Blue Ribbon Panel on Dental Sedation / Anesthesia Safety of the Texas State Board of Dental Examiners

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Report to the Texas Sunset Advisory Commission

Blue Ribbon Panel on Dental Sedation/Anesthesia Safety of the Texas State Board of Dental Examiners

Panel Members:

Ernest B. Luce, D.D.S., Chairman Robert G. M cN eill, D.D.S., M.D. David H. Yu, D.D.S., M.S.

Reena Kuba, D.D.S., M.S. Bryce S. Chandler, D.D.S.

Ronald J. Redden, D.D.S.

January 2017

 Agency Contact: Kelly Parker, Executive Director 333 Guadalupe,  Tower  3, Suite 800

Austin,  TX 78701-3942

Phone (512) 463-6400    Fax (512) 463-7452

 

Table of Contents

Summary of Recommendations Full Report

 Introduction

Page

  1. Blue Ribbon Panel Membership and Meetings 3
  1. Current Sedation Permit Levels 5
  2. Review and Analysis of De-identified Data 5
    1. Major Events 6
    2. Mishaps 6
  3. Summary Comments Regarding Trends In Sedation/Anesthesia 7
  • Review and Analysis of Dental Rules and Laws in  Other

States and Anesthesia Related Organizations                        10

  1. Conclusions and Recommendations 14

Clinical  Recommendations                             15

Administrative Recommendations                            16

Administrative Suggestions                                17

Appendices

Appendix 1- Texas Administrative Code Appendix 2 – De-identified Data Methodology

Report to the Texas Sunset Advisory Commission Blue Ribbon Panel on Dental Sedation/Anesthesia Safety

of the Texas State Board of Dental Examiners January 2017

Summary of Recommendations

The Blue Ribbon Panel on Dental Sedation/Anesthesia Safety (BRP) reviewed de-identified data compiled during board investigations in fiscal years 2012 through 2016  involving patient mortalities and patient harm during or following dental treatment at which sedation/anesthesia was administered and evaluated the appropriate substance and application of emergency  protocols related to the administration of  sedation/anesthesia.

Panel members, with the assistance of SBDE staff, performed an intensive review of 78 cases. Examination of these 78 cases resulted in the determination that 19 of these events were related to mishandled sedation/anesthesia. BRP identified six of the 19 cases as major events. BRP identified 13 of the 19 cases as mishaps. The panel also reviewed other state laws/rules and scientific literature.

A summary of the BRP recommendations are as follows: Clinical  recommendations:

  • SBDE shall have full authority to inspect dental offices where any level of sedation/anesthesia is provided with emphasis on assessing competency of the sedation provider;
  • Texas dentists should be required to have written emergency protocols and should be required to document that they practice these protocols with  office  staff  through exercises such as “drills” several times per year;
  • The SBDE mandate that at least one support staff member assisting with a sedation procedure (level 2, 3, 4) receive training in the recognition and management of sedation/anesthesia related emergencies;
  • Texas dentists providing moderate/deep/general anesthesia (levels 2, 3, 4) to children under the age of 8 be required to document to the SBDE age specific sedation training;
  • Texas dentists providing moderate/deep/general anesthesia (levels 2,3,4) to “high risk” patients (age 75 and older, BMI greater than or equal to 30,ASA classification 3, 4) be required to document to the SBDE specific training regarding these groups of patients;
  • Offices where portable providers practice be required to have basic ventilation equipment onsite;
  • Capnography and precordial stethoscope be mandated for level 2, 3 and 4 procedures.

Administrative recommendations:

  • The SBDE should establish a standing independent sedation advisory panel to continue to review and advise the SBDE regarding sedation/anesthesia issues;
  • The SBDE make public de-identified sedation  related  major events and  mishaps;
  • The SBDE collect data regarding sedations performed by Texas dentists. (non­ accident  data);
  • The SBDE create a system to evaluate and approve sedation/anesthesia continuing education;
  • The SBDE mandate that the sedation record for a dental procedure be a required part of the dental record, even if the sedation provider is a non-dentist;
  • The SBDE consider creation of a recurrent sedation/anesthesia written examination covering sedation/anesthesia rules; and
  • The Texas Legislature make an effort to encourage other state legislatures to share de-identified sedation/anesthesia data

Administrative suggestions :

  • The SBDE consider creation of a required online sedation/anesthesia rules examination;
  • The SBDE consider encouraging or mandating that dentists use a preoperative sedation  checklist; and
  • The SBDE consider including more detail in the SBDE rules regarding appropriate pre-operative evaluation and an acceptable sedation/anesthesia record.

Report to the Texas Sunset Advisory Commission

of the Blue Ribbon Panel on Dental Anesthesia/Sedation Safety Texas State Board of Dental Examiners

January 2017

  1. Introduction

 On August 22, 2016, the Sunset Review Commission directed the Texas State Board of Dental Examiners (SBDE) to establish an independent Blue Ribbon Panel (BRP) to review dental anesthesia-related deaths and mishaps in Texas. On August 31, 2016, SBDE met to establish the BRP, charging the BRP with:

  1. reviewing de-identified investigative data related to dental anesthesia­ related deaths and mishaps investigated by SBDE between 2011 and 2016;
  2. reporting on trends and commonalities in the de-identified  data;
  3. reviewing sedation/anesthesia laws, regulations, and studies from other jurisdictions and review relevant published scientific literature;
  4. opining on whether present laws, regulations, and board policies are sufficient to protect patients;
  5. recommending appropriate changes to the laws, regulations, and board policies related to the administration of sedation/anesthesia to dental patients in Texas; and
  6. evaluating emergencies

The members of the BRP are active sedation providers from various disciplines of dentistry. SBDE selected members of the BRP from its existing dental review panel of licensed Texas dentists who serve as expert reviewers in SBDE’s investigations.

The members of the BRP are:

  • Bryce Chandler, DDS, general dentist, level  2 provider
  • Rena Kuba, DDS, pediatric dentist, level 2  provider
  • Ernie Luce, DDS, general dentist, level 3 provider, portable  –   Chairman
  • Robert McNeill, MD, DDS, oral and maxillofacial surgeon, physician, level 4 provider
  • Ronald Redden,  DDS, dentist anesthesiologist,  level  4 provider,  portable
  • David Yu, DDS, periodontist, level 3 provider

Three of the members, Drs. Kuba, Luce, and Redden teach sedation/anesthesia in a Texas dental school.

The BRP met in person, in meetings open to the public, on four occasions. BRP member attendance at each of the meetings was   100%.

Project Chronology:

22 August, 2016  Sunset Advisory  Commission Decision Hearing 31 August, 2016  SBDE open meeting to establish  BRP

15 September, 2016 BRP open meeting #1

6 October, 2016           Staff distributed Master Data Set to BRP (123 cases) 25 October, 2016                                    BRP open meeting #2 – selected cases (78 cases)

  • November, 2016 Staff distributed detailed data on selected cases (78 cases) 15 November, 2016 BRP open meeting #3 – identified major events/mishaps

(19 cases)

  • December, 2016 BRP meeting  #4 – analyzed  data, identified  trends and made  summary recommendations

4 January, 2017           BRP  submitted   written   report  to  the   Sunset  Advisory Commission

11January,  2017           Sunset Advisory Commission Hearing

III.           Definitions

AAOMS – American Association of Oral and Maxillofacial Surgeons AAPD – American Academy of Pediatric  Dentistry

ASDA – American Society of Dentist Anesthesiologists ASA – American Society of Anesthesiology

ASA 1, 2, 3, 4, 5 – scale created by the American  Society of Anesthesiology  to  make  a general  assessment  of the  physical  status of  a patient

BMI  – body mass index, a measure  of obesity based  on height and  weight

High  risk – describes  patients  who are obese (BMI          30, compromised health (ASA 3 and 4) or elderly (75 years of age or older)

IV.           Current Sedation Permit Levels

The SBDE formally permits Texas dentists to provide different levels of sedation/anesthesia based on educational experience.1 The higher  the  level  of sedation, the greater the educational requirements to  obtain  that  permit.  The levels are:

Nitrous oxide/ oxygen (laughing gas J – typically the lightest level of sedation.

Level 1 sedation (minimal) – a single oral sedative, may be mixed with nitrous oxide, patients become relaxed, but will respond normally to gentle touch. They are very  easily awakened.

level 2 sedation  (moderate oral) – multiple oral sedatives are allowed, patients   are relaxed but respond purposely to gentle touch. They are easily awakened.

Level  3 sedation  (moderate  parenteral}  – multiple  sedatives  may  be  administered by injection (such as an intravenous line). Patients are relaxed but respond  purposely  to gentle touch, as in level 2.  They are easily awakened.

Level 4 sedation /anesthesia (deep sedation/general anesthesia } – multiple sedatives may be administered by any route, including injection. Patients are “asleep”. A painful stimulus must be repeatedly applied to the patient in order to elicit a response, if they respond at all.  They are difficult or impossible to wake up with physical stimulation.

  1. Review and Analysis of De-identified Data Major Events and Mishaps

 The BRP made an in-depth review of 78 cases investigated by SBDE in search of evidence of mishandled sedation/anesthesia.2 BRP identified six of the 78 cases as major sedation/anesthesia events. BRP identified 13 of the 78 cases as sedation/anesthesia  mishaps.  Findings were defined as:

  1. major events meaning the case resulted in mortality or permanent morbidity and was directly related to mishandled sedation/anesthesia
  1. mishaps meaning that an adverse event occurred without permanent injury and was directly related  to mishandled sedation/anesthesia

1 See Appendix 1for SBDE Sedation/Anesthesia rules.

2 Seventy-five of the 78 cases were resolved at the time of review. Three of the 78 cases were under SBDE investigation at the time of BRP review but were incorporated into the BRP review due to their high profile nature and relevance to BRP charge.

Major Events Summary of the Six Major Sedation/Anesthesia Events

 

Patient Age Health Status S f A Provider Intended Level Outcome
adult under 75 obese, cardiac dz Dentist anesth 4, deep IV mortality
adult under 75 obese, DM, CV dz Periodontist 3, moderate IV mortality
child under 8 healthy General dentist 2, moderate oral brain damage
child under 8 healthy Pediatric dentist 2, moderate oral mortality
child under 8 cardiac disease MD anesth 4, GA mortality
child u nder 8 healthy MD anesth 4, GA mortality

BRP Findings Regarding the Six Major Sedation/Anesthesia Events:

  1. Every event involved either young children (child under 8) or adults with high  risk factors (obese/compromised  health/elderly).
  1. Highly trained specialists (including physicians) or a general dentist provided the sedation/anesthesia in each of the major
  1. For the intended level 2 and 3 events, the patient almost certainly became more deeply sedated than Once deeply sedated, the patient is difficult or impossible to awaken with physical stimulation. It  is at this point that breathing becomes compromised. If not recognized  and corrected quickly, brain damage or death ensues  rapidly.
  1. Poor pre-operative evaluation, drug overdose, not following current monitoring requirements and poor emergency management were also prominent in these
  1. Regarding portable providers, a total of four of the major  events involved a provider practicing on a portable basis. Two of these four major events involved  portable  physician    Being porta ble did not appear to contribute directly to these major  events.

The other two of these four major events involved a portable dentist sedation/anesthesia provider, a level 3 and a level 4 provider. In these two cases, the provider appeared to not have required emergency equipment that would have been useful in the evolving emergency.

It is unknown how many sedation/anesthetics are performed in Texas on a “portable” basis vs. a “non-portable” basis.

Mishaps – Summary of the 13 Sedation/Anesthesia Mishaps

Of the 78 cases studied by BRP, BRP identified 13 cases in which a sedation/anesthesia mishap occurred. Pertinent factors in the mishaps  include:

  1. Eight of the 13 mishaps involved children under 8 or high-risk adults (obese, compromised health or elderly).
  1. Dental specialists (oral & maxillofacial surgeons – one case, dentist anesthesiologist – one case, periodontists – two cases and pediatric dentists – three cases) as well as general dentists – six cases, provided the sedation/anesthesia in  these
  1. The severity of the mishaps ranged from minor to
  1. The nature of the mishaps was also quite varied and included drug overdose, premature discharge, predictable but unanticipated drug interaction due to poor drug selection, bolus drug administration (instead of slow, careful, incremental drug administration), and poor management in the early stages of a developing urgency allowing the condition to further deteriorate to an emergent condition and delayed calls to
  1. Some of the mishaps occurred in the office while some developed after what was a premature or inappropriate
  1. When an emergency did develop in  the  office,  poor  emergency management was present in almost all  cases.
  1. Every mishap involving  a  high  risk  adult  patient  also  involved  inadequate or poorly documented pre-proced ural patient evaluation and some element of poor sedation technique (such as bolus drug administration, not utilizing required monitors or not being attentive to monitors that were being used while indicating a developing  urgency).

VI.  Summary Comments Regarding Trends in Sedation/Anesthesia

The SBDE has 16,719 dentists with an active license, and 7,502 licensees hold a Level 1-4 permit. The SBDE has not been required to collect data on each administration of sedation/anesthesia that occurs during dental procedures in Texas (estimated at 500,000 to 1,000,000 administrations per year below). Lacking this detailed information regarding all sedations done in the state limits the statistical conclusions that can be drawn.

However, the BRP was able to study case specific information of actual adverse events that occurred in Texas by reviewing de-identified data collected in board investigations that occurred between 2011and 2016 involving patient mortalities and patient harm during or following dental treatment at which sedation/anesthesia was administered and evaluated the appropriate substance and application of emergency protocols related to the administration of sedation/anesthesia.

Many level 1, 2, and 3 sedation providers offer  sedation  on  an episodic  basis,  ranging from only a few times a year to several cases per  day.  I n  contrast,  most  level  4  providers provide sedation/anesthesia multiple times per  day.  The  OMS  National Insurance Company (OMSNIC) estimates that the average AAOMS member in Texas performs 669 sedation/anesthetics per year. If each of the approximately 400 OMFS in  Texas performs sedation/anesthesia at this  rate,  approximately  270,000 sedation/anesthetics  are performed  by  Texas  OMFS  each year.

The American Society of Dentist Anesthesiologists includes 25 members in Texas (also level 4 providers). Estimates from three of their mem bers suggest that the average dentist anesthesiologist in Texas treats 435 patients per year suggesting that 10,875 anesthetics are performed annually by Texas Dentist Anesthesiologists.

According to the ADA, there are 659 “professionally active” pediatric dentists in Texas. Anecdotal information  among active pediatric dentists suggests that, on average, each  of these practitioners performs approximately 200 minimal/moderate (mostly level  1 and  2)  sedations  each year.        Based  on  these  numbers,  it  is  estimated  that Texas Pediatric Dentists perform  approximately  130,000  sedations annually.

Between oral and maxillofacial surgeons, pediatric dentists and dentist anesthesiologists,  approximately  411,000  sedation/anesthetics  are   performed annually in Texas. This group of dentists represents only 1084 of the approximately 7,502 sedation permit holders in the  state.  Estimating  the  number  of  sedation  proced ures completed by other dentists in Texas  (primarily  endodontists, periodontists and general dentists) is even more speculative than the estimates above. Likely, the total number of sedation procedures provided by all Texas dentists is somewhere between 500,000 and 1,000,000 annually. For the 5 years of data the BRP evaluated, we estimate between 2,500,000 and 5,000,000 sedation/anesthetic procedures were performed. Five deaths and one brain injury directly related to sedation/anesthesia  occurred  in that time period.

It is important to or keep in mind that patients receiving nitrous oxide/oxygen, level 1 minimal sedation, level 2 or 3 moderate sedation are either awake or easily roused by quiet voice or gentle touch throughout the sedation. Patients receiving level 4 deep sedation/general anesthesia are difficult or impossible to arouse.

By far, the most common proximate cause of morbidity and mortality in sedation is compromised ventilation. Most of the commonly used sedative drugs will depress ventilation in the sedated patient, sometimes to the point that breathing stops completely. When breathi ng stops or becomes severely limited, the practitioner must recognize this condition, diagnose the specific reason for the compromise and rectify the situation all within a very few minutes. If panic or indecision sets in, emergency equipment/medications are not immediately available, or there is a lack of familiarity with the equipment/medications, or there is a lack of a clearly understood emergency plan, the chance of a poor outcome rises dramatically. Efficient teamwork among the doctor(s) and support staff is essential to help ensure swift resolution of the situation.

 

The margin of safety is narrower in certain specific patient groups. In you ng children, this time period to manage the evolving crisis is dramatically reduced. Obese individuals also decompensate much faster than  slender,  healthy  adults  when breathing becomes compromised. Many medically compromising conditions  also  result in much more rapid decompensation if breathing stops. You ng children and elderly/obese/medically-compromised   patients  pose extra sedation risks.

Almost without exception, when a mortality occurs associated with minimal or moderate sedation (levels 1, 2, 3), the practitioner  allowed  the patient to reach  a level  of deep sedation, where the patient became difficult or impossible to  arouse  by  physical stimulation. It is only at this point that ventilation becomes significantly compromised. Minimal and moderate sedation patients that are kJmJ. at a minimal and

moderate state do not develop airway compromise. Therefore the root cause of minimal/moderate   sedation   morbidity/ mortality   is  essentially  always   that  the  doctor

allowed the patient to become deeply sedated. Preventing the loss of responsiveness will prevent the vast majority of minimal/moderate sedation adverse outcomes. Accomplishing this single goal will have the greatest impact to reduce adverse outcomes  in minimal/moderate  sedation.

Current SBDE rules require that any patient considered for sedation/anesthesia be “…suitably evaluated prior to the start of any sedative procedure.” and go on to state that, “A focused physical evaluation must be performed  as  deemed  appropriate.”  Every event (major events and mishaps) in our series involving a high-risk patient also involved very poor pre-operative evaluation and limited or no physical  evaluation.

Interestingly, among the cases BRP reviewed involving high-risk patients (both major events and mishaps), all of these patients had some sort of medical consultation done prior to the sedation procedure. Lack of medical consultation does not seem to be a factor in the evolution of the mishap or major event in our patients. Data from this patient series does not support the need to mandate  enhanced  medical  consultation.

If the patient becomes more deeply sedated than permitted, current rules require the level 1, 2, and 3 provider to stop the dental procedure and return the patient to the intended level of sedation. The sedation provider is required to continually verify responsiveness and ventilation.

In addition, the current rules mandate that the sedation provider remain in the dental operatory until the patient has reached a defined level of recovery. While unverifiable, there is a strong suspicion that three of the six major events involved the sedation provider leaving the operatory for some period of time while the patient was still sedated, and the crisis developed/evolved during this time period. Leaving a sedated patient unattended is a major contributor to a patient becoming deeply sedated when only  minimal  or  moderate  sedation  was  intended.          (The  delivery of dental care is stimulating, and this                      helps  keep minimally and moderately sedated patients responsive.   If the dental care stops, the stimulation stops and the patient may become unintentionally deeply sedated and possibly stop breathing. If the patient has been left alone, there is no one available in the room to rescue the patient.)

 

Current          rules          mandate that         the dentist have emergency
protocols/equipment/medications immediately available in    the event     of    an

emergency. Unfortunately, there was a pattern of poor emergency management in the BRP’s case reviews: of the 12 cases reviewed where an emergency occurred in the  office, emergency management by the dentist was judged to be poor or inadequate in 11of those cases. The emergency failures observed in the major events and mishaps involved cases where:

  • emergency drugs were available but given in the wrong dose
  • emergency ventilation equipment was available, but was used ineffectively
  • emergency ventilation equipment was not available
  • supplemental oxygen was available but not administered when indicated
  • the provider was slow to activate EMS – (this  was  the  most common )

 Long delays before activation of the emergency medical system (EMS – 911) were common, but not universal in our cases. For some doctors, making the decision to call 911 represents a personal failure and can become a major obstacle for the doctor to overcome. As the potentially liable individual in the office, making the call to summon assistance may, in the eyes of the doctor, open the door to unwanted investigation by a regulatory agency, such as the SBDE, and subsequent fear of punishment. Lack of hands on practice in crisis management likely also contributes to poor performance during an emergency.

For five of the six major events, the sedation provider received his/her training in a university/hospital facility versus a continuing education course. For the mishaps, the majority of the providers were trained in a university/hospital setting. The data does not support the concern that dentists trained outside of the university/hospital setting have more sedation accidents.

 

  • Review and Analysis of Dental Rules and Laws in other States and Anesthesia Related Organizations

 

Dental Board of California:  Pediatric Anesthesia Study, Draft July  2016

The Dental Board of California undertook a review of pediatric sedation/anesthesia incidents between 2010 and 2015. During this window of time, nine pediatric deaths were noted with various combinations of local anesthesia, sedation, and general anesthesia. Fifty-six additional pediatric hospitalizations were also described, many of which were still being investigated.  Limited  details are present in the draft report regarding the deaths. Attempting to determine the proxi mate and root cause of death from the report would be speculative. The draft report includes an extensive review of dental sedation/anesthesia rules/laws in United States. Of  note,  twenty-five  states  have special requirements for pediatric  patients.  Nine  states have  a separate permit for sedation of pediatric patients. States are not consistent in the way they define a  child.

Combined statement of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry:

Cote, CJ Wilson S. AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF

PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During and after Sedation for Diagnostic and Therapeutic Proced u res: Update.  2016. Pediatrics 2016;138(1);e20161212

Comments pertinent to BRP’s inquiry:

  • The use of emergency checklists is
  • A protocol for immediate access to back-up emergency services should be clearly
  • Support staff should be specifically trained to be able to assist with a pediatric
  • All team  members  should  practice  emergency  protocols
  • In moderate sedation, use of capnography or precordial stethoscope is strongly recommended (required if bidirectional verbal communication not possible).
  • In deep sedation, use of capnography is

American Association of Oral and Maxillofacial Surgeons (AAOMS) – Parameters of Care: Clinical Practice Guidelines for Oral and Maxillofacial Surgery (AAOMS ParCare 2012) – policy requires that, every five years, members undergo an on-site anesthesia office inspection (by AAOMS inspectors) to ensure proper monitoring and emergency  equipment  is  present  as well  as to  review  emergency protocols.

California Dental Board in December 2016 adopted new sedation rules for the sedation of children:

  • For deep sedation/ general anesthesia-limitations to operator/ anesthetist model of
  • For moderate sedation – capnography is a required monitor, sedation training equivalent to that of an accredited pediatric dentistry residency, at least one additional staff member trained in Pediatric Advanced Life Support (PALS), for children less than seven years, an additional staff member dedicated to patient monitoring is
  • (California Legislature and the Governor must approve these rules in order for them to take effect)

October 2016, the American Dental Association  (ADA)  House  of  Delegates adopted a resolution to modify their Guidelines for the Use of Sedation and General Anesthesia in Dentistry. In part, this resolution includes a mandate for the use of capnography  for  patients  receiving  moderate   sedation.

Texas State Board of Dental Examiners’ Review of State Dental Boards, determined that 36 of the 50 state dental boards require some sort of dental office inspection, but the details regarding implementation  and  structure  of  these  inspections vary widely from state to state. Literature regarding the effectiveness of office inspections is described in the next section.

June 2014, the Texas Medical Board adopted a plan to inspect medical offices that provide anesthesia services. (Texas Administrative Code  192.5)

TAC 192.6 allows MDs to request an inspection with a non-binding advisory (for a fee)

Sunset Staff Report 2016-2017: Texas Medical Board-comments regarding medical office inspections where anesthesia is administered. The board  currently  registers 2,482 physi cians who provide office-based anesthesia. (Approximately 7000 Texas dentists have some type of sedation  permit)

Issue 2, key recommendation: “Authorize the board to establish a risk-based approach  to its office-based anesthesia inspection, focusing on the length of time  since  equipment and procedu res were last  inspected.”

Recommendation 2.9 “The board should focus its efforts on the inspection  of equipment and office proced ures instead of the registered physician to ensure that the inspectors do not waste time re-inspecting  equipment approved and  procedures.”

(BRP recommendation will emphasize  assessing  the  competency  of  the  provider  if office  inspections   are implemented)

VIII. Review and Consideration  of Scientific Literature

Haynes AB et al. A Surgical Safety Checklist to Red uce Morbidity and Mortality in a Global Population. New England Journal of Medicine 2009;360:491-9. This article presents  the  results  from  a  global  study  to  evaluate  the  effectiveness  of  a   newly

created “checklist” to be used by medical surgical teams prior to the start of a surgical procedure.

Comments pertinent to BRP’s inquiry:

  • Use of the pre-operative checklist reduced surgically related deaths from 5% to 0.8% (highly statistically significant).
  • Use of the checklist reduced the overall complication rate from 0% to 7.0% (highly statistically significant).

Arriaga AF et al. Simulation-Based Trial of Surgical-Crisis Checklists. New England Journal of Medicine 2013;368:246-53. This article details the results of 17 surgical teams participating  in 106  simulated surgical-crisis scenarios.

Comment pertinent to BRP’s inquiry:

  • Use of an emergency checklist reduced “missed steps” from 23% to 6% in these simulated emergencies using high fidelity human  simulators

Ilgen JS et al Technology-enhanced Simulation in Emergency Medicine: A Systematic Review and Meta-Analysis. Academic Emergency Medicine 2013;20:117-127. This article reviews 85 studies, which compare simulation training to conventional training  to no intervention at all.

Comment pertinent to BRP’s inquiry:

  • Simulation based recurrent emergency training was superior to traditional recurrent emergency training and far superior to no recurrent emergency training at all

Shapiro MJ et al. Simulation based teamwork training for emergency department staff: does it improve clinical team performance when added to an  existing  didactic teamwork curriculum? Quality and Safety in Healthcare 2004;13:417-21. This article reviews the results of a study to determine if adding team training (involving the staff, not just the doctors) would improve team clinical  performance.

Comment pertinent to BRP’s inquiry:

  • Training involving the entire team improved clinical performance of the team

Bhanankar SM et al. Injury and Liability Associated with Monitored Anesthesia Care. Anesthesiology 2006;104:228-34. This article compares closed claims data for monitored anesthesia care (MAC) vs. general anesthesia. Data was abstracted from the Closed  Claims  database  of  the  American  Society  of  Anesthesiologists.   Monitored

anesthesia care in the operating room is similar to level 3 moderate  parenteral  sedation, possibly becoming level 4 deep sedation at times.

Comment pertinent to BRP’s inquiry:

  • The most common cause of death/injury in MAC was associated with respiratory compromise – ventilation became inadequate during the procedure but was not adequately addressed or managed by the anesthesia

Gaulton TG et al. Administrative issues to ensure safe anesthesia care in the office­ based setting. Current Opinion in Anesthesiology  2013;26:692-697.  The authors in  this article review the wide variations between states regarding medical office based anesthesia vs. national administrative based structures to regulate office-based anesthesia. They also comment on literature concerning office  Inspection/  accreditation and the use of checklists.

Comments pertinent to BRP’s inquiry:

  • Regarding the effectiveness of office inspections/accreditation: little literature exists to improve outcomes in medicine where office based anesthesia is administered. The few studies available  suggest  a reduction in complications in accredited facilities,  but  these  studies have also drawn criticism concerning methodological limitations. The authors note, “Although the decrease in adverse events did coincide with an increase in practice accreditation, it is impossible to conclude causality.”
  • Regarding the use of checklists, the authors present multiple studies all showing that the use of checklists significantly reduce the incidence of complications. The authors were robust in their endorsement of the use  of checklists, also noting that federal regulatory agencies such as Centers for Medicaid and Medicare Services (CMS) require the use of surgical safety  checklists in their accredited ambulatory surgical centers (ASCs).
  1. Conclusion and Recommendations

 The reasons patients die or become permanently disabled in connection with dental care are quite varied. In the BRP case reviews, only a minority of deaths appeared directly related to mishandled sedation/anesthesia. Each of the six major events in this review included at least one significant failure on the part of the sedation provider to follow traditionally accepted core concepts of proper sedation/anesthesia technique. Failures included: poor pre-operative evaluation, poor technique, poor monitoring, and poor emergency management. In fact, all six of the major events included at least two major failures.

In the six major events studied by BRP, if current rules had been closely followed and the failures avoided, there likely would have been no sedation related event. Every patient would have been thoroughly evaluated pre-operatively for the planned sedation/anesthetic, drugs would have been conservatively and  cautiously  administered, and keeping patients closely monitored both electronically  and  personally by the dentist throughout the procedure. For the minimal and moderate sedation providers, patients would never have become unresponsive. If a truly unpredictable emergency event had occurred, the well-trained and practiced  team would have worked together to efficiently manage the situation, including a rapid  call to  911 when appropriate.

Unfortunately, these events did occur and they appear related to failures by the sedation/anesthesia provider at a basic level: poor preparation, poor technique and poor performance when an emergency did occur. It is unclear why practitioners allow this to happen. Equally challenging is to know how to remedy the situation.

The challenge to this panel is to consider whether or not reasonable changes to laws, rules or enforcement will motivate dentists to not be lax, but be meticulously attentive to each step in the sedation/anesthesia process and maintain the highest standard of safety. Rules changes should not limit access to care and should create a regulatory structure to foster best practices in sedation/anesthesia.

The BRP discussed many possible recommendations and suggestions that might be helpful, some clinical in nature, some administrative.

Clinical  recommendations : 

The SBDE should have the authority to conduct inspections of dentists administering sedation/anesthesia. Thirty-six states have some type of sedation/anesthesia office provider inspection. The BRP suggests any inspections emphasize evaluation of the competency of the  dentist.

The SBDE have the authority to review sedation records of level 2, 3 and 4 providers. Determination that the records did not meet the standard of care would be used as an indicator for an on-site office inspection. In the 19 major events/mishaps, there was a strong correlation between poor documentation and poor performance during an office emergency.

The SBDE mandate that sedation providers have written emergency protocols and that they be required to practice these protocols six times per year.

Of the cases where an emergency occurred in the office, 11 of 13 mishaps were  managed poorly. Literature clearly supports not only the use of emergency protocols (checklists) but also the use of pre-operative checklists. This should include a mechanism to encourage rapid activation of EMS when an emergency occurs and assure adequate access for EMS services.

The SBDE mandate that at least one support staff assisting with a sedation procedure (level 2, 3, 4) receive training in the recognition and management of sedation/anesthesia related emergencies. Literature clearly documents that emergency management improves as the entire team is trained as opposed to only the doctor.

The SBDE require level 2, 3, 4 providers who desire to sedate/anesthetize children under 8 years of age to document specific training in the management  of this age group of patients.

The SBDE require level 2, 3, 4 providers who desire to sedate/anesthetize high­ risk adults (75 years of age and older, ASA 3 or 4, obese – BMI greater than or equal to 30) to document specific training in the management of this group of patients. Each of the major events in this case series involved a child less than 8 years or a high-risk adult.

The SBDE mandate that offices where portable providers function have basic ventilation equipment on-site. Two of the six major events involved a portable provider who attempted to manage an emergency without ventilation    equipment.

The SBDE mandate the use of capnography and a precordial  stethoscope for level  2, 3 and 4 sedation. Of all the potential recommendations discussed by the BRP, this was the only one that did not garner almost immediate and unani mous support. The recommendation  passed but with clear reservation by several members.  Valid concerns were raised regarding applicability in level 2 and 3 sedation. Literature  support for the use of capnography or a precordial stethoscope in deep sedation is well accepted, but is controversial  in moderate sedation.  Further consideration and study   of the issue is needed by an ongoing committee of the board.

Administrative recommendations:

The SBDE continue  to  utilize  an  independent  panel  of  expert  sedation/anesthesia providers to advise the Board. This  BRP  was  given  only  a short period of time to accomplish their assigned task. An ongoing group can continue to discuss and more fully evaluate ideas based on  evolving scientific literature that  may allow improved patient safety.

The SBDE make public de-identified sedation related major events and mishaps. If other state dental boards would do the same, a much larger pool of information would be available with which to draw better conclusions.

The Texas Legislature make an effort to encourage other state legislatures to share de-identified sedation/anesthesia data publicly. If a  majority of  states would participate, a much more scientifically valid pool of data would be available for study. This would include both accident data and non-accident data.

The SBDE collect data regarding sedations performed by Texas dentists. (non­ accident data)

The SBDE create a system to evaluate and approve sedation/anesthesia continuing education programs.

The SBDE mandate that the sedation record for a dental procedure be a required part of the dental record, even if the sedation provider is a non-dentist.

Administrative suggestions:

The SBDE consider creation of a required online sedation/anesthesia rules examination.

The SBDE consider encouraging or mandating that dentists use a preoperative sedation checklist.

The SBDE consider including more detail in the SBDE rules regarding appropriate pre-operative evaluation and an acceptable sedation/anesthesia record.

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Texas Administrative  Code 

TITLE 22               EXAMINING  BOARDS

PART 5                  STATE BOARD OF DENTAL EXAMINERS CHAPTER 110  SEDATION AND ANESTHESIA

 

Rules

  • 110.1
  • 110.2
  • 110.3
  • 110.4
  • 110.5
  • 110.6
  • 110.7
  • 110.8
  • 110.9
  • 110.10

Definitions Sedation/Anesthesia Permit

Nitrous Oxide/Oxygen Inhalation Sedation Minimal Sedation

Moderate Sedation

Deep Sedation or General Anesthesia Portability

Provisional Anesthesia and Portability Permits Anesthesia  Permit Renewal

Use of General Anesthetic  Agents

 

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TITLE 22

PART S CHAPTER   110 RULE §110.1

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Definitions

Unless the context clearly indicates otherwise, the following words and terms shall have the following meaning when used in this  chapter.

  • Analgesia–the diminution  or elimination  of
  • Behavioral management–the use of pharmacological or psychological techniques,  singly or in combination, to modify behavior  to a level that dental treatment  can be performed  effectively and
  • Board/Agency–the Texas State Board of Dental Examiners, also known as the State Board of Dental Examiners, and, for brevity,  the Dental Board, the Agency,  or the
  • Child/children–a patient twelve (12) years  of age or
  • Competent–displaying special  skill or knowledge  derived  from training  and
  • Deep sedation–a drug-induced depression of consciousness during which patients cannot be easily aroused  but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous  ventilation  may be    Cardiovascular  function  is usually maintained.
  • Direct supervision–the dentist responsible for the sedation/anesthesia procedure shall be physically present in the facility and  shall be  continuously  aware of the patient’s  physical  status and well-being.
  • Enteral–any technique of administration of sedation in which the agent is absorbed through the gastrointestinal (GI) tract  or oral mucosa  (i.e., oral, rectal,  sublingual).
  • Facility–the location where a permit holder practices dentistry and provides anesthesia/sedation services. (10) Facility inspection–an  on-site inspection  to detennine  if a facility where  the applicant proposes  to

provide  anesthesia/sedation  is supplied, equipped,  staffed  and maintained  in a condition  to support provision  of anesthesia/sedation  services that  meet  the minimum  standard  of care.

  • General anesthesia–a drug-induced loss of consciousness during which patients  are not  arousable, even by painful stimulation. The ability to independently maintain ventilatory function  is often impaired.  Patients often require assistance in maintaining a patent  airway, and positive pressure  ventilation  may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular  function  may  be
  • Immediately available–on-site  in the facility  and available  for immediate
  • Incremental dosing–administration of multiple doses of a drug until a desired effect is reached, but not to exceed the maximum recommended  dose  (MRD).
  • Local anesthesia–the elimination of sensation, especially pain, in one part of the body by the topical application or regional  injection  of a

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  • Maximum recommended dose (applies to minimal sedation)–FDA maximum  recommended  dose (MRD) of a drug, as printed  in FDA-approved  labeling  for unmonitored  home
  • Minimal sedation–a minimally depressed  level of consciousness,  produced  by a pharmacological method, which retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. Medication administered for the purpose  of minimal  sedation  shall not  exceed the maximum  doses recommended  by the drug

Nitrous  oxide/oxygen  may be used  in combination  with  a single enteral  drug in minimal  sedation. During longer periods of minimal sedation in which the total amount of time of the procedures exceeds the effective duration of the sedative effect of the drug used, the supplemental dose of the sedative shall not exceed total safe dosage  levels based  on the effective half-life  of the drug used.  The total  aggregate  dose must not exceed  one and one-half times the MRD on the day of treatment. The use of prescribed, previsit sedatives for children aged twelve (12) or younger should be avoided due to the risk of unobserved respiratory  obstrnction  during the  transport  by  untrained individuals.

  • Moderate sedation–drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. A Level 2 permit is required for moderate sedation limited to enteral routes of administration. A Level 3 permit is required for moderate sedation including parenteral routes of administration. In accordance with this particular definition, the drugs or techniques used shall carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent before the effects of previous dosing can be fully appreciated may result in a greater alteration of the state of consciousness than is the intent of the dentist. A patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.
  • Parenteral–the administration of pharmacological agents intravenously, intraosseously, intramuscularly, subcutaneously, submucosally,  intranasally,  or
  • Patient Physical  Status Classification:
  • ASA–American Society of Anesthesiologists
  • ASA I–a normal healthy patient
  • ASA II–a patient with mild  systemic disease
  • ASA 111–a patient with  severe systemic disease
  • ASA IV–a patient with  severe systemic disease that is a constant threat to    life
  • ASA V–a moribund patient  who  is not expected  to  survive without  the operation
  • ASA VI–a declared brain-dead  patient  whose  organs  are being removed  for donor purposes
  • E–emergency operation  of any variety  (used to modify ASA I – ASA  VI).
  • Portability–the ability of a permit holder  to provide permitted  anesthesia  services in a location  other than a facility  or satellite
  • Protective reflexes–includes  the ability  to  swallow  and cough
  • Satellite facility–an additional office or offices owned or operated by the permit holder, or owned or operated by a professional organization through which the permit holder practices dentistry, or a licensed hospital

http://texreg.sos.state.tx .us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=5&ch=1  10&rl=1                                                                                                                                                                                                                        ‘213

 

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  • Supplemental dosing (applies to minimal sedation)–during minimal sedation, supplemental  dosing is a single additional dose of the initial dose of the initial drug that may be necessary for prolonged procedures. The supplemental  dose should not exceed  one-half of the initial  dose and should not be  administered  until  the  dentist has determined the clinical half-life of the initial dosing has passed. The aggregate dose must not exceed  one and one-half times the MRD  on the day of
  • Time-oriented anesthesia record–documentation at appropriate time intervals of drugs, doses, and physiologic data obtained during patient monitoring. Physiologic data for moderate sedation, deep sedation and general anesthesia must be taken and recorded at required intervals unless patient cooperation interferes or  prohibits
  • Titration (applies to moderate sedation)–administration of incremental doses of a drug until the desired effect is reached. Knowledge of each drug’s time of onset, peak response and duration  of action is essential to  avoid over-sedation. When the intent is moderate sedation, one must know whether the previous  dose has taken full effect before  administering  an  additional  drug

Source Note: The provisions of this §110.1 adopted to be effective May 10, 2011, 36 TexReg 2833

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TITLE 22

PART S CHAPTER 110 RULE §110.2

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Sedation/Anesthesia  Permit

  • A dentist licensed under Chapter 101 of this title shall obtain an anesthesia permit for the following anesthesia procedures  used  for the purpose  of performing dentistry:
  • Nitrous Oxide/Oxygen  inhalation sedation;
  • Level 1: Minimal sedation;
  • Level 2: Moderate  sedation limited to enteral routes  of  administration;
  • Level 3: Moderate  sedation which  includes parenteral  routes  of administration; or
  • Level 4: Deep  sedation or general
  • A dentist licensed to practice in Texas who desires to administer nitrous oxide/oxygen inhalation sedation or Level 1, Level 2, Level 3 or Level 4 sedation must obtain a pennit from the State Board of Dental Examiners (Board). A permit is not required to administer Schedule II drugs prescribed for the purpose of pain control or post-operative
  • A permit may be obtained by  completing  an application  f01m  approved  by the
  • The application form must be  filled out completely  and appropriate  fees
  • Prior to issuance  of a sedation/anesthesia  permit,  the Board  may require that the applicant undergo  a  facility  inspection  or further review  of credentials.  The Board may direct an Anesthesia  Consultant, who has  been appointed by the Board, to assist in this inspection or review. The applicant will be notified in writing if an inspection is required  and provided  with the name  of an Anesthesia  Consultant who will coordinate  the inspection. The applicant must make arrangements  for completion  of the inspection within  180 days of the date  the notice is An extension of no more than ninety (90) days may be granted if the designated

Anesthesia  Consultant  requests one.

  • An applicant for a sedation/anesthesia permit must be licensed by and should be in good standing with the Board. For purposes of this chapter  “good standing” means that the dentist’s license is not suspended, whether     or not the suspension is probated. Applications  from licensees  who are not in good standing may not be  approved.

Source Note:  The provisions  of this  §110.2 adopted  to be effective May  10, 2011,  36 TexReg 2833

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TITLE 22 PART 5

CHAPTER   110 RULE §110.3

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Nitrous  Oxide/Oxygen  Inhalation Sedation

  • Education and Professional Requirements. A dentist applying for a nitrous oxide/oxygen inhalation sedation pennit shall meet  one of the  following  educational/professional  criteria:
  • satisfactory completion of a comprehensive training program consistent with that described for nitrous oxide/oxygen inhalation sedation administration in the American Dental Association (ADA) Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This includes a minimum of fourteen (14) hours of training, including a clinical component, during which competency in inhalation sedation technique is achieved. Acceptable courses include those obtained from academic programs of instruction recognized by the ADA Commission on Dental Accreditation (CODA); or courses approved  and recognized  by the ADA Continuing Education Recognition Program (CERP); or courses approved and recognized by the Academy of General  Dentistry  (AGD) Program Approval  for Continuing  Education (PACE);
  • satisfactory completion of an ADA/CODA approved or recognized pre-doctoral dental or postdoctoral dental training program which affords comprehensive training necessary to administer and manage nitrous oxide/oxygen inhalation  sedation; or
  • is a Texas licensed dentist, has a current Board-issued nitrous oxide/oxygen inhalation sedation permit, and has been using nitrous oxide/oxygen inhalation sedation in a competent manner immediately prior to the implementation  of this chapter on June  1, 2011.  Any dentist  whose Board-issued  nitrous  oxide/oxygen inhalation  sedation permit  is active on June  1, 2011  shall automatically  continue to hold  this
  • Standard of Care Requirements. A dentist performing nitrous oxide/oxygen inhalation sedation shall maintain the minimum  standard  of care for anesthesia,  and in addition  shall:
  • adhere to the clinical requirements  as detailed  in this  section;
  • maintain under continuous direct supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of nitrous oxide/oxygen inhalation sedation;
  • maintain current certification in Basic Life Support (BLS) for Healthcare  Providers  for the assistant  staff by having them pass  a course that includes  a written  examination  and a hands-on  demonstration  of skills;  and
  • not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a nitrous  oxide/oxygen inhalation sedation procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed. This provision and similar provisions in subsequent sections address dentists and are not intended  to address the scope of practice  of persons  licensed by  any other
  • Clinical Requirements. A dentist must meet the following clinical requirements to utilize nitrous oxide/oxygen inhalation  sedation:
  • Patient Evaluation. Patients considered for nitrous oxide/oxygen inhalation  sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II), this  may consist of a review of their current medical history and medication use. However, patients with significant medical considerations (ASA III, IV) may require consultation with the patient’s primary care physician or consulting  medical

 

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  • Pre-Procedure Preparation  and Informed Consent
  • The patient, parent, guardian, or care-giver must be advised of the risks associated with the delivery of nitrous oxide/oxygen  inhalation  sedation  and must provide  written,  informed  consent for the proposed
  • The dentist shall determine that an adequate oxygen supply is available and evaluate equipment for proper operation and delivery  of inhalation  agents prior to use  on each
  • Baseline vitals must be obtained  in accordance with  108.7 and  §108.8 of this  title.
  • Personnel and  Equipment
  • In addition to the dentist, at least one member of the assistant staff should be present during the administration of nitrous  oxide/oxygen  inhalation  sedation  in nonemergency
  • The inhalation equipment must have a fail-safe system that is appropriately checked and calibrated. The equipment must  also have either:
  • a functioning device that prohibits  the delivery  of less than  30% oxygen;  or
  • an appropriately calibrated  and functioning  in-line  oxygen  analyzer with  audible
  • If nitrous oxide and oxygen delivery equipment capable of delivering less than 30% oxygen is used, an in-line oxygen analyzer must be
  • The equipment must  have  an  appropriate nitrous  oxide/oxygen  scavenging
  • The ability of the provider and/or the facility to deliver positive  pressure  oxygen  must be
  • The dentist must induce the nitrous oxide/oxygen inhalation sedation and must remain in the room with the patient during the maintenance of the sedation until phannacologic and physiologic vital sign stability is established .
  • After pharmacologic and physiologic  vital  sign stability has been  established,  the dentist may delegate   the monitoring of the nitrous oxide/oxygen inhalation sedation to a dental auxiliary who has been certified to monitor the administration  of nitrous  oxide/oxygen  inhalation  sedation by the State Board of Dental Examiners
  • Pre-operative baseline  vitals  must be
  • Individuals present during administration must be
  • Maximum concentration  administered  must  be
  • The start and finish times of the inhalation  agent must be
  • Recovery and
  • Recovery from nitrous oxide/oxygen inhalation sedation, when used alone, should be relatively quick, requiring only that the patient  remain  in an operatory  chair as
  • Patients who have unusual reactions to nitrous oxide/oxygen inhalation sedation should be assisted and monitored either in an operatory  chair or recovery  room until  stable for

 

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  • The dentist must determine that the patient is appropriately responsive prior to discharge. The dentist shall not leave the facility until the patient meets the criteria for discharge and is discharged from the
  • Emergency Management. Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Ifa patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must  stop the dental procedure until the patient returns  to the intended  level of sedation.   The dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis  and  treatment of emergencies related to the administration of the nitrous oxide, and providing the equipment and protocols for patient rescue. A dentist must be able to rescue patients who enter a deeper state of sedation than intended. The dentist, personnel and facility must be prepared to treat emergencies that may arise from the administration  of nitrous  oxide/oxygen  inhalation
  • Management of Children. For children twelve (12) years of age and under, the dentist should observe the American Academy of Pediatrics/ American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric Patients  During  and After  Sedation  for Diagnostic  and Therapeutic
  • A dentist who holds a nitrous oxide/oxygen inhalation sedation permit shall not intentionally administer minimal sedation, moderate  sedation,  deep  sedation, or general


Source Note:
The provisions  of this  § 110.3 adopted to be effective May  10, 2011, 36 TexReg  2833

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TITLE 22 PART S

CHAPTER   110 RULE §110.4

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Minimal Sedation

  • Education and Professional Requirements. A dentist applying for a Level 1 Minimal Sedation permit shall meet one of the following  educational/professional  criteria:
  • satisfactory completion of training to the level of competency in minimal sedation consistent with that prescribed in the American Dental Association (ADA) Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students, or a comprehensive training program in minimal sedation that satisfies the requirements described in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This includes a minimum of sixteen (16) hours of didactic training and instruction in which  competency  in enteral  and/or  combined  inhalation-enteral  minimal  sedation technique  is demonstrated; or
  • satisfactory completion of an advanced education program accredited by the ADA Commission on Dental Accreditation (CODA) that affords comprehensive training necessary to administer  and manage  minimal sedation, commensurate with the ADA’s Guidelines for Teaching Pain  Control and Sedation to Dentists  and Dental  Students; or
  • is a Texas licensed dentist, has a current Board-issued enteral permit,  and has been using minimal  sedation  in a competent manner immediately prior to the implementation of this chapter on June 1, 2011. Any Texas  licensed  dentist who was  issued an enteral sedation permit before June  1, 2011 and whose  enteral sedation  permit was active on June  1, 2011 shall automatically  have the permit  reclassified  as a Level  1 Minimal  Sedation permit on June 1, 2011. A Texas licensed dentist whose permit is reclassified from an enteral sedation pennit to a Level 1 Minimal Sedation permit on June 1, 2011 may continue to administer enteral sedation until January  1, 2013. On or before  January  1, 2013, the dentist shall either provide proof  that  adequate education   has been obtained by submitting an application  for a Level 2 permit  on or before that date, or shall comply with  the requirements  of a Level  1 permit  after that date. A dentist shall always follow the standard of care and   clinical requirements  for the level of sedation  he or she is
  • Standard of Care Requirements. A dentist performing minimal sedation shall maintain the minimum standard of care for anesthesia, and in addition   shall:
  • adhere to the clinical requirements as detailed  in this  section;
  • maintain under continuous direct supervision auxiliary personnel who shall be capable of reasonably assisting in procedures,  problems,  and emergencies  incident to the use of minimal   sedation;
  • maintain current certification in Basic Life Support (BLS) for Healthcare  Providers  for the assistant staff  by having them pass  a course that includes  a written  examination  and a hands-on  demonstration  of skills;  and
  • not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a minimal sedation procedure unless the dentist holds a permit  issued by the Board  for the sedation procedure  being
  • Clinical Requirements. A dentist must meet the following clinical requirements for utilization of minimal sedation:
  • Patient Evaluation. Patients considered for minimal sedation must be suitably evaluated prior to the start of  any sedative procedure.  In healthy  or medically  stable individuals  (ASA I, II), this may consist of a review  of their current medical history and medication use. However, patients with significant medical considerations (ASA III, IV) may require  consultation  with  their primary  care physician  or consulting medical  specialist.
  • Pre-Procedure Preparation  and  Informed
  • The patient, parent, guardian,  or care-giver  must be advised regarding  the procedure  associated  with the

delivery  of any sedative agents and must provide  written,  informed  consent  for the proposed  sedation.

  • The dentist shall determine that an adequate oxygen supply is available and evaluate equipment for proper operation  and delivery  of adequate  oxygen under positive
  • Baseline vital signs must be obtained  in accordance with  108.7 and  §108.8 of this  title.
  • A focused physical evaluation  must be performed  as deemed
  • Pre-procedure dietary restrictions  must be considered  based  on the sedative technique
  • Pre-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver.
  • Personnel and Equipment
  • In addition to the dentist, at least one additional person trained in Basic Life Support (BLS) for Healthcare Providers  must be
  • A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
  • When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment  must  also have either:
  • a functioning device that prohibits the delivery of less than 30% oxygen; or
  • an appropriately calibrated  and functioning  in-line  oxygen  analyzer with  audible
  • An appropriate scavenging  system must be  available  if gases other than  oxygen  or air are
  • The dentist administering the sedation must remain in the operatory room to monitor the    patient until the patient meets the criteria for discharge to the recovery  area. Once the patient  meets the criteria  for discharge to the recovery  area, the dentist may delegate monitoring  to a qualified  dental auxiliary.  Monitoring  during the  administration  of  sedation must include:
  • Color of mucosa, skin, or blood must be evaluated
  • Oxygen saturation monitoring by pulse-oximetry should be used when a single drug minimal sedative is used. The additional use of nitrous oxide has a greater potential to increase the patient’s level of sedation to moderate sedation,  and a pulse  oximeter  must be
  • The dentist (or appropriately qualified individual) must observe chest excursions and must verify respirations continually.
  • Blood pressure and heart rate should be evaluated preprocedurally, post-procedurally and intra-procedurally as necessary.
  • Documentation must be made in accordance with §108.7 and §108.8 of this title and must include the names and dosages of all drugs administered and the names of individuals present during administration of the drugs.
  • A time-oriented sedation record  may be  considered  for documentation  of all monitoring
  • Pulse oximetry, heart rate, respiratory rate, and blood pressure are the parameters which may be documented at appropriate intervals  of no more than  10
  • Recovery and
  • Oxygen and suction equipment must be immediately available in the recovery area if a separate recovery area is
  • The qualified dentist must monitor the patient during recovery until the patient is ready for discharge by  the dentist. The dentist may delegate this task to an appropriately  qualified  dental
  • The dentist must determine and document that the patient’s level of consciousness, oxygenation, ventilation, and circulation are satisfactory prior to discharge. The dentist shall not leave the facility until the patient meets the criteria for discharge and is discharged  from the
  • Post-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver. Post-procedure, patients should be accompanied by an adult caregiver for an appropriate period of recovery.
  • Emergency Management. Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. If a patient enters a deeper level of sedation than the dentist is qualified to  provide, the dentist must  stop the dental procedure  until the patient returns  to the intended  level of sedation.  The dentist is responsible for the sedative management,  adequacy of the facility and staff, diagnosis and  treatment of emergencies related to the administration of minimal sedation, and providing the equipment and protocols for patient rescue. A dentist must be able to rescue patients who enter a deeper state of sedation than intended.
  • Management of Children. For children twelve (12) years of age and under, the dentist should observe the American Academy of Pediatrics/American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric  Patients  During  and After  Sedation  for Diagnostic  and Therapeutic
  • A dentist who holds a minimal sedation permit shall not intentionally administer moderate sedation, deep sedation, or general

Source Note: The provisions  of this  §110.4 adopted  to be effective May  10, 2011, 36 TexReg  2833

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TITLE 22

PART S CHAPTER 110 RULE §110.5

——-

  • Education and Professional

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Moderate  Sedation

  • A dentist applying for a Level 2 Moderate Sedation permit (limited to enteral route of administration) must satisfy at least one of the  following  educational/professional  criteria:
  • satisfactory completion of a comprehensive training program consistent with that described for moderate enteral sedation in the American Dental Association (ADA) Guidelines for Teaching Pain  Control and  Sedation  to Dentists and Dental Students. This includes a minimum of twenty-four (24) hours of instruction, plus management of at least ten (10) case experiences in enteral moderate sedation. These ten (10) case experiences must include at least three live clinical dental experiences managed  by participants  in groups  of no larger than  five (5). The remaining cases may include simulations and/or video presentations,  but must  include one  experience  in returning  (rescuing)  a patient  from deep to moderate  sedation; or
  • satisfactory completion of an advanced  education program  accredited by the ADA Commission  on  Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary to administer and manage enteral moderate sedation, commensurate with the ADA’s Guidelines for Teaching Pain Control and Sedation  to Dentists  and Dental  Students; or
  • is a Texas licensed dentist who was issued an enteral sedation permit before June 1, 2011 and whose  enteral sedation pennit  was active on June  1, 2011 . Dentists  in this category shall automatically  have their  permit reclassified  as a Level  1 Minimal  Sedation permit  on June  1, 2011. A Texas licensed dentist whose permit  is reclassified  from an enteral sedation permit to a Level  1 Minimal  Sedation permit  on June  1, 2011 may continue to administer  enteral  sedation until January  1, 2013. On or before  January  1, 2013, the dentist shall either provide proof that adequate education has been obtained by submitting an application for a Level 2 permit  on or before that date, or shall comply with the requirements  of a Level  1 permit  after that date. A   dentist shall always follow the standard of care and clinical requirements for the level of sedation he or she is performing.
  • A dentist applying for a Level 3 Moderate Sedation permit (inclusive of parenteral routes of administration) must  satisfy  at least  one of the  following  educational/professional criteria:
  • satisfactory completion of a comprehensive training program consistent with that described for parenteral moderate sedation in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This includes a minimum of sixty (60) hours of didactic training and instruction and  satisfactory management of a minimum of twenty (20) dental patients, under supervision, using intravenous sedation; or
  • satisfactory completion of an advanced education program accredited by the ADA/CODA that affords comprehensive and appropriate training necessary to administer and manage parenteral moderate sedation, commensurate with the ADA’s Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students; or
  • satisfactory completion of an internship or residency which included intravenous moderate sedation training equivalent  to that  defined in this  subsection; or
  • is a Texas licensed dentist who had a current parenteral sedation permit issued by the Board and has been using parenteral sedation in a competent  manner  immediately prior to the implementation  of this chapter on  June 1, 2011. A Texas licensed dentist whose Board-issued permit  to perform parenteral  sedation is active on  June 1, 2011 shall automatically have the permit reclassified as a Level 3 Moderate Sedation (inclusive of parenteral  routes  of administration)
  • A dentist applying for a Level 2 or 3 Moderate Sedation permit must satisfy the following emergency management certification  criteria:
  • Licensees holding moderate sedation permits shall document:
  • Current (as indicated by the provider), successful completion of Basic Life Support (BLS) for Healthcare Providers; AND
  • Current (as indicated by the provider), successful completion of an Advanced Cardiac Life Support (ACLS) course, OR current (as indicated by the provider), successful completion of a Pediatric Advanced Life Support (PALS)
  • Licensees holding Level 2 or Level 3 Moderate Sedation permits who provide anesthesia services to children (age twelve  (12) or younger)  must  document  current, successful completion  of a PALS
  • Standard of Care Requirements. A dentist must maintain  the minimum  standard of care as outlined   in
  • 108.7 of this title and in addition shall:
  • adhere to the clinical requirements  as detailed in this  section;
  • maintain under continuous personal supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems,  and emergencies  incident to the use of moderate   sedation;
  • maintain current certification in Basic Life Support (BLS) for Healthcare Providers for the assistant  staff  by having them pass  a course that includes  a written  examination  and a hands-on  demonstration  of skills; and
  • not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a moderate sedation procedure unless the dentist holds a permit  issued by the Board  for the sedation procedure  being
  • Clinical Requirements .
  • Patient Evaluation. Patients  considered  for moderate  sedation must be suitably evaluated prior to the start  of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this should consist of at least a review of the patient’s current medical history and medication use. However, patients with significant medical considerations (ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.
  • Pre-Procedure Preparation  and Informed
  • The patient, parent, guardian, or care-giver must be advised regarding the procedure associated with the delivery of any sedative agents and must provide written, informed consent for the proposed sedation. The informed consent must be specific to the procedure being performed and must specify that the risks related  to   the procedure  include cardiac arrest, brain  injury, and
  • The dentist shall determine that an adequate oxygen supply is available and evaluate equipment for proper operation and delivery  of adequate oxygen under positive  pressure .
  • Baseline vital signs must be obtained  in accordance with  108.7 and  §108.8 of this  title.
  • A focused physical evaluation must be performed  as deemed
  • Pre-procedure dietary restrictions  must be considered  based  on the  sedative technique
  • Pre-procedure verbal or written instructions must be given to the patient, parent, escort, guardian, or care­ giver.
  • Personnel and  Equipment
  • In addition to the dentist, at least one additional person trained in Basic Life Support (BLS) for Healthcare Providers  must be
  • A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
  • When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have  either:
  • a functioning device that prohibits  the delivery  of less than 30% oxygen;  or
  • an appropriately calibrated  and  functioning in-line oxygen  analyzer with  audible
  • An appropriate  scavenging system must be available if gases other than oxygen or air are used.
  • The equipment necessary  to establish  intravenous  access must be
  • The dentist  administering  moderate  sedation must  remain  in the  operatory room  to monitor the patient  continuously  until  the patient  meets the criteria for recovery.  When  active treatment  concludes  and the patient recovers to a minimally sedated level, the dentist may delegate a qualified dental auxiliary to remain with the patient and continue to monitor the patient until he/she is discharged  from the facility. The dentist must  not leave the facility until the patient meets the criteria for discharge and is discharged  from the facility.  Monitoring  must include:
  • Level of consciousness (e.g., responsiveness to verbal command) must be continually assessed.
  • Color of mucosa, skin, or blood must be evaluated
  • Oxygen saturation must be  evaluated  by pulse-oximetry
  • Chest excursions must be continually
  • Ventilation must be continually evaluated. This can be accomplished by auscultation of breath sounds, monitoring end-tidal  CO2 or by verbal  communication  with  the
  • Blood pressure and heart rate must be  continually
  • Continuous EKG monitoring  of patients  sedated under moderate  parenteral  sedation is required .
  • Documentation .
  • Documentation must be made  in accordance with  108.7 and  §108.8 of this  title.
  • A written time-oriented anesthetic record must be maintained and must  include the names  and dosages of all drugs administered  and the names  of individuals present  during administration  of the
  • Pulse-oximetry, heart rate, respiratory rate, and blood pressure must be continually monitored and documented at appropriate  intervals of no more than ten (10)
  • Recovery and
  • Oxygen and suction equipment must be immediately  available  if a separate recovery  area is
  • While the patient is in the recovery area, the dentist or qualified clinical staff must continually monitor  the patient’s  blood pressure,  heart rate,  oxygenation,  and level  of
  • The dentist must determine and document that the patient’s level of consciousness,  oxygenation,  ventilation, and circulation are satisfactory for discharge. The dentist shall not leave the facility until the patient meets the criteria for discharge  and is discharged  from the
  • Post-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver. Post-procedure, patients should be accompanied by an adult caregiver for an appropriate period of recovery.
  • If a reversal agent is administered before discharge criteria have been met, the patient must be monitored until recovery is
  • Emergency
  • The dentist is responsible for the sedation management, adequacy of the facility and staff, diagnosis and treatment of emergencies associated with the administration of moderate sedation, and providing  the equipment and protocols  for patient    This includes immediate  access to pharmacologic  antagonists  and equipment for establishing  a patent  airway  and providing  positive pressure  ventilation  with oxygen.
  • Advanced airway  equipment  and resuscitation  medications  must be
  • A defibrillator should be available when ASA I and II patients are sedated under moderate sedation. A defibrillator must be  available when  ASA III and IV patients  are sedated under moderate
  • Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Ifa patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns to the intended level of sedation. The dentist administering moderate sedation must be  able to recover patients  who  enter a deeper  state of sedation than
  • Management of Children. For children twelve (12) years of age and under, the dentist should observe the American Academy of Pediatrics/ American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric  Patients  During  and After  Sedation for Diagnostic  and Therapeutic
  • A dentist who holds a moderate sedation permit shall not intentionally administer deep sedation or general anesthesia.

Source Note: The provisions of this § 110.5 adopted  to be effective May  10, 2011, 36 TexReg 2833; amended  to be effective  September  3, 2014,  39 TexReg 6857

 

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TITLE 22 PART S

CHAPTER   110 RULE §110.6

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Deep Sedation or General Anesthesia

  • Education and Professional  Requirements .
  • A dentist applying for a permit to administer deep sedation or general anesthesia must satisfy one of the following criteria:
  • satisfactory completion  of an advanced  education program  accredited by the American Dental  Association (ADA) Commission on Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary  to administer  and manage  deep sedation or general  anesthesia;   or
  • is a Texas licensed dentist who holds a current permit to administer deep sedation or general anesthesia  issued by the Board and who has been using deep sedation or general anesthesia in a competent manner  immediately prior to the implementation of this chapter on June 1, 2011. A Texas licensed dentist whose Board­ issued permit to perform deep  sedation or general anesthesia  is active on June  1, 2011  shall automatically  have the permit reclassified  as a Level  4 Deep  Sedation or General Anesthesia
  • A dentist applying for a permit to administer deep sedation or general anesthesia must satisfy the following emergency management  certification  criteria:
  • Licensees holding deep sedation or general anesthesia permits  shall    document:
  • Current (as indicated by the provider), successful completion of Basic Life Support (BLS) for Healthcare Providers; AND
  • Current (as indicated by the provider), successful completion of an Advanced Cardiac Life Support (ACLS) course, OR current (as indicated by the provider), successful completion of a Pediatric Advanced Life Support (PALS)
  • Licensees holding deep sedation or general anesthesia permits who provide anesthesia services to children (age twelve  (12) or younger)  must  document  current, successful completion  of a PALS
  • Standard of Care Requirements . A dentist must maintain the minimum standard of care for the administration of anesthesia  as outlined  in §108.7 of this title  and  in addition shall:
  • adhere to the clinical requirements as detailed in this    section;
  • maintain under continuous direct supervision a minimum of two qualified dental auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of deep sedation and/or  general anesthesia;
  • maintain current certification in Basic Life Support (BLS) for Healthcare Providers  for the assistant  staff  by having them pass  a course that includes a written  examination  and a hands-on  demonstration    of skills; and
  • not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a deep sedation/general anesthesia procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed.
  • Clinical
  • Patient Evaluation . Patients considered for deep sedation or general anesthesia must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this must consist of at least a review of their current medical history, medication use, and NPO However, patients with significant medical considerations (ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.
  • Pre-Procedure Preparation  and  Informed
  • The patient, parent, guardian, or care-giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and must provide written, informed consent for the proposed deep sedation or general anesthesia procedure. The informed consent must be specific to the deep sedation and/or general anesthesia procedure being performed and must specify that the risks related to the procedure include cardiac arrest, brain injury, and
  • The dentist shall determine that an adequate oxygen supply is available and evaluate equipment for proper operation  and delivery  of adequate oxygen under positive
  • Baseline vital signs must be obtained  in accordance  with  108.7 and §108.8 of this  title.
  • A focused physical evaluation  must be performed  as deemed
  • Pre-procedure dietary restrictions must be considered based on the sedative/anesthetic technique prescribed.
  • Pre-procedure verbal and written instruction s must be given to the patient, parent, escort, guardian, or care-giver.
  • An intravenous line, which is secured throughout the procedure,  must be established  except as provided  in paragraph  (7) of this  subsection, regarding  Pediatric  and  Special Needs Patients.
  • Personnel and Equipment
  • A minimum  of three  (3) individuals  must be present  during the procedure:
  • a dentist who is qualified to administer the deep sedation  or general  anesthesia who is currently certified  in ACLS and/or PALS;  and
  • two additional individuals who have current certification of successfully completing a course in Basic Life Support (BLS) for Healthcare Providers, one of which must be dedicated to assisting with patient monitoring.
  • A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
  • When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment  must  also have either:
  • a functioning device that prohibits  the delivery of less than 30% oxygen;    or
  • an appropriately calibrated  and functioning in-line  oxygen analyzer with  audible
  • An appropriate scavenging  system must be  available  if gases other than  oxygen  are
  • The equipment necessary  to  establish  intravenous  access must be

 

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  • Equipment and drugs necessary to provide advanced airway management and advanced cardiac life support must be  immediately
  • If volatile anesthetic agents are utilized, an inspired agent analysis monitor and capnograph should be considered.
  • Emergency medications  and a defibrillator  must be  immediately
  • A qualified dentist administering deep sedation or general anesthesia must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring  must  include:

(i) Color of mucosa, skin, or blood must be continually evaluated.

(ii) Oxygenation  saturation  must  be evaluated  continuously  by pulse oximetry.

  • Intubated patient: End-tidal  CO2 must be  continuously  monitored  and
  • Non-intubated patient: Breath sounds via auscultation and/or end-tidal CO2 must be continually monitored and
  • Respiration rate must be  continually  monitored  and
  • Heart rate and rhythm via EKG and pulse rate via pulse oximetry must be evaluated throughout the procedure.
  • Blood pressure must be continually monitored .
  • A device capable of measuring body temperature must be readily available during the administration of deep sedation or general
  • The equipment to continuously monitor body temperature should be available and must be performed whenever triggering  agents associated with malignant  hyperthermia  are
  • Documentation must be made in accordance with 108.7 and §108.8 of this title and must include the names, times and dosages of all drugs administered and the names of individuals  present  during administration  of the drugs.
  • A written time-oriented  anesthetic record  must  be
  • Pulse oximetry and end-tidal CO2 measurements (if taken with an intubated patient), heart rate, respiratory rate, and blood pressure  must be continually  recorded  at five (5) minute
  • Recovery and Discharge
  • Oxygen and suction equipment must be immediately available  if a separate recovery  area    is utilized.
  • The dentist or clinical staff must continually monitor the patient’s blood pressure, heart rate, oxygenation, and level of sedation
  • The dentist must determine and document that the patient’s level of consciousness, oxygenation, ventilation, and circulation are satisfactory prior to discharge. The dentist shall not leave the facility until the patient meets the criteria for discharge  and is discharged  from the
  • Post-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver. Post-procedure, patients should be accompanied by an adult caregiver for an appropriate period of recovery.
  • Special Needs Patients. Because many dental patients undergoing deep sedation or general anesthesia are mentally and/or physically  challenged,  it is not  always possible  to have a comprehensive  physical  examination or appropriate  laboratory  tests prior to  administering  When  these situations occur, the dentist responsible  for administering the deep sedation or general  anesthesia  shall document the reasons preventing  the pre­  procedure  management.
  • Management of Children. For children twelve (12) years of age and under, the dentist should observe the American Academy of Pediatrics/American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric  Patients  During  and After  Sedation  for Diagnostic  and Therapeutic
  • Emergency
  • The dentist is responsible for the sedation management, adequacy of the facility and staff, diagnosis and treatment of emergencies associated with the administration of deep sedation or general  anesthesia,  and  providing the equipment and protocols for patient rescue. This includes immediate access to pharmacologic antagonists and equipment for establishing a patent airway and providing positive pressure ventilation  with oxygen.
  • Advanced airway  equipment,  emergency medications  and  a defibrillator  must be  immediately
  • Appropriate pharmacologic agents must be immediately available if known triggering agents of malignant hyperthermia are part  of the  anesthesia

 
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TITLE 22 PART S

CHAPTER  110 RULE §110.7

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Portability

  • A sedation/anesthesia permit  is valid for the dentist’s facility, if any, as well as any satellite facility.
  • A Texas licensed dentist who holds the Board-issued privilege of portability on or before June 1, 2011 will automatically continue to hold that privilege provided  the dentist complies with the renewal requirements  of  this
  • Portability of a sedation/anesthesia permit will be granted to a dentist who, after June 1, 2011, applies for portability, if the dentist:
  • holds a Level 4 Deep  Sedation/General Anesthesia  permit;
  • holds a Level 3 Moderate Parenteral Sedation permit and the permit was granted based  on education  received in conjunction with the completion of a oral and maxillofacial specialty education program or a dental anesthesia program;  or
  • holds a Level 3 Moderate Parenteral Sedation permit and   if:
  • the training for the permit was obtained on the basis of completion of any of the following American Dental Association (ADA)  Commission  on Dental  Accreditation  (CODA) recognized  or approved programs:
  • a specialty program;
  • a general practice residency;
  • an advanced education  in general  dentistry program; or
  • a continuing education program. Dentists seeking a portability privilege designation based  on this method of education shall also successfully complete no less than sixty (60) hours of didactic instruction and manage no less than  twenty  (20) dental patients  by the intravenous  route  of administration;  and
  • the applicant provides proof of administration of no less than thirty (30) cases of personal  administration  of Level 3 sedation on patients in a primary  or satellite practice  location within the six (6) month period  preceding the application for portability, but following the issuance of the sedation permit. Acceptable documentation shall include, but not be limited to, patient records demonstrating the applicant’s anesthetic technique,  as well as provision  of services by the  applicant within  the minimum  standard  of
  • A dentist providing anesthesia services utilizing a portability permit remains responsible for providing these services in strict compliance with all applicable laws and rules. The dentist shall ascertain that the location is supplied, equipped, staffed, and maintained in a condition to support provision  of anesthesia  services that meet  the standard  of
  • Any applicant whose request for portability status is not granted on the basis of the application will be provided an opportunity  for hearing pursuant  to Texas Government  Code,  Chapter 2001 et


Source Note:
The provisions  of this  §110.7 adopted to be effective May  10, 2011,  36 TexReg  2833

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TITLE 22 PART S

CHAPTER   110 RULE §110.8

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Provisional  Anesthesia  and Portability Permits

  • The Board may elect to issue a temporary sedation/anesthesia and/or portability permit that will expire on a stated date. A full sedation/anesthesia or portability permit may be issued after the dentist has complied with requests of the Board which  may include, but  shall not be limited to, review  of the dentist’s  anesthetic  technique, facility inspection, and/or review of patient records to ascertain that the minimum standard of care is being  Ifa full permit  is not issued, the temporary permit  will  expire on the stated   date.
  • A dentist licensed by the Board who is enrolled and approaching graduation in a specialty or General     Practice Residency/Advanced Education in General Dentistry (GPR/AEGD) program as detailed in this chapter may, upon approval of the Board or its designees, obtain a provisional permit from the Board to administer  moderate parenteral sedation and/or deep sedation and general anesthesia. A dentist licensed by the Board who holds a Level IV permit issued by the Board may, upon  approval of the Board  or its designees, obtain a   provisional permit from the Board to provide anesthesia  on a portable basis.  To qualify for a provisional  permit the  applicant must:
  • meet all requirements  under  this chapter;
  • have a letter submitted  on the applicant’s  behalf:
  • on the letterhead of the  school  administering  the program;
  • signed by the director of the  program;
  • specifying the specific  training  completed; and
  • confirming imminent  graduation  as a result  of successful  completion  of all requirements  in the
  • For the purposes of this chapter, “completion” means the successful conclusion of all requirements of the program in question, but  not  including the  formal graduation
  • Any provisional permit issued under this section shall remain in effect until the next-scheduled regular Board meeting, at which  time  the Board  will consider ratifying  the provisional
  • On ratification of a provisional permit, the status of the permit will change to that of a regular permit under this

Source Note: The provisions of this §110.8 adopted to be effective May I 0, 2011, 36 TexReg 2833

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TITLE 22 PART 5

CHAPTER   110 RULE §110.9

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Anesthesia  Permit Renewal

  • The Board shall renew an anesthesia/sedation permit annually if required fees are paid and the required emergency management training and continuing education requirements are satisfied. The Board shall not renew an anesthesia/sedation permit if, after notice and opportunity for hearing, the Board finds the permit holder has provided, or is likely to provide, anesthesia/sedation services in a manner that does not meet the minimum standard of If a hearing is held, the Board shall consider factors including patient complaints, morbidity, mortality, and anesthesia consultant recommendations.
  • Annual dental license renewal certificates shall include the annual permit renewal, except as provided  for in this section. The licensee shall be assessed an annual renewal fee in accordance with the fee schedule in Chapter  102 of this title.
  • Continuing Education
  • In conjunction with the annual renewal of a dental license, a dentist seeking to renew a minimal sedation, moderate sedation, or deep sedation/general anesthesia permit must submit proof  of completion of the    following hours of continuing education every two years on the administration of or medical emergencies associated with the permitted  level  of  sedation:
  • Level 1: Minimal  Sedation – six (6) hours
  • Levels 2 and 3: Moderate Sedation – eight (8)   hours
  • Level 4: Deep Sedation/General Anesthesia – twelve (12) hours
  • The continuing education requirements under this section shall be in addition to any additional courses required for licensure. Advanced Cardiac Life Support (ACLS) course and Pediatric Advanced Life Support (PALS) course may not be used to fulfill the continuing education requirement for renewal of the permit under this
  • Continuing education  courses must meet the provider  endorsement  requirements  of 104.2 of this  title.

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TITLE 22

PART S CHAPTER 110 RULE §110.10

EXAMINING  BOARDS

STATE BOARD OF DENTAL EXAMINERS SEDATION  AND ANESTHESIA

Use  of General Anesthetic  Agents

  • No dentist shall administer or employ the general anesthetic agent(s) listed in subsection (b) of this section, which has a narrow margin for maintaining  consciousness, unless the dentist possesses  a valid  Level 4 –   General Anesthesia  or Deep  Sedation permit  issued by the
  • The following drugs are general anesthesia agents with a narrow margin for maintaining consciousness and must only be used by a dentist holding a Level 4 – General Anesthesia  or Deep  Sedation permit:
  • short acting barbiturates including,  but not limited to thiopental,  sodium methohexital,  and   thiamylal;
  • short acting analogues of fentanyl  including,  but not  limited to remifentanil,  alfentanil,  and sufentanil;
  • alkylphenols including precursors or derivatives, which includes, but not limited to propofol and fospropofol;
  • etomidate;
  • dissociative anesthetics – ketamine;
  • volatile inhalation  anesthetics  including, but not  limited  to sevoflurane,  desflurane  and isoflurane; and
  • similarly acting drugs or quantity of agent(s), or technique(s), or any combination thereof that would likely render a patient deeply sedated,  generally  anesthetized  or otherwise  not meeting the conditions of the definition of moderate  sedation as stated in  110.1 of this chapter  (relating to  Definitions).
  • No permit holder shall have more than one person under general anesthesia at the same time exclusive of recovery.

Source Note: The provisions  of this  § 110.10 adopted to be effective August  25, 2013, 38 TexReg   5262

 

A PPENDIX 2

BLUE RIBBON PANEL

REVIEW OF DEIDENTIFIED  DATA FOR FY 2012-2016 

Direction  of the Sunset Commission:

As a management action, direct the board to establish in an expedited rule an independent five to 10-member blue ribbon panel that would review de-identified data, including confidential investigative information, related to dental anesthesia deaths and mishaps over the last five years, as well as evaluate emergency protocols. The Committee  should  make recommendations to the Legislature by the Sunset Commission’s January 11, 2017 meeting. 


Phase One – Case Identification
I PROJECT SUMMARY

Purpose: Staff identifies cases in which a “dental anesthesia death or mishap” may have occurred. Locate dentist expert/consultation report and patient records for such cases.

  • September 15, 2016, to October 10, I COMPLETED OCTOBER 7, 2016

Phase Two – Case Selection

Purpose: Blue Ribbon Panel (BRP) defines “dental anesthesia death or mishap.” BRP selects cases in which a “dental anesthesia death or mishap” occurred. Identify data points to be analyzed related to selected cases.

  • October 10, 2016, to October 25, 2016.  I COMPLETED  OCTOBER  25,  2016

Phase Three – Data Compilation

Purpose: Staff compiles data requested by BRP in Phase Two for the cases selected by BRP in Phase Two.

  • October 25, 2016, to November 10, 2016. I COMPLETED NOVEMBER 10, 2016

Phase Four Data Analysis

Purpose: BRP reviews de-identified data compiled in Phase Three and develops recommendations to report to the Sunset Commission.

  • November 10, 2016, to January  4, 2017. I COMPLETED  JANUARY  4,  2017

I PROJECT DETAILS

I PHASE ONE – CASE IDENTIFICATION

Purpose: Identify cases in which an “anesthesia death or mishap” may have occurred. Locate dentist expert/consultation report and patient records for such cases.

Participants: Staff of the Dental Practice Division

Timeframe: September 15, 2016, to October 10, 2016

Completed: October 7, 2016

Methodology: The database cannot be queried for “anesthesia deaths and mishaps.” Anesthesia deaths and mishaps must be identified through manual review of case files.

  1. Staff identifies all cases in which sedation/anesthesia was administered and/or identified as a possible concern in the agency’s initial case
    • Queried database for all cases with the following allegation codes:

Allegation codes are determined during complaint intake.

  • QOC4 – QOC – Anesthesia
  • SR1 – SR – Self-Report
  • SR2 – SR – Patient Hospitalization o SR3 – SR – Patient Mortality
  • Full text search of database for all cases with any of the following words in the summary field:

Summary  field is determined  during complaint  intake.

  • Nitrous o      Over sedated
  • Sedation o      Over sedation
  • Anesthesia o      Enteral
  • N20 o      Parenteral
  • IV
  • Halcion
  • Overdose
  • Sedate
  • Sedated

!RESULT: 816 case 

o   Intravenous o   Anaphylaxis o    Allergic

  • Allergy
  • Gas
  1. Staff eliminates cases with the following attributes:
    • On-going investigation or final adjudication pending (180 cases)
    • Not subject to a written review by an expert dentist (283 cases)
    • Case file purged pursuant to Records Retention Schedule or unable to be located (51 cases)
    • Treatment did not involve the administration of sedation/anesthesia (179 cases)

!RESULT: 123 case 

  1. Staff dentist derives summaries of cases identified in Step 2 from the written report of the dentist expert or consultant who participated in the investigation .
    • Narrative summary
    • Complaint source: patient or self-report

!RESULT: 123 case summaries provided to BRP on October 7,  201
Purpose: Define “dental anesthesia death or mishap.” Select cases in which  sedation/anesthesia was administered and in which a “dental anesthesia death or mishap” occurred. Identifies data to be compiled concerning cases in which a “dental anesthesia death  or mishap” occurred.PHASE TWO – CASE SELECTION – October 10, 2016, to October 25, 2016

Participants: Members of the Blue Ribbon Panel Timeframe: October  10, 2016, to October 25, 2016

Completed: October 25, 2016 Methodology:

  1. BRP determines meaning of “dental anesthesia death or mishap” for purposes of BRP project.
  2. BRP reviews narrative summaries and identifies cases that indicate an “anesthesia death or “
  3. BRP identifies data to be collected concerning the cases identified in Step

Detailed data points to be collected on the 75 cases identified by BRP

 

Respondent Data Investigative Data Sedation/Anesthesi a Treatment, Cont’d
Dental school education Primary planned procedure Did an emergency occur at the treatment facility?

<YIN/Unknown)

Sedation permit issue date DRP/expert report notes Pre-op H&P (who did it  when was it done)
SIA trainina information Amiravatina factors Pre-op Vitals
Medicaid provider? Mitigatina factors Pre-op 02
Self-reported practice area Notes regarding emergency response Pre-op airway analysis
Highest SIA  permit held Written    emergency    protocol?    Adequate? Initiated? NPO
Portabilitv? SOC violation as per expert review Duration of SIA (start time : end time)
Patient Data Anesthesia violation as per expert review SIA monitoring (vitals, Sa02.RR. capn. eka. etc.)
Age SOC anesthesia clinical violation Delivery method/route
Age category SOC anesthesia monitoring or documentation violation Drugs, dosage, route
Gender Sedation/Anesthesia Treatment Local anesthetic given
Height Sedation data Personnel present
Weight SIA level administered . Did respondent provide s/a (YIN) Airway Management – planned or emergency response
BMI Did respondent provide or intend to provide

dental treatment? (Y/Nl

IV access – pre-op or emergency response
Patient ASA {respondent) Was s/a provided using portabilitv permit (Y/Nl Legal Data
Patient ASA (other source) Administrator of S/A Previous public Board action related to anesthesia
Additional patient information Treatment facility tvpe Compliance with prior actions of the Board

 

!RESULT: 75 cases identified and 48 data points identified!

Purpose: Compile data requested by BRP in Phase Two for the cases selected by BRP in Phase TwoJ   PHASE THREE – DATA COMPILATION – October 25, 2016, to November 10, 2016

Participants: Staff of the Dental Practice Division Timeframe: October 25, 2016, to November 10, 2016

Completed: November  10, 2016

!RESULT:  Specific  data (48 data  points)  regarding 78 cases  provided to  BRP onl

!November 10, 201§

NOTE: Three additional cases eliminated in Phase One as pending investigation were re-incorporated in Phase Three due to their high-profile nature and relevance to the BRP charge.
Purpose: Review and analyze de-identified data compiled in Phase Three and develop recommendations to report to the Sunset CommissionI PHASE FOUR – DATA ANALYSIS – November 10, 2016, to January 11, 2017

Participants: Members of the Blue Ribbon Panel. Timeframe: November 10, 2016, to January 4,  2017

Completed: January 4, 2017

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