02-313-14 Me. Code R. § V

Current through 2024-51, December 18, 2024

Section 313-14-V - DENTIST RESPONSIBILITIES

A dentist providing sedation services or an operating dentist utilizing the services of a sedation provider as outlined in this chapter must comply with the following:

A.Patient Recovery. The operating dentist must ensure that the sedation provider remains at the location where services were provided until any patient given moderate or deep sedation/general anesthesia has been assessed for discharge in accordance with this chapter and the ADA Sedation guidelines. Patient assessment and discharge information such as level of consciousness, oxygenation, ventilation, and circulation must be documented in each patient record.

B.Levels of Anesthesia. The dentist, the operating dentist and the sedation provider must be prepared to manage deeper than intended levels of anesthesia. If a patient enters a deeper level of sedation than the provider is qualified to provide, then the dental procedure must stop until the patient returns to the intended level of sedation.

C.Equipment Required When Administering Minimal Sedation, Moderate Sedation, Deep Sedation and/or General Anesthesia. The dentist or operating dentist must ensure that that following requirements are met as it relates to the delivery of sedation:

(1) A dentist whose practice includes the administration of minimal sedation must provide the following equipment, which is required to be functional at all times:

a. Emergency equipment, including:

i. An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up.

ii. Oral and nasopharyngeal airway device.

iii. Appropriate emergency medications.

iv. An external defibrillator - manual or automatic.

v. Broselow pediatric measuring tape

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

i. A continuous pulse oximeter.

ii. 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) A dentist or operating dentist whose practice includes the administration of moderate sedation must provide the following equipment, which is required to be functional at all times:

a. Emergency equipment, including:

i. An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up.

ii. Oral and nasopharyngeal airway device.

iii. Appropriate emergency medications.

iv. An external defibrillator - manual or automatic.

v. ACLS algorithms card

vi. Broselow pediatric measuring tape.

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

i. A continuous pulse oximeter.

ii. 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. Equipment necessary to establish intravenous (IV), intraosseous (IO), or sublingual (SL) access.

g. Electrocardiograph if providing sedation services to patients with American Society of Anesthesiologists Physical Status Classification of ASA III or higher.

h. Ventilation monitoring system (e.g. color CO2, auscultation of breath sounds). Permit holders are required to obtain and use an end-tidal carbon dioxide monitor (capnography).

(3) A dentist or operating dentist whose practice includes the administration of deep sedation and/or general anesthesia must provide the following and equipment, which is required to be functional at all times:

a. Emergency equipment, including:

i. An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up.

ii. Oral and nasopharyngeal airways.

iii. Appropriate emergency medications.

iv. An external defibrillator - manual or automatic.

v. ACLS algorithms card

vi. Broselow pediatric measureing tape.

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

i. A continuous pulse oximeter.

ii. 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. Equipment necessary to establish intravenous (IV), intraosseous (IO) or sublingual (SL) access.

g. Electrocardiograph.

h. Ventilation monitoring system (e.g. color CO2, auscultation of breath sounds). Permit holders are required to obtain and use an end-tidal carbon dioxide monitor (capnography).

i. Additional emergency equipment to manage difficult airways, including:

i. Laryngeal mask airway, and/or endotracheal tubes and/or a LMA suitable for patients being treated.

ii. Laryngoscope with reserve batteries and bulbs.

iii. Endotracheal tube forceps (e.g. Magill).

iv. At least one additional airway management device.

v. Equipment to establish surgical airway

(4)Emergency Protocols: A dentist or operating dentist whose practice includes the use of moderate sedation or general anesthesia must have written emergency protocols, and must provide training at least annually to familiarize office personnel in the treatment of the following clinical emergencies:

a. Laryngospasm.

b. Bronchospasm.

c. Emesis and aspiration.

d. Airway blockage by foreign body.

e. Angina pectoris.

f. Myocardial infarction.

g. Hypertension/Hypotension.

h. Allergic and toxicity reactions.

i. Seizures.

j. Syncope.

k. Intra-arterial injection.

l. Hyperventilation/Hypoventilation.

m. Cardiac arrest.

n. Cardiac arrhythmias.

A dentist or operating dentist must maintain for inspection a permanent record, which reflects the date, time, duration, names of attendees, and type of emergency protocol training provided.

D.Drugs. A dentist or operating dentist must have the following drugs and/or categories of drugs with a current shelf life easily accessible from the operatory and recovery room when providing the services below:

(1)Moderate Sedation Services

a.Level I (Enteral)

i.Cardiac Drugs

1. Vasopressor (e.g. Epinephrine)

2. Nitroglycerin (spray or tablets)

3. Anticoagulant (aspirin)

4. Glucose (D50 or liquid glucose)

ii.Reversal Agents (required only for administration of benzodiazepines or narcotics)

1. Flumazenil (benzodiazepine reversal agent)

2. Narcan (narcotic reversal agent)

iii.Other

1. Antihistamine (e.g. Benadryl IV or PO)

2. Bronchodilator (e.g. Albuterol inhaler)

b.Level II (Parenteral)

i.Cardiac Drugs

1. Vasopressor (e.g. Epinephrine)

2. Nitroglycerin (spray or tablets)

3. Anticoagulant (aspirin)

4. Glucose (D50 or liquid glucose)

5. Lidocaine

6. Atropine

7. Adenosine

8. Diltiazem

9. Beta Blocker (e.g. Labetalol, Esmolol)

ii.Reversal Agents (required only for administration of benzodiazepines, narcotics, or triggering agents of malignant hypothermia)

1. Flumazenil (benzodiazepine reversal agent)

2. Narcan (narcotic reversal agent)

3. Dantrolene, Ryanodex (volatile gas reversal agent)

iii.Other

1. Antihistamine (e.g. Benadryl IV or PO)

2. Bronchodilator (e.g. Albuterol inhaler)

3. Corticosteroid (e.g. Solu-Medrol)

4. Muscle Relaxant (e.g. Succinylcholine)

5. Narcotics (e.g. morphine, fentanyl)

6. Antihypertensive drugs (e.g. Propranolol, Verapamil)

(2)Deep Sedation and/or General Anesthesia Services

a.Cardiac Drugs

i. Vasopressor (e.g. Epinephrine)

ii. Nitroglycerin (spray or tablets)

iii. Anticoagulant (aspirin)

iv. Glucose (D50 or liquid glucose)

v. Lidocaine

vi. Atropine

vii. Adenosine

viii. Diltiazem

ix. Beta Blocker (e.g. Labetalol, Esmolol)

b.Reversal Agents (required only for administration of benzodiazepines, narcotics, or triggering agents of malignant hypothermia)

i. Flumazenil (benzodiazepine reversal agent)

ii. Narcan (narcotic reversal agent)

iii. Dantrolene, Ryanodex (volatile gas reversal agent)

c.Other

i. Antihistamine (e.g. Benadryl IV or PO)

ii. Bronchodilator (e.g. Albuterol inhaler)

iii. Corticosteroid (e.g. Solu-Medrol)

iv. Muscle Relaxant (e.g. Succinylcholine)

v. Narcotics (e.g. morphine, fentanyl)

vi. Antihypertensive drugs (e.g. Propranolol, Verapamil)

E.Anesthesia Gas Delivery Systems - must include all of the following:

(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) Inhalation equipment with an appropriate scavenging system.

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

(6) Engineering controls and maintenance procedures to ensure safety of inhalation equipment.

F.Patient Documentation - must include, but is not limited to, all of the following:

(1) For administration of minimal sedation, moderate sedation, deep sedation or general anesthesia -

a. Medical History - current and comprehensive.

b. Height and Weight.

c. American Society of Anesthesiology (ASA) Classification.

d. Dental Procedure(s).

e. Informed Consent.

f. Time oriented anesthesia record, which includes:

i. Parenteral access site and method, if utilized.

ii. Medication(s) administered - medication (including oxygen), dosage, route, and time given.

iii. Vital signs before and after anesthesia is utilized.

iv. Intravenous fluids, if utilized.

v. Response to anesthesia - including any complications

g. Condition of patient at discharge charted with objective data or scale such as the Modified Aldrete scoring system.

(2) In addition, for administration of moderate sedation, deep sedation or general anesthesia -

a. Physical examination - airway assessment, baseline heart rate, blood pressure, respiratory rate, and oxygen saturation;

b. Time oriented anesthesia record, which includes:

i. Time anesthesia commenced and ended.

ii. At least every 5 minutes record blood pressure, heart rate, oxygen saturation (SpO2), and respiratory rate.

iii. Continuous electrocardiograph (ECG) and documentation of changes in rhythm, if clinically indicated by patient history, medical condition(s), or age.

G.Patient Monitoring - Must include, but is not limited to the following:

(1) For the administration of Minimal Sedation -

a. Continuous heart rate and respiratory status;

b. Continuous oxygen saturation (SpO2); and

c. Pre and post procedure blood pressure.

(2) For the administrationof Moderate Sedation -

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

b. Intermittent blood pressure, taken at least every 5 minutes;

c. Continuous electrocardiograph of patients with significant cardiovascular disease;

d. End-tidal carbon dioxide monitoring (capnography); and

e. Continuous monitoring of level of consciousness

(3) For the administration of Deep Sedation or General Anesthesia -

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

b. Intermittent blood pressure, taken at least every 5 minutes;

c. Continuous electrocardiograph;

d. End-tidal carbon dioxide monitoring (capnography); and

e. Continuous monitoring of level of consciousness

(4) When the level of cooperation in a pediatric or special needs patient does not reasonably allow for full compliance with some monitoring requirements, the dentist must use professional judgment regarding monitoring and must document the reasons preventing the recommended management.

H.Miscellaneous Requirements

(1)Life Support Certification(s)

a. Dentists must ensure that all dental personnel successfully complete Basic Life Support for Healthcare Providers (BLS) certification and maintain current BLS certification when utilizing, administering, or monitoring local anesthesia, nitrous oxide analgesia, minimal sedation, moderate sedation, deep sedation, or general anesthesia.

b. Any dentist who files an application under this chapter for either a permit or a 14 Day Notification to utilize the services of a sedation provider must obtain and maintain life support certification in BLS and advanced life support certification in Advanced Cardiac Life Support (ACLS). Advanced life support certification in Pediatric Advanced Life Support (PALS) is required when providing sedation services to pediatric patients and may be used in meeting the ACLS advanced life support certification requirements of this chapter.

c. Online life support certification training and online advanced life support certification training are not accepted unless hands-on participation with the instructor as a component of the training is verified.

(2)Personnel

a.Minimal/Moderate Sedation - When providing minimal or moderate sedation at a dental practice location, the operating dentist and at least one other individual who is experienced in patient monitoring and documentation, and trained to handle emergency situations must be present.

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

(3)Monitoring and medication administration - The dentist retains full accountability, but delegation as authorized by the Maine Dental Practice Act to 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 dentist or sedation provider.

02-313 C.M.R. ch. 14, § V