Aspect Reporter

Despite the fact that TB is treatable and curable, 10 million people fell ill with TB in 2020 and 1.5 million people died. Rapid diagnosis and timely treatment initiation are crucial factors to sustainability of TB control efforts.

The TB care cascade involves a complex process to achieve a positive health outcome. This includes accessing testing, receiving a diagnosis, initiating treatment, completing treatment, follow up, notification and reporting. Primary healthcare (PHC) facilities are at the forefront for providing these services and it is only through the provision of quality care that health outcomes can be improved.

Nigeria, the most populous country in Africa, has both a high TB and high drug resistant TB burden. In 1993, the National TB and Leprosy Control Programme (NTBLCP) started the implementation of DOTS (Directly Observed Treatment) strategy through PHCs and there are currently 6000 DOTS facilities aimed at improving access to TB care. Despite these efforts, Nigeria still ranks first in Africa and 6th among 30 high TB burden countries in the world (WHO Global TB report, 2019). In 2020, the country accounted for over 300,000 undetected TB cases and reported less than 50% treatment coverage. The WHO estimated that only 11% of drug resistant TB (DR-TB) cases were diagnosed and only 9% placed on treatment in 2018.

The high TB and DR-TB burden in this country is a direct reflection of challenges experienced by a fragmented health system which faces multiple challenges in the management of TB patients. Several studies have identified major bottlenecks along the care cascade which impact on the quality of TB services provided by PHC facilities.

Firstly, accessing diagnostic services is extremely challenging due to segmented and uncoordinated logistics, especially in very remote areas. Once a person does access services, turnaround times for TB testing and results reporting are notoriously slow due to archaic paper-based systems. This leads to delays in ordering tests, sample losses, lost/misplaced results, and delays in result receipt. The time factor associated with these delays can prolong illness, exacerbate factors that fuel drug resistant TB, prohibit improvement in case detection, and constrain efforts to improve patient outcomes. Added to this, studies have found that healthcare providers are overburdened and under-trained. Poor health worker performance, including high absence, low competence, and low productivity has also been identified as factors hindering performance of PHC’s. This in turn leads to delays in patient management, inability to confirm patients on treatment, and patients lost to follow-up, all of which severely limit progress in infectious disease treatment programs. A 2019 study found that of DR-TB patients diagnosed in Nigeria, only half were treated and only 1 in 4 received treatment within 30 days after diagnosis.

Identifying gaps in the TB care cascade can enable targeted interventions at the stages of the care cascade where losses and drop-outs occur most frequently. 

Aspect Reporter is a mobile application (app) designed to be used by healthcare providers to receive digital diagnostic results in real-time. We propose to digitize the TB care cascade from sample registration to linkage to care using our Aspect Reporter app, by building in an additional sample referral system (SRS) capable of registering, referring and tracking specimens, reporting results and linking to care. Reporter will thus have 3 components:

1. Sample referral: Healthcare workers will register TB samples at the PHC level by scanning the sample barcode using the app (and capture name of referring facility) and refer those samples to labs for testing. Once arriving at the lab, lab staff can receive the specimen, including marking the sample as rejected if unsuitable for testing or accepted into the testing queue. This will be done by using our connectivity software, Aspect, to scan the unique barcode/QR code at the time of testing.

2. Real-time reporting: Once the diagnostic testing is complete in the lab, results will be sent to Aspect. Aspect will match the result with the sample by unique sample ID barcode and send the result back to the health facility via Reporter app in real-time.

3. Linkage to care: On receiving the digital lab result on the app, the healthcare provider acknowledges receipt and will use the app to capture information on whether the patient is placed onto treatment and what treatment regime or capture any other patient outcomes i.e. patient died, loss to follow up, referred out.

By digitizing this data along the TB care cascade, from sample registration to linkage to care, we hope to achieve 3 main objectives:

1. Streamline TB sample logistics to improve access to and timeliness of diagnostic services at PHCs

2. Reduce turnaround times for diagnostic result reporting to improve time to patient management

3. Monitor linkage to treatment rates as a proxy for monitoring the performance of healthcare providers and use this to identify facilities/staff requiring additional support and training.

The solution will directly serve both the Ministry of Health and the National TB program by digitizing TB data along the cascade of care to provide insight into TB health services in the country.  Providing logistics, turnaround times, diagnostic data and treatment initiation rates will assist the program in identifying bottlenecks and facilitating more targeted interventions.

Aspect Reporter will also serve the healthcare workers providing primary care to TB patients. Reporter will provide immediate access to TB diagnostic results at their fingertips, eliminating the need for paper-based reports which take time and energy to sift through. The laboratory staff will also be served by having a lesser workload and requirement for data-entry in the lab. 

Patients accessing PHCs for TB services will also be helped indirectly through our solution. The process of making the healthcare system accountable for every diagnostic result they receive, is called diagnostic accountability. Diagnostic accountability can be used as a proxy to measure quality of care provided i.e. by monitoring that diagnostic results are being actioned and patients are being linked to treatment (and the appropriate regime in appropriate timeframe) we provide a proxy for monitoring the performance of healthcare providers. This in turn will help identify facilities/staff requiring support and training in order to improve the quality of care they provide.

SystemOne have been working in Nigeria since 2012 when the Ministry of Health (MoH)/ National Tuberculosis and Leprosy Control Programme (NTBLCP) engaged SystemOne to assist them with challenges around paper-based reporting. SystemOne have completed integration of their entire TB diagnostic network (~511 GeneXpert instruments) to SystemOne’s connectivity platform, Aspect. The development and requirements of Reporter app was conducted through engagement with the MoH and the NTBLCP, with whom SystemOne have a long-established relationship. To date, SystemOne have distributed 1050 mobile phones with Aspect Reporter app installed to healthcare providers in 740 DOTS centers in Nigeria to allow them to receive real time notifications. The current plan with the NTP is to scale Aspect Reporter to 1050 centers across 5 states namely, Kaduna, Oyo, Rivers, Kano and Sokoto.

At present, we also have a local support team on the ground in Nigeria seconded to work with the MoH, who attends all national strategic planning and quarterly meetings. As such, SystemOne is already included in the country’s National Strategic plan.

We are still a relatively small company of 30 employees that does not generate sufficient revenue to be able to invest the necessary resources required to accelerate this implementation without external funding. The resources supplied by this grant would enable us to focus time and effort on building the SRS component in Nigeria.

• We are in a very niched place in terms of the lab-clinic interface. Not only do we provide the software but also the low bandwidth network to ensure services are continuously functional and able to communicate test results and sample information in real time. 

• To enable broader impact, one of the core components of our system is to provide API’s to share information collected with any upstream solutions (in real-time).

• By incorporating a SRS component in our Reporter app, we can digitize the cascade of care from sample registration to linkage to care. Other connectivity systems do exist for each component, but none integrates the entire process. Digitizing this data will improve data quality by orders of magnitude and allow the NTP to track, at a national, regional and facility level the Turn-around-time (TAT) of all Xpert TB results.

• Aspect reporter creates diagnostic accountability to facilitate linkage to care.  Why is this important? Because merely reporting results is not enough to effect change. We need to ensure that every result is acted upon in a timely manner to ensure patient impact. There are no ways currently to measure/monitor whether healthcare providers are actioning results upon receipt.

1-year goals

• 1050 DOTS centers trained and implementing SRS.

• Use data to identify sample, quality, referral, training issues

• Deliver 100% of TB results to correct referring facilities 

• Deliver TB results within 1 day of availability

• Provide a framework to measure turnaround times for sample registration to collection and transport, testing, and result delivery

• Reduce administrative effort of lab staff by removing requirements of lab staff to capture information for result delivery   

• Improve resource allocation and planning for laboratories as they can pre-allocate adequate resources based on workload

• Reduce time to TB treatment initiation to within 30 days of diagnosis

• Improve TB treatment initiation rates from 50% to 60%

• Improve DR-TB treatment initiation rates from 50% to 60%

• Aggregate data on linkage to treatment to identify PHCs with poor treatment initiation rates for investigation/retraining

5-year goals

• Map existing TB services: Track where patients are accessing care, identify gaps, monitor whether the right patients are being referred for testing as per national guidelines.

• Dynamically reflex samples for any diagnosis from overburdened labs to labs with capacity available (e.g. extend to HIV, HCV samples)

• Ensure 100% of samples are delivered to correct laboratories within allowable timeframes for sample quality

• Improve patient satisfaction with services provided

• Improve healthcare worker satisfaction

• Improve laboratory staff satisfaction

• Number of healthcare providers trained on Reporter

• Number of samples referred for testing

• Number of results delivered to Aspect reporter

• Number of results unable to be delivered to Aspect Reporter

• Time from sample registration to sample receipt at lab

• Time from sample receipt to sample testing completion

• Time from result available to result delivery on Aspect Reporter

• Time to HCW acknowledgement of a result on Reporter

• Time to linkage to treatment

• Number of TB positive diagnoses placed on treatment

• Number of DR-TB diagnoses placed on treatment

• Number of facilities identified for retraining

Activities

• Map sample logistics system in Nigeria

• Develop SRS module into Aspect reporter

• Deploy SRS to Reporter in 1050 DOTS centers

• Train healthcare providers on Aspect Reporter SRS

Outputs

• Healthcare providers use Reporter to register samples at facilities.  

• Samples are tracked from registration to arrival at laboratory

• Lab tech uses Aspect to pre-queue samples and plan their day 

• Lab techs uses Aspect  to receive samples

• Once diagnostic result is available, a digital copy is sent via Aspect to Reporter in referring facility. 

• Healthcare providers use Aspect reporter to receive digital results and confirm result receipt.

• Healthcare providers bring patients back to clinic sooner for management and linkage to care

• Healthcare providers use Aspect reporter to link patients to treatment, capture regime details/capture patient outcomes

Short term outcomes

• Reduction in paper-based result losses and errors – 100% of digital diagnostic results are delivered to PHCs. In Malawi, we showed 5% of paper reports were lost during transport.

• Digital laboratory results are delivered to PHCs in a shorter turnaround time compared with paper reporting. We showed a 95% reduction in result delivery TAT using digital reporting in Malawi (Gous et al, CROI, 2018)

• Reduced times to treatment initiation. A recent study (Banamu et al, PHA, 2019) showed a decrease in time to treatment initiation from 35 days to 10 days using our system.

• Improved treatment initiation rates by reducing TAT for result delivery. Banamu et al (PHA, 2019) showed the proportion of patients initiating treatment increased from 25% to 54% using our system.

• MoH and TB program can identify ‘problem’ facilities not initiating patients on care or in required timeframes and launch targeted re-trainings for PHCs requiring support

• More educated healthcare staff

Long term outcomes

• TB sample transport and logistics are streamlined and optimized.

• Optimized lab workflows

• Less overall pre-treatment loss to follow up due to immediate availability of results

• Improved quality of TB care provided

• Turnaround times for TB cascade improved

• Improved patient initiation and the ability to track patient treatment initiation, prescribed treatment and outcome. 

SystemOne leverages an Internet of Things (IoT) approach to diagnostic instruments to communicate the data and disease information, in real-time, to the upstream components of the health system to respond to the events. Coupled with the hardware (routers and multi-IMSI SIM cards), SystemOne also developed and provided the back-end technology, Aspect, specifically designed to absorb and communicate the information to the relevant stakeholders in real-time.

The Aspect technology is designed to connect directly to molecular diagnostic instruments located in remote or centralized testing sites to collect a digital copy of the diagnostic test result which is then sent to a (privately hosted or an in-country) server. Aspect can interface with a variety of different diagnostic instruments and assays and is thus device and disease-agnostic.

Aspect is specifically designed to integrate with other health systems ensuring the data is leveraged to services such as laboratory and health information systems (LIS, HIS), case management systems, logistics, patient outreach & contact tracing, treatment initiation and outcomes. Since the data coming into Aspect is real-time patient results and additional meta-data from diagnostic devices in the field, we utilize a rule-based notification engine to push events from Aspect out to other systems based on the content of the test result.

Aspect reporter is a react-native mobile application for both IOS and Android devices for use on either the HCW’s existing mobile phone or devices provided by SystemOne that are locked via a Kiosk application restricting the use of the device for only the Aspect Reporter and SRS application. Similarly, SystemOne also currently provide the internet connection for these devices in Nigeria ensuring uptime. The global-roaming, multi-IMSI SIM cards connect to any available network in country as well as networks for all bordering countries to ensure the best quality and stability of the connection and service.

HCW will collect the sample information and in return, they would receive results back in a significantly reduced (automated) turnaround time by, initially, simply scanning a barcode.

Laboratory technicians receive the benefit of the initial HCW entering the sample and/or patient information by not having to complete this task themselves. Simply using the same barcode will automatically allow the reporting of the result back to the correct HCW and/or facility without any additional input from the laboratory staff thus addressing the issues of (1) reduced TAT; (2) ensuring all results are returned to facilities, and (3) that all results are returned to the correct facilities.

As a global company, SystemOne operates in over 40 countries, each with its own distinctive culture and traditions.  As our team members engage stakeholders (subcontractors, customers, system-users), it is critical that we operate in an inclusive manner that does not intimidate, discriminate, or otherwise disadvantage anyone based on their gender, sexual orientation, ethnicity, nationality, or age. 

As the company has grown we have added diversity to our staff, ownership, Management Team, Board of Directors, and Advisory Board.  Our leadership groups now include women and men from more than 10 countries on four continents with a variety of backgrounds.  We are committed to continuing to diversify the voices that help guide and strengthen our future.

SystemOne operationalizes its commitment to diversity through 5 pillars:

Team: our team is what makes SystemOne special.  It is not a coincidence that the first section of this Human Resource Handbook affirms that SystemOne is an Equal Opportunity Employer.  Team members are chosen based on merit.

Equitable Compensation: Team member compensation should be based on merit and the local employment market.  SystemOne conducts an annual review of compensation paid to its team members, which includes the categorization of team members by gender, age and ethnicity, to ensure there is fair and equitable compensation.

Professional Development and Acknowledgement– SystemOne encourages all of its managers to develop skills in its team members.  We can ensure the excellence and diversity of our next generation of leadership by making sure that all team members, regardless of gender, age or background, take advantage of our Professional Development opportunities.  Managers should seek to provide employees and stakeholders with opportunities for public acknowledgement through the publication of papers and presentations.  

Benefits - Our benefit plan which includes medical coverage, paid time off (including parental leave) has been designed to provide flexibility for our team members so that they can work effectively while living a fulfilling life.

Subcontractors and Vendors - SystemOne is predominantly a software development and services company.  Occasionally we are asked to help specify equipment needed by our customers to integrate their medical information systems, or are asked to install equipment or train their staff.  In these instances, we may hire subcontractors or vendors.   Vendor/supplier selection must be based on quality and cost competitiveness while ensuring vendors meet our ethical, environmental and gender mainstreaming standards.

 While SystemOne’s regional gender ratios reflect the cultural norms across our markets, we remain committed to work towards equal opportunities for all genders and promote diversity within our business, our markets and beyond.

SystemOne is for-profit business providing services in a Software-as-a-Service (Saas) model. SystemOne provides the following services:

·   Provision of licenses to use the Aspect Software to collect, analyze and action results from diagnostic instruments in real time. Along with the provision of the Software, SystemOne includes collaborative partnership with the Ministry of Health by providing human resources to work with the respective MoH to ensure the system is producing the desired data and having the impact required. Additionally, SystemOne assist the Ministry of Health by providing custom data analysis and reporting sharing insights into the country data, performance of the health program and/or disease stream as well as providing suggested interventions to improve the ROI on the deployed laboratory instrumentation and infrastructure. Localization, customizations and defined reports and templates and API’s to downstream systems are all included in the per-test pricing model.

·   Provision of a managed network. While software is the core of what SystemOne do, it was recognized early in the company’s existence that even the best software in the world to help fight infectious disease is useless when there’s no way to get the data into the system. As such, SystemOne built out an entire technical team to provide a managed network (modern-day IoT approach) whereby SystemOne provide not only the Software to Ministries, but also a full end-to-end managed internet connection to ensure that results from the diagnostic instruments are able to transmit data to central or locally hosted servers in real-time. SystemOne are responsible for managing the network and ensuring the devices are able to upload results, especially in remote, decentralized settings with poor network infrastructure. SystemOne currently support around 4,000 connected devices throughout our LMIC footprint. The price for the network is bundled into the per-test pricing model.

·   Provision of a mobile application for result delivery and treatment initiation tracking. SystemOne additionally supply a mobile Application (Aspect Reporter) that provides Healthcare Workers (HCW) with the results relevant to their patients or their facilities. This application is similarly provided on a per-test basis through our SaaS model.

SystemOne was founded in 2012, and as any startup, have undergone numerous cycles of operating at a loss, expansion, contraction, profitability and growth. SystemOne currently have a footprint in over 40 countries (Africa, Asia) and are currently contracted to provide services in 14 LMIC’s.

Typically, SystemOne provide a SaaS model to countries whereby the number of tests forecast to be conducted on the diagnostic instruments are priced on a per-test basis to ensure equity between the disease streams for countries multiplexing on single instruments. These funds are generally covered by Global Fund or USAID grants but with contracts directly with the Ministry of Health (MoH) in each country. The funding includes, at least, the provision of the Aspect software to assist the MoH with collecting, analyzing and actioning, in real-time, the diagnostic data for various infectious diseases, new disease outbreak, detection, and response.

The COVID pandemic has highlighted the need for outbreak detection and response and SystemOne have been operating in this space since 2012. The global impact of COVID has led to multi-billion dollar investments globally (including $6.5bn allocation to USAID) for pandemic preparedness – of which real time, digital data is at the very core.

SystemOne is currently financially stable and plan to remain financially stable through continuing to selling our product on a per-test basis in the SaaS model. SystemOne had previously conducted a Series A capital raise with The Rise Fund and TPG and SystemOne to assist SystemOne in fine-tuning the business model and scaling out the company operations.

Under the SaaS model, SystemOne has been able to crossover from running at a loss to generating some profit in 2021 with a target to remain profitable with ongoing activities.

As previously mentioned above, SystemOne uses annual licensing to generate revenue for its software and services.  We began offering our software and service licenses for national level networks in 2017.  We currently have 23 active contracts which have a collective backlog of $2.8M.  The most recent examples include the following:

• A one-year licensing agreement with the Ghana Health Ministry and IoT management of their GeneXpert fleet ($141,000, funded by The Global Fund);

• A licensing agreement with ICF, an NGO funded by the US Infectious Disease Surveillance System, to supply the Mozambique MOH with Aspect and IoT management of their GeneXpert fleet  ($133,000); 

• A one-year license agreement with the Kingdom of Eswatini for Aspect ($20,700) funded by The Global Fund.

• A one year agreement with Danaher Corporation to provide equipment performance data for the fleet of GeneXperts in Zimbabwe ($40,000).

• A 3 year agreement with the Bangldesh MOH for Aspect and IoT management of their GeneXpert fleet at 700 clinics.  The $2M contract was funded by The Global Fund.