LSJ_-__Military_Portable_Ventilator__redacted.pdf

LIMITED SOURCE JUSTIFICATION

1. Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, Electronic

Cataloging (ECAT) 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 under Zoll Medical’s ECAT contract number

SPM2D1-13-D-8220 which expires September 3, 2018.

3. The US Air Force (USAF) has a requirement for the following item:

National Stock Number (NSN): 6515-01-586-5898

Item Description: Military Portable Ventilator

Zoll Medical Part Number (P/N): 800-EMVP-04/ Model 731 EMV+

Document Number: FM4444-7275-0001

Quantity: 89 each

Unit Price: $12,191.69

Total Estimated Dollar Value: $1,085,060.41

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 USAF has an immediate requirement for Zoll Medical portable ventilators to replace older model 754 portable ventilators that have exceeded their life expectancy. (Zoll has replaced the

754 portable ventilators with the 731 EMV+ in their product line.) These portable ventilators are an integral part of Patient Movement Item (PMI) aeromedical and ground assemblages.

The USAF has identified the following minimum requirements/ Essential Characteristics (ECs) for these portable ventilators:

a) Shall have FDA 510(k) clearance

b) Shall have a Joint (Dual) Airworthiness Certification (JAC) consisting of a Safe-to-Fly letter from the U.S. Air Force (for fixed-wing aircraft) and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification letter from the U.S. Army (for rotary aircraft).

c) Shall have an electrically operated internal compressor.

d) Shall be capable of accepting external medical oxygen input pressures of 35 - 75 psi.

e) Shall have automatic compensation for altitude changes.

f) Shall have filter filtration rate for use in chemical and biological environments.

g) Shall have recharge rate of 6 hours or less.

h) Shall have Integrated SpO2 monitoring to allow continuous monitoring of heart rate and oxygen saturation.

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

j) Shall have capability to perform pressure and volume breaths as well as

Spontaneous Impenitent Mandatory Ventilation (SIMV) and Continuous Positive

Airway Pressure (CPAP) with or without pressure support.

k) Shall have a Positive End-Expiatory Pressure (PEEP) range of 0 to 25 cmH20.

The 731 EMV+ portable ventilator identified above is the only USAF Safe-to-

Fly and US Army Airworthiness certified ventilator on ECAT that can meet all of the customer’s minimum requirements specified above.

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

Specifically, we are receiving a 36% discount off of Zoll’s commercial catalog price. This is the best discount and lowest price offered by Zoll. By comparison, Zoll offers its two best Group

Purchasing Organizations (GPOs) discounts of 22% (Novation) and 35% (UHS). This order represents the best value to the Government consistent with FAR 8.404(d). Notwithstanding the above, an attempt will be made to obtain a lower price based on the quantity to be ordered.

6. (a) The USAF performed market research in November 2017 using the minimum requirements/ECs delineated above.

The models reviewed were as follows: The Pulmonetic LTV 1000 and LTV 1200 manufactured by Care Fusion/Viasys. Only the LTV 1000 has the USAF Safe-to-Fly and the US Army

Airworthiness certifications; the LTV 1200 does not. Both ventilator models have limitations including inability to automatically compensate for changes in altitude and a limited PEEP range.

Both have a PEEP range of 0–20 cmH2O. In addition, neither have Integrated SpO2 monitoring to allow continuous monitoring of heart rate and oxygen saturation. In summary, the LTV 1000 does not meet the minimum requirements e, h, and k and the LTV 1200 does not meet the minimum requirements b, e, h, and k.

The Zoll 731 EMV+ is the only known portable ventilator that provides the full range of functionality required and has the USAF Safe-to-Fly certification and US Army Airworthiness certification for use on fixed and rotary wing DoD aircraft.

(b) Additional market research in the ECAT system was performed in November 2017 by the

DLA Engineer that shows only one ECAT supplier, Zoll Medical that provides the 731 EMV+ portable ventilator meeting the minimum requirements/ECs. Although four other ECAT vendors were identified as supplying similar portable and transport ventilators, their ventilators did not meet one or more of the minimum requirements/ECs as delineated below:

First Nation Group is an authorized distributor for the Philips’ Respironics line of ventilators manufactured by Philips Healthcare. They supply two portable ventilators -

Respironics V60 and Trilogy 202. Neither Respironics’ ventilator has the required USAF Safe-to-Fly certification and US Army Airworthiness certification, the automatic compensation for altitude changes or the integrated SpO2 capability. In addition, Respironics V60 does not have capability to perform SIMV. In summary, the Respironics V60 does not meet the minimum requirements/ECs b, e, h, and j and the Trilogy 202 does not meet the minimum requirements/ECs b, e, and h.

Draeger Medical supplies Oxylog 3000 Plus ventilator. Oxylog 3000 ventilator does not have the USAF Safe-to-Fly certification and US Army Airworthiness certification and integrated

SpO2 monitoring capability. In addition, Oxylog 3000 Plus has PEEP ranges from 0 to 20 cmH2O. In summary, the Oxylog 3000 Plus does not meet the minimum requirements/ECs b, h, and k.

Hamilton, Inc., manufacturers and supplies Hamilton-T1 portable ventilator. This ventilator has the US Army Airworthiness certification but does not have the USAF Safe-to-Fly certification; therefore, the Hamilton-T1 portable ventilator does not meet the minimum requirement/EC b.

CareFusion manufacturers and supplies Pulmonetic LTV 1000 and 1200. As stated in paragraph (a) above, neither unit meets the identified minimum requirements/ECs.

7. ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract at any time. Any ECAT vendor not currently offering the required item will have the opportunity to add it 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 a battlefield environment.

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.

GIUNTA.ANTHON

Digitally signed by

GIUNTA.ANTHONY.F.1229197211

Y.F.1_2_2_9_19_7_2_1_1 D_ate_: 2_01_7_.12_.1_9 0_6:_31_:00 -05'00'

Date ANTHONY GIUNTA

Contracting Officer

-05'00'

ED.P.1288811470

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.

TO.TUYEN.P.12919 Digitally signed by TO.TUYEN.P.1291931509

31509 Date: 2017.12.18 11:01:53 -05'00'

Date TUYEN P. TO

Biomedical Engineer

I have reviewed this justification and recommend approval.

ZALEWSKI.ROBE

ZALEWSKI.ROBERT.F.122870601

_R_T._F_.1_22_8_7_0_60_1_5_D_ate_: 2_017_.12_.19_06_:43_:47

Date ROBERT F. ZALEWSKI

Chief, Critical Care IST

I have reviewed this justification and recommend approval.

WECHTER.ANDRE Digitally signed by

WECHTER.ANDREW.R.1229145840

_W_.R_._12_2_9_1_45_8_4_0 Da_te:_20_17._12._20_07:_12:_27_-05_'00_'

Date ANDREW R. WECHTER Chief, Capital Equipment

I have reviewed this justification for legal sufficiency.

WEISSBERGER.JAR Digitally signed by

WEISSBERGER.JARED.P.1288811470

_____________ D_ate_: 2_01_7.1_2.2_0 1_6:_02_:53_-0_5'00'

Date DLA Counsel - Troop Support

I have reviewed and hereby approve this justification.

PANICHELLE.ROBERT.J.

1229157139

PANICHELLE.ROBERT.J.1229157139

D_at_e:_2_01_8_.0_1.03 10:06:26 -05'00' Date ROBERT J. PANICHELLE

DLA Troop Support Competition Advocate