Current through September 24, 2024
(1) Definitions.
(a) Advanced Cardiac Life Support (ACLS). A
certification that means a person has successfully completed an advanced
cardiac life support course offered by a recognized accrediting
organization.
(b) American Society
of Anesthesiologists (ASA) Patient Physical Status Classification
1. ASA I - A normal healthy
patient.
2. ASA II - A patient with
mild systemic disease.
3. ASA III -
A patient with severe systemic disease.
4. ASA IV - A patient with severe systemic
disease that is a constant threat to life.
5. ASA V - A moribund patient who is not
expected to survive without the operation.
6. ASA VI - A declared brain-dead patient
whose organs are being removed for donor purposes.
7. E - Emergency operation of any variety
(used to modify one of the above classifications, i.e., ASA III-E).
(c) Antianxiety premedication
(anxiolysis). The prescription of pharmacologic substances for the relief of
anxiety and apprehension.
(d)
Certified Registered Nurse Anesthetist (CRNA). A registered nurse currently
licensed by the Tennessee Board of Nursing who is currently certified as such
by the American Association of Nurse Anesthetists.
(e) Conscious sedation. A minimally depressed
level of consciousness that retains the patient's ability to independently and
continuously maintain an airway and respond appropriately to physical
stimulation or verbal command and that is produced by a pharmacological or
non-pharmacological method or a combination thereof.
(f) Deep sedation. An induced state of
depressed consciousness accompanied by partial loss of protective reflexes,
including the inability to continually maintain an airway independently and/or
to respond purposefully to physical stimulation or verbal command, and is
produced by a pharmacological or non-pharmacological method or a combination
thereof.
(g) Dental facility. The
office where a permit holder or permit applicant practices dentistry and
provides or is applying to provide anesthesia/sedation services.
(h) Dental facility inspection. An on-site
inspection to determine if a dental facility is equipped to support the
provision of anesthesia/sedation services under 0460-02-.07(6)(b) and
0460-02-.07(7)(b).
(i) Dental
facility permit. Permit issued by the Board to a dental facility which allows
an anesthesia/sedation permit holder to administer anesthesia/sedation services
at that dental facility.
(j)
Enteral. Any technique of administration in which the agent is absorbed through
the gastrointestinal (GI) tract or oral mucosa [i.e, oral, rectal,
sublingual].
(k) General
anesthesia. An induced state of unconsciousness accompanied by partial or
complete loss of protective reflexes, including the inability to continually
maintain an airway independently and respond purposefully to physical
stimulation or verbal command, and is produced by a pharmacological or
non-pharmacological method or a combination thereof.
(l) Hospital. A hospital licensed by the
Department of Health's Division of Health Care Facilities.
(m) Inhalation. A technique of administration
in which a gaseous or volatile agent is introduced into the pulmonary tree and
whose primary effect is due to absorption through the pulmonary bed.
(n) Mobile dental anesthesia provider. A
licensed dentist with an anesthesia/sedation permit who provides office based
anesthesia/sedation for dental offices.
(o) Nitrous oxide inhalation analgesia. The
administration by inhalation of a combination of nitrous oxide and oxygen
producing an altered level of consciousness that retains the patient's ability
to independently and continuously maintain an airway and respond appropriately
to physical stimulation or verbal command.
(p) Pediatric Advanced Life Support (PALS). A
certification that means a person has successfully completed an pediatric
advanced life support course offered by a recognized accrediting
organization.
(q) Parenteral. A
technique of administration in which the drug bypasses the gastrointestinal
(GI) tract [i.e., intramuscular (IM), intravenous (IV), intransal (IN),
submucosal (SM), subcutaneous (SC)].
(r) Physician. A person licensed to practice
medicine and surgery pursuant to Tennessee Code Annotated Title 63, Chapters 6
or 9.
(2) Permits
required.
(a) No permit is required for the
administration of nitrous oxide inhalation analgesia; however, dentists must
comply with the provisions of 0460-02-.07(4).
(b) No permit is required for the use of
antianxiety premedication (anxiolysis); however, dentists must comply with the
provisions of 0460-02-.07(5).
(c)
Dentists must obtain a permit to administer conscious sedation. A conscious
sedation permit may be limited or comprehensive.
1. A limited conscious sedation permit
authorizes dentists to administer conscious sedation by the enteral and/or
combination inhalation-enteral method.
2. A comprehensive conscious sedation permit
authorizes a dentist to administer conscious sedation by the enteral,
combination inhalation-enteral or parenteral method.
3. Children thirteen (13) and under
(i) Dentists who administer conscious
sedation by any method to children thirteen (13) and under must have a
comprehensive conscious sedation permit.
(ii) Agents used to produce conscious
sedation/deep sedation/general anesthesia in children thirteen (13) years of
age and under must be given under the direct supervision of the
dentist.
4. Dentists
issued limited or comprehensive conscious sedation permits must comply with
Rule 0460-02-.07(6).
(d)
Dentists must obtain a permit to administer deep sedation/general anesthesia
and comply with Rule 0460-02-.07(7).
(3) Determination of degree of sedation.
(a) The degree of sedation or consciousness
level of a patient is the determinant for the application of these rules, not
the route of administration. Determining the degree of sedation or level of
consciousness of a patient is based upon:
1.
The type and dosage of medication that was administered or was proposed for
administration to the patient;
2.
The age, physical size and medical condition of the patient receiving the
medication; and
3. The degree of
sedation or level of consciousness that should reasonably be expected to result
from that type and dosage of medication.
(b) In a proceeding of the Board at which the
board must determine the degree of sedation or level of consciousness of a
patient, the board will base its findings on the provisions of subparagraph
(a).
(4) Nitrous oxide
inhalation analgesia.
(a) Nitrous oxide may be
administered by a licensed dentist or a licensed and properly certified dental
hygienist under the direct supervision of a licensed dentist. The administering
or supervising dentist must be on the premises at all times that nitrous oxide
is in use.
(b) An authorized person
must constantly monitor each patient receiving nitrous oxide. In addition to
dentists, any licensed dental hygienist or registered dental assistant who has
complied with Rules
0460-03-.06
or
0460-04-.05
is an authorized person and may monitor patients who are receiving nitrous
oxide.
(c) Monitoring nitrous
oxide. Monitoring patients receiving nitrous oxide inhalation analgesia as an
adjunct to dental or to dental hygiene procedures consists of continuous direct
clinical observation of the patient and begins after the dentist or dental
hygienist has initiated the analgesia. The dentist must be notified of any
change in the patient which might indicate an adverse effect on the patient.
Those certified in nitrous oxide monitoring may terminate the administration of
nitrous oxide inhalation analgesia.
(d) All equipment for the administration of
nitrous oxide must be designed specifically to guarantee that an oxygen
concentration of no less than thirty percent (30%) can be administered to the
patient.
(e) All equipment for the
administration of nitrous oxide must be equipped with a scavenger
system.
(5) Antianxiety
premedication (anxiolysis).
(a) The
regulation and monitoring of this modality of treatment are the responsibility
of the ordering dentist. The drugs used should carry a margin of safety wide
enough to never render unintended loss of consciousness. If the administration
is for antianxiety purposes, the appropriate initial dosing of a single enteral
drug can be no more than the maximum recommended dose (MRD) of a drug that can
be prescribed for nonmonitored home use. The co-administration of nitrous oxide
is allowed. If the MRD is exceeded then a limited conscious sedation permit is
required.
(b) A dentist using
antianxiety premedication must employ auxiliary personnel who are certified in
BLS for Healthcare Providers, or CPR/AED for Professional Rescuers, or an
equivalent course, which provides training for healthcare professionals in CPR
and the use of an AED by a Board-approved training organization. The course
must be conducted in person and include a skills examination on a manikin with
a certified instructor.
(c) All
antianxiety premedications and all sedation techniques (except nitrous oxide
and oxygen) used for children age thirteen (13) and under require a
comprehensive conscious sedation permit.
(6) Conscious sedation.
(a) Dentists must obtain a permit from the
Board of Dentistry to administer conscious sedation in the dental office.
Conscious sedation permits are either limited or comprehensive.
1. To obtain a limited conscious sedation
permit, a dentist must provide proof of current certification in ACLS (a
pediatric dentist may substitute PALS), and must provide proof of one (1) of
the following:
(i) Completion of an ADA
accredited postdoctoral training program which affords comprehensive training
necessary to administer and manage enteral and/or combination
inhalation-enteral conscious sedation, or
(ii) Completion of a continuing education
course which consists of a minimum of twenty four (24) hours of didactic
instruction plus ten (10) clinically-oriented experiences which provide
competency in enteral and/or combination inhalation-enteral conscious
sedation.
2. To obtain a
comprehensive conscious sedation permit, a dentist must provide proof of
current certification in ACLS (a pediatric dentist may substitute PALS), and
must provide proof of one (1) of the following:
(i) Completion of an ADA accredited
postdoctoral training program which affords comprehensive training to
administer and manage parenteral conscious sedation, or
(ii) Completion of a continuing education
course consisting of a minimum of sixty (60) hours of didactic instruction plus
the management of at least twenty (20) patients which provides competency in
parenteral conscious sedation. The course content must be consistent with that
described for an approved continuing education program in these techniques in
the ADA Guidelines for Teaching the Comprehensive Control of Anxiety and Pain
in Dentistry, 2000 edition, or its successor publication.
3. Dentists who provide conscious sedation
for children must provide evidence of adequate training in pediatric sedation
techniques and in pediatric resuscitation including the recognition and
management of pediatric airway and respiratory problems.
4. A dentist who utilizes a Certified
Registered Nurse Anesthetist (CRNA) to administer conscious sedation must have
a valid comprehensive conscious sedation permit.
5. A dentist may utilize a physician (MD or
DO), who is a member of the anesthesiology staff of an accredited hospital, or
a permitted dentist to administer conscious sedation in that dentist's office.
Such person must remain on the premises of the dental facility until all
patients given conscious sedation meet discharge criteria. The office must
comply with the general rules for conscious sedation, i.e. Rule
0460-02-.07(6)(b). A dentist utilizing such person and complying with these
provisions does not require a conscious sedation permit.
(b) General rules for conscious sedation.
1. Physical facilities.
(i) The treatment room must be large enough
to accommodate the patient adequately on a table or in a dental chair and to
allow an operating team, consisting of at least two persons, to move freely
about the patient.
(ii) The
operating table or dental chair must allow the patient to be placed in a
position such that the operating team can maintain the airway, allow the
operating team to alter the patient's position quickly in an emergency, and
provide a firm platform for the management of cardiopulmonary
resuscitation.
(iii) The lighting
system must be adequate to allow an evaluation of the patient's skin and
mucosal color and provide adequate light for the procedure.
(iv) Suction equipment must be available that
allows aspiration of the oral and pharyngeal cavities.
(v) A system for delivering oxygen must have
adequate full-face masks and appropriate connectors, and be capable of
delivering oxygen to the patient under positive pressure.
(vi) A recovery area must be provided that
has available oxygen, adequate lighting, suction and electrical outlets. The
recovery area may be the treatment room. A member of the staff must be able to
observe the patient at all times during the recovery.
(vii) An alternate lighting system
sufficiently intense to allow completion of any procedure and an alternate
suction device that will function effectively must be available for emergency
use at the time of a general power failure.
(viii) In offices where pediatric patients
are treated, appropriate sized equipment must be available.
(ix) Inspections of the anesthesia and
sedation equipment shall be made each day the equipment is used and a log kept
recording the inspection and its results.
2. Personnel.
(i) During conscious sedation at least one
(1) person, in addition to the operating dentist, must be present.
(ii) Members of the operating team must be
trained for their duties according to protocol established by the dentist and
must be currently certified in BLS for Healthcare Providers, or CPR/AED for
Professional Rescuers, or an equivalent course, which provides training for
healthcare professionals in CPR and the use of an AED by a Board-approved
training organization. The course must be conducted in person and include a
skills examination on a manikin with a certified instructor.
(iii) All operatory room and/or recovery
personnel who provide clinical care shall hold a current, appropriate Tennessee
license/registration pursuant to Tennessee Code Annotated, Title 63.
(iv) Unlicensed/unregistered personnel may
not be assigned duties or responsibilities that require professional
licensure.
(v) Notwithstanding the
provisions of subpart (iv), duties assigned to unlicensed/unregistered
personnel shall be in accordance with their training, education, and experience
and under the direct supervision of a licensed dentist.
3. Patient evaluation. Patients subjected to
conscious sedation must be suitably evaluated prior to the start of any
sedative procedure. In healthy or medically stable individuals (ASA I, II) this
may be simply a review of their current medical history and medication use.
However with individuals who may not be medically stable or who have a
significant health disability (ASA III, IV) consultation with their primary
care physician or consulting medical specialist is recommended.
4. Dental records. The dental record must
include:
(i) A medical history including
current medications and drug allergies;
(ii) Informed consent for the type of
anesthesia used;
(iii) Baseline
vital signs including blood pressure and pulse. If determination of baseline
vital signs is prevented by the patient's age, physical resistance or emotional
condition, the reason(s) should be documented;
(iv) A time-oriented anesthesia record which
includes the drugs and dosage administered;
(v) Documentation of complications or
morbidity; and
(vi) Status of the
patient on discharge.
5.
Monitoring.
(i) Direct clinical observation of
the patient must be continuous;
(ii) Interval recording of blood pressure and
pulse must occur;
(iii) Oxygen
saturation must be evaluated continuously by a pulse oximeter;
(iv) The patient must be monitored during
recovery by trained personnel until stable for discharge;
(v) If monitoring procedures are prevented by
the patient's age, physical resistance or emotional condition, the reason(s)
should be documented; and
(vi) If a
patient enters a deeper level of sedation than the dentist is qualified to
provide, the dentist must stop the dental procedure until the patient returns
to the intended level of sedation.
6. Emergency management.
(i) Written protocols must be established by
the dentist to manage emergencies related to conscious sedation including but
not limited to laryngospasm, bronchospasm, emesis and aspiration, airway
occlusion by foreign body, angina pectoris, myocardial infarction,
hypertension, hypotension, allergic and toxic reactions, convulsions,
hyperventilation and hypoventilation. Written protocols must be kept with the
emergency equipment and drugs.
(ii)
Training to familiarize the operating team with these protocols must be
periodic and current. Regular staff education programs and training sessions
shall be provided and documented which include sessions on emergencies, life
saving measures, medical equipment, and utility systems.
(iii) A cardiac defibrillator or automated
external defibrillator must be available.
(iv) Equipment and drugs on a list available
from the Board and currently indicated for the treatment of the above listed
emergency conditions must be present and readily available for use. Emergency
protocols must include training in the use of this equipment and these
drugs.
7. Recovery and
discharge.
(i) Patients must be monitored for
adequacy of ventilation and circulation. The dental record must reflect that
ventilation and circulation are stable and the patient is appropriately
responsive prior to discharge.
(ii)
The dental office must develop specific criteria for discharge parameters for
conscious sedation for both adult and pediatric patients.
(iii) The dental record must reflect that
appropriate discharge instructions were given, and that the patient was
discharged into the care of a responsible person.
(7) Deep
sedation/general anesthesia.
(a) Dentists must
obtain a permit from the Board of Dentistry to administer deep sedation/general
anesthesia in the dental office.
1. Obtaining
the permit.
(i) To obtain a deep
sedation/general anesthesia permit, a dentist must provide proof of current
certification in ACLS (a pediatric dentist may substitute PALS), and must
provide certification of one (1) of the following:
(I) Successful completion of a minimum of one
(1) year advanced training in anesthesiology and related academic subjects
beyond the undergraduate dental school level in a training program as described
in the most recent version of the ADA Guidelines for Teaching the Comprehensive
Control of Pain and Anxiety in Dentistry, or
(II) Proof of successful completion of a
graduate program in oral and maxillofacial surgery which has been approved by
the Commission on Accreditation of the American Dental Association;
or
(III) Proof of successful
completion of a residency program in general anesthesia of not less than one
(1) calendar year that is approved by the Board of Directors of the American
Dental Society of Anesthesiology for eligibility for the Fellowship in General
Anesthesia or proof that the applicant is a Diplomate of the American Board of
Dental Anesthesiology.
(ii) Dentists who provide deep
sedation/general anesthesia for children must provide evidence of adequate
training in pediatric sedation techniques, in general anesthesia, and in
pediatric resuscitation including the recognition and management of pediatric
airway and respiratory problems.
2. A dentist may utilize a physician (MD or
DO), who is a member of an anesthesiology staff of an accredited hospital, or
another dentist who holds a deep sedation/general anesthesia permit to
administer deep sedation or general anesthesia in that dentist's office. Such
person must remain on the premises of the dental facility until all patients
given deep sedation or general anesthesia meet discharge criteria. The office
must comply with the general rules for deep sedation/general anesthesia, i.e.
Rule 0460-02-.07(7)(b). A dentist utilizing such person and complying with
these provisions does not require a deep sedation/general anesthesia
permit.
3. A dentist who utilizes a
Certified Registered Nurse Anesthetist (CRNA) to administer deep
sedation/general anesthesia must have a valid deep sedation/general anesthesia
permit.
4. A dentist who holds a
deep sedation/general anesthesia permit may administer conscious
sedation.
(b) General
rules for deep sedation/general anesthesia.
1.
Physical facilities.
(i) The treatment room
must be large enough to accommodate the patient adequately on a table or in a
dental chair and to allow an operating team, consisting of at least three (3)
persons, to move freely about the patient.
(ii) The operating table or dental chair must
allow the patient to be placed in a position such that the operating team can
maintain the airway, allow the operating team to alter the patient's position
quickly in an emergency, and provide a firm platform for the management of
cardiopulmonary resuscitation.
(iii) The lighting system must be adequate to
allow an evaluation of the patient's skin and mucosal color and provide
adequate light for the procedure.
(iv) Suction equipment must be available that
allows aspiration of the oral and pharyngeal cavities.
(v) A system for delivering oxygen must have
adequate full-face masks and appropriate connectors, and be capable of
delivering oxygen to the patient under positive pressure.
(vi) A recovery area must be provided that
has available oxygen, adequate lighting, suction and electrical outlets. The
recovery area may be the treatment room. A member of the staff must be able to
observe the patient at all times during the recovery.
(vii) An alternate lighting system
sufficiently intense to allow completion of any procedure and an alternate
suction device that will function effectively must be available for emergency
use at the time of a general power failure.
(viii) In offices where pediatric patients
are treated, appropriate sized equipment must be available.
(ix) Inspections of the deep sedation/general
anesthesia equipment shall be made each day the equipment is used and a log
kept recording the inspection and its results.
2. Personnel.
(i) During deep sedation/general anesthesia
at least two (2) persons, in addition to the operating dentist, must be
present.
(ii) Members of the
operating team must be trained for their duties according to protocol
established by the dentist and must be currently certified in BLS for
Healthcare Providers, or CPR/AED for Professional Rescuers, or an equivalent
course, which provides training for healthcare professionals in CPR and the use
of an AED by a Board-approved training organization. The course must be
conducted in person and include a skills examination on a manikin with a
certified instructor.
(iii) When
the same individual administering the deep sedation/general anesthesia is
performing the dental procedure, there must be a second (2nd) individual
trained in patient monitoring.
(iv)
All operatory room and/or recovery personnel who provide clinical care shall
hold a current, appropriate Tennessee license/registration pursuant to
Tennessee Code Annotated, Title 63.
(v) Unlicensed/unregistered personnel may not
be assigned duties or responsibilities that require professional
licensure.
(vi) Notwithstanding the
provisions of subpart (v), duties assigned to unlicensed/unregistered personnel
shall be in accordance with their training, education, and experience and under
the direct supervision of a licensed dentist.
3. Patient evaluation. Patients subjected to
deep sedation/general anesthesia must be suitably evaluated prior to the start
of any sedative procedure. In healthy or medically stable individuals (ASA I,
II) this may be simply a review of their current medical history and medication
use. However with individuals who may not be medically stable or who have a
significant health disability (ASA III, IV) consultation with their primary
care physician or consulting medical specialist is recommended.
4. Dental records. The dental record must
include:
(i) A medical history including
current medications and drug allergies;
(ii) Informed consent for the type of
anesthesia used;
(iii) Baseline
vital signs including blood pressure, pulse and temperature. If determination
of baseline vital signs is prevented by the patient's age, physical resistance
or emotional condition the reason(s) should be documented;
(iv) A time-oriented anesthesia record which
includes the drugs and dosage administered and an interval recording of blood
pressure and pulse;
(v)
Documentation of complications or morbidity; and
(vi) Status of the patient on
discharge.
5.
Monitoring.
(i) Direct clinical observation of
the patient must be continuous;
(ii) Interval recording of blood pressure and
pulse must occur;
(iii) Oxygen
saturation must be monitored continuously by pulse oximeter;
(iv) Continuous EKG monitoring with
electrocardioscope must occur;
(v)
Respirations must be monitored by end tidal CO2 unless precluded or invalidated
by the nature of the patient, procedure, or equipment;
(vi) If anesthetic agents implicated in the
etiology of malignant hyperthermia are used, body temperature must continuously
be monitored; and
(vii) The patient
must be monitored during recovery by trained personnel until stable for
discharge.
6. Emergency
management.
(i) Written protocols must be
established by the dentist to manage emergencies related to deep
sedation/general anesthesia including but not limited to laryngospasm,
bronchospasm, emesis and aspiration, airway occlusion by foreign body, angina
pectoris, myocardial infarction, hypertension, hypotension, allergic and toxic
reactions, convulsions, hyperventilation and hypoventilation. Written protocols
must be kept with the emergency equipment and drugs.
(ii) If anesthetic agents implicated in the
etiology of malignant hyperthermia are used, written protocols to treat the
malignant hyperthermia must be established.
(iii) Training to familiarize the operating
team with these protocols must be periodic and current. Regular staff education
programs and training sessions shall be provided and documented which include
sessions on emergencies, life saving measures, medical equipment, and utility
systems.
(iv) A cardiac
defibrillator or automated external defibrillator must be available.
(v) Equipment and drugs on a list available
from the Board and currently indicated for the treatment of the above listed
emergency conditions must be present and readily available for use. Emergency
protocols must include training in the use of this equipment and these
drugs.
7. Recovery and
discharge.
(i) Patients must be monitored for
adequacy of ventilation and circulation. The dental record must reflect that
ventilation and circulation are stable and the patient is appropriately
responsive prior to discharge.
(ii)
The dental office must develop specific criteria for discharge parameters for
deep sedation/general anesthesia for both adult and pediatric
patients.
(iii) The dental record
must reflect that appropriate discharge instructions were given, and that the
patient was discharged into the care of a responsible adult.
(8)
Continuing education. In order to maintain a limited or comprehensive conscious
sedation or deep sedation/general anesthesia permit, a dentist must:
(a) Maintain current certification in ACLS (a
pediatric dentist may substitute PALS); or
(b) Certify attendance every two (2) years at
a Board-approved course comparable to ACLS or PALS and devoted specifically to
the prevention and management of emergencies associated with conscious sedation
or deep sedation/general anesthesia; and
(c) Obtain a minimum of four (4) hours of
continuing education in the subject of anesthesia and/or sedation as part of
the required forty (40) hours of continuing education for dental licensure.
ACLS or PALS certification shall not be included as any part of the required
four (4) hours.
(9)
Reporting injury or mortality.
(a) A written
report shall be submitted to the board by the dentist within thirty (30) days
of any anesthesia-related incident resulting in patient injury or mortality,
which occurred when the patient was under the care of the dentist and required
hospitalization. In the event of patient mortality, concurrent with a sedation
or anesthesia-related incident, this incident must be reported to the board
within two (2) working days, to be followed by the written report within thirty
(30) days.
(b) A written report
shall include:
1. Description of dental
procedure;
2. Description of
preoperative physical condition of the patient;
3. List of the drugs and dosages
administered;
4. Detailed
description of techniques utilized in administering the drugs;
5. Description of adverse occurrence to
include:
(i) Detailed description of symptoms
of any complications including, but not limited to, onset and type of symptoms
in the patient;
(ii) Treatment
instituted on patient; and
(iii)
Response of the patient to treatment; and
6. Description of the patient's condition on
termination of any procedure undertaken.
(10) Permit process (limited conscious
sedation, comprehensive conscious sedation, deep sedation/general anesthesia).
(a) To obtain a limited or comprehensive
conscious sedation permit or deep sedation/general anesthesia permit, a dentist
must apply on an application form provided by the board and submit the
appropriate fee as established by the board.
(b) The applicant must submit acceptable
proof to the Board:
1. For a limited conscious
sedation permit:
(i) That the educational
requirements of 0460-02-.07(6)(a) 1. are met; and
(ii) Compliance with general Rules
0460-02-.07(6)(b).
2.
For a comprehensive conscious sedation permit:
(i) That the educational requirements of
0460-02-.07(6)(a) 2. are met; and
(ii) Compliance with general Rules
0460-02-.07(6)(b).
3.
For a deep sedation/general anesthesia permit:
(i) That the educational requirements of
0460-02-.07(7)(a) have been met; and
(ii) Compliance with general Rules
0460-02-.07(7)(b).
(c) A permit must be renewed every two (2)
years by payment of the appropriate renewal fee as established by the board and
by certification of the continuing education requirement [ 0460-02-.07(8) ] and
by certification of compliance with the general rules for conscious sedation [
0460-02-.07(6)(b) ] or deep sedation/general anesthesia [ 0460-02-.07(7)(b)
].
(11) Anesthesia
Consultants.
(a) In addition to the Board
Consultant and his/her duties, as provided in Rule
0460-01-.03,
Anesthesia Consultants shall be appointed by the board to assist the board in
the administration of this rule. All Anesthesia Consultants shall be licensed
to practice dentistry in Tennessee and shall all hold current, valid
comprehensive conscious sedation or deep sedation/general anesthesia
permits.
(b) The Anesthesia
Consultants shall be:
1. A
periodontist;
2. A pediatric
dentist;
3. A general
dentist;
4. Two (2) oral and
maxillofacial surgeons;
5. A
dentist anesthesiologist; and
6. A
rotating member who is a licensed general dentist or specialty dentist with a
valid comprehensive conscious sedation or deep sedation/general anesthesia
permit. The term of the rotating member will be two (2) years.
(c) The Anesthesia Consultants
shall advise the Board of Dentistry regarding the continuing education courses,
to be approved by the Board, to satisfy the requirements in subpart
(6)(a)1.(ii), item (6)(a)2.(i)(II) and subparagraph (8)(b).
(12) Facility Permits and
Inspections. A dental facility permit is required of the office where an
anesthesia/sedation permit holder practices dentistry and provides
anesthesia/sedation services. A dental facility permit is separate from a
dentist's individual anesthesia/sedation permit. The dental facility permit
will expire five (5) years from the date of issuance or renewal of the dental
facility permit.
(a) Dentists who currently
hold an anesthesia/sedation permit as of the effective date of this rule shall
apply for a dental facility permit prior to the expiration of their dental
license. Only one dental facility permit is required per location.
(b) Prior to the issuance of a licensee's
initial anesthesia/sedation permit, the Board shall require an on-site
inspection of the dental facility's equipment and drugs to determine if the
requirements of 0460-02-.07(6)(b) and 0460-02-.07(7)(b) have been met.
Compliance with these rules is a condition to obtaining an initial
anesthesia/sedation permit. The cost of the on-site inspection will be the
responsibility of the dental facility.
(c) The individual, organization, or agency
conducting the inspection may also notify the board of other violations
discovered during the inspection. Violations that may have been observed during
the inspection, but not related to equipment and drug requirements may be
separately pursued by the Board.
(d) All dental facilities wherein
anesthesia/sedation may be administered shall be inspected once every five (5)
years beginning from the date of the initial dental facility permit to ensure
that the dental facility has remained in compliance with the requirements of
0460-02-.07(6)(b) and 0460-02-.07(7)(b).
(e) The dental facility will be notified in
writing within 120 days prior to the dental facility permit expiration date of
when the inspection is required. Failure to receive the written notification
does not exempt the dental facility from obtaining an inspection prior to the
expiration of the dental facility permit. The written notice will also include
a Board inspection form to be completed by the individual, organization or
agency conducting the inspection.
(f) The inspection must be performed by an
individual, organization or agency that has been approved by the Board. The
dental facility must complete the inspection prior to the dental facility
permit expiration date. Upon conclusion of the inspection, the dental facility
must receive either a pass or fail recommendation.
(g) The recommendation of the inspection and
Board inspection form must be submitted to both the dental facility and the
Board's administrative office by the individual, organization or agency
conducting the inspection within 30 days after completing the inspection. The
recommendation and Board inspection form can be sent by regular or electronic
mail. The Board is not bound by this recommendation.
(h) The Board consultant will review the
recommendation and Board inspection form to determine whether the dental
facility has passed or failed the inspection. Written notification of the
decision will be provided to the dental facility within 30 days after receipt
of the recommendation and Board inspection form.
(13) Failure upon inspection.
(a) Any dental facility with missing or
malfunctioning equipment or that is not in compliance with 0460-02-.07(6)(b) or
0460-02-.07(7)(b) shall cease administering anesthesia/sedation until all
deficiencies have been remedied.
(b) The dental facility must remedy all
deficiencies within thirty (30) days from receipt of the Board consultant's
decision.
(c) If a dental facility
fails the inspection because of extenuating circumstances, it may submit a
written request for an extension of time to remedy all deficiencies. The
written request must include a complete explanation of the extenuating
circumstances and the dental facility's plan for remedying all deficiencies. If
an extension is granted after the Board consultant's review of the written
request, the Board consultant shall establish the duration of the extension of
time for the dental facility to remedy the deficiencies. The dental facility
shall cease administering anesthesia/sedation until all deficiencies have been
remedied and deemed compliant by the Board consultant. The dental facility must
submit proof of the remedial measures taken to the Board consultant for review.
Once the Board consultant has determined the dental facility is compliant, the
dental facility will be notified by the Board.
(14) In the case of a dentist who practices
as a mobile dental anesthesia provider, an inspection shall be conducted of the
mobile dental anesthesia provider's equipment and drugs required by
0460-02-.07(6)(b) and 0460-02-.07(7)(b).
(15) Exceptions to facility inspections.
(a) An on-site inspection is not required
when anesthesia/sedation is administered in a CODA (Commission on Dental
Accreditation) accredited educational institution, hospital setting or federal
facility.
(b) A dentist may submit
proof of successful completion of the American Association of Oral and
Maxillofacial Surgeons' Office Anesthesia Evaluation in lieu of the on-site
inspection required by 0460-02-.07(12).
Authority: T.C.A. §§
4-5-202,
4-5-204,
63-5-105,
63-5-107,
63-5-108,
63-5-112,
63-5-115, 63-5-117, 635-122, and 63-5-124.