SOW Radiographic Unit Dental Cone Beam.pdf

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Manchester, NH VA Medical Center

Statement of Work

Radiographic Dental Cone Beam 3-D Imaging

Unit

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INTRODUCTION

The VHA Manchester Health Care System has a requirement to purchase Radiographic Dental Cone

Beam 3-D Imaging Unit with an authorized vendor to supply and deliver the item(s) identified in

Table 1 below to properly replace end of life units in our Dental Radiology Department of the clinic.

See salient characteristics below. This is a Brand Name or Equal Requirement. This requirement is in support of the current footprint to include infrastructure for a Carestream CS9600.

Table 1 – Package Item Summary

Item # Item Description Part # (basis of design)

Q t y

1 CS 9600 w/5yrs & 2yrs warranty 1758192 1

2 Patient Seat for CS 9600 family (Included) 5501200 1

3 120KV License for CS9600 Family (Included) 5330642 1

4 Extracoral FMS License for CS 9600 (Included) 5330709 1

5 Advanced Radiology Kit for CS 9600 5940085 1

6 CS Face Scan Kit for CS 9600 5940069

7 PDIP License CSH 2 Workstations 5321948 1

8 Voucher for CS Airway- 2 Activations 5500590 1

9 License Server > 20 users DICOM CS18 5942966 1

Additional Item Requirements

The vendor will provide service manuals that include theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA HTM Department.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

GENERAL CONDITIONS

Site Address

The address of the Manchester, NH VA Medical Center is provided below.

718 Smyth Road

Manchester, NH 03104

Delivery Schedule

Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

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Table 2 – Anticipated Building Outfitting Schedule

Building Name Est. Delivery Start Date Est. Delivery End Date

Manchester VAMC 9/30/2025 60 Days after date of contract award

Schedule and Order Management

2.3.1 The above delivery schedule is based upon the current estimated site work completion.

Due to the nature of the efforts and manpower timelines, dates may vary and shift. Delivery dates need to be flexible. The delivery of items for installation is dependent upon the completion of applicable areas within the building. If there is a delay, the Contractor may be required to adjust the delivery date at no cost to the Government. The Contractor will coordinate with the on-site

POC’s before delivery.

2.3.2 The awardee’s actual delivery dates will be confirmed by VA upon award.

2.3.3 Post-award, the vendor will coordinate delivery identified in this document with the VA

(See Section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO, COR, and the vendor.

Delivery and Receiving

Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact VA POC, Mary Ellen Aleksza at (603) 624-4366 X201752, MaryEllen.Aleksza@va.gov.

☒ Manchester, NH VA Medical Center (Direct Delivery to address detailed in paragraph 2.1)

2.4.1 The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

2.4.2 The delivery of items identified in this document shall take place during normal loading dock business hours which are defined as: 8:00 AM to 3:30 PM Eastern Standard Time, Monday through Friday, and excluding Federal Holidays.

2.4.3 Delivery trucks will not be permitted to remain in the receiving area. Trucks shall be unloaded, moved from the receiving area, and then brought back to the receiving area if required to haul out any waste, tools, or excess materials.

2.4.4 Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product.

Clean Up and Disposal

2.5.1 There are no dumpsters available for vendor use.

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2.5.2 The removal of waste and/or excess material shall be conducted through the loading dock area.

Assembly, Installation, and Calibration Required (Yes ☒ No ☐)

The proposed installation date will occur after delivery of equipment. The current timeframe of delivery is within 60 days after date of contract award.

2.6.1 The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

2.6.2 The vendor is required to coordinate the install with both Healthcare Technology

Management and Dental Service.

2.6.3 The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

2.6.4 The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage that occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur because of the vendor’s (or associated subcontractors) installation.

2.6.5 During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and the VA Medical Center. The on-site representative can be the installer. All instructions provided by COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

Training Required (Yes ☒ No ☐)

2.7.1 The vendor is required to provide live clinical training on set up, operation, shut down, and troubleshooting procedures to nursing staff.

2.7.2 The vendor shall coordinate training dates with the on-site Project Manager. Post-award, these dates will be confirmed with the vendor to meet the clinical schedule.

The proposed training date will occur after the installation of equipment and prior to first patient day. The current timeframe of delivery is within 60 days after date of contract award.

2.7.3 The vendor shall provide documentation and/or certification to each staff member that has successfully completed training.

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Confidentiality and non-disclosure

2.8.1 This equipment does connect to a VA network. Therefore, in accordance with Appendix

A, Handbook 6500.6 Checklist, block 6, the C&A requirements apply to this requirement, and a

Security Accreditation Package is required.

2.8.2 This equipment does hold or stores patient information. Therefore, in accordance with

Appendix A, Handbook 6500.6 Checklist block 7, Appendix B and C provisions apply.

2.8.3 Appendix B: 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.

2.8.4 Appendix C: VA will own this equipment. If a vendor needs access during delivery, assembly, installation or repair, the contractor shall be escorted by a VA employee to ensure there is no exposure to VA sensitive information. The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.

Salient Characteristics

Radiographic Unit Dental Cone Beam 3-D Imaging

Total Quantity: 1

☒ Network Required if Checked ☒ Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked ☒ End User Training Required if Checked

Basis of Design: Carestream CS 9600

Brand Name or Equal Requirement

Description: A dental radiographic unit providing three-dimensional images. The unit uses a cone-shaped beam to acquire an image in a single pass. The unit provides a superior high resolution 3D image with low radiation dosage. Allows comprehensive examination and precise information on the anatomy of a patient’s mouth, face, and jaw areas by producing 3D images of all oral and maxillofacial structures.

Salient Characteristics:

• Shall have 16x 17 edition designed for Implants, Oral and Maxillofacial Surgery, Periodontics, Prosthodontics

• Shall have integrated patient seat that is retractable for wheelchair patients

• Shall have 120KV License

• Shall have CBCT STL file Converter

• Shall have Extracoral FMS License to generate full mouth images from a 2D panoramic exam

• Shall have an Prosthetic-Driven Implant Planning Module (PDIP)for implant planning and verification of implants, abutments, and crowns

• Must be 120V AC, 60Hz, 20A

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• Shall have Airway Software licenses that can automatically segment and measure the upper airway with 3D imaging

• Shall have DICOM Licenses for at least 20 users for dental imaging software to display 2D/3D

Images and CAD/CAM data