SPECIAL NOTICE
65 -- Action Plan Request : VISN 7 Infusion Pump Industry day |Vendor Fair (VA-23-00087047)
- Notice Date
- 12/26/2023 12:52:24 PM
- Notice Type
- Special Notice
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- 247-NETWORK CONTRACT OFFICE 7 (36C247) AUGUSTA GA 30904 USA
- ZIP Code
- 30904
- Solicitation Number
- 36C24724Q0094
- Response Due
- 1/12/2024 9:00:00 AM
- Archive Date
- 03/12/2024
- Point of Contact
- Joseph E. Horn, Admin Contract Specialist, Phone: 404-431-6148
- E-Mail Address
-
Joseph.Horn@va.gov
(Joseph.Horn@va.gov)
- Awardee
- null
- Description
- Special Notice Special Notice Page 4 of 4 Special Notice *= Required Field Special Notice Page 1 of 4 DESCRIPTION Industry Day for VISN-7 Infusion Pump System Request for Industry Day for High Volume Infusion Pumps for the VISN-7 Medical Centers (Located in Alabama, Georgia, and South Carolina) 1. Industry Day Date: January 24, 2024 Time: 8:00 am 4:30 pm Eastern Standard Time Location: Augusta VA Medical Center (Education Auditorium Room 3B125) One Freedom Way Augusta, Georgia 30904-6258 Delivery: Participants will meet and deliver equipment at Education Auditorium Room 3B125 Augusta VA Medical Center, One Freedom Way, Augusta GA 30904-6258 Points of Contact: CS: Joseph E. Horn, Email: Joseph.Horn@va.gov POC: Vincent Dang, Email: Vincent.Dang636@va.gov (470-985-8645) COR: James Gaudio Email: James.Gaudio@va.gov (706-733-0188 x32447) 2. Agenda: 8:00 a.m.- 10:00 a.m. Set-up of equipment 10:00 a.m.- 3:00 p.m. Demonstrations of Equipment 3:00p.m.- 4:30 p.m. Removal of equipment 3. Request to attend: All request to attend the Industry Day must be submitted via email Friday, January 12, 2024 by noon Eastern Standard Time (EST) to Vincent Dang at Vincent.Dang636@va.gov (470-985-8645 ) and James Gaudio Contracting Officer Representative (COR) at James.Gaudio@va.gov. Please include the name of the individual (s) attending, phone number(s) and email address (es); company name and address; business size and type; and DUNS number. Also provide electronic brochures and applicable research studies and literature for the High-Volume Infusion Pump. Statement of Work Industry Day for Infusion Pumps General Information Title of Project: Industry Day for High Volume Infusion Pumps for the VISN-7 Medical Centers (Located in Alabama, Georgia, and South Carolina). Scope of Work: The contractor shall provide all labor; supervision and all other resources required to deliver and operate Infusion Pump System. The vendor will be required to answer all technical question concerning the equipment such as description, specification, operation, maintenance, etc. and provide brochures. Background: The medical center is interested in evaluating Infusion Pump Systems. Performance Period/Schedule: January 24, 2024 8:00am-4:30pm Eastern Standard Time General Requirements Vendor must provide presentation and hands-on demonstration of equipment and include provide electronic brochures and applicable research studies and literature for the infusion pump systems. Requested information and representative name (s) and contact information must be emailed to POC the Friday prior to Industry Day date. Specific Mandatory Tasks and Associated Deliverables Location for Industry Day: Augusta VA Medical Center Uptown (Education Auditorium Room 3B111) One Freedom Way Augusta, Georgia 30904-6258. Specific Tasks: Provide VISN-7 Infusion Pump System, applicable research studies and literature to Vincent Dang at Vincent.Dang636@va.gov and James Gaudio, Contracting Officer Representative at Jame.Gaudio@va.gov when sending in intent to participate (include list of participants and contact information). Also provide an electronic brochures and applicable research studies and literature for the Infusion Pump System available at the Industry Day. Contractor shall deliver all materials for safe operation of the Infusion Pump System. Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in PWS. Training: N/A Government Responsibilities: Augusta VA Medical Center(Uptown) will provide: Provide access to building for the Industry Day. Performance Work Statement Department of Veterans Affairs VISN 7 Infusion Pump System GENERAL INFORMATION Purpose: Veterans Integrative Service Network 7 (VISN 7) healthcare systems and medical centers require a 100% replacement of existing Alaris infusion pumps and modules. This requires a contractor to provide hardware, software, installation, project management and training, such that VISN 7 healthcare systems and medical centers implement a new fleet of infusion pumps. Background: To provide world-class service to Veteran patients in VISN 7, infusion pump technology is critical for controlled delivery of liquid medications and other solutions. This technology includes hardware such as controller units, large-volume (LV) pump module, syringe pump module, patient-controlled analgesic (PCA) pump module, end-tidal carbon dioxide (EtCO2) monitoring module, as well as dose error reduction system (DERS) software. The existing infusion pump fleet in VISN 7 is beyond or approaching end of life, and full fleet replacement is required for reliable infusion-based therapy. The existing fleet resides at all VISN 7 healthcare systems and medical centers, except for Carl Vinson VA Medical Center. CONTRACT REQUIREMENTS General Requirements The contractor shall provide all labor, equipment, tools, materials, supervision, documentation, personnel, project management and other items necessary for infusion pump delivery and implementation to the following VISN 7 facilities: Facility Name Address City, State Zip Code Atlanta VA Health Care System 1670 Clairmont Road Decatur, GA 30033 Birmingham VA Health Care System 700 South 19th Street Birmingham, AL 35233 Central Alabama VA Health Care System Montgomery 215 Perry Hill Road Montgomery, AL 36109 Central Alabama VA Health Care System Tuskegee 2400 Hospital Road Tuskegee, AL 36083 Charlie Norwood VA Medical Center 950 15th Street Augusta, GA 30904 Wm. Jennings Bryan Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 Ralph H. Johnson VA Medical Center 109 Bee Street Charleston, SC 29401 Tuscaloosa VA Medical Center 3701 Loop Road East Tuscaloosa, AL 35404 The contractor shall provide the following equipment types and quantities: Equipment Description Quantity Large-Volume Pump Controller 1427 Infusion Module: Large Volume Pump 2604 Infusion Module: Patient Controlled Analgesia 293 Infusion Module: Syringe Pump 38 Infusion Module: EtCO2 252 Equipment Large-Volume Pump Controller Must run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550 Must be FDA approved Must be FIPS 140-2 certified with plan to transition to FIPS 140-3 Must be able to download drug library updates wireless Must be able to send data to central repository for analysis 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 Must have ability to run multiple infusions concurrently Device must have flow rate specifications capability with at least a range window of 0.1 mL/hr to 999 mL/hr and with incremental rate minimum of 0.1 mL/hr. Must have ingress protection for liquids Must have free flow prevention mechanism Must have the ability to set manual parameters within drug library Must have ability to change to different drug libraries Must have primary and secondary infusion modes Must have a minimum warranty of 1-year parts & labor Must have parts support for the next 10 years Must be transportable with battery backup Must include IV pole for each LVP, with ability to hold LVP Must have patient tampering safety feature Must have loading and bolus dose capabilities Must have alarm volume control and alarm momentary silence capability Must have event storage capability Modules: Large-Volume Pumps (LVP) Modules: Patient Controlled Analgesia Pumps (PCA) Must have accumulated dose limit monitoring Must have patient pendant for PCA dose requests Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes) Modules: Syringe Pumps Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes) Modules: End-Tidal Carbon Dioxide Monitoring (EtCO2) Must have ability to silence, override alarms (anesthesia mode) Must have alarm volume control and alarm momentary silence Dose Error Reduction System (DERS) 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 Must allow medication drug library catalog updates to be wirelessly pushed to devices Must have ability to program custom dilutions for critical/dangerous medications Must be able to program DERS limits and infusion devices which actively use DERS for: Medication doses Number of drug entries is greater than 400 With options for different care therapies (i.e., 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 and modules 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 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 Must have all events 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 Alarms and Indicators Fault condition alarms Vein and line blocked Clamped secondary line alarm Air-in-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 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 Must include list of consumables required and starter supplies Project Management Must provide lead coordination for delivery, hardware configuration, software implementation, and training. Coordination activities must include, but are not limited to: Determining project tasks and deliverables Scheduling calls Developing and tracking timelines Informing stakeholders of timeline risks Closing out project with clear sustainment plan 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 CST, Mon-Fri. Must provide a list of approved sources to purchase necessary repair parts to ensure equipment operates to original manufacturer specifications. Must comply with current FDA regulations pertaining to Recalls and Medical Device correction notices 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 Service and 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
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/1a4a8a24b89646989cdb84eb39a2736f/view)
- Record
- SN06921580-F 20231228/231226230043 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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