2015 - 2016 Regular Bill No: AB 2235 Hearing Date: June 13, 2016
April 11, 2016
Subject: Board of Dentistry: pediatric anesthesia: committee
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.
Establishes the DBC within the Department of Consumer Affairs to administer the Dental Practice Act. (Business and Professions Code (BPC) § 1601.1)
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)
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))
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))
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)
Requires, for the administration of anesthesia to dental patients on an outpatient basis, a dentist to either: (BPC § 1646.1 (a))
Possess a current license in good standing to practice dentistry and holds a valid general anesthesia permit issued by the Board; or,
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.
Requires a dentist ordering the administration of general anesthesia to be physically within the dental office at the time of the administration. (BPC § 1646.1 (b))
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)
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)
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)
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)
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 current license in good standing to practice dentistry in California and either holds a valid anesthesia permit or obtains a permit issued by the DBC authorizing the dentist to administer conscious sedation; or,
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.
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))
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)
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))
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))
Defines a “minor patient” as a dental patient under the age of 13 years.
(BPC § 1647.10 (b))
States that the failure to report to the DBC in writing within seven days of any of the following is unprofessional conduct: (BPC § 1680 (z))
The death of his or her patient during the performance of any dental or dental hygiene procedure;
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
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.
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.
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.
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.
A physician anesthesiologist who holds a general anesthesia permit from the DBC, chosen from a list provided by the California Society of Anesthesiologists.
A pediatrician, chosen from a list provided by the American Academy of Pediatrics, California.
An oral surgeon, chosen from a list provided by the Oral and Facial Surgeons of California.
A pediatric dentist, chosen from a list provided by the California Society of Pediatric Dentistry.
A dentist who has completed a dental anesthesiology residency, chosen from a list provided by the American Society of Dentist Anesthesiologists.
A general dentist, chosen from a list provided by the California Dental Association.
Defines a pediatric dental patient as a person under 21 years old.
Requires the committee to do the following to ensure that California’s statutes and regulations adequately protect pediatric dental patients:
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.
Review the policies and guidelines of other states and national dental associations, and studies regarding the use of pediatric anesthesia.
Review California’s statutory and regulatory definitions relating to sedation and anesthesia and recommend any necessary revisions.
Not disclose any confidential, privileged, or personally identifiable information contained in the DBC’s records, except as permitted by law.
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.
Requires the DBC to provide the committee’s report to the Legislature with the DBC’s evaluation of the report and its own recommendations.
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.
Requires the DBC to provide a report on pediatric deaths related to general anesthesia in dentistry as part of its Sunset Review.
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 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.”
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.
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.
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.
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.
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).
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.
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. 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
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.
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.
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.
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 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.”
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 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.”
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
Support if amended:
California Dental Association
Oppose unless amended:
Oral and Facial Surgeons of California