COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Clinical Laboratories Must Protect Themselves Against Litigation Risk with SARS-CoV-2 Testing

litigation risks clinical laboratories

Health practice attorney discusses steps for how to mitigate legal risk with SARS-CoV-2 testing

The COVID-19 pandemic has created an unprecedented response from the clinical laboratory community. President Donald Trump reported May 13 that the United States would reach 10 million SARS-CoV-2 tests performed nationally—an incredible number of tests for a virus that has been transmitted between humans for less than one year. 

Performing the high volume of testing seen during the COVID-19 pandemic has required rapid development of numerous assays that have been implemented on a wide scale, without going through the normal channels of regulatory approval.

Amid this unique and unprecedented situation, two categories of litigation risks have become evident. One involves screening as a service to employers. The other involves risks arising in the context of the traditional diagnostic setting. 

To help clinical laboratories understand these risks and how to address them, the COVID-19 STAT Intelligence Briefings Service spoke with Richard S. Cooper, a partner with the national firm of McDonald Hopkins. 


For the COVID-19 STAT Intelligence Briefings Service, Richard S. Cooper, partner at McDonald Hopkins, explained two categories of legal risks faced by clinical laboratories, as well as steps labs can take to mitigate these risks. (Photo courtesy of Richard Cooper.)

Cooper explained that many labs are working with employers to screen employees for COVID-19 (See The Dark Report: New Lab Revenue Source: COVID-19 Worker Screening). The screenings aim to ensure that employee groups are not at risk for spreading infection to other employees or customers.

“In recent weeks, we’ve been asked by a growing number of clinical labs about the legal issues associated with performing COVID-19 testing for employers who want to screen their employees for this disease,” Cooper said. “There are important steps a lab should take to mitigate the risks it might incur as a result of testing for COVID-19 on behalf of an employer.”

1. Legal Risks When Testing on Behalf of an Employer

“Employee screening will become very prevalent and will continue to be a part of COVID-19 testing because many employers are requiring these tests as a screening process before workers are allowed back into the workplace,” added Cooper. “Employers need to limit the possibility that infected employees can infect the on-site workforce. Employers also have certain legal obligations to ensure a safe workplace.”

According to Cooper, there are three steps that clinical laboratories should take when participating in this screening. “First, the lab needs to make it clear to the employer and to the employer’s workers that the COVID-19 testing is for screening purposes only to determine if the employee can return to work,” he noted. “The lab is not providing a diagnostic test to the employee.

“Second, the lab needs to make it clear that it is not establishing a patient relationship with the employees being tested,” Cooper continued. “The fact that these two disclosures are made—hopefully in both the contract with the employer and in the disclosure consent forms that employees sign—would be important in terms of defending a claim of professional liability,” explained Cooper.

“Third, your lab wants to inform the patient that the laboratory will provide results to both the patient and to the employer,” Cooper warned. “This is not true in a normal clinical testing situation where a lab reports test results to the patient’s physician, but not to the patient’s employer. In fact, in a diagnostic setting, under the Health Insurance Portability and Accountability Act (HIPAA), reporting a test result to anyone but a patient and the patient’s physician would likely violate HIPAA.”

2. Legal Risks Within the Context of Traditional Diagnostic Testing

While clinical laboratories need to be aware of potential legal implication of contracting with employers for employee screening, we also asked Cooper about litigatory risks that could arise in the context of traditional diagnostic testing.

“There, you arguably have a patient course of action against you,” Cooper said. “There is a more direct nexus between you and the patient, and it gives the patient a greater likelihood of bringing a legal action against you. You are also in a position where you are, in fact, providing a diagnosis to the patient upon which they will rely for health decision making, as opposed to something that is being used for screening by a third party,” added Cooper. “Both of those things provide greater exposure.”

On actions that clinical laboratories can take to reduce their risks, “It’s a matter of indicating in writing what the tests are for, what they mean, what their limitations are, and what patients ought to do if they get a positive result,” Cooper said. “It would also be best to have it in writing in terms of what you should and shouldn’t if you have a positive test.”As clinical laboratories perform testing, either for diagnostic clinical purposes or for employee screening, it is important that they understand the legal pitfalls they could encounter and take precautions to mitigate these risks.

Caleb Williams

—By Caleb Williams, Editor, COVID-19 STAT

Related Resources:

May 13 White House Briefing

The Dark Report: New Lab Revenue Source: COVID-19 Worker Screening XXVII(7)

HIPAA and COVID-19 Guidance from HHS