R380-200-3. Reporting of Patient Safety Events

  (1) Each facility shall report to the Department all patient safety events within seventy-two 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 referenced by other reporting rules.

  (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 in which 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 and episode of care;

  (x) Any care ordered by 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;

  (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 immediately 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. "Intraoperative" means literally during surgery. "Immediately post-operative" means within 24 hours after surgery, or other invasive procedure was completed, or after induction of anesthesia if surgery not completed;

  (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 in which the device is used for an off-label use, except where 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/HLA incompatible blood or blood products;

  (viii) Arising from hypoglycemia, the onset of hypoglycemia which 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.

  (c) Reportable events required by other reporting rules:

  The following set of reportable events is governed by other existing Utah law or rule and facility reporting to the reporting portal under this rule is not needed.

  (i) Prolonged fluoroscopy with cumulative dose greater than 1500 rads to single field (R313-20-5);

  (ii) Radiology to the wrong body region (R313-20-5);

  (iii) Radiotherapy greater than 25% above the prescribed radiotherapy dose(R313-20-5);

  (iv) Death or permanent loss of function related to a healthcare acquired infection (R386-705); and

  (v) Provider Preventable Conditions (R414-1-29).

  (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) All facility required reports 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.