N0018321Q0063 Redacted.pdf

USE OF OTHER THAN FULL AND OPEN COMPETITION FOR AN

ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD

l__c_l in_ic_�l _I n�e§ti_g_ation D_eea i:tm1=nt

4/14/2021

Guidelines/ Instructions are in Blue-make sure you DELETE all guidelines/instructions afier completion of form and before sending it lo the Contracting Division

I. BACKGROUND:

The service or material listed on I _HTP?"1:?��VlG� ___ _ _ ____________ J for competition is precluded for the reasons indicated below on this justification for other than full and open competition, in accordance with:

FAR 13.106-1 (b)(l)(i): states for purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available FAR 13.106-3(b)(3)(i): this memorandum explains the absence of competition for this acquisition, as only one source will be solicited for this requirement ( or for a portion of the requirement) and the requirement is not expected to exceed the simplified acquisition threshold)

II. DESCRIPTION OF ITEM OR SERVICE:

Manufacturer Details:

Provide original manufacturer's name (if a sole source manufacturer distributes via dealers, include dealer information as well

Name· ____________ _ ______________________ J

POC: I_ ________________ _

Phone Number: L _ ______ _____ • E-mail: L --�

Manufacturer's Dealer/Rep Details (if applicable):

Name: ;.,:...._....:...._.....:.......:........:.....:..........:.......:....:::..::--=.......::......:;__:_......:;;;.:.;.:...........:�=-===..;;;;.:::..::;;;;;;.;===:;;;;;;:;

-- -- __ J POC: -- ----- -- - - -- - --- ----

Phone Number: E-mail:

PROVIDE A DESCRIPTION OF THE ITEM OR SERVICE REQUIRED: (include its intended use and the required delive date/J eriod o erformance.)

RDD/POP: I_ __ Estimated Cost: _ Description:

--- _________ J

The /RB-approved protocol NMCP.2018.0093 -"Is ultrasound localization equivalent to X-ray localization for confirmation of placement of ER-REBOA catheter in a cadaver model?" and NMCP.2021.0009-will require 10 cadavers to conduct all study procedures. There is no sex preference or weight range. Cadavers should have no major femoral or aortic surgery and be over 18 y/o.

Page 1 of4

D UNIQUE FEATURES. Similar products lack features that are necessary to meet the Government's minimum needs (i.e. Bechnan WA-96 Plus analvzer vs. Becton Phoenix M50 analvzer). Provide the following information:

� OTHER REASONS. Other reason not identified above.

The purpose of the study protocol is to test ultrasound locolization of REBOA in a cadaver model. In order to conduct the study, we must acquire 10 natural, not embalmed fresh cadavers without amputations above the mid thigh or prior femoral or aortic surgery. In addition, the donors need to be delivered as soon as they are acquired to avoid as little third space edema as possible edema obscures the ultrasound images. Acquisition of these cadavers is critical to the completion of the study.

SECTIONB:

D BRAND NAME. Item required must be a brand name product, or feature of a product, particular to one manufacturer.

SECTION C:

□ UNUSUAL AND COMPELLING URGENCY.

The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent Requirements are supplies or services that will result in a work stoppage, or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

I. Date on which the requirement was first identified: I __ -- - - - -- --- - ---- ---

2. Required delivery date/period of performance: I_----- .. ---· ___ __ i

3. Explanation of why delivery/commencement of services by the date mentioned above is required:

Page 3 of4

4. If aoorooriate, include anv additional oertinent information.

IV.CERTIFICATIONS/APPROVALS:

Section 1: Department Representative I Technical Reviewer complete the following:

Requirements Certification: I certify that the facts and representation under my cognizance which are included in this justification are complete and accurate to the best of my knowledge and belief.

Signature: L PrintName I __ _

Phone Number: I _ ______ _ E-maiJJ _ _ Date:

Section 2: Contracting Officer (KO) complete the following:

Requirements Certification: I certify that the justification is accurate and complete to the best of the contracting officer's knowledge and belief.

. �=y--=

KO Signature: �- _ _ _ ________ Danny_W�-<!Y�--- Comraemtg Officer

KOPrintName ---- _ _________ _ ___ _ Phone Number: I_ J_:-_;&J:,?_ _______ . E-mail:,...I_-__ -__ ---------------==-=--�- Date:

The antici