6515--Full Replacement of Infusion Pump System at Wilkes Barre VA Medical Center

Statement of Need

Department of Veterans Affairs

VISN 4 Wilkes-Barre VAMC Infusion Pump System Procurement

General Information

Background: The Veterans Integrated Service Network 4 (VISN 4) Wilkes-Barre Veterans Affairs Medical Center is dedicated to the provision of health care training and education using advanced technologies, sharpening the skill set of all VA staff to provide the best care to Veterans. Infusion pumps are important for every hospital. With Large Volume and syringe infusion pumps, patients can receive the necessary nutrients in their body.

Scope of Work: The contractor shall provide all labor, equipment, tools, materials, supervision, documentation, personnel, equipment required and other items necessary for LVP and PCA Smart Infusion Pumps Systems to be provided and implemented at Wilkes-Barre VISN 4 Medical Center located at 1111 East End Boulevard, Wilkes-Barre PA 18711. Required quantities for both LVP and PCA smart infusion pumps systems for each location are also provided.

General Requirements for all infusion Pump Systems - System devices must run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550.

Must be FDA approved (Reference Federal Food Drug & Cosmetic Act (FD&C Act), Title 21 CFR Parts 800-1299)

Wireless communication must support and use FIPS 140-2 or FIPS 140-3 with provided validation from NIST (National Institute of Standard and Technology) Cryptographic Module Validation Program. If FIPS 140-2 certified, vendor must provide a plan to transition to FIPS 140-3.

(Reference: FISMA Federal Information Security Management Act, Federal Information Processing Standards Publications 140-2 and 140-3 (FIPS Pub), VA Directive 6550)

Must have wireless communication (Reference: VA Directive 6550, Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

Must be able to interface with CPRS along with being required to have Cerner capability (Reference: DUSHOM policy; Cerner CareAware Device List Q1 2022 pages 7,8,9)

System will not operate appropriately without ability to interface with Cerner. Would lose required smart pump features including auto-programming, auto-documentation, and alert management without compatibility with Cerner. ECRI Institute. Infusion pump integration: why is it needed, and what are the challenges? [guidance article]. Health Devices 2013 Jul;42(7):210-21. aami-infusion-anthology-10-8-20.pdf

Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 Medical electrical equipment Part I: General requirements for basic safety and essential performance. )

Must have ability to run multiple infusions pumps concurrently.Co

Must send infusion data wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

Must have primary and secondary infusion modes (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

Must have a minimum warranty of 1-year parts & labor (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

Must be portable transportable with battery backup (Reference: 8 hours (standard battery) 4 hours (wireless module) FDA-2006-D-0300 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

Must be mountable to an IV pole (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

All our required needs must be met by only using 1 drug library.

Service & Maintenance

Must be cleanable with hospital grade disinfectant

Must come with manuals (user, service, maintenance)

Must provide manufacturer training and service onsite

Must provide training for clinical end-users, BioMed and pharmacy staff prior to implementation

Must have company staff on site during implementation

Must provide 24/7 phone line for troubleshooting

Must have parts to support equipment repair at VAMC

Modules:

Large Volume Pump (LVP)

Must be FDA Approved

Must have FIPS 140-2 wireless capability

Must be able to update drug library wirelessly

Must be validated with Cerner s CareAware smart pump programming, infusion management, and event management workflows (DUSHOM memo with direction -Bob Steldt)

Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 Medical electrical equipment Part I: General requirements for basic safety and essential performance. )

Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 MM.08.01.01, PI.01.01.01, EPs 1, 5, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

Must have fluid resistance ingress protection

Device must have flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr.

Reference: Infusion Nursing Reference guide

ECRI comparison chart:

https://www.ecri.org/Components/HPCS/Pages/Infusion-Pumps,-Large-Volume.aspx?tab=2

ECRI publication:

ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.

Must default to the Dose Error Reduction System (DERS) upon startup

Must have free flow prevention mechanism

Must have the ability to set manual parameters within drug library

Must have anesthesia mode

Must have ability to program drug libraries specific to different areas (i.e. ICU, Med-Surg, Oncology, etc)

Must have secondary infusion capability

Must have automatic switching to battery power upon line-power interruption

Must have patient tampering safety feature

Must have loading dose capability

Must have alarm volume control and alarm momentary silence

Must be cleanable with hospital grade disinfectant

All our required needs must be met by only using one drug library.

Syringe PumpÂ

Must be FDA ApprovedÂ

If a separate controller system it must have FIPS 140-2 wireless capability Â

Must be able to update drug library wirelesslyÂ

Must be validated with Cerner s CareAware smart pump programming, infusion management, and event management workflows (DUSHOM memo with direction -Bob Steldt)Â

Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 Medical electrical equipment Part I: General requirements for basic safety and essential performance. )Â Â

Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)Â

Must have fluid resistance ingress protectionÂ

Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr. Â

Must default to the Dose Error Reduction System (DERS) upon startupÂ

Must have free flow prevention mechanismÂ

Must have the ability to set manual parameters within drug library  Â

Must have patient tampering safety featureÂ

Must have loading dose capabilityÂ

Must be cleanable with hospital grade disinfectant Â

Must have alarm volume control and alarm momentary silence Â

Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes)Â

Patient Controlled Analgesia (PCA)

Must be FDA ApprovedÂ

If a separate controller system it must have FIPS 140-2 wireless capability Â

Must be able to update drug library wirelesslyÂ

Must be validated with Cerner s CareAware smart pump programming, infusion management, and event management workflows

Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 Medical electrical equipment Part I: General requirements for basic safety and essential performance. )Â

Must have low battery, depleted battery alarms Â

Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)Â

Must have fluid resistance ingress protectionÂ

Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr. Â

Must default to the Dose Error Reduction System (DERS) upon startupÂ

Must have free flow prevention mechanismÂ

Must have multiple infusion capabilityÂ

Must have patient tampering safety featureÂ

Must be cleanable with hospital grade disinfectant Â

Must have accumulated dose limit monitoring Â

Must have patient pendant for PCA dose requests Â

Must have bolus capability Â

Must have loading dose capability Â

Must have alarm volume control and alarm momentary silenceÂ

Must be able to accommodate various syringe volumes minimum 10mL & maximum 60mL volumes)

All our required needs must be met by only using one drug library

Dose Error Reduction System (DERS):

Must be FDA ApprovedÂ

Must be configurable with soft limits, hard limits, and/or soft limits nested within hard limitsÂ

Must have capacity to download drug library updates wirelesslyÂ

Must utilize Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systemsÂ

Must be able to customize DERS and drug libraryÂ

Drug library and health record need to match what is in drug library in pumpsÂ

Must allow medication drug library catalog updates to be wirelessly pushed to devicesÂ

Must have ability to program custom dilutions for critical/dangerous medicationsÂ

Anesthesia mode may run with or without EtCO2 monitoringÂ

Must be able to edit as needed.

Must be able to program DERS limits and infusion devices which actively use DERS for:Â

Medication dosesÂ

Define minimum # of meds/care areas that need to be programmed (ECRI greater than 10 care areas needed)

Number of drug entries is greater than 400Â

With options for different care therapies (same drug different limits)Â

Medication concentration limitsÂ

Infusion rate limitsÂ

Titration limitsÂ

Continuous infusion limits Â

Intermittent and secondary infusion limitsÂ

Bolus dose and loading dose infusion limitsÂ

Patient weight for weight-based dosingÂ

DERS Software must be common across all pumpsÂ

PCAÂ

Large VolumeÂ

SyringeÂ

Configurable soft limits, hard limits, and/or soft limits nested within hard limitsÂ

Configurable alarm volume limitsÂ

Configurable infusion pauses duration limits and delayed start duration limitsÂ

Configurable clinical alerts to clinicians to be acknowledged during infusion device programming (example requires central line )Â

Must provide the following data analytics/DERS compliance reports:Â Â

Med specific compliance and alert reportsÂ

Total rates of alerts by med Â

Reports of meds with low use frequency and high alert rateÂ

Rates of overrides by medÂ

Infusion parameter specific alerts reports (dose-rate, concentration, duration alerts)Â

Facility compliance Â

Programming outside of DERSÂ

Event logs - In the event of patient incident or near miss/close call event logs need to be availableÂ

Downloadable and printable after download using MS office or Adobe PDFÂ

Events storedÂ

Dose limitÂ

Key presses, program settings, alarms, volume infused, dose limit warnings, Â

All timestampedÂ

Must have DERS safety features available on infusion devices during network downtimeÂ

Must be validated with Cerner s CareAware smart pump programming, infusion management, and event management workflows

Must provide the following EHR integration data analytics:Â

Integration compliance (rate of usage of smart pump workflows)Â

Auto-documentation mismatchÂ

Failed auto-programming attemptsÂ

Adhere to IHE model for EHR infusion Pump IntegrationÂ

Must provide network security documentation

Provide a list of Ports, Protocols, and Services required for network communications.Â

Alarms & Indicators for Overall SystemÂ

Fault condition alarmsÂ

Vein and line blockedÂ

Clamped secondary line alarmÂ

Air is in the line for LV, PCAÂ

Infusion completed alertÂ

Infusion near endÂ

Empty reservoirÂ

Flow errorÂ

Set loaded improperlyÂ

Empty syringeÂ

Plunger disengagedÂ

Filter replacementÂ

Pressure Sensor (high pressure/occlusion)Â

Occlusion upstream and downstreamÂ

Less than 15 psi for downstreamÂ

Detection mechanismÂ

Door/latch open sensorÂ

System MalfunctionÂ

Low battery/ Depleted batteryÂ

Volume control capabilityÂ

Momentary silence less than 2 minutesÂ

Pre-Deployment Requirements:

Must provide all necessary documentation to meet VA Directive 6550 and Enterprise Risk Assessment requirementsÂ

MDS2 for each componentÂ

Topology DiagramÂ

Hardware/Software InventoryÂ

Provide a list of Ports and Protocols the systems use to communicate on the networkÂ

6550 Appendix A for each componentÂ

Must follow all required VA Handbook 6500 requirements to provide remote support of server components of the system including but not limited to background investigations, MOU/ISA, PIV badge issuance, check-in requirements.Â

Must provide a listing of any required Government Furnished Equipment (GFE) and/or software if required including but not limited to server specifications, workstations specifications, software prerequisites that would be necessary for the infusion system and its associated information support systems.Â

Must participate in pre-implementation meetings with VA information security professionals to review system operation to obtain an ERA. A current ERA is required for these systems to operate on the VA networkÂ

Training and Support:Â

Must certify local Biomedical Engineering staff to perform maintenance and repairs on all equipment. Â

Must provide phone technical support during normal business hours 7am-5pm EST, Mon-Fri.Â

Must provide a list of approved sources to purchase necessary repair parts to ensure equipment operates to original manufacturer specifications.Â

Parts availability should be generally available next-day shipment.Â

Must comply with current FDA regulations pertaining to Recalls and Medical Device correction notices (site FDA regulation -- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation)Â

Must provide training for clinical usersÂ

Initial training for frontline users will be onsite and conducted by company representativesÂ

Remote training must be available over digital platform, recorded and available for future referenceÂ

Must provide access to clinical user education/reference materials via online company site and physical user manual and instructions for use.Â

Must have 1:1 support available Â

Must provide notices for software, IFU, user manuals updates Â

Must provide education on updates via company online site and physical user manual and instructions for use Â

Contractor must be here for the delivery and implementation of equipment.

Deliverables/Installation/Incidental Services: Contractor shall complete delivery, installation, and implementation of all equipment once contract is awarded in coordination with the facility POC and facilities biomed service. Warehouse has a dock so no liftgate is needed for delivery. Once Delivery dates are known serial numbers of the pumps/controllers should be emailed before delivery so our property managers can input the information into our inventory system as not to hold up delivery to each service once items are in our medical facility.

Delivery Requirement: Delivery should be made by going thru our warehouse and the hours of delivery are 8am to 4pm Monday thru Friday, excluding all Federal holidays. Warehouse has a dock so no liftgate is needed for delivery.