K065--Equipment/Software, Polysmith 12 Upgrade - Sleep Lab, IND

Statement of Work for the Richard L. Roudebush VAMC Polysmith 12 and Windows 10 Upgrade Introduction of Required Specifications: Purpose: The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded contractor in relation to provisions, installation, integration and implementation of the upgrade of the Polysmith equipment and HL7 integration/implementation at the Richard L. Roudebush VAMC, Indianapolis, IN. Contractor must provide all necessary tools, equipment/hardware, software, licenses, installation, maintenance, warranty, and training in accordance with this SOW. Primary Goals: This procurement will upgrade the current Government-owned Polysmith to version 12, as well as update the operating system to Windows 10, and custom HL7 integration/implementation. This upgrade will replace equipment that is current reached its life expectancy and bring all Polysmith instruments within the facility to the same configuration. Equipment: All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements for allowable operating system platforms. Industry Standards: Unless otherwise stated, all equipment must be held to current industry standards for such equipment as present within the current market for polysomnography system equipment, supplies, and related services. Contractor must meet all minimum requirements contained in section 1.3. Definitions: Polysmith Sleep System: Polysomnography equipment used to diagnose sleep apnea (OSA) with combined EEG and PSG multi-modality tools, data management, and IT compatible solutions. This system must include amplifiers, processors, software, and hardware necessary to diagnose and treat sleep disorders. Clinical acceptance: Initial Clinical use means the delivered equipment as determined by the Government performs the basic intended clinical function of the system in a safe manner for the purpose for which it was designed, with most or all system functionality, allowing the equipment to be used clinically. This begins the initial Contractor warranty period. Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period. HL7: Health Level Seven or HL7 refers to a set of international standards for the transfer of clinical and administrative data between software applications used by various healthcare providers. Polysmith Software: Sophisticated and easy-to-use software for data acquisition and analysis of sleep. Automated analysis of sleep stages, respiratory events, desaturations. Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period. Somnoware Cloud: The Somnoware Cloud is a web hosted application provided by Somnoware. Equipment Minimum Requirements: Polysmith 12 Upgrade: Computer hardware must be compatible with Polysmith 12 software. Must have two-port NIC card for use in SFF and Tower PCs. Must include Live View Panel Observer software and license. Acquistion and Review Software Upgrades: Must have Polysmith review license for scoring and editing. Must be compatible with existing Government-owned equipment currently in place. HL7 Third Party Interface Customization: 1.4.1 Server and Storage Locations: SQL Server instances that support the Polysmith system are stored on VA provided virtual servers on VA premises. Polysmith HL7 Interfaces (Inbound ADT/ORM) are hosted on VA provided virtual servers on VA premises. Polysmith is configured to store sleep study data on VA provided storage on VA premises. 1.4.2 Third-party communication with Polysmith: Polysmith uses HL7 for communication with third party systems. 1.4.2.1 Hospitals and clinics use complex systems, incorporating many different technologies including medical devices, electronic medical records (EMRs), and Medical Device Data Systems (MDDS). To maintain the best experience, reliability, and security, Polysmith software interfaces with these different medical systems using HL7 to exchange data. 1.4.2.2 The use of HL7 as the standard for data exchange between digital systems provides a common interface to ensure compatibility, interoperability, and interchangeability. Each digital system used in a healthcare environment is developed by different organizations under different quality and regulatory requirements to ensure safety and effectiveness. HL7 allows these systems to remain independent under their own regulatory regimes. 1.4.2.3 Data standards, such as HL7, provide the common language that lets different digital systems work together. A key benefit of the HL7 data standard is that it provides secure access to the right health information when and where it is needed. This reduces data exchange errors between systems. Using the HL7 protocol ensures that Polysmith understands what data needs to be exchanged with other HL7 compatible digital systems. 1.4.2.4 Adhering to the HL7 protocol gives integrators a high level of confidence that their systems can communicate safely and effectively. This avoids custom protocols that would require extensive testing to validate the integration between different digital systems. Furthermore, any changes to a custom protocol require regression testing and continuous development to adhere to the changes. This places a significant burden on both healthcare institutions and their vendors since the likelihood of compatibility errors increases exponentially over time as the systems are updated. The transparency of the HL7 data standard also minimizes the potential for errors, resulting in improved patient care. 1.4.2.5 Lastly, the use of HL7 avoids disruption when a new digital system replaces an existing one. For example, the VA s migration from Vista Electronic Health Record (EHR) to Cerner s MHS Genesis EHR is streamlined since vendors can rapidly implement updates to HL7 messages. Polysmith s HL7 messaging has full customization which does not require customers to wait for a new version of Polysmith. 1.4.3 Polysmith Study Review: Data collected using the Polysmith system requires the use of the Polysmith application to review and score polysomnography data in accordance with contractor Software License Agreement. Scoring and clinical interpretation by VA staff will be done within the Polysmith application as hosted by VA owned IT resources and licensing. Upon completion of scoring and clinical interpretation, the VA staff will initiate HL7 transfer of discrete variables of Polysmith data by initiating the HL7 button within Polysmith. The contractor will provide the discrete data as determined by the VA clinical staff to be sent to the Somnoware via Polysmith HL7. No clinical reports for official use or as determined as official diagnosis will be generated within the Polysmith application. 1.4.3.1 Clinical reports as generated within the Somnoware cloud are the responsibility of the VA clinical staff and Somnoware. The VA has contracted the Somnoware system to store will store Polysmith sleep study data in the Somnoware cloud. Somnoware will use a manual or automated process of their making to perform the action of storing the PSG data collected by Polysmith action. However, this method will bypass the Polysmith DMS database in SQL Server which will prevent any further use of Polysmith DMS features as a result. In context of this paragraph, Polysmith and Polysmith DMS should be considered separate components of the same application. 1.4.4 Customers are notified of new release versions of Polysmith through the DrawBridge licensing system. It is the responsibility of the customer to ensure other third-party systems are aware of new software releases and performing due diligence for compatibility if they choose to install the new Polysmith release. Installation Considerations: 1.5.1 IT systems configuration and implementation for two days, including travel time, configuration and training up to 5 8 systems. 1.5.2 Contractor must comply with all VA mandated and local permitted/safety requirements. 1.5.3 Contractor will dispose of all boxes, trash and debris resulting from installation IAW hospital policy. 1.5.4 Delivery of equipment will be NLT 120 days ARO. 1.5.6 Installation of equipment and/or clinical training will be NLT five months ARO, if applicable. 1.5.7 This SOW includes moving existing Government-owned equipment to a new location. As part of this move the following terms apply: Hospital is responsible for installing the CAT6 cable runs to the new rooms prior to arriving. Also, hospital is responsible for physically moving to the new location once the uninstall is complete and any drilling into the walls. 1.5.8 The facility is responsible for patching, repairing, and/or painting any walls or ceilings affected as a result of either, new equipment being installed, and/or existing equipment being relocated. Support Features: 1.6.1 Telephone Support: Must include 24x7x365 Unlimited Telephone Support, 24x7 Go-Live Clinical Support by Telephone per Department, 24x7 Ongoing Clinical Support by Telephone per Department for the life of the system. This support must be at no additional cost to the Government. 1.6.2 Remote Support: The contractor will ensure they understand and implement the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. The facility will work with the contractor to establish a MOU-ISA for this requirement/equipment. 1.6.3 Moving data/archiving, software performance in the Somnoware Cloud and IT issues related to the Somnoware system will be directed to Somnoware. Contactor support is limited to the local Polysmith acquisition system at the facility and HL7 communication between Polysmith and any third-party system that utilizes a Polysmith HL7 interface. 1.7 Warranty: 1.7.1 Equipment Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period. 1.8 Licensing: 1.8.1 All Polysmith licensing shall be the property of the facility. Instances of Polysmith hosted in the Somnoware cloud will connect to Polysmith Drawbridge Cloud License Server to register and will use VA licensing. 1.9 Cybersecurity: 1.9.1 Facility will sponsor and submit necessary paperwork thru appropriate channels in order for equipment contained in this contract to obtain TRM and/or RMF and/or any other necessary cybersecurity approvals, if applicable. 1.10 Exclusions: 1.10.1 Contractor will not provide support for services, hardware, or software provided by Somnoware. 1.10.2 Contractor is not responsible for presentation of Polysmith data on VA web-based platform. 1.10.3 Contractor is not responsible for presentation of Polysmith data on Somnoware web-based platform. 1.10.4 The VA is responsible for any Windows patching and any security and critical updates for systems owned and operated within the VA domain. 1.10.5 Somnoware is responsible for any Windows patching and any security and critical updates for systems owned and operated by Somnoware. 1.10.6 Nihon Kohden is not responsible for reports, branding, etc that does not belong to Nihon Kohden and/or is generated directly from Nihon Kohden equipment. 1.10.7 Nihon Kohden is not responsible for maintaining any file or document which lists variables and maps data between the Polysmith system and Somnoware. It is the responsibility of the VA and/or Somnoware to maintain this document and its contents. 1.10.8 The facility is responsible for hanging any devises on the wall/ceiling that require drilling behind sheetrock. 1.10.9 The facility is responsible to repair-patch and/or paint any walls or ceilings effected by installation or deinstallation of equipment. 1.10.10 The facility is responsible for any new network or cabling required for the installation of the system. End Statement of Work