JEFO Portable Ventilator-Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

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

(2) The action submitted for approval is a JEFO for an acquisition from Zoll Medical (Zoll) under Corporate Exigency Contract (CEC) SPE2D1-17-D-0043, valid through September 29, 2022.

(3) This acquisition is for the purchase of 184 Self Contained Portable Ventilators, Model 731 EMV+ (Part Number 800-EMVP-04, NSN 6515-01-586-5898) for Scott Air Force Base. The total estimated dollar value of this action is $2,243,270.96.

(4) The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(B), only one awardee 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 Zoll 731 EMV+ Portable Ventilator identified above is the only product available in the Medical Readiness CEC Program as a Patient Movement Item (PMI) that can meet all of the minimum requirements of the United Stated Air Force (USAF).

The USAF will be purchasing the Zoll model 731 EMV+ Portable Ventilator as a replacement for the Zoll 754M Portable Ventilators currently in USAF PMI centers, aeromedical evacuation and ground medical assemblages. The 731 EMV+ is a small, lightweight self-contained, portable ventilator intended for use throughout the Air Force in its Special Operations Forces, aeromedical evacuation, and ground medical deployable medical equipment assemblages.

The current Zoll 754M ventilators have exceeded their life expectancy (average age is eight (8) years with some in use for over twelve (12) years). The advanced age of the current inventory of the Zoll 754M is evidenced by an increased number of failures, maintenance issues and the obsolescence of its technology that limits the standard of care the Department of Defense (DOD) can provide in regard to movement of patients that are on portable ventilation.

The minimum requirements required by the USAF and supported by this model ventilator (the other ventilators on CEC do not meet all the minimum requirements they only meet some of the requirements) are as follows:

• Shall have a Joint (Dual) Airworthiness Certification (JAC) consisting of a

Safe-to-Fly (STF) letter from the USAF (for fixed-wing aircraft) and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification letter from the U.S. Army (for rotary aircraft).

• Shall have 510(k) approval by the Food and Drug Administration (FDA).

• Shall have an electrically operated internal compressor.

• Shall have automatic compensation for altitude changes.

• Shall have a recharge rate of six (6) hours or less.

• Shall have integral SpO2 monitoring to allow for continuous monitoring of heart rate and oxygen saturation.

• Shall have operating times of greater than or equal to two (2) hours using an internal compressor.

• Shall have the capability to perform pressure and volume breaths as well as Spontaneous Intermittent Mandatory Ventilation (SIMV) and Continuous Positive Airway Pressure (CPAP) with or without pressure support.

• Shall have a Positive End-Expiatory Pressure (PEEP) range of 0 to 25 cmH2O.

The capability to move critically injured, ventilated trauma patients in a deployed environment is a key contributor to the improved survivability and decreased mortality/morbidity of trauma patients over the past ten (10) years. The USAF has an immediate need to transition its inventory to newer technology with enhanced clinical capabilities in support of its aeromedical evacuation mission. The Zoll 731 EMV+ portable ventilator is the only known model that has USAF Safe-to-Fly (STF) certification on all USAF fixed and rotary wing aircraft as well as U.S. Army AWR and Aeromedical certification for rotary wing aircraft available on CEC.

(5) The Zoll ventilators that are required are available on Zoll’s CEC SPE2D1-17-D-0043. 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 to the Government will be fair and reasonable, and that the subject procurement represents the best value to the government.

(6) Extensive market research has been performed by the USAF based on prescribed equipment minimum requirements, including performance specifications, oxygen use parameters, power requirements, capability to integrate/attach with transport devices, displays and alarms, and safe-to-fly certification on fixed and rotary wing aircraft. The Zoll 731 EMV+ Self Contained Portable Ventilator is the only known portable ventilator that provides the full range of functionality required that is also air certified for use on both fixed and rotary wing DOD aircraft.

Hamilton Medical manufactures a similar ventilator, the Hamilton T1 Military Ventilator, NSN 6515-01-648-3814 (CEC number SPE2D1-17-D-0042), which is available on a CEC contract. However, this ventilator is only certified to be used on rotary wing and does not have the fixed wing specifications and certifications, and therefore does not meet the USAF minimum requirements as specified in section four (4) of this JEFO.

(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 opportunity to achieve dual aeromedical certification and obtain a CEC. Additional vendors obtaining CECs and certification will enhance competition for future acquisitions.

(8) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge.

I hereby certify that the requirements that form the basis of this justification are accurate, that these supplies meet the Government's minimum needs and that this justification is accurate and complete to the best of my knowledge and belief.