1.1                          A bill for an act 
  1.2             relating to health; establishing a reporting system 
  1.3             for adverse health care events; proposing coding for 
  1.4             new law in Minnesota Statutes, chapter 144. 
  1.5   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.6      Section 1.  [144.706] [CITATION.] 
  1.7      Sections 144.706 to 144.7069 may be cited as the Minnesota 
  1.8   Adverse Health Care Events Reporting Act of 2003. 
  1.9      Sec. 2.  [144.7063] [DEFINITIONS.] 
  1.10     Subdivision 1.  [SCOPE.] Unless the context clearly 
  1.11  indicates otherwise, for the purposes of sections 144.706 to 
  1.12  144.7069, the terms defined in this section have the meanings 
  1.13  given them. 
  1.14     Subd. 2.  [COMMISSIONER.] "Commissioner" means the 
  1.15  commissioner of health. 
  1.16     Subd. 3.  [FACILITY.] "Facility" means a hospital licensed 
  1.17  under sections 144.50 to 144.58. 
  1.18     Subd. 4.  [SERIOUS DISABILITY.] "Serious disability" means 
  1.19  (1) a physical or mental impairment that substantially limits 
  1.20  one or more of the major life activities of an individual, (2) a 
  1.21  loss of bodily function, if the impairment or loss lasts more 
  1.22  than seven days or is still present at the time of discharge 
  1.23  from an inpatient health care facility, or (3) loss of a body 
  1.24  part. 
  1.25     Subd. 5.  [SURGERY.] "Surgery" means the treatment of 
  2.1   disease, injury, or deformity by manual or operative methods.  
  2.2   Surgery includes endoscopies and other invasive procedures. 
  2.3      Sec. 3.  [144.7065] [FACILITY REQUIREMENTS TO REPORT, 
  2.4   ANALYZE, AND CORRECT.] 
  2.5      Subdivision 1.  [REPORTS OF ADVERSE HEALTH CARE EVENTS 
  2.6   REQUIRED.] Each facility shall report to the commissioner the 
  2.7   occurrence of any of the adverse health care events described in 
  2.8   subdivisions 2 to 7 as soon as is reasonably and practically 
  2.9   possible, but no later than 15 working days after discovery of 
  2.10  the event.  The report shall be filed in a format specified by 
  2.11  the commissioner and shall identify the facility but shall not 
  2.12  include any identifying information for any of the health care 
  2.13  professionals, facility employees, or patients involved.  The 
  2.14  commissioner may consult with experts and organizations familiar 
  2.15  with patient safety when developing the format for reporting and 
  2.16  in further defining events in order to be consistent with 
  2.17  industry standards. 
  2.18     Subd. 2.  [SURGICAL EVENTS.] Events reportable under this 
  2.19  subdivision are: 
  2.20     (1) surgery performed on a wrong body part that is not 
  2.21  consistent with the documented informed consent for that 
  2.22  patient.  Reportable events under this clause do not include 
  2.23  situations requiring prompt action that occur in the course of 
  2.24  surgery or situations whose urgency precludes obtaining informed 
  2.25  consent; 
  2.26     (2) surgery performed on the wrong patient; 
  2.27     (3) the wrong surgical procedure performed on a patient 
  2.28  that is not consistent with the documented informed consent for 
  2.29  that patient.  Reportable events under this clause do not 
  2.30  include situations requiring prompt action that occur in the 
  2.31  course of surgery or situations whose urgency precludes 
  2.32  obtaining informed consent; 
  2.33     (4) retention of a foreign object in a patient after 
  2.34  surgery or other procedure, excluding objects intentionally 
  2.35  implanted as part of a planned intervention and objects present 
  2.36  prior to surgery that are intentionally retained; and 
  3.1      (5) death during or immediately after surgery of a normal, 
  3.2   healthy patient who has no organic, physiologic, biochemical, or 
  3.3   psychiatric disturbance and for whom the pathologic processes 
  3.4   for which the operation is to be performed are localized and do 
  3.5   not entail a systemic disturbance. 
  3.6      Subd. 3.  [PRODUCT OR DEVICE EVENTS.] Events reportable 
  3.7   under this subdivision are: 
  3.8      (1) patient death or serious disability associated with the 
  3.9   use of contaminated drugs, devices, or biologics provided by the 
  3.10  facility when the contamination is the result of generally 
  3.11  detectable contaminants in drugs, devices, or biologics 
  3.12  regardless of the source of the contamination or the product; 
  3.13     (2) patient death or serious disability associated with the 
  3.14  use or function of a device in patient care in which the device 
  3.15  is used or functions other than as intended.  Device includes, 
  3.16  but is not limited to, catheters, drains, and other specialized 
  3.17  tubes, infusion pumps, and ventilators; and 
  3.18     (3) patient death or serious disability associated with 
  3.19  intravascular air embolism that occurs while being cared for in 
  3.20  a facility, excluding deaths associated with neurosurgical 
  3.21  procedures known to present a high risk of intravascular air 
  3.22  embolism. 
  3.23     Subd. 4.  [PATIENT PROTECTION EVENTS.] Events reportable 
  3.24  under this subdivision are: 
  3.25     (1) an infant discharged to the wrong person; 
  3.26     (2) patient death or serious disability associated with 
  3.27  patient disappearance for more than four hours, excluding events 
  3.28  involving adults who have decision-making capacity; and 
  3.29     (3) patient suicide or attempted suicide resulting in 
  3.30  serious disability while being cared for in a facility due to 
  3.31  patient actions after admission to the facility, excluding 
  3.32  deaths resulting from self-inflicted injuries that were the 
  3.33  reason for admission to the facility. 
  3.34     Subd. 5.  [CARE MANAGEMENT EVENTS.] Events reportable under 
  3.35  this subdivision are: 
  3.36     (1) patient death or serious disability associated with a 
  4.1   medication error, including, but not limited to, errors 
  4.2   involving the wrong drug, the wrong dose, the wrong patient, the 
  4.3   wrong time, the wrong rate, the wrong preparation, or the wrong 
  4.4   route of administration, excluding reasonable differences in 
  4.5   clinical judgment on drug selection and dose; 
  4.6      (2) patient death or serious disability associated with a 
  4.7   hemolytic reaction due to the administration of ABO-incompatible 
  4.8   blood or blood products; 
  4.9      (3) maternal death or serious disability associated with 
  4.10  labor or delivery in a low-risk pregnancy while being cared for 
  4.11  in a facility, including events that occur within 42 days 
  4.12  postdelivery and excluding deaths from pulmonary or amniotic 
  4.13  fluid embolism, acute fatty liver of pregnancy, or 
  4.14  cardiomyopathy; 
  4.15     (4) patient death or serious disability directly related to 
  4.16  hypoglycemia, the onset of which occurs while the patient is 
  4.17  being cared for in a facility; 
  4.18     (5) death or serious disability, including kernicterus, 
  4.19  associated with failure to identify and treat hyperbilirubinemia 
  4.20  in neonates during the first 28 days of life.  
  4.21  "Hyperbilirubinemia" means bilirubin levels greater than 30 
  4.22  milligrams per deciliter; 
  4.23     (6) stage 3 or 4 ulcers acquired after admission to a 
  4.24  facility, excluding progression from stage 2 to stage 3 if stage 
  4.25  2 was recognized upon admission; and 
  4.26     (7) patient death or serious disability due to spinal 
  4.27  manipulative therapy. 
  4.28     Subd. 6.  [ENVIRONMENTAL EVENTS.] Events reportable under 
  4.29  this subdivision are: 
  4.30     (1) patient death or serious disability associated with an 
  4.31  electric shock while being cared for in a facility, excluding 
  4.32  events involving planned treatments such as electric 
  4.33  countershock; 
  4.34     (2) any incident in which a line designated for oxygen or 
  4.35  other gas to be delivered to a patient contains the wrong gas or 
  4.36  is contaminated by toxic substances; 
  5.1      (3) patient death or serious disability associated with a 
  5.2   burn incurred from any source while being cared for in a 
  5.3   facility; 
  5.4      (4) patient death associated with a fall while being cared 
  5.5   for in a facility; and 
  5.6      (5) patient death or serious disability associated with the 
  5.7   use of restraints or bedrails while being cared for in a 
  5.8   facility. 
  5.9      Subd. 7.  [CRIMINAL EVENTS.] Events reportable under this 
  5.10  subdivision are: 
  5.11     (1) any instance of care ordered by or provided by someone 
  5.12  impersonating a physician, nurse, pharmacist, or other licensed 
  5.13  health care provider; 
  5.14     (2) abduction of a patient of any age; 
  5.15     (3) sexual assault on a patient within or on the grounds of 
  5.16  a facility; and 
  5.17     (4) death or significant injury of a patient or staff 
  5.18  member resulting from a physical assault that occurs within or 
  5.19  on the grounds of a facility. 
  5.20     Subd. 8.  [ROOT CAUSE ANALYSIS; CORRECTIVE ACTION 
  5.21  PLAN.] Following the occurrence of an adverse health care event, 
  5.22  the facility must conduct a root cause analysis of the event.  
  5.23  Following the analysis, the facility must:  (1) implement a 
  5.24  corrective action plan to implement the findings of the analysis 
  5.25  or (2) report to the commissioner any reasons for not taking 
  5.26  corrective action.  If the root cause analysis and the 
  5.27  implementation of a corrective action plan are complete at the 
  5.28  time an event must be reported, the findings of the analysis and 
  5.29  the corrective action plan must be included in the report of the 
  5.30  event.  The findings of the root cause analysis and a copy of 
  5.31  the corrective action plan must otherwise be filed with the 
  5.32  commissioner within 60 days of the event. 
  5.33     Subd. 9.  [ELECTRONIC REPORTING.] The commissioner must 
  5.34  design the reporting system so that a facility may file by 
  5.35  electronic means the reports required under this section.  The 
  5.36  commissioner shall encourage a facility to use the electronic 
  6.1   filing option when that option is feasible for the facility. 
  6.2      Subd. 10.  [RELATION TO OTHER LAW.] (a) Adverse health 
  6.3   events described in subdivisions 2 to 6 do not constitute 
  6.4   "maltreatment" or "a physical injury that is not reasonably 
  6.5   explained" under section 626.557 and are excluded from the 
  6.6   reporting requirements of section 626.557, provided the facility 
  6.7   makes a determination within 24 hours of the discovery of the 
  6.8   event that this section is applicable and the facility files the 
  6.9   reports required under this section in a timely fashion. 
  6.10     (b) A facility that has determined that an event described 
  6.11  in subdivisions 2 to 6 has occurred must inform persons who are 
  6.12  mandated reporters under section 626.5572, subdivision 16, of 
  6.13  that determination.  A mandated reporter otherwise required to 
  6.14  report under section 626.557, subdivision 3, paragraph (e), is 
  6.15  relieved of the duty to report an event that the facility 
  6.16  determines under paragraph (a) to be reportable under 
  6.17  subdivisions 2 to 6. 
  6.18     (c) The protections and immunities applicable to voluntary 
  6.19  reports under section 626.557 are not affected by this section. 
  6.20     (d) Notwithstanding section 626.557, a lead agency under 
  6.21  section 626.5572, subdivision 13, is not required to conduct an 
  6.22  investigation of an event described in subdivisions 2 to 6. 
  6.23     Sec. 4.  [144.7067] [COMMISSIONER DUTIES AND 
  6.24  RESPONSIBILITIES.] 
  6.25     Subdivision 1.  [ESTABLISHMENT OF REPORTING SYSTEM.] (a) 
  6.26  The commissioner shall establish an adverse health event 
  6.27  reporting system designed to facilitate quality improvement in 
  6.28  the health care system.  The reporting system shall not be 
  6.29  designed to punish errors by health care practitioners or health 
  6.30  care facility employees. 
  6.31     (b) The reporting system shall consist of: 
  6.32     (1) mandatory reporting by facilities of 27 adverse health 
  6.33  care events; 
  6.34     (2) mandatory completion of a root cause analysis and a 
  6.35  corrective action plan by the facility and reporting of the 
  6.36  findings of the analysis and the plan to the commissioner or 
  7.1   reporting of reasons for not taking corrective action; 
  7.2      (3) analysis of reported information by the commissioner to 
  7.3   determine patterns of systemic failure in the health care system 
  7.4   and successful methods to correct these failures; 
  7.5      (4) sanctions against facilities for failure to comply with 
  7.6   reporting system requirements; and 
  7.7      (5) communication from the commissioner to facilities, 
  7.8   health care purchasers, and the public to maximize the use of 
  7.9   the reporting system to improve health care quality. 
  7.10     (c) Reports, analyses, and corrective action plans 
  7.11  submitted under section 144.7065, subdivisions 1 and 8, shall be 
  7.12  afforded the protections and immunities set forth in section 
  7.13  145.64, subdivision 1, paragraph (b). 
  7.14     (d) The commissioner is not authorized to select from or 
  7.15  between competing alternate acceptable medical practices. 
  7.16     Subd. 2.  [DUTY TO ANALYZE REPORTS; COMMUNICATE 
  7.17  FINDINGS.] The commissioner shall: 
  7.18     (1) analyze adverse event reports, corrective action plans, 
  7.19  and findings of the root cause analyses to determine patterns of 
  7.20  systemic failure in the health care system and successful 
  7.21  methods to correct these failures; 
  7.22     (2) communicate to individual facilities the commissioner's 
  7.23  conclusions, if any, regarding an adverse event reported by the 
  7.24  facility; 
  7.25     (3) communicate with relevant health care facilities any 
  7.26  recommendations for corrective action resulting from the 
  7.27  commissioner's analysis of submissions from facilities; and 
  7.28     (4) publish an annual report: 
  7.29     (i) describing, by institution, adverse events reported; 
  7.30     (ii) outlining, in aggregate, corrective action plans and 
  7.31  the findings of root cause analyses; and 
  7.32     (iii) making recommendations for modifications of state 
  7.33  health care operations. 
  7.34     Subd. 3.  [SANCTIONS.] (a) The commissioner shall take 
  7.35  steps necessary to determine if adverse event reports, the 
  7.36  findings of the root cause analyses, and corrective action plans 
  8.1   are filed in a timely manner.  The commissioner may sanction a 
  8.2   facility for: 
  8.3      (1) failure to file a timely adverse event report under 
  8.4   section 144.7065, subdivision 1; or 
  8.5      (2) failure to conduct a root cause analysis, to implement 
  8.6   a corrective action plan, or to provide the findings of a root 
  8.7   cause analysis or corrective action plan in a timely fashion 
  8.8   under section 144.7065, subdivision 8. 
  8.9      (b) If a facility fails to develop and implement a 
  8.10  corrective action plan or report to the commissioner why 
  8.11  corrective action is not needed, the commissioner may suspend, 
  8.12  revoke, fail to renew, or place conditions on the license under 
  8.13  which the facility operates. 
  8.14     Sec. 5.  [144.7069] [INTERSTATE COORDINATION; REPORTS.] 
  8.15     The commissioner shall report the definitions and the list 
  8.16  of reportable events adopted in this act to the National Quality 
  8.17  Forum and, working in coordination with the National Quality 
  8.18  Forum, to the other states.  The commissioner shall monitor 
  8.19  discussions by the National Quality Forum of amendments to the 
  8.20  forum's list of reportable events and shall report to the 
  8.21  legislature whenever the list is modified.  The commissioner 
  8.22  shall also monitor implementation efforts in other states to 
  8.23  establish a list of reportable events and shall make 
  8.24  recommendations to the legislature as necessary for 
  8.25  modifications in the Minnesota list or in the other components 
  8.26  of the Minnesota reporting system to keep the system as nearly 
  8.27  uniform as possible with similar systems in other states. 
  8.28     Sec. 6.  [ADVERSE HEALTH CARE EVENTS REPORTING SYSTEM 
  8.29  TRANSITION PERIOD.] 
  8.30     (a) Effective July 1, 2003, limited implementation of the 
  8.31  Adverse Health Care Events Reporting Act shall begin, provided 
  8.32  the commissioner of health has secured sufficient nonstate funds 
  8.33  for this purpose.  During this period, the commissioner must: 
  8.34     (1) solicit additional nonstate funds to support full 
  8.35  implementation of the system; 
  8.36     (2) work with organizations and experts familiar with 
  9.1   patient safety to review reporting categories in Minnesota 
  9.2   Statutes, section 144.7065, make necessary clarifications, and 
  9.3   develop educational materials; and 
  9.4      (3) monitor activities of the National Quality Forum and 
  9.5   other patient safety organizations, other states, and the 
  9.6   federal government in the area of patient safety. 
  9.7      (b) Effective July 1, 2003, facilities defined in Minnesota 
  9.8   Statutes, section 144.7063, subdivision 3, shall report any 
  9.9   adverse health care events, as defined in Minnesota Statutes, 
  9.10  section 144.7065, to the incident reporting system maintained by 
  9.11  the Minnesota Hospital Association.  The association shall 
  9.12  provide a summary report to the commissioner that identifies the 
  9.13  types of events by category.  The association shall consult with 
  9.14  the commissioner regarding the data to be reported to the 
  9.15  commissioner, storage of data received by the association but 
  9.16  not reported to the commissioner, and eventual retrieval by the 
  9.17  commissioner of stored data. 
  9.18     (c) The commissioner shall report to the legislature by 
  9.19  January 15 of 2004 and 2005, with a list of the number of 
  9.20  reported events by type and recommendations, if any, for 
  9.21  reporting system modifications, including additional categories 
  9.22  of events that should be reported. 
  9.23     (d) From July 1, 2003, until full implementation of the 
  9.24  reporting system, the commissioner of health shall not make a 
  9.25  final disposition as defined in Minnesota Statutes, section 
  9.26  626.5572, subdivision 8, for investigations conducted in 
  9.27  licensed hospitals under the provisions of Minnesota Statutes, 
  9.28  section 626.557.  The commissioner's findings in these cases 
  9.29  shall identify noncompliance with federal certification or state 
  9.30  licensure rules or laws. 
  9.31     (e) Effective July 1, 2004, the reporting system shall be 
  9.32  fully implemented, provided (1) the commissioner has secured 
  9.33  sufficient funds from nonstate sources to operate the system 
  9.34  during fiscal year 2005, and (2) the commissioner has notified 
  9.35  facilities by April 1, 2004, of their duty to report. 
  9.36     (f) Effective July 1, 2005, the reporting system shall be 
 10.1   operated with state appropriations.