BILL ANALYSIS Ó
AB 2235
Page 1
Date of Hearing: April 5, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
AB 2235
(Thurmond) - As Amended March 31, 2016
SUBJECT: Board of Dentistry: pediatric anesthesia: committee.
SUMMARY: Requires the Dental Board of California (DBC), on or
before March 31, 2017, to establish a committee to investigate
current laws and regulations for the use of pediatric anesthesia
in dentistry; requires the committee, on or before September 1,
2017 to review all pediatric anesthesia incidents between the
years of 2011 and 2016 and further requires the committee to
review the policies of other states and dental associations, as
specified; provides that the committee makes recommendations to
the DBC on measures to reduce potential injury or death;
provides that the DBC submit a report to the Legislature on or
before January 1, 2018, detailing the committee's
recommendations and specifies that this report be made
publically available; requires a dentist who is permitted to
administer general anesthesia or deep sedation to obtain written
informed consent, as specified.
EXISTING LAW:
1)Provides that the DBC and the Dental Practice Act licenses and
regulates those engaged in the practice of dentistry.
(Business and Professions Code (BPC) §1600 et seq.)
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2)Authorizes all committees of the DBC to evaluate all
suggestions or requests for regulatory changes related to
their committee, and requires the committees to include in any
report regarding a proposed regulatory change, at a minimum,
the specific language or the proposed change or changes and
the reasons therefor and any facts supporting the need for the
change. (BPC §1601.3)
3)Defines "dentistry" as the diagnosis or treatment, by surgery
or other method, of diseases and lesions and the correction of
malpositions of the human teeth, alveolar process, gums, jaws,
or associated structures; and such diagnosis or treatment may
include all necessary related procedures as well as the use of
drugs, anesthetic agents, and physical evaluation. (BPC §1625)
4)Defines "general anesthesia," as a controlled state of
depressed consciousness or unconsciousness, accompanied by
partial or complete loss of protective reflexes, produced by a
pharmacologic or nonpharmacologic method, or a combination
thereof. (BPC §1646)
5)Provides that that the educational standards presently
required for general anesthesia should be required when the
degree of sedation in the continuum of sedation is such that
there is a reasonable possibility that loss of consciousness
may result, even if unintended. These degrees of sedation have
been referred to as "deep sedation" and "light general
anesthesia" in dental literature. (BPC §1647(c))
6)Provides that a licensed physician and surgeon may administer
general anesthesia in the office of a licensed dentist for
dental patients, without regard to whether the dentist
possesses a permit if he or she possesses a current license in
good standing to practice medicine in this state, and holds a
valid general anesthesia permit issued by the DBC, as
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specified. (BPC §1646.9(a))
7)Requires an applicant for a permit to administer general
anesthesia or order the administration of general anesthesia
by a nurse anesthetist must be a licensed dentist in
California who:
a) Has completed a residency program in general anesthesia
at least one calendar year; or,
b) Has completed a graduate program in oral and
maxillofacial surgery which has been approved by the
Commission on Dental Accreditation. (Title 16, California
Code of Regulations Section (16 CCR) 1043.1)
8)Provides that the office in which general anesthesia is
conducted must meet standards of facility and equipment,
records maintenance, and emergency drugs on hand, as
specified. (16 CCR 1043.3)
9)Provides that a dental procedure utilizing general anesthesia
administered by an applicant for a general anesthesia permit
must be observed and evaluated for his or her demonstration
that he or she has knowledge of the uses of the equipment
required by 16 CCR 1043.3(a) and is capable of using that
equipment. (16 CCR 1043.4(a))
10)Provides that an applicant for a general anesthesia permit
must have knowledge of and must physically demonstrate that
the applicant (i.e. dentist) and his or her operating team can
respond to simulated emergencies, as specified. (16 CCR
1043.4)
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11)Provides that a general anesthesia permit must be renewed
biennially upon certification by the permit holder that he or
she has met all applicable continuing education requirements,
has paid the required fee and if required, has successfully
completed an onsite inspection and evaluation. (16 CCR 1043.8)
12)Requires a physical evaluation and medical history to be
taken before the administration of conscious sedation, and
further requires a dentist holding a permit to maintain
records of the physical evaluation, medical history, and
conscious sedation procedures used as required by board
regulations. (BPC §1647.6)
13)Provides that it is unprofessional conduct for a dentist to:
(BPC §1682)
a) Perform dental procedures having more than one patient
undergoing conscious sedation or general anesthesia, on an
outpatient basis at any given time, unless each patient is
being continuously monitored on a one-to-one ratio while
sedated by either the dentist or another licensed health
professional authorized by law to administer conscious
sedation or general anesthesia.
b) Fail to have the patients recovering from conscious
sedation or general anesthesia closely monitored by
licensed health professionals experienced in the care and
resuscitation of patients recovering from conscious
sedation or general anesthesia. If one licensed
professional is responsible for the recovery care of more
than one patient at a time, all of the patients must be
physically in the same room to allow continuous visual
contact with all patients and the patient to recovery staff
ratio should not exceed three to one.
c) Fail to have patients who are undergoing conscious
sedation continuously monitored during the dental procedure
with a pulse oximeter or similar or superior monitoring
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equipment required by the board.
d) Have dental office personnel, who are not certified in
basic cardiac life support (CPR) and recertified
biennially, directly involved with the care of those
patients who are undergoing conscious sedation.
e) Fail to obtain the written informed consent of a patient
prior to administering general anesthesia or conscious
sedation. In the case of a minor, the consent must be
obtained from the child's parent or guardian.
14)Requires a dentist, registered dental hygienist, registered
dental hygienist in alternative practice, or registered dental
hygienist in extended functions to report to the board all
deaths occurring in his or her practice with a copy sent to
the Dental Hygiene Committee of California if the death was
the result of treatment by a licensed dentistry professional,
as specified. (BPC §1680(z))
15)States that for general anesthesia, conscious sedation or
oral conscious sedation, a minimally depressed level of
consciousness should be maintained for that a very young or
handicapped individual incapable of the usually expected
verbal response. (BPC §§1647.1(c), 1647.10(2) and 1647.18(2))
THIS BILL:
1)Requires the Dental Board of California (DBC), on or before
March 31, 2017, to establish a committee to investigate
current laws and regulations for the use of pediatric
anesthesia in dentistry.
2)Requires the committee, on or before September 1, 2017 to
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review all pediatric anesthesia incidents between the years of
2011 and 2016 and further requires the committee to review the
policies of other states and dental associations.
3)Requires the committee, on or before January 1, 2018, to make
recommendations to the DBC measures to reduce potential injury
or death of minors.
4)Requires the DBC to report, on or before January 1, 2018, to
the Legislature committee's recommendations and make this
report publically available on its Internet Web site.
5)Requires a dentist who is permitted to administer general
anesthesia or deep sedation to obtain written informed consent
of a minor patient's parent or guardian on a form or forms
approved the DBC that contains information regarding:
a) Increased risk associated with one person simultaneously
administering general anesthesia or deep sedation and
performing the dental procedure, and
b) Increased risk associated with deviating from the use of
monitoring technologies that are recommended by the
American Academy of Pediatric Dentists.
6)Specifies that administering general anesthesia or deep
sedation includes, but is not limited to, directing the
administration of general anesthesia or deep sedation,
7)Provides that the information listed in the informed consent,
in the case of a minor, is not to be construed as reasonable
standard of care administering general anesthesia or deep
sedation.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
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Legislative Counsel.
COMMENTS:
Purpose. According to the author, "Dentists, including oral
surgeons, are administering anesthesia, including general
anesthesia and sedation, more frequently to children and are
using more powerful drugs in their procedures. Dentists are also
the only healthcare professionals allowed to perform procedures
while simultaneously administering anesthesia. Other healthcare
professions require a separate person extensively trained in
anesthesia, to administer anesthesia and to monitor the patient.
Dentists are also less likely to use recommended monitoring
technologies, such as capnography or EKG, when administering
anesthesia. As a result, there are a disproportionate number of
deaths and injuries, especially of children, linked to dental
anesthesia.
To date, data collection regarding the administration of
anesthesia while performing dental operations has been
unscientific, unreliable, and inaccessible. Based on their
experience with medical professionals, parents do not understand
their children are being exposed to additional risks when
anesthesia is administered during a dental procedure."
It is the intent of the author, as this bill moves forward, to
make the anonymized data collected in the DBC's review of
pediatric anesthesia in dentistry available to the public and to
facilitate the epidemiological study of pediatric anesthesia and
sedation. The author wishes to establish and maintain a database
of adverse events related to pediatric anesthesia and sedation
in outpatient settings.
Use of Anesthesia. Pursuant to BPC §1647(a), the Legislature
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has found, "a commendable patient safety record has been
maintained in the past by dentists and those other qualified
providers of anesthesia services who, pursuant to a dentist's
authorization, administer patient sedation, and that the
increasing number of pharmaceuticals and techniques used to
administer them for patient sedation require additional
regulation to maintain patient safety in the future."
Previous to 1980, state laws described separate and distinct
definitions for general anesthesia and the state of
consciousness. Since then, the Legislature has declared that
there exists a continuum of consciousness that may not be
predictable in every case. However, in most instances, the
level of consciousness is correlated with the level of sedation.
According to the author, hard data for the use of pediatric
anesthesia in dentistry related incidents of injury or death, is
unavailable or inaccessible from the DBC.
Currently, the state does not delineate the minimum number of
people involved in administering general anesthesia during a
dental procedure, only that the operating room be large enough
to accommodate at least three people. The author cites more
than 20 states that require a person to solely monitor the vital
signs of a patient while a separate person performs the dental
procedure. The author also asserts that other health professions
that administer general anesthesia are required to have the same
model.
DBC Subcommittee. On February 8, 2016, the Chair of the Senate
Committee on Business, Professions and Economic Development
(BPED) sent a letter to DBC requesting that the DBC form a
subcommittee to investigate pediatric anesthesia in dentistry,
and requested that information from that investigation be
reported back to the BPED Committee no later than January 1,
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2017.
According to the DBC, at its March 4th, board meeting, a
subcommittee was voluntarily created, pursuant to the request of
the Chair of the BPED Committee, and two members were appointed
to the subcommittee by the DBC Chair, Dr. Morrow: 1) Dr. Bruce
Whitcher (Oral and Maxillofacial Surgeon), and 2) Ms. Meredith
McKenzie (attorney and public member).
The subcommittee is charged with reviewing all incident reports
related to pediatric anesthesia in California for the years 2011
through 2016, inclusive. The subcommittee will also assess the
policies used by other states and dental associations to ensure
that California is protecting young patients.
ARGUMENTS IN SUPPORT:
PDI Surgery Center writes in support, "There is no reason that
the California Dental Board should not have patient safety,
especially for children, as its first priority. To enable the
Dental Board to make the right decisions concerning how to
improve patient safety, it needs information about what is
happening during adverse events with dental anesthesia. I
support creating a database of adverse events that is publicly
available to facilitate epidemiological study of dental
anesthesia. We also support requiring dentists accurately to
inform patients, or their parents or guardians, of the risks
associated with having the same person perform a procedure and
administer anesthesia, or of failing to use appropriate
monitoring technologies. Many people believe that general
anesthesia and sedation is safe, because in many instances it is
safe. But those instances involve a person whose only job during
the procedure is to administer the anesthesia and monitor the
patient. The American Society of Anesthesiology has specifically
warned against having the same person perform a procedure and
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administer anesthesiology. Patients should be clearly informed
if their dentist is not going to follow that basic safety
requirement. Patients should also be clearly informed if their
dentist is not using proper monitoring technology."
California Society of Anesthesiologists write in support, "We
strongly believe that the standard of care regarding the
administration and monitoring of anesthesia services must be
consistent whether that patient is six or 60 or receiving
anesthesia care in a dentist office, ambulatory surgery center,
or acute care hospital"
ARGUMENTS IN OPPOSITION:
California Dental Association writes in opposition, "The DBC's
urgent attention to this issue, combined with its recent
disciplinary action for the incident prompting this legislation,
negates the need for [the] amendments. These amendments step out
ahead of the review and would hinder meaningful solutions that
could come from a thoroughly researched and vetted DBC
recommendation.
Oral and Facial Surgeons of California writes in opposition,
"The declaratory statements in [these] amendments cannot be
factually substantiated. In addition, codifying technologies of
a private professional health association is very problematic
and is not an established legislative practice."
POLICY ISSUE(S) FOR CONSIDERATION:
1)The committee established by this bill is charged with
reviewing incidents, as specified, in California, the policies
and procedures of this state, as well as the policies of other
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states and dental associations. In order to gain a
comprehensive understanding of the use of pediatric anesthesia
in dentistry, the author may wish to consider including
studies published about pediatric anesthesia.
2)For purposes of the Dental Practice Act, a "minor patient" is
one who is younger than 13 years of age. In many other
related professions, namely the medical field, a pediatric
patient is one who is younger than 18 years of age, unless
otherwise specified. In addition, Family Code 6500 et seq.
defines a minor as an individual who is under 18 years of age.
The author may wish to consider expanding the committee's
research to include patients who are not minors according to
the Dental Practice Act, but are statutorily defined as minors
in other instances.
3)It is unclear what influenced the decision for reviews to only
cover the past five years. The author may wish to expand this
review to include all incidents on record with the DBC in
order to provide a more comprehensive report of incidents.
4)Should this bill be enacted, a permanent committee will be
established within the DBC. It is unclear whether the current
voluntary subcommittee will be converted to the permanent
committee mandated by this bill, or if a new committee will be
formed in addition to the subcommittee.
5)The membership of the committee is not specified in this bill;
however, the DBC's voluntary subcommittee is currently
comprised of an oral and maxillofacial surgeon and an
attorney. The data collected in the committee's review may
shed light on the use of pediatric anesthesia in dentistry,
which directly involves the scope of practice of a dental
anesthesiologist. As such, the author may wish to request
that the DBC include a dental anesthesiologist.
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6)Some national professional organizations recommend that while
a person performs a dental procedure involving general
anesthesia or deep sedation, a separate person should solely
monitor the vital signs of the patient. However, not all
professional associations agree that a separate person is
necessary because a dentist who has been granted a general
anesthesia permit by the DBC has extensive training in
administering general anesthesia and associated response to
emergency situations. Currently, data to substantiate either
model (i.e. a single operator-anesthetist or a separate person
to solely monitor vital signs) is difficult to access or is
inconsistent. The goal of the committee is to review the data
related to pediatric anesthesia in dentistry and make it
publically available through a report to the DBC and the
Legislature.
AMENDMENTS:
1)To address the issue of breadth, the author should amend the
bill as follows:
On page 3, line 4, after "dental associations" insert "as
well as studies regarding the use of pediatric anesthesia"
2)The report that the DBC submits to the legislature should
have, at minimum, anonymized patient information regarding his
or her demographic, primary diagnosis and conditions of the
procedure. The author should amend the bill as follows:
On page 3, line 18, strike "Web site." and insert
"Web site, and shall include, but is not limited to, the
following anonymized demographic data of each patient
reviewed: his or her age, weight and sex; his or her
primary diagnosis; the procedures performed; the sedation
setting; the medications used; the monitoring equipment
used; the provider responsible for sedation oversight; the
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provider delivering sedation; the provider monitoring the
patient during sedation; whether the sedation supervision
performed one or more of the procedures."
3)The information gathered in the committee's review will be a
snapshot of information regarding the incidents of deaths
connected to pediatric anesthesia. In order for the DBC to
continue monitoring the use of pediatric anesthesia, a report
of pediatric deaths related to general anesthesia or deep
sedation in dentistry should be submitted each time the DBC is
reviewed pursuant to BPC Section 1601.1(d). The author should
amend the bill as follows:
After Section 1601.4, insert
"The board shall provide a report on pediatric deaths related to
general anesthesia or deep sedation in dentistry at the time of
its regular review as referenced in Business and Professions
Code Section 1601.1(d)."
4)The committee should be allowed to conduct its review and
submit its findings to the DBC and the Legislature in order to
provide evidence of greater risk involving a single person
administering anesthesia while simultaneously performing the
dental procedure. Additionally, the recommendations provided
by the AAPD may change without regard to state law. The author
should amend the bill as follows:
On page 4, lines 9-10, strike "be obtained from the child's
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parent or guardian." and insert "contain the following
information:"
and on page 4, strike lines 14-22 and insert
"All sedation and anesthesia medications involve risks of
complications and serious possible damage to vital organs
such as the brain, heart, lung, liver, and kidney, and in
some cases use of these medications may result in
paralysis, cardiac arrest, or death from both known and
unknown causes. As such, use of appropriate monitoring
equipment, as referenced in Business and Professions Code
Section 1682(c), is required."
REGISTERED SUPPORT:
PDI Surgery Center
California Society of Anesthesiologists
39 individuals
REGISTERED OPPOSITION:
California Dental Association
Oral and Facial Surgeons of California
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Analysis Prepared by:Gabby Nepomuceno / B. & P. / (916) 319-3301