3 Colo. Code Regs. § 709-1.14

Current through Register Vol. 47, No. 22, November 25, 2024

Section 3 CCR 709-1.14 - Anesthesia

A. Introduction

1. This Rule 1.14 is authorized by the Dental Practice Act including, but not limited to, sections 12-220-106(1)(a) (II-III), and (f), 12-220-305(1)(p) and (q), 12-220-306, 12-220-504(1)(c), 12-220-501(3)(a)(V), 12-220-201(1)(cc) and (ll), 12-220-411 and 12-220-508(1)(c)(VI), C.R.S.

2. The purpose of this Rule 1.14 is to make the process for obtaining an anesthesia permit well defined, transparent, and consistent for the dental professionals while at the same time protecting and promoting patient safety.

B. The Anesthesia Continuum

1. The anesthesia continuum represents a spectrum encompassing analgesia, local anesthesia, sedation, and general anesthesia along which no single part can be simply distinguished from neighboring parts. It is not the route of administration that determines or defines the level of anesthesia administered. The location on the continuum defines the level of anesthesia administered.

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2. The level of anesthesia on the continuum is determined by the definitions listed under section (C) of this Rule 1.14 . Elements used to determine the level of anesthesia include the level of consciousness and the likelihood of anesthesia provider intervention(s), based upon the following patient parameters:

a. Responsiveness;

b. Airway;

c. Respiratory (breathing); and

d. Cardiovascular.

C. Definitions Related to Anesthesia

1. Anesthesia- The art and science of managing anxiety, pain, and awareness. It includes analgesia, local anesthesia, minimal sedation, moderate sedation, deep sedation, and general anesthesia.

2. Analgesia- The diminution or elimination of pain.

3. Local Anesthesia- The elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug.

4. Minimal Sedation- A minimally depressed level of consciousness produced by a pharmacological method, that 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.

5. Moderate Sedation- A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

6. 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 inadequate. Cardiovascular function is usually maintained.

7. 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 impaired.

8. Monitoring- Evaluation of patients to assess physical condition and level of anesthesia.

9. Peri-anesthesia Period- The time from the beginning of the pre-anesthesia assessment until the patient is discharged from anesthesia care.

10. Anesthesia Provider- The licensed and legally authorized individual responsible for administering medications that provide analgesia, local anesthesia, minimal, moderate or deep sedation, or general anesthesia.

11. Pediatric Designation- Board-granted designation required, in addition to an anesthesia permit, if administering minimal sedation, moderate sedation, or deep sedation/general anesthesia to a patient under twelve years old.

D. General Rules for the Safe Administration of Anesthesia

1. The anesthesia provider's education, training, experience, and current competence must correlate with the progression of a patient along the anesthesia continuum.

2. The anesthesia provider must be prepared to manage deeper than intended levels of anesthesia as it is not always possible to predict how a given patient will respond to anesthesia.

3. The anesthesia provider's ultimate responsibility is to protect the patient. This includes, but is not limited to, identification and management of any complication(s) occurring during the peri-anesthesia period.

4. No dentist shall administer or employ any agent(s) with a narrow margin for maintaining consciousness including, but not limited to, ultra-short acting barbiturates, propofol, parenteral ketamine, 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 minimal sedation or moderate sedation in section C of this Rule 1.14, unless he/she holds a valid Deep Sedation/General Anesthesia Permit issued by the Colorado Dental Board.

E.Anesthesia Privileges Included in Colorado Dental Licensure

1. The following anesthesia privileges are included with a Colorado issued dentist license and academic license:

a. Local Anesthesia;

b. Analgesia;

c. Medication prescribed/administered for the relief of anxiety or apprehension to non-pediatric patients, limited to the following:

(1) A dose of a single drug (no more than the maximum recommended dose) that can be prescribed for unmonitored home use; or

(2) The above plus nitrous oxide; and

d. Nitrous Oxide/Oxygen Inhalation Analgesia in compliance with section G of this Rule 1.14.

2. A dentist who elects to engage the services of another anesthesia provider in order to provide anesthesia in his/her dental office is responsible for ensuring that the office meets the requirements outlined in this Rule 1.14.

F. Anesthesia Permits

1. Local Anesthesia Permit for dental therapists and dental hygienists-

a. To administer local anesthetic or local anesthetic reversal agents under the indirect supervision of a dentist, a dental therapist and a dental hygienist shall obtain a Local Anesthesia Permit.

b. A Local Anesthesia Permit will be issued once and will remain valid as long as the licensee maintains an active license to practice, except as otherwise provided in section 12-220-411, C.R.S., or this Rule 1.14.

c. In order to initially apply for, renew, or reinstate a Local Anesthesia Permit pursuant to this Rule 1.14, an applicant must pay a fee established by the Director of the Division of Professions and Occupations pursuant to section 12-20-105, C.R.S.

2. Inspection Permit-

a. A dentist will be issued an Inspection Permit upon meeting the educational and/or experience requirements for a Moderate Sedation Permit or for a Deep Sedation/General Anesthesia Permit as outlined in this Rule 1.14 prior to successfully completing his/her clinical onsite inspection.

b. Unless otherwise authorized by the Board, the Inspection Permit will be issued once and will remain valid for a maximum of ninety days.

c. An Inspection Permit can only be used to administer anesthesia for purposes of a Board authorized inspection.

3. Minimal Sedation Permit-

a. To administer minimal sedation, a dentist shall have a Minimal Sedation Permit, Moderate Sedation Permit, or a Deep Sedation/General Anesthesia Permit issued in accordance with this Rule 1.14.

b. A Minimal Sedation Permit shall be valid for a period of five years, after which such permit may be renewed upon reapplication.

c. In order to initially apply for, renew, or reinstate a Minimal Sedation Permit pursuant to this Rule 1.14, an applicant must pay a fee established by the Director of the Division of Professions and Occupations pursuant to section 12-20-105, C.R.S.

4. Moderate Sedation Permit-

a. To administer moderate sedation, a dentist shall have a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit issued in accordance with this Rule 1.14.

b. A Moderate Sedation Permit shall be valid for a period of five years after which such permit may be renewed upon reapplication.

c. In order to initially apply for, renew, or reinstate a Moderate Sedation Permit pursuant to this Rule 1.14, an applicant must pay a fee established by the Director of the Division of Professions and Occupations pursuant to section 12-20-105, C.R.S.

5. Deep Sedation/General Anesthesia Permit-

a. To administer deep sedation/and or general anesthesia, a dentist shall have a Deep Sedation/General Anesthesia Permit issued in accordance with this Rule 1.14.

b. A Deep Sedation/General Anesthesia Permit shall be valid for a period of five years after which such permit may be renewed upon reapplication.

c. In order to initially apply for, renew, or reinstate a Deep Sedation/General Anesthesia Permit pursuant to this Rule 1.14, an applicant must pay a fee established by the Director of the Division of Professions and Occupations pursuant to section 12-20-105, C.R.S.

G. Nitrous Oxide/Oxygen Inhalation Requirements

1. A dentist may delegate under direct supervision the monitoring and administration of nitrous oxide/oxygen inhalation to appropriately trained dental personnel, pursuant to sections 12-220-305(1)(p) and (q), 12-220-501(3)(c), and 12-220-411(4), C.R.S.

2. The supervising dentist is responsible for determining and documenting the maximum percent-dosage of nitrous oxide administered to the patient. Documentation shall include the length of time nitrous oxide was delivered.

3. It is the responsibility of the supervising dentist to ensure that dental personnel who administer and/or monitor nitrous oxide/oxygen inhalation are appropriately trained.

4. If nitrous oxide is used in the practice of dentistry, then the supervising dentist shall provide and ensure the following:

a. Fail safe mechanisms in the delivery system and an appropriate scavenging system;

b. The inhalation equipment must be evaluated for proper operation and delivery of inhalation agents;

c. Any administration or monitoring of nitrous oxide/oxygen inhalation to patients by dental personnel is performed in accordance with generally accepted standards of dental, dental therapy or dental hygiene practice.

H. Local Anesthesia Permit for Dental Therapists and Dental Hygienists

1. A dental therapist and a dental hygienist may obtain a Local Anesthesia Permit after submitting a Board-approved application and upon successful completion of courses conducted by a school accredited by the Commission on Dental Accreditation (CODA) or was developed prior to February 6, 2015, and at the time of graduation was accredited by the Minnesota Board of Dentistry or certified by the Alaska Community Health Aide Program Certification Board.

2. Courses must meet the following requirements:

a. Twelve hours of didactic training, including but not limited to:

(1) Anatomy;

(2) Pharmacology;

(3) Techniques;

(4) Physiology; and

(5) Medical Emergencies.

b. Twelve hours of clinical training that includes the administration of at least six infiltration and six block injections.

I. Minimal Sedation Permit- A dentist may obtain a Minimal Sedation Permit after submitting a Board-approved application and upon successful completion of the educational requirements, or by endorsement of authorized administration in another state/jurisdiction set forth below:

1. A specialty residency or general practice residency recognized by the Commission on Dental Accreditation (CODA) that includes comprehensive and appropriate training to administer and manage minimal sedation; or

2. Educational criteria for a Moderate Sedation Permit or for a Deep Sedation/General Anesthesia Permit; or

3. A minimum of sixteen hours of Board-approved coursework completed within the past 5 years that provides training in the administration and induction of minimal sedation techniques and management of complications and emergencies associated with sedation commensurate with the American Dental Association (ADA) 2012 "Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students".

a. The coursework must contain an appropriate combination of didactic instruction and practical skills training.

b. The applicant must submit for Board approval documentation of the training course(s) to include, but not be limited to, a syllabus or course outline of the program and a certificate or other documentation from course sponsors or instructors indicating the number of course hours, content of such courses and date of successful completion.

c. Course content leading to current Basic Life Support (BLS) and/or Advanced Cardiac Life Support (ACLS) and/or Pediatric Advanced Life Support (PALS) cannot be considered as part of the sixteen hours of classroom and clinical instruction.

4. At its discretion, the Board may consider qualifications accepted in another state or jurisdiction that resulted in a comparable permit to be issued by that state or jurisdiction which is substantially equivalent to the requirements for a Minimal Sedation Permit in Colorado. At a minimum, the applicant must demonstrate that he/she has successfully administered minimal sedation in twenty cases within the last two years prior to applying, and has had no discipline, morbidity to a patient requiring hospital admission, or patient mortality associated with the administration of sedation.

5. Pediatric Designation- A dentist is only eligible for a Pediatric Designation on his/her Minimal Sedation Permit by successfully completing one of the following:

a. Completing a pediatric residency pursuant to paragraph (1)(a) of Rule 1.14(J) below.

b. Meeting the educational criteria pursuant to paragraph (1)(b) of Rule 1.14(J) below, or

c. Completing:

(1) A minimum of thirty hours of education specific to pediatric patients in addition to or as part of the residency pursuant to paragraph (1)(a), or the sixty hours of education pursuant to paragraph (2)(a) of Rule 1.14(J) below; and

(2) Ten pediatric cases in addition to or as part of the residency pursuant to paragraph (1)(a), or the twenty cases of experience pursuant to paragraph (2)(b) of Rule 1.14(J) below.

J. Moderate Sedation Permit- A dentist may obtain a Moderate Sedation Permit after submitting a Board-approved application and upon successful completion of education only, or a combination of approved education and experience, or by endorsement of authorized administration in another state or jurisdiction as set forth below:

1. Education Only Route- Must submit proof of having successfully completed one of the following:

a. A specialty residency or general practice residency recognized by the Commission on Dental Accreditation (CODA) that at a minimum includes:

(1) Sixty hours of training in the administration and induction of moderate sedation techniques and management of complications and emergencies associated with sedation commensurate with the American Dental Association (ADA) 2012 "Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students"; and

(2) Sedation cases performed by the applicant on twenty unique patients that were completed as part of the residency where the applicant is both the primary provider of the sedation and direct provider of dental care; or

b. Educational criteria for a Deep Sedation/General Anesthesia Permit.

2. Education/Experience Route- Must submit proof of successfully completing moderate sedation course(s) and acceptable sedation cases as follows:

a. Education

(1) Sixty hours of Board-approved coursework completed within the past five years that provides training in the administration and induction of moderate sedation techniques and management of complications and emergencies associated with sedation commensurate with the American Dental Association (ADA) 2012 "Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students".

(2) Such coursework must include an appropriate combination of didactic instruction and practical skills training. Coursework must also include documented training in parenteral techniques in order to perform parenteral sedation once a Moderate Sedation Permit is issued.

(3) The applicant must submit for Board approval documentation of the training course(s) to include, but not be limited to, a syllabus or course outline of the program and a certificate or other documentation from course sponsors or instructors indicating the number of course hours, content of such courses and date of successful completion.

(4) Course content leading to current Basic Life Support (BLS) and/or Advanced Cardiac Life Support (ACLS) and/or Pediatric Advanced Life Support (PALS) cannot be considered as part of the sixty hours of classroom and clinical instruction.

b. Experience

(1) Sedation cases performed by the applicant on twenty unique patients that were completed as part of or separate from the Board-approved sedation training course.

(2) If completed as part of a Board-approved sedation training course, then time spent on cases does not count towards the sixty-hour course requirement.

(3) If completed separate from the course, then all cases must be completed during the one year period immediately after completion of the approved training program.

(4) All of the cases must be performed and documented under the on-site instruction and supervision of a person qualified to administer anesthesia at a deep sedation/general anesthesia level.

(5) Pursuant to section 12-220-411(4)(b), C.R.S., the applicant must both be the primary provider of the sedation and directly provide dental care for all required casework.

(6) Cases may be performed on live patients or as part of a hands-on high-fidelity sedation simulation center or program; however, a maximum of five hands-on high fidelity simulation cases may be accepted as part of the required twenty sedation cases.

(7) Cases must meet the documentation and monitoring requirements for moderate sedation set forth in sections (O) and (P) of Rule 1.14. The cases must meet generally accepted standards for the provision and documentation of moderate sedation in Colorado, regardless of where the cases occurred.

3. Endorsement Route- At its discretion, the Board may consider qualifications accepted in another state or jurisdiction that resulted in a comparable permit to be issued by that state or jurisdiction which is substantially equivalent to the requirements for a Moderate Sedation Permit in Colorado. At a minimum, the applicant must demonstrate that he/she has successfully administered moderate sedation in twenty cases within the last two years prior to applying, and has had no discipline, morbidity to a patient requiring hospital admission, or patient mortality associated with the administration of sedation.

4. Pediatric Designation- A dentist is only eligible for a Pediatric Designation on his/her Moderate Sedation Permit by successfully completing one of the following:

a. Completing a pediatric residency pursuant to paragraph (1)(a) of this Rule 1.14(J).

b. Meeting the educational criteria pursuant to paragraph (1)(b) of this Rule 1.14(J), or

c. Completing:

(1) A minimum of thirty hours of education specific to pediatric patients in addition to or as part of the residency pursuant to paragraph (1)(a), or the sixty hours of education pursuant to paragraph (2)(a) of this Rule 1.14(J); and

(2) Ten pediatric cases in addition to or as part of the residency pursuant to paragraph (1)(a), or the twenty cases of experience pursuant to paragraph (2)(b) of this Rule 1.14(J).

K. Deep Sedation/General Anesthesia Permit- A dentist may obtain a Deep Sedation/General Anesthesia Permit after submitting a Board-approved application and upon successful completion of one of the following educational requirements:

1. A residency program in general anesthesia that is approved by the Commission on Dental Accreditation (CODA), the Accreditation Council for Graduate Medical Education, or any successor organization to any of the foregoing; or

2. An acceptable post-doctoral training program (e.g. oral and maxillofacial surgery or dental anesthesiology) that affords comprehensive and appropriate training necessary to administer and manage deep sedation and general anesthesia commensurate with the American Dental Association (ADA) 2012 "Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students".

3. A dentist issued a Deep Sedation/General Anesthesia Permit is automatically eligible to obtain a Pediatric Designation.

L. Clinical On-Site Inspection for Obtaining, Renewing, or Reinstating a Moderate Sedation or Deep Sedation/General Anesthesia Permit

1. Applications for a Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit

a. Any dentist applying for a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit must successfully complete a clinical on-site inspection as a condition of obtaining a Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit.

b. Upon satisfying the requirements of section (J) or (K) of Rule 1.14, the dentist applying for a Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit will initially be issued an Inspection Permit. The dentist must then undergo a clinical on-site inspection. The Inspection Permit may only be utilized for purposes of undergoing the Board-approved clinical on-site inspection.

c. Upon issuance, an Inspection Permit is effective for ninety days, and unless otherwise authorized by the Board, the clinical on-site inspection must be successfully completed within those ninety days while the Inspection Permit is in effect.

2. Applications for Renewing (only available to those licensed dentists actively administering anesthesia in Colorado) or Reinstating a Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit

a. Any dentist applying to renew or reinstate a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit must submit an updated clinical on-site inspection as required pursuant to section 12-220-411(5), C.R.S.

b. Any dentist who has his/her dental office inspected pursuant to paragraphs (4) and (8)(b)(3) of Rule 1.14 must submit an updated clinical on-site inspection every five years.

c. To renew an active permit a clinical on-site inspection must be completed within the three months before the expiration date of the permit or within a three month grace-period after the expiration date of the permit; otherwise the permit will expire and the dentist will no longer be authorized to administer any level of anesthesia requiring a permit.

d. Any dentist whose Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit has expired is required to first obtain an Inspection Permit before proceeding with a clinical on-site inspection.

3. A separate clinical on-site inspection is not required for dentists who receive a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit pursuant to this Rule 1.14 for one dental office and travel to other dental office locations in Colorado to administer anesthesia. However, it is the responsibility of the anesthesia provider to ensure that each dental office where moderate sedation and/or deep sedation/general anesthesia is administered meets the requirements outlined in this Rule. This responsibility also extends to a dentist without a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit who elects to engage the services of another anesthesia provider to provide such anesthesia in his/her dental office.

4. A clinical on-site inspection is also required of any dentist who is not issued a Moderate Sedation Permit or Deep Sedation/General Anesthesia Permit and instead contracts with an anesthesia provider that is not subject to the rules and regulations of the Colorado Dental Board (i.e. Colorado licensed physician or certified registered nurse anesthetist (CRNA)) prior to the administration of moderate sedation and/or deep sedation/general anesthesia in his/her dental office.

5. A clinical on-site inspection is not required for dentists administering only in a hospital setting.

6. In the case of a dentist who practices exclusively from a mobile or portable facility, a clinical on-site inspection shall be conducted in the office of a Colorado licensed dentist. A written list of all monitors, emergency equipment, and other materials which the mobile anesthesia provider agrees to have available at all times while administering in multiple locations shall be provided to the inspector, who in turn will provide it with his/her inspection report to the Board.

7. The dentist requiring the clinical on-site inspection is responsible for all fees associated with and must bear the cost of the inspection. The dentist must pay any fee incurred directly to the approved inspector. The inspector may charge a reasonable inspection fee, plus actual travel expenses for lodging, meals, and mileage at the current United States Internal Revenue Service (IRS) rate per mile. An inspection fee up to $500 is reasonable.

8. The clinical on-site inspection shall consist of the following parts:

a. Review of the office equipment, records, and emergency medications required in sections (M), (N), (O), (P)(3), and (P)(4) of Rule 1.14.

b. Surgical/Anesthetic Techniques.

(1) The inspector shall observe at least one case while the dentist administers anesthesia at the level for which he/she is making application to the Board. The inspector may require additional cases to observe at his/her discretion.

(2) Any dentist requesting a Pediatric Designation that is applying for, renewing, or reinstating a Moderate Sedation Permit and is eligible for the designation through completion of a pediatric specialty training program or a combination of acceptable pediatric education (thirty hours) and experience (ten pediatric cases) is required to have at least one pediatric case observed as part of his/her inspection.

(3) If the dentist is undergoing a clinical on-site inspection pursuant to paragraph (4) of Rule 1.14, then he/she is not required to have his/her surgical/anesthetic techniques evaluated in accordance to paragraph (8)(b) of Rule 1.14, Rather, a separate on-site inspection form will be used to review the facility, office equipment, and emergency medications available; and the on-site inspection will be completed with both the dentist and an anesthesia provider of his/her choice participating with the goal of facilitating communications between the non-anesthetizing dentist and his/her staff in case of an anesthetic emergency.

c. Simulated Emergencies. The dentist and his/her team must demonstrate adequately managing a minimum of eight emergencies.

d. Discussion Period.

9. The inspector shall be a Board-approved Colorado licensed physician or certified registered nurse anesthetist (CRNA) trained in dental outpatient deep sedation/general anesthesia and moderate sedation, or a dentist issued a Deep Sedation/General Anesthesia Permit pursuant to section 12-220-411(5)(a), C.R.S. A dentist issued a Moderate Sedation Permit may perform the clinical on-site inspection for another dentist renewing a Moderate Sedation Permit only.

10. The inspector shall not have an unethical agreement or conflict of interest with an applicant.

11. Inspectors shall be considered consultants for the Board and shall be immune from liability in any civil action brought against him/her occurring while acting in this capacity as set forth in section 12-20-402, C.R.S.

12. The documentation of the anesthesia inspection must be completed on Board-approved forms and submitted for review along with the anesthesia record(s).

M. Office Facilities and Equipment for Provision of Minimal Sedation, Moderate Sedation, Deep Sedation and/or General Anesthesia

1. Any dentist whose practice includes the administration of minimal sedation by any anesthesia provider must provide the following office facilities and equipment, which are required to be functional at all times:

a. Emergency equipment and facilities, including:

(1) An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up;

(2) Oral and nasopharyngeal airways;

(3) Appropriate emergency medications; and

(4) An external defibrillator- manual or automatic.

b. Equipment to monitor vital signs and oxygenation/ventilation, including:

(1) A continuous pulse oximeter; and

(2) A blood pressure cuff of appropriate size and stethoscope, or equivalent blood pressure monitoring devices.

c. Oxygen, suction, and a pulse oximeter must be immediately available during the recovery period.

2. Any dentist whose practice includes the administration of moderate sedation by any anesthesia provider must provide the following office facilities and equipment, which are required to be functional at all times:

a. Emergency equipment and facilities, including:

(1) An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up;

(2) Oral and nasopharyngeal airways;

(3) Appropriate emergency medications; and

(4) An external defibrillator- manual or automatic.

b. Equipment to monitor vital signs and oxygenation/ventilation, including:

(1) A continuous pulse oximeter; and

(2) A blood pressure cuff of appropriate size and stethoscope, or equivalent blood pressure monitoring devices.

c. Oxygen, suction, and a pulse oximeter must be immediately available during the recovery period.

d. Back-up suction equipment.

e. Back-up lighting system.

f. Parenteral access or the ability to gain parenteral access, if clinically indicated.

g. Electrocardiograph, if clinically indicated.

h. End-tidal carbon dioxide monitor (capnography) by July 1, 2016.

3. Any dentist whose practice includes the administration of deep sedation and/or general anesthesia by any anesthesia provider must provide the following office facilities and equipment, which are required to be functional at all times:

a. Emergency equipment and facilities, including:

(1) An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up;

(2) Oral and nasopharyngeal airways;

(3) Appropriate emergency medications; and

(4) An external defibrillator- manual or automatic.

b. Equipment to monitor vital signs and oxygenation/ventilation, including:

(1) A continuous pulse oximeter; and

(2) A blood pressure cuff of appropriate size and stethoscope, or equivalent blood pressure monitoring devices.

c. Oxygen, suction, and a pulse oximeter must be immediately available during the recovery period.

d. Back-up suction equipment.

e. Back-up lighting system.

f. Parenteral access or the ability to gain parenteral access, if clinically indicated.

g. Electrocardiograph.

h. End-tidal carbon dioxide monitor (capnography) by July 1, 2016.

i. Additional emergency equipment and facilities, including:

(1) Endotracheal tubes suitable for patients being treated;

(2) A laryngoscope with reserve batteries and bulbs,

(3) Endotracheal tube forceps (i.e. magill); and

(4) At least 1 additional airway device.

N. Anesthesia Gas Delivery Systems- Shall include:

1. Capability to deliver oxygen to a patient under positive pressure, including a back-up oxygen system;

2. Gas outlets that meet generally accepted safety standards preventing accidental administration of inappropriate gases or gas mixture;

3. Fail-safe mechanisms for inhalation of nitrous oxide analgesia;

4. The inhalation equipment must have an appropriate scavenging system if inhalation anesthetics are used; and

5. Gas storage facilities, which meet generally accepted safety standards.

O. Documentation- Shall include, but is not limited to:

1. For administration of local anesthesia and analgesia-

a. Pertinent medical history, including weight; and

b. Medication(s) administered and dosage(s).

2. For administration of minimal sedation, moderate sedation, deep sedation or general anesthesia

a. Medical History- current and comprehensive, to include current medications;

b. Informed Consent- for the administration of anesthesia;

c. Anesthesia Record, which includes:

(1) Height and Weight of the patient to allow for the calculation of Body Mass Index (BMI) and dosage of emergency medications;

(2) American Society of Anesthesiology (ASA) Classification;

(3) NPO status;

(4) Dental Procedure(s);

(5) Time anesthesia commenced and ended;

(6) Parenteral access site and method, if utilized;

(7) Medication(s) administered- medication (including oxygen), dosage, route, and time given;

(8) Vital signs before and after anesthesia is utilized, to include heart rate, blood pressure, respiratory rate and oxygen saturation for all patients, and to include temperature for pediatric patients;

(9) Intravenous fluids, if utilized;

(10) Response to anesthesia, including any complications; and

(11) Condition of patient at discharge.

3. In addition, for administration of minimal sedation (pediatric only), moderate sedation, deep sedation or general anesthesia-

a. Airway assessment (day of procedure for pediatric patients); and

b. Anesthesia record, which includes:

(1) At least every five minutes- oxygen saturation (SpO2), blood pressure, and heart rate.

(2) At least every fifteen minutes- respiratory rate.

(3) At least every fifteen minutes- electrocardiograph (ECG) rhythm for the administration of deep sedation/general anesthesia.

(4) At least every fifteen minutes- electrocardiograph (ECG) rhythm for the administration of moderate sedation, if clinically indicated by patient history, medical condition(s), or age.

(5) At least every fifteen minutes- ventilatory status (spontaneous, assisted, controlled) for the administration of general anesthesia to a patient with an advanced airway in place (e.g. endotracheal tube or laryngeal mask airway).

(6) At least every fifteen minutes- temperature for the administration of volatile anesthesia gases or medications which are known triggers of Malignant Hyperthermia (MH); otherwise the ability to measure temperature should be readily available.

P. Patient Monitoring- Shall include, but is not limited to the following for the administration of:

1. Local Anesthesia and Analgesia- General state of the patient.

2. Minimal Sedation

a. Continuous heart rate and respiratory rate;

b. Continuous oxygen saturation (SpO2);

c. Pre and post procedure blood pressure; and

d. Level of anesthesia on the continuum.

3. Moderate Sedation

a. Continuous heart rate, respiratory rate, and oxygen saturation;

b. Intermittent blood pressure every five minutes or more frequently;

c. Continuous electrocardiograph, if clinically indicated by patient history, medical condition(s), or age;

d. End-tidal carbon dioxide monitoring (capnography) by July 1, 2016; and

e. Level of anesthesia on the continuum.

4. Deep Sedation or General Anesthesia-

a. Continuous heart rate, respiratory rate, and oxygen saturation;

b. Continuous ventilatory status (spontaneous, assisted, controlled) for the administration of general anesthesia to a patient with an advanced airway in place (e.g. endotracheal tube or laryngeal mask airway);

c. Intermittent blood pressure every five minutes or more frequently;

d. Continuous electrocardiograph;

e. Continuous temperature for the administration of volatile anesthesia gases or medications which are known triggers of Malignant Hyperthermia (MH); otherwise the ability to measure temperature should be readily available;

f. End-tidal carbon dioxide monitoring (capnography) by July 1, 2016; and

g. Level of anesthesia on the continuum.

5. When the level of cooperation in the pediatric or special needs patient does not reasonably allow for full compliance with some monitoring requirements, the treating dentist shall use professional judgment and shall document available monitoring parameters to the best of his/her ability.

Q. Miscellaneous Requirements

1. Life Support Certification(s)

a. Successful completion and continuous certification of Basic Life Support (BLS) training for health care providers that meets the requirements of Rule 1.6(H) is required for:

(1) All dentists and dental personnel utilizing, administering, or monitoring local anesthesia, analgesia (including nitrous oxide), minimal sedation, moderate sedation, deep sedation, or general anesthesia; and

(2) All dental therapists and dental hygienists utilizing, administering, or monitoring local anesthesia.

b. Additionally, any dentist applying for or maintaining a Moderate Sedation Permit or a Deep Sedation/General Anesthesia Permit must have successfully completed current Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS), as appropriate for the dentist's practice, and maintain continuous certification.

c. Successful completion of PALS training and continuous certification is required for a dentist that applies for and/or maintains a Pediatric Designation.

2. Personnel

a. Minimal/Moderate Sedation- During the administration of minimal or moderate sedation, the supervising dentist and at least one other individual who is experienced in patient monitoring and documentation must be present.

b. Deep sedation/general anesthesia- During the administration of deep sedation or general anesthesia, the supervising dentist and at least two other individuals, one of whom is experienced in patient monitoring and documentation, must be present.

3. Monitoring and medication administration- The supervising dentist retains full accountability, but delegation to trained dental personnel may occur under:

a. Direct supervision by the dentist when a patient is being monitored; or

b. Direct, continuous, and visual supervision by the dentist when medication, excluding local anesthetic, is being administered to a patient.

4. Discharge- Patient discharge after sedation and/or general anesthesia must be specifically authorized by the anesthesia provider.

R. Additional Requirements for Permits: Demonstration of Continued Competency and Reinstatement of Expired Permits

1. An applicant for a Local Anesthesia Permit, Minimal Sedation Permit, Moderate Sedation Permit, or a Deep Sedation/General Anesthesia Permit shall demonstrate to the Board that he/she has maintained the professional ability and knowledge required to perform anesthesia when the applicant has not completed a residency program or the coursework set forth in this Rule 1.14 within the past five years immediately preceding the application. The applicant may demonstrate competency as follows:

a. Submit proof satisfactory to the Board that he/she has engaged in the level of administration of anesthesia within generally accepted standards of dental, dental therapy, or dental hygiene practice and in compliance with sections (O) and (P) of this Rule at or above the level for which the applicant is pursuing a permit for at least one of the five years immediately preceding the application; or

b. Submit proof satisfactory to the Board of an evaluation, completed within one year preceding the application by a person or entity approved by the Board that certifies the applicant's ability to administer anesthesia within generally accepted standards of dental, dental therapy, or dental hygiene practice and in compliance with sections (O) and (P) of this Rule at or above the level for which he/she is requesting a permit. The proposed procedure for the evaluation and the proposed evaluating person or entity must be submitted and be pre-approved by the Board.

2. If a dentist allows his/her Colorado dental license to expire then his/her Minimal Sedation Permit, Moderate Sedation Permit, or Deep Sedation/General Anesthesia Permit shall also expire. The dentist may apply for reinstatement of his/her Minimal Sedation Permit, Moderate Sedation Permit, or Deep Sedation/General Anesthesia Permit simultaneously with or subsequent to application for reinstatement of licensure.

3. If a dental therapist or a dental hygienist allows his/her Colorado license to expire then his/her Local Anesthesia Permit shall also expire. The dental therapist or dental hygienist may apply for reinstatement of his/her Local Anesthesia Permit simultaneously with or subsequent to application for reinstatement of licensure.

4. If a dentist, dental therapist or dental hygienist has not had a permit within the two years immediately preceding an application for reinstatement of his/her permit, he/she shall demonstrate to the Board the same competency requirements set forth in section (R)(1) of this Rule.

5. Effective March 1, 2016, a dentist renewing his/her permit is required to complete seventeen hours of Board-approved continuing education credits specific to anesthesia or sedation administration during the five-year permit renewal period as a condition of renewing it.

a. These credits may also be applied to the thirty continuing education hours required every two years as part of licensure renewal. However, they may only apply to the license renewal period in which they were earned and cannot be re-applied towards a subsequent license renewal period.

b. A dentist permitted to administer either minimal sedation, moderate sedation, or deep sedation/general anesthesia may not apply time spent maintaining current BLS, ACLS, or PALS towards this requirement.

c. Board-approved continuing education credits in anesthesia or sedation administration are limited to any course or program recognized by the (or successor organization):

(1) American Dental Association (ADA) Continuing Education Recognition Program (CERP);

(2) Academy of General Dentistry (AGD) Program Approval for Continuing Education (PACE);

(3) American Medical Association (AMA); or

(4) Commission on Dental Accreditation (CODA) accredited institution.

S. Anesthesia Morbidity/Mortality Reporting Requirements- A complete written report shall be submitted to the Board by the anesthetizing dentist or dental therapist/dental hygienist and his/her supervising dentist, or the dentist contracting with an anesthesia provider that is not subject to the rules and regulations of the Colorado Dental Board in order to anesthetize patients in his/her dental office within fifteen days of any anesthesia related incident resulting in morbidity to a patient requiring hospital admission or patient mortality. A morbidity or mortality report shall include:

1. The complete anesthesia record for the patient at issue;

2. The anesthetizing dentist's, dental therapist's or dental hygienist's narrative of all events, or a narrative of all events provided by the dentist contracting with an anesthesia provider that is not subject to the rules and regulations of the Colorado Dental Board; and

3. All records related to the incident.

T. Effect of Pediatric Designation Requirements

1. Any dentist whose Board-issued permit to perform deep sedation/general anesthesia is active on June 30, 2015, may elect to automatically obtain a Pediatric Designation on his/her permit.

2. Any dentist whose Board-issued permit to perform moderate sedation is active on June 30, 2015, may elect to automatically obtain a Pediatric Designation on his/her permit for one year. In order to continue or regain that designation, he/she will be required to apply for and obtain a Pediatric Designation in accordance with section (J)(4) of this Rule.

3. Any dentist whose Board-issued permit to perform minimal sedation is active on June 30, 2015, may elect to automatically obtain a Pediatric Designation on his/her permit for one year. In order to continue or regain that designation, he/she will be required to apply for and obtain a Pediatric Designation in accordance with section (I)(5) of this Rule.

U. Board Reserved Rights

1. Dentists, dental therapists or dental hygienists utilizing anesthesia that requires a permit shall be responsible for practicing within generally accepted standards of dental, dental therapy, or dental hygiene practice in administering anesthesia and complying with the terms of this Rule, pursuant to section 12-220-201(1), C.R.S.

2. Dentists, dental therapists or dental hygienists utilizing anesthesia that requires a permit, under this Rule without first obtaining the required permit, or utilizing such anesthesia with an expired permit, may be disciplined pursuant to section 12-220-201(1)(cc) and (ll), C.R.S.

3. Upon a specific finding of a violation of this Rule, and/or upon reasonable cause, the Board may require a supervising dentist to submit proof demonstrating that applicable staff has the appropriate education/training in order to administer nitrous oxide/oxygen and/or are otherwise acting in compliance with this Rule.

4. The Board may discipline a license or deny an application for a violation of this Rule, unprofessional conduct, and/or any other grounds pursuant to section 12-220-201(1), C.R.S.

5. In addition to the remedies set forth above, nothing in this Rule shall limit the authority of the Board, upon objective and reasonable grounds, to order summary suspension of an anesthesia permit pursuant to section 24-4-104(4), C.R.S.

6. In addition to the remedies set forth above, nothing in this Rule shall limit the authority of the Board, upon objective and reasonable grounds, to order summary suspension of a license to practice dentistry, dental therapy or dental hygiene, pursuant to section 24-4-104(4), C.R.S.

7. Upon review of a morbidity/mortality report and/or upon reasonable concern regarding the use of anesthesia, the Board may require an on-site inspection of the dental office utilized by the anesthesia provider in administering anesthesia.

8. The Board reserves all other powers and authorities set forth in the Dental Practice Act, Article 220 of Title 12, C.R.S. and the Administrative Procedure Act, Article 4 of Title 24, C.R.S.

3 CCR 709-1.14

Amended February 1, 1998, August 1, 2000; August 11, 2004; October 27, 2004; October 26, 2006; July 9, 2009, Effective December 31, 2006; Amended January 21, 2010, Effective March 30, 2010; Amended April 30, 2015, Effective June 30, 2015; Amended April 28, 2016, Effective June 30, 2016

38 CR 04, February 25, 2015, effective 3/30/2015

38 CR 11, June 10, 2015, effective 6/30/2015

39 CR 04, February 25, 2016, effective 3/16/2016

39 CR 10, May 25, 2016, effective 6/30/2016

39 CR 16, August 25, 2016, effective 9/14/2016

41 CR 04, February 25, 2018, effective 3/17/2018

41 CR 11, June 10, 2018, effective 7/3/2018

41 CR 14, July 25, 2018, effective 8/14/2018

42 CR 11, June 10, 2019, effective 6/30/2019

42 CR 23, December 10, 2019, effective 1/1/2020

44 CR 11, June 10, 2021, effective 6/30/2021

44 CR 16, August 25, 2021, effective 9/14/2021

44 CR 23, December 10, 2021, effective 12/30/2021

45 CR 21, November 10, 2022, effective 10/4/2022

45 CR 23, December 10, 2022, effective 12/10/2022

45 CR 23, December 10, 2022, effective 12/30/2022