Alabama Administrative Code › Title 270 - BOARD OF DENTAL EXAMINERS OF ALABAMA › Chapter 270-X-2 - DENTISTS › Section 270-X-2-.17 - Criteria For On-Site Inspection For The Use Of General Anesthesia And Parenteral Sedation/Moderate Sedation

Current through Register Vol. 42, No. 9, June 28, 2024
(1) This rule contains the procedures,
			 criteria, and information mandatory for the clinical administration of general
			 anesthesia and parenteral/moderate sedation. These shall be used by the
			 inspecting team in determining whether a dentist's facilities, equipment, and
			 personnel have satisfied the requirements imposed by law and this rule for the
			 issuance of a general anesthesia or a parenteral/moderate sedation permit.
(a) Clinical Use of General Anesthesia and/or
			 Parenteral/Moderate Sedation. Two (2) procedures utilizing general anesthesia
			 and/or parenteral/moderate sedation shall be observed. This portion of the
			 evaluation shall not exceed two (2) hours. No evaluation can be considered
			 complete unless this part is included.
(b) Simulated Emergencies.
1. The examiners will simulate the emergency
			 situations/techniques listed below. The permittee and office staff should be
			 competent in managing all of these:
(i)
			 Laryngospasm
(ii)
			 Bronchospasm
(iii) Emesis and
			 aspiration of vomitus
(iv)
			 Management of foreign bodies in the airway
(v) Angina pectoris
(vi) Myocardial infarction
(vii) Cardiopulmonary resuscitation
(viii) Hypotension
(ix) Hypertensive crisis
(x) Acute allergic reaction
(xi) Hyperventilation syndrome
(xii) Convulsion of unknown
			 etiology
(xiii) Syncope
(c) Office Equipment,
			 Records, and Emergency Medications.
1. All
			 office equipment and records related to patient care should be available for
			 inspection by the examiners.
2.
			 Specific attention shall be directed to the following areas:
(i) The oxygen and supplement gas-delivery
			 system; backup system
(ii)
			 Provision for suction and backup system
(iii) Auxiliary lighting system
(iv) The gas storage facilities
(v) Suitability of the operatory
(vi) Patient transportation equipment (if
			 used)
(vii) Recovery area
(viii) Sterilization areas
(ix) Preparation of medications
(x) Completeness of emergency anesthetic
			 equipment and medications
(xi)
			 Completeness of office patient-care records
(xii) Monitoring equipment
(d) Outline of
			 Information that Shall be Obtained and Recorded in the Patient's Record. The
			 information shall provide a resource that aids in treatment planning and
			 selection of the anesthetic and/or sedation and furnish needed data if an
			 unexpected physiologic change occurs during the course of a surgical and/or
			 operative procedure. A written record of this evaluation is a requirement for
			 proper patient care. This section sets forth the material that should be
			 obtained and recorded.
1. Vital Statistics.
			 These shall include at least:
(i) Patient's
			 full name
(ii) Address(es) - home
			 and work
(iii) Telephone(s) - home
			 and work
(iv) Date of
			 birth
(v) Gender
(vi) Marital status (name of
			 spouse)
(vii) Occupation
(viii) Name of parent or guardian, if patient
			 is a minor
2. Patient
			 Evaluation (Medical History).
(i) The
			 patient's chief complaint, followed by a history of the present illness or a
			 statement about the patient's problem, shall be recorded. The history shall
			 fulfill two basic requirements:
(I) It must
			 elicit the core medical information that will enable the dentist to identify
			 the risk status of the patient.
(II) It shall provide written evidence that
			 the process of patient evaluation was performed and that the treatment was
			 logical.
(ii) The Core
			 Physical Examination. Vital signs include blood pressure, pulse rate, and
			 respiratory rate. Preoperative blood pressure and pulse rate measurements shall
			 be made and documented in the patient's record.
(iii) Additional Data that Shall be in the
			 Patient's Record:
(I) Documentation of the
			 proposed procedure clearly indicated, as well as documentation that likely
			 complications were discussed with the patient.
(II) A written formal consent for the
			 proposed procedure.
(III) When
			 indicated, adequate radiographs shall be available and shall delineate clearly
			 the areas to be treated.
(IV) A
			 record of the anesthesia and/or sedation shall be made. The anesthetic and
			 other agents and amounts given shall be indicated. Preoperative,
			 intraoperative, and post-operative vital signs shall be recorded and any
			 unusual reactions or complications shall be documented. Starting and ending
			 times for anesthesia shall be recorded. The persons present during the
			 procedure shall be noted.
(V) A
			 record of prescriptions given shall be included.
(e) Office Facilities
			 and Equipment. This section deals with the physical requirements for conducting
			 office anesthesia/sedation.
1. The
			 fundamental physical requirements for the anesthesia and/or sedation facility
			 are:
(i) The Operating Room/Operatory - The
			 operatory shall be large enough to adequately accommodate the patient on a
			 table or in a dental chair and permit the anesthesia and/or sedation team,
			 consisting of the dentist and two or three trained assistants, to move freely
			 about the patient.
(ii) The
			 Operating Table or Dental Chair - The table or chair shall permit the patient
			 to be positioned so the anesthesia team can maintain the airway, allows quick
			 alteration of patient position in an emergency, provides a firm platform for
			 the management of cardiopulmonary resuscitation, and provides easy access to
			 the patient's oral cavity.
(iii)
			 Lighting Systems.
(I) Room lighting shall be
			 adequate to permit evaluation of the patient's skin and mucosal
			 color.
(II) There shall be
			 provisions for auxiliary lighting should the power fail in the operatory.
			 Backup lighting shall be battery powered and of sufficient intensity to permit
			 completion of any procedure underway at the time of general power
			 failure.
(iv) Suction
			 Equipment.
(I) Aspiration shall be provided
			 either by a portable suction unit or by a central suction installation. It is
			 important to provide for auxiliary suction should the pump or electrical power
			 fail.
(II) Multiple suction tips,
			 including tonsil suction tips, shall be available.
(v) Oxygen and Supplemental Gas-Delivery
			 System.
(I) An oxygen and supplemental
			 gas-delivery system capable of delivering metered oxygen and/or gas under
			 positive pressure shall be required.
(II) Gas outlets for remote delivery systems
			 shall be coded to prevent accidental administration of the wrong gas. Fail-safe
			 mechanisms on anesthetic machines are mandatory.
(vi) Patient Recovery.
(I) Patients shall be retained in the surgery
			 area until all protective reflexes have fully returned unless the dental staff
			 is in immediate attendance at all times in the recovery area to continue
			 vital-sign and airway observations.
(II) A patient recovering from a general
			 anesthetic or sedation procedure shall be monitored in the recovery area. This
			 recovery area shall include sufficient room to treat any emergency situation.
			 The recovery area shall be equipped to provide oxygen under positive pressure
			 and have adequate lighting, access to suction, and electrical outlets for
			 connecting cardiac monitoring and defibrillating equipment.
(vii) Drug and Instrument
			 Preparation and Storage Area-An adequate outpatient facility shall contain an
			 area conducive to the sterile preparation and storage of drugs used in
			 anesthesia and/or sedation. There should be provisions for refrigeration to
			 store certain drugs. The drug preparation area shall include a secure storage
			 site for narcotics and other dangerous drugs.
(viii) Gas Storage Area.
(I) Permissible Categories
I. Gas may be stored in a central location
			 used by one or multiple practitioners within the same building.
II. Gas may be stored in the individual
			 operatory.
III. There shall be
			 reserve tanks of gas not connected for immediate use.
(II) Requirements
I. All gas storage shall be maintained
			 according to local building, fire, and safety codes.
II. Gas stored in a central location shall
			 have a central low-pressure alarm, which shall be easily heard in the treatment
			 area where the procedure is being performed. In lieu of a central alarm, a
			 daily gas log may be maintained and checked by the dentist.
(f) Monitoring.
1. The various methods and physiologic
			 parameters used in monitoring patients shall be designed to immediately detect
			 the changes produced either by dental stimulation or the anesthetics or
			 sedatives employed.
2. All patients
			 shall be monitored when anesthetics and/or sedation are employed. The doctor
			 shall continually observe the patient's status and make moment-to-moment
			 assessments of the patient's condition so necessary adjustments may be
			 made.
3. Mechanical monitoring
			 shall be used with every patient. Blood pressure, cardiac rate, oxygen
			 saturation, end tidal CO2 (capnography), and electrocardiogram (EKG) all are
			 required to be monitored during the pre-anesthetic and/or pre-sedation and
			 intra- and post-operative intervals.
4. All equipment, both manual and automated,
			 required by this rule for the monitoring of respiration, heart rate, and blood
			 pressure under parts (g), (h), and (i) below must be maintained in each
			 facility location where a dentist possesses a permit to use general anesthesia
			 and/or parenteral/moderate sedation, and shall not be shared or transported
			 between multiple facility locations. Documentation of compliance with
			 manufacturers' recommended maintenance of monitors, anesthesia delivery
			 systems, and other anesthesia-related equipment shall be maintained.
(g) Required Monitoring of
			 Respiration.
1. Oximetry. Oximeter using a
			 peripheral (finger, ear, or toe) transmitted wave-form monitor.
2. Capnography. Capnograph to monitor and
			 measure the concentration or partial pressure of carbon dioxide in the
			 respiratory gases, as well as the competency of the airway for gas exchange.
			 The dentist shall monitor ventilation and/or breathing by monitoring end tidal
			 carbon dioxide unless precluded or invalidated by the nature of the patient,
			 procedure, or equipment.
(h) Required Monitoring of Heart Rate.
1. Pre-cordial stethoscope or pulse
			 oximeter.
2. Electrocardiogram
			 (EKG).
(i) Required
			 Monitoring of Blood Pressure. Systolic pressure, diastolic pressure, and heart
			 rate must be recorded.
1. Sphygmomanometer and
			 stethoscope or an automatic equivalent.
(j) Emergency Drugs
1. At a minimum each facility in which
			 general anesthesia and/or parenteral/moderate sedation is used by a dentist,
			 must maintain a secure stock of current emergency drugs from each of the
			 following categories. Any specific drug selected must satisfy current advanced
			 cardiac life support (ACLS) and/or American Association of Oral and
			 Maxillofacial Surgeons (AAOMS) standards:
(i)
			 Anticonvulsant
(ii)
			 Antihypoglycemic
(iii)
			 Anticholinergic
(iv)
			 Antiarrhythmics
(v)
			 Steroid
(vi)
			 Antihistamine
(vii) Cardiac
			 stimulant/antihypotensive agent
(viii) Analgesic
(ix) Benzodiazepine antagonist
(x) Narcotic antagonist
(xi) Paralytic Agent for Laryngospasms along
			 with the paralytic agent's reversal agent, of any
(xii) Antihypertensive
(xiii) Nitrate
2. The aforementioned emergency drugs must be
			 maintained at each facility in which general anesthesia and/or
			 parenteral/moderate sedation is used by a dentist and shall not be shared or
			 transported between multiple facility locations.
(k) Personnel.
1. For the administration of
			 parenteral/moderate sedation, at least two (2) individuals, each appropriately
			 trained, are required to be present throughout the procedure, consisting of the
			 doctor and an assistant trained to monitor appropriate physiologic
			 variables.
2. For the
			 administration of general anesthesia, at least three (3) individuals, each
			 appropriately trained, are required to be present throughout the procedure,
			 consisting of the doctor who directs the general anesthesia, a person whose
			 responsibilities are observation and monitoring of the patient, and a third
			 person who assists the operating dentist.
(l) The Board shall appoint examiners for the
			 purpose of conducting the on-site inspections of dental facilities, equipment,
			 and personnel as prescribed in Rule
			 270-X-2-.24.
(m) Upon receipt of an initial application
			 for the administration of general anesthesia or parenteral/moderate sedation, a
			 preliminary facility evaluation of the applicant's facility will be conducted
			 by examiners appointed by the Board. This preliminary facility evaluation will
			 fully assess the safety of the facility, the presence of emergency equipment,
			 the presence of necessary drugs, and the credentials of the individuals who
			 will participate in the procedures. Subsequent to a satisfactory preliminary
			 facility evaluation, a temporary permit for the administration of general
			 anesthesia or parenteral/moderate sedation shall be issued. This temporary
			 permit shall be valid for no more than ninety (90) days, until a subsequent
			 evaluation which fully examines the criteria set forth in this rule is
			 conducted by examiners appointed by the Board.
(n) If upon an initial application for the
			 issuance of a permit for the administration of general anesthesia or
			 parenteral/moderate sedation, the primary office of a dentist(s) has received a
			 satisfactory on-site inspection and the dentist(s) also applies for the
			 issuance of a permit to administer general anesthesia or parenteral/moderate
			 sedation at a secondary office(s) or location(s), any on-site inspection
			 thereof shall be limited only to the dental facility and equipment, provided
			 that the same personnel satisfactorily evaluated at the primary office(s) of
			 the dentist(s) will be engaged or involved in the administration of general
			 anesthesia or parenteral/moderate sedation at the said secondary office(s) or
			 location(s). If upon a request for renewal by a dentist(s) of a permit to
			 administer general anesthesia or parenteral/moderate sedation at both his
			 primary and secondary office(s) or location(s), the Board of Dental Examiners
			 of Alabama determines that an on-site inspection of these office(s) or
			 location(s) is required, the same procedure as outlined above in relation to
			 the initial application for these permits shall be utilized.
(o) The examining team shall submit to the
			 Board the report of their on-site inspection within fourteen (14) days from the
			 date of said inspection. If the results of the initial evaluation are deemed
			 unsatisfactory, the anesthesia certificate is immediately suspended and the
			 applicant must reapply by submitting another application and fee to the
			 Board.