H.F. 2215 Section 1. NEW SECTION . 135S.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Director” means the director of inspections, appeals, 4 and licensing, or the director’s designee. 5 2. “Facility” means a hospital as defined in section 135B.1, 6 an ambulatory surgical center as defined in section 135R.1, or 7 a pregnancy resource center. 8 3. “Health care professional” means an individual licensed 9 under chapter 148 to practice medicine and surgery or 10 osteopathic medicine and surgery, a physician assistant 11 licensed under chapter 148C, a podiatrist licensed under 12 chapter 149, an advanced registered nurse practitioner licensed 13 under chapter 152, an advanced practice registered nurse under 14 chapter 152E, or a pharmacist licensed under chapter 155A. 15 4. “Pregnancy resource center” means a nonprofit entity 16 that provides pregnancy support services as defined in section 17 217.41C. 18 5. “Serious injury” means any of the following: 19 a. A physical or mental impairment that substantially limits 20 one or more of the major life activities of an individual or a 21 loss of bodily function, if the impairment or loss lasts more 22 than seven days or is still present at the time of discharge 23 from an inpatient health care facility. 24 b. The loss of a body part. 25 6. “Surgery or other invasive procedure” includes the 26 treatment of disease, injury, or deformity by manual or 27 operative methods, including invasive testing. 28 Sec. 2. NEW SECTION . 135S.2 Facility reporting 29 requirements. 30 1. a. Each facility shall report to the director the 31 occurrence of an applicable serious reportable event described 32 in this section as soon as is reasonably and practicably 33 possible, but no later than fifteen working days after 34 discovery of the event. 35 -1- LSB 5296YH (1) 90 pf/ko 1/ 15

H.F. 2215 b. The report shall be filed in a format specified by 1 the director and shall identify the facility but shall not 2 include any identifying information for any of the health care 3 professionals, facility employees, or patients involved. 4 c. The director may consult with experts and organizations 5 familiar with patient safety when developing the format for 6 reporting and in further defining serious reportable events in 7 order to be consistent with industry standards. 8 2. Serious reportable events under this section include all 9 of the following: 10 a. Surgical events including all of the following: 11 (1) Surgery or other invasive procedure performed on a wrong 12 body part that is inconsistent with the documented informed 13 consent for that patient. Serious reportable events under this 14 subparagraph do not include situations requiring prompt action 15 that occur in the course of surgery or situations whose urgency 16 precludes obtaining informed consent. 17 (2) Surgery or other invasive procedure performed on the 18 wrong patient. 19 (3) The wrong surgery or other invasive procedure performed 20 on a patient that is inconsistent with the documented informed 21 consent for that patient. Serious reportable events under this 22 subparagraph do not include situations requiring prompt action 23 that occur in the course of surgery or situations whose urgency 24 precludes obtaining informed consent. 25 (4) Retention of a foreign object in a patient after surgery 26 or other invasive procedure, excluding objects intentionally 27 implanted as part of a planned intervention and objects present 28 prior to surgery that are intentionally retained. 29 (5) Death during or immediately after surgery or other 30 invasive procedure of a normal, healthy patient who has no 31 organic, physiologic, biochemical, or psychiatric disturbance 32 and for whom the pathologic processes for which the operation 33 is to be performed are localized and do not entail a systemic 34 disturbance. 35 -2- LSB 5296YH (1) 90 pf/ko 2/ 15

H.F. 2215 b. Product or device events including all of the following: 1 (1) Death or serious injury of a patient associated with the 2 use of contaminated drugs, devices, or biologics provided by 3 the facility when the contamination is the result of generally 4 detectable contaminants in drugs, devices, or biologics 5 regardless of the source of the contamination or the product. 6 (2) Death or serious injury of a patient associated with the 7 use or function of a device in patient care in which the device 8 is used or functions other than as intended. “Device” includes 9 but is not limited to catheters, drains, and other specialized 10 tubes, infusion pumps, and ventilators. 11 (3) Death or serious injury of a patient associated with 12 intravascular air embolism that occurs while being cared for 13 in a facility, excluding deaths associated with neurosurgical 14 procedures known to present a high risk of intravascular air 15 embolism. 16 c. Patient protection events including all of the following: 17 (1) Discharge to the wrong person of a patient of any age 18 who does not have decision-making capacity. 19 (2) Death or serious injury of a patient associated with a 20 patient disappearance, excluding events involving adults who 21 have decision-making capacity. 22 (3) Suicide, attempted suicide resulting in serious injury, 23 or self-harm of a patient resulting in serious injury or death 24 of the patient while being cared for in a facility due to the 25 patient’s actions after admission to the facility, excluding 26 the death of a patient resulting from self-inflicted injuries 27 that were the reason for admission to the facility. 28 d. Care management events including all of the following: 29 (1) Death or serious injury of a patient associated with a 30 medication error including but not limited to errors involving 31 the wrong drug, the wrong dose, the wrong patient, the wrong 32 time, the wrong rate, the wrong preparation, or the wrong route 33 of administration, excluding reasonable differences in clinical 34 judgment on drug selection and dose. 35 -3- LSB 5296YH (1) 90 pf/ko 3/ 15

H.F. 2215 (2) Death or serious injury of a patient associated with 1 unsafe administration of blood or blood products. 2 (3) Maternal death or serious injury associated with labor 3 or delivery in a low-risk pregnancy while being cared for 4 in a facility, including events that occur within forty-two 5 calendar days postdelivery and excluding deaths from pulmonary 6 or amniotic fluid embolism, acute fatty liver of pregnancy, or 7 cardiomyopathy. 8 (4) Death or serious injury of a neonate associated with 9 labor or delivery in a low-risk pregnancy. 10 (5) Stage 3 or 4 or unstageable ulcers acquired after 11 admission to a facility, excluding progression from stage 2 to 12 stage 3 if stage 2 was recognized upon admission. 13 (6) Artificial insemination with the wrong donor sperm or 14 wrong egg. 15 (7) Death or serious injury of a patient associated with a 16 fall while being cared for in a facility. 17 (8) The irretrievable loss of an irreplaceable biological 18 specimen. 19 (9) Death or serious injury of a patient resulting from the 20 failure to follow up or communicate laboratory, pathology, or 21 radiology test results. 22 e. Environmental events including all of the following: 23 (1) Death or serious injury of a patient associated 24 with an electric shock while being cared for in a facility, 25 excluding events involving planned treatments such as electric 26 countershock. 27 (2) Any incident in which a line designated for oxygen or 28 other gas to be delivered to a patient contains the wrong gas 29 or is contaminated by toxic substances. 30 (3) Death or serious injury of a patient associated with 31 a burn incurred from any source while being cared for in a 32 facility. 33 (4) Death or serious injury of a patient associated with the 34 use or lack of restraints or bedrails while being cared for in 35 -4- LSB 5296YH (1) 90 pf/ko 4/ 15

H.F. 2215 a facility. 1 f. Potential criminal events including all of the following: 2 (1) Any instance of care ordered by or provided by someone 3 impersonating a health care professional. 4 (2) Abduction of a patient of any age. 5 (3) Sexual assault on a patient within or on the grounds of 6 a facility. 7 (4) Death or serious injury of a patient or staff member 8 resulting from a physical assault that occurs within or on the 9 grounds of a facility. 10 g. Radiologic events including death or serious injury of a 11 patient associated with the introduction of a metallic object 12 into the magnetic resonance imaging. 13 Sec. 3. NEW SECTION . 135S.3 Root cause analysis and 14 corrective action plan. 15 1. Following the occurrence of a serious reportable event as 16 specified under section 135S.2, a facility shall conduct a root 17 cause analysis of the event. 18 2. Following the analysis, the facility shall do one of the 19 following: 20 a. Implement a corrective action plan to address the 21 findings of the analysis. 22 b. Report to the director any reasons for not taking 23 corrective action. 24 3. If the root cause analysis and the implementation of a 25 corrective action plan are already completed at the time an 26 event is required to be reported, the findings of the analysis 27 and the corrective action plan shall be included in the report 28 of the event. 29 4. If the root cause analysis is completed, but 30 implementation of a corrective action plan is not completed at 31 the time an event is required to be reported, the findings of 32 the root cause analysis and a copy of the proposed corrective 33 action plan shall be filed with the director within sixty 34 working days of the event. 35 -5- LSB 5296YH (1) 90 pf/ko 5/ 15

H.F. 2215 Sec. 4. NEW SECTION . 135S.4 Electronic reporting. 1 1. The director shall design the serious reportable event 2 reporting system to allow a facility to file the reports 3 required under this chapter by electronic means. 4 2. The director shall encourage a facility to use the 5 electronic filing option when that option is feasible for the 6 facility. 7 Sec. 5. NEW SECTION . 135S.5 Relation to other law and 8 duties —— confidentiality of data. 9 1. a. Serious reportable events described under section 10 135S.2 do not constitute child abuse as defined in section 11 232.68 or dependent adult abuse as defined in section 235B.2, 12 and are excluded from the reporting requirements of chapters 13 232 and 235B, if the facility makes a determination within 14 twenty-four hours of discovery of the serious reportable event 15 that this chapter is applicable and the facility files the 16 reports required under this chapter in a timely fashion. 17 b. A facility that determines a serious reportable event 18 described in section 135S.2 has occurred shall inform persons 19 within the facility who are mandatory reporters of child abuse 20 under section 232.69 or dependent adult abuse under section 21 235B.3. A mandatory reporter otherwise required to report 22 child abuse or dependent adult abuse is relieved of the duty to 23 report an event the facility determines to be reportable under 24 section 135S.2. 25 c. The protections and immunities applicable to reporting 26 of child abuse under section 232.73 and dependent adult abuse 27 under section 232.68 are not affected by this section. 28 2. a. If a serious reportable event is reported by a 29 facility in compliance with this chapter, no other state agency 30 or licensing board is required to conduct an investigation of 31 or obtain or create investigative data based upon other reports 32 of the same event. 33 b. If a facility is required to report a serious reportable 34 event pursuant to another state law that meets the requirements 35 -6- LSB 5296YH (1) 90 pf/ko 6/ 15

H.F. 2215 for compliance with this chapter, the department shall 1 recognize the report as compliance with this chapter in lieu of 2 a report made under this chapter if the department is provided 3 a copy of the report. 4 3. a. Data contained in the following records are 5 confidential records under section 22.7: 6 (1) Reports of serious reportable events made to the 7 director by a professional licensing board. 8 (2) Serious reportable event reports, findings of root 9 cause analyses, and corrective action plans filed by a facility 10 under this chapter. 11 (3) Records created or obtained by the director in reviewing 12 or investigating the reports, findings, and corrective action 13 plans under subparagraph (2). 14 b. For purposes of this subsection, the reporting facility 15 is the subject of the report or data under chapter 22. 16 Sec. 6. NEW SECTION . 135S.6 Director duties and 17 responsibilities —— penalties. 18 1. The director shall establish a serious reportable event 19 reporting system designed to facilitate quality improvement 20 in the health care system. The reporting system shall not 21 be designed to punish errors by health care professionals or 22 facility employees. 23 2. The reporting system shall require and consist of all of 24 the following: 25 a. Mandatory reporting by facilities of the applicable 26 serious reportable events described in section 135S.2. 27 b. Mandatory completion of a root cause analysis and a 28 corrective action plan by the facility, and the reporting of 29 the findings of the analysis and the plan to the director, or 30 the reporting of reasons for not taking corrective action. 31 c. Analysis of reported information by the director to 32 determine patterns of systemic failure in the health care 33 system and successful methods to correct the failures. 34 d. Sanctions against facilities for failure to comply with 35 -7- LSB 5296YH (1) 90 pf/ko 7/ 15

H.F. 2215 reporting system requirements. 1 e. Communication from the director to facilities, health 2 care consumers, and the public to maximize the use of the 3 reporting system to improve health care quality. 4 3. In establishing the serious reportable event reporting 5 system, the director shall not select from or between alternate 6 acceptable medical practices. 7 4. The director shall do all of the following: 8 a. Analyze serious reportable event reports, corrective 9 action plans, and findings of the root cause analyses to 10 determine patterns of systemic failure in the health care 11 system and successful methods to correct these failures. 12 b. Communicate to individual facilities the director’s 13 conclusions, if any, regarding a serious reportable event 14 reported by a facility. 15 c. Communicate with relevant health care facilities any 16 recommendations for corrective action resulting from the 17 director’s analysis of submissions from facilities. 18 d. Publish an annual report, available on the internet site 19 of the department of inspections, appeals, and licensing, that 20 does all of the following: 21 (1) Describes, by facility type, serious reportable events 22 reported by facilities. 23 (2) Outlines, in aggregate, the findings of root cause 24 analyses and corrective action plans. 25 (3) Makes recommendations for modifications of state health 26 care operations. 27 5. a. The director shall take steps necessary to determine 28 if required serious reportable event reports, the findings of 29 the root cause analyses, and corrective action plans are filed 30 in a timely manner. 31 b. The director may do any of the following: 32 (1) Sanction a facility for failure to file a timely 33 serious reportable event report, conduct a root cause analysis, 34 implement a corrective action plan, or provide the findings of 35 -8- LSB 5296YH (1) 90 pf/ko 8/ 15

H.F. 2215 a root cause analysis or corrective action plan in a timely 1 fashion. 2 (2) Place conditions on the license under which a facility 3 operates if the facility fails to develop and implement a 4 corrective action plan, or report to the director the reason a 5 corrective action is not needed. 6 6. The director may collaborate with the department of 7 health and human services to administer this section. 8 Sec. 7. NEW SECTION . 135S.7 Reports from licensing boards. 9 1. The board of medicine, the board of physician assistants, 10 the board of nursing, the board of pharmacy, and the board 11 of podiatry shall maintain a record of all complaints that 12 come to the attention of the respective board that in the 13 judgment of the board qualify as a serious reportable event 14 under section 135S.2. Within thirty working days of making a 15 determination that an event qualifies as a serious reportable 16 event, the respective board shall forward a report of the event 17 to the director, including the name and address of the facility 18 involved, the date of the event, and information known to 19 the board regarding the event. The report shall not include 20 any identifying information of any health care professional, 21 facility employee, or patients involved. 22 2. The director shall forward a report received under 23 subsection 1 to the facility named in the report. 24 3. a. The facility shall determine whether the event 25 has been previously reported under this chapter, and shall 26 notify the director as to whether the event has been previously 27 reported. 28 b. If the event has not been previously reported, the 29 facility shall make a determination whether the event is 30 reportable under this chapter. If the facility determines the 31 event is reportable, the date of discovery of the event for 32 purposes of this chapter shall be as follows: 33 (1) If the director determines the facility knew or 34 reasonably should have known about the occurrence of the event, 35 -9- LSB 5296YH (1) 90 pf/ko 9/ 15

H.F. 2215 the date the event occurred shall be the date of discovery 1 of the event and the facility shall be considered out of 2 compliance with this chapter. 3 (2) If the director determines the facility did not know 4 about the occurrence of the event, the date the facility 5 receives the report from the director shall be the date of 6 discovery of the event. 7 c. If the facility determines the event was not reportable 8 under this chapter, the facility shall notify the director of 9 that determination. 10 Sec. 8. NEW SECTION . 135S.8 Interstate coordination and 11 reports. 12 1. The director shall report the list of serious reportable 13 events described under section 135S.2 to the national quality 14 forum, and through the national quality forum to other states. 15 2. The director shall monitor communications by the 16 national quality forum of amendments to the list of serious 17 reportable events maintained by the forum and shall report any 18 modification to the list to the general assembly. 19 3. The director shall also monitor efforts in other states 20 to establish a list of serious reportable events and shall 21 make recommendations to the general assembly as necessary for 22 modifications to the list of serious reportable events under 23 this chapter to maximize uniformity with the list maintained by 24 the national quality forum and by other states. 25 EXPLANATION 26 The inclusion of this explanation does not constitute agreement with 27 the explanation’s substance by the members of the general assembly. 28 This bill relates to the reporting of serious reportable 29 events by facilities including hospitals, ambulatory surgical 30 centers, and pregnancy resource centers. 31 The bill provides definitions used in the bill. 32 The bill requires each facility to report to the director 33 (director) of the department of inspections, appeals, and 34 licensing (DIAL) the occurrence of an applicable serious 35 -10- LSB 5296YH (1) 90 pf/ko 10/ 15

H.F. 2215 reportable event described in the bill as soon as is reasonably 1 and practicably possible, but no later than 15 working days 2 after discovery of the event. Reports shall be filed in a 3 format specified by the director of DIAL and shall identify the 4 facility but shall not include any identifying information for 5 any of the health care professionals, facility employees, or 6 patients involved. 7 The director may consult with experts and organizations 8 familiar with patient safety when developing the format for 9 reporting and in further defining serious reportable events in 10 order to be consistent with industry standards. 11 Serious reportable events under the bill include surgical 12 events, product or device events, patient protection events, 13 care management events, environmental events, potential 14 criminal events, and radiologic events detailed in the bill. 15 The bill requires that following the occurrence of a serious 16 reportable event, a facility shall conduct a root cause 17 analysis of the event, and following the analysis shall either 18 implement a corrective action plan to address the findings of 19 the analysis or report to the director any reasons for not 20 taking corrective action. If the root cause analysis and 21 the implementation of a corrective action plan are already 22 completed at the time an event is required to be reported, the 23 findings of the analysis and the corrective action plan shall 24 be included in the report of the event. If the root cause 25 analysis is completed but the implementation of a corrective 26 action plan is not completed at the time an event is required 27 to be reported, the findings of the root cause analysis and a 28 copy of the proposed corrective action plan shall be filed with 29 the director within 60 days of the event. 30 The director shall design the serious reportable event 31 reporting system to allow a facility to file the required 32 reports by electronic means and shall encourage a facility to 33 use the electronic filing option when that option is feasible 34 for the facility. 35 -11- LSB 5296YH (1) 90 pf/ko 11/ 15

H.F. 2215 The bill provides that serious reportable events under the 1 bill do not constitute child abuse or dependent adult abuse and 2 are excluded from the child abuse and dependent adult abuse 3 reporting requirements, if the facility makes a determination 4 within 24 hours of discovery of the serious reportable event 5 that the provisions of the bill apply and the facility files 6 the reports required under the bill in a timely fashion. 7 A facility that determines a serious reportable event 8 has occurred must inform persons within the facility who are 9 mandatory reporters of child abuse or dependent adult abuse. 10 A mandatory reporter otherwise required to report child abuse 11 or dependent adult abuse is relieved of the duty to report an 12 event the facility determines to be a serious reportable event 13 under the bill. The bill does not affect the protections and 14 immunities applicable to reporting of child abuse and dependent 15 adult abuse. 16 Additionally, if a serious reportable event is reported by a 17 facility in compliance with the bill, no other state agency or 18 licensing board is required to conduct an investigation of or 19 obtain or create investigative data based upon other reports 20 of the same event. Also, if a facility is required to report 21 a serious reportable event pursuant to another state law that 22 meets the requirements for compliance with the bill, DIAL shall 23 recognize the report as compliance with the bill in lieu of a 24 report made under the bill if DIAL is provided a copy of the 25 report. 26 Reports of serious reportable events made to the director 27 by a professional licensing board; serious reportable event 28 reports, findings of root cause analyses, and corrective action 29 plans filed by a facility under the bill; and records created 30 or obtained by the director in reviewing or investigating the 31 reports, findings, and corrective action plans are confidential 32 records under Code section 22.7. 33 The director shall establish a serious reportable event 34 reporting system requiring and consisting of mandatory 35 -12- LSB 5296YH (1) 90 pf/ko 12/ 15

H.F. 2215 reporting by facilities of the serious reportable events 1 described in the bill; mandatory completion of a root cause 2 analysis and a corrective action plan by the facility, and 3 the reporting of the findings of the analysis and the plan 4 to the director or the reporting of reasons for not taking 5 corrective action; analysis of reported information by the 6 director to determine patterns of systemic failure in the 7 health care system and successful methods to correct these 8 failures; sanctions against facilities for failure to comply 9 with reporting system requirements; and communication from the 10 director to facilities, health care consumers, and the public 11 to maximize the use of the reporting system to improve health 12 care quality. 13 The director shall analyze serious reportable event 14 reports, corrective action plans, and findings of the root 15 cause analyses to determine patterns of systemic failure in 16 the health care system and successful methods to correct 17 these failures; communicate to facilities the director’s 18 conclusions regarding a serious reportable event reported by 19 a facility; communicate with relevant health care facilities 20 any recommendations for corrective action resulting from the 21 director’s analysis of submissions from facilities; and publish 22 an annual report. The director shall take steps necessary to 23 determine if serious reportable event reports, the findings 24 of the root cause analyses, and corrective action plans are 25 filed in a timely manner. The director may sanction a facility 26 for failure to file a timely serious reportable event report, 27 conduct a root cause analysis, implement a corrective action 28 plan, or provide the findings of a root cause analysis or 29 corrective action plan in a timely fashion; or place conditions 30 on the license under which a facility operates if the facility 31 fails to develop and implement a corrective action plan or 32 report to the director the reason a corrective action is not 33 needed. 34 The director may collaborate with the department of health 35 -13- LSB 5296YH (1) 90 pf/ko 13/ 15

H.F. 2215 and human services to administer the director’s duties and 1 responsibilities. 2 The bill requires the boards of medicine, physician 3 assistants, nursing, pharmacy, and podiatry to maintain 4 a record of complaints that come to the attention of the 5 respective board, that in the judgment of the board qualify as 6 serious reportable events. Within 30 working days of making a 7 determination that an event qualifies as a serious reportable 8 event, the respective board shall forward a report of the 9 event to the director, including the name and address of the 10 facility involved, the date of the event, and information 11 known to the board regarding the event. The report shall 12 not include any identifying information of any health care 13 professional, facility employee, or patients involved. The 14 director shall then forward the report to the facility named in 15 the report and the facility shall determine whether the event 16 has been previously reported and shall notify the director as 17 to whether the event has been previously reported. If the 18 event has not been previously reported, the facility shall make 19 a determination whether the event is reportable and if it is 20 reportable, the date of discovery of the event, depending on 21 the circumstances, is either the date of discovery or the date 22 the facility receives the report from the director. If the 23 facility determines that the event is not reportable under this 24 Code chapter, the facility shall notify the director of that 25 determination. 26 The bill requires the director to report the list of serious 27 reportable events under the bill to the national quality forum 28 and through the national quality forum to other states. The 29 director shall monitor amendments to the national quality 30 forum’s list of serious reportable events and report any 31 modification to the list to the general assembly. The director 32 shall also monitor efforts in other states to establish a list 33 of serious reportable events and shall make recommendations to 34 the general assembly, as necessary, for modifications to the 35 -14- LSB 5296YH (1) 90 pf/ko 14/ 15