Addressing Confidentiality with the COVID-19 Surveillance System

Ordinarily, the Americans with Disability Act (ADA) prohibits an employer from performing medical tests/clinical exams on its employees – but these are no longer ordinary times – we are now living in a new normal with unfolding waves of the COVID-19 pandemic, prompting the EEOC and the ADA to issue updates regarding what is permissible in these times. 

On April 23, 2020, the Equal Employment Opportunity Commission (EEOC) stated that “an employer may choose to administer COVID-19 testing / temperature checks to employees before they enter the workplace to determine if they have the virus.” Recent updates with guidance from these organizations indicate that their existing laws are not to interfere with or prevent employers from following the guidelines and suggestions made by the CDC or state/local public health authorities with regards to steps employers need to take for COVID-19 to safeguard the health of coworkers, customers, and for participating in the control of the pandemic. Further, the EEOC update indicated that “During a pandemic, ADA-covered employers may ask employees if they are experiencing symptoms of the pandemic virus, such as fever, chills, cough, shortness of breath, or sore throat.” The EEOC indicated that Employers are to maintain all such information about an employee’s illness or absence thereof as a confidential medical record in compliance with the ADA.” 

The EEOC’s most recent update specifically provides an answer to the following question: “May an employer administer a COVID-19 test (a test to detect the presence of the COVID-19 virus) before permitting employees to enter the workplace?” In answering this question, the EEOC applies the ADA standard which requires medical testing of employees be “job related and consistent with business necessity.” Applying this standard to the current COVID-19 pandemic, the EEOC states employers may take steps to determine if employees entering the workplace have COVID-19 because an individual with the virus will pose a direct threat to the health of others. But, the EEOC notes that employers should ensure that the tests are “accurate and reliable.” The EEOC’s ADA regulations also require direct threat determinations be based “on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence.” To satisfy these standards, employers should consider FDA and CDC guidance concerning standards for safe and accurate testing, including evaluating the incidence of false positives or negatives with the test. So like its earlier statements, allowing employers to conduct temperature checks on employees, this latest addition provides employers with additional support for conducting or requiring employees to be tested for COVID-19 before returning to the workplace.

The COVID-19 Surveillance System embodies a comprehensive set of components to determine transmission and contraction risk (Click here to learn more): COVID-19 testing for active infection using the nasal RT PCR test from Quest Diagnostics, complete clinical evaluation at baseline of employees enrolled into the program (temperature checking, pulse oximeter readings if needed, paired with questions concerning potential COVID-19 symptoms or activities (e.g., attendance at mass gatherings, family member COVID status, etc.) that increase the risk of COVID-19 exposures. In addition all enrolled employees are also tested for antibodies (IgM & IgG). Though none of these tests are yet definitive or expressly recommended by the CDC, they provide additional data for computation of the different types of risk and the summary recommendations generated by the system for an employee. We have provided further information regarding serology tests from the FDA.

The other key issue to address here is the disclosure and confidentiality of an employee’s COVID-19 test results. According to the EEOC guidance, employers are to maintain confidentiality of employees’ medical information, including COVID-19 test results. After test results are received, the tester can share the results with a designated individual at the employer, who can then communicate the information to managers on a need-to-know basis only. And this is exactly the way the COVID-19 Surveillance System works – employee participation is decided upon by the employer and is voluntary and the results / recommendations from the data algorithms are accessed via a secure portal with restricted access to key designated users at the employer organization, and with employees having access to their own results. The information provided to the employer for a given employee is a summary based data driven recommendation – safe to return to work (green), work from home for XX days (yellow), and self-isolate to minimize transmission risk (red). An employee’s identity is only disclosed to their manager only if it is necessary to prevent a direct threat to safety to co-workers and or customers. 

Also, in accordance with the ADA / HIPAA, the system is compliant with requirements for an employer’s storage of medical information. As required by the ADA, the COVID-19 Surveillance System maintains the COVID-19 related medical information concerning an employee separately from the employee’s personnel file in a confidential and secure encrypted medical data repository. In addition, even after the end of their subscription, employers will have access to the data and information in the encrypted secure repository for the statutory period of 7 years.

We are expecting the EEOC and ADA guidelines to continue to evolve as testing becomes more widely available and state governments begin to loosen stay-at-home restrictions. These guidance are in place to address a “Direct Threat,” and most likely will no longer apply once the pandemic is no longer deemed a threat. What remains consistent under ADA guidelines, however, is the illegality of firing an individual over a condition like COVID-19. Also note that the EEOC’s opinion only addresses concerns under the ADA. Employers also need to consider state and local laws, including privacy concerns that might apply.

ADDITIONAL RESOURCES

1. To view the EEOC update, click here for the latest update: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.

2. To review the FDA’s device center’s webpage listing the serology tests that are administered under the EUA policy, some of which are directed toward a single antibody while others capture multiple antibodies, click on the link below. The list includes data on sensitivity and specificity along with positive and negative predictive values (PPV and NPV, respectively). The agency has advised that the PPV and NPV values are still based on an assumed prevalence of 5% in the area where a given serological test is administered.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

Other links with more detail on above topics:

https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act

https://www.venable.com/insights/publications/2020/04/eeoc-says-ok-for-mandatory-employee-covid19

https://www.natlawreview.com/article/eeoc-opines-covid-19-testing-employers

FAQs- COVID 19 Surveillance System

Coronavirus Update 8 – Convalescent Plasma Donation

The Dogma of the Realities of the Accuracy of SARS-CoV-2 Tests!

SARS-CoV-2, the virus responsible for the COVID-19 pandemic, is a new/novel virus for the human race. One of the pillars of managing this virus and the pandemic is accurate testing. Testing for the SARS-CoV-2 virus remains a challenge with regards to the accuracy of tests on the market. Epidemiologically, any diagnostic or laboratory test is always evaluated on two key metrics: it’s specificity and sensitivity rate.

Specificity

Specificity is the likelihood that the COVID test results are truly positive. That is, could a similar Non-COVID-19 Coronavirus be responsible for the positive result? A COVID test with a high specificity (i.e., reliable) will have a LOW false positive rate. Generally speaking it is desirable to have a test with high specificity. However, high specificity is attained at the expense of sensitivity. It is desirable to have a test with high specificity and sensitivity, but almost impossible to create a perfect test.

SARS-CoV-2 in its worldwide prevalence in the general population is still low. Even with the current pandemic raging, the prevalence and incidence is still low based on identified active cases (Some 5 million active cases identified worldwide out of a population of about 7.7 billion as of May 21, 2020). Aside from the diagnosed positive cases, it is estimated that the prevalence of coronavirus infection is more around 5% in the general population. We commonly associate a low prevalence of disease with increased false positive rates when testing. The current low prevalence of COVID infection affects the accuracy of SARS-CoV-2 tests coming into the market for use, with the risk of false positives becoming a major problem. Test manufacturers and regulators alike will have to be diligent and guard against a high number of false positives when developing and approving tests.

Sensitivity

Sensitivity of a SARS-CoV-2 molecular test or antibody test is the likelihood of how accurately the test will detect the virus or presence of the different types of antibodies. That is if you are infected with the virus, will the test correctly identify that you are infected, or will it not identify the virus in your respiratory system, resulting in a false negative. A highly sensitive test (i.e., accurate) will have a LOW false negative rate.

Most of the tests granted emergency use approval by the FDA during this pandemic have limited data with regards to their reliability and accuracy. Scientists at the Cleveland Clinic found that one popular rapid genetic test (the widely promoted Abbot test) told users they didn’t have the virus when they actually did (false negatives) about 15 percent of the time (1). Meanwhile, researchers at UCSF California studied 14 antibody tests on the market, some that were granted emergency use authorizations by the Food and Drug Administration (FDA), and found that only three of these tests delivered consistent results (1). Given the 5% prevalence rate, if a serological test has about 90% specificity, its positive predictive value (PPV) will be 32.1% – meaning nearly 70% of positive results will most likely be false. At this same disease prevalence, a test with 95% specificity will lead to a 50% chance that a positive result is wrong. Only at 99% specificity does the false positive rate become anywhere near acceptable, and even here the chances are that 16% of positive results would be wrong.

We know that a number of individuals with COVID infection are asymptomatic, sometimes for weeks, increasing the transmissibility of the disease in the population. For such cases it is important to have tests that can look for active infections with a high degree of sensitivity and specificity (low number of false negatives and false positives). If we can quickly identify such cases and isolate them, then we can prevent the rapid spread of this contagion.

The table below summarises test accuracy data, as of May 06, 2020, from selected manufacturers for their serological Covid-19 tests. However, when reviewing this data it has to be stressed that the validation tests these companies have performed have varied widely in size; Abbott’s antibody assay was tested on 1,200 specimens, whereas Epitope’s tests were run on only 54 samples from healthy people, and just 20 and 30 cases of PCR-confirmed Covid-19 cases for the IgM and IgG tests respectively.

Accuracy & Reliability of Selected COVID 19 Tests in the US & EU Markets:

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Note: All accuracy claims made by the companies. *Tests with FDA emergency use authorisation. Source: EvaluateMedTech & company websites.

Similar to most processes associated with COVID 19, since the emergence of the infection, tests for active infection and/or for antibodies are evolving daily by different clinical research laboratories, academic health organizations, and biomedical companies worldwide. However, in the US we are still facing a challenge with regards to ready and widespread availability of accurate and reliable COVID tests for both the molecular PCR test and the serological tests for the different antibodies. The situation is both dire and murky to say the least.

At this point, it is well recognized that both the molecular tests for Covid-19 (the nasal PCR that look for active infections) and the serological antibody tests (IgM for more recent and IgG for past infections) have had significant issues with respect to their accuracy. Shortage of good tests in turn means that we will not know how many active cases are out there in the public, or how many have recovered with a degree of short or long term immunity conferred on them to decrease the risk of contraction and/or rate of reinfection.

REFERENCES
1. https://www.vox.com/2020/5/1/21240123/coronavirus-quest-diagnostics-antibody-test-covid
2. Data compiled by EvaluateMedTech.
3. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerg Microbes Infect. 2020;9(1):747–756. doi:10.1080/22221751.2020.1745095
4. Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol2020. [Epub ahead of print] doi:10.1038/d41587-020-00010-2 pmid:32203294

Coronavirus Update 11: COVID-19 Surveillance System

In the upcoming weeks we expect businesses to begin the slow and cautious reopening process. We are rolling out a new service for business owners and employers to provide COVID-19 surveillance for their employees. This surveillance includes employee clinical evaluation, nasal pcr and antibody testing, as well as generation of summary reports for employers to monitor their workforce closely for risk of transmission. More details are available on our Facebook page group and website.

Facebook page group: www.facebook.com/groups/covidclear

Website: www.buckheadmedicine.com/covidclear

Preference for COVID-19 surveillance services will be given to our existing patients who are business owners or employers. We value your feedback as we roll out this service.
Additionally, as you know from our previous update, last week we initiated serum antibody testing in our office. This process is going well and we are continuing to build capacity within our office to handle more COVID-19 nasal PCR and serum antibody testing for our patients. Please call the office if you wish to be tested.

Stay Well and Stay Home,

Dr. Edward Espinosa
Buckhead Medicine