BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 2235 Hearing Date: June 13,
2016
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|Author: |Thurmond |
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|Version: |June 9, 2016 Amended |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Huchel |
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Subject: Board of Dentistry: pediatric anesthesia: committee
SUMMARY: Requires the Dental Board of California (DBC) to establish a
committee, as specified, to review specified information to
ensure that California's statutes and regulations adequately
protect pediatric dental patients; expands the definition of
unprofessional conduct to include failure to notify the DBC
about an adverse event relating to dental sedation; encourages
DBC to support a third party public database of adverse events;
establishes consent language for the administration of general
anesthesia for a minor dental patient; requires the DBC to
approve a form for the reporting of adverse event information;
and creates a penalty for failure to report information to the
DBC.
Existing law:
1)Establishes the DBC within the Department of Consumer Affairs
to administer the Dental Practice Act. (Business and
Professions Code (BPC) § 1601.1)
2)States that protection of the public shall be the DBC's
highest priority in exercising its licensing, regulatory, and
disciplinary functions. Whenever the protection of the public
is inconsistent with other interests sought to be promoted,
the protection of the public shall be paramount. (BPC §
1601.2)
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3)Defines the practice of "oral and maxillofacial surgery" as
the diagnosis and surgical and adjunctive treatment of
diseases, injuries, and defects which involve both functional
and esthetic aspects of the hard and soft tissues of the oral
and maxillofacial region. (BPC § 1638 (a))
4)Authorizes the DBC to issue an oral and maxillofacial surgery
permit to an applicant who has furnished evidence satisfactory
to the Board that he or she is currently certified or eligible
for certification in oral and maxillofacial surgery by a
specialty board recognized by the Commission on Accreditation
of the American Dental Association and holds a current license
in good standing to practice medicine in the state. (BPC §
1638 (c))
5)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)
6)Requires, for the administration of anesthesia to dental
patients on an outpatient basis, a dentist to either: (BPC §
1646.1 (a))
a) Possess a current license in good standing to practice
dentistry and holds a valid general anesthesia permit
issued by the Board; or,
b) Possesses a current oral and maxillofacial surgery
permit or a permit to perform elective facial cosmetic
surgery and holds a valid general anesthesia permit issued
by the DBC.
7) Requires a dentist ordering the administration of general
anesthesia to be physically within the dental office at the
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time of the administration. (BPC § 1646.1 (b))
8)Authorizes the DBC to require an onsite inspection and
evaluation of the licentiate and the facility, equipment,
personnel, and procedures utilized by the licentiate prior to
the issuance or renewal of a permit for the use of general
anesthesia or conscious sedation. (BPC §§ 1646.4, 1647.7)
9)Requires a dentist holding a permit to administer general
anesthesia to maintain medical history, physical evaluation,
and general anesthesia records as required by DBC regulations.
(BPC § 1646.3)
10)Authorizes a physician and surgeon to administer general
anesthesia in the office of a licensed dentist for dental
patients, without regard to whether the dentist possesses an
anesthesia permit, if the physician and surgeon holds a
current license to practice medicine in California and holds a
valid general anesthesia permit issued by the DBC. (BPC §
1646.9)
11)Defines "conscious sedation" as a minimally depressed level
of consciousness produced by a pharmacologic or
nonpharmacologic method, or a combination thereof, that
retains the patient's ability to maintain independently and
continuously an airway, and respond appropriately to physical
stimulation or verbal command. "Conscious sedation" does not
include the administration of oral medications or the
administration of a mixture of nitrous oxide and oxygen,
whether administered alone or in combination with each other.
(BPC § 1647.1)
12)Requires a dentist administering or ordering the
administration of conscious sedation on an outpatient basis
for dental patients to have either: (BPC § 1647.2(a))
a) A current license in good standing to practice dentistry
in California and either holds a valid anesthesia permit or
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obtains a permit issued by the DBC authorizing the dentist
to administer conscious sedation; or,
b) A current oral and maxillofacial surgery permit or a
permit to perform elective facial cosmetic surgery and
either holds a valid general anesthesia permit or a permit
to administer conscious sedation.
13)Requires a dentist ordering the administration of conscious
sedation to be physically present in the treatment facility
while the patient is sedated. (BPC § 1647.2 (d))
14)Requires a dentist to take a physical evaluation and medical
history prior to the administration of conscious sedation and
oral conscious sedation of a minor, and maintain records of
the physical evaluation, medical history, and conscious
sedation procedures as required by the DBC. (BPC §§ 1647.6,
1647.14)
15)Defines "oral conscious sedation" as a minimally depressed
level of consciousness produced by oral medication that
retains the patient's ability to maintain independently and
continuously an airway, and respond appropriately to physical
stimulation or verbal command. The drugs and techniques used
in oral conscious sedation shall have a margin of safety wide
enough to render unintended loss of consciousness unlikely.
Further, patients whose only response is reflex withdrawal
from painful stimuli would not be considered to be in a state
of oral conscious sedation. (BPC § 1647.10 (a))
16)States that, for very young or handicapped individuals,
incapable of the usually expected verbal response, a minimally
depressed level of consciousness should be maintained. (BPC §
1647.10 (a))
17)Defines a "minor patient" as a dental patient under the age
of 13 years.
(BPC § 1647.10 (b))
18)States that the failure to report to the DBC in writing
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within seven days of any of the following is unprofessional
conduct: (BPC § 1680 (z))
a) The death of his or her patient during the performance
of any dental or dental hygiene procedure;
b) The discovery of the death of a patient whose death is
related to a dental or dental hygiene procedure performed
by him or her; or
c) Except for a scheduled hospitalization, the removal to a
hospital or emergency center for medical treatment for a
period exceeding 24 hours of any patient to whom oral
conscious sedation, conscious sedation, or general
anesthesia was administered, or any patient as a result of
dental or dental hygiene treatment.
This bill:
1)States Legislative intent for the DBC to encourage dental
sedation providers to submit data regarding pediatric sedation
events to a pediatric sedation research database maintained by
a nonprofit organization, with the goal that the data
submitted will be used to formulate a systems-based approach
to improving the quality of services provided to pediatric
dental anesthesia patients in outpatient settings.
2)Requires the DBC to establish a committee to investigate
whether current statutes and regulations for the
administration and monitoring of oral conscious sedation,
conscious sedation, and general anesthesia provide adequate
protection for pediatric dental patients.
3)Establishes the committee as follows, and requires the DBC to
select at least one member of the committee as proposed by the
entities represented by (c), (d), or (f), who, at the time the
lists are provided, who is employed at an accredited dental
school and someone from (d) and/or (f) who holds at least one
sedation permit.
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a) A physician anesthesiologist who holds a general
anesthesia permit from the DBC, chosen from a list provided
by the California Society of Anesthesiologists.
b) A pediatrician, chosen from a list provided by the
American Academy of Pediatrics, California.
c) An oral surgeon, chosen from a list provided by the Oral
and Facial Surgeons of California.
d) A pediatric dentist, chosen from a list provided by the
California Society of Pediatric Dentistry.
e) A dentist who has completed a dental anesthesiology
residency, chosen from a list provided by the American
Society of Dentist Anesthesiologists.
f) A general dentist, chosen from a list provided by the
California Dental Association.
4)Defines a pediatric dental patient as a person under 21 years
old.
5)Requires the committee to do the following to ensure that
California's statutes and regulations adequately protect
pediatric dental patients:
a) Review all incident reports and relevant investigatory
information related to pediatric anesthesia in dentistry in
California for the years 2010 through 2016, by August 1,
2017.
b) Review the policies and guidelines of other states and
national dental associations, and studies regarding the use
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of pediatric anesthesia.
c) Review California's statutory and regulatory definitions
relating to sedation and anesthesia and recommend any
necessary revisions.
d) Not disclose any confidential, privileged, or personally
identifiable information contained in the DBC's records,
except as permitted by law.
6)Requires the committee to present its findings in a report to
the DBC by November 1, 2017, which shall include any
recommendations necessary to improve safety during the
administration and monitoring of oral conscious sedation,
conscious sedation, and general anesthesia for pediatric
dental patients.
7)Requires the DBC to provide the committee's report to the
Legislature with the DBC's evaluation of the report and its
own recommendations.
8)Requires the DBC to post the report on its Internet Web site
and include anonymized data from each incident reviewed, if
available from records in the DBC's possession, custody, or
control, including investigatory reports, as specified.
9)Requires the DBC to provide a report on pediatric deaths
related to general anesthesia in dentistry as part of its
Sunset Review.
10)States that the failure to provide the following written
informed consent language in cases regarding a minor
constitutes unprofessional conduct: "The administration and
monitoring of general anesthesia may vary depending on the
type of procedure, the type of practitioner, the age and
health of the patient and the setting in which anesthesia is
provided. Risks may vary with each specific situation. You
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are encouraged to explore all the options available for your
child's anesthesia for his/her dental treatment, and consult
with your dentist or pediatrician as needed."
11)Prohibits the informed consent language from being construed
to establish the reasonable standard of care for administering
or monitoring oral conscious sedation, conscious sedation, or
general anesthesia.
12)Removes the time period requirement for reporting an incident
to the DBC for a patient who was administered oral conscious
sedation, conscious sedation, or general anesthesia and is
removed to a hospital or emergency center for medical
treatment.
13)Requires the DBC to approve a form for the reporting of
adverse events related to a patient who was administered oral
conscious sedation, conscious sedation, or general anesthesia
that includes specified information.
14)Establishes a penalty of $100 per day for a licensee who
fails to report a specified adverse event to the DBC within
seven days, and allows the licensee to dispute the failure to
file the report within ten days of receiving notice that the
DBC has assessed a penalty.
FISCAL
EFFECT: This bill is keyed "fiscal" by the Legislative Counsel.
According to the Assembly Appropriations Committee analysis
dated April 20, 2015, this bill will have
minor increased staff and IT support costs, under $50,000 per
year for two years, to perform required activities including
tracking and researching incidents, promulgating regulations,
and creating a consent form (State Dentistry Fund).
COMMENTS:
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1. Purpose. This bill is sponsored by the Author. According to
the Author's office, this legislation is necessary to require
the DBC to reevaluate California's statutes and regulations
regarding dental sedation in light of the recent tragedy of a
young boy who died while undergoing dental work. Statutes
haven't been evaluated in over a decade, and the Author
states that "There are legislation and regulations in many
other states that increases the safety of anesthesia and
sedation for dental procedures in outpatient settings. For
example, 20 other states require a third person to
participate in every dental procedure requiring anesthesia or
sedation whose sole responsibility is to monitor patients'
vital signs and direct the anesthesia or sedation. Several
other states also require that dental licentiates use
specific monitoring technologies when administering
anesthesia and sedation. It does not appear, however, that
other states have adopted similar requirements for study and
informed consent."
This bill also requires dentists and oral surgeons to use
specified language in their written consent form and
encourages licensees to participate in a statewide database.
2. Dental Sedation. Current law on dental sedation is largely a
product of recommendations from a 2003 DBC Blue Ribbon panel.
This panel was chaired by a dental anesthesiologist and
consisted of dentists recommended by the following
associations:
California Association of Oral and Maxillofacial
Surgeons
California Dental Association
California Dental Society of Anesthesiology
California Society of Dentist Anesthesiologists
California Society of Pediatric Dentists
California Society of Periodontists
The panel also included dentists using oral sedation
protocols of the Dental Organization for Conscious Sedation.
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These individuals reviewed all pertinent state laws and
regulations pertaining to the delivery of general anesthesia
and sedation services by California dentists, DBC data on
mortalities associated with dentistry, mortality and
morbidity data from The Dentists Insurance Company and the
Southern California Society of Oral and Maxillofacial
Surgeons, recent changes in dental rules and regulations of
other states, various documents and correspondence pertaining
to anesthesia and sedation in the dentist office, and
relevant national guidelines published by the following:
American Academy of Pediatric Dentistry
American Academy of Periodontology
American Association of Oral and Maxillofacial Surgeons
American Dental Association
American Society of Anesthesiologists
1. Current Board Activity. The DBC is currently preparing a
report similar to the one requested in this bill at the
request of Senator Hill. According to a memorandum dated
April 21, 2016 prepared for the DBC's May 2016 board meeting,
a two person subcommittee of the DBC, consisting of an oral
and maxillofacial surgeon and an attorney, was appointed at
the March board meeting to assist staff in conducting the
research.
DBC indicates the report will include the following:
A review of the present laws, regulations, and
policies in California; and a comparison of this
information to other states' and dental associations'
policies.
A review of all incident reports related to
pediatric anesthesia in California for the past five
years. The specific time frame will be July 1, 2010-June
30, 2015 to coincide with the Board reporting of its
annual statistics to the Department of Consumer Affairs.
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Methodology used to review the DBC's incident
reports.
Number of cases reviewed and results of the
review.
Explanation of the DBC's internal policies for
processing notification of violations of Business &
Professions Code 1680(z).
Explanation of the DBC's records retention
policies.
Input from stakeholder groups.
Possible recommendations for statutory or
regulatory changes.
DBC staff plans to submit a draft report to the full DBC
Board at its August 18-19, 2016 meeting during which the
Board and subcommittee will solicit public comment, followed
by a second draft to be presented at the DBC's December 1-2,
2016 board meeting. Senator Hill has asked that a report be
prepared and submitted to the Legislature by January 1, 2017.
1. Prior Related Legislation. AB 1386 (Laird, Chapter 539,
Statutes of 2005) revised the Dental Practice Act relating to
general anesthesia, conscious sedation, and oral conscious
sedation of minors and further establishes specific
provisions relating to oral conscious sedation for adults.
2. Arguments in Support. The Children's Partnership writes,
"Although the Dental Board of California has voluntarily
responded to requests from the Legislature to examine the
issue pediatric dental anesthesia and the best safety
practices of other states, it is entirely appropriate that
this examination be codified, based on actual recent
California epidemiological data, and with the results
reported back to the Legislature for further consideration
and made available to the public on the Board's website, as
required in AB 2235.
"The tragic child death that precipitated introduction of
this bill resulted in a finding of gross negligence on the
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part of the attending dentist, Dental Board discipline, and a
malpractice lawsuit under the current law. But the lack of
current data that might indicate how often such tragedies or
other adverse outcomes occur must be addressed, along with a
reexamination of current safety procedures and medical
protocols. These steps are essential to understanding
whether additional regulation is necessary to prevent child
injury or deaths in the future."
The American Academy of Pediatrics, California is sponsoring
this measure and writes, "AB 2235 would require the
California Dental Board to establish a committee to formally
study the safety of pediatric anesthesia in dental offices
and other states' regulations of those procedures. The bill
would also require licensed dentists who administer
anesthesia to provide information on the differing practices
and safety requirements currently in place. Additionally, the
board should facilitate the epidemiological study of
pediatric anesthesia and sedation by requiring the Dental
Board to collect more information regarding adverse events.
"The National American Academy of Pediatrics supports efforts
to improve regulations and guidelines for sedation used by
medical and dental practitioners for further improvement in
safety and outcomes, as noted in AAP Policy Guidelines for
Monitoring and Management of Pediatric Patients During and
After Sedation."
3. Arguments in Opposition: The Oral and Facial Surgeons of
California (OFSOC) oppose this bill unless amended to remove
the makeup of the committee, stating, "The most recent
amendments require a statutorily prescribed makeup of the
membership of the committee to be established by the Dental
Board of California. OFSOC opposes the perceived stacking of
the committee by healthcare providers who either do not have
an expertise in the pertinent issues; have previously stated
publically of the existence of a serious problem; or have
vested financial interests in changing the status quo. OFSOC
strongly believes the purpose of the proposed committee is to
objectively and reasonably review the available data
regarding dental anesthesia specifically as it relates to
minors and subsequently make appropriate recommendations. In
order to achieve that objectivity, OFSOC prefers that the
Dental Board of California unilaterally establish an
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investigatory committee that will meet the criteria set forth
in the provisions of AB 2235."
The California Dental Association (CDA) expresses support if
the Author accepts the committee amendment below, stating,
"CDA and our community of providers are deeply saddened by
the tragic loss of a young child. CDA is dedicated to
keeping general anesthesia and sedation in dentistry safe and
reducing the risks of adverse outcomes. All patients should
be able to access safe anesthesia and sedation needed to
maintain their oral health. While this bill arose out of a
tragic situation and we must always strive to improve safety,
all proposed solutions must arise from a thorough and
evidence-based process."
4. Recommended Amendment. The Author may wish to consider
removing the amendments prescribing the composition of the
committee, and allowing the DBC to decide the makeup of the
committee. The DBC's efforts to convene stakeholder groups
to evaluate dental issues have proven effective in the past,
and establishing a predetermined cast diminishes the DBC's
authority and responsibility in this area.
SUPPORT AND OPPOSITION:
Support:
American Academy of Pediatrics, California (Sponsor)
American Society of Dentist Anesthesiologists
California Association of Nurse Anesthetists
California Society of Anesthesiologists
The Children's Partnership
Numerous individuals
Support if amended :
California Dental Association
Oppose unless amended :
Oral and Facial Surgeons of California
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