EOS Imaging System Sole Source JA_MS signed_Redacted.pdf

Control Number: 21-RHCO-C-635

(Source Selection information - See FAR 2.101 and 3.104-4)

APR 2021

Sole Source Justification and Approval Review Document Under FAR 13.501*

Program/Equipment: X-Ray apparatus weight-bearing imaging system that provides 2D/3D images.

Authority: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

Amount:

Prepared by:

Title Date:

E-mail:

Contracting Officer: Date Reviewed

E-Mail:

Technical Representative:

Title: Date Reviewed

Requirements Representative:

Title: Date Reviewed:

Sole Source Justification and Approval Review Document

Under FAR 13.501*

1. Contracting Activity: US Army Health Contracting Activity, Regional Health Contracting Office – Central, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas 78234.

2. Description of Action: This is a new requirement for a firm fixed price contract with DHP funding. This request is for brand name low-dose X-Ray apparatus weight-bearing imaging system that provides 2D/3D images.

3. Description of Supplies/Services: Brooke Army Medical Center (BAMC) has a requirement to purchase a brand name low-dose X-Ray apparatus weight-bearing imaging system that provides 2D/3D images. EOS Imaging Inc. provides a low-dose X- Ray apparatus weight-bearing imaging system that provides 2D/3D images both standing and/or sitting imaging for patient X-Rays. The imaging system will replace CT 3D reconstruction, weight-bearing upright imaging for spine/lower limb imaging. Delivery expected 90 days after contract award. Purchase Request 0011638209 provided for

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

5. Reason for Authority Cited: The Government’s requirement is to obtain a low-dose imaging system that provides 2D/3D images, as well as standing and/or sitting imaging for patient X-Rays for the San Antionio Military Medical Center (SAMMC), JBSA Fort Sam Houston, Texas. The EOS imaging system will provide the above mentioned characteristics along with; replacing CT 3D reconstruction, weight-bearing upright imaging for spine/lower limb imaging, improved imaging pictures for pivotal outcomes, no image distortion, template software for joint replacements, improved understanding of deformity before surgery. The EOS platform is a unique combination of low dose 2D/3D imaging technology, software and services that add value to each step of the musculoskeletal patient care pathway. From diagnosis to long term follow-up, an EOS exam provides full body, 2D/3D images and patient-specific data sets to plan and control surgeries based on 3D anatomical models of the patient in a weight-bearing position.

6. Efforts to Obtain Competition Sources sought W81K00-21-R-3015 posted 17 June and closed 24 June with no response. An additional notice PANHCA-21-P-0000 007312 posted 09 July and closed 15 July. This notice resulted in one interested source.

CurveBeam LLC, a small business with no other socio-economic identifiers. CurveBeam responded with an alternate machine the HiRISE Weight-Bearing CT Imaging System.

However, the HiRISE does not include imaging of the spine and has a much higher dose of radiation than the EOS Imaging system. The HiRISE does not meet the need of the government.

7. Actions to Increase Competition: Justification will be available with solicitation at the

Government Point of Entry (GPE), www.betasam.gov. If in the future other Weight- Bearing CT Imaging System become available, market research performed to consider other sources that meet or exceed the current requirement. No other efforts made to obtain competition as only one responsible source; EOS Imaging Inc. is currently capable of meeting the requirement.

8. Market Research: Market research conducted 29 July 2021 via internet, brochures, literature review, and a comprehensive analysis of different X-Ray apparatus weight-bearing imaging system. Market research revealed EOS Imaging Inc. low-dose X-Ray apparatus weight-bearing imaging system that provides 2D/3D images both standing and/or sitting imaging for patient X-Rays. Confirmed there are no authorized dealers for this equipment and requires purchase directly from EOS Imaging Inc.

9. Interested Sources: A Sources Sought notice posted to the GPE on 13-19 July 2021.

This notice resulted in one interested source. CurveBeam LLC, a small business with no other socio-economic identifiers. CurveBeam responded with an alternate machine the HiRISE Weight-Bearing CT Imaging System. However, the HiRISE does not include imaging of the spine and has a much higher dose of radiation than the EOS Imaging system. The HiRISE does not meet the need of the government. A Notice of Intent to Sole Source posted to the GPE betasam.gov on 09 August 2021 in accordance with

5.201. The Contracting Officer does not anticipate any other vendor capable of meeting the requirement because their products does not include imaging of the spine and has a much higher dose of radiation than the EOS Imaging system. No other efforts made to obtain competition as only one responsible source; EOS Imaging Inc. is currently capable of meeting the requirement.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract numbers and dates of all awarded contracts for these same requirements.

N/A

(2) The competitive status of these actions. N/A

(3) Authority previously cited if less than full and open competition was used. N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts. N/A

11. Technical Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Title:

12. Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: Title

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. This determination made using price analysis techniques. The pricing received will be determined fair and reasonable by comparing the offer to the current and previous contracts, market research and other Government data. As a part of this basis, certified cost or pricing data is not required because the item and/or supplies acquired considered commercial.

Typed Name: Title: :

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

Based on the foregoing justification, I hereby approve the procurement of The EOS imaging system on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the equipment and property herein described have otherwise been authorized for acquisition.

Signature: ______