JEFO - Suction-Redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

SUCTION ASPIRATOR

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

(2) The action submitted for approval is a JEFO for an acquisition from Zoll Medical (Zoll) under

Corporate Exigency Contract (CEC) SPE2D1-19-D-0034, valid through September 24, 2024.

(3) This acquisition is for the purchase of 154 Zoll 330M Suction Aspirators (Part Number (P/N)

8651-001201-01, National Stock Number (NSN) 6515-01-672-4118) for United States Air Force (USAF) at Scott Air Force Base (Scott AFB). The total estimated dollar value of this action is $1,162,700.00.

(4) The authority waiving the competition requirement is FAR 16.505(b)(2)(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 requires the Zoll 330M Suction Aspirators to replace their current Zoll 326M Suction Aspirators. The current Zoll 326M Suction Aspirators have reached end of service life and are no longer supported by the manufacturer. The newer Zoll 330M Suction Aspirator will support the USAF medical Patient Movement Item (PMI) Centers, Aeromedical Evacuation (AE) Inflight Kits, Critical Care Air Transport Teams (CCATT), Tactical Critical Care Evacuation Team (TCCET), Small Aircraft Kits (C21), and Ground Medical Assemblages, as did its predecessor.

The required Suction Aspirators will cross the entire continuum of care in the USAF’s deployable medical systems.

The Suction Aspirator must meet the following minimum requirements which were developed, reviewed, edited, and approved by Headquarters, AMC/SGXM appointed Subject Matter Experts (SMEs) and adjudicated with USAF Surgeon General SMEs:

a. Device shall have a Joint (Dual) Airworthiness Certification (JAC) consisting of a Safe to

Fly (STF) letter from the USAF (for fixed and rotary wing), a Fleet Airworthiness Release (AWR) and an Aeromedical Certification letter from the U.S. Army

b. Device must be Food and Drug Administration (FDA) approved

c. Device shall provide two adjustable ranges of vacuum with a low adjustable vacuum range of ten (10) to a maximum of 200 mmHg for intermittent suction procedures and a high adjustable vacuum range of twenty (20) to at least 550 mmHg for continuous high vacuum procedures

d. Device must have greater than thirty (30) liters per minute of air flow rate at maximum vacuum

e. Device shall operate from 110-240 VAC, 50/60 Hz, and have an internal rechargeable battery

f. Device must run continuously on battery power on a single charge on maximum suction for a minimum of two (2) hours

g. Device must fully charge (> = 90 %) a depleted battery in less than or equal to six (6) hours

h. Device weight must be less than or equal to ten (10) pounds (lbs.)

i. Device must have a minimum two (2) year manufacturer warranty

The Zoll 330M Suction Aspirator is the only Suction Aspirator currently on the market and available in the CEC program that meets all of the minimum requirements specified above.

(5) The Zoll 330M Suction Aspirator is available on CEC SPE2D1-19-D-0034. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing, invoices, and other than certified cost or pricing data. The Contracting Officer has determined that the subject procurement represents the best value to the Government.

(6) A strategic market research effort was conducted by the Air Force Medical Evaluation Support

Activity from June 2019 to February 2020 to develop an understanding of markets, technologies, business developments and products of interest that may meet USAF’s set of validated minimum requirements. The following is a summary of the results:

Market research consisted of an equipment search in Emergency Care Research Institute (ECRI) comparison report. The search was worldwide and resulted in 55 potential Suction Aspirators for assessment. Assessment was done through a thorough review of manufacturer technical literature. The models identified in the ECRI comparison report were assessed against the minimum requirements. Although the basis for non-acceptance for some models was due to various minimum requirements not being met, a synopsis of the primary factors that resulted in the non-acceptance of models included the following:

• 17 out of 55 devices assessed were rejected because they do not have FDA approval.

These devices do not meet minimum requirement (b).

• 22 out of 55 devices assessed were rejected because they do not have two adjustable ranges of vacuum with a low adjustable vacuum range of 10 to a maximum of 200 mmHg for intermittent suction procedures and a high adjustable vacuum range of 20 to at least 550 mmHg for continuous high vacuum procedures. These devices do not meet minimum requirement (c).

• 4 out of 55 devices assessed were rejected because they do not have greater than 30 liters per minute of air flow rate at maximum vacuum. These devices do not meet minimum requirement (d).

• 7 out of 55 devices were rejected because they do not operate from an internal rechargeable battery. These devices do not meet minimum requirement (e).

• 3 out of 55 devices were rejected because they do not run continuously on battery power on a single charge on maximum suction for a minimum of 2 hours. These devices do not meet minimum requirement (f).

• 1 out of 55 devices was rejected because it does not fully charge (> = 90 %) a depleted battery in less than or equal to 6 hours. This device does not meet minimum requirement (g).

54 out of 55 devices assessed do not meet minimum requirement (a) since they do not have a Joint (Dual) Airworthiness Certification (JAC) consisting of a Safe to Fly (STF) letter from the USAF (for fixed and rotary wing), and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification letter from the U.S. Army.

The DLA Troop Support Biomedical Engineer performed additional market research. A Request for Information (RFI) and subsequent solicitation for an Aeromedically certified suction apparatus was issued in April of 2019. There was only one respondent besides Zoll Medical which was Laerdal Medical. Laerdal Medical did not meet all of the EC’s specified in the solicitation including the JAC minimum requirement (a) listed above in section 4.

The Zoll 330M Suction Aspirator is the only device that meets all of the minimum requirement specified herein.

(7) There are no other facts supporting the use of this JEFO. DLA Troop Support will continue to perform market research of Suction Aspirators to locate other acceptable sources for future acquisitions. However, any new device would be required to meet the USAF’s minimum requirements.

(8) 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.