DAR File No. 42334

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

Rule R434-150

Adverse Events from the Administration of Sedation or Anesthesia; Recording and Reporting

Notice of Proposed Rule

(New Rule)

DAR File No.: 42334
Filed: 11/16/2017 03:18:59 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule is to establish reporting requirements to the Utah Department of Health (Department) for anesthesia-related adverse events that occur in outpatient settings. The rule implements Section 26-1-40, which became effective 05/09/2017 because of H.B. 142 passed during the 2017 General Session, and requires reporting of adverse events starting 01/01/2018.

Summary of the rule or change:

This rule establishes a reporting database within the Department for anesthesia-related adverse events that occur in outpatient settings, as required by the relevant and governing statutes listed above. To implement the database and other requirements of statute, the rule also: 1) defines an adverse event, levels of sedation, near misses, and conditions under which escalation of care or rescue can be identified; 2) describes a level of harm scale; and 3) describes the data elements and formats of annual reports.

Statutory or constitutional authorization for this rule:

• Section 26-1-40

Anticipated cost or savings to:

the state budget:

The anticipated cost to state government is $30,000 per year based on 0.20 FTE for Patient Safety Director to meet with subject matter experts, develop set of regulations, publish regulations, respond to public comments and rewrite, design database, provide training and outreach to impacted provider groups, manage reporting function and database security, create annual reports and report to legislature findings. It is estimated that approximately 50 events might be reported on an annual basis from outpatient services. However, there is no way to determine the exact amount at this time.

local governments:

There is no anticipated impact to local governments due to the fact that there are not likely to be any local government-owned clinics that are administering anesthesia.

small businesses:

Total employers impacted is 1,750 clinics which are identified below. Small Businesses, under 621111, are: Individual physician's offices: direct fiscal costs; Small physician clinics: direct fiscal costs; Small dentists offices: direct fiscal costs; and Small group practices: direct fiscal costs. Non-small Businesses, under 621111, are: Individual physician�s offices: Direct fiscal costs; Physician clinics: direct fiscal costs; Dentists offices: direct fiscal costs; and Group practices: direct fiscal costs.

persons other than small businesses, businesses, or local governmental entities:

The number of licensed practitioners potentially impacted are identified below. Although these requirements only apply to outpatient clinics, the Department cannot determine which of these practitioners are working inpatient verses outpatient, therefore all are counted: Section 58-5a-502, Podiatry Physicians, 228; Section 58-31b-502.5, Nurse Practice Act, 38,842; Section 58-67-502.5, Utah Medical Practice Act, 12,175; Section 58-68-502.5, Utah Osteopathic Medical Act, 972; and Section 502.5, Utah Dentist and Dental Hygiene Act, 6,279. This totals 58,496.

Compliance costs for affected persons:

Small Businesses: 621111, 20 events per year at 30 minutes = 10 hours, $200 per hour = $2,000 per year. Non-small Businesses: 621111, 30 events per year at 30 minutes = 15 hours, 15 hours x $200 per hour = $3,000 per year.

Comments by the department head on the fiscal impact the rule may have on businesses:

Small and non-small businesses, that are medical care providers. who administer anesthesia in non-emergency department outpatient settings will be minimally impacted by the direct cost of reporting adverse events. I approve publication of this proposed new Rule R434-150.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Family Health and Preparedness, Primary Care and Rural Health
3760 S HIGHLAND DR
SALT LAKE CITY, UT 84106

Direct questions regarding this rule to:

• Iona Thraen at the above address, by phone at 801-273-6643, by FAX at 801-273-4150, or by Internet E-mail at ithraen@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

01/16/2018

This rule may become effective on:

04/07/2018

Authorized by:

Joseph Miner, Executive Director

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.

(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.

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

(a) the administration of sedation or anesthesia;

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

(c) that results in escalation of care, harm to, or rescue of the patient; and

(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 the use of:

(a) a rescue or reversal agent;

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

(c) unplanned assisted airway management;

(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;

(c) no harm;

(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.

(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.

(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;

(c) The healthcare provider(s) and facility type who administered the anesthesia;

(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.

(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.

(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

(c) any other reason acceptable to the Department.

(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.

(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;

(c) Types of facility where events occurred;

(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.

(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

(c) reported to DOPL for investigation of unprofessional conduct.

 

KEY: anesthesia adverse events, patient safety, sedation related events

Date of Enactment or Last Substantive Amendment: 2018

Authorizing, and Implemented or Interpreted Law: 26-1-40