What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

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Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential compliance time bombs hidden in plain sight in hospital (as well as independent and physician office) laboratories. Why does the warning alarm need to be sounded for hospital lawyers and administrators, and what contributes to the false sense of security about laboratory operations?

Simply put, the warning alarm is needed because laboratory testing is a valuable service that is an integral part of medical services in every setting. Laboratory testing affects 70 to 80 percent of physician decisions, and virtually every patient admitted to a hospital has one or more laboratory tests performed. A large hospital system can perform 10 million tests annually, and while laboratory testing may not generate large net revenues, a hospital cannot function without either performing or having access to laboratory testing.

Originally published in BNA’s Health Law Reporter on October 22, 2015.

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