A04 STATEMENT OF WORK lns edits rpd lns.docx

STATEMENT OF WORK (SOW)

1. Title. Dental Cone Beam Computed Tomography (CBCT) Brand Name or Equal, Dexis i-CAT FLX 17.

2. Background.

The Fort Hall Service Unit (FHSU) Dental Clinic has limited extraoral 2-D radiography capability and no 3-D radiography capability at this time. This limits provider ability to screen for TMJ disorders, diagnose orofacial fractures, assess periodontal bone topography in a non-surgical manner, and provide preliminary assessment of bone for implant placement candidacy. Additionally, the FHSU dental clinic does not have the capability to take extraoral radiographs via segmented imaging for pediatric, geriatric, and special needs patients who struggle with intraoral imaging as well as patients with severe gag reflexes.

3. Scope.

The scope of this project is the installation and configuration of a cone beam computed tomography (CBCT) unit and supporting equipment such as power conditioners. Required operational software will be installed and file storage configured on the attached Windows PC workstation (Windows 11) as well as the facility server. The CBCT unit will be calibrated and tested after installation. Dental clinic providers and staff will be trained on the use of both the CBCT unit as well as the operational software. The installation will include software bridges to existing dental imaging software (MiPACs) and electronic dental record (Dentrix Enterprise).

4. Specific Tasks or Specification.

The Fort Hall Service Unit, Dental Clinic, requires a cone beam computed tomography unit (Dexis i-CAT or equivalent) to include installation, a full license for CBCT software (e.g. Romexis or equivalent), available software bridge to MiPACs, wall mounted power conditioner, five (5) year service warranty, and onsite training of Government personnel of all equipment related to this purchase.

4.1 CBCT MINIMUM SPECIFICATIONS: The CBCT must (at a minimum) comply with the following salient characteristics:

Capability Panoramic radiography

Pediatric imaging capability for for all imaging listed above Imaging software

All in one sensor, that does not require alteration or exchange between 2-D and 3-D imaging modes All surfaces of the unit that may come into contact with patients must be compatible with a readily available disinfectant wipe, such as Caviwipe 1 or Clorox Healthcare Hydrogen Peroxide Disinfectant Wipes. Those areas that cannot be wiped should be clearly delineated in the manufacturer’s instructions for use, and should be barrier compatible.

All required accessories for imaging, such as dentulous and edentulous rests.

The unit should fit into the existing space 50” width x 52.5” depth x 94” height.

The largest field of view should be a minimum of 16cm x 10cm.

The unit should include seating to accommodate elders and mobility impaired patients.

4.2 Training

Onsite training for providers and dental staff, during office hours of 8:00 am and 5:00 pm (Mountain Standard Time), excluding Federal Holidays.

Telephone support for the lifetime of the machine

4.3 Warranty

4.4 INSTALLATION: The Contractor shall provide all personnel, equipment, tools, materials, supervision, transportation, and other items needed to setup/install the requested equipment. The installation technician should possess current installation credentials from the Original Equipment Manufacturer (OEM). Delivery should be scheduled during 0800-1600 Mountain Time, Monday through Friday, excluding federal holidays. The facility does have a loading dock. The existing panoramic unit will be removed by IHS facilities personnel prior to installation. Should the new CBCT unit require a different power supply than what is currently utilized, all electrical modifications will be made prior to delivery.

The Contractor shall install all requested equipment in accordance with manufacturer’s specifications. The Contractor will supply all tools, equipment, labor, and materials required to perform the delivery, installation, and training services as specified in this Scope of Work.

The Contractor shall ensure proper operation of the installed CBCT and operation software on workstation.

The Contractor shall calibrate the CBCT according to manufacture specifications.

Any equipment not functioning properly to manufacturer’s specifications shall be diagnosed and repaired by the Contractor.

Installation may be conducted after normal business hours, if feasible and agreed upon by both parties.

All manuals, operating instructions, and other materials shall be provided after installation is complete.

4.5 TRAINING: The Contractor shall conduct training of entire CBCT system to Government personnel. Training shall be conducted onsite at FHSU by a trainer with current training credentials from the OEM.

The Contractor will be available to remediate any installation-related issues as identified by the OEM technical support for 120 days after installation.

Vendor must be an authorized reseller for the Original Equipment Manufacturer (OEM) for the CBCT unit. Additionally, the installation technician and trainer should also be certified by the OEM for their respective roles. Proof of these certifications should be available upon request.

Delivery

1. Prior to delivery, the installation technician will coordinate with the FHSU Facilities Supervisor (208-238-5414) and Dental Supervisor (208-238-5422). This will include specification of the type of electrical outlet and power supply needed should the unit require something other than a standard 110V outlet.

2. The unit and all required accessory equipment (e.g. power conditioners) will be delivered to the FHSU loading dock in appropriate protective packaging. The installation technician will inspect the unit prior to installation for damage that might have occurred during shipping. If damage has occurred, or if the shipment is incomplete, the technician will work with the vendor to rectify any issues without incurring any additional cost to FHSU.

3. The technician will install the unit in the existing panoramic booth area. Any accessories such as power conditioners will be securely mounted, and required network and power cables connected.

4. Prior to the installation of the unit, the vendor or manufacturer’s support technician will contact the FHSU IT team at 208-238-5406 to install and configure both server and workstation software.

5. Once on site, the installation technician will verify correct installation of software interface and image storage via testing of the CBCT unit.

6. The CBCT unit shall be configured and tested according to the manufacturer’s instructions for use. A hard copy of these instructions will be left with the FHSU dental team.

7. On-site training for FHSU personnel shall be coordinated with installation to minimize disruption in services availability in the FHSU clinic. Facilities and IT personnel will be trained in the maintenance of the unit and operational software. Full physical documentation shall be left with the FHSU dental team.

8. Telephone technical support for both unit and operational software will be available during normal business hours for the duration of the warranty.

9. At the conclusion of the warranty period, the vendor and/or manufacturer will offer options for contracting extended service and warranty periods.

5. Performance Monitoring (if applicable).

The FHSU Contracting Officer Representative will monitor performance throughout the installation phase, training phase, and warranty phase of this contract. Deviations from performance standards will be immediately reported to the contracting officer for remediation.

6. Security Requirements.

The vendor and/or manufacturer will ensure that all installation and support personnel who may have access to FHSU systems, data, and patient information will have undergone training in HIPAA, HITECH, and other applicable data security training. Any breach of IT security that may possibly have exposed FHSU or Indian Health Service (IHS) systems, data, or patient information will be reported within twelve (12) hours of discovery to the FHSU IT team and the FHSU chief dental officer. Contact information for FHSU staff will be provided.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

The government will furnish a Windows 11 workstation (i7-8700 with 24GB RAM) for connection to the CBCT unit. Should the needs of the unit or operational software exceed this workstation, the vendor should include a workstation that meets required specifications in their bid (please note – operating system must be Windows 11 Pro 64 to ensure network compatibility).

8. Other Pertinent Information or Special Considerations.

None

a. Identification of Possible Follow-on Work.

FHSU would like to have the option for extended service contracts following the conclusion of the warranty period.

b. Identification of Potential Conflicts of Interest (COI).

None.

c. Inspection and Acceptance Criteria.

Initial inspection of the unit while in packaging will take place upon delivery. Any visible damage to the packaging or unit will be immediately reported to the vendor with photographs of said damage included in the notification. Upon installation, the unit and all accessories will be in new, unused condition free from defect or blemish upon installation. The installation technician will demonstrate the unit’s full capabilities to the chief dental officer, IT specialist, and/or their designees at delivery.

9. Risk Control Vendor will notify the FHSU chief dental officer at least two weeks prior to projected installation and training date. This will allow for the clinic schedule to be modified to allow for maximum dental team involvement in training and minimum patient traffic during installation. The FHSU dental clinic has a strong preference for installation on Thursday mornings during the clinic administrative time. Should training and/or installation take place during periods of active patient care, all vendor and manufacturer personnel will be provided with personal protective equipment appropriate for their proximity to patient care areas. They will also be provided with a brief orientation concerning the adjacent sterilization area (e.g. contaminated areas that should not be touched).

10. Place of Performance / Delivery Address.

Fort Hall Service Unit 33 N Mission Road Fort Hall, Idaho 83203

Should the vendor or manufacturer personnel be arriving by air, the closest airports are Pocatello Regional Airport (PIH) and Idaho Falls Regional Airport (IDA), both of which are served by major airlines. The Shoshone-Bannock Casino Hotel is the closest lodging to the FHSU clinic, and there are multiple additional lodging options in Pocatello, Blackfoot, and Idaho Falls (15, 20, and 45 minutes away respectively).

11. Period of Performance.

Shipping fees must be included in the quotation, at a firm fixed price.

Contractor shall deliver equipment to the Fort Hall Service Unit Dental Clinic, located at 33 N Mission Road, Fort Hall, Idaho 83203 Delivery will be no later than sixty (60) days, after receiving order. Training will be scheduled the next business day following installation.

12. Delivery Schedule.

Vendor shall provide written documentation on delivery that includes a minimum of manufacturer’s instructions for use, software training manual/materials, warranty information, and technical support contact information. DVD is an acceptable alternative to written.

13. Privacy

1. Privacy PRIVACY ACT (as amended by 5 U.S.C. 552a)

(a) The Contractor agrees to—

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies—

(i) The systems of records; and

(ii) The design, development, or operation work that the contractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a system of records on individuals that is subject to the Act; and

(3) Include this clause, including this paragraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a system of records.

(b) In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency.

(c)(1) “Operation of a system of records,” as used in this clause, means performance of any of the activities associated with maintaining the system of records, including the collection, use, and dissemination of records.

(2) “Record,” as used in this clause, means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and that contains the person’s name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint or voiceprint or a photograph.

(3) “System of records on individuals,” as used in this clause, means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

Privacy or Security Safeguards (Aug 1996)

(a) The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

Indemnification

Indemnification, Liability, Statute of Limitations: Any provisions in the Terms of Service (TOS) related to indemnification and filing deadlines are hereby waived, and shall not apply except to the extent expressly authorized by law. Liability for any breach of the TOS as modified by this Amendment, or any claim arising from the TOS as modified by this Amendment, shall be determined under the Federal Tort Claims Act, or other governing federal authority. Federal Statute of Limitations provisions shall apply to any breach or claim.

Governing law: Any arbitration, mediation or similar dispute resolution provision in the TOS is hereby deleted. The TOS and this Amendment shall be governed by and interpreted and enforced in accordance with the laws of the United States of America without reference to conflict of laws. To the extent permitted by federal law, the laws of the State of Oregon will apply in the absence of applicable federal law.

14. Payment Schedule

15. Invoicing

15.1 IPP invoicing is exercised with Invoices submitted upon completion of work as specified within this scope of work.

15.2 For payment status, please e-mail the contracting officer representative (COR) on file.

Note: Invoice must match the purchase order in description. Improper invoices will be rejected.

15.3 Upon receipt of the invoice, the COR shall review the invoice(s) for accuracy. Payments will be made after submission of a proper invoice and after the Government accepts the services. Payment shall be made only for services actually completed at the time of invoice submission.

15.4 Administration

The Contract Officer’s Representative (COR) and site contact under this contract shall be provided a copy of the procurement award upon execution. The COR’s responsibilities will be to coordinate with the provider the technical aspects of this service and review of performance hereunder. The Contract Officer’s Representative does not have the authority to change or alter the order amount, terms or conditions of this procurement award.

16 Additional Terms and Conditions

16.1 Indemnification and Liability

The contractor shall indemnify and hold harmless the Government from any claims, liabilities, or damages arising from the performance of this procurement award, to the extent permitted by law.

16.2 Governing Law

This contract shall be governed by and interpreted in accordance with the laws of the United States.