BILL ANALYSIS Ó AB 2235 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 2235 (Thurmond) As Amended August 16, 2016 Majority vote -------------------------------------------------------------------- |ASSEMBLY: | |(April 28, |SENATE: |38-0 |(August 18, | | | |2016) | | |2016) | | | | | | | | | | | | | | | -------------------------------------------------------------------- (vote not relevant) Original Committee Reference: B. & P. SUMMARY: Declares the Legislature's intent that the Dental Board of California (DBC) encourage dental sedation providers in this state to submit data regarding pediatric sedation events to a research database in order to improve the quality of services provided to pediatric dental anesthesia patients, as specified; requires the DBC, on or before January 1, 2017, to provide a report to the Legislature on whether current statutes and regulations for the administration and monitoring of pediatric anesthesia in dentistry provides adequate protection of pediatric dental patients; specifies the minimum information that a licensee must report to the DBC in the event of a death of his or her patient or removal of a sedation or anesthesia patient to a hospital or emergency center for medical treatment, AB 2235 Page 2 except as specified, and defines the categories of providers that are required to be specified; specifies that the information provided in this report is not an admission of guilt; authorizes the DBC to assess a fine on any licensee that fails to report an adverse event within a seven-day period and provides that the licensee may dispute a penalty within ten days; and, specifies the minimum information that a licensee include on the written informed consent in the case of a minor. The Senate amendments delete the Assembly version of this bill, and instead: 1)Declare the Legislature's intent that the DBC encourage all dental sedation providers in this state to submit data regarding pediatric sedation events to a research database maintained by a nonprofit organization to formulate a systems-based approach to improve the quality of services provided to pediatric dental anesthesia patients in outpatient settings. 2)Require the DBC, on or before January 1, 2017, to make provide a report to the Legislature on whether current statutes and regulations for the administration and monitoring of pediatric anesthesia in dentistry provides adequate protection of pediatric dental patients and requires that this report be made available on the DBC's Internet Web site. 3)Specify the minimum information that a licensee must report to the DBC within a seven-day reporting period of an a death of his or her patient or the removal of a sedation or anesthesia patient to a hospital or emergency center for medical treatment, except as specified, is required to include, but not limited to: a) The date of the procedure; the patient's age in years and months, weight, and sex; the patient's American Society AB 2235 Page 3 of Anesthesiologists (ASA) physical status; the patient's primary diagnosis; the patient's coexisting diagnoses; the procedures performed; the sedation setting; the medications used; the monitoring equipment used; b) The category of the provider responsible for sedation oversight; the category of the provider delivering sedation; the category of the provider monitoring the patient during sedation; whether the person supervising the sedation performed one or more of the procedures; c) The planned airway management; the planned depth of sedation; the complications that occurred; a description of what was unexpected about the airway management; whether there was transportation of the patient during sedation; d) The category of the provider conducting resuscitation measures; and, the resuscitation equipment utilized. 4)Provide that the disclosure of individually identifiable patient included in this report is limited to applicable law. 5)Provide that that this report is not admissible in any action brought by a patient of the licensee providing the report. 6)Define the categories of providers as General Dentist, Pediatric Dentist, Oral Surgeon, Dentist Anesthesiologist, Physician Anesthesiologist, Dental Assistant, Registered Dental Assistant, Dental Sedation Assistant, Registered Nurse, Certified Registered Nurse Anesthetist, or Other. 7)Specify that the information provided in this report is not an admission of guilt. AB 2235 Page 4 8)Authorize the DBC to assess a fine on any licensee that fails to report an adverse event not reported after the initial seven-day reporting period; provides that the licensee may dispute the failure to file a penalty within 10 days of receiving notice of the penalty. 9)Require 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 the following information: a) "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 or her dental treatment, and consult with your dentist or pediatrician as needed." b) 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: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, this bill will result in negligible state costs. 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 AB 2235 Page 5 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." Background. Use of Anesthesia. 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. 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, 2017. The DBC voluntarily created subcommittee, pursuant to the request of the Chair of the BPED Committee. The subcommittee is charged with reviewing all incident reports related to pediatric anesthesia in California for the years 2011 through 2016, inclusive, and will also assess the policies used by other states and dental associations to ensure that California is AB 2235 Page 6 protecting young patients. According to the DBC, "Over the last several months, a two-person subcommittee of the [DBC] has been doing a great deal of research into whether or not California's present laws, regulations, and policies are sufficient to provide protection of pediatric patients during dental sedation; reviewing the present laws, regulations, and policies in California and comparing these findings not only with the information available in other states, but also with dental associations' policies related to sedation. In addition, [the DBC] staff has been compiling six years of statistics (January 1, 2010-December 31, 2015) related to incidents that have occurred where all methods of sedation, including oral conscious sedation, conscious sedation, and general anesthesia have been used for pediatric patients 21 years of age and younger. Board staff also included incident reports related to the use of local anesthetic in the statistical analysis." The information is available to interested parties in the form of a "working document"; however, there are no recommendations for statutory and/or regulatory changes from the subcommittee at this time. Stakeholders were invited to meet with the subcommittee on Thursday, July 28, 2016, prior to its August board meeting to discuss the working document. Testimony was taken at this time from interested parties. Following the August meeting, the subcommittee will continue to refine the "working document" based on public comments. A final draft of the report will be submitted to the Board for discussion and possible action at the December 1-2, 2016 board meeting. Analysis Prepared by: Le Ondra Clark Harvey Ph.D. / B. & P. / (916) 319-3301 FN: 0004598 Gabby Nepomuceno AB 2235 Page 7