Frequently Asked Questions

Transcription

1 Frequently Asked Questions Process Questions: How am I sure that only de-identified data is being transmitted? The automatic default setting for Virena ensures that patient identified data is not transmitted or received. What data will be available for an organization to view? The following 38 fields of data will be available for an organization to view: Run Date and Time Sofia Serial Number Operator ID Analyte Name Test Result Facility Name SNOMED Code LOINC Code Instrument Type Time Zone Facility Address Firmware Revision Contact Name Contact Contact Phone Facility State Facility City Test Flag (final or Resent) Comment Organization Facility County Patient Age Patient Status Demographics Site ID Facility Country Kit Lot Number Cassette Lot Number Cassette Number Order Number Storage Date and Time Router Type Virena Router ID Assay (Flu, Strep, etc.) Registration Date Result Type (Patient, QC, Calibration) Assay Type = Assay number Transmission Date and Time Who is able to see the data? Access to the Virena website myvirena.com is given only to an organization s administrator and any approved authorized users. Changes to the organization s administrator or authorized users may be made by notifying Quidel by letter or via . By participating in the Virena surveillance program, an organization will provide encrypted, de-identified data to clouds administered by Quidel, for quality check and preparation for provision to public health agencies or other entities authorized by the organization. Therefore, surveillance sites will be able to view defined data fields described below. What Information will surveillance sites be able to view? To provide actionable surveillance information, surveillance sites will have access to the following fields of data: Run Date and Time Site ID Operator ID Analyte Name Test Result Facility Name SNOMED Code LOINC Code Organization Time Zone Facility Address Facility City Facility State Facility County Facility Country Patient Age Patient Status Comment Assay (Flu, Strep, etc.) Assay Type = Assay Number Transmission Date and Time Page 1 of 5

2 How often is data downloaded to the Virena website? Myvirena.com is scheduled to update once daily at 08h00 UTC. Quidel has the ability to change the frequency of downloads if circumstances warrant. How is data accessed from the website? Data is accessed by logging into myvirena.com and choosing the option to export a CSV file. This file may be imported into Excel. Also, through myvirena.com, a customer may generate reports and create charts that are available for printing and/or exporting. Only those users who have been authorized by your organization s administrator and Quidel will have access to the website. Authorized users will only be able to access data from their own organization. Why share data with Public Health? The primary goal of our public health surveillance is to provide an early warning system, allowing for intervention, prevention, and containment of disease. By providing patient de-identified data, an organization will be supporting their community, state, and nation s well-being and safety. How does Virena work? How does the Virena router connect to Sofia? If a laboratory has cellular wireless coverage, the standard configuration is to connect the Sofia to the Virena router using the provided Ethernet cable. The following are visual depictions showing how a Sofia can be connected to a Virena router. 1. Direct cellular transmission of data. Connect one Sofia directly to a Virena router via an Ethernet cable and send encrypted data through a cellular transmission to a secured database (Figure 1). Virena Clouds Figure 1 2. Direct cellular transmission of data from multiple Sofia(s). Connect one or more Sofia(s) to a Virena router via an Ethernet cable or LAN (local area network) and send encrypted data through a cellular transmission to a secure database (Figure 2). Page 2 of 5

3 Virena Clouds Figure 2 3. Wide Area Network (WAN) transmission of data. Connect one or more Sofia(s) directly to a Virena router via a LAN and send encrypted data through an internet transmission via a facility s WAN to a secured database (Figure 3). Virena Clouds Figure 3 Can one Virena router be used for multiple Sofia(s) in different locations? One Virena router may be linked to multiple Sofia(s) located at different sites (see Figure 3). The Virena router needs a fixed IP address to be assigned by an organization s network administrator. As more Sofia(s) are added through a local area network (LAN), you can configure each Sofia to communicate directly with the IP address of the Virena router. What type of connection is used? In the United States, Virena cellular wireless coverage is currently provided by Verizon or alternatively the Virena can transmit via the facility s internet connection. Quidel has negotiated for international cellular wireless coverage to be used with the Virena system. The carrier is dependent upon the customer s location. Do IT departments need to be involved in the installation? It depends on the configuration and the organization s policies. Does using Virena impact workflow? The Sofia and Virena router are pre-configured to require minimum set up time and effort at the user s facility. Results will automatically be sent to the router once completed. The operator does not need to take any action. Page 3 of 5

4 It is recommended for surveillance purposes to include basic demographic information such as age and patient status (in-patient or out-patient). In addition, the Sofia includes four additional demographic fields that may be defined by an organization for improved data gathering and analysis. Administrators and users are prohibited from including patient identifiable information in these fields. What if there is no cellular service where the Sofia is located? If a facility does not have cellular coverage, Virena may be installed through a facility s LAN and data will be transmitted via the WAN internet. Alternatively, the Virena router could be moved to a location where there is cellular service. What countries does the cellular service currently support? At this time Virena can support cellular surveillance in many countries. Please contact Quidel Technical Support for specific information regarding your country. Does Virena use WIFI? No. The Virena router does not have WIFI capabilities. The router must be connected by an Ethernet cable or LAN connection to the Sofia(s). How secure is the data? The data coming from Sofia to the Virena router is encrypted with a proprietary algorithm. Then, communications from the Virena router are secured again by using standard internet techniques (SSL over TCP/IP). The only information that is not encrypted is the serial number of the Sofia. Financial Questions How much is Virena? The investment in Virena is based upon the number of Sofia(s), the number of Virena routers and the type of connection required (cellular vs. internet). Please contact your Quidel Account Manager for a formal assessment and estimate. An investment in Virena requires the following components: Sofia, Virena router, remote installation fee and an annual access fee per Sofia. Additional customized support and services are available at an additional fee including: on-site installation, associated travel, on-site support and on-site training. As a reminder, Virena is very simple to install and activate so these additional services will only be required in special circumstances. How will Virena be billed? (Domestic and International) The installation and routers are an initial investment paid upon invoice. The annual access fee is typically payable in quarterly installments commencing 30 days from the effective date of the agreement. The annual access fee will cover up to 5 MB per month of data transmission; additional usage beyond the 5 MB per month of data may incur additional charges. What does the Virena access fee cover? The Virena access fee covers the Virena website, data transmission, support and costs of managing data and cloud usage. How often will updates occur? Our estimate is 1-2 times per year. Page 4 of 5

5 Will there be a charge for updates? Any update that improves a current feature or communication is included in the Virena program. If Quidel offers additional, new features, you have the option to purchase such features at an additional fee. Why is a Virena router more expensive than a retail router? The router used with Virena is a commercial grade router that utilizes special functionality. Quidel worked closely with our supplier to develop this customized router that provides Sofia specific programming, configurable routing and switching capabilities. Service Question How do I get technical support? Please contact Quidel Technical Support at (in the U.S.), (outside the U.S.) or technicalsupport@quidel.com if you have any questions regarding Virena or any Quidel product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time. 1211MI0713D-1 (12/13) Page 5 of 5