EDOCS_LSJ_redacted.pdf

LIMITED SOURCE JUSTIFICATION

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital

Equipment Division, is the contracting activity.

2. This justification is for the acquisition of brand name products or features essential to the

United States Air Force (USAF) under Pacific Consolidated Industries’ (PCI) electronic catalog (ECAT) contract number SPE2D1-18-D-0013 which expires on June 11, 2023.

3. The USAF has requirements for the following items:

Product Description: Expeditionary Deployable Oxygen Concentration System (EDOCS)

PCI Model/Part Number: EDOCS-120B-22 / 793980-001

Quantity: Eleven (11) Systems Continental United States (CONUS) Unit Cost: $233,584.65 Price: $2,569,431.15

Outside the Continental United States (OCONUS) Unit Cost: $239,363.35 Quantity: Six (6) Systems Price: $1,436,180.10

Total Estimated Dollar Value: $4,005,611.25

4. The authority waiving the competition requirements is FAR 8.405-6(a)(1)(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 oxygen generation systems identified above are the only products available on ECAT that can meet USAF’s minimum requirements.

The USAF will utilize the procurement of the eleven (11) oxygen generation systems for their War Reserve Materiel Medical Deployable Oxygen Package assemblies. Additionally, six (6) oxygen generation systems are required at Bagram Air Field, Afghanistan, at the Craig Joint Theatre Hospital (CJTH) since they currently only have two (2) functioning EDOCS. The oxygen generation system is a mission critical item that keeps patients alive while in surgery or in the intensive care unit. Due to the harsh conditions in-theatre and continuous operation, the current units are deteriorating faster than expected.

The required oxygen generation systems must satisfy the following minimum requirements established by the USAF.

a. The oxygen generation system shall be approved by the Food and Drug Administration (FDA) as a medical device in accordance with Federal law.

b. The oxygen generation system shall provide medical grade oxygen meeting the requirements of the United State Pharmacopeia (USP) of 93%.

c. The oxygen generation system shall produce gaseous oxygen at a flow rate of at least 120 liters per minute (lpm)

d. The oxygen generation system shall be able to operate during and after being exposed to harsh environmental conditions such as blowing sand, snow, sleet, dust, rain and high-salinity environments

PCI’s EDOCS-120B-22 oxygen generation system is the only system currently on the market and available on ECAT that meets all of the USAF’s requirements.

5. DLA Troop Support has already determined the price of these systems under the ECAT multiple award program fair and reasonable based on an audit of all direct and indirect costs. Defense Contract Audit Agency (DCAA) and DLA Troop Support Pricing Office determined all costs to be acceptable. A determination has been made by the contracting officer that this order represents the best value to the Government and results in the lowest overall cost alternative (considering price, special features, and administrative cost) consistent with FAR 8.404(d).

6. Market research was conducted in July 2018 by the DLA Biomedical Engineer via internet search engines assessing whether other vendors on ECAT could offer oxygen generation systems that meet all of the minimum requirements of the Air Force. The EDOCS-120B-22 Oxygen Generation System offered by PCI was proven to be the only one meeting all of the USAF’s minimum requirements.

Two (2) other Oxygen Generation vendors were identified as potential suppliers. Essex Industries and Onsite Gas were the two (2) vendors considered for this procurement action since they offered similar items and are available on ECAT.

• Essex Industries’ Next Generation Portable Therapeutic Liquid Oxygen System

(NPTLOX) is only capable of producing a flow rate of 66 lpm which does not meet minimum requirement (c) of producing a flow rate of 120 lpm of medical grade oxygen.

• Onsite Gas manufactures two (2) comparable units: the POGS 33C and the POGS

33C FHP Oxygen Generation systems.

• Onsite Gas’ Portable Oxygen Generation System (POGS 33C) is only capable of producing a flow rate of 33 lpm which also fails to meet minimum requirement (c).

• The POGS 33C FHP is the resulting oxygen generation system when daisy-chaining four (4) POGS 33C systems together to achieve the 120 lpm flow rate.

• Additionally, only the compressor portion of the POGS 33C is able to be operated outside in the elements while the remainder of the equipment must be located inside of a shelter or tent in order to operate which fails to meet minimum requirement (d).

EDOCS-120B-22 is the only device available on ECAT that is compliant with all of the USAF's minimum requirements.

7. ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract at any time; therefore, any ECAT vendor not currently offering the required product has the opportunity to add the product, thereby enhancing competition.

8. DLA Troop Support will attempt to locate other acceptable sources for future routine requirements as they arise; however, any new item would be required to meet the USAF’s requirements.

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

Digitally signed by

GIUNTA.ANTHON GIUNTA.ANTHONY.F.12291972 11

Date YA.FN.1T2H2O91N9Y72G1I1UNDTateA: 2018.08.14 06:58:01

Contracting Officer

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.