Clinical Alarms

Is it an environment of care issue when a patient dies because the crisis alarm setting on his heart monitor was inadvertently turned off?   

Yes. EC.04.01.01, EP1 covers human error: “The hospital establishes a process(es) for continually monitoring, internally reporting, and investigating the following: … medical or laboratory equipment management problems, failures, and use errors.”   Also, the former NPSG 6 from 2004 directly relates to this: "Implement regular preventive maintenance and testing of alarm systems and assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit." One last requirement: any such incident requires that the US Food and Drug Administration (FDA)  be notified as required by the Safe Medical Devices Act of 1990 per TJC standard EC.02.04.01 EP5.