6515--Brand Name Patient Care Monitoring System Lebanon VA Medical Center

STATEMENT OF NEED

PATIENT MONITORING SYSTEM REPLACEMENT AND UPGRADE

LEBANON VA MEDICAL CENTER

BACKGROUND

The Lebanon VA Medical Center, located at 1700 South Lincoln Avenue, Lebanon, PA 17042 has a brand name requirement to replace its facility wide Patient Monitoring System with a Phillips Patient Monitoring System.

PHILLIPS BRAND NAME REQUIREMENTS

Bedside monitoring

Must be touchscreen monitor with a large display that interfaces with a separate housing for the algorithmic module. The module should be entirely encapsulated by the housing for ease of cleaning and sanitization of equipment.

Monitor must: have both audible and color-coded visual alarm cues.

Contain the ability to sense ambient light and adjust display brightness accordingly.

Provide capabilities to perform custom trends and patterning of 96 hours of vital sign data. Trending capabilities must allow for customizable templates to be created that match our facilities clinical needs and protocols.

Possess the ability to display 16 vital signs (both waveforms and numerical values) concurrently. Selections displayed must be configurable to clinicians preferences.

Possess the ability to display the vital signs from the Telemetry transmitter worn by the patient assigned to the same room.

Must possess QRS detection threshold to eliminate noise or false readings on the telemetry units.

Must backlight active alarming sectors and keep all patient sectors in view, even with applications open.

Surveillance Station

Centralized control station that allows the connection of up to 6 touchscreen displays, one (1) mouse, one (1) keyboard, and allow the performance of all Admission, Discharge, and Transfer of hardwired and telemetry patients.

Centralized station must provide ability to remotely view monitored patients in any room (on beside and telemetry) up to 32 patients concurrently with display capabilities of multiple vital sign waveforms and numerical values for each patient.

Provides audible alarm tones.

Allow for the same trending and patterning capabilities as the bedside monitors.

Allow immediate display of all clinical data via an integral software application that provides complete access to all vital signs and monitored data. This application will provide the ability to measure aspects of the QRS-wave, view recorded arrhythmias and alarms, printing of automatically recorded events or manually chosen selections.

Telemetry & Antenna System:

Telemetric monitoring capabilities throughout the entire patient area of the unit, including reception, waiting, and lobby areas.

Small, patient-worn device that monitors a minimum of ECG rhythms and SPO2 physiological values.

This device must:

Be small enough to fit into the pocket of a typical patient gown (less than 1 D x 3 W x 6 H)

Be light for convenience of patient (less than 1 lb.)

Transmit wirelessly to a proprietary antenna system (to be installed by same vendor) that will feed all captured data into the system s database to allow for archiving and analysis.

Be fully interoperable with the system s ability to display the telemetric data on the bedside monitor (as noted in Bedside Monitoring section).

Be water-resistance and cleanable by standard hospital sanitization protocol.

Display waveforms and numerical values via an integral display on the telemetry transmitter. This display will allow for the real-time viewing of any vital sign that the patient is actively being monitored.

Use lead wires that are fully compatible with the bedside monitoring for ease in transitioning patients between the two systems as may be clinically required.

Be powered by 2 AA-sized batteries.

Transport Monitoring

Transport Monitors must:

Enable nursing to view up to 11 patient vital signs, wirelessly transmit data to the central monitoring station, and continuously send vital sign data to be archived on the centralized database.

Device must fully function as a permanently docked system with hardwired network connection as well if desired.

Allow the algorithmic module to be removed from the bedside monitor and be fully inserted into the transport monitor. This feature will allow for the transitioning of patient demographics, trending and customized alarm settings to move with the patient and eliminate the need to repeat the ADT process.

The algorithmic module will be fully encapsulated by the transport monitor for ease of cleaning and sanitization of the device.

Have a color touchscreen display, and ruggedly built so as to withstand a 1M fall.

Provide for capnography capabilities while on battery power and while connected to the power adapter.

Provide the ability to perform a 12-lead ECG test.

Clamp securely onto a standard IV pole with an integral mechanism.

Have a handle built-in for securely moving the device.

Provide the same data trending and analysis capabilities as is available on the bedside monitors.

Interfaces:

GE Muse

12-lead ECG

PICIS

CIS/ARK System via HL7

ADT

Admission/Discharge/Transfer capabilities

Tele-ICU

Philips eICU program

Ventilators

Hamilton G-5 and Covidien 980

]

Interfaces additional requirements:

System must utilize a centralized, server-based database that functions as the hub for data flow and communications between monitoring devices and peripheral functions including, but not limited to (alarm analytics, printing, vital sign review software, etc.) and external interfaces (12-lead ECG, Philips TeleICU, ADT).

Network architecture must be such that it promotes redundancy in the case of a central monitoring device or server outage.

Necessary servers, physical devices, cabling and leads, adapters, software, and device licensing must be included to enable the full functionality of the following interfaces:

GE Muse for the transmission of 12-lead ECG s taken on the bedside monitor. This allows for the 12-lead ECG to be included in the patient EMR.

PICIS Care suite CIS/ARK software system is utilized with all monitored beds in our ICU. Connection via serial cable is the preferred physical connection between the bedside monitor and the CIS/ARK computer to be located at the bedside.

Philips eICU program will be utilized with the monitoring system in our ICU. The interface will provide a method to export all numerical vital sign data from the monitoring system to the Philips eICU database that will reside outside of the Lebanon VAMC.

This interface will provide all necessary servers, peripheral devices, software, device or software licensing, and implementation to accomplish full integration with the Philips eICU program.

ADT interface with Vista-CPRS to provide accuracy and ease of patient admission, discharge, and transfer activities.

This will allow for one congruent patient record from time of admission to discharge as the patient moves throughout any unit at the Lebanon VAMC that utilizes a patient monitoring system.

The ADT interface will incorporate a barcode scanner for error-

free patient ID entry into the system, and the system will pull

necessary patient information from the Vista-CPRS database \

based upon the patient ID.

ADT function will enable the automatic discharge of a patient

from a bed/device when being admitted to another monitoring device in the event the patient is moved from one bed to another, or from the ICU to another unit with monitoring capabilities.

Software Requirements:

Is vetted and approved by the Dept. of VA Technology/Standards List (TRM-Approved)

Utilizes an access control method to maintain accountability and access to the system such as an Active Directory validation method, Single Sign On via government PIV-card, or other method to restrict access to caregivers that require the use of this program.

Allows the analysis and review of the past 72 hours (minimum) of vital sign data recorded during a patient s admission.

Analysis can be performed on selectable time ranges (past 72 hours, 24 hours, 4 hours, etc.)

Allows the review and printing of:

Vital sign trend data

Automatically recorded alarm events which are selectable by alarm type, priority/level, and category of alarm (Respiratory, SPO2, or Cardiac/ECG)

Arrhythmias

Near-real time bedside vital sign waveforms and numerical values

Includes a tool to allow for the inspection and analysis of short pieces of waveforms for diagnostic purposes

Allows for the addition of notes by the clinician that can be viewed by other clinicians

Allows for the management of automatically generated print documents

Requires a software-based methodology to analyze and manage the physiological monitoring alarms in order to better manage alarm fatigue in caregivers

Full integration with all existing physiological monitoring devices and databases

Fully incorporate all data from the existing physiological monitoring system into the analysis, manipulation, and functionality of the alarm management software

Analysis and review of alarms that can be displayed in formal reports custom manners as preferred by the clinicians, such as by

Room, Unit, Facility

Alarm level/Priority High/Medium/Low

Alarm Type

Alarm Frequency

Date of Alarm Occurrence

Reports shall include numerical and visual expression of the data such as graphs or waveforms

Custom selection of alarms to be analyzed

Modeling and forecasting of the impact that a change in an alarm level or trigger would have on alarm management. By identifying the impact, a slight change in an alarm level would have on the number of alarms, our caregivers will be able to provide a higher quality of care for our patients by eliminating medically unnecessary alarms on a per patient, per unit, or per facility level.

Overview for the admission of individual patients at the bed level that would better facilitate medical decisions by providing a custom view of vital signs data that is aggregated and trended for the entire duration of the patient s admission to any physiological monitor within our facility.

Shall permit vital sign waveform review by clinicians from any location with access to the analytical software

Shall provide visual indications of the frequency of alarms

Shall be customizable to allow the caregiver to analyze vital signs by specific date, or aggregate data as the patient has moved between units during their admission

All hardware, software configuration, peripheral equipment necessary to perform all requirements laid out within this scope will be provided, to include full configuration and deployment of required software and equipment.

User Training:Training will address all functions and features provided within this scope, to include but not limited to Bedside, Telemetry, Central hardware and functions, all software and applicable interfaces, system resources and tools such as alarm analytics, ADT, and alarm management.

INSTALLATION

The Contractor shall provide a system Installation Plan (IP) and sample schedule to the Contracting Officer with the quote. The Installation Plan shall include estimated timeline of start and completion and estimate unexpected delays/lead time.

Perform staging, programming, and configuration of all system infrastructures and components.

Perform all necessary test/audits on all system infrastructures.

Provide and install all backbone cabling necessary for a complete installation of the Patient Monitoring System.

Must comply with infection control risk assessment (ICRA) standards during installation

TEST AND ACCEPTANCE

Contractor shall test all equipment, cabling and interfaces after installation. The government shall accept equipment once installation and successful testing has been completed and approved.

WARRANTY/SERVICE CONTRACT

All equipment and materials shall come with a standard one-year warranty. Warranty shall begin after installation of equipment and completion of tests.

TRAINING

Training in courses targeted at Biomedical Engineering Staff are required for the:

repair, maintenance, and configuration of the model of in-room monitoring devices we receive.

basic operation, installation, maintenance, configuration and troubleshooting of the Clinical User s application.

Installation, maintenance, and configuration of the server software and interfaces.

Request Quantity:Â 2 credits to be used for each course noted above, attended at our convenience in accordance with the published Manufacture s schedule

Philips offers the following, requesting 2 seats for each:

CMS2460Â Â Â Â Â Â Â Â Â Â Â Â MX-Series Patient Monitor

CMS1IL008Â Â Â Â PIC iX Biomed Basics Overview

CONTRACTOR RESPONSIBILITIES

The contractor shall be responsible for the following:

Contractor shall provide qualified personnel to install all systems

Contractor shall be responsible for all system/software testing after installation and prior to government acceptance.

Contractor is responsible for onsite training. Training times shall be coordinated with the station point of contact.

Contractor is responsible for ensuring the proper disposal of all debris generated from installation activities.

Contractor is responsible for securing all materials, equipment, and tools while on government property or in government facility. Government is not liable for any lost or stolen items that are not properly secured.

GOVERNMENT RESPONSIBILITIES

The Government shall provide the following:

Provide site access and escorts through work areas as needed.

Provide primary electrical power.

Provide adequate space for the system equipment.

OTHER CONSIDERATIONS:

Contracting Officer Station Point Of Contact: The station point of-contact will be provided at award and shall be the technical point of contact for all work-related requirements. The station point of contact does not have authorization to change, alter, or remove any requirements stated in the performance work statement. The Contracting Officer is the only government authorized person to change the performance work statement or any resultant contract.

Place of Performance: Installation of systems shall occur at the Lebanon VA Medical Center.

Work Hours: Operational Hours are 0700-1700, Monday-Friday, The Government recognized US holidays are: New Year s Day, Martin Luther King, Jr. Day, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day and Christmas Day. If the holiday falls on Sunday, it is observed on Monday.

Delivery: Delivery is required 90 days ARO. All deliveries shall be coordinate with the point of contact before arrival. Failure to coordinate delivery will be grounds to refuse delivery. Delivers can be made to the Lebanon VA Medical Center, 1700 S. Lincoln Ave., Attn: Biomed, Lebanon, PA 17042