The following sentinel events involve death. Please click on the links to view the reporting requirements:
4A. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
All providers of health care, health care facilities, medical examiners, coroners and funeral homes must report immediately to their local and state health department, each death that is caused by, associated with or related to COVID-19 infection consistent with the CDC criteria. This includes information on the immediate cause of death, such as a heart attack or pneumonia, as well as any underlying disease. This CDC Guidance for Certifying Death Due to Coronavirus Disease 2019 (COVID-19) recommended reporting deaths where the patient has tested positive or, in the absence of testing, “if the circumstances are compelling within a reasonable degree of certainty.”
Employers must notify NVOSHA of all workplace accidents involving an employee fatality or fatalities within 8 hours after learning of the accident. Employers must report to NVOSHA all inpatient hospitalizations of one or more employees, amputations of a part of an employee’s body or an employee’s loss of an eye within 24 hours after learning of the hospitalization, amputation or loss of an eye. Employers must also record on the OSHA 300 Log the recordable injuries and illnesses of all employees on your payroll, whether they are labor, executive, hourly, salary, part-time, seasonal, or migrant workers. You also must record the recordable injuries and illnesses that occur to employees who are not on your payroll if you supervise these employees on a day-to-day basis. If your business is organized as a sole proprietorship or partnership, the owner or partners are not considered employees for recordkeeping purposes. The OSHA 300-A Annual Summary must also be posted each year.
Hospitals must report deaths associated with the use of seclusion or restraint.
Facilities are required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient or employee of the facility.
The FDA receives voluntary reports on other serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that facilities suspect is associated with the use of an FDA-regulated drug, biologic, dietary supplement or cosmetic.
Physician or APRN last in attendance must sign medical certificates of death, including stillbirth within 48 hours. The funeral director or person acting as undertaker shall present the completed certificate of death to the local registrar within 72 hours after the occurrence or discovery of death.