The Lebanon VA Medical Center (LVAMC), intends to negotiate on a Sole Source basis with PROAIM Medical, P.O. Box 724, Wildwood, MO 63040, to award a Contract to them, to furnish Five (5) adult Maquet, Inc. Servo I Ventilators, and additional Maquet, Inc. Servo I Ventilator Components, as well as, to train and certify LVAMC Biomed staff, in how to maintenance and repair this equipment, and to provide guidance to LVAMC IT Staff. Estimated amount of the Contract is $149,890. (See Statement of Need/SOW below). DEPARTMENT OF VETERAN AFFAIRS STATEMENT OF WORK Adult Ventilators A. GENERAL INFORMATION (1) Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. The Lebanon Veterans Affairs Medical Center (VAMC) is requesting the purchase of 5 adult Ventilators for the medical center. (2) Background: The Respiratory Therapy Department of the Lebanon VAMC has a requirement for new adult ventilators. The adult ventilators are being ordered for both new and replacement according to the Clinical requirements and to meet the compliances from The Joint Commission (TJC) for the critical/sentinel alarms. The ventilators shall transmit all data into the VAMC's PICIS System for safety and record management. As such, the following items shall be indwelling to ensure all information regarding function, changes, and alarms are transmitted to the PICIS System: Aerogen Nebulizer, CO2 Detection, and MRI compatible. B. CONTRACT AWARD MEETING The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting, or has advised the contractor that a kick off meeting is waived. C. GENERAL REQUIREMENTS Contractor shall be responsible to provide all services associated with the furnishing and installation of these ventilators. Contractor shall provide the most efficient means of optimizing training, system maintenance, and data exchange throughout the facility. By responding to this solicitation, the Contractor acknowledges that he/she understands that VA Lebanon has substantial interface requirements between the ventilators and ICU-Clinical Information System. Summary of Product and Services Required Line Item Line Item Description Quantity 1 Acute Care Ventilators without Heliox adaptor 05 units 3 Clinical Training 02 Jobs 4 Biomedical Training 01 Job 5 Installation 01 job 6 [Option] Trade-In of Existing Ventilators 05 units Place of Performance The Ventilators will be delivered and provide specified functionality to the following Lebanon VA Medical Center. Facility Address POC for Equipment Delivery (Name ) Lebanon VA Health Care System 1700 S Lincoln Ave, Lebanon PA 17042 Jodie Yoder Instructions to Offerors " Contractors shall provide statements for each required product and service in adequate detail to evaluate proposals. A description of the evaluation approach to be utilized is provided. The use of product brochures should be extremely limited, and when necessary, offeror's responses shall address the brochure by document title and page number. " Contractor shall respond to each mandatory and optional requirement to detail how the need is met by the contractor's solution. " Contractors shall complete the Manufactures Disclosure Statement for Medical Device Security Form. See Attachments. " Contractors shall provide a copy of Business Associate Agreement with the Department of Veterans Affairs, if already established. If not established, provide a statement so stating. " Contractor shall identify a single point of contact for all project management activities for the VA to correspond with throughout the installation and implementation process. " Contractor shall provide three references of similar scope ventilator contracts. REQUIREMENTS: A. Ventilator Product Requirements Ventilators The Ventilators shall meet or exceed the following specifications: " Mechanical ventilation " Flexible breathing circuit, capable of monitoring End Tidal CO2 " Control System " Gas Supply " Monitors and Alarms " Air/Oxygen mixing device (Oxygen blender) " Assist/control and SIMV, PRVC, Pressure control and Bivent modes " CPAP/PEEP and pressure support " Oxygen Analyzer that continuously monitors Oxygen/air mixture and includes an alarm for concentrations outside of the set range. Consumables The Ventilator vendor shall provide at least one (1) month of consumables used / required to treat the patients. Alarms Alarms should be distinct and easy to identify. If adjustable, alarms should not be capable of being turned below a certain set threshold. Alarm silence feature must reactivate automatically within two minutes if the condition is not corrected. Visual display should remain on in the event of alarms being silenced. Disinfection The Ventilators shall provide an automated method to disinfect the equipment between patients. Method shall include both heat and chemical disinfection. Clinical Functionality The vendor shall describe features and functions of the ventilators proposed that improve the clinical efficiency and efficacy of ventilated patient treatment. Interface to ICU-CIS The Ventilators must have a working interface to the ICU-Clinical Information System, Software, Hardware, and Licenses The vendor shall provide any software and licenses needed for full use of the ventilators. Any hardware, software, or licenses needed for interface to the CIS Controls Controls on the Ventilators (i.e. switches and knobs) should be designed in a way that clearly identifies each control and their functions. These controls should be designed such that they are protected against accidental setting changes and sealed to prevent fluid penetration. FDA Clearance Ventilators must have appropriate FDA clearance Controls/Setting Ranges Control/Settings Setting Ranges Tidal volume, mL 20-2,000 Inspiratory flow, L/min 3-180 Inspiratory pressure, cm H2O 0-80 Respiratory rate, breaths/min 0-120 Inspiratory time, sec 0-3 Expiratory time, sec 1-8 IE ratio 1:4 to 4:1 Inspiratory hold/plateau 0-3 sec Expiratory hold 0-3 sec FiO2, % 21-100 Manual breath button Yes PEEP/CPAP, cm H2O 0-45 Pressure support, cm 0-45 H2O Nebulizer Optional; user preference (pneumatic, ultrasound) Neb type Aerogen Trigger mechanism Pressure, flow Bias/base flow range, 1-20 L/min Pressure slope/ramp adjustment Yes/Yes Sigh breath function Yes Auto 100% O2 button Yes How long at 100% after button is activated, min 2 Control panel lock Yes Operating Modes The following operating modes must be included with the Ventilators except where indicated that the feature is optional: " Volume/control mode o Volume/Control volume breaths o Volume/Control pressure breaths " Pressure Support " SIMV and PRVC mode o SIMV/PRVC volume breaths o SIMV/PRVC pressure breaths o SIMVPRVC pressure support " Pressure Controlled Mode - variable volume at set pressure. " Guaranteed tidal volume at variable pressure and variable flow. " Spontaneous/CPAP mode o CPAP pressure support " Apnea-backup vent mode " Combination modes o Combo mode type " Active/responsive valve " Bilevel/APRV Mode " Non-invasive ventilation (e.g., NIV/NPPV) " High-frequency ventilation, [Option] " Features/Modes, [Option] o Nitric Oxide, [Option] o Neural regulated ventilation, [Option] Monitored/Displayed Parameters The following monitored/displayed parameters must be included with the Ventilators: " Peak inspiratory pressure (PIP) " Mean airway pressure (MAP) " PEEP pressure " Tidal volume: Spontaneous and Set " Minute volume " Spontaneous minute volume " FiO2 (analyzed %) " Respiratory rate: Spontaneous and Set " Inspiratory time " Expiratory time " IE ratio " Graphic package - ability to look at flow loops, and other trending capabilities. " Compliance measurement " Plateau pressure measurement Patient Alarms The following patient alarms must be included with the Ventilators: " Low/high FiO2 " Low minute volume " High minute volume " Low inspiratory pressure " High pressure " Loss of PEEP " Apnea " Continuous high pressure/occlusion " Inverse IE ratio " High respiratory rate " High PEEP " Breathing circuit disconnect " Trending of alarms " Low respiratory rate Equipment Alarms The following equipment alarms must be included with the Ventilators: " Gas supply failure " Power failure " Vent inoperative " Low battery " Self-diagnostics, Valve leak, sensor failure Display Display shall be easily read in high and low light. Offerors shall briefly describe the type of display on the ventilators, the data that is/can be displayed, the screen size, and configurable parts of the display. Patient Transport Capability A battery backup mode is required. The vendor will detail the battery configuration utilized (internal and/or external). The battery must have the capability to sufficiently supply a fully functioning ventilator for more than three (2) hours. Miscellaneous The following additional features must be included with the Ventilators: " External device interfaces " Output ports (minimum of 2) " Nurse Call interface/Remote alarm display port with cables " Analog output " Reporting (vent alarms and patient status) " View reports on display " Sends reports to printer " Save data to external media " Send all data via network to another system " Mounting hardware and mobile cart to mount ventilator equipment to mobile cart " All required cables " Holder for humidifier " Necessary hoses " Oxygen sensors are preferred over oxygen cells " Ventilator should support patients weighing >400 pounds. B. Space & Utilities: Electrical/Line Power The Ventilators shall use existing electrical services of VA Lebanon Medical Center. The system shall operate with a line power of 120 volts AC and current draw less than 20 amps. " Please describe the electrical requirements of your Ventilators Dimensions/Weight The vendor will provide cut sheets indicating the dimensions and weight of the ventilators C. Clinical Training Requirements On-Site User Training Clinical-User Training - The vendor providing the system will be responsible for training all clinical users on their application and use. The vendor prior to and at the time of installation shall provide staff education at the facility. On-Site or "Go-Live" training shall be a minimum of 30 hours. Four training manuals are to be provided to the facility. A clinical education professional shall administer the training. Education curriculum must include but is not limited to the following: " Operations and set-up " User maintenance " Safety " User Troubleshooting " Negotiating and understanding machine profiles to better serve the patient and staff D. Biomedical Engineering Training Requirements Biomedical Technical Training The vendor shall address how they will provide technical training for maintenance and service for two biomedical engineering personnel to include factory service training courses (If Applicable). " Please indicate details about each training session offered " Training shall include tuition, employees to attend each training session offered (i.e. Intermediate, Advanced, etc.). " Vendor shall provide any special service tools and/or test equipment comparable with that provided to the OEM's service personnel. " Training shall at minimum address the following topics. o Theory of Operation o Using schematics and circuit diagrams o Using the Technical Service Mode o Commissioning and Preventative Maintenance o Calibration Procedures o Troubleshooting o Interpreting and correcting alarm conditions o Spare parts " Upon Completion of Training, testing equipment, cables, and software necessary to perform PMs and troubleshooting in house shall be given to the attendees of the course. " Upon completion of training, attendees should be certified to fully troubleshoot, repair, and perform preventive maintenance on the ventilators. Attendees should be prepared to fully service equipment independent of vendor assistance. E. Installation Services Installation and Implementation The vendor shall provide installation services offered, specifically addressing each of the following requirements: " The vendor shall provide professional project management services to organize the trade-in, training, installation and go-live activities at the facility. . " The vendor shall be responsible for testing the system at the facility to ensure that the system is functioning as defined by the SOW. " The vendor shall be responsible for managing all waste created by the product installation, " The vendor shall define all site preparation requirements of the VA in writing as part of the submittal package. This shall include high voltage electrical requirements, network requirements, and any other required utilities not explicitly specified. " Ongoing clinical applications support via telephone, for 12 months following the installation. F. Service Requirements Manuals The vendor shall provide the following documentation for the proposed equipment: " One (1) copy per device plus two (2) additional copies of the Operator Manuals Two (2) copies of complete technical Service Manuals including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists delivered at the time of equipment delivery. Service The vendor shall address how they will meet the following service requirements: " Service during the guarantee period shall be provided within 1 hour of notification via phone. A routine service request will be issued upon any failure which degrades system performance but does not prevent continuation of patient care. " Prior to and during the guarantee period, all services shall be performed at no charge to the Government. " Parts guarantee to overnight parts is required Describe remote system support where applicable, including remote diagnostics via VPN/remote access. Contractor shall utilize the VA national Site-to-Site VPN, or the Contractor shall work with the Office of Cyber and Information Security and Lebanon VA Medical Center Information Security Officers to establish a client-based VPN. Post Warranty Maintenance For maintenance service after the warranty period, the vendor shall provide a service agreement proposal addressing at minimum the following items: " Guaranteed period of availability to overnight replacement parts " Delivery time for replacement parts upon receipt of order " Normal service hours for field service " 2 hour call back time Warranty Specifications: 1. At minimum vendor is to provide at minimum a one (1) year warranty after installation has been completed. Maintenance, to include preventative maintenance, during the warranty period will be at the cost of the manufacturer to include parts, labor and travel. Warranty period shall include: o Guaranteed period of availability of replacement parts o Delivery time for replacement parts upon receipt of order o Normal service hours for field service o 2 hour response time Trade-In Consideration [Option]: 1. Five CareFusion (Model: Vela) Ventilators will be provided for trade-in credit consideration. Note: In the event of trade in, all storage media (i.e. hard drives, etc.) will remain property of VA and shall not leave VA property. Delivery: " Required Delivery Date is 2/9/2015. " Delivery shall be made to the Lebanon VAMC, Bldg. 1 - 347 Respiratory, located at 1700 S. Lincoln Ave., Lebanon, PA 17042. This Notice of Intent is not a request for competitive proposals. Parties may identify their interest; accompanied by supporting literature, to the Contracting Officer no later than 4:00PM on 01/21/2015. Responses should be sent to
[email protected]. No telephone responses will be accepted. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. The NAICS Code for this procurement is 339112, and the Small Business Size Standard for this NAICS Code is 500 employees. Contracting Office Address: Attn: Department of Veterans Affairs Pittsburgh Healthcare System, Contracting Officer, 1010 Delafield Road, (90C-A), Pittsburgh, Pennsylvania 15215-1802 Point of Contact(s): Point of Contact - Ronald Mazzei, Contract Specialist. Ph 412-822-3770.