R429. Health and Human Services, Patient Safety Program.R429-2. Health Care Facility Patient Safety Program.
R429-2-1. Purpose and Authority.
(1) This rule establishes the requirement for designated facilities to have a patient safety program and effective internal patient safety processes for specified problems. The reporting under this rule will also help the department and health care providers to understand patterns of system failures in the health care delivery system and, where appropriate, to recommend statewide improvements to reduce the incidence of patient injuries. It limits access to identifiable health information that facilities report to the department under this rule.
(2) This rule is authorized by Section 26B-8-407 and Subsections 26B-1-202(26), 26B-7-202(1), 26B-1-202(29), and 26B-1-202(30).
R429-2-2. Definitions.
(1) "Adverse drug event" means any event involving a medication that causes or leads to patient harm while the medication is in the control of the facility. Such events may be related to professional practice, health care products, procedures, and systems, including: prescribing, order communication, product labeling, packaging and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.
(2) "Department" means the Utah Department of Health and Human Services.
(3) "Facility" means a general acute hospital, critical access hospital, ambulatory surgical center, psychiatric hospital, orthopedic hospital, rehabilitation hospital, chemical dependency or substance abuse hospital or chronic disease hospital as those terms are defined in Section 26B-1-229.
(4) "Harm" means death or temporary or permanent impairment of body function or structure requiring intervention such as:
(a) a change in monitoring the patient's condition;
(b) a change in therapy; or
(c) active medical or surgical treatment.
R429-2-3. Patient Injury Identification.
(1) Each facility shall implement processes to effectively identify and report to the department the incidence of each adverse drug event.
(2) Each facility shall report to the department through established, statewide, electronic health care facility reporting systems managed by the department.
(3) The report shall include codes applicable to the event from the current International Classification of Diseases Clinical Modification (ICD-CM) diagnosis coding, including codes for external cause of injury and codes for place of occurrence.
R429-2-4. Patient Injury Reduction.
(1) Each facility shall implement processes that are effective in reducing the incidence of adverse drug events.
R429-2-5. Confidentiality.
(1) Information received and stored by the department under this rule may only be disclosed with department approval under specific, enumerated conditions provided by Section 26B-8-406. The department is authorized to exercise its discretion to disclose information under the conditions of Section 26B-8-407.
(2) The department may not release information collected under this rule to any person pursuant to Subsections 26B-8-406(1) or 26B-8-406(8).
(3) Information provided by a facility to the department under this rule is privileged, as provided by Section 26B-1-229 and is not subject to discovery, use, or receipt in evidence in any legal proceeding of any kind or character.
R429-2-6. Penalties.
Any association, or corporation, or the officers of any of them, that violates any provision of this rule may be assessed a judicial civil or administrative money penalty not to exceed the sum of $5,000 or be punished for violation of a class B misdemeanor for the first violation and for any subsequent similar violation within two years for violation of a class A misdemeanor as provided in Section 26B-1-224.
KEY: hospital, sentinel event, quality improvement, patient safety
Date of Last Change: November 6, 2023
Notice of Continuation: August 10, 2026
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
