Relating to the reporting of serious reportable events, and providing penalties

Reports shall be filed in a format specified by the director of DIAL and shall identify the facility but shall not include any identifying information for any of the health care professionals, facility employees, or patients involved. The director may consult with experts and organizations familiar with patient safety when developing the format for reporting and in further defining serious reportable events in order to be consistent with industry standards. Serious reportable events under the bill include surgical events, product or device events, patient protection events, care management events, environmental events, potential criminal events, and radiologic events detailed in the bill. The bill requires that following the occurrence of a serious reportable event, a facility shall conduct a root cause analysis of the event, and following the analysis shall either implement a corrective action plan to address the findings of the analysis or report to the director any reasons for not taking corrective action. If the root cause analysis and the implementation of a corrective action plan are already completed at the time an event is required to be reported, the findings of the analysis and the corrective action plan shall be included in the report of the event. If the root cause analysis is completed but the implementation of a corrective action plan is not completed at the time an event is required to be reported, the findings of the root cause analysis and a copy of the proposed corrective action plan shall be filed with the director within days of the event. The director shall design the serious reportable event reporting system to allow a facility to file the required reports by electronic means and shall encourage a facility to use the electronic filing option when that option is feasible for the facility. The bill provides that serious reportable events under the bill do not constitute child abuse or dependent adult abuse and are excluded from the child abuse and dependent adult abuse reporting requirements, if the facility makes a determination within hours of discovery of the serious reportable event that the provisions of the bill apply and the facility files the reports required under the bill in a timely fashion. A facility that determines a serious reportable event has occurred must inform persons within the facility who are mandatory reporters of child abuse or dependent adult abuse. A mandatory reporter otherwise required to report child abuse or dependent adult abuse is relieved of the duty to report an event the facility determines to be a serious reportable event under the bill. The bill does not affect the protections and immunities applicable to reporting of child abuse and dependent adult abuse. Additionally, if a serious reportable event is reported by a facility in compliance with the bill, no other state agency or licensing board is required to conduct an investigation of or obtain or create investigative data based upon other reports of the same event. Also, if a facility is required to report a serious reportable event pursuant to another state law that meets the requirements for compliance with the bill, DIAL shall recognize the report as compliance with the bill in lieu of a report made under the bill if DIAL is provided a copy of the report.7. The director shall establish a serious reportable event reporting system requiring and consisting of mandatory reporting by facilities of the serious reportable events described in the bill; mandatory completion of a root cause analysis and a corrective action plan by the facility, and the reporting of the findings of the analysis and the plan to the director or the reporting of reasons for not taking corrective action; analysis of reported information by the director to determine patterns of systemic failure in the health care system and successful methods to correct these failures; sanctions against facilities for failure to comply with reporting system requirements; and communication from the director to facilities, health care consumers, and the public to maximize the use of the reporting system to improve health care quality. The director shall analyze serious reportable event reports, corrective action plans, and findings of the root cause analyses to determine patterns of systemic failure in the health care system and successful methods to correct these failures; communicate to facilities the director’s conclusions regarding a serious reportable event reported by a facility; communicate with relevant health care facilities any recommendations for corrective action resulting from the director’s analysis of submissions from facilities; and publish an annual report. The director shall take steps necessary to determine if serious reportable event reports, the findings of the root cause analyses, and corrective action plans are filed in a timely manner. The director may sanction a facility for failure to file a timely serious reportable event report, conduct a root cause analysis, implement a corrective action plan, or provide the findings of a root cause analysis or corrective action plan in a timely fashion; or place conditions on the license under which a facility operates if the facility fails to develop and implement a corrective action plan or report to the director the reason a corrective action is not needed. The director may collaborate with the department of health and human services to administer the director’s duties and responsibilities. The bill requires the boards of medicine, physician assistants, nursing, pharmacy, and podiatry to maintain a record of complaints that come to the attention of the respective board, that in the judgment of the board qualify as serious reportable events. Within working days of making a determination that an event qualifies as a serious reportable event, the respective board shall forward a report of the event to the director, including the name and address of the facility involved, the date of the event, and information known to the board regarding the event. The report shall not include any identifying information of any health care professional, facility employee, or patients involved. The director shall then forward the report to the facility named in the report and the facility shall determine whether the event has been previously reported and shall notify the director as to whether the event has been previously reported. If the event has not been previously reported, the facility shall make a determination whether the event is reportable and if it is reportable, the date of discovery of the event, depending on the circumstances, is either the date of discovery or the date the facility receives the report from the director. If the facility determines that the event is not reportable under this Code chapter, the facility shall notify the director of that determination. The bill requires the director to report the list of serious reportable events under the bill to the national quality forum and through the national quality forum to other states. The director shall monitor amendments to the national quality forum’s list of serious reportable events and report any modification to the list to the general assembly. The director shall also monitor efforts in other states to establish a list of serious reportable events and shall make recommendations to the general assembly, as necessary, for modifications to the list under the bill to maximize uniformity with the national list and the lists of other states.