S.F. 2185 Section 1. NEW SECTION . 135S.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Department” means the department of inspections, 4 appeals, and licensing. 5 2. “Director” means the director of inspections, appeals, 6 and licensing, or the director’s designee. 7 3. “Facility” means a hospital as defined in section 135B.1, 8 an ambulatory surgical center as defined in section 135R.1, or 9 a birth center as defined in section 135.131. 10 4. “Health care professional” means an individual licensed 11 under chapter 148 to practice medicine and surgery or 12 osteopathic medicine and surgery, a physician assistant 13 licensed under chapter 148C, a podiatrist licensed under 14 chapter 149, an advanced registered nurse practitioner licensed 15 under chapter 152, an advanced practice registered nurse under 16 chapter 152E, or a pharmacist licensed under chapter 155A. 17 5. “Serious injury” means any of the following: 18 a. A physical or mental impairment that substantially limits 19 one or more of the major life activities of an individual or a 20 loss of bodily function, if the impairment or loss lasts more 21 than seven days or is still present at the time of discharge 22 from an inpatient health care facility. 23 b. The loss of a body part. 24 6. “Serious reportable event” or “event” means an event on 25 the list of serious reportable events endorsed by the national 26 quality forum. 27 7. “Surgery or other invasive procedure” includes the 28 treatment of disease, injury, or deformity by manual or 29 operative methods, including invasive testing. 30 Sec. 2. NEW SECTION . 135S.2 Facility reporting 31 requirements. 32 1. Each facility shall report to the director the occurrence 33 of a serious reportable event as soon as is reasonably and 34 practicably possible, but no later than fifteen working days 35 -1- LSB 5650XS (5) 91 lh/jh 1/ 8

S.F. 2185 after discovery of the event. 1 2. The report shall be filed in a format specified by 2 the director and shall identify the facility but shall not 3 include any identifying information for any of the health care 4 professionals, facility employees, or patients involved. 5 3. The director may consult with experts and organizations 6 familiar with patient safety when developing the format for 7 reporting and in further defining serious reportable events in 8 order to be consistent with industry standards. 9 Sec. 3. NEW SECTION . 135S.3 Root cause analysis and 10 corrective action plan. 11 1. Following the occurrence of a serious reportable event, a 12 facility shall conduct a root cause analysis of the event. 13 2. Following the analysis, the facility shall do one of the 14 following: 15 a. Implement a corrective action plan to address the 16 findings of the analysis. 17 b. Report to the director any reasons for not taking 18 corrective action. 19 3. If the root cause analysis and the implementation of a 20 corrective action plan are already completed at the time an 21 event is required to be reported, the findings of the analysis 22 and the corrective action plan shall be included in the report 23 of the event. 24 4. If the root cause analysis is completed, but 25 implementation of a corrective action plan is not completed at 26 the time an event is required to be reported, the findings of 27 the root cause analysis and a copy of the proposed corrective 28 action plan shall be filed with the director within sixty 29 working days of the event. 30 Sec. 4. NEW SECTION . 135S.4 Electronic reporting. 31 1. The director shall design the serious reportable event 32 reporting system to allow a facility to file the reports 33 required under this chapter by electronic means. 34 2. The director shall encourage a facility to use the 35 -2- LSB 5650XS (5) 91 lh/jh 2/ 8

S.F. 2185 electronic filing option when that option is feasible for the 1 facility. 2 Sec. 5. NEW SECTION . 135S.5 Relation to other law and 3 duties —— confidentiality of data. 4 1. Upon the occurrence of a serious reportable event, 5 if prior to or during a root cause analysis of the serious 6 reportable event a facility determines the serious reportable 7 event may constitute child abuse or dependent adult abuse, 8 the facility shall inform persons within the facility who are 9 mandatory reporters of child abuse under section 232.69 or 10 dependent adult abuse under section 235B.3. 11 2. a. If a serious reportable event is reported by a 12 facility in compliance with this chapter, no other state agency 13 or licensing board is required to conduct an investigation 14 of or obtain or create investigative data based upon other 15 reports of the same event. This paragraph does not preclude 16 the department from requiring additional reports as deemed 17 necessary by the department. 18 b. If a facility is required to report a serious reportable 19 event pursuant to another state law that meets the requirements 20 for compliance with this chapter, the department shall 21 recognize the report as compliance with this chapter in lieu of 22 a report made under this chapter if the department is provided 23 a copy of the report. 24 3. a. Data contained in the following records are 25 confidential records under section 22.7: 26 (1) Reports of serious reportable events made to the 27 director by a professional licensing board. 28 (2) Serious reportable event reports, findings of root 29 cause analyses, and corrective action plans filed by a facility 30 under this chapter. 31 (3) Records created or obtained by the director in reviewing 32 or investigating the reports, findings, and corrective action 33 plans under subparagraph (2). 34 b. For purposes of this subsection, the reporting facility 35 -3- LSB 5650XS (5) 91 lh/jh 3/ 8

S.F. 2185 is the subject of the report or data under chapter 22. 1 Sec. 6. NEW SECTION . 135S.6 Director duties and 2 responsibilities —— penalties. 3 1. The director shall establish a serious reportable event 4 reporting system designed to facilitate quality improvement 5 in the health care system. The reporting system shall not 6 be designed to punish errors by health care professionals or 7 facility employees. 8 2. The reporting system shall require and consist of all of 9 the following: 10 a. Mandatory reporting by facilities of serious reportable 11 events. 12 b. Mandatory completion of a root cause analysis and a 13 corrective action plan by the facility, and the reporting of 14 the findings of the analysis and the plan to the director, or 15 the reporting of reasons for not taking corrective action. 16 c. Analysis of reported information by the director to 17 determine patterns of systemic failure in the health care 18 system and successful methods to correct the failures. 19 d. Sanctions against facilities for failure to comply with 20 reporting system requirements. 21 e. Communication from the director to facilities, health 22 care consumers, and the public to maximize the use of the 23 reporting system to improve health care quality. 24 3. In establishing the serious reportable event reporting 25 system, the director shall not select from or between alternate 26 acceptable medical practices. 27 4. The director shall do all of the following: 28 a. Analyze serious reportable event reports, corrective 29 action plans, and findings of the root cause analyses to 30 determine patterns of systemic failure in the health care 31 system and successful methods to correct these failures. 32 b. Communicate to individual facilities the director’s 33 conclusions, if any, regarding a serious reportable event 34 reported by a facility. 35 -4- LSB 5650XS (5) 91 lh/jh 4/ 8

S.F. 2185 c. Communicate with relevant health care facilities any 1 recommendations for corrective action resulting from the 2 director’s analysis of submissions from facilities. 3 d. Publish an annual report, available on the internet site 4 of the department that does all of the following: 5 (1) Describes, by facility type, serious reportable events 6 reported by facilities. 7 (2) Outlines, in aggregate, the findings of root cause 8 analyses and corrective action plans. 9 (3) Makes recommendations for modifications of state health 10 care operations. 11 5. a. The director shall take steps necessary to determine 12 if required serious reportable event reports, the findings of 13 the root cause analyses, and corrective action plans are filed 14 in a timely manner. 15 b. The director may do any of the following: 16 (1) Sanction a facility for failure to file a timely 17 serious reportable event report, conduct a root cause analysis, 18 implement a corrective action plan, or provide the findings of 19 a root cause analysis or corrective action plan in a timely 20 fashion. 21 (2) Place conditions on the license under which a facility 22 operates if the facility fails to develop and implement a 23 corrective action plan, or report to the director the reason a 24 corrective action is not needed. 25 6. The director may collaborate with the department of 26 health and human services to administer this section. 27 Sec. 7. NEW SECTION . 135S.7 Reports from licensing boards. 28 1. The board of medicine, the board of physician assistants, 29 the board of nursing, the board of pharmacy, and the board of 30 podiatry shall maintain a record of all complaints that come 31 to the attention of the respective board that in the judgment 32 of the board qualify as a serious reportable event. Within 33 thirty working days of making a determination that an event 34 qualifies as a serious reportable event, the respective board 35 -5- LSB 5650XS (5) 91 lh/jh 5/ 8

S.F. 2185 shall forward a report of the event to the director, including 1 the name and address of the facility involved, the date of the 2 event, and information known to the board regarding the event. 3 The report shall not include any identifying information of 4 any health care professional, facility employee, or patients 5 involved. 6 2. The director shall forward a report received under 7 subsection 1 to the facility named in the report. 8 3. a. The facility shall determine whether the event 9 has been previously reported under this chapter, and shall 10 notify the director as to whether the event has been previously 11 reported. 12 b. If the event has not been previously reported, the 13 facility shall make a determination whether the event is 14 reportable under this chapter. If the facility determines the 15 event is reportable, the date of discovery of the event for 16 purposes of this chapter shall be as follows: 17 (1) If the director determines the facility knew or 18 reasonably should have known about the occurrence of the event, 19 the date the event occurred shall be the date of discovery 20 of the event and the facility shall be considered out of 21 compliance with this chapter. 22 (2) If the director determines the facility did not know 23 about the occurrence of the event, the date the facility 24 receives the report from the director shall be the date of 25 discovery of the event. 26 c. If the facility determines the event was not reportable 27 under this chapter, the facility shall notify the director of 28 that determination. 29 EXPLANATION 30 The inclusion of this explanation does not constitute agreement with 31 the explanation’s substance by the members of the general assembly. 32 This bill relates to the reporting of serious reportable 33 events by facilities including hospitals, ambulatory surgical 34 centers, and birth centers. 35 -6- LSB 5650XS (5) 91 lh/jh 6/ 8

S.F. 2185 The bill requires each facility to report to the director 1 (director) of the department of inspections, appeals, and 2 licensing (DIAL) the occurrence of a serious reportable 3 event as soon as is reasonably and practicably possible, 4 but no later than 15 working days after discovery of the 5 event. Reports shall be filed in a format specified by the 6 director of DIAL and shall identify the facility but shall not 7 include any identifying information for any of the health care 8 professionals, facility employees, or patients involved. 9 The bill requires that following the occurrence of a serious 10 reportable event, a facility shall conduct a root cause 11 analysis of the event and shall either implement a corrective 12 action plan or report to the director any reasons for not 13 taking corrective action. 14 The director shall design the serious reportable event 15 reporting system to allow a facility to file the required 16 reports by electronic means and shall encourage a facility to 17 use the electronic filing option when that option is feasible 18 for the facility. 19 Upon the occurrence of a serious reportable event, if prior 20 to or during a root cause analysis the facility determines 21 the serious reportable event may constitute child abuse or 22 dependent adult abuse, the facility shall inform persons within 23 the facility who are mandatory reporters of child abuse and 24 dependent adult abuse. 25 Additionally, if a serious reportable event is reported 26 by a facility, no other state agency or licensing board is 27 required to conduct an investigation of or obtain or create 28 investigative data based upon other reports of the same event. 29 DIAL is not precluded from requiring additional reports as 30 deemed necessary by DIAL. If a facility is required to report 31 a serious reportable event pursuant to another state law that 32 meets the requirements for compliance with the bill, DIAL shall 33 recognize the report in lieu of a report made under the bill if 34 DIAL is provided a copy of the report. 35 -7- LSB 5650XS (5) 91 lh/jh 7/ 8

S.F. 2185 Reports of serious reportable events made to the director 1 by a professional licensing board; serious reportable event 2 reports, findings of root cause analyses, and corrective action 3 plans filed by a facility under the bill; and records created 4 or obtained by the director in reviewing or investigating the 5 reports, findings, and corrective action plans are confidential 6 records under Code section 22.7. 7 The director shall establish a serious reportable event 8 reporting system requiring certain information as detailed in 9 the bill. 10 The director shall take action relating to serious 11 reportable events as described in the bill. 12 The director may collaborate with the department of health 13 and human services to administer the director’s duties and 14 responsibilities. 15 The bill requires the boards of medicine, physician 16 assistants, nursing, pharmacy, and podiatry to maintain 17 a record of complaints that come to the attention of the 18 respective board and are determined to qualify as serious 19 reportable events. Within 30 working days of making a 20 determination that an event qualifies as a serious reportable 21 event, the respective board shall forward a report of the event 22 to the director. The director shall then forward the report 23 to the facility named in the report and the facility shall 24 determine whether the event has been previously reported and 25 shall notify the director as detailed in the bill. 26 -8- LSB 5650XS (5) 91 lh/jh 8/ 8