lsj_redacted_(002).pdf

LIMITED SOURCE JUSTIFICATION

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

2. This justification is for the acquisition of brand name product(s) or features essential to the Government's requirements available under Fedmedical’s ECAT Contract SPE2Dl-16-D-0003 which expires on January 4, 2021.

3. The Air Mobility Command (AMC), Scott Air Force Base (AFB), IL, has requirements for the following item:

National Stock Number (NSN): 6515-01-535-2728 Item Description: Onyx II Finge1iip Pulse Oximeter with Justice Mark II Protective Case, Nonin Medical Part Number: 9550-MIL (This military version differs from the commercial equivalent (9550) in that it includes a reusable case.)

Document Numbers: FM4444-8190-0048 Quantity: 2,120 each Unit price: $310.00 Total Estimated Dollar Value: $657,200.00

4. The authority waiving the competition requirements is FAR 8.405-6(a)(l)(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 Onyx II Fingertip Pulse Oximeter identified above is the only product that can meet the customer's minimum requirements, as follow:

• The Fingertip Pulse Oximeter shall be Food and Drug Administration (FDA) cleared.

• The Fingertip Pulse Oximeter shall be US Air Force Safe-to-Fly (USAF STF) certified for use on both fixed and rotary wing Department of Defense (DoD) aircraft.

• The Fingertip Pulse Oximeter shall be Patient Movement Item (PM!) approved.

• The Fingertip Pulse Oximeter shall have a pulse rate display range of no less than 18-321 beats per minute (BPM).

• The Fingertip Pulse Oximeter shall have an Oxygen Saturation (SpO2) display range of 0-

100%.

• The Fingertip Pulse Oximeter shall include a ruggedized, carrying case that is de-contaminable and designed to prevent damage to the device during operation and transport.

The Onyx II fingertip pulse oximeter manufactured by Nonin has USAF Safe-to-Fly (STF) certification on all DoD fixed and rotary wing aircraft and is the standardized fingertip pulse oximeter used for Patient Movement Items (PMI). This PMI fingertip pulse oximeter is used throughout the entire continuum of care in the USAF's Special Operations Forces, Aeromedical evacuation, and ground medical deployable medical equipment assemblages. The Onyx II Fingertip Pulse Oximeter (Model 9550-MIL) is the only known fingertip pulse oximeter that can provide the full range of functionality required.

5. DLA Troop Support has determined the prices of supplies under the DLA Troop support ECAT contract fair and reasonable based on a favorable comparison to commercial pricing.

DLA Troop Suppo1t will try to obtain further decreases based on quantity discounts.

6. Market research was performed by DLA Troop Support in July 2018 by researching the characteristics of this particular manufacturer's model number in the ECAT system. The result shows that the Onyx II Pulse Oximeter manufactured by Nonin is the only fingertip pulse oximeter that can meet all of the minimum requirements of the USAF as specified in section four

(4) of this LSJ.

There are similar fingertip pulse oximeters available from two (2) manufacturers on ECAT. The two (2) manufacturers are Masimo Inc. and American Diagnostic Corporation.

Masimo's similar products are the MightySAT Rx finge1tip pulse oximeters model numbers 9709, 9809, and 9909. The Masimo MightySAT Rx models can only provide a pulse rate display range of25°240 BPM while the required pulse rate display range is no less than 18-321 BPM. In addition, the Masimo MightySAT Rx fingertip pulse oximeters are not PM! approved;

therefore, the Masimo MightySAT Rx fingertip pulse oximeters do not meet the USAF minimum requirements.

American Diagnostic's similar products are the Diagnostix 2100, Adimals 2150, and Advantage 2200 fingertip pulse oximeters supplied by Dental Health Products. These American Diagnostic models only provide a pulse rate display range of 30-235 BPM while the required pulse rate display range ofno less than 18-321 BPM. In addition, only Diagnostix 2100 has the required SpO2 display range of 0-100%. The Adimals 2150 has a SpO2 display range of 70-100% and the Advantage 2200 has a SpO2 display range of 70-99%. In addition, the American Diagnostic fingertip pulse oximeters are not USAF STF certified for use on both fixed and rotary wing DOD aircraft; therefore, these American Diagnostic models do not meet the specified minimum

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

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 which 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.