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Frequently Asked Questions

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Understanding COVID-19 Surveillance

It’s a population health program established by an employer, school or other organization intent on identifying an outbreak in that organization’s environment, and is essential to getting employees, students and patrons back to business as usual. Data collected in a surveillance program will enable detection of infection and inform targeted interventions designed to suppress and limit the contagion. Your surveillance program can be used to:

  • Identify asymptomatic infection spread early,
  • Pause your defined sub-group’s interactions if there is reason to suspect an infection, and refer individuals for confirmatory diagnostic testing, Assist in contact tracing efforts,
  • Increase employees’ or students’ confidence in the safety of their environment, and
  • Increase patrons’ confidence in the safety of the business or school they are visiting.

The intent is not to clinically diagnose an individual. Rather, it is to collect data to make informed decisions on your protocols to identify an outbreak. The data is collected on a de-identified basis and reported out in a manner that informs on the effectiveness in the surveillance programs goal, in this case to suppress or limit the spread of Covid 19. Data may be collected through a number of means, including point of care rapid resulting testing. Since the intent of the program is to gather data and not exclusively to test, the following information should be gathered:

  • Subjective data (daily questions),
  • Objective data (temperature readings, the use of point of care rapid tests on premises),
  • Your plan for a person who has been identified as “at risk” in order to facilitate treatment, request quarantine, or initiate other appropriate control measures, and
  • Any other specific goals you set for your program.

It is important to note that to be compliant, it is crucial that your organization be collecting and reporting data to demonstrate that you are surveilling for the sake of suppressing the contagion and not screening or testing outside of a medical or clinical care path with the sole intention of testing to diagnose. By collecting data you are able to show, for example, that on a de-identified basis your infection rate of a given population decreased over time and therefore your preventative measures were effective.

According to the Food & Drug Administration (FDA):

  • Surveillance testing looks for infection within a population or community, and can be used for making health management decisions at a population level rather than at an individual level. It includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing and evaluating public health practice. Surveillance programs do not include the documentation of test outcomes, but instead will simply flag the individual or other pre-defined subset of your population to go in for confirmatory testing. A patient-specific outcome from your surveillance testing is not to be tracked at an individual level, as this would violate HIPAA regulations.
  • Screening is looking for an occurrence at the individual level even if there is no reason to suspect infection such as known exposure. It is considered screening if tests are used on asymptomatic individuals with the intention of making individual decisions based on the test results. An example of screening is if a workplace / school were to self-test all employees / students returning to the workplace or school, regardless of exposure or signs and symptoms, with the intent of using those individual results to determine who may return or what protective measures are to take place on an individual basis. This may violate HIPAA if conducted onsite by the employer or school.
  • Diagnostic testing is performed when there is a reason to suspect that an individual may be infected. This could include a recent exposure or the presence of symptoms that often come with a COVID-19 infection. This type of testing is generally expected to be conducted in a medical or clinical setting.

Employer sponsored population health surveillance gathers and interprets data on a defined population to monitor and support remedial measures directed to a population health initiative. Surveillance may be a precursor to the medical care path and identifies individuals that should be directed to a medical care path by doing the following:

  • Gathering data on a de-identified basis, which does not require a medical provider oversight or administration,
  • Collecting de-identified information NOT personal health information subject to HIPAA compliance,
  • Monitoring pool prevalence to identify an outbreak to move those pools into a medical care path for confirmatory testing,
  • Unlike surveillance, the medical care path starts with a clinical evaluation and possible diagnosis of a patient in a HIPAA-compliant environment, such as a doctor’s office.

Cost, control, flexibility, convenience, sustainability, customization and ability to extend your program to a broader group. A surveillance program could include roommates or significant others of your employees / students, trainers, or even patrons of your business or school if your program is set up correctly. The key to being able to perform testing is that you are surveilling a population without capturing HIPAA-regulated data by advancing the individuals included in the pre-defined cohort for confirmatory testing if someone in that cohort tests positive.

The data collected will be organized to further inform protocols and procedures to suppress or limit spread and guard against the contagion.

Conducting COVID-19 Testing

MiroDX has found that collecting data through rapid antigen screening is highly effective. In addition to capturing subjective information on exposure and symptoms, objective testing is a simple, inexpensive and effective solution with no overnight shipping or lab involved. Under a surveillance program, you are not required to use any specifically authorized product.

That is up to the organization. Many organizations test their populations 1-2 times per week with antigen tests, and some design their program to include a rotation of antigen tests and much more costly PCR tests. The NCAA recommends antigen 3 times per in its guidelines. As test results are representative of only the specific moment in which the test was administered, testing frequency is an important consideration in surveilling for potential infection. A sporadic testing regimen puts your organization at greater risk of undetected infections spreading to others in your population. Even testing once per week allows you to detect and slow the spread of COVID-19, compared to no testing effort at all.

No. For data integrity, you should test onsite. This ensures that the person you intend on testing is actually the person that is using the test.

No. If testing within a surveillance program, a medical professional is not required. If you determine that your need is to screen or diagnose your population, then other medical / clinical involvement is required.

Moreover, the US Centers for Medicare & Medicaid Services (CMS) states that facilities using a pooled sampling procedure to report non patient-specific results do not require CLIA certification during the public health emergency. The MiroDX surveillance program is designed to allow facilities without CLIA certificates to meet this requirement.

The Center for Disease Control (CDC) and the Food and Drug Administration (FDA) do not generally regulate the use of a test for surveillance purposes, such as determining the prevalence of acute infections in a population. The CDC defines public health surveillance, and the employer oversees it. During the COVID-19 public health emergency, the FDA understands that results have been returned to individuals tested for COVID-19 surveillance purposes. Unless surveillance testing is performed by a CLIA certified lab, an individual who tests positive should have a confirmatory test through a medical care pathway.

None, because you are not doing diagnostic testing. Your organization is collecting data on the risk or prevalence of a defined group, for which that group can be flagged and notified to be escalated for confirmatory testing in a medical / clinical setting.

Surveillance Platform

We are currently in Beta testing of our new COVID Surveillance Platform for disease and health surveillance data collection, testing and tracing. It supports your efforts to avoid the collection of protected health information (PHI) so your organization doesn’t violate HIPAA regulations, and saves you from having report-generating responsibilities (reporting is one of key elements of a surveillance program). Administering a non-compliant program exposes your company to risk, and while Clara is a robust solution, it should be used as a part of your organization’s surveillance program rather than a replacement for it. Note that MiroDX does not design or oversee an organization’s comprehensive surveillance program.

A link to the platform for daily employee / student use could be added to your website for ease of use. See link for more detailed information about surveillance and our platform.

Additionally, we sell affordable point of care rapid tests to conduct testing within your surveillance program.

We are currently in Beta testing and anticipate a full-scale rollout by late September 2021.

Yes, so long as the test you have purchased has an Emergency Use Authorization (EUA).

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