Technology Solutions for COVID-19 Testing

 

In a briefing about COVID-19, held on Monday, March 16, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said, “… we have not seen an urgent enough escalation in testing, isolation and contact tracing – which is the backbone of the response.”

The WHO guidelines specify that identifying new cases and encouraging self-isolation is critical to slowing the spread of COVID-19 and reducing the burden on the healthcare system. However, test availability is presently not able to meet demand and our healthcare systems are already overloading with patients. 

Delivering COVID-19 clinical testing rapidly and then scaling that service requires much more than validating an assay. Maintaining clinical integrity and sound patient care requires innovative solutions to connect the following groups of people to testing solutions:

• Organizations & Universities
• Health Systems & Physicians
• Clinical Laboratories

COVID-19 will not wait for the healthcare system to build new infrastructures. Healthcare providers are left to fumble through inadequate systems and inefficient patient flows. Symptomatic patients are being sent home, without being tested, with the guideline to self-isolate. However, without a confirmed positive test for COVID-19, many cannot access sick leave benefits.  They are returning to work, and maybe spreading COVID-19 to their community, but we won’t know because we weren’t able to test them.

 

FINDING COVID-19 TESTING SOLUTIONS 

Hearing the plea from the WHO for swift action coupled with frustrations from our existing partners in both clinical labs and digital healthcare systems, the team at ixlayer has been working around the clock on a solution.

If you want to experience the ixlayer platform in process, we encourage you to engage with the ixlayer platform in action and use the following log-in credential to access the Physician ordering platform and Patient Portal for product demonstration:

Physician ordering platform: 

• portal.covid19clinicaltest.com
• Login: demo@ixlayer.mars-cdn.com
• Password: ixlayer_demo

Patient Portal: 

• www.covid19clinicaltest.com

We have adapted the ixlayer testing platform, already being used by several national labs and healthcare groups to offer genetic and precision health testing, to now connect the pieces needed to scale COVID-19 testing, including connecting organizations and universities, healthcare systems and physicians, and clinical laboratories.

Ixlayer COVID-19 Testing Platform

The ixlayer platform combines 6 building blocks into an efficient flow:

1. Clinical laboratory
2. Customer relationship management (CRM)
3. Cloud
4. Scientific algorithms
5. Physician/Scientist
6. Patient portal and patient experience

All six components need to be integrated and in place to offer scalable testing to physicians and patients across the US. Interestingly, much of this process is undifferentiated, so ixlayer was able to quickly adapt each component to address the requirements for scalable COVID-19 testing, highlighted in the table below.

Basically, the ixlayer platform includes everything needed to launch a COVID-19 test in a fraction of the time and cost it would take to do so without the platform. If clinical laboratories have their assay validated, interfacing the ixlayer platform with their LIMS can likely be finalized within days. This rapid production is critical for meeting the ever-growing demand for COVID-19 testing and is delivered while also including best-in-class quality throughout the user experience, security, and scalability. 

Related | 5 steps to launch a Precision Health Test

Physician Approved COVID-19 Clinical Testing

The COVID-19 clinical testing website, built on the ixlayer platform, provides patients with current guidelines from the Centers for Disease Control and World Health Organization throughout the testing flow. The content, written and reviewed by physicians, and experts in health education, cytogenetics, and patient experience, ensure patients understand:

• Signs and symptoms of COVID-19
• When to seek immediate medical care
• The criterion for testing 
• The ordering process 
• Steps to take, while they wait for results, to reduce transmission of the virus that causes COVID-19 to others, and 
• What their test results will and will not tell them.

This is delivered using a secure Patient Portal, where patients complete a health screening questionnaire that is reviewed by their physician to determine if the test is a good fit for them.

 

How Can Your Group Benefit from Connecting to the ixlayer Platform for COVID-19 Testing?

ORGANIZATIONS AND UNIVERSITIES

Whether you are:

• A pharmacy wanting to offer testing services to your clients, 
• An organization wanting to offer employee testing, or 
• A university looking for testing options for research, 

the ixlayer platform can connect you with the services and partners you need.

Although employee COVID-19 testing demand presently exceeds supply, connecting to the ixlayer platform provides your clients, employees, or participants opportunities to access physician-authorized COVID-19 testing on a contractual bulk order.

Also, the Health Screening Eligibility Questionnaire (part of the patient intake) includes questions about COVID-19 symptoms, travel questions, and community contact questions.  All have been written in a format that allows for simple coding for statistical analyses so ordering groups can track trends. 

HEALTHCARE SYSTEMS AND PHYSICIANS

Thankfully healthcare has evolved to the point where most providers can connect with their existing patients through telehealth models. Assessing patient symptoms and ordering diagnostic testing from afar is critical at a time where bringing potentially contagious patients into waiting rooms is not recommended from an infectious disease standpoint.

However, not all physician’s offices are connected to these technologies yet. Furthermore, even for large health systems that have begun putting them in place, the existing mechanisms are not sufficient or cannot be improved fast enough to meet the demand for COVID-19 testing. The ixlayer platform allows physicians to connect with their NPI number, and the platform will communicate with each patient’s EHR.

CLINICAL LABORATORIES

Due to the time-intensive nature of developing laboratory tests, the Food and Drug Administration (FDA) granted CLIA-certified, high-complexity laboratories an accelerated pathway to offer COVID-19 testing. However, mass-producing physician-approved COVID-19 testing, requires many additional steps beyond regulatory oversight of labs to be hastened.

Therefore, due to the logistical questions, many labs are still determining whether to offer COVID-19 testing. Thankfully, ixLayer has a solution that can support many of the pain points for bringing a test online, handling insurance or private pay billing logistics, and communicating with physicians or employee groups. Even more importantly the ixlayer platform is:

• Completely secure, with industry-standard encryption
• HIPAA compliant, and
• Able to communicate with the EHR.

COMMON CHALLENGES OF LABORATORY TESTING

Even under the best circumstances, delivering laboratory testing to both patients and healthcare providers can face challenges including:

• Software development is costly and time-consuming
• Platform development takes time – typically 8 months to two years before becoming fully operational
• Security guidelines and regulatory barriers, (HIPAA, SOC2, GDPR, CLIA, etc), have to be fully implemented before testing platform launches
• The user experience has to be developed for both the patient and the healthcare team, which takes tremendous time. The learning curve between MVP and good user experience is often steep and improved extensively after launch. Even Google and Facebook have come a long way since launch and continually work on their platforms.

For many laboratories, even under situations where there is the time to move through this process, these critical steps are not part of their core competencies as an organization. 

Thankfully, these core processes are the same for COVID-19 as they are for the precision health testing that has already emerged in the marketplace – and ixlayer has the solution in place that addresses these challenges.

LEVERAGING BEST-IN-CLASS LABORATORY SOLUTIONS

Ixlayer is a first-of-its-kind platform offering laboratory solutions to the challenges listed above. The HIPAA-compliant Cloud platform integrates with the needed steps and services to launch tests professionally, effectively, and what is also important in today’s climate – QUICKLY & EFFICIENTLY. 

The ixlayer platform provides:

• Physicians to either directly place requests for tests for patients or review patient test requests and health screening questionnaires to approve and deliver tests
• Integration into the clinical labs’ information management system (LIMS)
• Health organizations the ability to engage physicians through electronic health records
• Integration into interpretation services
• Delivery of result counseling to patients, if requested
• E-commerce solutions for out-of-pocket payments, as well as insurance reimbursement

Related | ixLayer launches first-of-its-kind precision health testing platform to improve delivery of diagnostic testing.

RAPID RESPONSE

The ixlayer platform is everything needed to launch a precision health test or genetic product. Launching a COVID-19 test requires the lab to follow the FDA steps for EUA delivery, which include validating the assay and completing the template for FDA notification.  

The website content about testing, screening questionnaire, technology interface, security and compliance mechanisms are ready for the labs to connect immediately. Once labs have validated the sample and their internal mechanisms complete, the IT team at ixlayer will help your team with the integration of their platform to your lab management system.

CLOSER LOOK AT EACH STEP

The diagram below is an example of the user, sample, and data flow for a test using the ixlayer platform, beginning in this example with the patient initiating a testing request.

STEP 1: Education & Ordering

• Education

A patient is guided to the COVID-19 clinical test website through marketing channels, by a healthcare provider, or by an organization. The patient accesses easily to understand content about COVID-19, symptoms, and testing, and can directly request the test online.

• Ordering

Patients have three possible ways to order the test:

1. Out-of-pocket: payment is made through 3rd party eCommerce platforms integrated into the platform
2. Insurer pay: payment is made through reimbursement services
3. Sponsored: payment is made through government programs, organizations, or institutions

STEP 2: Intake Process & Physician Approval

Once the patient has requested a test, they are guided to an onboarding process which includes:

• Account registration
• Electronic consent
• Intake health questionnaire

These steps are fully customizable based on each client’s needs. The patient’s data is securely stored in a HIPAA-compliant cloud. The health data is shared with:

• A physician through EHR or 
• A physician network through API integration

Then, a physician reviews the intake assessment and approves the test for the patient, which is sent back to ixlayer through the API or EHR (FHIR, HL7).  If the physician determines the test is not a good fit and does not approve the test, ixlayer reimburses the patient for the test and sends them an explanation of communication regarding their test denial. 

STEP 3: Sample Collection

If the test is approved for the patient, ixlayer will send the order through the API Notifier fulfillment center, which depending on the laboratory, will either:

• Send out a sample collection kit to the patient for at-home collection,
• Provide directions to the nearest testing center, or 
• Send notification to schedule an appointment for a collection agent to come to their home to collect the sample

For sample kits that are mailed out, the sample collection tube and box, as well as the shipping method, are all customizable based on the client’s needs. The ixlayer platform is integrated with selected laboratories and will notify them if a patient has registered their collection box and has shipped their sample back to the lab.

STEP 4: Lab process

Once the lab receives the sample, it is able to begin the analysis. Analysis time varies by laboratory and testing volume. Ixlayer will receive notifications from the lab, through the API integration, about each step the sample has moved through, and can also inform the patient about the status of their sample in the Patient Portal.

When the analysis is complete, the lab will securely transmit the data to ixlayer through an encrypted channel. The ixlayer platform can support different file formats, such as FASTQ VCF or can be interpreted as a result in PDF or JSON.

STEP 5: Generating the Report

There are three paths for generating the report for the patient:

1. The Physician or Physician Network can receive the results in a PDF format directly from the lab, through ixlayer.
2. The lab sends the raw data to ixlayer, where ixlayer can host your interpretation algorithms, running the data to your algorithm to produce a report for the patient.
3. Using external interpretation services, whether third-party services or internal, on a different server or Cloud. Through secure API transfer, ixlayer will send data to the interpretation service and receive and interpret the results for the patients.

STEP 6: Physician signs off

The result is forwarded to the ordering physician or physician network for review. Based on the physician’s decision, the results can be shown immediately to the patient via the Patient Portal, or if physician counsel is needed, the patient will be triggered to schedule an appointment to review their results with the ordering healthcare provider.

Throughout this entire process, the patient has a seamless experience. They do not know or see the complicated steps described above. But rather, they:

1. Are directed to an information website.
2. Complete a health eligibility screening assessment.
3. Follow the instructions for sample collection that are communicated to them.
4. Receive their result either on the phone with their provider or directly through the HIPAA secure Patient Portal.
5. The patient can book a physician counseling session online to review any questions they may have about their test results.

CONCLUSION

Later in his address on Monday, March 16, 2020, WHO Director-General Tedros Adhanom Ghebreyesus added, “We have a simple message for all countries: Test, test, test.”

In order to scale COVID-19 testing to meet demand, the organizations and researchers, healthcare systems and physicians, and clinical laboratories all need tools right now that handle the regulatory, security, privacy, and technology portions of the testing and resulting process, so they can each focus on their critical component of meeting the WHO’s demand for swift action. ixlayer offers the platform we have created for COVID-19 testing to serve as a vital step in this circle of patient testing, so critically needed in America right now.