Clinical laboratories create policies, processes and procedures to define how operations are to be performed by staff to ensure consistency of clinical practice and to meet the requirements defined by regulatory and standards organizations. All testing and tasks must be performed per the approved policies, processes, and procedures.
An event is a deviation from an approved policy, process or procedure. Any time a deviation occurs the event needs to be documented per an organization's event management process. The event should be documented as soon as it is identified by the person(s) who discover the event so all pertinent information is included. The event management process should allow any employee who observes a deviation to document it.
Other types of occurrences that can be considered events are complaints and patient or blood donor reactions.
Organizations need to manage events to ensure compliance, patient safety, and, if necessary, to improve their policies, processes and procedures.
