Written By: Compliance Blogger
This article addresses COVID testing and consent considerations for: healthcare organizations, nursing homes and business associates or non-healthcare workplaces. This article is not intended as legal or consulting advice. Employers are encouraged to collaborate with state, territorial, tribal and local health officials to determine whether and how to implement COVID testing strategies.
SARS-CoV-2 (COVID-19) continues to be a health risk to be mitigated by health care institutions and at the workplace. Employers paying for testing of employees should put procedures in place for rapid notification of results and establish appropriate measures based on testing results, including instructions regarding self-isolation and restrictions on workplace access.
An employer’s testing program (including the implementation of a testing protocol to test employees) may be complex and technical. Certain aspects of the testing program may be more relevant than others to an employee’s decision whether to accept an offered test. Obtain guidance from experts to assist your organization in navigating risk.
Business Associates (non-healthcare organizations)
The Center for Disease Control (CDC) provides guidance for non-healthcare workplaces, which would apply to most business associates who have partnered with a health care institution, such as legal or accounting firms; medical billing companies; IT managed service providers, etc. Workplace-based testing should not be conducted without the employee’s informed consent. Encourage and answer questions during the consent process.
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. Consult legal counsel when developing your informed consent form for employees.
To fully support employee decision-making and consent, employers should take the following measures when developing a testing program:
- Ensure safeguards are in place to protect an employee’s privacy and confidentiality.
- Provide complete and understandable information about how the employer’s testing program may impact employees’ lives, such as if a positive test result or declination to participate in testing may mean exclusion from work.
- Explain any parts of the testing program an employee would consider especially important when deciding whether to participate. This involves explaining the key reasons that may guide their decision.
- Provide information about the testing program in the employee’s preferred language using non-technical terms. Consider obtaining employee input on the readability of the information. Employers can use the CDC tool to create clear messages: https://www.cdc.gov/ccindex/
- Encourage supervisors and co-workers to avoid pressuring employees to participate in testing.
- The consent process is active information sharing between an employer or their representative and an employee, in which the employer discloses the information, answers questions to facilitate understanding, and promotes the employee’s free choice.
Disclosures for Non-healthcare Workplace Testing
Individuals tested are required to receive patient fact sheets as part of the test’s emergency use authorization (EUA):
A basic disclosure for COVID-19 should include the following elements to provide information to employees so they understand what is involved when consenting to the test, such as clear information on the manufacturer and name of the test, the type of test, the purpose of the test, the performance specifications of the test, any limitations associated with the test, who will pay for the test, how the test will be performed, how and when they will receive test results, and; how to understand what the results mean, actions associated with negative or positive results, the difference between testing for workplace screening versus for medical diagnosis, who will receive the results, how the results may be used, and any consequences for declining to be tested.
According to the Americans with Disabilities Act (ADA), when employers implement any mandatory testing of employees, it must be “job related and consistent with business necessity.” In the context of the COVID-19 pandemic, the U.S. EEOC notes that testing to determine if an employee has SARS-CoV-2 infection with an “accurate and reliable test” is permissible as a condition to enter the workplace because an employee with the virus will “pose a direct threat to the health of others.” EEOC notes that tests administered by employers which are consistent with current CDC guidance will meet the ADA’s business necessity standard. However, workplace-based testing should not be conducted without the employee’s consent.
Infection Control for Healthcare Facilities
The CDC has made recent changes to infection control guidance for all U.S. settings where healthcare is delivered, including home health. The updated healthcare infection prevention and control (IPC) recommendations as of September 10, 2021 are in response to the COVID-19 vaccination. Consult with legal counsel regarding disclosures and consents appropriate for your organization.
Healthcare Personnel (HCP): HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, dental healthcare personnel, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).
Healthcare settings refers to places where healthcare is delivered and includes, but is not limited to, acute care facilities, long-term acute-care facilities, inpatient rehabilitation facilities, nursing homes, home healthcare, vehicles where healthcare is delivered (e.g., mobile clinics), and outpatient facilities, such as dialysis centers, physician offices, dental offices, and others.
Source control is the use of respirators, well-fitting facemasks, or well-fitting cloth masks to cover a person’s mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing. Source control devices should not be placed on children under age 2, anyone who cannot wear one safely, such as someone who has a disability or an underlying medical condition that precludes wearing one safely, or anyone who is unconscious, incapacitated, or otherwise unable to remove their source control device without assistance. Face shields alone are not recommended for source control.
Several of the IPC measures (e.g., use of source control, screening testing) are influenced by levels of SARS-CoV-2 transmission in the community. There are two different indicators in CDC’s COVID-19 Data Tracker which are used to determine the level of SARS-CoV-2 transmission for the county where the healthcare facility is located – Access the COVID Data Tracker:
If the two indicators suggest different transmission levels, the higher level is selected.
Source control and physical distancing (when physical distancing is feasible and will not interfere with provision of care) are recommended for everyone in a healthcare setting. This is particularly important for individuals, regardless of their vaccination status, who live or work in counties with substantial to high community transmission or who have:
- Not been fully vaccinated; or
- Suspected or confirmed SARS-CoV-2 infection or other respiratory infection (e.g., those with runny nose, cough, sneeze); or
- Had close contact (patients and visitors) or a higher-risk exposure (HCP) with someone with SARS-CoV-2 infection for 14 days after their exposure, including those residing or working in areas of a healthcare facility experiencing SARS-CoV-2 transmission (i.e., outbreak); or
- Moderate to severe immunocompromised; or
- Otherwise had source control and physical distancing recommended by public health authorities.
Perform SARS-CoV-2 Testing
Anyone with even mild symptoms of COVID-19, regardless of vaccination status, should receive a viral test as soon as possible, according to the CDC recommendation.
Asymptomatic HCP with a higher-risk exposure and patients with close contact with someone with SARS-CoV-2 infection, regardless of vaccination status, should have a series of two viral tests for SARS-CoV-2 infection.
- In these situations, testing is recommended immediately (but not earlier than 2 days after the exposure) and, if negative, again 5–7 days after the exposure.
- Note - testing is not recommended for people who have had SARS-CoV-2 infection in the last 90 days if they remain asymptomatic; this is because some people may have detectable virus from their prior infection during this period (additional information is available here). Criteria for use of post-exposure prophylaxis are described elsewhere.
Expanded screening testing of asymptomatic HCP without known exposures is required in nursing homes and could be considered in other settings. It should be conducted as follows:
- Fully vaccinated HCP may be exempt from expanded screening testing.
- Guidance for expanded screening testing for nursing homes is described in the Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes | CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html
Performance of pre-procedure or pre-admission viral testing is at the discretion of the facility. The yield of this testing for identifying asymptomatic infection is likely low when performed on vaccinated individuals or those in counties with low or moderate transmission. However, these results might continue to be useful in some situations (e.g., when performing higher risk procedures on unvaccinated people) to inform the type of infection control precautions used (e.g., room assignment/cohorting, or PPE used).
Click Here for more detailed information about infection control guidance.