ATTACHMENT B - SOW-Specifications.docx
DOCX document 126 KB Posted
- Attached to
- 6515--ENT Guided Navigation System Federal contract opportunity
- Solicitation number
- 36C26223Q1766
About this file
This statement of work outlines requirements for an ENT guided navigation system for the VA Phoenix Healthcare System. The VA seeks to procure a surgical computerized guided navigation ENT system including required software, accessories, power cords, instruments, trays and consumables. The system must be a computerized surgical navigation system designed to guide endoscopic sinus and trans-nasal skull base surgery, dynamically presenting the location of a surgical instrument mapped to a pre-acquired CT scan. Delivery must be within 30 days to an address provided upon award, with installation to be coordinated after hours and on weekends. The contractor must provide standard 12 month warranty and extended warranty options, and all necessary documentation. Installation plans require approval from the contracting officer's representative and engineering.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36C26223Q1766.docx | DOCX document | |
| RFQ Description (ENT Guided Navigation System).docx | DOCX document | |
| Certificate of Compliance (return with offer) NMR Waiver Granted.pdf | ||
| ATTACHMENT A - Salient Characteristics.docx | DOCX document |
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() {SEPG#// EER# //644-110-17-}
36C26223Q1766
Statement of Work/Specifications
ENT Guided Navigation System (Surgical Service)
VA Phoenix Healthcare System 650 E. Indian School Road Phoenix, AZ 85012
1.0 Scope of Work (Purpose)
The purpose of this Statement of Work (SOW) is to procure a surgical computerized guided/navigation ENT system.
· Specifically, this procurement must include required software, accessories, necessary power/accessory cords/cables, instruments/trays, and consumables to enable ENT surgeons to perform complex ENT cases as needed for Veteran care at the Carl T. Hayden VA Medical Center, OR Department rooms located in Phoenix AZ.
The contractor/vendor shall provide the equipment in accordance with this description of the specification and other requirements of this request.
2.0 Specifications & Supplies Description:
2.1. Device Description
· An ENT computer-guided surgical system is a computerized surgical navigation system, designed to guide endoscopic sinus and trans-nasal skull base surgery, dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head.
· The system is designed to allow ENT surgeons to perform basic to complex cases.
· These systems which is a combination of hardware and software, work in conjunction with special trackable instruments to help guide surgeons during surgical procedures. To achieve this guidance, the system tracks the position of a specialized instrument in relation to the surgical anatomy and transmits that information to the software. The software then displays the instrument’s position on diagnostic or intraoperative images of the patient.
3.0 Delivery and Shipping Information. The contractor shall provide the following for shipment and delivery of equipment:
3.1 The Delivery information will be finalized when the Award is made. The primary delivery address is: VA Phoenix Healthcare System, 650 E. Indian School Rd.
· POCs will be provided when the Award is made.
| 3.2 | The Contractor shall be responsible for assessing the Medical Center for all required cabling and other equipment needed for installation. |
| 3.3 | The contractor will assemble the system, uncrate, and set up the new machine in place, and assemble the new unit and make all internal connections. |
| 3.4 | The contractor will re-connect the new unit to the existing utilities and perform the start-up check to ensure proper function |
| 3.5 | The Contractor will consult and coordinate with the in-house Engineering and Bio Medical group to gain access to restricted areas |
| 3.5 | The Contractor will consult and coordinate with the in-house Sterilization Processing Section (SPS) to advise of proper supply/back stock levels of instruments and consumables |
| 3.6 | The Contractor will advise/assist for any future software/hardware upgrades necessary to enable the unit to function at 100% of its designed abilities |
| 3.7 | All installation plans will be reviewed and signed off on by the project COR and engineering representative |
4.0 System Documentation:
| 4.1 | The contractor’s proposal shall provide a complete set of unabridged operator manual, service manuals, electronic schematics, troubleshooting guides, and parts lists for each piece of equipment which is part of the system procured |
| 4.2 | The contractor’s proposal shall provide a complete set of manufacturer’s cleaning guidelines/instruction for each system component that is used |
5.0 Warranty:
5.1 The contractor shall provide the standard 12 months warranty; with options for Bio Medical to purchase extended warranties upon request.
6.0 Period and Place of Performance:
The system must ship within 30 days as this is an essential piece of equipment for the hospital with cases pending.
7.0 Operating Constraints:
| 7.1 | All installation and implementation work may be completed after regular business hours and on weekends due to the impedance of patient care. The hours for installation will be coordinated/agreed upon prior to installation. |
| 7.2 | PVAHCS must have the discretion to defer/hold any installations if locations are not accessible for the installation process. |
8.0 Security Requirements:
| 8.1 | In reference to VHA Handbook 6500.6 Appendix A, blocks 6 and 7, the equipment included in this contract does not capture and process ePHI over the hospital network. |
| 8.2 | In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract may involve connection of IT devices to a VA network. Networking of the date from the unit may be facilitated by the installer, but is the responsibility of IT people at VA. |
| 8.3 | The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract. |
| 8.4 | During install, training, warranty repair and/or maintenance provided by the contractor, they may have physical administrative access to the equipment included in this contract that capture and process ePHI. If warranty repair is done off-site, all hard drives or other data storage devices will be retained by VA and will not be released to contractor. |
| 8.5 | Privacy and HIPAA Focused Training Web-Based (WBT): VA Course No. VA10203 is the official privacy training for VA employees, contractors, and volunteers who have access to facilities, equipment, or information. All contracted employees will complete this training prior to accessing the facility or subject equipment, or to the data therein. The training is available on the VA TMS website at: https://www.tms.va.gov/secureauth35 . Contractor will provide evidence of training to the COR, if requested. |
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