JEFO - Hamilton C6_Final_Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

LANDSTUHL REGIONAL MEDICAL CENTER

(1) The Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting authority.

The action submitted for approval is a JEFO for an acquisition from Hamilton Medical, Inc. under PMCE contract SPE2D119D7009.

(2) This acquisition is for the purchase of twelve (12) HAMILTON-C6 VENTILATOR PACKAGE for Landstuhl Regional Medical Center in Landstuhl, Germany which is a part of the US Army Medical Command.

Manufacturer Part Number: 160021 Supplier Part Number: 160021 Product Description: HAMILTON-C6 VENTILATOR PACKAGE Quantity: 12 Unit Price:

The total estimated dollar value of this action is .

(3) The authority waiving the competition requirements is FAR16.505(b)(2)(i)(B) only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. The Hamilton C6 Ventilator identified above is the only product available on that can meet the US Army's minimum requirements.

US Army personnel have identified a need to procure mechanical ventilators. Mechanical ventilation is required for the patient population that cannot breathe on their own. Ventilators are used to deliver high concentrations of oxygen into the lungs. This could result from many factors that may include protecting the airways due to a neurologic cause, respiratory failure, premature birth or surgical procedures. The minimum requirements established for the ventilators by the US Army are as follows:

Pressure Management Pressure Controller

Modes for adult, pediatric, and neonatal patients.

built in lung protection Single, easy to read screen with patient monitoring data showing ventilation status.

Lung assessment and recruitment Automatic cuff pressure control Transpulmonary pressure measurement high flow oxygen therapy Pulse oximetry Serial interface for connection to PDMS or patient monitors Integration with MHS Genesis

Mainstream (volumetric) and side stream capnography On-screen help for alarm troubleshooting Mobile cart with Narrow footprint for use during patient movement between hospital locations and cart basket

US Customization Humidifier Holder O2 Cylinder Holder Neonatal Application nCPAP-PS Application High Flow O2 Therapy Application

CO2 SENSOR

Flow Sensor, infant Flow Sensors, Pediatric Flow Sensors, Adult Water Bag Pole

Positioning Support Arm 220V 50hz power compatible or dual voltage.

The HAMILTON-C6 ventilators are for intensive care ventilation of adults, pediatric, and optionally infants as well as neonatal patients. The main area of use is in a hospital setting. In addition, the HAMILTON-C6 are also designed for transfer of ventilated patients within the hospital. The products feature an integrated monitor with touch screen display and integrated alarm lamp; ventilation unit for gas mixing and control;

and patient breathing circuit for gas delivery and exchange. In addition, oxygen monitoring and connectivity to other sensors, devices, and external data interfaces are available. The ventilators consolidate the monitoring data and display it in intuitive graphics. These graphics provide a quick overview of the patients’ current ventilation status and provide a reliable basis for therapy decisions. It shows tidal volume, lung compliance, resistance, and patient efforts/triggers all in real time.

Currently the only ventilator on the market that meets these requirements is the Hamilton C6 ventilator supplied by Hamilton Medical, Inc.

(5) The Hamilton ventilators that are required are available on Hamilton’s PMCE contract SPE2D119D7009. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing, invoices, and other than certified cost or pricing data. In view of this earlier determination, the Contracting Officer has determined that the anticipated cost will be fair and reasonable to the Government, and that the subject procurement represents the best value to the government.

(6) Extensive market research has been performed by the US Army and validated by Defense Logistics Agency (DLA) personnel. Market research consisted of online product research, contacting ventilator manufacturers, accessing market research tools such as Emergency Care Research Institute (ECRI), and reviewing ECAT offerings for comparable alternatives. This research identified the following competitors as alternative solutions to the government’s requirements:

(7)There are no other facts supporting the use of this JEFO. DLA Troop Support will continue to monitor other Medical Ventilator vendors as they may have the capability to satisfy the government’s minimum requirements.