R434-150. Adverse Events from the Administration of Sedation or Anesthesia; Recording and Reporting, R434. Health, Family Health and Preparedness, Primary Care and Rural Health, Utah Administrative Code

Utah Administrative Code (Current through November 1, 2019)

R434. Health, Family Health and Preparedness, Primary Care and Rural Health

R434-150. Adverse Events from the Administration of Sedation or Anesthesia; Recording and Reporting

R434-150-1. Purpose and Authority

Latest version.

(1) To establish reporting requirements to the Utah Department of Health Anesthesia Adverse Events Database that include:

(a) the format of the reports; and

(b) what constitutes a reportable adverse event.

R434-150-2. Definitions

Latest version.

(1) "Adverse event" means a reportable event that includes:

(a) the administration of sedation or anesthesia;

(b) in an outpatient, non-emergency room setting;

(d) while under the direct care of the provider at the facility or within 24 hours of discharge.

(2) "Department" means the Utah Department of Health.

(3) "Escalation of care or rescue of a patient" means rescuing a patient from levels of sedation deeper than intended in order to prevent harm or death to a patient. This may include but is not limited to the use of:

(a) a rescue or reversal agent;

(b) aborting a procedure secondary to complications of sedation or anaesthesia;

(d) 911 call for Emergency Medical Services;

(e) transfer to a higher level of care; or

(f) any other intervention.

(4) "Harm scale" means a systematic method of designating a patient's level of harm that includes:

(a) unsafe conditions;

(b) near miss;

(d) additional monitoring or treatment to prevent harm;

(e) temporary harm requiring intervention;

(f) temporary harm requiring hospitalization;

(g) permanent patient harm;

(h) intervention to sustain life; or

(i) patient death.

(5) "Healthcare Providers" means any healthcare provider who uses sedation or anaesthesia and is located in any outpatient location (e.g., office, urgent care, dentists, podiatrist, etc.) who is not currently required to report under Rule R380-200.

(6) "Levels of sedation" means physiologic states that are induced through the administration of medication by any route. Standards associated with differing levels of sedation are defined in the Centers for Medicare and Medicaid Conditions of Participation Interpretive Guidelines 482.51(b)(5) Interpretive Guidelines (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf. These interpretive guidelines are the expected standards of practice, unless otherwise specified by the individual practitioner's scope of practice as defined in the Utah Licensure Practice Act and Title 58 of the Utah Code.

(7) "Near miss" means stopping or aborting a procedure for the safety of the patient due to the administration of anaesthesia or sedation.

(8) "Unprofessional Conduct" is defined in statute for each Utah Department of Professional licensure category. See Utah Code Sctions 58-5a-502, 58-31b-502.5, 58-67-502.5, 58-68-502.5, and 58-69-502.5.

R434-150-3. Anesthesia Adverse Event Database

Latest version.

(1) The Anesthesia Adverse Event Database is managed through the Department's anesthesia reporting system.

(2) The Department shall establish the event report format.

R434-150-4. Event Reporting

Latest version.

(1) Once an adverse event has been determined by a licensed healthcare provider, and the provider(s) who administered the sedation or anesthesia involved in the event have been notified, the adverse event shall be reported to the Department within 72 hours.

(2) To report an event:

(a) The individual reporting the event must:

(i) register with the State of Utah to get a state ID; and

(ii) notify the program manager that they have registered.

(b) The program manager shall:

(a) verify the reporting registrant's Utah state ID; and

(b) give the reporting registrant access to report their case to the Anesthesia Adverse Event Database.

(3) The reporting individual shall submit the following data and information at the time of the report:

(a) The person who reports the event;

(b) The healthcare provider(s) and facility type who conducted the procedure;

(d) Description of the event;

(e) Description of the sedation used;

(f) Level of harm experienced;

(g) Patient demographics (birthdate, gender, and weight), to give context to the event;

(h) Surgical classification of the procedure, using American Society of Anesthesiologist physical status classification system;

(i) Description of rescue activities;

(j) Description of monitoring that took place:

(k) Description of escalation of care;

(l) Description of emergency equipment and supplies available at the time of the event; and

(m) Any additional or concluding remarks.

R434-150-5. Confidentiality

Latest version.

(1) Information received and stored by the Department under this Rule may only be disclosed with Department approval under specific, enumerated conditions provided by Utah Code Section 26-3-7. Because of the public interest in fostering health care systems improvements, the Department is authorized Utah Code Section 26-3-8 to exercise its discretion to disclose information under those conditions.

(a) However, the Department shall not release information collected under this Rule to any person pursuant to the provisions of Subsections (1) or (8) of Section 26-3-7.

(2) Information provided by a facility to the Department under this Rule is privileged, as provided by Utah Code Title 26, Chapter 25, and is not subject to discovery, use, or receipt in evidence in any legal proceeding of any kind or character.

R434-150-6. Extensions and Waivers

Latest version.

(1) The Department may grant an extension of any reporting time requirement of this rule, if the facility demonstrates that:

(a) the delay is due to factors beyond its control,

(b) the delay will not adversely affect the purposes of this rule; or

(2) A facility requesting a waiver shall submit its request to the Department representative prior to the deadline for the required action.

(3) The Department may grant a waiver of any other provision of this Rule if the facility demonstrates that the waiver will not adversely affect the Department's root cause analysis and the purposes of this Rule.

R434-150-7. Annual Aggregate Reports

Latest version.

(1) The Department's Anesthesia Adverse Event Database program manager shall report the following information to the legislature and public annually:

(a) Number of deaths and adverse events;

(b) Distribution of provider types involved in events by license category and specialty;

(d) Number of non-provider reports;

(e) Procedures being performed when events occurred; and

(f) An analysis of the impact of these reporting requirements in reducing adverse events.

R434-150-8. Penalties

Latest version.

(1) As provided in Utah Code Section 26-23-6, an entity or person who violates any provision of this rule may be:

(a) assessed a civil penalty not to exceed $10,000;

(b) subject to criminal prosecution for:

(i) a first violation as a class B misdemeanor;

(ii) each subsequent similar violation within two years of the first violation as class A misdemeanor; and