Frequently Asked Questions
What is a COVID-19 surveillance program?
It’s a population health program created and implemented by an employer, school or other organization with the intention of suppressing the contagion in that organization’s environment. A surveillance program is essential to getting employees, students and patrons back to business as usual. The data collected will enable detection of infection and inform targeted interventions. Your surveillance program can be used to:
Identify asymptomatic infection spread early,
Halt your 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.
What are the essential elements of a surveillance program?
Since the intent of a surveillance program is to gather data and not to perform diagnostic testing, your organization should have its end goal in mind (e.g. minimize the risk of infection in the organization) and design your program to reach that goal using data.
Data may be collected from multiple sources, including:
Point of care rapid testing
Your program should also include a protocol for when someone is identified as “at risk” in order to facilitate treatment, request quarantine, or initiate other appropriate control measures.
In order to be compliant, your organization must both collect and report data on a de-identified basis to demonstrate that you are surveilling for the sake of suppressing the spread of the virus, and not testing to diagnose. As an example, your reports may show that the infection rate of a given population decreased over time and therefore your preventative measures were effective.
What’s the difference between surveillance, screening, and diagnostic testing for COVID-19?
A: 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.
What’s the difference between testing in a surveillance program vs. the medical care path?
Employer sponsored population health surveillance gathers and interprets data on a defined population to monitor and support 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 subject to HIPAA,
Providing information to impact the protocols put in place to achieve the health initiative, and
Identifying an individual who is “at risk,” thus moving them into a medical care path, without a diagnosis given by the employer.
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.
Why should my organization establish a surveillance program rather than a diagnostic testing program?
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 / 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.
What type of tests should I use for my surveillance program?
MiroDX has found that collecting data through rapid antigen screening is highly effective. It’s 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.
How often should my organization conduct surveillance testing?
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.
Can I send tests home with employees or students for them to test remotely?
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.
Do I need to have a medical professional conduct the testing in my place of employment or school?
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.
Which governmental agencies oversee or monitor an organization’s COVID safety program?
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.
How can MiroDX support my organization with our efforts to keep our environment safe?
We are currently in Beta testing of our new COVID Surveillance Platform called Clara 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.
When will MiroDX’s surveillance platform be available?
We are currently in Beta testing and anticipate a full-scale rollout by early April 2021.
What information do I need to be reporting to any government agency on the outcomes of my organization’s testing?
None, because diagnostic testing is not being conducted. 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.
Can I coordinate a surveillance program with my organization’s healthcare payer or on site clinical partner?
Yes, so long as the test you have purchased has an Emergency Use Authorization (EUA).
I have questions. Can we talk?
Yes! Please reach out to firstname.lastname@example.org or call (888) 656-3444