Cardiohelp_redacted_lsj.pdf

LIMITED SOURCES JUSTIFICATION (LSJ)

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 Atlantic Diving Supply’s (ADS) Electronic Catalog (ECAT) contract number SPM2Dl-18-D-0011 expiring on 4/9/2023.

3. The USAF has requirements to purchase ECMO Pumps to support their medical mission. The device will be utilized at the 59th Medical Wing to support transport of DoD beneficiaries from around the world as well as to treat inpatients at San Antonio Military Medical Center. The requirements are broken down as follows:

Item Description: Extracorporeal Membrane Oxygenation (ECMO) Pump Manufacturer (Maquet) Part Number: 70104.8012

Requisition Number: FM8911 8205 0001 Quantity: 4 each Unit Price: $94,647.57 Total Dollar Value: $378,590.28

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 Cardiohelp ECMO pump identified above is the only product available on ECAT that can meet USAF's minimum requirements.

The ECMO pump must meet the following minimum requirements which were developed by the United States Air Force.

a. Shall have extensive integral monitoring capability of multiple parameters related to pump performance.

b. Shall be composed of single module that is composed of a polymethylpentene oxygenator with biocompatible coating integrated with centrifugal pump.

c. Shall have the ability to operate using a manual hand crank in the event of prolonged electrical failure.

The Maquet Cardiohelp ECMO pump is the only ECMO pump currently on the market and available in ECAT that meets all of the minimum requirements specified above.

5. DLA Troop Support has already determined the prices of supplies under the ECAT multiple award program fair and reasonable.

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, etc.) consistent with FAR 8.404(d).

6. A strategic market research effort was undertaken to develop an understanding of markets, technologies, business developments and products of interest that may meet the USAF's set of validated Essential Characteristics (ECs) and Key Performance Parameters (KPPs). This effort was conducted in August 2018 by San Antonio Military Medical Center Adult ECMO Program.

The following is a summary of the results:

There are a relatively small number of devices approved for use in the US. All have significant shortcomings relative to the device being sought.

• The Maquet Rotaflow is an older generation device from the same manufacturer. This device has no integral monitoring capability which fails to meet minimum requirement (a). This necessitates multiple external devices to be attached in order to achieve the same degree of safety.

• Sorin Revolution is another similar device but also has limitations because it requires external monitoring which fails to meet minimum requirement (a). It is also designed to be utilized on a large cart that is not suitable for transport.

• The Thoratec Centrimag has the same limitations of requiring external monitoring and fails to meet minimum requirement (a). It is also entirely dependent on electricity due to electromagnetic levitation of the pump head. A short term electrical failure would be survivable on the internal battery but there is no option to use manual power during a prolonged electrical failure which fails to meet minimum requirement (c).

• The Tandem Life pump is new and unproven for respiratory failure patients which is San Antonio’s most common patient population. The device also lacks integral monitoring and biocompatible coating which does not meet minimum requirement (a) and (b).

The Maquet Cardiohelp ECMO pump, therefore, is the only device that is able to meet all of the minimum requirements determined by the USAF as listed in Section 4 of this LSJ. The market research performed determined that other companies’ similar products do not meet the USAF’s needs.

7. Any ECAT vendor not currently offering the required product will have the opportunity to add the product, enhancing competition. Furthermore, ECAT vendors have the opportunity to add products that fall within the scope of the ECAT contract, ECMO pumps, at any time.

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 USAF 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 LSJ is accurate and complete to the best of my knowledge and belief.

Date ANTHONY GIUNTA

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.

Date SHIVAM SITAPARA

Biomedical Engineer

I have reviewed this justification and recommend approval.

Date ROBERT F. ZALEWSKI Chief, Critical Care IST