(A)
No dentist shall
administer general anesthesia or deep sedation to a patient of any age in the
state of Ohio unless such dentist possesses a general anesthesia permit issued
by the board or has obtained provisional general anesthesia privileges as set
forth in paragraph (C) of this rule. The dentist holding such a permit shall be
subject to review and such permit must be renewed biennially.
No dentist shall administer or employ
any agent(s) with a narrow margin for maintaining consciousness including, but
not limited to, potent volatile anesthetic agents, ultra-short acting
barbiturates, propofol, ketamine, and similarly acting drugs, or a quantity of
agents, or techniques, or any combination thereof that would likely render a
patient deeply sedated, generally anesthetized or otherwise not meeting the
conditions of the definition of minimal sedation or moderate sedation in
paragraph (B) of rule
4715-3-01 of the Administrative
Code, unless the dentist holds a valid general anesthesia permit or provisional
general anesthesia privileges issued by the board.
(B)
General
anesthesia permit - In order to receive a general anesthesia permit, the
dentist must apply on a prescribed application form to the board, submit the
application fee, and produce evidence showing that he or she:
(1)
Has completed one
of the following:
(a)
An advanced dental education program accredited by the
commission on dental accreditation which affords appropriate training necessary
to competently administer deep sedation and general anesthesia;
or
(b)
A post-doctoral training program in anesthesiology from
an approved accredited educational institution or program that affords
comprehensive and appropriate training necessary to competently administer and
manage deep sedation and general anesthesia commensurate with the American
dental association (ADA) "Guidelines for Teaching the Comprehensive Control of
Pain and Anxiety at the Advanced Education Level (Part 2)" in effect at the
start of their training, if training took place prior to accreditation by the
Commission on dental accreditation of dental anesthesia residencies (one year
training prior to July 1, 1993, and two years thereafter);
(2)
Has a
properly equipped facility(s), whether fixed, mobile, or portable, for the
administration of general anesthesia or deep sedation in which the permit
holder has available and agrees to utilize adequate monitoring, personnel,
emergency equipment and drugs as recommended in the "Guidelines for the Use of
Sedation and General Anesthesia by Dentists" as adopted by the October 2016
American dental association house of delegates and/or the American association
of oral and maxillofacial surgeon's "Office Anesthesia Evaluation Manual," 9th
edition; and
(3)
At the time of application, maintains successful
completion of basic life support for healthcare providers (BLS-HCP) and
advanced cardiac life support (ACLS) course(s).
(C)
Provisional
privileges - prior to the issuance of a general anesthesia permit, if the
applicant dentist meets the requirements set forth in paragraph (B) of this
rule:
(1)
The
board shall issue to the applicant dentist provisional general anesthesia
privileges valid for up to one year pending successful completion of the
clinical onsite evaluation;
(2)
Unless otherwise
authorized by the board, a dentist with provisional general anesthesia
privileges shall request an extension no later than ninety days before the
expiration of their provisional privileges if necessary to complete the onsite
evaluation.
(D)
Onsite clinical evaluation
(1)
Prior to the
issuance of a general anesthesia permit, the board shall require an onsite
evaluation of the facility(s) equipment, personnel, anesthetic techniques, and
related document(s) to determine if the aforementioned requirements have been
met. This evaluation shall be conducted by a qualified consultant appointed by
the board and will follow the October 2016 "Guidelines for the Use of Sedation
and General Anesthesia by Dentists" as adopted by the American dental
association house of delegates and/or the American association of oral and
maxillofacial surgeons "Office Anesthesia Evaluation Manual," 9th
edition;
(2)
In the case of a mobile or portable facility, one
inspection of that facility shall be conducted in the office of an Ohio
licensed dentist where deep sedation or general anesthesia is administered. A
written list of all monitors, emergency equipment, and other materials which
the mobile anesthesia provider agrees to have available at all times while
administering moderate sedation, deep sedation, and general anesthesia in
multiple locations shall be provided to the board.
(3)
The applicant
shall be responsible for the cost of this evaluation not to exceed four hundred
dollars.
(E)
Unsatisfactory permit application - In the event the
board deems the application or evaluation unsatisfactory, a written explanation
documenting deficiencies and suggested remedies shall be forwarded to the
applicant. The board may issue a permit based on documentation that
deficiencies have been corrected; or the board may require a reevaluation; or
the board may issue a notice of opportunity for hearing pursuant to Chapter
119. of the Revised Code to deny the application for a general anesthesia
permit.
(F)
Permit renewal - The board shall without charge renew
the general anesthesia permit biennially at the time of dental licensure
renewal, provided the permit holder attests to the board that the permit
holder:
(1)
Maintains successful completion of:
(a)
A basic life
support course for healthcare providers (BLS-HCP);
(b)
A course in
advanced cardiac life support (ACLS) and, for anesthetic care of children under
eight years of age, pediatric advanced life support (PALS); and
(c)
A minimum of six
hours of board approved continuing education devoted specifically to the
management and/or prevention of emergencies which may result from the use of
deep sedation and general anesthesia.
(2)
Has performed
emergency drills at least quarterly during the biennium, documenting in a log
the date, nature of simulated emergencies and names and roles of all
participants. Required simulated emergencies include, at least annually, the
following scenarios:
(a)
Recognition and management of chest pain progressing to
cardiac arrest;
(b)
Hypotensive, hypertensive, bradycardic and tachycardic
emergencies;
(c)
Recognition and management of loss of capnography
tracing requiring appropriate management of the airway and of the underlying
cause, e.g. anesthetic overdose, secretions, etc. due to:
(i)
Hypoventilation
that progresses to respiratory arrest;
(ii)
Soft tissue or
foreign body obstruction of the airway;
(d)
Unexpected
decline in level of consciousness, including consideration of multiple possible
etiologies, e.g. oversedation, stroke, street drug use, hypoxia, anaphylaxis,
etc.; and
(e)
In offices where deep sedation or general anesthesia is
performed less frequently than quarterly, or for the first time, the
requirement for emergency drills may be satisfied by performing emergency
drills for, at a minimum, all of the above scenarios immediately preceding the
administration of deep sedation or general anesthetic for an actual
patient.
(3)
Is in compliance with all requirements of paragraphs
(J) and (K) of this rule;
(4)
Has reviewed the laws and rules governing the
administration of deep sedation and general anesthesia; and
(5)
Verified that all
licensed/registered personnel involved in the administration of deep sedation
and general anesthesia maintain current, active, licensure or
registration.
(G)
Reciprocity - The board may grant a general anesthesia
permit to a dentist who has administered general anesthesia in another state
when training as outlined in paragraph (B)(1) of this rule was completed more
than two years before the submission of the application and the applicant
provides a log of all general anesthesia cases performed during the previous
two years. A minimum of twenty cases logged in the preceding two years is
required to demonstrate current competency. The board may request complete
general anesthesia records of cases selected from this log.
(H)
Certified
registered nurse anesthetist (CRNA) - A dentist holding a general anesthesia
permit may supervise a licensed CRNA for any anesthetic procedures for which
the dentist is qualified by permit. The permitted dentist must provide direct,
personal, on-site supervision of the CRNA throughout the entire anesthesia
time.
(I)
Facility notification - All permit holders shall
provide written notification within ten days to the board if anesthesia
services are provided at any new facility(s) other than those already listed
with the board.
(J)
Employing general anesthesia provider - A dentist who
employs or works with a general anesthesia provider must:
(1)
Ensure that the
general anesthesia provider meets the requirements defined in paragraph (B) of
rule 4715-3-01 of the Administrative
Code;
(2)
Ensure that the facility meets the requirements set
forth in paragraph (B)(2) of this rule; and
(3)
Be currently
certified in basic life support for healthcare providers (BLS-HCP) and able to
assist the general anesthesia provider in an emergency if
needed.
(K)
Anesthetic team - During deep sedation or general
anesthesia for a patient eight years of age or over, the following three
persons must be physically present in the room and caring exclusively for the
patient under anesthesia:
(1)
A general anesthesia provider;
(2)
Either of the
following:
(a)
An Ohio-licensed dentist with current BLS-HCP or ACLS
certification who can assist the anesthesia provider in an emergency if needed;
or
(b)
An individual currently certified in BLS-HCP who is
experienced in patient monitoring and documentation and whose duties are solely
dedicated to patient monitoring and documentation and, if needed, assisting the
general anesthesia provider in an emergency.
(3)
One individual
whose duties may include assisting with dental
procedures.
(L)
Anesthetic team for very young patients - During deep
sedation or general anesthesia for a patient under eight years of age, the
following three persons must be physically present in the room and caring
exclusively for the patient under anesthesia:
(1)
Either of the
following:
(a)
A
general anesthesia provider with current certification in Pediatric advanced
life support (PALS) who exclusively administers and monitors the anesthetic and
is not otherwise involved with the dental procedure;or
(b)
A general
anesthesia provider with current certification in PALS who is also involved in
the dental procedure and who maintains a log of performing deep sedations or
general anesthetics for a minimum of twenty cases per year or an aggregate of
at least forty cases in children under eight years of age during the preceding
twenty-four month period; and
(2)
Either of the
following:
(a)
An Ohio-licensed dentist with current certification in PALS
who is able to provide emergency assistance to the general anesthesia provider
if needed; or
(b)
An individual currently certified in BLS-HCP who is
experienced in patient monitoring and documentation and, if needed, able to
assist the general anesthesia provider in an emergency;
and
(3)
One individual whose duties may include assisting with
dental procedures.
(M)
Post-anesthetic
monitoring - Once the patient has regained consciousness and responds
appropriately to light tactile stimulation or verbal command, the patient's
recovery must be monitored by an individual who is experienced in patient
monitoring and documentation and is certified in BLS-HCP.
(N)
Supervision of
care - A general anesthesia provider must remain on the premises of the dental
facility until any patient given deep sedation or general anesthesia regains
consciousness and has been discharged. Once the patient has regained
consciousness and responds appropriately to light tactile stimulation or verbal
command, further recovery until ready for discharge must be monitored by one
person as described in paragraph (J)(1) or (J)(2) of this rule.
(O)
Reevaluation -
The board may, upon informing the permit holder in writing, conduct at any time
an evaluation, as described in paragraph (D) of this rule, of the permit
holder's facility(s) and/or methods. In determining whether such evaluation is
necessary, the board shall consider such factors as it deems pertinent
including, but not limited to, patient complaints, reports of adverse
occurrences, and random quality assurance audits. Such quality assurance
audit(s), may include, but are not limited to, a review of documentation of
pre-anesthetic evaluation(s), anesthetic and recovery records, and
documentation of appropriateness for discharge, The permit holder shall be
responsible for any costs incurred in a formal reevaluation, not to exceed four
hundred dollars.
(P)
Reference materials for paragraphs (B)(1)(b) and (B)(2)
of this rule may be found at the following addresses:
(1)
American dental
association: 211 E. Chicago avenue, Chicago, Illinois, 60611-2678; telephone -
312-440-2500; facsimile - 312-4402800; internet website address -
www.ada.org
.
(2)
American association of oral and maxillofacial
surgeons: 9700 West Bryn Mawr avenue, Rosemont, Illinois, 60018-5701; telephone
- 847-678-6200 or 800-822-6637; facsimile - 847-678-6286; internet website
address -
www.aaoms.org
.
Replaces: 4715-5-05
Notes
Ohio Admin. Code
4715-5-05
Effective:
4/1/2024
Five Year Review (FYR) Dates:
03/31/2029
Promulgated
Under: 119.03
Statutory
Authority: 4715.03
Rule
Amplifies: 4715.03,
4715.09,
4715.13
Prior
Effective Dates: 08/01/1974, 10/01/1988, 03/03/1995, 04/27/1998, 05/15/2003,
04/07/2005, 04/02/2010, 05/05/2014,
05/30/2020