site license for all current generation products including software and communication technologies, including mandatory software upgrades and updates. This includes all licensing required for proper system functionality, locally and remotely, for the life of the system. This includes but is not necessarily limited to the following list:

- Unlimited Monitor to Monitor

- Monitor to Central Station

- Central to Central Communication

- Unlimited Patient Data Transfer

10. Information Assurance (IA):

10.1. The system shall be Risk Management Framework (RMF certified prior to installation in order to ensure secure transmission of patient data via the AFNET and DHA based WiFi network.

10.1A Contractor shall review in full-detail and must be able to comply with Authorization to Connect (ATC) and Authorization to Operate (ATO) in Attachment II ATOs and ATCs. and corresponding attachments.

10.2. Must run a STIG (Security Technical Implementation Guide) Windows Server 2012 or higher and McAfee Antivirus Version 10 or provide a copy of the extended service agreement with Microsoft and provide this service agreement at “no cost” to the government until the pathway to Windows 10 is achieved.

10.3. Must test OS patches and release them according to the IA requirements listed below throughout the life cycle of the equipment.

10.4 If a new or updated version of the products quoted become commercially available prior to the date of delivery, Vendor may substitute any such products with the new or updated version (must be at no additional cost) and customer agrees that delivery of such substituted products shall constitute a conforming delivery.

11. Additional Information:

11.1. Equipment delivery and installation to be completed within 365 days maximum (or earlier, to maximum extent practicable) of procurement, in phases with the initial phase to include telemetry and central monitoring equipment and the following phase to include the balance of the bedside monitoring equipment.

SSTATEMENT OF WORK As of: 21 August 2020

• ACRONYNMS

• AFNET- Air Force Network

• AHLTA - Armed Forces Health Longitudinal Technology Application

• ICU - Intensive Care Unit

• DHA- Defense Health Agency

• ER - Emergency Room

• MSU - Multi-Service Unit

• PNU - Prenatal Unit

• PACU - Post-Anesthesia Care Unit

• HIPAA - Health Insurance Portability and Accountability Act

• UPS - Uninterruptible Power Supply

• BMET- Bio Medical Equipment Technicians

• STIG - Security Technical Implementation Guide

• IA - Information Assurance

• EHR - Electronic Health Record

• NIBP - Noninvasive Blood Pressure

• MAP - Mean Arterial Pressure

• OS – Operating System