Ala. Admin. Code r. 270-X-2-.17 - Criteria For On-Site Inspection For The Use Of General Anesthesia And Parenteral Sedation/Moderate Sedation
(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.
Notes
Author: Board of Dental Examiners of Alabama
Statutory Authority: Code of Ala. 1975, ยงยง 34-9-43, 34-9-60, 34-9-63, 34-9-65.
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