Sole Source Justification_Bioprinting Support_09.13.2022_FE.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 FOR OTHER THAN FULL AND OPEN COMPETITION

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), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Healthcare Innovation and Learning

(OHIL).

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

This activity proposes to negotiate a non-competitive award firm fixed price sole source award to Advanced Solutions Life Sciences, LLC. (ASLS), a Large Business, to provide equipment and services to expand bioprinting across the VHA enterprise, including BioBone, as well as other current and future projects.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

OHIL is coordinating a national bioprinting program known as the BioFabrication Community of Science (CoS). The flagship project of this program has the ambitious goal to create the first-ever FDA cleared 3D printed living bone product. The project, dubbed “VA Impact”, is a collaboration between ASLS and VHA. The product, named “VA BioBone” is a vascularized, living 3D printed bone that can be printed in the shape of a patient’s bone defect, relieving the need to remove another piece of bone from elsewhere in the patient (such as the fibula bone in the lower leg). This product is designed to be manufactured within VA hospitals, at the point of care. It is created with a unique biomanufacturing suite of equipment made by ASLS, including a Bio-Assembly Bot bioprinter, a Biostorage Bot, and a biosafety enclosure that maintains needed environmental conditions for optimal fabrication.

The estimated total value for this acquisition is $6,718,055.67, for a period of performance of one 12-month base period, with four, 12-month option periods.

4. Authority:

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority cited.

This award specifies equipment that is compatible with existing infrastructure within the VA, including a BioAssemblyBot, BioStorageBot, and custom ISO Class 5 Cleanroom Enclosure.

Additionally, the current bioprinting process jointly developed by VHA and ASLS utilizes Angiomics® haMV, which are proprietary to ASLS. VHA has invested three (3) years and millions of dollars in developing this bioprinting process.

Strategic Acquisition Center (SAC)

If VA is unable to utilize equipment compatible with this existing infrastructure, this will invalidate all work to date from a regulatory/ FDA perspective and will delay this essential care reaching Veterans by at least three (3) years. This will also impact work in surgical processes and development of future VHA operating rooms that are being laid out based on existing equipment and infrastructure.

ASLS has extensive expertise and experience in this specific work which will allow them to immediately begin supporting this effort. It is imperative that the Government utilize a contractor with expertise in this subject matter to ensure successful performance.

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 Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Business Opportunities Page in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

7. A determination by the Contracting Officer that the anticipated cost to the

Government will be fair and reasonable:

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

8. A description of the market research conducted and the results, or a statement of the reason market research was not conducted:

In addition to ASLS, six other potential vendors were identified. Each vendor’s website was reviewed for mention of bioprinted bone, vascularized bone, end-to-end bioprinting technologies, and other key terms from the listed requirements set out in the scope of work and also highlighted above.

Only one vendor mentioned any of the required key terms, Lynntech, which did list Bioengineering as a technology and one bioprinter, the CellInk Bio-X bioprinter, in their facilities. However, this printer cannot fabricate the VA Biobone product, and thus this vendor is not acceptable. Further, this vendor does not hold patented technology for microvessels.

Additional market research was performed by reading scientific papers, attending conferences, and through engagement within VHA’s VA Biofabrication Symposium on May 4-5, 2022, where industry was invited to join. No further vendors were discovered.

The select services/supplies are not readily available on an existing purchasing vehicle (such as a GWAC, Internal IDIQ, GSA FSS, etc.)

Strategic Acquisition Center (SAC)

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

VHA requires the appropriate partner to support the efforts outlined above. A strategic partnership with ASLS will ensure that VHA does not incur further delays or a significant impact to efforts over the last three (3) years to further critical services in support of Veteran healthcare.

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

Advanced Solutions Life Sciences, LLC 1901 Nelson Miller Parkway Louisville, Kentucky 40223

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:

Insert All future requirements will be handled on a case-by-case basis. Toward the expiration of this contract, consideration will be given as to whether the future acquisition should be competitive

Strategic Acquisition Center (SAC)

Technical and Requirements Certification :

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

Julie Ramirez Date Program Management Analyst Office of Healthcare Innovation and Learning (OHIL)

Contracting Officer Certification:

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

Kimberly Sandi Date Contracting Officer Strategic Acquisition Center-Frederick (SAC-F)

Competition Advocate Approval:

In my role as Contracting Activity Competition Advocate , based on the forgoing justification, I hereby approve this acquisition on an “other-than-full- and-open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $15M, the certification below required by FAR 6.304 serves as approval.

Efrain Fernandez Date Director/Competition Advocate Strategic Acquisition Center-Frederick (SAC-F) Tracking Number 22F-0194a