redacted_lsj.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 Government's requirements under Zoll Medical Electronic Catalog (ECAT) contract number SPM2Dl-13-D-8220 which expires on September 03, 2018.

3. The US Navy has requirements for the following item:

National Stock Number (NSN) -NIA Item Description: Ventilator, EMV+, 731 Series, with Pox Cables Zoll Medical Part Number: 800-EMVP-01-0I Unit Price: $12,362.93 Req. Number: N0025981104818 Quantity: 35 each

Total Estimated Dollar Value: $432,702.55

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 Zoll 731 EMV+ Portable Ventilator identified above is the only product available on ECAT that can meet Navy's minimum requirements.

The Navy will be purchasing the Zoll Model 731 portable ventilator as a replacement for Zoll 754 portable ventilators throughout Naval Medical Center San Diego (NMCSD). Zoll stopped manufacturing the 754 and replaced it with the 731 in its' product line in 2013. Due to exceeding the life expectancy of the current Zoll Model 754 series ventilator, NMCSD is in need of a replacement and an equipment technology refresh.

The required portable ventilator must satisfy the following minimum requirements that were established by the US Navy:

a. 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 Ce1tification letter from the U.S. Army (for rotary aircraft).

b. Shall have automatic compensation for altitude changes.

c. Shall have a recharge rate of 6 hours or less.

d. Shall have operating times of greater than or equal to 2 hours using internal compressor.

e. 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.

f. Shall have a Positive End-Expiatory Pressure (PEEP) range of Oto 25 cm H20

Zoll Medical's 731 EMV+ self-contained ventilator is the only ventilator currently in the market that meets all USAF requirements and that has been field tested to the USAF's satisfaction. In 2014, ventilators such as the Hamilton Tl and the CareFusion Revel were tested alongside Zoll's 731 EMV+ at high altitudes. The end result is that the Tl and the Revel were unable to perfo1m successfully because they were unable to maintain tidal volume delivery resulting in failure to compensate at high altitudes.

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

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. The USAF conducted market research in August 2018 on portable ventilators including the Hamilton Tl, Applied Healthcare Products AHP300, CareFusion Respiratory LTV I 000, and Draeger Medical Oxylog 3000 plus. These systems did not meet the USAF's minimum clinical performance requirements as stated in Section 4 for the following reasons:

• The Tl, AHP300, LTV 1000 and Oxylog 3000 plus ventilators have not achieved

Safe-To-Fly certificates from the USAF for fixed winged aircraft and, therefore, do not meet the joint certification minimum requirement (a).

• In addition, the LTV 1000 was unable to automatically compensate for altitude changes as stated in minimum requirement (b), took twenty-four (24) hours to recharge while. essential characteristic (c) requires a recharge cycle of six (6) hours, has an operating time of one (I) hour while essential characteristic (d) has a threshold requirement of two (2) hours and has a PEEP range of 0-20 cmI-12O while minimum requirement (f) states that a minimum PEEP range of 0-25 cm H2O is required.

• In addition, the Oxylog 3000 plus has a PEEP range of 0-20 cmH2O while minimum requirement (f) states that a minimum PEEP range of0-25 cmH2O is required.

The Zoll 731 EMV+ Self Contained P011able Ventilator is the only known portable ventilator that provides the full range of functionality required by the USAF and is also air certified for use on both fixed and rotary wing DoD aircraft. A review of the contracts on ECAT revealed that Zoll Medical’s 731 EMV+ portable ventilator is the only product currently available on ECAT that can meet the USAF's minimum requirements.

7. ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract at anytime; 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 rigorous requirements since there are life and death consequences if the item cannot function in adverse conditions.

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.

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.