SPECIAL NOTICE
65 -- Dexis/Elos Dental Equipment
- Notice Date
- 3/13/2024 6:20:02 AM
- Notice Type
- Special Notice
- NAICS
- 339114
— Dental Equipment and Supplies Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24124Q0352
- Response Due
- 3/19/2024 7:00:00 AM
- Archive Date
- 05/03/2024
- Point of Contact
- Divianna Mathurin, Contract Specialsit, Phone: 914-325-3258
- E-Mail Address
-
divianna.mathurin@va.gov
(divianna.mathurin@va.gov)
- Awardee
- null
- Description
- NOTICE OF THE INTENT TO SOLE SOURCE TO ProAlliance Corp, 300 W Front St Ste 203K, Harvard, IL 60033, UNITED STATES. Response Due Date: March 19, 2024, by 10:00PM (EST) NOTICE OF THE INTENT TO SOLE SOURCE SYNOPSIS Network Contract Office 1, Procurement Office East on behalf of The Department of Veterans Affairs, Jamacia Plain VA Medical Center located at 150 S. Huntington Avenue Jamaica Plain, MA 02130-4817 intends to award a firm-fixed contract with no options to ProAlliance Corp to provide delivery/installation for (4) DEXIS IS 3800W Scanners, (6) DEXIS IS 3800 s, (3) SprintRay Pro 55 s, and (3) SprintRay Pro 55 s along with various dental accessories for Boston s Oral Surgery Department .The proposed procurement is for products for which the Government intends to solicit and negotiate with only one source under the authority of 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5. The North American Industry Classification System code (NAICS) for this requirement is 339114. All responsible sources that feel they should be considered qualified to provide the above-mentioned products may submit a response to this notice (by the response due date shown above) to Divianna.Mathurin@va.gov . The information provided shall include detailed (and relevant) documentation to allow the government to perform adequate market research and make a proper determination. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. REQUESTS FOR A SOLICITATION WILL NOT RECEIVE A RESPONSE. VA BOSTON HEALTHCARE SYSTEM NOBEL BIOCARE 3D PRINTERS & SCANNERS FOR JP & BR STATEMENT OF WORK Privacy Statement: Contractor shall adhere to all VA Privacy & Security, and Privacy Act and HIPAA requirements if exposed to protected health information (PHI) or when obtaining or reviewing information. This includes all log files, error traps, screen capture images and database query results used to aid staff with product troubleshooting or product support activities. Introduction VA Boston Healthcare System is looking to procure (4) Dental 3D PRINTERS AND SCANNERS for Jamaica Plain and Brockton. Intra oral scanners are of digital devices that takes impressions of oral structures. The digital file is then combined with the Dicom image files from the Conebeam CT for the dentists and dental lab technicians to digitally plan dental implant surgeries, make surgical guides (3D printing) or to design dental prothesis. The 3D printers are then feed the designed surgical guides or dental prosthesis and manufacture them using 3D printing technology. Background This procurement will help the dental service, replacing analog impressions reduces or eliminates the need to buy impression material and pay shipping costs. The digital workflow helps to reduce costs since the impressions don't need to be shipped to the lab and stored in the practice. A 3D scan eliminates the need to take alginate or PVS impressions, which are often less accurate and more uncomfortable than digital impressions. The 3D scanner digitally captures the structure of your teeth and gums through a small, hand-held, and radiation-free wand. Most people are worried about x-rays because of radiation, and they have a right to be. However, you should not be worried about the radiation emitted by a 3D x-ray machine because it is extremely small. These machines have even been cleared by the American Academy of Pediatric Dentistry to be used on children. Scope The scope of this procurement is a technology upgrade. The vendor will perform all work associated with installing the hardware in the Dental clinics in Jamaica Plain and Brockton. The scanner must fit in the existing spaces. Deliverables The contractor shall be able to deliver and install all hardware, software, and support for the installation and proper functioning of these Dental Nobel Biocare 3D printers and scanner systems, for Jamaica Plain and Brockton. Applicable Directives The contractor must comply with the rules and regulations of the Veterans Affairs Administration. All contractors accessing the equipment during installation and training must be certified (i.e., proper approval shall be obtained from the VA Information System Security Officer). The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. All contractor personnel (without exception) must report to the Clinical Engineering Department, to sign in where a contractor identification badge is verified before any work is performed. Contractor personnel will be escorted by Clinical Engineering staff for the duration of work performed and return to the same location to sign out and turn-in documented service report for the service performed. If there is a need to replace any hard drive, a hard drive, and all information on it, is the property of the VA and must remain in the control of the VA Clinical Engineering department for Medical Destruction. Records Management Language: The following standard items relate to records generated in executing the contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C241-24-AP-1901 Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, VISN 1, Togus VA Medical Center, Togus VA Medical Center, 1 VA Center, Augusta, ME 04330-6796. Funding 523-24-2-7821-0044. Nature and/or Description of the Action Being Approved: This is a new, brand name, sole source requirement. The Contracting Activity is looking to acquire dental equipment manufactured by OEM LB NOBEL BIOCARE (UEI: MPZPHDXKAHL7) 200 S KRAEMER BLVD BLDG E BREA, CA 92821 for Jamacia Plain VA Medical Center s Oral Surgery Department. Total Contract Value ____________ Description of Supplies/Services Required to Meet the Agency s Needs: VA Boston Healthcare System is looking to procure (4) DEXIS IS 3800W Scanners, (6) DEXIS IS 3800 s, (3) SprintRay Pro 55 s, and (3) SprintRay Pro 55 s along with various dental accessories for their Jamaica Plain and Brockton Campus. Intra oral scanners are digital devices that takes impressions of oral structures. The digital file is then combined with the Dicom image files from the Conebeam CT for the dentists and dental lab technicians to digitally plan dental implant surgeries, make surgical guides (3D printing) or to design dental prothesis. The 3D printers are then feed the designed surgical guides or dental prosthesis and manufacture them using 3D printing technology.The IS 3800W wireless scanner is a wireless intraoral scanner with a high-performance experience. The scanner offers up to one-hour of continuous scanning. The smart charging station, back-up power cable and optional extra batteries and charging unit ensure the scanner is always ready for use. The DEXIS IS 3800W is a completely novel approach to obtaining impressions. Totally wireless, the IS 3800W gives the freedom to move effortlessly and take on practically every indication. The Dexis IS 3800 is Nobel BioCare s premium wired scanner. The IS 3800 weighs only 190 grams and is one of the lightest intraoral scanners in the market with a compact form factor that fits comfortably in the hand. The SprintRay Pro55 is an ultra-high-resolution printer. SprintRay Pro55 is the perfect 3D printer for jobs that require razor-thin margins without all the hassles that come with other manufacturing methods. It s the ideal tool for 3D printed definitive crowns, multi-unit temps, hybrid dentures, and much more. The SprintRay Pro95 is a production workhorse with the accuracy and throughput for all manner of dental appliances and also SprintRay s fastest printer. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR 819.7009 (DEVIATION) up to $5,000,000. Check the specific VAAR clause used below: ( X ) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; The manufacture for this equipment was contacted via email at mark.dzierzgowski@envistaco.com and hannah.booko@envistaco.com . Nobel BioCare is a global innovator of dental solutions and Nobel BioCare is part of Envista Holdings Corporation, a global family of more than 30 trusted dental brands including Nobel BioCare, Ormco, DEXIS, and Kerr United. On 11/27/2024 I contacted OEM LB Envista s Development Executive, Universities Hannah Booko to inquire if Envista has any Service-Disabled Veteran Owned Small Business (SDVOSB) , Veteran Owned Small Business (VOSB) or Small Business (SB) that qualify as authorized distributors of this dental equipment. On 11/28/2024 Envista s Director of Strategic Markets, Mark Dzierzgowski informed me that their dealer partner is SDVOSB ProAlliance Corp, and they are the only one s authorized to provide both Nobel and Dexis equipment. or ( ) 819.7009 Sole source awards to a certified veteran-owned small business Demonstration that the Contractor s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): West Haven VAMC s Dental Department is seeking a technology upgrade, digital scanners and printers that can work with the design of VA s dental prosthesis. Dexis scanner meets IT/security requirements for VA. Another brand iTero was denied by IT along with not being compatible. No software subscription fees, open access scanner, local support reps. Scanner offers up to one hour of continuous scanning with scanning time of 25 seconds per arch, which will free up time to focus on patients. Can capture 3800W s enlarged at 16mm x 14mm field of view and 21mm depth of capture which ensures details are noted precisely for patients. Scanner is lightweight and portable with interchangeable tips reducing consumable costs and ensures proper sterilization which benefits patients at the Boston VA Dental. Biomed section was consulted to ensure compatible as well. SprintRay 3D printers are made for dental other brands looked into were too expensive or were made for laboratories. Have tried other brands such as Formlabs which haven t worked as well or held up with demand which leads to repair costs and patient care being interrupted. FDA compliant while also the emphasis has been on improving mechanical properties to provide intraoral parts that have great strength and a high resistance to wear. Important to choose a 3D printer that offers support for third-party materials. SprintRay Pro can produce a full platform of dental arches in around 25 minutes. Simple touchscreen interface, swivel hood, and magnetized build plate, 5 minutes is all that it takes to turn the printer around for another job. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies: The Contracting Activity published a Special Notice on Contract Opportunities as an Intent to Sole Source to SDVOSB ProAlliance under solicitation ID: 36C24124Q0352 on 03/13/24 with a closing date of 03/19/2024. To date no relevant responses have been received. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This procurement will help the dental service, replacing analog impressions reduces or eliminates the need to buy impression material and pay shipping costs. The digital workflow helps to reduce costs since the impressions don't need to be shipped to the lab and stored in the practice. A 3D scan eliminates the need to take alginate or PVS impressions, which are often less accurate and more uncomfortable than digital impressions. The 3D scanner digitally captures the structure of your teeth and gums through a small, hand-held, and radiation-free wand. Most people are worried about x-rays because of radiation, and they have a right to be. However, you should not be worried about the radiation emitted by a 3D x-ray machine because it is extremely small. These machines have even been cleared by the American Academy of Pediatric Dentistry to be used on children. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Contracting Activity queried various Government wide databases of contracts and other procurement instruments which included VetBiz, FPDS, VetCert, SBA DSBS, and GSA e Library. The Contracting Activity conducted its first search on VetCert using NAICS Any Other Facts Supporting the Use of Other than Full and Open Competition: None, this procurement will be sole sourced to SDVOSB ProAlliance, the only vendor authorized by Envista Co to provide their Dexis and Nobel BioCare line of equipment using the authority under 38 USC 8127(c). Listing of Sources that Expressed, in Writing, an Interest in the Acquisition. SDVOSB ProAlliance Corp., (UEI : PRFPQB8APUG7), ProAlliance Corp, 300 W Front St Ste 203K, Harvard, IL 60033has expressed interest in this acquisition in writing several times on 12/13/23, 12/26/23, 02/06/24, and 02/27/24 through email correspondences. 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: No actions are planned. Boston VA Healthcare System s Dental Staff will continue to research new and innovative technology that may better outcomes for acquiring dental impressions and consider that equipment for future procurements when the need arises. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.
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