P03 - JOTFOC_E4 Scanner (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

SIMPLIFIED ACQUISITION SOLE SOURCE JUSTIFICATION AND

APPROVAL

UNDER FAR SUBPART 13.5

1. Identification of the agency and the contracting activity.

This Justification and Approval (J&A) for Other Than Full and Open Competition (JOTFOC) is executed by the Strategic Acquisition Center (SAC), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA) Office of Advanced Management (OAM).

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

This activity proposes to negotiate a non-competitive award (sole source) with Zahn Dental, a division of Henry Schein, Inc., a large business, for the procurement of four

(4) “all-in-one” dental scanners for use within the specified dental department sites.

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

To meet VHA OAM’s current need, the contractor shall provide the following:

• Four (4) Dental Scanners and accessories

• Description: Hardware used to scan models, dies, impressions and bites for designing and manufacturing dental equipment

• Minimum Requirements of Hardware:

o Ability to scan models, dies, and bite all in one scan o Ability to scan the upper and lower model simultaneously o Able to scan color texture o Minimum Camera resolution of 5MP o Minimum accuracy of at least four (4) microns o Minimum scan speed for full arch impression of 45 seconds o Must include calibration kit

• Accessories included as part of the scanner package (One (1) of each item for each scanner purchased):

o Dental impression fixtures o Wax Up Bridge fixture o Occlusion set up tool

• Contractor shall provide high performance PC, monitor, mouse, and keyboard as part of complete product package

SOLE SOURCE JUSTIFICATION

• Scanning software shall be included with the hardware

• Package shall include, but is not limited to, any cables, leads, mount kits, Installation, hardware, and cleaning kits needed to make the equipment fully functioning

The estimated period of performance (PoP) for this requirement is a 60-day base period with no options, and the estimated dollar amount is $98,840.00.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting the use of noncompetitive procedures is 41 U.S.

Code § 1901(a)(2), as implemented by the Federal Acquisition Regulation (FAR) Subpart 13.501, entitled “Special documentation requirements.” Only one source is capable of providing the supplies or services required, four (4) “3Shape Novux E4 Scanners,” accessories, installation, and training. Additionally, the manufacturer does not allow their product sold to any other third party other than Zahn Dental.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

3Shape is currently the only device that can be utilized for the intended 3D dental printing purpose, the E4 operates on a proprietary system and the use of any secondary contractor to modify the current and new proposed software will negate any warranty on the equipment and software. As previously stated, the 3Shape software is needed to operate the E4 3D printer. 3Shape has given notice to the VHA Innovation Ecosphere that any unauthorized alteration in 3Shape hardware or software would negate the warranty for this equipment.

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.

A Request for Information (RFI) #36C10X21Q0121 was published on April 19, 2021 through the NASA SEWP website. A total of thirty-three interested vendors were queried to the RFI as potential sources for the requirement. Of the thirty-three responses, Henry Schein Inc. was determined to be the only source capable of meeting the need. None of the other potential contractors were able to meet the Government’s requirements.

Henry Schein, Inc. asserted that 3Shape does not allow their products to be sold through any third party, in their response. Henry Schein, Inc. is approved and authorized to distribute 3Shape Dental 3D Printers. Further, Henry Schein is suited to meet the technical requirement and presents the best value to the Government.

A notice is not required to be posted on Beta.SAM.Gov, formerly FBO in accordance with FAR 5.202 (a)(10), The proposed contract action is made under conditions described in 6.302-3, or 6.302-5 with regard to brand name commercial products for authorized resale.

7. Determination of Best Value:

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 catalog prices that have already been determined to be fair and reasonable however, additional discounts will be requested. Additionally, this determination will include a comparison of current contract pricing, past proposal submissions and an Independent Government Cost Estimate. The Government’s intention is to award based on achieving pricing which is the same or less than prices previously paid and is in the best interest of the U.S. Government.

8. Market Research:

Market research was conducted, and details are contained in the Market Research Memorandum. Zahn Dental, a division of Henry Schein, Inc, has been determined to be a responsible source with respect to performance.

A review of Henry Schein, Inc’s Representations and Certifications was conducted in SAM on March 22, 2022, and Henry Schein, Inc. represented that they are a Large Business under the NAICS code for this requirement, 339112 – Dental Equipment and Supplies Manufacturing.

In addition, the Federal Awardee Performance, and Integrity Information System (FAPIIS) was queried on March 22, 2022, and FAPIIS shows no reports for Henry Schein, Inc. that would indicate defective pricing, instances of contractor fault or recipient not-qualified, terminations for cause, default, or material failure to comply, or non-responsibility of the contractor.

Based on the above information, the intended acquisition strategy is to issue a sole source, open market, award to Henry Schein, Inc.

9. Other Facts:

The long-term solution for VA 3D printing is to continue to procure the latest, safest commercial items in the marketplace; therefore, future acquisitions will not necessarily be required to utilize authorized and approved distributors. The Government awarding directly to the manufacturer retains valid warranties on the items that might not be honored through resellers.

A Commercial-Off-The-Shelf (COTS) program is therefore required to provide hardware servicing, software updated, and warranty care at the facility level. The long-term solution for the VHA is the VA’s planned transition from procuring 3D printers to making custom 3D printers in house; 3D printers, making 3D printers.

This is a possible future end state and is not yet supported by technology or VHA infrastructure. It is estimated that future acquisitions for this product will still be required. The 3Shape E4 Dental System can be installed without risk and safely operated with the understanding that the hardware, software, and warranty are fully covered by 3Shape and any additional software, interface development or warranty work will be covered by 3Shape through their authorized and approved distributor Henry Schein, Inc.

10. Interested Sources:

HENRY SCHEIN, INC. (012430880)

135 Duryea RD, Special Markets E-255 Melville, New York 11747-3824, United States

11. Overcome Barriers:

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.