On January 21, 2021, the U.S. Center for Disease Control (CDC) issued new guidance for non-healthcare employers who conduct workplace COVID-19 testing. While the CDC previously confirmed that workplace testing is permissible as part of a comprehensive approach to reducing virus transmission, the new guidance clarifies that it should not be conducted without employees’ informed consent. According to the CDC, “informed consent requires disclosure, understanding, and free choice, and is necessary for an employee to act independently and make choices according to their values, goals, and preferences.”
According to the CDC, employers should adopt at least the following measures to promote free decision-making and informed consent to COVID-19 testing in the workplace:
- Implement safeguards to protect employee privacy and confidentiality.
- Provide complete and understandable information about how a testing program may impact employees’ lives, such as whether a positive test result or refusal to participate in testing may mean exclusion from work for any period of time.
- Explain parts of the testing program that would be particularly important to employees as they decide whether to participate (i.e., key reasons that may guide their decision).
- Inform employees about the testing program in their preferred languages using clear, non-technical terms. Solicit employee input on the readability of the information.
- Train supervisors and managers on their roles and responsibilities regarding testing and encourage them to avoid pressuring employees to participate in testing.
- Consider the consent process as an active information-sharing process between the employer and the employee. Throughout the process, encourage and answer employees’ questions, facilitate their understanding, and promote their free choice.
In addition, employers must ensure the disclosures listed below are made to employees:
- The manufacturer and name of the test.
- The type of test and its purpose.
- How the test will be performed.
- The known and potential risks of harm, discomforts, and benefits of the test.
- What it means to have a positive or negative test result, including test reliability and limitations and any public health guidance triggered by a particular result.
Many of these are contained in the FDA’s emergency use authorization patient fact sheet for each approved COVID-19 test (scroll down on the linked page to find the test-specific fact sheet), which must be provided to any party receiving that test.
Employers who conduct workplace COVID-19 testing must develop plans to address a host of other testing-related topics and questions, including:
- Their reasons for testing, frequency of testing, and consequences to employees of testing/non-testing.
- Locations, scheduling, procedures, and payment for testing.
- Communication and interpretation of test results, applicable leaves and/or benefit policies.
- Personal information needed to test and privacy of results.
- Internal resources for employees who need additional information, assistance, treatment after test procedure.
Given the CDC’s detailed requirements for informed consent and disclosures relating to workplace-based COVID-19 testing, employers in non-healthcare settings should proceed cautiously when considering the implementation of testing programs or protocols. Rather than conduct workplace testing, some employers may be well-advised to minimize administrative burdens and legal exposure by strongly encouraging employees to undergo frequent COVID-19 testing administered by reliable, unrelated third parties.