Employers focused on maintaining safe and healthy workplaces are evaluating a variety of different strategies to identify employees infected with SARS-CoV-2. While the CDC is currently suggesting a strategy of symptom-based screening, some organizations (like Smithfield Foods and Tyson Foods)are implementing programs to test employees for the virus or the presence of antibodies. Should your company be doing the same?
There are a handful of considerations in evaluating this concept, from what tests you intend to use, to the logistics of testing employees, to the legal implications. All in all, requiring employee testing can have significant advantages in protecting employee health, but is currently challenging to implement. Here are a few things you should be asking if this is a route you are considering:
What tests are currently available?
First things first: When we discuss testing, we are not referring to symptom-based screening, in which individuals are assessed for SARS-CoV-2 symptoms through temperature checks or symptom questionnaires. If you are interested in this approach, please refer to our article on the topic.
In contrast, testing involves a biological sample and evaluates that sample for the presence of specific molecules or particles. Depending on the exact test being used, testing can greatly increase the likelihood of flagging someone who was or is asymptomatic, or who is presymptomatic (infected, but not yet exhibiting symptoms).
There are two major categories of testing you should be aware of: diagnostic and serological (antibody) testing.
Diagnostic testing determines whether an individual is currently infected. Diagnostic testing today is available in two forms: molecular tests that detect the viral genome (most common), and antigen tests that detect proteins specific to SARS-CoV-2. Both of these types of tests are performed using a sample from a patient’s respiratory system, typically gathered through a nasal swab or throat swab.
Based on the current data, the FDA believes that molecular tests approved with the Emergency Use Authorization standard are “highly accurate. This means that a positive or a negative result from a molecular test is likely to be true.” Antigen tests “are not as sensitive as molecular tests. This means that a positive result is highly accurate, but there is a higher chance of false negatives, so a negative result does not rule out infection.” In fact, the FDA suggests confirming the negative results of an antigen test with a molecular test.
However, antigen tests often have faster turnaround times than molecular tests, even as low as a few minutes. Some have suggested that clinics use antigen tests to perform quick screens of symptomatic individuals, and follow up with a confirmatory molecular test if an antigen test’s results are negative. Turnaround times for molecular tests vary significantly, from a few days to less than an hour, depending on the particular test equipment in use, whether processing is performed at the point-of-care or at an offsite laboratory, and the size of the processing backlog a laboratory might face right now.
Serological (Antibody) testing:
For the sake of completeness, we will also cover serological (antibody) testing; however, in its current state this is not a particularly helpful option for employers for a variety of reasons we cover below.
The goal of serological (antibody) testing is to determine if an individual was recently or previously infected by detecting the presence of antibodies in a patient’s blood sample. The human body produces antibodies to a virus like SARS-CoV-2 as part of the body’s immune response. Critically, this means that according to the FDA serological tests “CANNOT be used for diagnosis of infection” (emphasis added). In fact, the CDC points out “it can take 1-3 weeks after infection to make antibodies” - in other words, an individual could currently be infected and contagious and still receive negative serological test results.
Alternatively, some countries and organizations around the globe have expressed a desire to use antibody testing to identify individuals who have previously been infected and certify them as “immune.” However, as of right now, the CDC warns, “We do not know yet if having antibodies to the virus can protect someone from getting infected with the virus again, or how long that protection might last.” Furthermore, it might be possible that an individual with antibodies can still infect others. As of May 24, the CDC explicitly states, "Serological test results should not be used to make decisions about returning persons to the workplace."
You may be wondering - what is the point of serological testing, then? Right now, serological testing is mostly helpful for public health authorities and researchers. The FDA explains, “Serology tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who have antibodies to SARS-CoV-2 virus and have developed an adaptive immune response. In the future, this may potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection.”
Can an employer legally require employees to be tested?
According to the US Equal Employment Opportunity Commission (EEOC), during the current state of an officially declared pandemic, “an employer may choose to administer COVID-19 testing to employees before they enter the workplace to determine if they have the virus” (emphasis added). The wording makes it clear that a diagnostic test would be acceptable; however, serological tests do not determine if an employee is a “direct threat” and therefore employers may be prohibited from requiring serological testing under the Americans with Disabilities Act (ADA). On top of that, the EEOC requires that any medical examinations are accurate and reliable, and there have been concerns regarding the accuracy of many serological tests (see FDA statement on the topic). American law firm Fox Rothschild summarizes, “It is unlikely that the EEOC would authorize employers to require antibody testing that at best establishes an employee’s presence in the workplace poses no direct threat to her own health. It is possible that, once antibody testing is more reliable, widely FDA-approved, and shown to establish that an employee has immunity protection for a substantial period of time, the EEOC will authorize its use by employers on a voluntary basis.”
In the case of diagnostic testing, the same standards apply - the ADA requires employers to ensure such tests are “accurate and reliable,” taking under consideration guidance from the FDA, as well as the incidence rate of false positives or negatives associated with a given test. Refer to the FDA’s up-to-date list of all test kits that have received Emergency Use Authorization.
The ADA also dictates that if an organization receives any medical information from employee testing, they must keep this information confidential, and store it separately from personnel files.
Finally, note that the allowance for SARS-CoV-2 testing is applicable during this officially declared pandemic, but the ADA restricts employer-mandated medical testing under normal circumstances. Specifically, during employment, “the ADA prohibits...employee medical examinations unless they are job-related and consistent with business necessity.” Employers should monitor the EEOC guidance on the topic to ensure they remain compliant as the outbreak and response continue to evolve.
What are the logistics behind required testing?
The idea of testing employees is much easier to say than it is to execute. While Amazon has declared its intent to build its own labs to test employees, this is likely not a viable path for most organizations. There are important measures at each step of the testing process to ensure testing is safe, accurate, and compliant:
- Sampling: While there are a few diagnostic test kits with Emergency Use Authorization that enable at-home sample collection, the vast majority require in-person sampling. For a diagnostic test, this is typically collected through what we would call a nasal or throat swab. Samples should be collected by a trained healthcare provider; the CDC warns that “a specimen that is not collected correctly may lead to false negative results.”
- Transportation: Unless sampling and processing are performed in the same facility, samples will need to be transported to a laboratory. The CDC advises that specimens can be stored “at 2-8 degrees C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70 degrees C or below.” Specimens also need to be packed and shipped in accordance with regulations like UN 3373.
- Testing/processing: The FDA and CDC require that any lab testing COVID-19 samples be certified under the Clinical Laboratory Improvement Amendments (CLIA), a regulation governed by the Centers for Medicare & Medicaid Services (CMS) and enforced at the state level.
In summary, if you are interested in performing testing on-site at your workplace, you should engage trusted third-party healthcare providers and certified laboratories to ensure the end-to-end process is safe, accurate, and compliant. Alternatively, you could ask employees to be tested elsewhere in a certified testing facility.
In either case, there is another logistical hurdle to requiring testing, and that is the question of frequency. According to UC Davis Health, “tests are like a photograph – they are only a snapshot for the time when the sample is taken.” In other words, even if an employee is free of SARS-CoV-2 on Monday, they may test positive for the virus later that week. As of right now, there is no standard protocol for what constitutes an acceptable frequency of testing.
The short-lived usefulness of the results is further complicated by the fact that it may take up to a few days to get results from a test. According to Sarah Krouse of the Wall Street Journal, "Long waits for results—up to 72 hours—and an uncertain timetable for when rapid-result testing will reach most workplaces, mean that companies’ grasp on workers’ health remains imperfect at best, even with costly testing."
Ms. Krouse's reference to cost is yet another challenge facing employers, coupled with the limited availability of tests on the market. In a recent Financial Times interview of Terry Stone, managing partner of Oliver Wyman’s health and life sciences group, Ms. Stone lamented, “It’s extraordinarily hard to get your hands on adequate testing right now and it’s cost prohibitive: you can’t test everybody every day. We’re estimating the cost is $50 to $120 per person per PCR [molecular diagnostic] lab test.” Depending on an organization's employee population and the frequency of its testing program, unit costs of that magnitude add up quickly.
With all these considerations, it is understandable why employee survey company Mercer reports that among surveyed companies who are conducting employee screenings and assessments, fewer than 7% were implementing diagnostic testing (as of the date of publication). That number is likely to increase as the availability and speed of testing increases, and employers should continue to monitor the options available to them as the testing landscape evolves.
Note: Commentary from TeamSense should not be construed to be authoritative legal or public health guidance. Organizations should follow the latest guidance from relevant governmental and public health authorities and seek counsel from appropriate Legal, HR, and EHS professionals