R429-1-3. Reporting of Patient Safety Events

(1) Every facility shall report to the department any patient safety event within 72 hours of the facility's determination that a patient safety event may have occurred. (2) Patient safety events are categorized as: (a) reportable events with outcome assessed by harm scale; (b) reportable events resulting in permanent patient harm, intervention to sustain life, or patient death; and (c) reportable events in Subsection (3)(c). (3) Patient safety events include: (a) reportable events required to be reported through the reporting portal and with the outcome level assessed by a harm scale: (i) surgery or procedures requiring consent performed on the wrong body part; (ii) surgery or procedures requiring consent performed on the wrong patient; (iii) incorrect surgery or procedures requiring consent performed on a patient; (iv) unintended retention of a foreign object in a patient after surgery or other procedures requiring consent; (v) infant discharged to the wrong person; (vi) neonatal hyperbilirubinemia, where bilirubin is greater than 25 milligrams per deciliter; (vii) stage 3 or 4 pressure ulcers acquired after admission to the facility, except for pressure ulcers that progress from Stage 2 to Stage 3, if the Stage 2 ulcer was documented upon admission; (viii) any incident when a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance; (ix) unexpected flame or unanticipated smoke during an episode of care; (x) any care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other licensed or certified health care provider; (xi) abduction of a patient of any age; (xii) non-consensual sexual contact on a patient, staff member, or visitor by another patient, staff member or unknown perpetrator while on the premises of the facility; or (xiii) elopement or disappearance of a patient with cognitive impairment for more than 4 hours; and (b) reportable events resulting in permanent patient harm, intervention to sustain life, or patient death required to be reported to the reporting portal; (i) arising from Intraoperative or immediate post-operative death of a patient who the facility classified prior to surgery as Anesthesia Surgical Assessment Class I or discharged home from an ambulatory surgical center; (ii) arising from the use of contaminated drugs, devices, or biologics provided by the facility; (iii) arising from the use or function of a device in patient care when the device is used for an off-label use, except when the off-label use is pursuant to informed consent; (iv) arising from intravascular air embolism that occurs while being cared for in the facility, except for intravascular air emboli associated with neurosurgical procedures; (v) arising from patient suicide or unsuccessful attempt while in the facility or ER within 72 hours of discharge; (vi) arising from a medication error; (vii) arising from a hemolytic reaction due to the administration of ABO or HLA incompatible blood or blood products; (viii) arising from the onset of hypoglycemia that occurs while the patient is being cared for in the facility; (ix) arising from the irretrievable loss of an irreplaceable biological specimen; (x) arising from failure to follow up or communicate laboratory, pathology, or imaging test results; (xi) arising from an unintended electric shock while being cared for at a health care facility, excluding emergency defibrillation in ventricular fibrillation and electroconvulsive therapies; (xii) arising from a burn incurred from any source while being cared for in a facility; (xiii) arising from the use of restraints or bedrails while being cared for in a facility; (xiv) arising from a fall while being cared for in a health care facility; (xv) arising from a criminal assault or battery that occurs on the premises of the health care facility; (xvi) arising from the introduction of a metallic object into the MRI area; (xvii) arising from labor or delivery while being cared for in a facility; or (xviii) of an infant born at gestation equal to or greater than 32 weeks excluding congenital causes; and (c) reportable events required by other reporting rules; and (d) reportable events governed by other existing law or rule and are not required to be reported to the reporting portal: (i) prolonged fluoroscopy with cumulative dose greater than 1500 rads to single field, R313-30-5; (ii) radiology to the wrong body region, R313-30-5; (iii) radiotherapy greater than 25% above the prescribed radiotherapy dose, R313-30-5; (iv) death or permanent loss of function related to a healthcare acquired infection, R386-705; and (v) provider preventable conditions, R414-1-28. (4) If a facility suspects that a patient safety event may have occurred to a patient who was transferred from another facility, the receiving facility shall report the suspected patient safety event to the transferring facility. (5) Each facility-required report will be submitted through a secured reporting portal and consist of the following: (a) facility information; (b) patient information; (c) condition information; (d) type of occurrence; (e) analysis findings; and (f) corrective actions.