Senate File 48 - Introduced SENATE FILE 48 BY LOFGREN , SALMON , SHIPLEY , ALONS , KRAAYENBRINK , ROWLEY , EVANS , TAYLOR , GRUENHAGEN , CAMPBELL , and KLIMESH A BILL FOR An Act relating to the reporting of serious reportable events, 1 and providing penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1455XS (4) 91 lh/ko
S.F. 48 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 directors 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 pregnancy resource center. 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. Pregnancy resource center means a nonprofit entity 18 that provides pregnancy support services as defined in section 19 217.41C. 20 6. Serious injury means any of the following: 21 a. A physical or mental impairment that substantially limits 22 one or more of the major life activities of an individual or a 23 loss of bodily function, if the impairment or loss lasts more 24 than seven days or is still present at the time of discharge 25 from an inpatient health care facility. 26 b. The loss of a body part. 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. a. Each facility shall report to the director the 33 occurrence of an applicable serious reportable event described 34 in this section as soon as is reasonably and practicably 35 -1- LSB 1455XS (4) 91 lh/ko 1/ 13
S.F. 48 possible, but no later than fifteen working days after 1 discovery of the event. 2 b. The report shall be filed in a format specified by 3 the director and shall identify the facility but shall not 4 include any identifying information for any of the health care 5 professionals, facility employees, or patients involved. 6 c. The director may consult with experts and organizations 7 familiar with patient safety when developing the format for 8 reporting and in further defining serious reportable events in 9 order to be consistent with industry standards. 10 2. Serious reportable events under this section include all 11 of the following: 12 a. Surgical events including all of the following: 13 (1) Surgery or other invasive procedure performed on a wrong 14 body part that is inconsistent with the documented informed 15 consent for that patient. Serious reportable events under this 16 subparagraph do not include situations requiring prompt action 17 that occur in the course of surgery or situations whose urgency 18 precludes obtaining informed consent. 19 (2) Surgery or other invasive procedure performed on the 20 wrong patient. 21 (3) The wrong surgery or other invasive procedure performed 22 on a patient that is inconsistent with the documented informed 23 consent for that patient. Serious reportable events under this 24 subparagraph do not include situations requiring prompt action 25 that occur in the course of surgery or situations whose urgency 26 precludes obtaining informed consent. 27 (4) Retention of a foreign object in a patient after surgery 28 or other invasive procedure, excluding objects intentionally 29 implanted as part of a planned intervention and objects present 30 prior to surgery that are intentionally retained. 31 (5) Death during or immediately after surgery or other 32 invasive procedure of a normal, healthy patient who has no 33 organic, physiologic, biochemical, or psychiatric disturbance 34 and for whom the pathologic processes for which the operation 35 -2- LSB 1455XS (4) 91 lh/ko 2/ 13
S.F. 48 is to be performed are localized and do not entail a systemic 1 disturbance. 2 b. Product or device events including all of the following: 3 (1) Death or serious injury of a patient associated with the 4 use of contaminated drugs, devices, or biologics provided by 5 the facility when the contamination is the result of generally 6 detectable contaminants in drugs, devices, or biologics 7 regardless of the source of the contamination or the product. 8 (2) Death or serious injury of a patient associated with the 9 use or function of a device in patient care in which the device 10 is used or functions other than as intended. Device includes 11 but is not limited to catheters, drains, and other specialized 12 tubes, infusion pumps, and ventilators. 13 (3) Death or serious injury of a patient associated with 14 intravascular air embolism that occurs while being cared for 15 in a facility, excluding deaths associated with neurosurgical 16 procedures known to present a high risk of intravascular air 17 embolism. 18 c. Patient protection events including all of the following: 19 (1) Discharge to the wrong person of a patient of any age 20 who does not have decision-making capacity. 21 (2) Death or serious injury of a patient associated with a 22 patient disappearance, excluding events involving adults who 23 have decision-making capacity. 24 (3) Suicide, attempted suicide resulting in serious injury, 25 or self-harm of a patient resulting in serious injury or death 26 of the patient while being cared for in a facility due to the 27 patients actions after admission to the facility, excluding 28 the death of a patient resulting from self-inflicted injuries 29 that were the reason for admission to the facility. 30 d. Care management events including all of the following: 31 (1) Death or serious injury of a patient associated with a 32 medication error including but not limited to errors involving 33 the wrong drug, the wrong dose, the wrong patient, the wrong 34 time, the wrong rate, the wrong preparation, or the wrong route 35 -3- LSB 1455XS (4) 91 lh/ko 3/ 13
S.F. 48 of administration, excluding reasonable differences in clinical 1 judgment on drug selection and dose. 2 (2) Death or serious injury of a patient associated with 3 unsafe administration of blood or blood products. 4 (3) Maternal death or serious injury associated with labor 5 or delivery in a low-risk pregnancy while being cared for 6 in a facility, including events that occur within forty-two 7 calendar days postdelivery and excluding deaths from pulmonary 8 or amniotic fluid embolism, acute fatty liver of pregnancy, or 9 cardiomyopathy. 10 (4) Death or serious injury of a neonate associated with 11 labor or delivery in a low-risk pregnancy. 12 (5) Stage 3 or 4 or unstageable ulcers acquired after 13 admission to a facility, excluding progression from stage 2 to 14 stage 3 if stage 2 was recognized upon admission. 15 (6) Artificial insemination with the wrong donor sperm or 16 wrong egg. 17 (7) Death or serious injury of a patient associated with a 18 fall while being cared for in a facility. 19 (8) The irretrievable loss of an irreplaceable biological 20 specimen. 21 (9) Death or serious injury of a patient resulting from the 22 failure to follow up or communicate laboratory, pathology, or 23 radiology test results. 24 e. Environmental events including all of the following: 25 (1) Death or serious injury of a patient associated 26 with an electric shock while being cared for in a facility, 27 excluding events involving planned treatments such as electric 28 countershock. 29 (2) Any incident in which a line designated for oxygen or 30 other gas to be delivered to a patient contains the wrong gas 31 or is contaminated by toxic substances. 32 (3) Death or serious injury of a patient associated with 33 a burn incurred from any source while being cared for in a 34 facility. 35 -4- LSB 1455XS (4) 91 lh/ko 4/ 13
S.F. 48 (4) Death or serious injury of a patient associated with the 1 use or lack of restraints or bedrails while being cared for in 2 a facility. 3 f. Potential criminal events including all of the following: 4 (1) Any instance of care ordered by or provided by someone 5 impersonating a health care professional. 6 (2) Abduction of a patient of any age. 7 (3) Sexual assault on a patient within or on the grounds of 8 a facility. 9 (4) Death or serious injury of a patient or staff member 10 resulting from a physical assault that occurs within or on the 11 grounds of a facility. 12 g. Radiologic events including death or serious injury of a 13 patient associated with the introduction of a metallic object 14 into the magnetic resonance imaging. 15 Sec. 3. NEW SECTION . 135S.3 Root cause analysis and 16 corrective action plan. 17 1. Following the occurrence of a serious reportable event as 18 specified under section 135S.2, a facility shall conduct a root 19 cause analysis of the event. 20 2. Following the analysis, the facility shall do one of the 21 following: 22 a. Implement a corrective action plan to address the 23 findings of the analysis. 24 b. Report to the director any reasons for not taking 25 corrective action. 26 3. If the root cause analysis and the implementation of a 27 corrective action plan are already completed at the time an 28 event is required to be reported, the findings of the analysis 29 and the corrective action plan shall be included in the report 30 of the event. 31 4. If the root cause analysis is completed, but 32 implementation of a corrective action plan is not completed at 33 the time an event is required to be reported, the findings of 34 the root cause analysis and a copy of the proposed corrective 35 -5- LSB 1455XS (4) 91 lh/ko 5/ 13
S.F. 48 action plan shall be filed with the director within sixty 1 working days of the event. 2 Sec. 4. NEW SECTION . 135S.4 Electronic reporting. 3 1. The director shall design the serious reportable event 4 reporting system to allow a facility to file the reports 5 required under this chapter by electronic means. 6 2. The director shall encourage a facility to use the 7 electronic filing option when that option is feasible for the 8 facility. 9 Sec. 5. NEW SECTION . 135S.5 Relation to other law and 10 duties confidentiality of data. 11 1. a. Serious reportable events described under section 12 135S.2 do not constitute child abuse as defined in section 13 232.68 or dependent adult abuse as defined in section 235B.2, 14 and are excluded from the reporting requirements of chapters 15 232 and 235B, if the facility makes a determination within 16 twenty-four hours of discovery of the serious reportable event 17 that this chapter is applicable and the facility files the 18 reports required under this chapter in a timely fashion. 19 b. A facility that determines a serious reportable event 20 described in section 135S.2 has occurred shall inform persons 21 within the facility who are mandatory reporters of child abuse 22 under section 232.69 or dependent adult abuse under section 23 235B.3. A mandatory reporter otherwise required to report 24 child abuse or dependent adult abuse is relieved of the duty to 25 report an event the facility determines to be reportable under 26 section 135S.2. 27 c. The protections and immunities applicable to reporting 28 of child abuse under section 232.73 and dependent adult abuse 29 under section 235B.3 are not affected by this section. 30 2. a. If a serious reportable event is reported by a 31 facility in compliance with this chapter, no other state agency 32 or licensing board is required to conduct an investigation of 33 or obtain or create investigative data based upon other reports 34 of the same event. 35 -6- LSB 1455XS (4) 91 lh/ko 6/ 13
S.F. 48 b. If a facility is required to report a serious reportable 1 event pursuant to another state law that meets the requirements 2 for compliance with this chapter, the department shall 3 recognize the report as compliance with this chapter in lieu of 4 a report made under this chapter if the department is provided 5 a copy of the report. 6 3. a. Data contained in the following records are 7 confidential records under section 22.7: 8 (1) Reports of serious reportable events made to the 9 director by a professional licensing board. 10 (2) Serious reportable event reports, findings of root 11 cause analyses, and corrective action plans filed by a facility 12 under this chapter. 13 (3) Records created or obtained by the director in reviewing 14 or investigating the reports, findings, and corrective action 15 plans under subparagraph (2). 16 b. For purposes of this subsection, the reporting facility 17 is the subject of the report or data under chapter 22. 18 Sec. 6. NEW SECTION . 135S.6 Director duties and 19 responsibilities penalties. 20 1. The director shall establish a serious reportable event 21 reporting system designed to facilitate quality improvement 22 in the health care system. The reporting system shall not 23 be designed to punish errors by health care professionals or 24 facility employees. 25 2. The reporting system shall require and consist of all of 26 the following: 27 a. Mandatory reporting by facilities of the applicable 28 serious reportable events described in section 135S.2. 29 b. Mandatory completion of a root cause analysis and a 30 corrective action plan by the facility, and the reporting of 31 the findings of the analysis and the plan to the director, or 32 the reporting of reasons for not taking corrective action. 33 c. Analysis of reported information by the director to 34 determine patterns of systemic failure in the health care 35 -7- LSB 1455XS (4) 91 lh/ko 7/ 13
S.F. 48 system and successful methods to correct the failures. 1 d. Sanctions against facilities for failure to comply with 2 reporting system requirements. 3 e. Communication from the director to facilities, health 4 care consumers, and the public to maximize the use of the 5 reporting system to improve health care quality. 6 3. In establishing the serious reportable event reporting 7 system, the director shall not select from or between alternate 8 acceptable medical practices. 9 4. The director shall do all of the following: 10 a. Analyze serious reportable event reports, corrective 11 action plans, and findings of the root cause analyses to 12 determine patterns of systemic failure in the health care 13 system and successful methods to correct these failures. 14 b. Communicate to individual facilities the directors 15 conclusions, if any, regarding a serious reportable event 16 reported by a facility. 17 c. Communicate with relevant health care facilities any 18 recommendations for corrective action resulting from the 19 directors analysis of submissions from facilities. 20 d. Publish an annual report, available on the internet site 21 of the department that does all of the following: 22 (1) Describes, by facility type, serious reportable events 23 reported by facilities. 24 (2) Outlines, in aggregate, the findings of root cause 25 analyses and corrective action plans. 26 (3) Makes recommendations for modifications of state health 27 care operations. 28 5. a. The director shall take steps necessary to determine 29 if required serious reportable event reports, the findings of 30 the root cause analyses, and corrective action plans are filed 31 in a timely manner. 32 b. The director may do any of the following: 33 (1) Sanction a facility for failure to file a timely 34 serious reportable event report, conduct a root cause analysis, 35 -8- LSB 1455XS (4) 91 lh/ko 8/ 13
S.F. 48 implement a corrective action plan, or provide the findings of 1 a root cause analysis or corrective action plan in a timely 2 fashion. 3 (2) Place conditions on the license under which a facility 4 operates if the facility fails to develop and implement a 5 corrective action plan, or report to the director the reason a 6 corrective action is not needed. 7 6. The director may collaborate with the department of 8 health and human services to administer this section. 9 Sec. 7. NEW SECTION . 135S.7 Reports from licensing boards. 10 1. The board of medicine, the board of physician assistants, 11 the board of nursing, the board of pharmacy, and the board 12 of podiatry shall maintain a record of all complaints that 13 come to the attention of the respective board that in the 14 judgment of the board qualify as a serious reportable event 15 under section 135S.2. Within thirty working days of making a 16 determination that an event qualifies as a serious reportable 17 event, the respective board shall forward a report of the event 18 to the director, including the name and address of the facility 19 involved, the date of the event, and information known to 20 the board regarding the event. The report shall not include 21 any identifying information of any health care professional, 22 facility employee, or patients involved. 23 2. The director shall forward a report received under 24 subsection 1 to the facility named in the report. 25 3. a. The facility shall determine whether the event 26 has been previously reported under this chapter, and shall 27 notify the director as to whether the event has been previously 28 reported. 29 b. If the event has not been previously reported, the 30 facility shall make a determination whether the event is 31 reportable under this chapter. If the facility determines the 32 event is reportable, the date of discovery of the event for 33 purposes of this chapter shall be as follows: 34 (1) If the director determines the facility knew or 35 -9- LSB 1455XS (4) 91 lh/ko 9/ 13
S.F. 48 reasonably should have known about the occurrence of the event, 1 the date the event occurred shall be the date of discovery 2 of the event and the facility shall be considered out of 3 compliance with this chapter. 4 (2) If the director determines the facility did not know 5 about the occurrence of the event, the date the facility 6 receives the report from the director shall be the date of 7 discovery of the event. 8 c. If the facility determines the event was not reportable 9 under this chapter, the facility shall notify the director of 10 that determination. 11 Sec. 8. NEW SECTION . 135S.8 Interstate coordination and 12 reports. 13 1. The director shall report the list of serious reportable 14 events described under section 135S.2 to the national quality 15 forum, and through the national quality forum to other states. 16 2. The director shall monitor communications by the 17 national quality forum of amendments to the list of serious 18 reportable events maintained by the forum and shall report any 19 modification to the list to the general assembly. 20 3. The director shall also monitor efforts in other states 21 to establish a list of serious reportable events and shall 22 make recommendations to the general assembly as necessary for 23 modifications to the list of serious reportable events under 24 this chapter to maximize uniformity with the list maintained by 25 the national quality forum and by other states. 26 EXPLANATION 27 The inclusion of this explanation does not constitute agreement with 28 the explanations substance by the members of the general assembly. 29 This bill relates to the reporting of serious reportable 30 events by facilities including hospitals, ambulatory surgical 31 centers, and pregnancy resource centers. 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 1455XS (4) 91 lh/ko 10/ 13
S.F. 48 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 Serious reportable events include surgical events, product 8 or device events, patient protection events, care management 9 events, environmental events, potential criminal events, and 10 radiologic events detailed in the bill. 11 The bill requires that following the occurrence of a serious 12 reportable event, a facility shall conduct a root cause 13 analysis of the event and shall either implement a corrective 14 action plan or report to the director any reasons for not 15 taking corrective action. 16 The director shall design the serious reportable event 17 reporting system to allow a facility to file the required 18 reports by electronic means and shall encourage a facility to 19 use the electronic filing option when that option is feasible 20 for the facility. 21 The bill provides that serious reportable events under the 22 bill do not constitute child abuse or dependent adult abuse and 23 are excluded from the child abuse and dependent adult abuse 24 reporting requirements, if the facility makes a determination 25 within 24 hours of discovery of the serious reportable event 26 and files the reports required in a timely fashion. 27 A facility that determines a serious reportable event 28 has occurred must inform persons within the facility who are 29 mandatory reporters of child abuse or dependent adult abuse. 30 A mandatory reporter otherwise required to report child abuse 31 or dependent adult abuse is relieved of the duty to report 32 an event the facility determines to be a serious reportable 33 event. The bill does not affect the protections and immunities 34 applicable to reporting of child abuse and dependent adult 35 -11- LSB 1455XS (4) 91 lh/ko 11/ 13
S.F. 48 abuse. 1 Additionally, if a serious reportable event is reported 2 by a facility, no other state agency or licensing board is 3 required to conduct an investigation of or obtain or create 4 investigative data based upon other reports of the same event. 5 Also, if a facility is required to report a serious reportable 6 event pursuant to another state law that meets the requirements 7 for compliance with the bill, DIAL shall recognize the report 8 in lieu of a report made under the bill if DIAL is provided a 9 copy of the report. 10 Reports of serious reportable events made to the director 11 by a professional licensing board; serious reportable event 12 reports, findings of root cause analyses, and corrective action 13 plans filed by a facility under the bill; and records created 14 or obtained by the director in reviewing or investigating the 15 reports, findings, and corrective action plans are confidential 16 records under Code section 22.7. 17 The director shall establish a serious reportable event 18 reporting system requiring certain information as detailed in 19 the bill. 20 The director shall take action relating to serious 21 reportable events as described in the bill. 22 The director may collaborate with the department of health 23 and human services to administer the directors duties and 24 responsibilities. 25 The bill requires the boards of medicine, physician 26 assistants, nursing, pharmacy, and podiatry to maintain 27 a record of complaints that come to the attention of the 28 respective board and are determined to qualify as serious 29 reportable events. Within 30 working days of making a 30 determination that an event qualifies as a serious reportable 31 event, the respective board shall forward a report of the event 32 to the director. The director shall then forward the report 33 to the facility named in the report and the facility shall 34 determine whether the event has been previously reported and 35 -12- LSB 1455XS (4) 91 lh/ko 12/ 13
S.F. 48 shall notify the director. 1 The bill requires the director to report the list of serious 2 reportable events to the national quality forum. The director 3 shall monitor amendments to the national quality forums 4 list of serious reportable events, monitor efforts in other 5 states, and report any modification to the list to the general 6 assembly. 7 -13- LSB 1455XS (4) 91 lh/ko 13/ 13