Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

Dentsply Sirona AXEOS 3D Panorex X-Ray Unit Statement of Need Background: The Lebanon VA Medical Center (LVAMC) has an Urgent need for a brand name, firm fixed price requirement for one (1) Dentsply S... Dentsply Sirona AXEOS 3D Panorex X-Ray Unit Statement of Need Background: The Lebanon VA Medical Center (LVAMC) has an Urgent need for a brand name, firm fixed price requirement for one (1) Dentsply Sirona AXEOS 3D X-Ray Unit, SiCAT Software, Implant and Airway Included, and multiple Schick 33 #1(16), and #2(4) Sensors, Windows 10 Workstations (28), SIDICOM, Xeon Quad Core 3D Server (RACK), and Cerec Primescan accessories. Installation, Clinical Training, Biomed Service is included. Scope of Work: The current Panorex 3D Xray Unit the facility owns is no longer working properly. It is no longer fiscally responsible to repair the current unit and is a patient safety issue. Therefore, a new unit is to be purchased. The Dentsply, Sirona Unit mentioned above is the unit required based on quality of imaging, durability, and that it has CEREC Primescan and CEREC MC integration which are other Dentsply systems utilized in conjunction with this unit and dental care within the LVAMC. The software and equipment are completely integrated with each other for single click user deployment from product to product. Salient Characteristics of the Brand Name Dentsply AXEOS 3D X-Ray Unit: Provides a combo of 2D and 3D imaging with DCS Sensor Must be on the VA approved DICOM Modality list VistA Imaging Approved DICOM Modality Interfaces (va.gov) Includes endodontic option Includes Software with a feature for simultaneous display of multiple images obtained from a variety of sources. Allowing side-by-side anatomical comparisons on the same screen. i.e. CBCT, Digital X-ray, and Face Scan images Includes Integrated Implantology Has a SICAT function for simple workflow and functional diagnosis and therapy for misc. conditions. Sharp Layer Technology Metal Artifact Reduction for 3D Images providing a High Resolution of 100 µm Has automatic positioning aids which are easily operated by users. Offers choice of multiple volume selections for endodontic treatment and simple implant planning. Wheel Chair Accessible Maximum operations space requirements Width 55 in. Height 96 in. Depth 59 in. Intraoral #2 and #1 Sensors (16/4) - 9 ft. From Computer USB Port to Intraoral sensor must reach a minimum distance of 20ft Must be on the VA approved DICOM Modality list VistA Imaging Approved DICOM Modality Interfaces (va.gov) USB Cable 5M Software for Viewing, Capturing, Image Processing of Intraoral X-rays, 2D and 3D Panographic X-rays, and Reconstruction of 3D images. Software must be TRM approved Must be the newest approved version listed in the Decisions tab or if newer, a TRM request will need created and approved prior to purchase https://www.oit.va.gov/services/TRM/SearchPage.aspx Viewing Capability for a minimum of 35 concurrent users Intraoral Image processing for a minimum of 16 concurrent users 3D Reconstruction processing for up to 10 concurrent users Must integrate with SimplantPro Version 18 software Software must include Endodontic specific tools to assist with Endodontic treatment planning Integrate with VISN MiPACs software Integrate with VA EHR Vista Integrate with Incoming VA EHR Cerner 3D Reconstruction/Viewing Software Storage Server Rack Style Must Run Windows Server 2019 or newer Minimum 5TB SSD Hard drive Capacity Must meet Software and Panographic X-Ray Minimum Required Specs Minimum 1GB/s Network RJ-45 ports (2) Windows 10 64bit Workstations (28) Minimum 1TB SSD Hard drive Minimum 16GB RAM Graphics Card that meets or exceeds 3D reconstruction minimum requirements Minimum 1GB/s Network RJ-45 port Able to be VA Gold Imaged Must be on the Attached Approved List Technical Stats: AXEOS 3D X-Ray Unit User Interface: EasyPad Patient Positioning: Standing/Sitting, chin support/bite block, occlusal bite block with automatic patient positioning, universal bite block with colored stop positions Cerec Integration simultaneous prosthetic and surgical planning Views: Ceph lat., Ceph p.a./a.p., freely tiltable 2D slices, PAN with 3D slice navigation, TSA, LSA, axial, sagittal, coronal, 3D model, implant-oriented, high resolution detail volumes Retrofit Options: Airway Volume, Ceph Autofocus Direct Conversion Sensor Cerec Primescan Brand Name Accessories Salient Characteristics: SpeedFire Oven Disposable Camera Sleeve Primescan Sleeve Primescan Sapphire, Spare Delivery: Delivery shall be within thirty (30) days from the time of award. Need date is 1/1/2020. The Dentsply Sirona AXEOS 3D model Panorex unit and accessories shall be delivered to the Lebanon V AMC located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn; Warehouse. Bio-Medical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. 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. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. e. 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. 3. VA INFORMATION CUSTODIAL LANGUAGE a. 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). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. 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. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor must accept the system without the drive; (2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least three (3) relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 9. TRAINING a. 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.