JA_BodyTom_Redacted_pdf.pdf

Control Number NCD: NCD‐18‐31

Justification and Approval For Other Than Full and Open Competition

For actions over $700,000 but not to exceeding $13.5M

Program/Equipment: BodyTom® Elite Portable CT System

Authority: FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items.

Amount $997,856.30

Prepared By:

Name: Paul T. Barnicott, GS‐15, DAF Telephone: (210) 292‐5687 Title: Deputy Director, 59th Clinical Research Division, 59th Medical Wing Date: 20 April 2018

Contracting Officer:

Name: Eileen Emond Telephone: (508) 233‐6136 Title: Contracting Officer Date Reviewed: 20 April 2018

Technical Representative:

Name: Paul T. Barnicott, GS15, DAF Telephone: (210) 292‐5687 Title: Deputy Director, 59th Clinical Research Division, 59th Medical Wing Date Reviewed: 20 April 2018

Requirements Representative:

Name: Paul T. Barnicott, GS15, DAF Telephone: (210) 292‐5687 Title: Deputy Director, 59th Clinical Research Division, 59th Medical Wing Date Reviewed: 20 April 2018

Reviews:

I have reviewed this justification and find it adequate to support other than full and open competition.

Name: Paul Barnicott Phone: (210) 292‐5687 Signature:

Date:

Legal Counsel:

Name:

Phone:

Signature:

Date:

Justification and Approval For Other Than Full and Open Competition

For actions over $700,000 but not exceeding $13.5M

1. Contracting Activity

Army Contract Command‐Aberdeen Proving Ground Natick Contracting Division, ATTN: CCAP‐SCN, General Greene Avenue, Natick, MA 01760

2. Description of Action

Approval is requested to solicit on the basis of other than full and open competition for a:

New Contract

The Contract is in Support of:

Clinical Investigations and Research at the 59th Medical Wing 59th Medical Wing

Type of contract contemplated:

Firm Fixed Price, Supply

Reason for type of Contract:

This is a 1 year contract for the procurement of commercial brand name medical equipment. In accordance with FAR 16.103(b) a firm‐fixed‐price contract shall be used when the risk involved is minimal or can be predicted with an acceptable degree of certainty. A FFP type contract is consistent with the procurement of BodyTom® Elite Portable CT System as there is minimal risk to the contractor providing the equipment.

Funding information:

Funded with procurement dollars from the Air Force Medical Modernization Panel

Fiscal Year: 18

Type of Money to be used:

Procurement

3. Description of Supplies/Services

One BodyTom Elite Core System consisting of software, scanning platform, installation, training, annual service agreement in the estimated amount of $997,857.

4. Authority Cited:

The statutory authority permitting other than full and open competition is FAR Subpart 13.5 Simplified

Procedures for Certain Commercial Items.

5. Reason for Authority Cited:

The requested Research Program equipment will be utilized to support essential Clinical Investigation Program, Graduate Health Sciences Research, 59 MDW RDT&E projects using large animal models, and En Route Care, as well as Operational Medicine, and Combat Casualty Care Projects. The Clinical Investigation Program supports many clinical investigations that require detailed imaging available only with the BodyTom® Elite Portable CT System of various structures within the body that are essential to the mission of the 59th Clinical Research Division for research in cardiology, vascular technology, post‐ traumatic stress disorder, surgical device implant studies, and other studies as well as survival studies on new devices and techniques to gather research data in support of new protocols. These include imaging of white brain matter injuries following high altitude exposure in pilots, heart imaging for vascular injury management, and foreign body removal for Emergency Medicine. The BodyTom® is a portable, full‐ body, 32‐slice CT (computed tomography) scanner. It has multi‐departmental imaging solutions capable of transforming any room in our vivarium into an advanced imaging suite. The system boasts an 85cm gantry and 60cm field of view, the largest field of view available in a portable CT scanner; and has an internal drive system that allows a single operator to transport and setup the scanner anywhere it needs to go. Corridors are easily navigated using the 130° wide‐angle camera and the system has the ability to perform axial, helical (CTA), and dynamic scanning. These features make it ideal for providing multi‐ departmental imaging solutions.

The only equipment identified that provided a portable CT system that satisfies agency requirements and has a large enough opening to scan large animals was Neurologica Corporation’s BodyTom® Elite Portable CT system. There are several other commercial portable CT units available, but none of these units are able to provide a system that is capable of full body scanning of large animals. These other systems are unable to provide this due to their restrictive openings. The BodyTom® Elite Portable CT system was the only system that allowed for full body imaging of large research animals.

If the BodyTom® Elite Portable CT System were not acquired it would limit the types of research conducted at the 59th Clinical Research Division. As our research portfolio grows, research in cardiology, vascular technology, post‐traumatic stress disorder, surgical device implant studies, and other studies that need intraoperative imaging would not be possible. The 59th Medical Wing has a research portfolio valued at over $100M over the next five years. This research portfolio depends on integrated capability to support both Clinical Investigations and Research and Development protocols. We have current research and future research proposals that require advanced imaging including CT. There is a potential loss of up to $5M in research if CT capability of large animals cannot be added to the 59th CRD. Request for research in these areas have created the requirement for the CT system. We have had to stop advanced research in cardiology, cardiac surgery, and vascular surgery because of the lack of CT imaging in our facility. We have had additional requests for CT follow‐up of surgical research subjects to insure devices or surgical repairs have been successful without having to euthanize the research subject and perform a necropsy to verify research procedures. This allows us to do survival studies on new devices and techniques to gather research data in support of new protocols. Without the CT system we cannot undertake this type of research. This significantly impacts the mission of the 59th Clinical Research Division, the Science and the 59th Medical Wing. In addition, for the 59th CRD to put a full sized CT unit at our facility it would require a facility building project to construct a CT suite integrated into our current facility. Currently there is no property adjacent to our facility that would accommodate this type of facility addition. The approximate cost to add this type of facility and integrate it into our current facility is approximately $1.5 M. This funding is not available and will not be available in the near future.

With the scarcity of Building Program Dollars, there is a potential 5 – 10 year wait on new facility projects. Samsung and Toshiba were brought in to determine if the current facility had enough space to accommodate a traditional CT system. Both companies advised that there was not enough available space and that a separate CT suite would be needed to accommodate a traditional CT system. It was determined that roughly 1,500 square feet of dedicated CT space would be needed.

There are two other benefits to acquiring a portable CT system over a traditional system. The first is that one technician would be able to move the system to the subject. This eliminates the need for multiple personnel to transport the subject to a specific room for CT scanning. Another benefit is that the risk to the animals can be reduced as there is less time under anesthesia as the system can be moved into the area after the procedure has taken place.

The requirement for CT imaging in research has been validated and the only way this can be accomplished is with the acquisition of the BodyTom® Elite Portable CT System. This system will allow us to meet current and projected Research Imaging Requirements.

6. Effort to Obtain Competition:

This requirement will be synopsized as a brand name requirement in FBO utilizing FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items. Market research has identified that the BodyTom® Elite Portable CT System is sold by two sources; Neurologica Corporation and RadSource Imaging Technologies.

7. Action to Increase Competition:

As technology adapts it is possible that another system will be able to meet the requirements of the 59th Medical Wing in the future. When useful life of this equipment no longer satisfies the requirements of the 59th Medical Wing, market research will be conducted to continue to search for a suitable alternative. It is anticipated that if comparable or more advanced equipment is discovered that satisfies the agency’s requirements, then full and open competition will take place at that time pending availability of funds.

The Brand name justification will be posted in accordance with FAR 5.102(a)(6) with the solicitation.

8. Market Research:

Market research was conducted by:

Paul T. Barnicott, GS15, DAF Telephone: (210) 292‐5687 Title: Deputy Director, 59th Clinical Research Division, 59th Medical Wing

Literature review, industry notices and discussions with leading imaging companies on the availability of portable CT units was used as the basis of the market research. Some of these systems included:

Xoran MiniCATIQ‐ Reviewed 3/21/2018

This system is a small system designed to perform CT imaging of the Sinus and Temporal Bone areas of the skull. It does not allow for whole body imaging of large animals. It has specific applications in the

Ear, Nose, and Throat Physician office setting, but does not allow for full body imaging of large animals.

It does not meet stated requirements and cannot be modified to meet requirements.

Neurologica Corporation CereTom‐ Reviewed 3/21/2018

The CereTom is designed strictly for Head CT imaging and does not allow for full body imaging. The System is limited to 8 slice resolution and the bore size is only 12 inches in diameter. The small bore size and the 8 slice resolution does not meet stated requirements. The 12 inch bore size does not allow for large animal imaging and the 8 slice resolution will not provide the anatomical detail required by our researchers. This system does not meet the requirement to allow for full body imaging of large animals and does not have the required resolution for our researchers. This system cannot be modified to meet our requirements.

Neurologica Corporation Omnitom‐ Reviewed 3/21/2018

Neurologica Corporation Omnitom is a small body imager that is limited in resolution to 16 slice and has a bore size of 15.4 inches. The small bore size and does not allow for large animal full body imaging and the 16 slice resolution does not meet the stated requirements. The system is ideally designed for head neck and pediatric imaging and is not designed for large animals (pigs and sheep). This system does not meet stated minimum requirements and cannot be modified to meet our needs.

These systems were evaluated and it was determined that only one of these systems meets the minimum required size needed to scan large animal subject. That system is the BodyTom® Elite Portable CT System. Additional research has identified that the BodyTom® Elite Portable CT System is sold by two sources; Neurologica Corporation and RadSource Imaging Technologies.

When: June‐Sept 2017 and February‐April 2018

A search of GSA provided no other results for portable CT scanners from any manufacturer. Search was conducted on 12 April 2018.

9. Interested Sources:

There has only been two interested source identified:

NeuroLogica Corporation ‐ 14 Electronics Avenue, Danvers MA 01923, Fax: 978‐560‐0602, POC: J Fernando Corredor, Phone: 415‐336‐1576, Email: Fcorredor@neurologica.com.

RadSource Imaging Technologies‐ 8121 NW 97th Terrace, Kansas City, MO 64153. Phone: 866‐680‐3380

When the 59th Clinical Research Division began exploring the possibility of adding large animal CT capability a literature search was conducted to find appropriate equipment that would meet the needs of the agency. Initially both full‐size CT units as well as portable CT capability were explored. When the agency deemed that a full‐size CT system would not be feasible in the facility, the research effort centered on portable CT units. Internet searches revealed that NeuroLogica Corporation offered the BodyTom® Elite Portable CT System. This system is the only system that has met all of the 59th Clinical Research Division’s requirements. Neurologica Corporation is the only manufacturer of B BodyTom®

Elite Portable CT System. At that time, further research did not reveal any other manufacturers or companies that could provide a system that could meet the basic requirements of the 59th Medical Wing research program.

As the acquisition process progressed, research by Mr. Brandon Rivett, Contract Specialist, Natick Contracting Division, discovered that the BodyTom® Elite Portable CT System was also available from RadSource Imaging Technologies. RadSource Imaging Technologies is a supplier of the BodyTom® Elite Portable CT System.

These two sources are the only known suppliers of the BodyTom® Elite Portable CT System.

10. Other Facts:

a. Procurement History

There is no procurement history, as this is a new requirement

b. Acquisition Data Availability

N/A

c. Unusual and Compelling Urgency

N/A

d. Subcontracting Competition

Subcontracting opportunities will be identified by the awardee

e. Follow‐on Contracts This is not a Follow‐on contract.

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.

Type Name: Paul T. Barnicott, GS‐15, DAF Date:

12. Requirement 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.

Name: Paul T. Barnicott, GS‐15, DAF Date: 11 April 2018

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.

The techniques to be used to determine fair and reasonable prices are:

Price Analysis

A price analysis will be performed to compare each offeror’s proposed price.

Certified cost or pricing data will not be required. FAR 15.403‐1(b)(1), Exceptions to certified cost and price data requirement when the contracting officer determines that prices agreed upon are based on adequate price competition.

Name: Brandon Rivett Date: 20 April 2018 Title: Contract Specialist

14. Contracting Officer Certification:

I certify that this justification is accurate and completed to the best of my knowledge and belief.

Name: Eileen Emond Title: Contracting Officer Date Reviewed: 20 April 2018

Approval

Based on the foregoing justification, I hereby approve the procurement of:

BodyTom® Elite Portable CT System

On an other than full and open competition basis pursuant to the authority of FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Dennis Longo Date:

Advocate for Competition