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Infusion Pumps

Inactive

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-Bar... 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 Pump Must be FDA Approved If a separate controller system it 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 12, 13, 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 0.1-99mL/hr. and in increments of 0.1 mL/hr.  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 patient tampering safety feature Must have loading dose capability Must be cleanable with hospital grade disinfectant  Must have alarm volume control and alarm momentary silence  Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes) Patient Controlled Analgesia (PCA) Must be FDA Approved If a separate controller system it 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 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 low battery, depleted battery alarms  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.) Must have fluid resistance ingress protection Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr.  Must default to the Dose Error Reduction System (DERS) upon startup Must have free flow prevention mechanism Must have multiple infusion capability Must have patient tampering safety feature Must be cleanable with hospital grade disinfectant  Must have accumulated dose limit monitoring  Must have patient pendant for PCA dose requests  Must have bolus capability  Must have loading dose capability  Must have alarm volume control and alarm momentary silence 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 Approved Must be configurable with soft limits, hard limits, and/or soft limits nested within hard limits Must have capacity to download drug library updates wirelessly Must utilize Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems Must be able to customize DERS and drug library Drug library and health record need to match what is in drug library in pumps Must allow medication drug library catalog updates to be wirelessly pushed to devices Must have ability to program custom dilutions for critical/dangerous medications Anesthesia mode may run with or without EtCO2 monitoring Must be able to edit as needed. Must be able to program DERS limits and infusion devices which actively use DERS for: Medication doses 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 400 With options for different care therapies (same drug different limits) Medication concentration limits Infusion rate limits Titration limits Continuous infusion limits  Intermittent and secondary infusion limits Bolus dose and loading dose infusion limits Patient weight for weight-based dosing DERS Software must be common across all pumps PCA Large Volume Syringe Configurable soft limits, hard limits, and/or soft limits nested within hard limits Configurable alarm volume limits Configurable infusion pauses duration limits and delayed start duration limits Configurable clinical alerts to clinicians to be acknowledged during infusion device programming (example requires central line ) Must provide the following data analytics/DERS compliance reports:  Med specific compliance and alert reports Total rates of alerts by med  Reports of meds with low use frequency and high alert rate Rates of overrides by med Infusion parameter specific alerts reports (dose-rate, concentration, duration alerts) Facility compliance  Programming outside of DERS Event logs - In the event of patient incident or near miss/close call event logs need to be available Downloadable and printable after download using MS office or Adobe PDF Events stored Dose limit Key presses, program settings, alarms, volume infused, dose limit warnings,  All timestamped Must have DERS safety features available on infusion devices during network downtime Must be validated with Cerner s CareAware smart pump programming, infusion management, and event management workflows Must provide the following EHR integration data analytics: Integration compliance (rate of usage of smart pump workflows) Auto-documentation mismatch Failed auto-programming attempts Adhere to IHE model for EHR infusion Pump Integration Must provide network security documentation Provide a list of Ports, Protocols, and Services required for network communications. Alarms & Indicators for Overall System Fault condition alarms Vein and line blocked Clamped secondary line alarm Air is in the line for LV, PCA Infusion completed alert Infusion near end Empty reservoir Flow error Set loaded improperly Empty syringe Plunger disengaged Filter replacement Pressure Sensor (high pressure/occlusion) Occlusion upstream and downstream Less than 15 psi for downstream Detection mechanism Door/latch open sensor System Malfunction Low battery/ Depleted battery Volume control capability Momentary silence less than 2 minutes Pre-Deployment Requirements: Must provide all necessary documentation to meet VA Directive 6550 and Enterprise Risk Assessment requirements MDS2 for each component Topology Diagram Hardware/Software Inventory Provide a list of Ports and Protocols the systems use to communicate on the network 6550 Appendix A for each component 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. 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. 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 network Training and Support: Must certify local Biomedical Engineering staff to perform maintenance and repairs on all equipment.  Must provide phone technical support during normal business hours 7am-5pm EST, Mon-Fri. Must provide a list of approved sources to purchase necessary repair parts to ensure equipment operates to original manufacturer specifications. Parts availability should be generally available next-day shipment. 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) Must provide training for clinical users Initial training for frontline users will be onsite and conducted by company representatives Remote training must be available over digital platform, recorded and available for future reference Must provide access to clinical user education/reference materials via online company site and physical user manual and instructions for use. Must have 1:1 support available  Must provide notices for software, IFU, user manuals updates  Must provide education on updates via company online site and physical user manual and instructions for use  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.