JA FAR Part 6 SB-3D Printing Reg. Consultant_(SAM)_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

Justification and Approval for Other than Full and Open Competition

6.302- 1 - Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

1. Identification of the agency and the contracting activity.

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC) in Frederick Maryland, on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), VA VHA Innovators Network (iNET).

2. Nature and/or description of the action being approved.

This activity proposes to negotiate a non-competitive firm-fixed price sole source award with LG Strategies LLC (a woman-owned small business) to provide technical services to the VA leadership team responsible for scaling up a quality management system (QMS) appropriate for a distributed 3D printing manufacturing approach. The estimated value for this acquisition is $1,133,600.00, and period of performance is twelve (12) months from the award date, with one twelve (12) month option period.

(including the estimated value).

In the past several years, 3D printing has been implemented in several innovative VA and DoD hospitals. The majority of medical 3D printing within the DoD is completed at Walter Reed National Military Medical Center. At Walter Reed, a small staff of dedicated employees design and print patient-matched medical models, surgical implants, prosthetic and orthotic devices/componentry, assistive technology, dental applications, as well as new simulator/task trainers for provider training. Walter Reed is one of the few hospitals in the world with on-site metal 3D printers and has excelled in creating patient-matched titanium implants over the past 8 years. At the same time, the VA has coordinated 3D printing efforts across 34 field hospitals through the creation of a national VHA 3D Printing Advisory Committee and a national VHA 3D Printing Network, with VA Puget Sound serving as one of three flagship sites. Hospitals within the VHA 3D printing network create patient-matched medical models, prosthetic and orthotic devices, assistive technology devices and dental applications. Fully developing the prototype of the application for review, feedback, and refinement. Technical specification of deeper details behind the data and functionalities to reduce application development costs.

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703 speaking to many vendors, non-profit organizations, academic institutional leaders, and members of the FDA, it was determined that VA required a specific vendor with experience as follows; 1) working with FDA; 2) medical device development; 3) 3D printing for Original Equipment Manufacturer (OEM); and 4) specific knowledge in powder bed printing technologies such as Selective Laser Sintering, as this is the technology that will be used for the majority of our early medical devices.

At this time LG Strategies LLC, a woman-owned small business, is the only company with the experience necessary to perform the services required. LG Strategies LLC has an active status in Sam.Gov and is the only company with the unique qualifications required below:

Formal engineering training Experience formulating business strategies for Medical 3D printing Worked as a senior member with FDA Additive Manufacturing Work Group within the Center for Devices and Radiological Health, and thus has extensive knowledge of the specific regulatory thinking of the FDA with respect to a wide variety of additively manufactured products.

Has at least 2 years of industry experience with a 3D printing OEM that produces both polymer and metal 3D printers

Recognized leader in the field of additive manufacturing, presenting at national and international conferences

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703 comparison of current contract pricing, past proposal submissions (if available), other information made available, and an Independent Government Cost Estimate.

Additionally, contract award can be made at a fair and reasonable price that offers best value to the Government. The rates will be verified using the IGCE, current market conditions, published price lists and technical expertise. A fair and reasonable price determination will be made prior to award.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market Research was conducted to determine the suitability and availability of may not be satisfied by commercialized product(s) available in the commercial marketplace that meet the definition of commercial items(s) in accordance with FAR Subparts 2.101 and 10.002. Market Research was conducted through VIP.Vetbiz.gov and through external research.

The VIP search utilized the search Terms: 3D printing, Additive Manufacturing, and returned 214 businesses. 17 were confirmed to be related to 3D printing/ additive manufacturing services (those for 2D printing, 3D modeling or 3D scanning only, or creation of chemical additives were excluded from mention below). In the end, 0 met the needs outlined above.

9. Any other facts supporting the use of other than full and open competition.

JIF is an award between the VA Medical Center and Walter Reed National Military Medical Center (WRNMMC). The JIF award focuses on the Department of Defense/VA 3D Printing Consortium for Medical Applications. According to Military Health System (MHS) officials, the JIF was established under Section 721 of the FY 2003 National

DoD/VA joint sharing initiatives to recapture Purchased Care (The TRICARE Health Program is often referred to as purchased care), improve quality and drive cost savings at facilities, regional and national levels. JIF is only designated for use by the Veterans Health Administration (VHA) and Defense Health Agency (DHA) entities for direct medical sharing initiatives or for services or systems that facilitate DOD/VA

Not proceeding with this procurement would jeopardize the ability to comply with Section 721 of the FY 2003 National Defense Authorization Act. Additionally, it would compromise collaborations across hospital departments and within DOD, to provide physicians and other professionals with the opportunity to use the state-of-the-art technology to positively impact the quality of life for military members and their families.

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

This sole source justification and approval for other than full and open competition shall apply to the base contract and all option exercises.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

LG Strategies, LLC 2001 Parker Lane, Apt 122 Austin, TX, 78741-3847

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

All future requirements will be handled on a case-by-case basis. Toward the expiration of this contract, should this concept solution be proven effective, market research will be conducted in order to determine if there are other capable vendors who can provide the required services and consideration will be given as to whether the future acquisition should be competitive.

12. Certifications / Signatures.

Technical Representative Certification:

I certify that the foregoing justification is complete and accurate to the best of my knowledge and belief

Beth A. Ripley, MD PhD Date Program Manager

Contracting Officer Certification:

Pursuant to (FAR 6.303-2(a)(12)), I certify that this justification is accurate and complete to the best of my knowledge and belief.

David Rupert Date Contracting Officer Strategic Acquisition Center- Frederick (SAC-F)

Strategic Acquisition Center (SAC)

5202 Presidents Ct, Suite 103 Frederick, MD 21703

Competition Advocate Approval:

Competition Advocate Approval

Upon the basis of the above justification, I hereby approve, as advocate for competition for the procuring activity, the solicitation of the proposed procurement described herein using other than full and open competition, pursuant to the authority of 38 U.S. Code 8127(c).

Efrain Fernandez Date Competition Advocate Strategic Acquisition Center (SAC)