R380.  Health, Administration.
R380-210.  Health Care Facility Patient Safety Program.
R380-210-1.  Purpose and Authority.
	(1)  This rule establishes the requirement for designated facilities to have a patient safety program and have in place 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 Utah Code Subsections 26-1-30(2)(a), (b), (d), (e), and (g) and Section 26-3-8.

R380-210-2.  Definitions.
	"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."
	"Facility" means a general acute hospital, critical access hospital, ambulatory surgical center, psychiatric hospital, orthopedic hospital, rehabilitation hospital, chemical dependency/substance abuse hospital or chronic disease hospital as those terms are defined in Title 26, Chapter 21.
	"Harm" means death or temporary or permanent impairment of body function or structure requiring intervention such as:
	(1)  a change in monitoring the patient's condition;
	(2)  a change in therapy; or
	(3)  active medical or surgical treatment.

R380-210-3.  Patient Injury Identification.
	(1)  Each facility shall implement processes to effectively identify and report to the Department the incidence of all:
	(a)  adverse drug events.
	(2)  Reporting to the Department may occur 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 (E-codes) and codes for place of occurrence.

R380-210-4.  Patient Injury Reduction.
	(1)  Each facility shall implement processes that are effective in reducing the incidence of:
	(a)  adverse drug events.

R380-210-5.  Confidentiality.
	(1)  Information that the Department holds under this rule is confidential under the provisions of Title 26, Chapter 3.  Because of the public interest needs to foster health care systems improvements, the Department exercises its discretion under Section 26-3-8 and shall not release information collected under this rule to any person pursuant the provisions of Subsections 26-3-7(1) or (8).
	(2)  Information produced or collected by a facility is confidential and privileged under the provisions of Title 26, Chapter 25.

R380-210-6.  Penalties.
	As required by Section 63G-3-201(5):  An entity that violates any provision of this rule may be assessed a civil 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 26-23-6.

KEY:  hospital, injury prevention, quality improvement, patient safety
Date of Enactment or Last Substantive Amendment:  July 26, 2010
Notice of Continuation:  September 13, 2016
Authorizing, and Implemented or Interpreted Law:  26-1-30(2)(a); 26-1-30(2)(b); 26-1-30(2)(d); 26-1-30(2)(e); 26-1-30(2)(g); 26-3-8