R380-200-2. Definitions

  (1) "Adverse event" is an injury associated with healthcare processes rather than the underlying patient condition or disease itself and that prolongs medical intervention or results in harm, disability or death.

  (2) "Causal analysis" means a process for identifying the basic or causal factor(s) that underlie variation in performance, resulting in the occurrence or possible occurrence of a patient safety event, which may include a Root Cause Analysis, a Failure Mode and Effect Analysis, hazards analysis, evidence review, observation or any other relevant analytical process aimed at identifying and understanding contributing factors.

  (3) "Contaminated" means contamination that can be seen with the naked eye, or with use of detection mechanisms in general use, as they become reported or known to the health care facility.

  (4) "Harm Scale" is a systematic method to designate a patient's level of harm that includes;

  (a) unsafe conditions,

  (b) near miss which is an event that was stopped prior to reaching the patient,

  (c) no harm,

  (d) additional monitoring or treatment to prevent harm,

  (e) temporary harm requiring intervention,

  (f) temporary harm requiring hospitalization,

  (g) permanent patient harm,

  (h) intervention to sustain life, or

  (i) patient death.

  (5) "Health care facility" as defined in Title 26, Chapter 21 Part 1, Section 2, (13)(a).

  (6) "Incident facility" means a facility where the patient safety event occurred while in the facility or immediately following discharge within a certain time period defined by specifically by the type of event from that facility.

  (7) "Medication Error" means medication administration:

  (a) of a drug other than as prescribed or indicated;

  (b) of a dose other than as prescribed or indicated;

  (c) to a patient who was not prescribed the drug;

  (d) at a time other than prescribed or indicated;

  (e) at a rate other than as prescribed or indicated;

  (f) of an improperly prepared drug;

  (g) by a means other than as prescribed or indicated; or

  (h) unintentional administration of a drug to a patient who has a known allergy or drug interaction to the prescribed medication.

  (8) "Patient safety events" are a compilation of serious, largely preventable, and harmful clinical adverse events that includes but are not limited to surgical events, product or device events, patient protection events, care management events, environmental events and criminal events.