JEFO - 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 the acquisition of eighty (80) Portable

Volume Ventilators under Hamilton Medical’s Patient Monitor and Capital Equipment (PMCE) contract SPE2Dl-19-D-7009, which expires on July 21, 2029.

(3) Several countries in the United States Southern Command (SOUTHCOM) Area of

Responsibility (Argentina, Bolivia, Colombia, Haiti, Paraguay, Trinidad & Tobago, and Uruguay) have the following requirements:

National Stock Number (NSN): 6515-01-648-5814 Item Description: Portable Volume Ventilator Part Number: Hamilton Medical P/N 11001M Unit Price: $16,487.49 Quantity: 80 units Each Total Dollar Value: $1,318,999.20

(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 Hamilton T-1 Transportable Ventilator it is the only product that can meet the minimum requirements stated below.

The SOUTHCOM Humanitarian Assistance Program (HAP) plans to purchase eighty

(80) transportable ventilators at the request of the various Ministers of Health (MOH) of the aforementioned countries. The ventilators will be used in Mobile Field Hospitals SOUTHCOM has donated to the countries indicated above. The field hospitals were donated with beds, HVACs, and generators but without medical equipment. The ventilators must meet the SOUTHCOM requirements indicated below to accommodate the environment where they are being used. For example, the power grids in many of the countries where the ventilators will be shipped can be unreliable and generators can fail making the battery life of the ventilators extremely important. Air worthiness and weight requirements are necessary in the event patients need to be airlifted from the field hospital to a brick-and-mortar hospital. The recipient SOUTHCOM countries have been severely impacted by the pandemic and lack sufficient lifesaving equipment.

They have requested that the United States assist with the procurement of these transportable ventilators and the HAP Team at SOUTHCOM will use their Overseas Humanitarian, Disaster Assistance, and Civic Aid Appropriation (OHDACA) to make this purchase and subsequently donate the equipment on behalf of the United States Government.

The required transportable ventilators must satisfy the following minimum requirements established by SOUTHCOM:

a. The ventilator shall successfully meet Army Medical Evacuation /Rotary Winged Air Worthiness Release testing.

b. The ventilator shall have the ability to operate in a chemically and biologically contaminated environment.

c. The ventilator shall not require computer support and/or proprietary or unique Test, Measurement, & Diagnostic Equipment (TMDE) to calibrate or perform preventive maintenance of the system.

d. Biomedical Equipment Maintainer (BEM) training shall be provided, but BEMs shall not be required to attend the manufacturer’s training in order to obtain replacement parts for the ventilator for Army field-repair operations.

e. The ventilator shall not require medical quality oxygen above ninety-three

(93) percent for maintenance calibration.

f. The device itself shall weigh no more than fourteen (14) pounds, with the total weight including the hardened case no more than forty-five (45) pounds.

g. The batteries shall operate for a minimum of nine (9) hours and shall be hot-swappable (hot-swappable describes a component device that can be removed or installed without stopping, shutting down or rebooting the system).

h. The warranty shall be for at least two (2) years.

i. The ventilator must operate independent of compressed air.

(5) The required Hamilton T-1 Transportable Ventilator is available on PMCE contract

SPE2Dl-19-D-7009. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing and other than certified cost or pricing data. The Contracting Officer determined that the subject procurement represents the best value to the Government.

(6) Market research was conducted February 2021 through April 2021 via internet search engines assessing whether other vendors could offer portable oxygen generation systems that meet all of the minimum requirements above. The Hamilton T-1 Transportable Ventilator was found to be the only one meeting all of the MOH’s minimum requirements.

Three (3) ventilator vendors were identified as potential suppliers from the market research. Allied Healthcare’s AHP300, L762; Becton-Dickinson (BD) Model 19260-001 and Zoll 731 series EMV +, were the three (3) vendors considered for this procurement action since they offered similar items, with the following results:

• Allied Healthcare’s AHP300 weighs 18.8 lbs. Therefore, the Allied Healthcare’s AHP300 does not meet minimum requirement (f) specified in paragraph 4.

• Allied Healthcare’s L762 battery life is only 7.5 hours. Therefore, the Allied Healthcare’s L762 does not meet minimum requirement (g) specified in paragraph 4.

• The BD Model 19260-001 has a four (4) hour battery life. Therefore, the BD Model 19260-001 does not meet minimum requirement (g) as specified in paragraph 4.

• Zoll 731 series EMV + requires proprietary or unique Test, Measurement, & Diagnostic Equipment to perform calibration/preventive maintenance. The medical facility will need specific computer/software to perform necessary preventive maintenance. Therefore, the Zoll’s model does not meet minimum requirement (c) as specified in paragraph 4. Zoll 731 series EMV +(Contract Number: SPE2D1-19- D-7003) Part Number 800-EMPVP-04 is available on ECAT but does not meet all the requirements.

(7) There are no other facts supporting the use of this JEFO.

(8) Currently, only the Hamilton T-1 Transportable Ventilator is compliant with all of the

MOH’s minimum requirements. DLA Troop Support will continue to perform market research and monitor other ventilator vendors capable of meeting the Government’s minimum requirements in an effort to overcome barriers to competition.

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

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.