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Genetic Testing Lab Found to be Licensed Health Care Provider


A pediatric patient experienced seizures. The treating physician sent the patient’s DNA to a genetic testing laboratory for the purpose of diagnosing the patient’s disease or disorder. After the test results were received by the treating physician, the patient died.

 

The patient’s estate filed a wrongful death action against the genetic testing laboratory. The complaint alleged that the laboratory failed to properly determine the patient’s condition.

 

The laboratory argued that the claim was barred by South Carolina’s statute of repose applicable to medical malpractice claims. The laboratory asserted that it was a “licensed health care provider” as defined by South Carolina’s statute of repose applicable to medical malpractice claims.

 

The United States District Court for the District of South Carolina certified the following question to the Supreme Court of South Carolina. Is a federally licensed genetic testing laboratory acting as a “licensed health care provider” as defined by South Carolina’s statute of repose applicable to medical malpractice claims when, at the request of a patient’s treating physician, the laboratory performs genetic testing to detect an existing disease or disorder?

 

The Supreme Court of South Carolina answered affirmatively. The court held that a federally licensed genetic testing laboratory is acting as a “licensed health care provider” as defined by South Carolina’s statute of repose applicable to medical malpractice claims when, at the request of a patient’s treating physician, the laboratory performs genetic testing to detect an existing disease or disorder.

 

A federally licensed genetic testing laboratory is acting as a “licensed health care provider” as defined by South Carolina’s statute of repose applicable to medical malpractice claims when, at the request of a patient’s treating physician, the laboratory performs genetic testing to detect an existing disease or disorder. The statute did not expressly state that genetic testing laboratories were licensed health care providers. The statute did include hospitals and any similar category of licensed health care providers in the definition of licensed health care providers. The court reasoned that a genetic testing laboratory that performs testing at the request of a patient’s treating physician for the purpose of assisting the treating physician in detecting an existing disease or disorder falls within the definition of “licensed health care providers” because the genetic testing laboratory is performing diagnostic testing at the request of a treating physician for the purpose of diagnosis and treatment, which is a core function of hospitals in diagnosing and treating patients. Under the circumstances presented, the genetic testing laboratory fit within the category provided by one of the specified designations in the statute: a hospital. Consequently, a genetic testing laboratory in these circumstances clearly falls within the statute’s catchall of “any similar category of licensed health care providers.”

 

The Supreme Court of South Carolina answered the district court’s certified question affirmatively holding that the genetic testing laboratory was acting as a licensed health care provider under South Carolina’s statute of repose applicable to medical malpractice claims.

 

See: Williams v. Quest Diagnostics, Inc., 2018 WL 3131540 (S.C., June 27, 2018) (not designated for publication).

 

See also Medical Law Perspectives Report: Unlocking Genetic Secrets: Liability Risks for Genetic Testing and Information Providers 

 

See also Medical Law Perspectives Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks 

 

 

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