A.02.03_Justification_and_Approval_for_Other_than_Full_and_Open_Competition_Redacted.pdf

Control No.: 16-RHCO-P-490

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $150K)

1. Contracting Activity: US Army Medical Command Regional Health Contracting Office - Pacific

Bldg 339, Clark Road Fort Shafter, HI 96858

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _DHP_ Total Dollar Value: $

Name of Intended Contractor: International BioMedical Street Address: 8206 Cross Park City, State, Zip: Austin, TX 78754-4557

Phone: 512-873-0033

3. Description of Supplies/Services: Military Approved Voyager Infant Transport System Model 20M. Manufactured by International Biomedical Inc.

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) 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 are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: (Only one source) International Biomedical is the only source that manufacturers and distributes a Neonatal Transport Incubator system that has been approved for flight within the Air Force Aeromedical Evacuation Equipment Standards and can be used on fixed and rotary wing aircraft. The United States Air Force Medical Equipment Development Laboratory evaluated and approved the model 20M manufactured by International Biomedical Corp and is documented in the United States Air Force Research Laboratory report AFRL-HE-BR-TR-2000-0029 dated February 2000. There is no other transport system that is built by another source that is approved for military flight. The Air Force Instruction 41-309 dated 1 November 2001 lists the approved medical equipment that can be used on fixed and rotary wing aircraft. In paragraph 2.5 of Chapter 1 of the Air Force Instruction, it lists four approved incubators. International Biomedical manufactures 3 of the 4. The first, model 185, is just an incubator that does not include the airway options and monitor options that the model 20M system includes. The second and third refer to model 20H. The second is just the incubator and the third includes other parts that make it a transport system. The third model is the required neonatal transport system, model 20H, which was the original name of the model that was tested and approved. International Biomedical chose to change the name of the product to model 20M to signify that it was passed by the military testing.

The model 20H is identical to the model 20M that is referenced in the AFRL-HE-BR-TR-2000-0029 report. The fourth model is the Ohio Air-Vac transport incubator that has since been discontinued and is no longer manufactured by a company that was separate from International Biomedical. Thus, the infant transport system, model 20M manufactured and distributed by International Biomedical is currently the only system that meets the requirements and is approved by the United States Air Force.

This incubator is a replacement for our current system which was manufactured by the same company. It would not be practical to purchase other than the recommended neonatal transport system from International Biomedical as we would not be able to use in military evacuation aircraft.

6. Actions to Increase Competition: We will continue to conduct on-going research of the industry market place to determine if there are new entrants into this product arena.

A synopsis will be posted on FBO to increase competition and allow other companies to submit proposals which will be evaluated by the Government.

7. Market Survey: The Air Force Airevac team confirmed the required specifications for Military Air Transports. It has been determined that this equipment is the gold standard for all Department of Army and Air Force Neonatal Evacuations Programs. Substitutions of any other equipment will result in failure to meet flight worthiness for the Air Force. Additionally, the standardized equipment is required to maintain consistency throughout the Department of the Army and Air Force.

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A W81K02-13-P-0133 Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 6.302-1

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Submitted By:

Position Title : NCOIC Neonatal ICU

Email address:

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name:

Position Title: Contracting Officer

Email address:

Date: