Rule R380-210. Health Care Facility Patient Safety Program.

As in effect on August 1, 2009

Table of Contents

• R380-210-1. Purpose and Authority.
• R380-210-2. Definitions.
• R380-210-3. Patient Injury Identification.
• R380-210-4. Patient Injury Reduction.
• R380-210-5. Confidentiality.
• R380-210-6. Penalties.
• KEY
• Date of Enactment or Last Substantive Amendment
• Notice of Continuation
• Authorizing, Implemented, or Interpreted Law

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.

(4) Each facility shall have the implementation and accuracy of the internal patient safety identification processes required in R380-210-3(1) audited every three years by an independent auditor approved by the Department's Facility Licensing Committee.

R380-210-4. Patient Injury Reduction.

(1) Each facility shall implement processes that are effective in reducing the incidence of:

(a) adverse drug events.

(2) Each facility shall have the implementation and effectiveness of the internal patient injury reduction processes required in R380-210-4(1) audited every three years by an independent auditor approved by the Department's Facility Licensing Committee.

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

October 15, 2001

Notice of Continuation

October 10, 2006

Authorizing, 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