1. (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. (2) Patient safety events are categorized as:

   1. (a) reportable events with outcome assessed by harm scale;
   2. (b) reportable events resulting in permanent patient harm, intervention to sustain life, or patient death; and
   3. (c) reportable events in Subsection (3)(c).

3. (3) Patient safety events include:

   1. (a) reportable events required to be reported through the reporting portal and with the outcome level assessed by a harm scale:

      1. (i) surgery or procedures requiring consent performed on the wrong body part;
      2. (ii) surgery or procedures requiring consent performed on the wrong patient;
      3. (iii) incorrect surgery or procedures requiring consent performed on a patient;
      4. (iv) unintended retention of a foreign object in a patient after surgery or other procedures requiring consent;
      5. (v) infant discharged to the wrong person;
      6. (vi) neonatal hyperbilirubinemia, where bilirubin is greater than 25 milligrams per deciliter;
      7. (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;
      8. (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;
      9. (ix) unexpected flame or unanticipated smoke during an episode of care;
      10. (x) any care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other licensed or certified health care provider;
      11. (xi) abduction of a patient of any age;
      12. (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
      13. (xiii) elopement or disappearance of a patient with cognitive impairment for more than 4 hours; and

   2. (b) reportable events resulting in permanent patient harm, intervention to sustain life, or patient death required to be reported to the reporting portal;

      1. (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;
      2. (ii) arising from the use of contaminated drugs, devices, or biologics provided by the facility;
      3. (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;
      4. (iv) arising from intravascular air embolism that occurs while being cared for in the facility, except for intravascular air emboli associated with neurosurgical procedures;
      5. (v) arising from patient suicide or unsuccessful attempt while in the facility or ER within 72 hours of discharge;
      6. (vi) arising from a medication error;
      7. (vii) arising from a hemolytic reaction due to the administration of ABO or HLA incompatible blood or blood products;
      8. (viii) arising from the onset of hypoglycemia that occurs while the patient is being cared for in the facility;
      9. (ix) arising from the irretrievable loss of an irreplaceable biological specimen;
      10. (x) arising from failure to follow up or communicate laboratory, pathology, or imaging test results;
      11. (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;
      12. (xii) arising from a burn incurred from any source while being cared for in a facility;
      13. (xiii) arising from the use of restraints or bedrails while being cared for in a facility;
      14. (xiv) arising from a fall while being cared for in a health care facility;
      15. (xv) arising from a criminal assault or battery that occurs on the premises of the health care facility;
      16. (xvi) arising from the introduction of a metallic object into the MRI area;
      17. (xvii) arising from labor or delivery while being cared for in a facility; or
      18. (xviii) of an infant born at gestation equal to or greater than 32 weeks excluding congenital causes; and
   3. (c) reportable events required by other reporting rules; and

   4. (d) reportable events governed by other existing law or rule and are not required to be reported to the reporting portal:

      1. (i) prolonged fluoroscopy with cumulative dose greater than 1500 rads to single field, R313-30-5;
      2. (ii) radiology to the wrong body region, R313-30-5;
      3. (iii) radiotherapy greater than 25% above the prescribed radiotherapy dose, R313-30-5;
      4. (iv) death or permanent loss of function related to a healthcare acquired infection, R386-705; and
      5. (v) provider preventable conditions, R414-1-28.
4. (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. (5) Each facility-required report will be submitted through a secured reporting portal and consist of the following:

   1. (a) facility information;
   2. (b) patient information;
   3. (c) condition information;
   4. (d) type of occurrence;
   5. (e) analysis findings; and
   6. (f) corrective actions.

KEY: hospital, sentinel event, quality improvement, patient safety

Date of Last Change: November 6, 2023

Authorizing, and Implemented or Interpreted Law: 26B-1-202(25); 26B-1-202(26); 26B-7-202(1); 26B-1-202(29); 26B-1-202(30); 26B-8-406; 26B-8-407