Utah Admin. Code 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.

Notes

Utah Admin. Code R429-1-3

Adopted by Utah State Bulletin Number 2021-17, effective 8/18/2021