CMS Class LSJ-Redacted.pdf

CLASS LIMITED SOURCE

JUSTIFICATION

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity for the proposed Class Limited Source Justification.

2. This justification is for the acquisition of accessories used on Combat Medical’s SAVe II ventilators (Manufacturer Automedx) under Combat Medical's Electronic Catalog (ECAT) contract number SPE2DE- 20-D-0003, expiring on October 23, 2024.

3. The US Government has ongoing requirements for the following accessory items:

Item Description: SAVe II Patient Circuits w/HEPA Filter, Disposable, R Combat Medical P/N: 25-257-10

Item Description: SAVe II HEPA Filter Combat Medical P/N: 25-157

Item Description: Tubing, supplemental oxygen, D 6146 Combat Medical P/N: 25-160

Item Description: SAVe II Power Cord/Charger Combat Medical P/N: 25-245

Item Description: SAVe II Oxygen Reservoir, Reusable Combat Medical P/N: 25-260

Item Description: SAVe II Noise Attenuator Combat Medical P/N: 25-265

Item Description: SAVe Universal Headstrap for Patient Mask Combat Medical P/N: 25-120

Maximum Dollar Value: $30,000,000.00 (not to exceed)

4. The authority waiving the competition requirements is FAR 8.405-6 (a)(1)(i)(A): an urgent and compelling need exists, and following procedures would result in unacceptable delays.

On March 13th, 2020, President Trump declared a national emergency in response to the emerging threat of the Coronavirus (Covid-19) pandemic in the United States. This procurement is part of the Department of Defense’s mission to support the US Government’s response to the pandemic. The proposed acquisition is urgently required to meet the overwhelming demand for accessories used on the Combat Medical SAVe II ventilator, used by military medical treatment facilities that are treating patients suffering from the COVID -19 viral infection and other diseases. This acquisition will also backfill accessories used in support of the Combat Medical SAVe II ventilators that have been and may be provided from military medical treatment facilities to civilian medical treatment facilities where the supply of this equipment is inadequate to handle the treatment of Covid-19 cases, particularly in areas where the virus is rapidly spreading and has overburdened the existing capability of those medical facilities. Without these ventilator accessories the most critically ill patients will likely die.

Deliveries are forecasted to take place over a 150 day (five (5) month) period, starting ten days after receipt of orders. The not to exceed maximum dollar value of $30,000,000.00 is based on service estimates along with an execution plan that was developed by DLA Troop Support Senior leaders and the Defense Health Agency Medical Logistics Command.

BROWN.MARK.MA Digitally signed by

RVIN.1248988866 6

Date: 2020.03.31 10:45:46 -04'00'

-04'00'

ZALEWSKI.ROB Digitally signed by

ERT.F.12287060

5. The Combat Medical SAVe II ventilator accessories are available on Combat Medical’s ECAT contract number SPE2DE-20-D-0003. The pricing on this contract has previously been determined fair and reasonable via comparison with commercial pricing, commercial invoices, and other than certified cost or pricing data.

In view of this earlier determination, the Contracting Officer has determined that the anticipated cost will be fair and reasonable to the Government and represents the best value consistence with 8.404(d).

6. Due to the urgent and compelling nature of this acquisition, market research was not conducted

7. There are no other facts supporting the use of this authority.

8. For future routine requirements, as they arise, DLA Troop Support will attempt to locate other acceptable sources of the Automedx SAVe II ventilator accessories through ECAT or other established Medical contract arrangements.

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.

Digitally signed by

GIUNTA.ANTHONY.1229197211

NY.1229197211 Date: 2020.03.31 10:23:18

Date ANTHONY GIUNTA Contracting Officer, FSD

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.

Date MARK M. BROWN

Biomedical Engineer, FSDC

I have reviewed this justification and recommend approval.

Date ROBERT F. ZALEWSKI Chief, Critical Care IST

Digitally signed by

WECHTER.ANDREW.R.122914584

W.R.1229145840 0 Date: 2020.03.31 11:57:38 -04'00'

Date ANDREW R. WECHTER Div. Ch., Capital Equipment, FSD

GIUNTA.ANTHO

WECHTER.ANDRE

I have reviewed this justification for legal sufficiency.

FURMAN.GALE.B.1229118

Date GALE FURMAN

Digitally signed by

FURMAN.GALE.B.1229118672

Date: 2020.04.03 11:47:42 -04'00'

Supply Chain Counsel DLA Counsel-Troop Support

PANICHELLE.ROBERT.J.122 Digitally signed by

9157139

PANICHELLE.ROBERT.J.1229157139

Date: 2020.04.01 10:17:40 -04'00'

Date ROBERT J. PANICHELLE DLA Troop Support Competition Advocate

I have reviewed and hereby approve this justification.

Date WILLIAM J. KENNY

Executive Director DLA Troop Support Contracting and Acquisition Management