P03 Sole Source Justification - PM7.pdf

Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C249-25-AP-1493

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-25-AP-1493

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Services

Network (VISN 09), Network Contracting Office (NCO) 9, James H. Quillen VAMC, 1 Veterans Way Mountain Home, TN 37684.

PR/2237: 621-25-2-091-0036

2. Nature and/or Description of the Action Being Processed:

This procurement is for brand name products set forth in section 3 below to be awarded under a firm-fixed price contract in accordance with (IAW) FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The requested equipment below is for James H. Quillen Dental Service to make in-house removable monolithic dentures.

3. Description of Supplies/Services Required to Meet the Needs:

Requested equipment are items peculiar to the following manufacturer Ivoclar Vivadent Inc.

(Large Business). These items are to be used at the James H. Quillen Dental Clinic and the Knoxville Dental Clinic.

Product QTY PrograMill PM7 System 2

PrograMill Base Set 2 PrograMill/PrograPrint PC 2

Monitor widescreen 2 PrograMill CAM Set incl. RFID-Reader 2

Optical mouse 2 Keyboard (English) 2

E4 Red Dental System Scan Only (NO PC) 2 Scan only LabCare 2

Desktop High Performance PC Bundle 2 PrograMill tool green 5.0 for PM7 10 PrograMill tool green f1.5 for PM7 10

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Acquisition ID#: 36C249-25-AP-1493

PrograMill tool green 2.5c for PM7 10 PrograMill tool green 1.0c for PM7 10 PrograMill tool green 0.5c for PM7 10

Ivotion A2/Pref 98.5U/1 60 PrograMill Holder-ring DD for PM 3/5/7 2

Impression holder 2

UTS CAD (ID) 2

Service PM7 3 Years (754285) 2 DS Complete Rest. Bundle with Scanner 2 Ivotion Denture System Library 3Shape 2

The estimated delivery for these items is 30 days after receipt of order (ARO).

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5.

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The James H. Quillen VAMC Dental Service is requesting brand name, Progamill PM7

Currently, the dental clinic has three 3Shape Intraoral scanners that is used to scan intraorally, with two more requested in this package, titled DS Complete Rest. Bundle with Scanner as listed above. The additional scanners are for lab use. The clinic/facility would have to purchase costly, additional scanners to work with the Coritec mill as the 3Shape scanners work with the PM7 system. The Coritec system is currently not approved for use on the and gold imaging standard to securely and effectively work on existing the VA network. The requested design software (approved for use on the VA network and needed to fabricate the final product/denture) is the Ivotion Denture Library. This works with the 3Shape scanners we currently have. The Ivotion Denture Library has not been tested on the Coritec mill, and

REVISION: 01

Acquisition ID#: 36C249-25-AP-1493 there is no indication it or any other system would work with the 3Shape scanners.

Purchasing different additional scanners would create significate backlog, work stoppage, increased community costs, and decreased access to the clinics. The PM7 milling unit requires fundamental equipment to properly operate, a modular dryer and an oiless compressor. Both the modular dryer and oiless compressor have been purchased in FY24, which was purposed planned and prepared over two years ago, to outfit the PM7 unit and have been delivered to the Knoxville Dental Clinic site. The facility advised the services to purchase equipment that was listed in the current and upcoming FY SEPG plans because they had the funding to do so. The compressor and dryer were both separate fundamental units which required pre- installation before adding the milling unit. The service currently has those items installed awaiting the PM7 system to operate as designed. Each item was below the 10K threshold.

The PM7 System consists of hardware and software components that are capable of producing multiple make one-piece dentures (monolithic dentures) which are more sustainable and a more superior (stronger) product for Veterans. Other systems have a two-piece option which means teeth must be added or have individual teeth milled and glued individually into the denture base which causes teeth to become more likely to break off or fall out than a complete denture made from one piece which involves no gluing. The requested equipment, PM7 from Ivoclar, can produce up to 8 single arch dentures and 4 complete dentures using an automated/carousel mechanism that does not require manpower to physically remove a completed arch in order to start another. Other mills, such as the Imes Icore, use a single-action mechanism which requires physical manpower to change each completed product in order to mill another. The PM7 can complete one denture arch in 72 minutes where other systems can take upwards of 4 hours for one denture arch. In FY 24, the clinics produced 427 dentures. FY 25 to date, the clinics have produced 223, demonstrating an upward trend, the clinics have already produced more than half the total amount in only 6 months of the current FY. The number of Dental-eligible Veterans is projected to grow 8% each year due to increased eligibility (PACT Act, etc.), which yields 1,000 additional Veteran patients each year. Denture fabrication will increase each year as the number of Veteran patients grow.

The intended use for the request equipment/system is to make in-house removable monolithic dentures-meaning dentures are made from one piece, not multiple pieces which require additional manpower and time for a lab technician to individually glue teeth into a denture base. Inability to acquire this item would significantly affect the mission of the Dental Service within the VA. Milling dentures in-house will increase clinical access by eliminating the need for additional appointments needed in conventional methods. Currently, it takes approximately 4-5 appointments over a 6 8-month timeframe for a Veteran to receive a removable denture. The future of dentistry lies in digital dentistry, using digital technology, can reduce the number of appointments needed to 2-3 appointments while reducing their wait time to receive the denture.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Sources Sought Notice (SSN) 36C24925Q0207 was posted on sam.gov Contract Opportunities from 03/26/2025 to 04/10/2025, with responses from interested parties

REVISION: 01

Acquisition ID#: 36C249-25-AP-1493 identifying the brand name and other models that are not capable of meeting or being able to modify their product to meet this requirement.

1) AVCO Enterprises dba Dentserve (WOSB)- PM7 System- not an authorized distributor per the manufacturer.

2) Begini Howard Private Equity (BHPE) LLC (SDVOSB)- Responded as an interested vendor. There was no indication of the item purposed.

3) Contemporary Product Solutions Inc. (SDVOSB)- PM7 System

4) Bright Labs Diagnostics (WOSB)- There was no indication of the item purposed.

5) Al-Samaa Al Qahira Company (Large Business)- PM7 System- not an authorized distributor per the manufacturer.

6) AB Martin Services, Inc (SDVOSB)- The Planmeca does not meet the need for efficiency and workflow and is required to milled teeth into the denture base.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

Fair and reasonable will be determined via one of the basis for award found under FAR 13.106-3 prior to contract award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. Market research found no domestic end product sources to meet this requirement. Market research found the Ivoclar Progamill PM7 System is wide database of contracts and other procurement instruments intended for use by multiple agencies were queried and yielded no alternative sources; Interactive, on-line communication among industry, acquisition personnel, and customers was executed with no alternatives found;

Source lists of similar items from other contracting activities or agencies, trade associations or other sources were obtained but yielded not alternative sources.

Market research reveals there are no denture-milling units actually made/manufactured in the United States. The Buy American Act (BAA) does apply. Government is seeking a BAA nonavailability waiver PM7 System to include hardware and software because items are manufactured in Austria for the main system, however, the additional components come from various countries such as Germany, Czechia, China, Denmark, Italy, and Poland for all Ivoclar Vivadent Inc. products.

While there is a NMR class waiver for this NAICS, it does not apply as this will be procured via a SDVOSB OEM authorized distributor.

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Acquisition ID#: 36C249-25-AP-1493

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

VA Directive 6550, Appendix A, 2.1

Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacture).

Biomedical Engineering (now HTM) and OI&T, have performed countless hours reviewing and validating the dental milling devices in question. The CORITEC IMES ICORE Dental Lab Mill should not be purchased under any circumstances since it would be a direct violation of VA Directive 6550. Even if the device were to be purchased, once it is received, it would be flagged and planned for immediate replacement as per VA Directive 6550, concerning unsupported Operating Systems As per the Enterprise Risk assessment (ERA) RITM6757051 that is a joint review with OI&T and HTM, the review shows that the CORITEC IMES ICORE Dental Lab Mill uses a Windows 7 Operating System (OS), which is no longer supported (end of life was Jan 13, 2020) and is unauthorized for purchase under VA Directive 6550. If received, it will immediately require a POAM (Plans of Action and Milestone) for mitigation, and the only mitigation for an outdated operating system is replacement. This is a serious Cyber-Security threat due to the system no longer receives security patches and is open to numerous vulnerabilities, and guarantee that the ISSO would approve the POAM, so there is a good chance that the system could never be used.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

One SDVOSB (Contemporary Product Solutions Inc) has express interest in providing the exact requested items to meet this requirement and an authorized distributor letter has been provided by the manufacturer.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The Government will continue to reassess future procurements for the PM7 System that are in the best interest of the Government. Competitive procedures to replace or upgrade the PM7 System may be available in the future that are dependent upon introduction of new technology and changes in facility standards.