P03-DentsplySirona_Brand Name Justification Revised.pdf

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DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: VA-24-0004529

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Hunter Holmes

Richmond VA Medical Center (652). This will be processed through the NCO6, Hampton VA Medical Center, 100 Emancipation Drive, Hampton, VA 23667. 2237 #: 652-24-2-066-0021

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Fredericskburg HCC (affiliated with Richmond VA Medical Center) has a need for brand-name Dentsply Sirona Axeos 3D Imaging System, Heliodent Plus equipment, workstations and supporting software/operating system and Schick 3.0 Starter and Sensor Kits. Heliodent Plus is the latest generation of intraoral X-ray generator designed for optimum image quality in digital radiography on patients of all shapes and sizes. The Heliodent Plus features quick and safe operation that enhances your practice worktlow. With multiple lengths and multiple activation and control options available, the Heliodent Plus offers flexibility for installation in any environment. An intuitive user display with preprogramed settings and easy service capabilities help deliver greater clinician control for day-to-day practice workflow. This will be a firm-fixed price contract for the sum of $236,053.80 with delivery, installation, and included on the quote. This is a new contract.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

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( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302- 6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

From the end-users: This equipment is only available from one source because we must integrate this equipment to the existing equipment in the Richmond VAMC facility.

Currently, Richmond VAMC has a Sirona CBCT/Panoramic machine and 15 operatories with Sirona radiograph equipment. They also already have 2 Dentsply Sirona CEREC CAD/CAM systems. For the new HCC equipment, the equipment being purchased must integrate with these systems, must operate on the same operating systems and communicate on the same interface. The entire dental clinic uses Sidexis radiology software, and this software is Sirona specific software. In order to maintain the current practice, all new radiograph systems to need to operate in this system. According to the end-users (Dr. Cassidy Turner and Carmalita Turner), purchasing equipment from any other manufacturer would render the Richmond facilities existing equipment useless and create an extreme expense for the facility and delay patient care.

Additionally, the facility Biomed and OIT teams have experience servicing and troubleshooting the Dentsply Sirona systems and software and have purchased replacement and repair components for these systems. Purchasing this equipment from a different source would require retraining, repurchasing, and duplication of tasks. All these repercussions would result in increased facility spending and delays to patient care. Finally, the entire clinic infrastructure has been completed and is designed, built, wired and ready for this exact equipment. Any alteration would require a redesign and deconstruction of the multimillion-dollar project and would result in significant patient delays.

The name brand being requested has an excellent history and track record in the dental field and in the VA system. Numerous facilities across the VA and DOD use these devices and products. The equipment being requested is brand specific and cannot be purchased except through the manufacturer. Having radiographic equipment and CAD/CAM technology is essential to our clinic as it is a key diagnostic pillar and if our systems cannot communicate or function together than it will compromise patient care.

As demonstrated above, the Richmond VAMC has standardized their practices on the Sirona Dentsply System and this brandname requirement will add to their current inventory/equipment, while seamlessly integrating into their already existing platform, allowing for larger storage capacity and increased image capabilities.

Although this is a new facility, it is not an entirely “stand-alone” facility. This facility will have software, equipment connections, and staff that all interchange between the main Richmond facility and the Fredericksburg HCC. Moreover, many of the clinical providers- doctors, nurses, and administrative personnel, will be moving between clinics. It is not a feasible solution to purchase a new system that they will need to be cross-trained in.

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Equipment must be compatible with existing equipment and software. Based on facility need and existing conditions at the ‘parent’ facility- the Richmond VAMC, like or similar items will not suffice. Procuring from another vendor at this time would require a complete overhaul of the current system, undermine current SOP's, create a training burden and interrupt current patient care, all while incurring additional costs that aren't anticipated to be recouped through a competitive solicitation for a different system.

Supplies, needs, and technology demands will be monitored, ordered, tracked and managed by personnel who sit in both facilities- therefore the systems MUST integrate with eachother. The only way to guarantee this is by sole-sourcing this equipment.

4. Description of market research conducted and results or statement why it was not conducted: VIP was searched utilizing NAICS code 339114 and keyword "dental manufacturing." 49 vendors were found; 43 Service-Disabled Veteran- Owned Small Businesses (SDVOSBs) and 4 VeteranOwned Small Businesses (SDVOSBs). See MR list for complete report. VIP Search didn't produce any vendors that manufactured like or similar items. The VIP search along with other market research findings indicates that the Rule of Two cannot be met for this requirement. Furthermore, this requirement calls for a brand-name system, and the OEM (Dentsply Sirona) is a large business. Communication directly with the manufacturer (Dentsply Sirona) revealed that VHSS (SDVOSB) is the only authorized distributor for the items in need for this requirement. Since the OEM is a Large Business, VHSS cannot provide their items as a nonmanufacturer IA W the 4th prong of the NMR. With VHSS being the only authorized distributor, IRIS Solutions does not have a reasonable expectation of receiving 2 or more quotes from SB's if we were to set this requirement aside as 100% small business. Market research indicates that it would be in the best interest of the government to pursue an unrestricted, full and open competition and award to Dentsply Sirona.

Other Actions: Other VA medical and dental facilities are using Dentsply Sirona products and numerous Sources Sought, Justification and Authorization, Intents to Sole Source and Notices of Sole Source. Examples of these contracts include:

36C24422Q0226 (Intent to Sole Source Axeos 3D/2D System), 36C24620Q0308 (Heliodent Plus Intraoral 81- the same make and model listed here), 36C24618Q0682 (Sirona Dental X-Ray Sole Source), FA481422TF108 (notice to sole source), and many more.

5. Contracting Officer's Certification: Purchase is approved in accordance with

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466

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