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.) AB 2235 Page 2 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 AB 2235 Page 3 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) AB 2235 Page 4 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 AB 2235 Page 5 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 AB 2235 Page 6 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 AB 2235 Page 7 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 AB 2235 Page 8 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, AB 2235 Page 9 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 AB 2235 Page 10 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 AB 2235 Page 11 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. AB 2235 Page 12 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 AB 2235 Page 13 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 AB 2235 Page 14 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 AB 2235 Page 15 Analysis Prepared by:Gabby Nepomuceno / B. & P. / (916) 319-3301