V12 Infusion System Technical Matrix.xlsx

XLSX spreadsheet 37 KB Posted

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VISN 12 Infusion Pumps System RFI
Solicitation number
47QSWC22K0100
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This document contains a Request for Information (RFI) for a VISN 12 Infusion Pumps System. The RFI seeks information to define requirements and determine acquisition approach for a potential purchase order or delivery order for large volume pumps, syringe pumps, end tidal CO2 monitors, and patient controlled analgesia pumps. Responses are requested by July 28th to complete an attached technical specification matrix and provide contact information, small business status, ability to meet requirements, willingness to participate in follow up calls August 2nd-4th, and any other relevant information. The RFI will be used for market research and planning purposes to determine if requirements can be met via small business set-aside, single award, or multiple awards through GSA Multiple Award Schedules or open market procurement.

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Requirements for Infusion System - Final.pdf PDF

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LVP Module

VISN 12 Infusion Pump System - LVP Module
TECHNICAL SPECIFICATION MATRIX
Respondents to complete all blue fields
LVP MANUFACTURER
LVP MODEL
SPECIFICATION / SALIENT CHARACTERISTICS
NOTE: DO NOT CHANGE ANY INFORMATION IN THIS COLUMN.PRODUCT SPECIFICATION / SALIENT CHARACTERISTIC COMPARISON (Select from Drop Down if product solution meets, does not meet, or exceeds required specifications)PRODUCT LITERATURE REFERENCE (Provide Page Number, Section/Paragraph of product literature that addresses required specifications)COMMENTS (If product solution involves different specifications, provide a detailed explanation for how product specification lacks or exceeds the Government's requirements.)
Compliance Specifications
System devices run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550MEETS
FDA approvedDOES NOT MEET
FIPS 140-2 certified with plan to transition to FIPS 140-3EXCEEDS
Validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (have Cerner capability)
Performance Specifications
Device has flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr.
Defaults to the Dose Error Reduction System (DERS) upon startup
Able to customize DERS and drug library
Able to program DERS limits and infusion devices which actively use DERS
Programming outside of DERS
Ability to program custom dilutions for critical/dangerous medications
Able to run anesthesia mode able to run without requiring EtCO2 Module
Number of drug entries is greater than 400
Options for different care therapies (same drug different limits)
Ability to set manual parameters within drug library
Ability to change to different drug libraries
Bolus or loading dose infusion limits
Patient weight for weight-based dosing
Accumulated dose limit monitoring
Medication concentration limits
Infusion rate limits
Titration limits
Continuous infusion limits
Intermittent and secondary infusion limits
Ability to run multiple infusions concurrently with minimal control units
Bolus capability
Fluid resistance ingress protection
Free flow prevention mechanism
Has anesthesia mode
Patient tampering safety feature
Primary and secondary infusion modes
Secondary infusion capability
Multiple infusion capability
Event logs - In the event of patient incident or near miss/close call event logs need to be available
Provides the following EHR integration data analytics:

Integration compliance (rate of usage of smart pump workflows) Auto-documentation mismatch Failed auto-programming attempts

Has automatic switching to battery power upon line-power interruption
Mountable to an IV pole
Portable – transportable with battery backup
Able to be cleaned with hospital grade disinfectantEXCEEDS
Alarm/Alert Specifications
System Malfunction alarm
Fault condition alarm
Vein and line blocked alarm
Clamped secondary line alarm
Air is in the line for LV, PCA alarm
Flow error alarm
Set loaded improperly alarm
Plunger disengaged alarm
Pressure Sensor (high pressure/occlusion) alarm
Ability to silence, override alarms (anesthesia mode)
Alarm volume control and alarm momentary silence
Momentary silence of alarm less than 2 minutes
Industry standard default alarms
Able to configure alarm settings
Filter replacement alert
Infusion completed alert
Infusion near end alert
Empty reservoir alert
Occlusion upstream and downstream alert, Less than 15 psi for downstream, Detection mechanism
Door/latch open sensor
Low battery/ Depleted battery alert
Computer System/Wireless Specifications
Wireless communication capability
Infusion data sent wirelessly from equipment to central repository for analysis
Able to download drug library updates wirelesslyDOES NOT MEET
Allow medication drug library catalog updates to be wirelessly pushed to devices
Utilizes Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems
Customer Support Specifications
Company staff on site during implementation
Provide network security documentation: Ports, Protocols, and Services required for network communications.
Provide a list of Ports and Protocols the systems use to communicate on the network
Anticipated parts support for the next 10 years.
Parts available to support equipment repair at VAMC sites
Minimum warranty of 1-year parts & labor
Includes manuals (user, service, maintenance)
24/7 customer support for troubleshooting
Provides manufacturer training and service onsite for BioMed
Provide training for clinical end-users, BioMed and pharmacy staff prior to implementation
Include list of consumables required and starter supplies
Delivery After Receipt of Order - No Later Than 12 months

Syringe Module

VISN 12 Infusion Pump System - Syringe Module
TECHNICAL SPECIFICATION MATRIX
Respondents to complete all blue fields
SYRINGE MANUFACTURER
SYRINGE MODEL
SPECIFICATION / SALIENT CHARACTERISTICS
NOTE: DO NOT CHANGE ANY INFORMATION IN THIS COLUMN.PRODUCT SPECIFICATION / SALIENT CHARACTERISTIC COMPARISON (Select from Drop Down if product solution meets, does not meet, or exceeds required specifications)PRODUCT LITERATURE REFERENCE (Provide Page Number, Section/Paragraph of product literature that addresses required specifications)COMMENTS (If product solution involves different specifications, provide a detailed explanation for how product specification lacks or exceeds the Government's requirements.)
Compliance Specifications
System devices run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550MEETS
FDA approvedDOES NOT MEET
FIPS 140-2 certified with plan to transition to FIPS 140-3EXCEEDS
Validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (have Cerner capability)
Performance Specifications
Device has flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr.
Defaults to the Dose Error Reduction System (DERS) upon startup
Able to customize DERS and drug library
Able to program DERS limits and infusion devices which actively use DERS
Programming outside of DERS
Ability to program custom dilutions for critical/dangerous medications
Able to run anesthesia mode able to run without requiring EtCO2 Module
Number of drug entries is greater than 400
Options for different care therapies (same drug different limits)
Ability to set manual parameters within drug library
Ability to change to different drug libraries
Bolus or loading dose infusion limits
Patient weight for weight-based dosing
Accumulated dose limit monitoring
Accommodate various syringe volumes
Medication concentration limits
Infusion rate limits
Titration limits
Continuous infusion limits
Intermittent and secondary infusion limits
Ability to run multiple infusions concurrently with minimal control units
Able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes)
Bolus capability
Fluid resistance ingress protection
Free flow prevention mechanism
Has anesthesia mode
Patient tampering safety feature
Primary and secondary infusion modes
Secondary infusion capability
Multiple infusion capability
Event logs - In the event of patient incident or near miss/close call event logs need to be available
Provides the following EHR integration data analytics:

Integration compliance (rate of usage of smart pump workflows) Auto-documentation mismatch Failed auto-programming attempts

Has automatic switching to battery power upon line-power interruption
Mountable to an IV pole
Portable – transportable with battery backup
Able to be cleaned with hospital grade disinfectantEXCEEDS
Alarm/Alert Specifications
System Malfunction alarm
Fault condition alarm
Vein and line blocked alarm
Clamped secondary line alarm
Air is in the line for LV, PCA alarm
Flow error alarm
Set loaded improperly alarm
Empty syringe alarm
Plunger disengaged alarm
Pressure Sensor (high pressure/occlusion) alarm
Ability to silence, override alarms (anesthesia mode)
Alarm volume control and alarm momentary silence
Momentary silence of alarm less than 2 minutes
Industry standard default alarms
Able to configure alarm settings
Filter replacement alert
Infusion completed alert
Infusion near end alert
Empty reservoir alert
Occlusion upstream and downstream alert, Less than 15 psi for downstream, Detection mechanism
Door/latch open sensor
Low battery/ Depleted battery alert
Computer System/Wireless Specifications
Wireless communication capability
Infusion data sent wirelessly from equipment to central repository for analysis
Able to download drug library updates wirelesslyDOES NOT MEET
Allow medication drug library catalog updates to be wirelessly pushed to devices
Utilizes Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems
Customer Support Specifications
Company staff on site during implementation
Provide network security documentation: Ports, Protocols, and Services required for network communications.
Provide a list of Ports and Protocols the systems use to communicate on the network
Anticipated parts support for the next 10 years.
Parts available to support equipment repair at VAMC sites
Minimum warranty of 1-year parts & labor
Includes manuals (user, service, maintenance)
24/7 customer support for troubleshooting
Provides manufacturer training and service onsite for BioMed
Provide training for clinical end-users, BioMed and pharmacy staff prior to implementation
Include list of consumables required and starter supplies
Delivery After Receipt of Order - No Later Than 12 months

PCA Module

VISN 12 Infusion Pump System - PCA Module
TECHNICAL SPECIFICATION MATRIX
Respondents to complete all blue fields
PCA MANUFACTURER
PCA MODEL
SPECIFICATION / SALIENT CHARACTERISTICS
NOTE: DO NOT EDIT INFORMATION IN THIS COLUMN.PRODUCT SPECIFICATION / SALIENT CHARACTERISTIC COMPARISON (Select from Drop Down if product solution meets, does not meet, or exceeds required specifications)PRODUCT LITERATURE REFERENCE (Provide Page Number, Section/Paragraph of product literature that addresses required specifications)COMMENTS (If product solution involves different specifications, provide a detailed explanation for how product specification lacks or exceeds the Government's requirements.)
Compliance Specifications
System devices run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550MEETS
FDA approvedDOES NOT MEET
FIPS 140-2 certified with plan to transition to FIPS 140-3EXCEEDS
Validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (have Cerner capability)
Performance Specifications
Device has flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr.
Defaults to the Dose Error Reduction System (DERS) upon startup
Able to customize DERS and drug library
Able to program DERS limits and infusion devices which actively use DERS
Programming outside of DERS
Ability to program custom dilutions for critical/dangerous medications
Able to run anesthesia mode able to run without requiring EtCO2 Module
Number of drug entries is greater than 400
Options for different care therapies (same drug different limits)
Ability to set manual parameters within drug library
Ability to change to different drug libraries
Bolus or loading dose infusion limits
Patient weight for weight-based dosing
Accumulated dose limit monitoring
Medication concentration limits
Infusion rate limits
Titration limits
Continuous infusion limits
Intermittent and secondary infusion limits
Ability to run multiple infusions concurrently with minimal control units
Bolus capability
Fluid resistance ingress protection
Free flow prevention mechanism
Has anesthesia mode
Patient tampering safety feature
Primary and secondary infusion modes
Secondary infusion capability
Multiple infusion capability
Event logs - In the event of patient incident or near miss/close call event logs need to be available
Provides the following EHR integration data analytics:

Integration compliance (rate of usage of smart pump workflows) Auto-documentation mismatch Failed auto-programming attempts

Patient pendant for PCA dose requests
Has automatic switching to battery power upon line-power interruption
Mountable to an IV pole
Portable – transportable with battery backup
Able to be cleaned with hospital grade disinfectantEXCEEDS
Alarm/Alert Specifications
System Malfunction alarm
Fault condition alarm
Vein and line blocked alarm
Clamped secondary line alarm
Air is in the line for LV, PCA alarm
Flow error alarm
Set loaded improperly alarm
Plunger disengaged alarm
Pressure Sensor (high pressure/occlusion) alarm
Ability to silence, override alarms (anesthesia mode)
Alarm volume control and alarm momentary silence
Momentary silence of alarm less than 2 minutes
Industry standard default alarms
Able to configure alarm settings
Filter replacement alert
Infusion completed alert
Infusion near end alert
Empty reservoir alert
Occlusion upstream and downstream alert, Less than 15 psi for downstream, Detection mechanism
Door/latch open sensor
Low battery/ Depleted battery alert
Computer System/Wireless Specifications
Wireless communication capability
Infusion data sent wirelessly from equipment to central repository for analysis
Able to download drug library updates wirelesslyDOES NOT MEET
Allow medication drug library catalog updates to be wirelessly pushed to devices
Utilizes Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems
Customer Support Specifications
Company staff on site during implementation
Provide network security documentation: Ports, Protocols, and Services required for network communications.
Provide a list of Ports and Protocols the systems use to communicate on the network
Anticipated parts support for the next 10 years.
Parts available to support equipment repair at VAMC sites
Minimum warranty of 1-year parts & labor
Includes manuals (user, service, maintenance)
24/7 customer support for troubleshooting
Provides manufacturer training and service onsite for BioMed
Provide training for clinical end-users, BioMed and pharmacy staff prior to implementation
Include list of consumables required and starter supplies
Delivery After Receipt of Order - No Later Than 12 months

EtCO2 Monitor

VISN 12 Infusion Pump System - EtCO2 Module
TECHNICAL SPECIFICATION MATRIX
Respondents to complete all blue fields
EtCO2 MANUFACTURER
EtCO2 MODEL
If EtCO2 is part of another component (built-in),idenitfy which component(s) have EtCO2 built-in, then complete lines 10-13 and 15-37 below:
SPECIFICATION / SALIENT CHARACTERISTICS
NOTE: DO NOT CHANGE ANY INFORMATION IN THIS COLUMN.PRODUCT SPECIFICATION / SALIENT CHARACTERISTIC COMPARISON (Select from Drop Down if product solution meets, does not meet, or exceeds required specifications)PRODUCT LITERATURE REFERENCE (Provide Page Number, Section/Paragraph of product literature that addresses required specifications)COMMENTS (If product solution involves different specifications, provide a detailed explanation for how product specification lacks or exceeds the Government's requirements or does not apply.)
Compliance Specifications
System devices run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550
FDA approved
FIPS 140-2 certified with plan to transition to FIPS 140-3
Validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (have Cerner capability)
Performance Specifications
Defaults to the Dose Error Reduction System (DERS) upon startup
Able to customize DERS and drug library
Able to program DERS limits and infusion devices which actively use DERSMEETS
Programming outside of DERSDOES NOT MEET
Ability to program custom dilutions for critical/dangerous medicationsEXCEEDS
Number of drug entries is greater than 400
Options for different care therapies (same drug different limits)
Ability to set manual parameters within drug library
Ability to change to different drug libraries
Patient weight for weight-based dosing
Accumulated dose limit monitoring
Medication concentration limits
Infusion rate limits
Titration limits
Continuous infusion limits
Intermittent and secondary infusion limits
Ability to run multiple infusions concurrently with minimal control units
Fluid resistance ingress protection
Free flow prevention mechanism
Patient tampering safety feature
Primary and secondary infusion modes
Secondary infusion capability
Multiple infusion capability
Event logs - In the event of patient incident or near miss/close call event logs need to be available
Provides the following EHR integration data analytics:

Integration compliance (rate of usage of smart pump workflows) Auto-documentation mismatch Failed auto-programming attempts

Has automatic switching to battery power upon line-power interruption
Mountable to an IV pole
Portable – transportable with battery backup
Able to be cleaned with hospital grade disinfectantEXCEEDS
Alarm/Alert Specifications
System Malfunction alarm
Fault condition alarm
Flow error alarm
Alarm volume control and alarm momentary silence
Momentary silence of alarm less than 2 minutes
Industry standard default alarms
Able to configure alarm settings
Low battery/ Depleted battery alert
Computer System/Wireless Specifications
Wireless communication capability
Infusion data sent wirelessly from equipment to central repository for analysis
Able to download drug library updates wirelesslyDOES NOT MEET
Allow medication drug library catalog updates to be wirelessly pushed to devices
Utilizes Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems
Customer Support Specifications
Company staff on site during implementation
Provide network security documentation: Ports, Protocols, and Services required for network communications.
Provide a list of Ports and Protocols the systems use to communicate on the network
Anticipated parts support for the next 10 years.
Parts available to support equipment repair at VAMC sites
Minimum warranty of 1-year parts & labor
Includes manuals (user, service, maintenance)
24/7 customer support for troubleshooting
Provides manufacturer training and service onsite for BioMed
Provide training for clinical end-users, BioMed and pharmacy staff prior to implementation
Include list of consumables required and starter supplies
Delivery After Receipt of Order - No Later Than 12 months

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