Active

Contract Opportunity

Procurement Technical Assistance Centers (PTACs) are an official government contracting resource for small businesses. Find your local PTAC (opens in new window) for free government expertise related to contract opportunities.

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY.

This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this source sought notice. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response.

No solicitation exists. Therefore, do not request a copy of a solicitation.
See instructions on page 10.

Brand name or equal to the Plum 360 Infusion pump System

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 Veteran Affairs Medical Center Station 693 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 VISN 4 Medical Center listed below. Required quantities for both LVP and PCA smart infusion pumps systems for each location are also provided. Wilkes-Barre would like to have this as a task order for 5 days after the award of the contract in case the approximate quantities we have indicated for our facilities needs might be able to be adjusted. Wilkes-Barre VAMC has a need to also trade in all Alaris pumps for credit IF POSSIBLE. Wilkes-Barre VAMC would like to hold a vendor day before pumps are awarded so our end users will be able to have hands on look at the the pumps to get so they can get familiar with the different MFG s.

VA Contracting Officer s Point Of Contact (POC) will act as a liaison between the Wilkes-Barre VISN 4 facility dedicated representative.

General Requirements for all infusion Pump Systems
The contractor shall provide all labor, equipment, tools, materials, supervision, documentation, personnel, equipment required and other items necessary for infusion pumps to the Wilkes-Barre VISN 4 Medical Center located at 1111 East End Boulevard, Wilkes-Barre PA 18711. Must be able to trade in all Alaris pumps for credit.

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)
Must be FIPS 140-2 certified with 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 concurrently with minimal control units
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.)
Contractor cannot propose a device that does not have anticipated parts support for the next 10 years.
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
Must be able to trade in all our Alaris Pumps for credit

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 download drug library updates 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 (market research needed to confirm not specific to singular mfr.)
Must have ability to change to different drug libraries
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 1 drug library
Must be able to trade in all Alaris pumps for credit

Syringe PumpÂ
Must be FDA ApprovedÂ
Must have FIPS 140-2 wireless capability Â
Must be able to download drug library updates 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
All our required needs must be met by only using 1 drug library
Must be able to trade in all Alaris pumps for credit

End-tidal Carbon Dioxide (EtCO2) Monitoring (capnography monitory function)Â

Must be FDA ApprovedÂ
Must have FIPS 140-2 wireless capability Â
Must have automatic switching to battery power upon line-power interruption
Must have industry standard default alarms
Must be able to configure alarm settingsÂ
Must have ability to silence, override alarms (anesthesia mode)Â Â
Must have alarm volume control and alarm momentary silence Â
Must be cleanable with hospital grade disinfectant Â
Must include list of consumables required and starter suppliesÂ
All our required needs must be met by only using 1 drug library
Must be able to trade in all Alaris pumps for credit

Patient Controlled Analgesia (PCA)

Must be FDA ApprovedÂ
Must have FIPS 140-2 wireless capability Â
Must be able to download drug library updates 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 volumesÂ
All our required needs must be met by only using 1 drug library
Must be able to trade in all Alaris pumps for credit

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
Must have anesthesia mode to run 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
All our needs must be met by only using 1 drug library
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.

Estimated Schedule of Items

Infusion pumps
Item #30010
Facility needs 188
Mini poles for infusion pumps
13853-01
Facility needs 188
PCA pumps LIFECARE
20837
Facility needs 10
ICU MEDICAL MEDNETT IMPLEMENTATION ON SITE ONE SERVER, ONE DRUG LIBRARY
17544-03

ICU MEDICAL MEDNETT ONE YEAR LICENSE
16037-70

SMTH 4000-0106-01 MEDFUSION 4000
SYRINGE PUMP
SMTH 4000-0106-01

Facility needs 6
SMTH 22-0014-0106-01 MEDICATION SAFETY SOFTWARE PHARMGUARD
SMTH 22-0014-0106-01

Facility needs 6
SMTH 22-1050-51 ROTATING POLE CLAMP
SMTH 22-1050-51

Facility needs 6
SMTH 22-0026-001 STARTER SOFTWARE
SMTH 22-0026-001
SINGLE IV STAND 6-LEGS 25"(A)
ICU3000-A
Facility needs 150
HORIZONTAL PUMP CARRIER
ICU3PC
FACILITY NEEDS 4
DUAL IV STAND W STEEL SUPPORT HANDLE
ICU6000-SH-A
FACILITY 30
POWER STRIP - 4 OUTLET
205
FACILITY NEEDS 146

Deliverables/Installation/Incidental Services: Contractor shall complete delivery, installation, and implementation of all equipment within 120 days of contract award Lift gate will be needed for delivery. Once Delivery dates are known serial numbers of the pumps 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: Wilkes-Barre VAMC would like to take delivery of these items by ____ 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. A lift gate will be needed to make sure ease of delivery.
Warehouse POC: Kaitlyn Varneke, 821-3521 x 27179, Warehouse Supervisor.
REQUEST FOR INFORMATION INSTRUCTIONS:
The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions:

Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?

Is your company considered small under the NAICS code identified under this RFI?

Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers.

Does your company exceed 500 employees;

Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;

Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice;

Obtained an individual or class waiver?

If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).

If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job.

Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.

If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?

General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes?

Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.

Please provide your UEI number.

Complete the VA Form 6550 for VA Interconnectivity (Attached)

This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor@va.gov no later than, 16:00 PM Eastern Time (ET) on July 3, 2023. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Andrew Taylor. Questions or responses will include the Source Sought number 36C24423Q0925 in the subject line.

All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.

Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer.

If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov include 36C24423Q0925 in the subject line.

DISCLAIMER
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

End of Document

Attachments/Links