STANDARD 13: Moderate Sedation

13.1 General 

1. Dental organizations that furnish moderate sedation shall comply with all requirements of AACI International Accreditation Standard for Dental Organizations.

2. If the dental organization provides moderate sedation, it shall be provided in a well-organized manner under the direction of a qualified Doctor of Dental Medicine, Doctor of Dental Surgery, or similarly educated, trained, and qualified LIP.

3. Policy, procedures, and personnel associated with sedation duties shall be consistent with and perform in concert with national law and recognized national/international standards of care.

Where any standards are in conflict with AACI requirements, the most stringent shall be in force.

4. All dentists who perform conscious sedation shall have an unexpired sedation permit/license from the relevant national or local authority.

5. The responsible practicing dentist administering moderate sedation shall meet at least one of the following criteria consistent with national or local law: 

a) completion of a relevant nationally accredited post-doctoral training program which affords comprehensive training necessary to administer and manage moderate sedation, or

b) completion of a defined course consistent with requirements of national law or local authority.

6. The practicing dentist shall successfully complete an ACLS (or similar) course within the 12 months prior to the date of accreditation survey.

7. The practicing dentist shall complete at least 6 hours annual continuing education at least in one or possibly more of the following areas: 

a) pediatric or adult sedation; 

b) airway management; 

c) monitoring sedation and the use of monitoring equipment; 

d) pharmacology of drugs and agents used in sedation; 

e) physical diagnosis and evaluation;

f) patient safety and risk assessment; 

g) behavioral management; 

h) other relevant sedation topics.

8. The practicing dentist or managing director shall ensure that BLS certification for the required number of assisting personnel shall be maintained and current in keeping with national law.

9. Personnel assisting in the delivery moderate sedation shall obtain at least 3 hours of sedation related continuing education annually in relevant topics. This requirement is in addition to BLS qualification requirements.

10. The practicing dentist or managing director shall maintain a record of the credentialing, educational, and regulatory requirements of Section A1 as documented information.

13.2 Procedures and Protocols

 1. The practicing dentist or managing director shall establish, maintain, review, and continually update the following operational procedures, manuals or protocols for use and guidance in the provision of moderate sedation: 

a) pre-sedation, fasting, and medication instructions for the patient;

b) intraoperative moderate sedation procedures for monitoring, medication use, and patient record requirements; 

c) recovery and post-sedation protocols; 

d) discharge procedures and instructions for the patient and vested adult; 

e) rescue protocols including establishment of a liaison with a local healthcare facility for consultation and emergency patient referral;

f) other management procedures as needed.

2. The practicing dentist shall document and ensure that all assisting sedation personnel have read and understand the above protocols at least yearly. Remedial and/or review of updated protocols shall be required as indicated.

13.3 Equipment 

1. The dental organization furnishing moderate sedation shall be equipped with at least the following: 

a) a procedure area of size and design to permit access of emergency equipment and personnel, as well as accommodate reasonable delivery of emergency treatment; 

b) a cardiopulmonary resuscitation (CPR) board or a dental chair without enhancements, suitable for patient access to provide emergency treatment;

c) lighting as necessary to provide emergency equipment; 

d) suction equipment including tonsillar and catheter suction devices; 

e) non-electrical back-up suction;

f) a positive pressure oxygen delivery system, including full face masks for small, medium, and large patients and, back-up E-cylinder portable oxygen tank apart from an existing central system; 

g) when N2 O inhalation equipment is used, a fail-safe system that is appropriately checked and calibrated. The equipment shall 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 alarm; 

h) an appropriate scavenging system if gases other than oxygen or air are used; i) small, medium, and large oral and nasal airways;

j) a blood pressure monitoring device; 

k) an EKG monitor with pads; 

l) a pulse oximeter; 

m) an automatic external defibrillator (AED) with pads; 

n) a precordial stethoscope; 

o) a capnograph if applicable;

p) a thermometer; 

q) a vascular access set-up as necessary for specific procedures, including hardware and fluids; 

r) a laryngoscope with working batteries and appropriate blades; 

s) intubation tubes, including Magill or similar forceps;

t) syringes as necessary; 

u) IV fluids, solution administration sets, and catheters in adequate numbers; 

v) tourniquet and tape.

2. Compliance documentation with manufacturers’ recommended maintenance and completion of calibration requirements of monitors, sedation delivery systems, and other related equipment shall be maintained.

13.4 Medication Requirements 

1. The appropriate quantity of the resuscitative medications included by ACLS directives shall be maintained in unexpired condition. These may include but are not limited to: 

a) epinephrine, and/or similar α / β adrenergic agents as required; 

b) atropine; 

c) antiarrhythmics as necessary (adenosine, amiodorone, lidocaine, similar depending on individual patient anticipated needs); 

d) antihistamine/antiemetic; 

e) antihypertensive; 

f) bronchodilator; 

g) corticosteroid; 

h) anticonvulsant; 

i) muscle relaxant;

j) appropriate sedation reversal agents; 

k) nitroglycerine; 

l) dextrose.

2. These and other medications shall be stored as per the requirements of standard 12. They shall be easily available at the point of need in the procedure and recovery area.

NOTE 1 An easily available “crash cart” fully stocked and supplied as per standard of care, or consistent with ACLS requirements is recommended.

3. These medications shall be inspected frequently to assure currency and that the intended stock levels are present.

13.5 Records 

1. The dentist shall establish and maintain the records required by national law and standard 15. The following additional record shall be required: 

a) patient's current written medical history including a past medical history, a review of systems noting relevant co-morbidities, medications, allergies, and overall patient physical status; 

b) an evaluation and approval of the patient by a physician when significant debilitating comorbidities exist; 

c) stated reason(s) for sedation; 

d) an informed consent consistent with the requirements of standard 9.2.; 

e) the identification and role of all personnel involved in the sedation procedure;

 f) the identity of the required vested adult; 

g) an operative record of the procedure as required by standard 15; 

h) records of the sedation process as noted in 13.5.2 and 13.5.3 below; 

i) a record confirming that discharge instructions, medications, and a contact for emergency care were given verbally and in writing to the patient and vested adult; 

j) a record shall confirm that all patient and vested adult questions were answered to their satisfaction; 

k) other special or individual pertinent information as required by standard of care.

2. A sedation record shall be maintained by a competent, licensed, and qualified individual.

This sedation record shall include: 

a) identification and role of all personnel involved in the sedation procedure; 

b) date, time, and duration of the procedure; 

c) gauge of needle and location of IV on the patient, if used; 

d) all drugs administered during the procedure including route of administration, dosage, strength, time, and sequence of administration; 

e) immediate patient response to medications given; 

f) base line and five-minute interval record of: i. level of consciousness (i.e.RASS or similar scale indicating the patient level of consciousness to be consistent with moderate sedation i.e., RASS scale not less than -3); ii.temperature; iii.blood pressure (unless patient behavior prevents recording); iv.pulse; v.respiratory rate; vi.oxygen saturation; vii.end tidal CO2 if capnography is utilized.

NOTE 1 For further reference on levels of consciousness please see the RASS, GLASGOW COMA, or similar scale:

 a) https://www.mdcalc.com/richmond-agitation-sedation-scale-rass b) https://www.mnhospitals.org/Portals/0/Documents/ptsafety/LEAPT%20Delirium/RASS%20 Sedation%20Assessment%20Tool.pdf c) https://www.cdc.gov/masstrauma/resources/gcs.pdf

3.On completion of the procedure, an immediate post-sedation summary describing the patient’s condition and their procedure tolerance shall be made. It shall document: 

a) ending level of consciousness (RASS or similar); 

b) vital signs; 

c) pain level;

d) nausea and/or vomiting; 

e) fluids given if any; 

f) other pertinent data as necessary.

13.6 Delivery of Moderate Sedation 

1. Prior to delivery of sedation and related dental care, the practicing dentist shall: 

a) review all records relating to the anticipated procedure, including the patient history, allergies, medications, and co-morbidities; 

b) confirm a satisfactory physical and mental status of the patient; 

c) review the related pre-sedation medication and fasting compliance; 

d) confirm the appropriate consent requirements are met and questions answered as required 

e) perform a “time-out” to review and confirm all aspects of the proposed sedation and procedure with all involved personnel; 

f) perform a check of all equipment for proper function; 

g) confirm all emergency supplies are adequately in order; 

h) review and plan any needed mitigation in the interest of patient safety.

2. During the procedure, the practicing dentist shall: 

a) maintain constant observation of the patient’s vital signs and level of consciousness throughout the procedure by communicating with the patient and the monitoring assistant; 

b) if the patient’s level of consciousness falls below the definition of conscious sedation noted above (RASS scale less than -3), the procedure shall be discontinued, and resuscitation/rescue shall be promptly initiated and continued until the level of consciousness returns to satisfactory levels (see NOTE 1 below); 

c) remain immediately available to the patient during the procedure and recovery stages.

3. After the procedure, the practicing dentist shall: 

a) complete an operative summary as required by this standard and national law; 

b) complete a post-sedation record noted in 13.5.3 above; 

c) assess the patient in recovery, and again prior to discharge.

4. At discharge the practicing dentist shall: a) Confer with the patient and vested adult to provide discharge instructions for meds and follow-up as noted in 13.5.1.; b) complete all procedural records as per established protocol, national or local law, and the regulation of this standard noted in 13.5.1,2,3 above. 

13.7 Quality Monitoring 

1.When complications of moderate sedation occur, these shall be documented and retained as documented information in accordance with standard 15.1.3. Complications can include but are not limited to: a) patient behavior; b) adverse drug reaction; c) over sedation; d) other unexpected untoward events as deemed necessary by the dental organization.

2. In such cases, the patient records shall be identified as non-conforming. They shall be analyzed for root cause, and the resulting aggregate data shall be reviewed. Corrections and/or corrective actions shall be made to prevent, reduce, or mitigate future occurrence.

3. The results of these corrections and/or corrective actions shall be monitored and measured to ensure that the desired outcomes are achieved.

4. Relevant sedation information shall be reported regularly to the dental organization quality management system as needed, or at least annually.

5. These records shall be maintained and retained as documented information in accordance with standard 15.1.3.