Comparison of connectivity solutions for TB diagnostics


1	A comparison of available data connectivity solutions for TB diagnostics: as of 24 August 2017
2		C360	CDP (Connected Diagnostics Platform)	DataToCare™ (previously GenXchange)	GxAlert™ (TB) and Aspect™ (A multi-disease platform)

3	Product developer / initiator	Cepheid	Blue Frontier (Awarded from FIND Q2 2017)	Savics founded in March 2016	SystemOne
4	Status	Available for installation	Available for installation (as of September 2017)	Available for installation	Available for installation
5	Lead contact person(s) and email address	Vish Kulkarni Global Marketing Manager vish.kulkarni@cepheid.com Priyesh Bhoora Global Product Support Engineer Priyesh.Bhoora@cepheid.com	James Fry Managing Director Jack Regnart Technical Contact cdp@bluefrontier.co.uk	Xavier Morelle, Chief Enthusiasm Officer xavier@savics.org	Jeff Takle, Chief Development Officer jtakle@systemone.id
6	How it can help ensure your GeneXpert network is functioning properly (device management)
7	Shows usage statistics by device (e.g. number of tests run over time) to see whether devices are operating	Yes Dashboard filters include daily, weekly, monthly or quarterly results with drill down capability by Country, State, District or Lab level – viewed graphically and numerically	Yes Dashboard charts show test numbers per device and by location as well as the number of days that devices have not reported data. Time period options are available are weekly, monthly, quarterly or annually. Time periods can also be customised by the user. Dashboards are customised for each deployment	Yes DataToCare Analytics shows charts with the number of tests per device for a timeframe defined by the user. The last laboratory connection timestamp is also monitored	Yes Dashboard shows totals and can be filtered by timeframe, location, specific instruments, etc. Also shows last time the GeneXpert sent results to the platform to help troubleshoot network issues
8	Shows utilization rates to see if devices are being used to capacity and to identify potential for additional assays (e.g. Ultra, HIV, Ebola, other)	Yes Medical dashboard shows usage by day, week, month or quarter. Results can also be exported in csv format to create pivot tables of site vs assay type usage within specified period	Yes In addition to the central dashboard showing aggregated data, a view of individual devices also shows data related to specific devices including utilization rates. Dashboards are customised for each deployment	Yes DataToCare Analytics shows utilization rates per lab for the time frame defined by the user. The user can set a time threshold to receive in-app or email notifications when results are not received from laboratories	Yes Dashboard shows utilization rates at the lab levels. Customizable so user can set utilization thresholds. We have used this to assist migration of Ebola-focused GeneXperts in West Africa to add both HIV QUAL and TB assays to those repurposed instruments
9	Shows results by device (detection of MTB and rifampicin resistance, errors, invalids, no results) and trends	Yes Medical dashboard filters by assay, timeline, Rif R and drills down to Country, State, District or Lab. Support dashboard segments Errors, Invalids, No Results vs Successful tests by above filters, to determine efficiency	Yes All possible test results are indicated by the use of colour coded icons. Errors and other result types are also displayed	Yes Dashboard shows all medical and operational results coming from the tests in a visual way. All information can merged into customizable reports and either be seen and downloaded or sent periodically via email in Excel files to specific users	Yes Dashboard shows disease results by all result types, color coded. Results can also be export to CSV or Excel, or embedded into notifications via Email, SMS text, or API to another software
10	Recommends which labs may need targeted support based on established quality indicator thresholds (for example, too many errors)	Yes Support dashboard segments Errors, Invalids, No Results vs Successful tests. ‘Datagrid’ tab indicates top 3 labs with high errors and users with highest error rates	Yes Various charts on the central or device specific dashboards but customised quality indicator thresholds are possible using the alerting engine to generate email or SMS messages	Yes Customizable quality indicator thresholds can be set or idle. If an indicator is triggered, an in-app notification is shown and a customized email is sent to the people asking to receive it to warn about the issue	Yes One main graphic shows overall error rates by lab to quickly help supervisors see where help is needed. Lab-specific dashboards highlight the most common errors at that lab. Exportable error reports break down errors into all categories and give finer level of detail. Notifications can be set for different errors for immediate feedback
11	Records and displays upcoming calibration dates	No (however, report for completed calibration can be accessed)	Planned for Q4 2017	Yes The DataToCare suite provides in-app notifications displaying and reminding machine calibration, maintenance or warranty deadlines. The notification time can be customized. Email can also be sent.	Yes. The "Service" Dashboard shows current status for instrument calibration and warranty, as well as any outstanding service requests recorded within the system. Can be tracked in aggregate or down to a specific instrument.
12	Provides a report for instruments requiring calibration	No	Planned for Q4 2017	Yes The DataToCare suite provides information about the calibration deadline by instrument (1 calibration per year or after 2000 tests per module, which ever comes first). It records and shows the module serial number for which the calibration failed. It allows MOH to forecast which instrument need calibration in the next x days.	Yes
13	Records and displays warranty information for compliance	Yes Warranty information can be derived from the usage dates of the systems	No	Yes The DataToCare suite tracks and displays compliance information by device and by lab (validation of the maintenance tasks, delay in the tasks, etc.)	Yes
14	Records and displays maintenance performed per instrument	No	No	Yes Pre-warning notifications can be sent to the laboratory staff to ensure compliance to the maintenance schedule. DataToCare suite records and displays the quality compliance status for each lab.	Yes. Provides alerts and warnings when instruments need maintenance. These can be packaged into a report for an Authorized Service Provider for the instrument.
15	Results can be sent directly to manufacturer for troubleshooting	Yes C360 is a solution of Cepheid, manufacturer of GeneXpert. Technical support is enhanced due to real-time errors/ invalids visibility	Yes A manufacturer account is possible allowing a restricted view of data for specific devices. Manufacturer views do not allow visibility of patient or test results. This permission needs to be extended to the manufacturer via the implementation owner CDP also contains an integration engine which allows the platform to send 'anonymised device data' to any customised endpoint.	Yes Customizable quality indicator thresholds can be set. If triggered, a customized email can be sent to the manufacturer to warn about the issue. The user decides whether to send it or not. The manufacturer can ask for a DataToCare Analytics account, but will only see relevant data; all patient and contact personal information will be hidden	Yes, via the Notifications feature set
16	Shows current connectivity and billing status of SIM card	No (Separate technical support portal)	No	Yes If an SMS modem is connected, the connection is tested and the billing status monitored (CFA remaining). If internet is used to send data, a connection indicator turns green when ok or red when not	No (However, that information is accessible to SystemOne Help Desk directly)
17	Shows current connectivity status of router, modem, or other communications device	No	No	Yes If an SMS modem is connected, the connection is tested and the status monitored, the connectivity status is color-coded (green ok vs red ko).	No (However, that information is accessible to SystemOne Help Desk directly)
18	Dashboard can be accessed from any computer or portable device (responsive design)		Yes CDP has been developed according to responsive design principles and as such can be viewed on various portable devices	Yes DataToCare Analytics has a responsive design and is accessible from any connected device	Yes GxAlert is built with responsive design and is accessible from any connected device.
19	Link(s) to websites displaying screenshots of dashboards	Website is currently being updated. Customer facing presentation that includes screenshots is under development which can be provided upon request.	Website live September 2017	Create a user account and play with the various features of DataToCare Analytics. Check us out at: analytics.datatocare.org	Overviews of the system can be accessed at www.SystemOne.id. Specific screenshots provided upon request
20	Plans for product updates: device management	- Report provided for instruments requiring calibration - Dashboard to record and displays maintenance performed per instrument - Dashboard to show current connectivity status	CDP is in a program of continuous development. We integrate with new and existing devices, subject to future and identified requirements which will be determined on a case by case basis.	Product updates are available for download at www.savics.org/datatocare/download Next device related upgrades will include: - The use of a scanner to track inventories and perform stock management	Aspect™, the next generation of GxAlert launches in Q4 2017. Aspect better handles large implementations >300 instruments and can visualize multiple instruments within a single disease; for example, see DR TB results across GeneXpert, MGIT, LPA, and Next Generation Sequencing (NGS) on the same dashboard. SystemOne's new strategic partnership with Vodafone allows us to access 600+ mobile networks across 195 countries and "drop ship" a connectivity kit within 3 days of initial order.
21	How it can help get your patients on the appropriate treatment faster (patient management)
22	Results (or notifications that results are ready) can be automatically sent to clinician, patient, supervisor or MOH staff via SMS text, email, or API	No Assay specific alerts can be created based on selected criteria that are sent via email C360 users. While C360 is not connected to LIS or EMR systems at this time GeneXpert systems are connected directly to LIS and EMR software.	Yes Notifications of results are definable by clinicians. A flexible engine allows clinicians to specify the criteria of the notification i.e. only alert if result is postive or between a quantitative range. Results can be sent to system users and ad-hoc recipients using SMS or Email.	Yes Notification of the results availability is sent to the defined persons via SMS as soon as the tests results are validated by the operator. The SMS or email with the results sent to the prescriber includes a link to access the patient medical records in one click as well as the patient phone number or email to make sure the physician can contact him as soon as possible.	Yes Notifications features is flexible and allows single results, or reports of results (Excel, CSV, PDF) to be automatically populated and sent to patients, clinicians, or anyone else in the health system, including another software (e.g. EMR, LIS, eTB Manager, etc.)
23	Connects to SMS printers, Results Reporting systems, and other clinical results reporting mechanisms	Yes (Included on Omni –upcoming Cepheid product release) While C360 is not connected to LIS or EMR systems at this time, GeneXpert systems are connected directly to LIS and EMR software.	Yes Results to SMS printers can be sent via the SMS reporting/alerting engine. Other systems can be connected by accessing the data via the CDP API.	Yes DataToCare send the test information to external systems. Depending on the local devices you have in place, some customization might be required.	Yes Notifications feature allows for direct connection into all SMS printers. SystemOne launched a new product in August 2017 called Aspect Reporter(TM), a solar-powered, self-contained communications hub for clinics to receive test results, submit new lab orders, and inspire better clinical decision-making.
24	Results can connect (via Application Programming Interface (API)) to Laboratory Information Management Systems (LIMs), Electronic Medical Records (EMRs) or case management tools like eTB Manager	No	Yes All data within CDP is accessible via its API. API tokens are managed via the CDP user interface. We have conducted trials in Vietnam, successfully integrating with eTB Manager and Vitimes. One of the key features of CDP is an integration engine which allows us to send data anonymised or patient (case) based to any customised endpoint, depending on program/stakeholder requirements.	Yes The DataToCare database structure complies with HL7 norms. The API can interact which every system, EMRs, LIMs, DHIS2 or other. Savics is in charge of the DHIS2 installation for Guinea and Senegal.	Yes Uses a common and secure RESTFUL API. Has already connected to eTB Manager in Nigeria and Indonesia; various LIMs in Kenya, Tanzania, Zimbabwe, etc.; and OpenMRS in Pakistan, Indonesia (via XpertSMS team)
25	Captures patient demographics necessary for clinical care / follow-up, e.g. patient phone number, age, sex, full name, HIV status or treatment category, etc.	Yes – Demographic info e.g. Gender, Ethnicity, Age group; No – Patient / Specimen Identifiers (future release)	Yes Basic patient information captured includes Name, Nickname/Alias, Permanent address, Contact address, Gender, Age/DOB, Phone, Email. Case management also captures HIV status, RR/MDR suspect, PTB/EPTB classification, History (new, previously treated (relapsed, LTFU), unknown previously), Drug resistance (mono, poly, multi, RIF, XDR). Additional or custom fields are defined during the implementation planning stages.	Yes DataToCare collects personal and medical information about the patient. The patient information capture window is always customized to your country needs to ensure that at least all information contained in the paper test requests/reports can be captured by the software.	Yes Fully customizable. We’ve developed a half-day “Data Collection Workshop” during rollout that matches available information from the lab referral forms with reporting needs of various stakeholders to customize the software and build tailored training and installation packages necessary to ensure compliance by lab techs.
26	Provides the ability for a clinician to order diagnostic tests (If yes, describe the workflow steps)	No	Yes 1 – Identify or create patient 2 – Add episode/case 3 – Order new test specifying disease, type of test i.e. Xpert or microscopy, add sample ID, add sample type, submit.	No	Yes, through the Aspect Reporter™ for clinics. This feature is currently in beta and expected to be fully operational at scale in Malawi by Q1 2018.
27	Provides the ability for a clinician to record a diagnosis	No	Yes Presumptive MTB, RR/MDR upon registration. Then bacteriologically confirmed or clinically diagnosed.	No	Yes, through the Aspect Reporter™ for clinics. This feature is currently in alpha testing and expected to be fully operational at scale in Malawi by Q3 2018.
28	Can a patient ID be captured	No	Yes	Yes	Yes
29	Is the system able to deal with aggregation/merging of sample IDs	No Currently no patient identifiable information is stored in the database to avoid	Yes Sample IDs generated or assigned to test orders by clinicians are stored alongside Lab IDs for the test order as the lab processes the order. This ensures all test results from laboratory are able to be linked to the ordering clinician and patient.	Yes DataToCare can merge patient IDs together and remove duplicates.	Yes The system automatically detects tests with the same sample ID and uses other data points to ascertain if it is a duplicate result or a second+ test of the same sample, and aggregates and reports that data accordingly. The system can also automatically detect and break out EQA, testing, or training samples if properly marked.
30	Has a contact list for MOH staff, supervisors, lab personnel, clinicians and patients and a routine method for obtaining and uploading this data	No Has a contact list for lab personnel utilizing the GeneXpert system only	Yes CDP is able to control individual users or groups of stakeholders and allocate different permissions to each based on role and site. Each stakeholder is identified using name, site, telephone and email.	Yes A first list of contacts is defined by your NRL and NTP staff prior the software implementation. Then, on an ongoing basis, operators can add/edit/remove prescribers, operators, clinicians, and other staff contact details to/from the system database. Each person is linked to an entity to control the reporting flow.	Yes As part of the setup process, the NTP, NRL, supervisors, lab managers, and other key staff contact details are added to the system and tagged to their respective geographies and assignments. This makes it possible to automatically send notifications. You can also individually search for and select people within the system and send them private messages or data about the system.
31	Can send scheduled reports of rifampicin-resistant cases to supervisors to reduce Loss-to-Follow-up	No Gathers information though reports cannot be scheduled for automatic dissemination	Yes Can be done via SMS or email alerts engine. Alerts can be on a case by case basis or aggregated by day, week month etc. Case alerts can also be subject to lab manager verification before the result is released.	Yes Reports are customizable (among others, case based or aggregated data) and are sent following your predefined schedule. (weekly, monthly, quaterly, etc)	Yes This can be done on a per-test basis, e.g. as soon as a single test registers Rif+ it triggers an SMS/email/API notification. Or, it can be done on a scheduled basis (weekly, monthly, etc.) for example sending an Excel based report every week.
32	Plans for product updates: patient management		CDP is integrated with DHIS2 patient management module. There is an inherent flexibility in the software to enable us to extend its functionality. Additional patient management requirements can be added as part of a specific deployment customisation, or integrated into the core ecosystem, depending on project requirements.	DataToCare Analytics will further develop its patient centric perspective by adding: -patient treatment and prescribers comments (Will be available in May 2017)	SystemOne is scaling up Aspect Reporter, a new clinical results reporting mechanism to 700 clinical sites in Malawi, under a USAID project. Initially used for HIV VL, Aspect Reporter is now also available for TB and other disease results.
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34	How it can facilitate supply management (forecasts stockouts and expiring cartridges)
35	Records current inventory on hand in a lab/clinic/instrument site	No	No	Yes	Yes, at each lab site via desktop application, or centrally via the web application
36	Forecasts stockouts	No	No	Yes	Yes
37	Forecasts expiration of cartridges	No	No	Yes	Yes
38	Recommends how to reallocate stock to reduce both stockouts and expiration of cartridges	No	No	Yes	Yes
39	Allows user to modify forecasting model	No	No	Yes	Yes
40	Automatically alerts labs and stock managers when instrument sites have less than a certain number of days (for example, <21 days) of inventory	No	No	Yes	Yes
41	Plans for product updates: supply management		Support for supply management functionality is subject to future and identified requirements which will be determined on a case by case basis. Integration into other logistics management solutions is possible as part of the CDP Integration engine. This enables the platform to be deployed as part of a larger ecosystem supporting and feeding into other software projects that do not have the same focus as CDP.	DataToCare will integrate a full supply/stock management system (patient sample, reagent, any other stock) to be released in 3Q17.
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43	Connectivity and data management services
44	What companies’ diagnostic instruments does the system currently connect?	Cepheid	Cepheid GeneXpert, Alere PIMA, Alere Q, Hain Genoscan, BD MGIT (requires BD Epicentre), FIO Deki Reader, Qiagen ESEQuant LR3. New intruments are easily connected through the CDP manifest system requiring a simple XML script to interpret data.	Cepheid. Test results from MGIT(BD) can be entered manually in the software. New instruments are easily connected to DataToCare through the creation of dedicated plugins. Culture and DST test results are also be captured by the software.	Cepheid, Alere, Abbott, Daktari, Hain, BD, Roche, Thermo Fisher, Fio, Qiagen. New instruments are easily connected through the GxAlert manifest system requiring a simple XML script to interpret data.
45	Does the system have an API for integrating with other systems like EMRs, LIMs, or DHIS2?	No	Yes	Yes	Yes
46	How does the system perform in conditions of poor or intermittent, connectivity (does the system cache data, is there an offline mode / Synchronization etc..)?	No data loss. System will retain information until connection is restored and will upload correctly to appropriate date, as long as data is not archived and deleted before connection resumption.	The CDP Bridge, a small utility that collects data from devices such as GeneXpert will cache data if internet is not available for sending when a connection is available.	DataToCare sends information to the server using the internet or SMS technology. If DataToCare is unable to send data, it will be kept locally until the new conditions allow for transmission. In addition, the software checks on a regular basis if all the data sent from a client is well arrived on the server to avoid data loss during transmission.	Ruggedized smart routers are deployed with global sims able to connect to any in-country network, external antennas, and smart-routing infrastructure. If connectivity breaks during an upload, the system caches and picks up the transmission where it left off, saving the expense of “phantom data”.
47	Can the system send the patient and medical information to the national server via SMS	No	No	Yes In the absence of internet, DataToCare sends all the information via SMS. Depending on your configuration, we need to send up to 3 SMS to convey one test result to the server in addition to the SMS you need to provide the information to the prescriber, the patient and other persons.	No. In over 2,000 field installations across 38 countries, this capability has not been required and adds considerable complexity.
48	Does the system support manual upload of .GXX data files?	No	Yes	Yes	Yes
49	Plans for product updates: connectivity and data management services		Support for additional connectivity and data management services is subject to future and identified requirements which will be determined on a case by case basis. Connectivity healthcheck dashboards that report on individual devices are currently being implemented as part of a wider planned rollout in RNTCP India (Q3 2017).	DataToCare product updates will be as following: - Connectivity with NGS machine planned for 2Q17 - Collect of HCV results foreseen for 2Q17	SystemOne announced a global strategic partnership with Vodafone in May 2017, providing us access to 600 mobile networks operating in 195 countries. Out of the box, our connectivity kits now can leverage any available network in your country.
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51	Data Control and Ownership
52	Can system be hosted in-country?	No	Yes	Yes	Yes
53	Can system be hosted in a private cloud?	No	Yes	Yes	Yes
54	Who is/are the owner(s) of the data on the system?	Customer. Cepheid owns the infrastructure.	Ministry of Health	Ministry of Health	Ministry of Health
55	Can multiple levels of data viewing be granted upon permission by the National TB Programme? (laboratory, regional TB programme, national TB programme, partner organization, Cepheid, WHO, etc)	Yes	Yes	Yes	Yes
56	Does the Terms of Use (TOU) clearly identify the permitted and non-permitted uses for the data?	Yes	Yes	Yes Savics adapts the TOU to the country requirements if they are more strict than our terms.	TOU is fully POPI, GPDR, and Privacy Shield compliant, and customized for all developing nations’ local laws.
57	Does the TOU require destruction of data within 30 days of the revocation of data access via the system?	No. Data destruction upon customer’s request	No. Data destruction as part of TOU is agreed on a case by case basis, in accordance with local legal requirements and industry best practice.	No, but the TOU could be modified to comply with this requirement if requested	Yes
58	Is the TOU compliant with South Africa’s Privacy of Personal Information (POPI) law?	Yes	Yes	No, but the TOU could be modified to comply with this requirement if requested	Yes
59	Is the TOU compliant with the General Data Protection Regulations (GDPR) from the EU?	Yes	Blue Frontier is GDPR compliant and we consider this as a baseline from a data protection standpoint. TOU documents provide guidance as to where the software facilitates compliance but cannot, in and of itself, be compliant.	No, but the TOU could be modified to comply with this requirement if requested	Yes
60	Is a sample TOU agreement available online? (provide URL)	Provided upon request	Provided on request	www.savics.org/legal	Provided upon request
61	Plans for product updates: Data control and ownership		Any updates / enhancements will be in accordance with our own data protection compliance obligations and considered on a per implementation basis		The GLI is currently undertaking an effort to define minimum data controls for this industry. SystemOne plans to contribute technical inputs into that discussion and adhere to the forthcoming GLI recommendations. Additionally, SystemOne was selected by USAID to participate in the MSTAR Responsible Data Use as a case study for how to follow appropriate regulations for data protections. We are honored to have been selected for that award.
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63	Experience of the software and team, and availability of support
64	What countries are actively using this system (reporting routinely and within the past 30 days), beyond a pilot level?	Namibia	None	Ivory Coast	Nigeria, Kenya, Uganda, Tanzania, Myanmar, Guatemala, Ethiopia, Botswana, Cameroon, East Timor, Guinea (Ebola), Kyrgyzstan, Mozambique, Swaziland, Papua New Guinea, Zimbabwe, Bangladesh, Sierra Leone (Ebola), Pakistan
65	What countries are actively using this system (reporting routinely and within the past 14 days) at a pilot level?	Tanzania, Zimbabwe, Botswana, South Africa, Kenya	None RNTCP India are currently (Q3 2017) planning and implementing a pilot for the CDP Bridge application to interact with their own TB ordering and monitoring systems. This will widen in scope to a full country-wide deployment of over 1,000 devices in (Q4 2017).	Benin, Cameroon, Uganda, Rwanda	Malawi, Philippines, Bangladesh (private sector), India (private sector), Nepal, Liberia (Ebola, TB), Indonesia, Russia, DRC, South Africa (private sector), Zambia, Tajikistan, Chad, Ghana, Moldova, Azerbaijan, Netherlands, Equitorial Guinea
66	How many GeneXperts are actively reporting on this system (reporting routinely and within the past 30 days)?	Since the commercial launch of the product in May 11, 2016, 76 systems have been reporting till date. Cepheid anticipates over 500 instruments reporting by December 2016. Approximately, 39 labs (48 systems) have been utilizing C360 since the Pilot phase.	None	21	>2,000
67	How many people in the company are dedicated to this specific software?	7 Development Engineers (Sweden, Europe) 8 Support Personnel (3 in US, 2 in Europe, 2 in Africa, 1 in India)	Blue Frontier has a staff of 35 personnel, the CDP team consists of 5 Developers, 1 compliance officer, 3 support engineers, 2 test analysts and 2 designers.	6 full time employees and two students	29
68	Describe the software support available	3 System Administrators, 2 Tier-2 Support Technicians. Technical support centers in US, France and South Africa. Web-based software, so immediate tech support view and assistance enabled	A full suite of documentation including installation guides, user guides, training, operations and support are available. We have support engineers and contracts for support available, based on individual requirements.	We have installation guides, user guides, videos, a software checklist near the Xpert assay for each lab, and we support you remotely through TeamViewer, skype, emails, and others. Check the documentation at www.savics.org/datatocare or write us an email to support@savics.org	• GxAlert SysAdmin Certifications Course • Monthly webinars on system features • Online help desk and knowledge base • Email support@gxalert.com • Dedicated WhatsApp Support Channel • Service Level Agreements (SLA) • User Guides • Technical documentation • Training materials for installation, systems administration, use, and troubleshooting
69	How many people in the company are dedicated to installation and implementation of this software?	5 dedicated employees	3 dedicated support engineers, supported by a wider team of 30+ specialists.	4 persons are dedicated for the IT installation and 2 are helping for the process to happen in a smooth way. It takes less than 10 minutes to install the software on client and server. IT qualifications are not required to perform the job, nor to run the software.	Implementation is run out of our office in Johannesburg, South Africa, where we have a team dedicated solely to installation and customer support. We can comfortably handle 4 simultaneous national-scale rollouts each month.
70	Describe the support available for installation and implementation of the software	Dedicated team for supporting the product remotely and on-site, as necessary. C360 is designed for simplicity – C360 Sync downloaded by hyperlink, and installed on each GX PC, generally in 30 Minutes. Training can be facilitated on Skype/ AT&T. Customer needs to only sign agreement and ensure an internet connection	A full suite of documentation including installation guides, user guides, training, operations and support are available. We have support engineers to support implementation available, based on individual requirements. We are also prepared to customise the software to support different deployment scenarios and Ministry of Health requirements.	We customize the patient medical history data collection to your needs (i.e. following extensive discussions with MOH, NTP, NRL and consultants) and link the DataToCare database (HL7 compliant) to the existing ones on request. We come 2 weeks in the country for a pilot implementation: we install the server and the software on 4 to 10 GeneXpert machines with the lab staff. Then, pending on your requirement, we provide an in-country support for a country wide implementation or provide remote support for DIY installations.	The implementation team conducts a 1-week in-country TOT with the MOH, NTP, and Implementing Partners. The team jointly installs the solution at 4-5 labs. SystemOne facilitates completion of the rollout, provides remote support, and ongoing training via webinar or in-country visits per the selected Service Level Agreement (SLA) for a given country. The global sims and smart routers enable much of the support to be provided remotely, thereby greatly reducing long-term support costs and improving sustainability.
71	How many different installations and implementations of this software has the team conducted? (List countries by name)	8 (Tanzania, Zimbabwe, Botswana, South Africa , Namibia, United States, Kenya, UK)	Vietnam (Q4 2016) India (Currently ongoing Q3 2017)	Benin, Cameroon, Ivory Coast, Rwanda, Uganda	We have conducted nearly 100 installations to date in the 37 countries listed above.
72	In what countries does the system currently integrate to an EMR, LIMs, or DHIS2 APIs in a live environment, for more than 90 days?	Not applicable for C360. Though, GeneXpert system can integrate with any system that support HL7 and ASTM communication protocols.	CDP has been successfully integrated in Vietnam to HIS, LIMS, e-TB Manager and VITIMES. Prototype integration with DHIS2.	We didn't connect yet the software to other local systems. We are currently discussing the integration with a LIMS	Nigeria, Kenya, Indonesia, Tanzania, Botswana, Mozambique, Philippines
73	Does the company provide implementation support to connect instruments in remote areas, e.g. routers, SIMs, training, and installations?	Installation and support via remote access software	No	Yes We provide full support for all the materiel needed for the implementation of DataToCare. In most cases, we can use the modems you already have in place to send data.	Yes Full-service rapid rollout provided with all necessary components
74	Is a sample service level agreement available (SLA) online?	No. Can be provided upon request.	No - can be provided on request	We do have a SLA for each mission we have. We do not publish these online since the SLA is specific to a given mission. Send an email to support@savics.org if you want to ask for a SLA sample	Sample SLA available upon request.
75	Plans for updates: team and support		Resource is carefully managed and will grow with demand.	1 employee shall reinforce the team in 1Q17	New certifications courses on Inventory Management,Service and Warranty Management, andLinkage to Care.
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77	Other
78	Current available languages of user dashboard	English	English, Vietnamese	English, French, Russian and Spanish are available for the dashboard and the client (data capture)	English, French, Portuguese, German, Russian, Kiswahili, Vietnamese, Bahasa Indonesian
79	Additional planned languages of user dashboard	French, German, Italian, Portuguese, Spanish	UTF-8 compliant. Any language can be supported. Language can be switched on login page or user profile page. Language translations are possible by country IT person or development team.	The dashboard and the data capture software are ready to host any language. The process is straight forward. We currently add Portuguese and Arabic to the DataToCare lexicon.	Any language can be supported with approximately 30 days notice.
80	Other diseases currently monitored using the system (e.g. HIV, Ebola, general bio chemistry, etc.)	Xpert BCR-ABL Monitor, Xpert C. Difficile, Xpert CT, Xpert CT/NG, Xpert Carba-R, Xpert EV, Xpert Ebola, Xpert Flu, Xpert Flu/RSV XC, Xpert GBS, Xpert GBS LB, Xpert HCV Quant, Xpert HIV Qual, Xpert HIV Quant, Xpert HPV, Xpert MRSA, Xpert MRSA/SA BC, Xpert MRSA/SA SSTI, Xpert MRSA/SA Nasal Complete, Xpert MTB/RIF, Xpert Norovirus, Xpert VanA/VanB	CDP has been developed to support TB, Ebola, and HIV using a case management approach.	We plan to cover HIV, Malaria, and others diseases in the course of 2017.	TB, Ebola, HIV VL, HIV QUAL, CD4, Zika, Dengue Fever, Lassa Fever, TB Next Generation Sequencing (NGS) and general biochemistry. Others added at no cost upon request.
81	Are external developers able to contribute code and/or plugins or modules to the system?	No	External developers are free to integrate with the CDP API. There is detailed documentation available on request to facilitate this development work.	Yes We welcome any developer to contribute to the improvement of DataToCare. To contribute, send an email to Aissa via support@savics.org	Yes External contributors are welcome to contribute feature ideas or actual code to support@gxalert.com.
82	What are the software license fees?	At this time, Cepheid is providing this software at no charge as an additional benefit to its customers	There is no license fee to use the software.	There is no licence fee to use DataToCare	There are no fees for public institutions like Ministries of Health
83	When was the last software version update?	May 2016	v1.3.6 in August 2017	DataToCare Biopics (client) v2.1.1: 28/02/2017 DataToCare Analytics (server) v1.2.2: 28/02/2017 DataToCare Storics (client) v1.0.0.: 08/03/2017 The software is continuously updating. Latest version always available at www.savics.org/datatocare/download	Code is updated on a weekly basis. As one project contributes new functionality, it is tested, released in limited fashion, and then released to the global GxAlert™/Aspect™ community so that everyone benefits.
84	How is the software updated? (Describe the process for updates and maintenance patches)	Cepheid utilizes established change control process for updating customer facing software. All C360 software components are updated automatically.	The CDP server software is updated on a bi-weekly basis for minor releases. Emergency releases can be performed at any time. Either in-country, or on private cloud platforms. The CDP Bridge software is updated via a publishing server that distributes updates automatically to all installed sites.	The update is done by running a setup on the client or the server. It is done in a few click and can be done by a non IT person. We also provide the required support when needed: Just ask for help at support@savics.org.	Countries using our private cloud installations are updated automatically at no cost. Teams with in-country servers can obtain the latest version of software at any time by emailing support@gxalert.com and can either upgrade themselves, or receive remote- or onsite- assistance from SystemOne at cost.
85	Current, short and mid-term activities planned for software updates	Version 1.5 ·Data security & encryption ·Secure / Compliant data centers ·User authentication ·Access control ·English U/I and Data only ·Reporting / Trend analysis ·Basic service and support dashboards ·Disease Alerts & notifications ·Test result/mobile lab geolocation ·Full assay menu support Version 2.0 ·GeneXpert Omni support ·Multi-lingual support both U/I and Data ·English ·French ·Spanish ·Portuguese Version 2.5 or higher ·Enhanced customer-facing service & support dashboards Enhanced reporting	Current planned activities - completing Q3 2017 - Integration engine. Expanding fields, records and triggers that can send notifications based on customised user requirements. - Expand datawarehouse to MoH reporting.	Adding Portuguese and Arabic languages - Connecting with other databases through an API - Integrating the BD MGIT 960 - Capture of new TB tests results (LPA) - HVC - HIV - Malaria - Connect a next sequencing generation assay - Full inventory management system	Q4 2017 - Launch of Aspect™ the next generation of GxAlert. Currently GxAlert users will be provided an upgrade path. The current versions of GxAlert will continue to be supported.
86	Software supports all major operating systems (Windows, Linux, Mac OS X)?	Windows XP, Windows 7	CDP server can be installed on any platform including Windows, Linux and Mac OS. Users of the platform are able to access the system using any current browser. Non-unix based deployments will be required to run Docker environments to support deployment. CDP Bridge has been actively used on Windows XP, Windows Vista, Windows 7, and Windows 10. Support for other versions has not been verified. However, is expected. There is currently development work in progress in order to 'future proof' the CDP Bridge software for future versions (i.e. DX 4.9 Windows 10 support). This will likely lead to a disparate CDP Bridge+ software which drops support for lower versions of Windows while improving the functionality and reliability for Windows 7 and Windows 10. The original CDP Bridge software will continue to be developed and supported to ensure Windows XP support remains a priority.	Yes DataToCare (client and server) can be installed on virtually all operating systems (Linux, Mac, Windows, etc.). The dashboard is accessible from any device (responsive design) connected to the internet using any browser.	Yes
87	Please describe any other components that are required to support the software	None for hosted version currently provided by Cepheid.	All software necessary for the operation and support of the software are provided in the installation package. Suitable server hardware is required for hosting. Sizing of hardware is subject to size of implementation.	For the in-country server solution, a dedicated space on a computer running 24/7 is needed to act as a server (Linux, Windows, Mac, etc.) . There is no need of a public IP address for the server to access it from any connected device. For the hosted solution, no additional material is required. The secured space required in the cloud to host the server is provided at no cost (only the service will be charged).	None for hosted versions. Server specs are: · Computer Hardware Minimum 4GB RAM, 80GB Hard drive, I5 processor or better, Ethernet · Operating System Windows Server 2008 R2 64bit Service Pack 1 or later. Windows Server 2012 works as well. Networking Publicly accessible IP number open on port 80 and port 3000.
88	Do these components come packaged with the system? (highlight any materials, systems or components that need to be procured separately in order to allow the service to work i.e. SMS gateway, performance monitors..)	N/A	All components of system for operation and monitoring are bundled. No need to procure anything separately unless specific software desired.	The only component to buy (if you want to send data from remote areas - without internet - per SMS) is a USB dongle modem (40$/piece - one per assay) and a SIM card. If you already have modems, we can usually work with these even if they are white label ones. If no server is available, there is a need to buy one.	We strongly recommend you use the full packaged product and do not substitute “parts” of the product as substitutions make it much more difficult and expensive to maintain.