(A) Use of moderate sedation
(1) The following may be
administered by any dentist, unless otherwise restricted by the
board:
(a) Patients thirteen years of age or older may receive
enteral minimal sedation, limited to a single dose of a single drug at not more
than the maximum recommended dose on the FDA-approved labeling indicated for
unmonitored home use, with or without nitrous oxide-oxygen minimal sedation and
local anesthesia;
(b) Patients of any age may receive nitrous oxide-oxygen
inhalation for minimal sedation.
(2) Notwithstanding
paragraph (A)(1) of this rule, no dentist shall administer moderate sedation in
the state of Ohio, in accordance with the definition of "moderate
sedation", as defined in paragraph (B)(19) of rule 4715-3-01 of the
Administrative Code, unless such dentist possesses a moderate sedation permit
or provisional moderate sedation privileges as set forth in paragraph (C) of
this rule is pending. The dentist holding such permit shall be subject to
review and such permit must be renewed biennially.
(3) The moderate sedation
provider's education, training, experience, and current competence must
clinically coincide with the progression of a patient along the anesthesia
continuum as defined in paragraph (B)(6) of rule 4715-3-01 of the
Administrative Code. The moderate sedation provider must be prepared to manage
a level of anesthesia deeper than intended as it is not always possible to
predict how a given patient will respond to anesthesia. The moderate sedation
provider's ultimate responsibility is to protect the patient including,
but not limited to, identification and management of any complication(s)
occurring during the anesthesia time.
(4) With the exception of
nitrous oxide-oxygen, no dentist shall administer to a patient under thirteen
years of age, any drug, or techniques, or any combination thereof that would
likely render the patient minimally or moderately sedated unless the dentist is
qualified as described in paragraph (B)(2) of this rule and holds a moderate
sedation permit with a pediatric endorsement, provisional moderate sedation
privileges with a pediatric endorsement, a general anesthesia permit or
provisional general anesthesia privileges.
(5) No dentist shall
administer or employ any agent(s) with a narrow margin for maintaining
consciousness including, but not limited to, potent volatile inhalation
anesthetic agents, ultra-short acting barbiturates, propofol, ketamine, and
similarly acting drugs, or quantity of agent(s), 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)(18) or
(B)(19) of rule 4715-3-01 of the Administrative Code, unless the dentist holds
a valid general anesthesia permit or provisional general anesthesia privileges
as issued by the board.
(B) Moderate sedation permit - In order
to receive a moderate sedation permit, the dentist must apply on a prescribed
application form to the board, indicate whether applying for a permit to sedate
patients age thirteen and over, patients under thirteen or both, submit the fee
as established by division (A) of section 4715.13 of the Revised Code, and
produce evidence showing that the dentist:
(1) Has satisfactorily
completed one of the following within two years of submitting the application
for moderate sedation permit to treat patients age thirteen or
older:
(a) A comprehensive predoctoral or advanced dental
education program accredited by the commission on dental accreditation which
includes training in moderate sedation commensurate with the "Guidelines
for Teaching Pain Control and Sedation to Dentists and Dental Students" as
adopted by the October 2016 American dental association house of delegates;
or
(b) A continuing education course in moderate sedation
commensurate with the "Guidelines for Teaching Pain Control and Sedation
to Dentists and Dental Students" as adopted by the October 2016 American
dental association house of delegates. The course must be approved by either
the American dental association commission for continuing education provider
recognition or the academy of general dentistry program approval for continuing
education council. The course must be designed to assess and document
competency in all aspects of moderate sedation. At a minimum, such courses must
include all the following:
(i) No fewer than sixty
hours of didactic instruction, excluding advanced cardiac life support (ACLS)
and basic life support for the healthcare provider (BLS-HCP) instruction time,
plus administration of moderate sedation as defined in this document for at
least twenty individually managed dental patients, ensuring that only a single
course participant earns credit for each patient encounter. An individual
patient may be sedated no more than once per day for these sedation
encounters;
(ii) Written
certification by the course director of competence in moderate sedation
techniques;
(iii) Written
certification of competence by the course director in rescuing patients from a
level of sedation deeper than intended including managing the airway,
intravascular or intraosseous access, and reversal medication use;
and
(iv) Provision of
additional clinical experience if the participant competency has not been
demonstrated in the alloted time.
(2) Has satisfactorily
completed one of the following within two years of submitting the application
for a moderate sedation permit to treat patients under age
thirteen:
(a) An advanced dental education program in pediatric
dentistry accredited by the commission on dental accreditation; or
(b) A program in pediatric moderate sedation for children
under age thirteen which includes:
(i) Sixty hours of
didactic instruction in pediatric sedation;
(ii) Written
documentation of competency in pediatric moderate sedation after having
completed a minimum of:
(a) Twenty-five moderate
pediatric sedation cases with other sedative agent(s) (with or without being
combined with nitrous oxide-oxygen) administered by any route, ensuring that
only a single course participant earns credit for each patient sedation
encounter. An individual patient may be sedated no more than once per day for
these sedation encounters;
(b) Twenty-five
additional sedation experiences by individual or group participation or with
human sedation/anesthesia simulation experiences or a combination thereof;
and
(c) Four weeks of a
hospital anesthesiology rotation experience that includes preoperative
evaluation/assessment, risk management, pharmacology, venipuncture, advanced
airway placement, patient monitoring, recognition and management of anesthetic
emergencies in pediatric patients.
(iii) Written
certification by the program director of competency in:
(a) Rescuing pediatric
patients from a level of anesthesia deeper than intended; an
(b) Reversal of sedation
medications.
(iv) A course provision
of additional clinical experience if participant competency has not been
demonstrated in the allotted time.
(3) Has maintained
records of instruction and clinical experiences, including complete records of
moderate sedation as defined in this document for all patients treated, and
certification(s) of competence;
(4) Documents successful
completion of basic life support for healthcare providers (BLS-HCP)
and;
(a) For sedating patients age thirteen and over, successful
completion of advanced cardiac life support (ACLS) courses; or
(b) For sedating patients under age thirteen, successful
completion of pediatric advanced life support (PALS) training.
(5) Has a properly
equipped facility for the administration of moderate 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.
(C) Provisional privileges - Prior to the
issuance of a moderate sedation 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 moderate sedation 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 moderate sedation
privileges shall request an extension no later than ninety days before the
expiration of their provisional moderate sedation privileges if necessary to
complete the onsite evaluation.
(D) Clinical onsite
evaluation
(1) The board shall
require an onsite evaluation of the facility(s), equipment, personnel, moderate
sedation techniques and related document(s) to determine if the requirements
set forth in paragraph (B) of this rule have been met. This evaluation shall be
conducted by a qualified consultant appointed by the board and for sedating
patients age thirteen and older must follow the "Guidelines for the Use of
Sedation and General Anesthesia by Dentists" as adopted by the October
2016 American dental association house of delegates, or, for sedating children
under thirteen, the "Guidelines for the Monitoring and Management of the
Pediatric Patient, Before, During, and After Sedation for Diagnostic and
Therapeutic Procedures" June 2019 revised policy of the American academy
of pediatrics;
(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 moderate sedation is
administered. A written list of all monitors, emergency equipment and other
materials which the mobile moderate sedation provider agrees to have available
at all times while administering moderate sedation in multiple locations shall
be provided to the board; and
(3) The applicant shall
be responsible for the cost of this evaluation, which will be an amount 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 the deficiencies have been corrected; or the board may require a formal
re-evaluation; 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
moderate sedation permit.
(F) Permit renewal - The board shall,
without charge, renew the moderate sedation 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) for
sedation of patients age thirteen and over, or for sedation of children under
age thirteen, 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 moderate sedation.
(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, on an annual basis, the
following scenarios:
(a) Hypotensive, hypertensive, bradycardic and tachycardic
emergencies;
(b) 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;
(iii) Laryngospasm;
and
(iv) Bronchospasm.
(c) An unexpected decline in level of consciousness,
including consideration of multiple possible etiologies, e.g. over-sedation,
stroke, seizure, street drug use, hypoxia, anaphylaxis, etc.;
(d) With the exception of those who solely possess a
pediatric endorsement, recognition and management of chest pain progressing to
cardiac arrest;
(e) In offices where moderate sedation 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 moderate
sedation for an actual patient.
(3) Has reviewed the laws
and rules governing the administration of moderate sedation; and
(4) Has verified that all
licensed/registered personnel involved in the administration of moderate
sedation maintain current, active licensure or registration.
(G) Licensed dentists who did not
complete a comprehensive predoctoral or advanced dental education program
accredited by the U.S. department of education as defined in paragraph
(B)(1)(a) or paragraph (B)(2)(a) of this rule who hold a current permit and
have been using or employing sedation prior to adoption of this rule and who
desire to continue to use or employ sedation, shall within one year of the
effective date of this rule submit an attestation to the board along with
evidence demonstrating competency of successful administration of sedation to a
minimum of twenty patients in the three years preceding attestation. Evidence
of competency shall be commensurate with each intended patient age range
whether:
(1) Patiens age thirteen
and over;
(2) Patients twelve years
or younger; or
(3) Both (forty case
total).
(H) Reciprocity - The board may grant a moderate sedation
permit to a dentist who has administered moderate sedation in another state
when training as outlined in paragraphs (B)(1) and/or (B)(2) of this rule was
completed more than two years before the submission of the application and the
applicant provides a log of all moderate sedation cases performed during the
previous three years. A minimum of twenty age-appropriate cases logged in the
preceding three years is required to demonstrate current competency. The board
may request complete moderate sedation records of cases selected from this
log.
(I) General anesthesia permit holders - A dentist holding a
general anesthesia permit under rule 4715-5-05 of the Administrative Code may
administer moderate sedation without a moderate sedation permit.
(J) Certified registered nurse anesthetist (CRNA) - A
dentist holding a moderate sedation permit may supervise a licensed, certified
registered nurse anesthetist only for moderate sedation procedures for which
the dentist is qualified by permit. The permitted dentist must provide direct,
personal, on-site supervision of the CRNA within the scope of the permit of the
CRNA throughout the entire anesthesia time.
(K) New facility - All moderate sedation permit holders
shall provide written notification within ten business days to the board if
conscious sedation services are to be provided an any new facility(s) other
than those already listed with the board.
(L) Anesthetic team - During moderate sedation, the
following persons must be physically present in the room and caring exclusively
for the patient:
(1) A moderate sedation
provider; and
(2) A person currently
certified in BLS-HCP who may assist the moderate sedation provider, shares the
patient monitoring and documentation duties and who is able to assist the
moderate sedation provider in an emergency if needed.
(M) Recovery monitoring - The moderate sedation provider
must remain on the premises of the dental facility until any patient given
moderate sedation has been discharged. Assuming that the patient continues to
respond appropriately to verbal command after the procedure has ended, further
recovery until ready for discharge must be monitored by one person described in
paragraph (K)(2) of this rule.
(N) Employing a moderate sedation provider - A dentist who
employs or works with a moderate sedation provider must:
(1) Ensure that the
anesthesia provider meets the requirements defined in paragraph (B)(4) or
(B)(5) of rule 4715-3-01 of the Administrative Code;
(2) Ensure that the
facility meets the requirements set forth in paragraph (B)(5) of this rule; and
(3) Be currently
certified in BLS-HCP and able to assist the moderate sedation provider in an
emergency if needed.
(O) Reevaluation - The board may conduct additional
evaluations, as described in paragraph (D) of this rule, upon informing the
permit holder in writing that a reevaluation is required of the permit
holder's facility(s) and/or methods. In determining whether such
reevaluation is necessary, the board shall consider such factors as it deems
pertinent including, but not limited to, patient complaints, report 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-sedation evaluation(s), sedation and recovery records, and documentation of
appropriateness for discharge. The permit holder shall be responsible for any
costs incurred in a reevaluation, not to exceed four hundred
dollars.
(P) Reference materials for paragraphs (B)(1)(b), (B)(5),
and (D) 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 - 312-440-2800; internet website address -
www.ada.org.
(2) American academy of
pediatrics: 345 Park avenue, Itasca, Illinois 60143; internet website address -
www.aappublications.org/news.