36C25526Q0667.pdf

36C25526Q0667

This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing.

The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potentially qualified businesses capable of providing the following:

Primescan AC Intraoral CAD/CAM Scanner (Cart Configuration) – Brand Name Only *** See Statement of Requirement below for details ***

If this is within your capability, please respond with the information below:

• Company Name

• Address

• Point of Contact

• Phone, Fax, and Email

• UEI number

• GSA Contract (as applicable)

• Capability Statement that clearly and convincingly identifies your ability to fulfill this requirement.

• References, with contract numbers, demonstrating the successful completion of work like the work required in this Sources Sought, performed in the past.

• Brochures of products being offered, to include specifications.

• Authorized service provider letter from OEM.

• Country of manufacture for each piece of equipment.

Interested firms are reminded that in accordance with FAR 4.203, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.203-1(b) states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in Small Business Search at https://search.certifications.sba.gov/.

Please include reference number 36C25526Q00667 in all correspondence regarding this Sources Sought.

Point of Contact for this Sources Sought is:

amanda.williams16@va.gov Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048 https://search.certifications.sba.gov/ mailto:amanda.williams16@va.gov

Statement of Requirement Primescan AC Intraoral CAD/CAM Scanner (Cart Configuration) – Brand Name Only

OBJECTIVE

The Robert J. Dole Veterans Health Administration in Wichita, KS requires one (1) Primescan AC Intraoral CAD/CAM Scanner (cart configuration) for the Dental Department. The Dental Department has transitioned from traditional impression techniques to advanced CAD/CAM technology for laboratory-fabricated dental restorations. Currently, the Dental Department utilizes a Primescan AC Intraoral CAD/CAM Scanner and is requesting a second Primescan AC Intraoral CAD/CAM Scanner to meet increased demand and patient need, while procuring equipment that is compatible with the existing software, networks, and workflows.

SCOPE OF WORK

The contractor shall provide all labor, equipment, materials, supplies, installation, configuration, integration, and training necessary to provide one (1) Primescan AC Intraoral CAD/CAM scanner (cart configuration) ready for clinical use.

The scope includes:

• Delivery of hardware, accessories, and all supporting documentation

• Onsite installation with IT and Biomedical Engineering coordination

• Integrate system with existing VA networks and CAD/CAM workflow

• Provide warranty and support documentation

• Conduct onsite training for clinical and technical staff

• Provide service support and maintenance during the warranty period

• Ensure all supplied items meet VA, FDA, and cybersecurity requirements

TECHNICAL REQUIREMENTS

The Primescan AC Intraoral CAD/CAM scanner must include, at a minimum, the following salient features and characteristics:

• Scanner type:

o 3D high resolution intraoral scanner with heated scanning components to enable uninterrupted, accurate imaging

• User input:

o Hand and foot-controlled enter keys

• Connectivity:

o Integrated ethernet and WLAN network capabilities o Multiple USB interfaces o Touchpad display

• Processing:

o Integrated image processing and scanner control electronics

• Mobility:

o Cart configuration for easy movement between operatories

• Operating System:

o Windows 11, 64-bit or the most recent VA-approved version o Fully compatible with VA IT architecture

• Workflow Compatibility:

o Seamless integration with existing and future CAD/CAM systems, including:

CEREC

Prime Mill SpeedFire 3D printing fabrication processes

• Regulatory Compliance:

o FDA-approved for clinical use o Meets all VA, industry, and federal medical device standards o Equipment and software must not require external cloud storage or processing

• Documentation:

o English-language technical manuals, warranty certificates, and service/support contact information

• Safety:

o Device must be certified for use in clinical and patient-care areas

• Warranty:

o Minimum one (1) year manufacturer warranty covering parts and labor

DELIVERABLES

CLIN 0001 – PrimeScan Intraoral CAD/CAM Scanner (Cart Configuration) – Brand Name Only

QTY: 1 EA

• In accordance with Statement of Requirement – Technical Requirements

CLIN 0002 – Installation

QTY: 1EA

CLIN 0003 – Warranty

QTY: 1EA

SECURITY REQUIREMENTS

VA Data Security: The device must not store, process, or transmit Protected Health Information (PHI) or any patient identifiers to systems or servers outside VA’s secured IT environment.

Under no circumstances shall data leave the VA network or be stored/processed in third-party or cloud environments.

Network Connectivity: All network connections must conform to VA Office of Information & Technology (OI&T) cybersecurity policies. Configuration, implementation, and connectivity will require VA OI&T approval prior to integration.

IT Compliance: The contractor must provide a Manufacturer Disclosure Statement for Medical Device Security (MDS2) upon delivery and complete any/all IT security checklists required by VA, including submission to and assessment by the VA Technical Reference Model (TRM) process if not already listed/approved.

Access Control: Any temporary access to the VA network required for installation or support must be coordinated with VA IT and Biomedical Engineering, with all access promptly revoked at project completion.

Data Disposal: Contractor must ensure that no PHI remains on the device or associated media at project completion or device disposal, in alignment with VA Handbook 6500 and NIST SP800-88 standards.

Personnel: All contractor personnel performing work onsite must complete VA security/privacy awareness training before beginning work and must adhere to all VA privacy, confidentiality, and security policies.

DELIVERY SCHEDULE

30 days after receipt of order (ARO)

DELIVERY LOCATION AND HOURS

Delivery Location:

Robert J. Dole Medical Facility 5500 East Kellogg Ave Wichita, Kansas 67218

Work must be performed during regular business hours: Monday–Friday, 8:00 AM–4:30 PM CST, excluding Federal Holidays.

After-hours work requires pre-approval from the Dental Department.

Contractor must adhere to all VA access, safety, and privacy protocols while onsite.

All maintenance, repair, and support services must be coordinated through authorized VA channels.