Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

CLINICAL ON-SITE INSPECTION INSTRUCTIONS APPLICANT: If you are applying for your first Moderate Sedation Permit or reinstating an expired one, you must be issued an Inspection Permit by the Colorado Dental Board (the “Board”) before continuing to the next step in the application process after successfully demonstrating appropriate education/training/experience at the moderate sedation level. If you received a Board-issued Inspection Permit, then you are eligible to proceed with your clinical on-site inspection. Your Inspection Permit is only effective for 90 days, and unless otherwise authorized by the Board, the clinical on-site inspection must take place within those 90 days. Your Inspection Permit may only be utilized for purposes of completing the Board-approved clinical on-site inspection. You must then successfully complete it as a condition of obtaining a Moderate Sedation Permit before you may begin administering moderate sedation to patients in this state. If you are renewing your Moderate Sedation Permit, then an Inspection Permit is not required to be inspected. Provide these instructions, the attached Inspector Report Form, and a current copy of Board Rule XIV (available at www.colorado.gov/dora/Dental_Board) to the authorized person performing the clinical on-site anesthesia inspection (Inspector). Pursuant to Board Rule XIV(L)(9), the Inspector must 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 Dentist issued a Deep Sedation/General Anesthesia Permit. If you are renewing a Moderate Sedation Permit, then you have the option of using a Board-approved Colorado licensed dentist issued a Moderate Sedation Permit to perform the clinical on-site inspection.

The Inspector must also have actively and consistently administered general anesthesia, deep sedation, and/or moderate sedation for the last three years in the state of Colorado. INSPECTOR: Pursuant to Board Rule XIV(L)(10), you shall not have an unethical agreement or conflict of interest with the applicant. This means that you cannot have a vested interest in the outcome of the inspection and must be able to maintain complete impartiality throughout the process. Further, the applicant must be an actively licensed dentist in Colorado. PURPOSE: To ensure the applicant has equipment, records, and emergency medications in compliance with sections M, N, O, and P of Rule XIV; is performing surgical and anesthetic techniques that are within the standard of care by observing at least one case while the applicant administers anesthesia at the moderate sedation level; and that his/her team knows how to provide moderate sedation in a safe manner and are prepared to adequately manage anesthesia related emergencies. PEDIATRIC DESIGNATION: Any applicant requesting a Pediatric Designation on his/her anesthesia permit is required to have at least one pediatric case (under 12 years old) observed at a moderate sedation level as part of his/her inspection if he/she is eligible for a Moderate Sedation Permit through completion of either of the following: -

Pediatric specialty training program, or Combination of acceptable pediatric education (30 hours) and experience (10 pediatric cases).

PAYMENT: Pursuant to Board Rule XIV(L)(7), the Inspector may charge the applicant a reasonable fee up to $500, plus actual travel expenses for lodging, meals, and mileage for each clinical on-site inspection performed. The applicant is responsible for paying all fees associated with the inspection. MULTIPLE LOCATIONS: Only one dental office is required to be part of the clinical on-site inspection. A separate clinical on-site inspection is not required if the applicant plans to travel to other dental office locations to administer anesthesia once issued a Moderate Sedation Permit. However, it is the applicant’s responsibility to ensure that each dental office where he/she administers moderate sedation meets the requirements of Rule XIV once he/she is issued a permit. HOSPITAL SETTING: A clinical on-site inspection is not required if the applicant is only administering moderate sedation in a hospital setting. MOBILE OR PORTABLE FACILITY: In the case of an applicant who plans to practice exclusively from a mobile or portable facility, a clinical on-site inspection must be conducted in the office of a Colorado licensed dentist. A written list of all monitors, emergency equipment, and other materials which the applicant agrees to have available at all times while administering in multiple locations must be provided to the Inspector, who in turn will provide it with his/her Inspection Report Form to the Board. Applicant: Keep this page for your records.

07/2017

Clinical On-site Inspection for Dentists Administering Moderate Sedation

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board INSPECTOR CHECKLIST

Review Rule XIV prior to conducting the clinical on-site anesthesia inspection. You must assure that the applicant is using medications and dosages that are commonly accepted to induce an appropriate level of moderate sedation. An adequate pre-operative evaluation and anesthesia record must also be present. Conduct the inspection of the dental office in compliance with Board Rule XIV. The inspection shall consist of the following four parts: PART I

Review of the office equipment, records, and emergency medications required in sections M, N, O, and P of Rule XIV, specifically the ones associated with the administration of moderate sedation.

PART II

Surgical/Anesthetic Techniques. Observe at least one (1) case while the applicant administers anesthesia at a moderate sedation level. You may require additional cases to observe at your discretion. If the applicant is requesting a Pediatric Designation, then you must observe at least one (1) pediatric case if the applicant’s anesthesia training consists of one of the following (please verify training with the Division staff before proceeding with the inspection if this applies):  

Pediatric specialty training program, or Combination of acceptable pediatric education (30 hours) and experience (10 pediatric cases).

PART III

Simulated Emergencies. The applicant and his/her team must be able to demonstrate their expertise in adequately managing a minimum of eight (8) emergencies.

PART IV

Discussion Period. Make sure the applicant and his/her team knows how to provide moderate sedation in a safe manner.

Offer suggestions to the applicant regarding improvements if you feel they are warranted. Report any concerns you have regarding the applicant’s ability to administer moderate sedation safely to the Board office immediately. Return the completed Inspector Report Form with a copy of the anesthesia record(s) of the case(s) completed as part of the clinical on-site inspection directly to the Board at the address at the top of this page. Please provide a copy to the applicant as well in case he/she is required to submit one to another organization, i.e. a specialty society for purposes of certification or re-certification with them. If you have questions or concerns regarding this inspection process, contact the Colorado Dental Board at [email protected].

Applicant: Keep this page for your records.

07/2017

Clinical On-site Inspection for Dentists Administering Moderate Sedation

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

INSPECTOR REPORT FORM Reason for clinical on-site inspection (check only one): Applying for a Moderate Sedation Permit Renewing a Moderate Sedation Permit Reinstating a Moderate Sedation Permit The applicant plans to practice exclusively from a mobile or portable facility (if Yes, a written list of all monitors, emergency equipment, and other materials which the mobile anesthesia provider agrees to have available at all times YES NO while administering in multiple locations must be submitted with this form). Was a clinical on-site inspection performed for a Pediatric Designation (under 12 years of age)?

YES

NO

APPLICANT Colorado Dentist License Number:

Expiration Date:

First

Name: Last:

Middle:

Suffix:

E-mail Address: (This will be the primary communication method) PO Box, Street:

Mailing Address: This is a

Home

Business

Daytime Telephone Number: (

City, State, Zip:

)

Area of Practice:

Date of Inspection:

INSPECTOR First

Name: Last:

Middle:

Suffix:

E-mail Address: (This will be the primary communication method) PO Box, Street:

Mailing Address: This is a

Home

Business

Daytime Telephone Number: (

City, State, Zip:

)

Clinical On-site Deep Moderate Anesthesia Inspection

07/2017

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

I have confirmed that the applicant required to undergo a clinical on-site inspection has been issued an Inspection Permit by the Colorado Dental Board or is eligible to renew his/her Moderate Sedation Permit (within the three months prior to the expiration date of his/her anesthesia permit or the threemonth grace-period). I swear or affirm that I am a Board-approved Colorado-licensed (check one):

Colorado License Number:

Physician trained in dental outpatient deep sedation/general anesthesia and moderate sedation Certified Registered Nurse Anesthetist (CRNA) trained in dental outpatient deep sedation/general anesthesia and moderate sedation

Expiration Date:

Dentist with an active Deep Sedation/General Sedation Permit Dentist with an active Moderate Sedation Permit (allowable for a Moderate Sedation Permit renewal inspection only) Signature

Clinical On-site Deep Moderate Anesthesia Inspection

Date:

07/2017

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

PART I – REVIEW OF OFFICE EQUIPMENT, RECORDS, AND EMERGENCY MEDICATIONS (See Sections M, N, O, P, and Q of Rule XIV) 1. OFFICE FACILITIES AND EQUIPMENT (REQUIRED). The following office facilities and equipment must be present and functional: a. Emergency equipment and facilities, 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; and iv. An external defibrillator – manual or automatic. b. Equipment to monitor vital signs and oxygenation/ventilation, including: i. A continuous pulse oximeter; and 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. Parenteral access or the ability to gain parenteral access, if clinically indicated. g. Electrocardiograph, if clinically indicated. h. End-tidal carbon dioxide monitor (capnography). 2. ANESTHESIA GAS DELIVERY SYSTEMS (REQUIRED): If present, must include the following: a. Capability to deliver oxygen to a patient under positive pressure, including a back-up oxygen system; b. Gas outlets that meet generally accepted safety standards preventing accidental administration of inappropriate gases or gas mixture; c. Fail-safe mechanisms for inhalation of nitrous oxide analgesia; d. The inhalation equipment must have an appropriate scavenging system if inhalation anesthetics are used; and e. Gas storage facilities, which meet generally accepted safety standards. 3. DOCUMENTATION (REQUIRED): Documentation of the administration of moderate sedation shall include, but not be limited to the following: a. Medical History – current and comprehensive, to include current medications; b. Informed Consent – for the administration of anesthesia; c.

Anesthesia Record, which includes: i. Height and Weight of the patient to allow for the calculation of Body Mass Index (BMI) and dosage of emergency medications; ii. American Society of Anesthesiology (ASA) Classification; iii. NPO status; iv. Dental Procedure(s); v. Time anesthesia commenced and ended; vi. Parenteral access site and method, if utilized; vii. Medication(s) administered – medication (including oxygen), dosage, route, and time given; viii. 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; ix. Intravenous fluids, if utilized (type and amount); x. Response to anesthesia, including any complications; and xi. Condition of patient at discharge.

d. Airway Assessment (day of procedure for pediatric patients); and Clinical On-site Deep Moderate Anesthesia Inspection

07/2017

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

3. DOCUMENTATION (REQUIRED) Continued. e. Anesthesia Record, which includes at least every: i. 5 minutes – oxygen saturation (SpO2), blood pressure, and heart rate. ii. 15 minutes – respiratory rate. iii. 15 minutes – End-tidal carbon dioxide (capnography). Open circuit Closed circuit iv. 15 minutes – electrocardiograph (ECG) rhythm for the administration of moderation sedation, if clinically indicated by patient history, medical condition(s), or age. v. 15 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. 4. PATIENT MONITORING (REQUIRED). Shall include, but is not limited to, the following for the administration of moderate sedation: a. Continuous heart rate, respiratory status, and oxygen saturation; b. Intermittent blood pressure every 5 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); and e. Level of anesthesia on the continuum. 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. 5. MISCELLANEOUS (REQUIRED). a. Does the applicant possess current Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS)? PALS is required if applying for and/or maintaining a Pediatric Designation. (Both ACLS YES NO and PALS are required for dentists who treat both adult and pediatric patients.) b. Do all dental personnel assisting the applicant in the utilization, administration, or monitoring of moderate sedation possess current certification of Basic Life Support (BLS) training for health care providers? YES NO c.

Was at least one (1) other individual present who is experienced in patient monitoring and documentation YES NO during the administration of moderate sedation by the applicant?

Clinical On-site Deep Moderate Anesthesia Inspection

07/2017

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

PART II – SURGICAL/ANESTHETIC TECHNIQUES The applicant must both be the primary provider of the sedation and directly provide dental care for all required case work, unless he/she does not intend to ever function as both the anesthesia provider and the dentist providing dental treatment, i.e. only operating as a dental anesthesiologist.

Did you observe at least one (1) case while the applicant administered moderate sedation?

Yes

Is the applicant requesting a Pediatric Designation, and if so, did you observe at least one (1) case while he/she administered moderate sedation to a pediatric patient (under 12 years old)? Yes

No

No

Did you require additional cases to observe?

Yes No If yes, please explain the reason(s) why:______________________________________________________________ ______________________________________________________________________________________________

PART III – SIMULATED EMERGENCIES The type of emergencies selected should be based on the emergencies likely to be seen in the type of practice in which the applicant and his/her team are engaged in the administration of moderate sedation. List all simulated emergencies the applicant and his/her team demonstrated adequately managing (minimum of 8 required).

1. _______________________________________________________________________________ 2. _______________________________________________________________________________ 3. _______________________________________________________________________________ 4. _______________________________________________________________________________ 5. _______________________________________________________________________________ 6. _______________________________________________________________________________ 7. _______________________________________________________________________________ 8. _______________________________________________________________________________ 9. _______________________________________________________________________________ 10. _______________________________________________________________________________ 11. _______________________________________________________________________________ 12. _______________________________________________________________________________ 13. _______________________________________________________________________________ 14. _______________________________________________________________________________ 15. _______________________________________________________________________________ 16. _______________________________________________________________________________

Clinical On-site Deep Moderate Anesthesia Inspection

07/2017

Division of Professions and Occupations Colorado Dental Board—Anesthesia 1560 Broadway, Suite 1350 Denver, CO 80202 (303) 894-7691 / Fax (303) 894-7764 www.colorado.gov/dora/Dental_Board

Clinical On-site Inspection for Dentists Administering Moderate Sedation

PART IV – DISCUSSION PERIOD Comments or suggestions to improve: ______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

______________________________________________________________________________________________

I state under penalty of perjury in the second degree, as defined in section 18-8-503, C.R.S., that the information contained in this report is true and correct to the best of my knowledge. In accordance with section 18-8501(2)(a)(I), C.R.S., false statements made herein are punishable by law and may constitute a violation of the Dental Practice Act.

______________________________________________________________________ Signature of Inspector

_______________________ Date

Upon completion of the inspection, return the Inspector Report Form to the Board at the following address: Division of Professions and Occupations Colorado Dental Board 1560 Broadway, Suite 1350 Denver, CO 80202 NOTE: The most current version of the Board’s Statutes, Rules and Policies is available online at: www.colorado.gov/dora/Dental_Board. OFFICE USE ONLY: Approved: ____________________________________ Not Approved: ___________________________________ Clinical On-site Deep Moderate Anesthesia Inspection

07/2017