SOLICITATION NOTICE
65 -- En-Route Critical Care
- Notice Date
- 2/18/2009
- Notice Type
- Presolicitation
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, 77AESG -Aeronautical Systems Group, 7980 Lindbergh Landing, Brooks City-Base, Texas, 78235-5119, United States
- ZIP Code
- 78235-5119
- Solicitation Number
- RFIA2009
- Response Due
- 3/20/2009 1:00:00 PM
- Archive Date
- 4/4/2009
- Point of Contact
- Terry Wilkinson, Phone: 2105364109
- E-Mail Address
-
terry.wilkinson@brooks.af.mil
- Small Business Set-Aside
- N/A
- Description
- En-route Critical Care System (ECC) for use in Aeromedical Evacuation of Patients by the U.S. Air Force Request for Information THIS ANNOUNCEMENT IS NOT A NOTICE OF SOLICITATION ISSUANCE. THIS IS A REQUEST FOR INFORMATION (RFI) FOR PLANNING PURPOSES ONLY. Any formal solicitations will be announced separately. It is not to be construed as a commitment by the Government nor will the Government pay for information provided in response to this RFI. PURPOSE: The 77th Aeronautical Systems Group at Brooks City-Base, TX is seeking information from sources that are capable of providing a portable En-route Critical Care unit which provides the following capabilities: (1) Ventilation, (2) Oxygen, (3) Fluid Resuscitation, (4) Physiologic Monitoring, (5) Hemodynamic Monitoring and Intervention, and (6) Flexible Power Utilization. This unit must meet the following general criteria: • Must weigh no more than 65 lbs • Must be able to operate and recharge on both alternating current (AC) and direct current (DC) power sources from any US Military electrical power source, including both 12 and 28 volt direct current (DC) from ground vehicles and C130 electrical power (110/220 volts, 400 MHz frequency. • Must have a back-up power source that provides at least 4-hour autonomous operation An air worthiness certification ("safe to fly") will be required for the ECC unit. Federal Drug Administration (FDA) approval of the ECC will also be required for the ECC unit. Environment, Safety and Occupational Health (ESOH) and Human Systems Interface design will be a factor in evaluation of the ECC. The small business size standard associated with NAICS code 315299 is 500 employees. All business sizes, to include small business and the sub-categories of small businesses, are being looked at during our market research phase. BACKGROUND/DESCRIPTION: The fixed-wing AE environment poses unique challenges for patient care, mission equipment, and AE crews. High noise levels on some aircraft interfere with voice recognition, obscure audible signals and alarms on patient equipment, and increase crew fatigue during missions, which may last up to 16 hours (an augmented mission may extend beyond 24 hours). Vibration can damage medical equipment or impair stability and accuracy. Turbulence subjects the entire patient care environment to unpredictable G-forces, and requires mechanical systems that provide adequate security. Cabin air temperatures are not always well regulated as aircraft altitude changes and can vary by more than 40ºF between deck level and a height of 60 inches above deck, creating challenges for care of patients susceptible to shock or suffering from circulatory problems. Relative humidity of cabin air is typically low, which may increase breathing difficulty for some patients.Existing medical equipment approved for use on aircraft does not fully meet the current mission demands for movement and clinical care of stabilized patients. Many items are too large, too heavy, or require excessive electrical power for patient loading and transport in ambulances and aircraft. Some medical equipment items are not certified for use on all aircraft. Loading and transport of critical care patients is cumbersome because unwieldy medical equipment does not fully exploit advances in miniaturization and wearable transducer technology. Existing equipment does not provide for in-flight telemedicine support or timely electronic transfer of patient care records to gaining medical units along the transport route. Communication must include voice/data between aircraft and ground nodes. All communications must be Net-centric compliant. SYSTEM DESCRIPTION AND REQUIREMENTS: The following two tables describe both the system performance requirements and the individual component requirements for the ECC system. 1. System Performance Requirements System Performance Requirement Required capability Volume, flow, and time-cycle capable. Capable of pressure- and volume-controlled ventilation modes. Capable of open lung concept of ventilation. Supports advanced ventilatory modes (i.e. pressure or volume control) for peds and adult patients Accept any medical oxygen input source/pressure 100 L/min at 40 cm H2O Minute ventilation 1-20 L/min Reliable/accurate delivery of positive end expiratory pressure (PEEP) 5-25, +/- 1 cm H2O Capable of providing humidified air at 100% sat Capable of high- and low-pressure medical oxygen source input Display and monitor inspired oxygen concentration (FiO2) Rapid fluid infuser capable 6 L/hr Drug calculations and library of medications. Ability to report similar to current triple channel pump. Record/time stamp changes and titration. Ability to utilize multiple factors (unit, concentration and time based) Capable of fluid/blood warming 37.5oC Vented bubble detector and removal End tidal CO2 Capable of handling 5 pressure inputs with the ability to accept intracranial pressure 3-5 lead monitoring with 12-lead capability Renew or change power sources without interrupting operations Store and export all patient data and documentation Upgrade capable for future decision making algorithm Visual (in addition to audio) alarming to Health-Care Provider (HCP) compatible with flight platforms/health-care settings and threat environment despite extremes of light, noise, or vibration for the ventilator. Must be manually adjustable. Visual (in addition to audio) alarming to Health-Care Provider (HCP) compatible with flight platforms/health-care settings and threat environment despite extremes of light, noise, or vibration for the multifunction platform. Must be manually adjustable. Central Control Processing Unit with interface points and unified control/Integrated display 2. Individual Component Requirements of ECC System (1=highest, 4=lowest) Component Priority (On a Scale of 1 to 4) Requirement Ventilation Component Programmable standard of care alarms: low pressure, high pressure, apnea, low source gas pressure, power supply low, low minute ventilation, high respiratory rate 1 Decision assist algorithms for all alarm conditions 3 Triggered by patient or pre-set ventilator frequency 1 Delivers adjustable fraction of inspired oxygen (FiO2) 1 21-100% +/- 5% Reliably measures expired tidal volume 1 20 ml to 2000 ml with 5% accuracy Default start-up parameters based upon HCP decision assist algorithms - Smart Device 3 Display ventilatory wave forms to include pressure, volume, and flow 2 Automatically maximizes oxygen or decision assist algorithms 3 Creates exportable record of ventilator performance 3 Capable of providing aerosolized medications 1 Automatically restart after unexpected power-down 1 Automatically defaults to previous patient settings after restarts 3 Consumables and connections common to all services and levels of care and matching existing standards 3 Display time remaining of operational battery life 1 Monitors and displays FiO2 1 Monitors and displays oxygen reserve based on current consumption 1 Ability to function/filter in NBC / chlorine gas environment 1 Closed-looped algorithms for ventilator control to emphasize lung protective strategies 3 Auto-regulation of PEEP 3 Context -sensitive help and guidelines for ventilatory management 3 Bookmark/capture to include waveforms and significant events 3 Filtration/scavenging of exhaled gas 4 High frequency capability 4 Ability to use nitric oxide/ heliox bleed in gases 4 Oxygen Component Integrated oxygen generation system capable of oxygen production 4 4 L/min of 93% United States Pharmacopoeia (USP) oxygen (+/-) 5% Control low flow oxygen source to maintain stable FiO2 4 +/- 10% and alarm Fluid Delivery Component Record: Patient measurements and interventions. Cumulative total fluid received (infused, and net volumes) Date/Time Stamp, Patient measurements and interventions (electronic record) 1 Using needleless standard safety 1 Free-flow protection. 1 Industry standard alarms - auditory and visual. Low battery alarms 1 Control: Decision assist algorithm based on provider input parameters 3 PCA system compatibility and capable on at least one channel with remote PCA 3 Control: Rate and volume of crystalloids, colloids, and blood products. Closed-loop algorithms control infusion rate and volume based on endpoint (blood pressure, UOP, hemoglobin, or other measure (s) TBD). 4 Epidural administration of anesthetic and analgesic drugs capability 3 Incorporate a "Syringe Holder" (up to three 20-60ml syringes simultaneous use capability) for use as the container for IV fluid to be infused for pediatrics. 4 Hemodynamic Monitoring Component Monitor and digitally display Heart Rate (derived from art line) 1 Intracranial pressure monitoring calculation and display capability 1 3-5 lead monitoring with 12-lead capability 1 Pulse oximetry monitoring 1 Arrhythmia alarm 1 Invasive hemodynamic monitoring calculation and display capability 1 Temperature monitoring-2 ports 1 Centralized monitoring capability 1 Data collection capability downloadable to DoD compliant database-with a backup capability 1 Non-Invasive cardiac output monitoring 3 Cardiac Output monitoring 3 Total Peripheral Resistance monitoring 3 Contractility monitoring 3 Stroke Volume monitoring 3 Transcutaneous PO2 / CO2 monitoring 3 BIS Monitoring 4 Measure / calculate shock indices: (e.g. Mean arterial pressure (MAP), pulse pressure, heart rate variability, sublingual CO2, transcutaneous O2, Urinary output (UOP), Radial pulse, mentation, (manual input) blood pressure (BP), pulse oxygen saturation (SpO2), temperature (manual/automatic), Values of systemic oxygenation (arterial blood gas [ABG], base deficit, lactate, noninvasive [NI] cardiac output, degree of coagulation, hemoglobin, hematocrit, continuous arterial blood pressure, systolic BP variation, stroke volume variation, transesophogeal echocardiogram [TEE]) 4 Calculated Indices: Decision assist 4 BAM ( Brain Acoustic Monitoring) 4 Power Source Universal power source able to read/report total power received, time to full charge, time to full discharge, usable power life "fuel gauge", be able to charge and use simultaneously 1 Documentation & Wireless Communication Component Industry standard data storage or data transfer technology (e.g. USB technology) 1 Wireless patient monitoring technology 4 Data transferable between ground to AE environment 1 Multi-function Platform Low heat transmission 1 90oF max heat generation from unit Integral attachment to NATO litter 1 The following components are in rank order for integration into the multi-function platform. Those with lower ranking may be integrated into the system or connected as a peripheral system. #1 Ventilator 1 #2 O2 - Regulation 2 #2 Fluid Delivery 2 #2 Monitoring 2 #3 Data storage 3 #3 Suction 3 #4 Monitor and display ambient barometric pressure 3 #5 O2 - Concentrator / Supply 4 #6 Power 4 #6 Defibrillation (AED) 4 #6 Pacing(external) 4 #7 Connect with Telemedicine 4 #8 Monitor and display acceleration 4 Suction/Hi-Lo/Wound Vacuum Component Device capable of suctioning with variable digital control and intermittent and constant suctioning capable of wound vacuum, high/low endotracheal tube, gastric and chest suctioning. 1 20mmHg-300mmHg Controlled digital value 1 Pop-off valves 1 Quiet 3 INFORMATION REQUESTED FROM INDUSTRY: In responding to this RFI, potentially interested parties are asked to submit information on the following: 1. Briefly describe your company, medical products and services, and any other information you deem relevant. 2. Describe any equipment you market that is similar in concept to what is described in this RFI. If you do not market equipment that meets the requirements described in this RFI but have equipment that, if modified or redesigned, could meet the requirements in this RFI, please briefly describe this equipment and how you would modify it. 3. Provide your recommendations, if possible, as to how the Air Force could provide the capabilities described for the ECC in an alternative arrangement of different equipment. 4. Would you be willing to furnish and demonstrate, at a later date, one prototype of your equipment for AF Medical experts/specialists to examine and test? 5. What is your business size? If you are a small business, do you also qualify under any of the sub-categories (8(a), small disadvantaged business, woman owned small business, veteran owned small business, HUB zone small business, service disabled veteran owned small business, and HBCU/MI)? 6. If you are a small business, would you consider submitting a proposal as a prime contractor? 7. In what socio-economic programs do you now participate (e.g. Mentor Protégé, Indian Incentive, etc.)? What is the extent of your participation in these programs? 8. For small business consideration, would your firm be able to compete under NAICS 315299? If not, why? Please provide your recommendations concerning the proposed NAICS. 3. ANTICIPATED ACQUISITION STRATEGY. The Government is contemplating a firm fixed price acquisition strategy with technical evaluation of bidders POINTS OF CONTACT: Please contact Mr. Bryant Stone at bryant.stone@brooks.af.mil for further information regarding this RFI.
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- SN01752595-W 20090220/090218220416-b2ba4d7dd11a1116538834ea8b57a461 (fbodaily.com)
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