SF 1112

Introduction - 83rd Legislature (2003 - 2004)

Posted on 12/15/2009 12:00 a.m.

  1.1                          A bill for an act 
  1.2             relating to health; modifying data collection 
  1.3             provisions; requiring approval of certain rules; 
  1.4             extending certain rulemaking authority; classifying 
  1.5             certain data; establishing a reporting system for 
  1.6             adverse health care events; appropriating money; 
  1.7             amending Minnesota Statutes 2002, sections 13.381, by 
  1.8             adding a subdivision; 62J.301, subdivision 4; 62J.311, 
  1.9             subdivision 1; 62J.321, by adding a subdivision; 
  1.10            proposing coding for new law in Minnesota Statutes, 
  1.11            chapter 144. 
  1.12  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.13                             ARTICLE 1 
  1.14                          DATA COLLECTION 
  1.15     Section 1.  Minnesota Statutes 2002, section 62J.301, 
  1.16  subdivision 4, is amended to read: 
  1.17     Subd. 4.  [INFORMATION TO BE COLLECTED.] (a) The 
  1.18  commissioner may collect encounter level data on the following 
  1.19  conditions: 
  1.20     (1) diabetes; 
  1.21     (2) asthma; 
  1.22     (3) cardiovascular conditions; 
  1.23     (4) cancer; and 
  1.24     (5) arthritis and osteoporosis. 
  1.25     The commissioner may not collect encounter level data in 
  1.26  individually identifiable form, as defined under section 
  1.27  144.335, subdivision 1, on mental health, obstetrical or 
  1.28  gynecological conditions, or conditions related to sexually 
  2.1   transmitted diseases. 
  2.2      (b) The data collected may include health outcomes data, 
  2.3   patient functional status, and health status.  The data 
  2.4   collected may include information necessary to measure and make 
  2.5   adjustments for differences in the severity of patient condition 
  2.6   across different health care providers, and may include data 
  2.7   obtained directly from the patient or from patient medical 
  2.8   records, as provided in section 62J.321, subdivision 1. 
  2.9      (b) (c) The commissioner may: 
  2.10     (1) collect the encounter level data required for the 
  2.11  research and data initiatives of sections 62J.301 to 62J.42, 
  2.12  using, to the greatest extent possible, standardized forms and 
  2.13  procedures; and 
  2.14     (2) process the data collected to ensure validity, 
  2.15  consistency, accuracy, and completeness, and as appropriate, 
  2.16  merge data collected from different sources. 
  2.17     (c) (d) For purposes of estimating total health care 
  2.18  spending and forecasting rates of growth in health care 
  2.19  spending, the commissioner may collect from health care 
  2.20  providers data on patient revenues and health care spending 
  2.21  during a time period specified by the commissioner.  The 
  2.22  commissioner may also collect data on health care revenues and 
  2.23  spending from group purchasers of health care.  Health care 
  2.24  providers and group purchasers doing business in the state shall 
  2.25  provide the data requested by the commissioner at the times and 
  2.26  in the form specified by the commissioner.  Professional 
  2.27  licensing boards and state agencies responsible for licensing, 
  2.28  registering, or regulating providers and group purchasers shall 
  2.29  cooperate fully with the commissioner in achieving compliance 
  2.30  with the reporting requirements. 
  2.31     Sec. 2.  Minnesota Statutes 2002, section 62J.311, 
  2.32  subdivision 1, is amended to read: 
  2.33     Subdivision 1.  [DATA ANALYSIS.] The commissioner shall 
  2.34  analyze the data collected to: 
  2.35     (1) assist the state in developing and refining its health 
  2.36  policy in the areas of access, utilization, quality, and 
  3.1   cost track and target best practices in the delivery of health 
  3.2   care; 
  3.3      (2) assist the state in promoting efficiency and 
  3.4   effectiveness in the financing and delivery of health 
  3.5   services assess the health care system and physicians' quality 
  3.6   of care; 
  3.7      (3) monitor and track accessibility, identify utilization, 
  3.8   quality, and cost of health care services within the 
  3.9   state trends; 
  3.10     (4) evaluate the impact of health care reform 
  3.11  activities provide early identification and targeting of 
  3.12  populations at risk; 
  3.13     (5) assist the state in its public health activities; and 
  3.14     (6) evaluate and determine the most appropriate methods for 
  3.15  ongoing data collection monitor patient safety; and 
  3.16     (6) monitor and report hospital mortality rates by chronic 
  3.17  condition identified under section 62J.301, subdivision 4, 
  3.18  clauses (1) to (5). 
  3.19     Sec. 3.  Minnesota Statutes 2002, section 62J.321, is 
  3.20  amended by adding a subdivision to read: 
  3.21     Subd. 9.  [PRIVACY OVERSIGHT PANEL.] A privacy oversight 
  3.22  panel is created, consisting of the attorney general or a 
  3.23  designee, the commissioner of health or a designee, and the 
  3.24  governor's appointed legal counsel.  The panel shall meet at 
  3.25  least every six months to determine compliance with the data 
  3.26  collection provisions of sections 62J.301 to 62J.42.  No rules 
  3.27  shall be adopted under sections 62J.301 to 62J.42 after the 
  3.28  effective date of this section unless the proposed rules are 
  3.29  approved by the privacy oversight panel. 
  3.30     Sec. 4.  [APPROVAL REQUIRED; RULEMAKING AUTHORITY 
  3.31  EXTENDED.] 
  3.32     The commissioner of health shall obtain approval of the 
  3.33  privacy oversight panel under section 3 before submitting the 
  3.34  notice of adoption to the State Register for proposed Minnesota 
  3.35  Rules, parts 4653.0100 to 4653.1400, published in the State 
  3.36  Register, volume 27, number 8, page 243, August 19, 2002.  
  4.1   Notwithstanding Minnesota Statutes, section 14.125, the 
  4.2   commissioner of health's authority to adopt the rules is 
  4.3   extended to January 1, 2005, to allow for modification of the 
  4.4   proposed rules to conform with this act.  If the rules are 
  4.5   adopted before the effective date of this act, the rules may not 
  4.6   be enforced, retroactive to the date of adoption, until the 
  4.7   rules are amended to conform with this act. 
  4.8      Sec. 5.  [EFFECTIVE DATE.] 
  4.9      Sections 1 to 4 are effective the day following final 
  4.10  enactment. 
  4.11                             ARTICLE 2 
  4.12                      ADVERSE EVENT REPORTING 
  4.13     Section 1.  Minnesota Statutes 2002, section 13.381, is 
  4.14  amended by adding a subdivision to read: 
  4.15     Subd. 7a.  [ADVERSE HEALTH EVENT REPORTING SYSTEM.] Data 
  4.16  collected by the commissioner of health for purposes of the 
  4.17  adverse health event reporting system are classified under 
  4.18  section 144.7067, subdivision 4. 
  4.19     Sec. 2.  [144.706] [CITATION.] 
  4.20     Sections 144.706 to 144.7069 may be cited as the Minnesota 
  4.21  Adverse Health Care Events Reporting Act of 2003. 
  4.22     Sec. 3.  [144.7063] [DEFINITIONS.] 
  4.23     Subdivision 1.  [SCOPE.] Unless the context clearly 
  4.24  indicates otherwise, for the purposes of sections 144.706 to 
  4.25  144.7069, the terms defined in this section have the meanings 
  4.26  given them. 
  4.27     Subd. 2.  [COMMISSIONER.] "Commissioner" means the 
  4.28  commissioner of health. 
  4.29     Subd. 3.  [FACILITY.] "Facility" means a hospital or other 
  4.30  entity licensed under sections 144.50 to 144.58. 
  4.31     Subd. 4.  [SERIOUS DISABILITY.] "Serious disability" means 
  4.32  (1) a physical or mental impairment that substantially limits 
  4.33  one or more of the major life activities of an individual or a 
  4.34  loss of bodily function, if the impairment or loss lasts more 
  4.35  than seven days or is still present at the time of discharge 
  4.36  from an inpatient health care facility or (2) loss of a body 
  5.1   part. 
  5.2      Subd. 5.  [SURGERY.] "Surgery" means the treatment of 
  5.3   disease, injury, or deformity by manual or operative methods.  
  5.4   Surgery includes endoscopies and other invasive procedures. 
  5.5      Sec. 4.  [144.7065] [FACILITY REQUIREMENTS TO REPORT, 
  5.6   ANALYZE, AND CORRECT.] 
  5.7      Subdivision 1.  [REPORTS OF ADVERSE HEALTH CARE EVENTS 
  5.8   REQUIRED.] Each facility shall report to the commissioner the 
  5.9   occurrence of any of the adverse health care events described in 
  5.10  subdivisions 2 to 7 as soon as is reasonably and practically 
  5.11  possible, but no later than 15 working days after discovery of 
  5.12  the event.  The report shall be filed in a format specified by 
  5.13  the commissioner and shall identify the facility but shall not 
  5.14  identify by name any of the health care professionals, facility 
  5.15  employees, or patients involved. 
  5.16     Subd. 2.  [SURGICAL EVENTS.] Events reportable under this 
  5.17  subdivision are: 
  5.18     (1) surgery performed on a wrong body part that is not 
  5.19  consistent with the documented informed consent for that 
  5.20  patient.  Reportable events under this clause do not include 
  5.21  situations requiring prompt action that occur in the course of 
  5.22  surgery or situations whose urgency precludes obtaining informed 
  5.23  consent; 
  5.24     (2) surgery performed on the wrong patient that is not 
  5.25  consistent with the documented informed consent for that 
  5.26  patient; 
  5.27     (3) the wrong surgical procedure performed on a patient 
  5.28  that is not consistent with the documented informed consent for 
  5.29  that patient.  Reportable events under this clause do not 
  5.30  include situations requiring prompt action that occur in the 
  5.31  course of surgery or situations whose urgency precludes 
  5.32  obtaining informed consent; 
  5.33     (4) retention of a foreign object in a patient after 
  5.34  surgery or other procedure, excluding objects intentionally 
  5.35  implanted as part of a planned intervention and objects present 
  5.36  prior to surgery that are intentionally retained; and 
  6.1      (5) death during or immediately after surgery of a normal, 
  6.2   healthy patient who has no organic, physiologic, biochemical, or 
  6.3   psychiatric disturbance and for whom the pathologic processes 
  6.4   for which the operation is to be performed are localized and do 
  6.5   not entail a systemic disturbance. 
  6.6      Subd. 3.  [PRODUCT OR DEVICE EVENTS.] Events reportable 
  6.7   under this subdivision are: 
  6.8      (1) patient death or serious disability associated with the 
  6.9   use of contaminated drugs, devices, or biologics provided by the 
  6.10  facility when the contamination is the result of generally 
  6.11  detectable contaminants in drugs, devices, or biologics 
  6.12  regardless of the source of the contamination or the product; 
  6.13     (2) patient death or serious disability associated with the 
  6.14  use or function of a device in patient care in which the device 
  6.15  is used or functions other than as intended.  Device includes, 
  6.16  but is not limited to, catheters, drains, and other specialized 
  6.17  tubes, infusion pumps, and ventilators; and 
  6.18     (3) patient death or serious disability associated with 
  6.19  intravascular air embolism that occurs while being cared for in 
  6.20  a facility, excluding deaths associated with neurosurgical 
  6.21  procedures known to present a high risk of intravascular air 
  6.22  embolism. 
  6.23     Subd. 4.  [PATIENT PROTECTION EVENTS.] Events reportable 
  6.24  under this subdivision are: 
  6.25     (1) an infant discharged to the wrong person; 
  6.26     (2) patient death or serious disability associated with 
  6.27  patient disappearance for more than four hours, excluding events 
  6.28  involving competent adults; and 
  6.29     (3) patient suicide or attempted suicide resulting in 
  6.30  serious disability while being cared for in a facility due to 
  6.31  patient actions after admission to the facility, excluding 
  6.32  deaths resulting from self-inflicted injuries that were the 
  6.33  reason for admission to the facility. 
  6.34     Subd. 5.  [CARE MANAGEMENT EVENTS.] Events reportable under 
  6.35  this subdivision are: 
  6.36     (1) patient death or serious disability associated with a 
  7.1   medication error, including, but not limited to, errors 
  7.2   involving the wrong drug, the wrong dose, the wrong patient, the 
  7.3   wrong time, the wrong rate, the wrong preparation, or the wrong 
  7.4   route of administration, excluding reasonable differences in 
  7.5   clinical judgment on drug selection and dose; 
  7.6      (2) patient death or serious disability associated with a 
  7.7   hemolytic reaction due to the administration of ABO-incompatible 
  7.8   blood or blood products; 
  7.9      (3) maternal death or serious disability associated with 
  7.10  labor or delivery in a low-risk pregnancy while being cared for 
  7.11  in a facility, including events that occur within 42 days 
  7.12  postdelivery and excluding deaths from pulmonary or amniotic 
  7.13  fluid embolism, acute fatty liver of pregnancy, or 
  7.14  cardiomyopathy; 
  7.15     (4) patient death or serious disability associated with 
  7.16  hypoglycemia, the onset of which occurs while the patient is 
  7.17  being cared for in a facility; 
  7.18     (5) death or serious disability, including kernicterus, 
  7.19  associated with failure to identify and treat hyperbilirubinemia 
  7.20  in neonates during the first 28 days of life.  
  7.21  "Hyperbilirubinemia" means bilirubin levels greater than 30 
  7.22  milligrams per deciliter; 
  7.23     (6) stage 3 or 4 ulcers acquired after admission to a 
  7.24  facility, excluding progression from stage 2 to stage 3 if stage 
  7.25  2 was recognized upon admission; and 
  7.26     (7) patient death or serious disability due to spinal 
  7.27  manipulative therapy. 
  7.28     Subd. 6.  [ENVIRONMENTAL EVENTS.] Events reportable under 
  7.29  this subdivision are: 
  7.30     (1) patient death or serious disability associated with an 
  7.31  electric shock while being cared for in a facility, excluding 
  7.32  events involving planned treatments such as electric 
  7.33  countershock; 
  7.34     (2) any incident in which a line designated for oxygen or 
  7.35  other gas to be delivered to a patient contains the wrong gas or 
  7.36  is contaminated by toxic substances; 
  8.1      (3) patient death or serious disability associated with a 
  8.2   burn incurred from any source while being cared for in a 
  8.3   facility; 
  8.4      (4) patient death associated with a fall while being cared 
  8.5   for in a facility; and 
  8.6      (5) patient death or serious disability associated with the 
  8.7   use of restraints or bedrails while being cared for in a 
  8.8   facility. 
  8.9      Subd. 7.  [CRIMINAL EVENTS.] Events reportable under this 
  8.10  subdivision are: 
  8.11     (1) any instance of care ordered by or provided by someone 
  8.12  impersonating a physician, nurse, pharmacist, or other licensed 
  8.13  health care provider; 
  8.14     (2) abduction of a patient of any age; 
  8.15     (3) sexual assault on a patient within or on the grounds of 
  8.16  a facility; and 
  8.17     (4) death or significant injury of a patient or staff 
  8.18  member resulting from a physical assault that occurs within or 
  8.19  on the grounds of a facility. 
  8.20     Subd. 8.  [ROOT CAUSE ANALYSIS; CORRECTIVE ACTION 
  8.21  PLAN.] Following the occurrence of an adverse health care event, 
  8.22  the facility must conduct a root cause analysis of the event.  
  8.23  Following the analysis, the facility must implement a corrective 
  8.24  action plan to implement the findings of the analysis.  If the 
  8.25  root cause analysis and the implementation of a corrective 
  8.26  action plan are complete at the time an event must be reported, 
  8.27  the findings of the analysis and the plan must be included in 
  8.28  the report of the event.  The findings of the root cause 
  8.29  analysis and a copy of the corrective action plan must otherwise 
  8.30  be filed with the commissioner within 60 days of the event. 
  8.31     Subd. 9.  [ELECTRONIC REPORTING.] The commissioner must 
  8.32  design the reporting system so that a facility may file by 
  8.33  electronic means the reports required under this section.  The 
  8.34  commissioner shall encourage a facility to use the electronic 
  8.35  filing option when that option is feasible for the facility. 
  8.36     Subd. 10.  [RELATION TO OTHER LAW.] (a) Adverse health 
  9.1   events described in subdivisions 2 to 6 do not constitute 
  9.2   "maltreatment" or "a physical injury that is not reasonably 
  9.3   explained" under section 626.557 and are excluded from the 
  9.4   reporting requirements of section 626.557, provided the facility 
  9.5   makes a determination within 24 hours of the event that this 
  9.6   section is applicable and the facility files the reports 
  9.7   required under this section in a timely fashion. 
  9.8      (b) A facility that has determined that an event described 
  9.9   in subdivisions 2 to 6 has occurred must inform persons who are 
  9.10  mandated reporters under section 626.5572, subdivision 16, of 
  9.11  that determination.  A mandated reporter otherwise required to 
  9.12  report under section 626.557, subdivision 3, paragraph (e), is 
  9.13  relieved of the duty to report an event that the facility 
  9.14  determines under paragraph (a) to be reportable under 
  9.15  subdivisions 2 to 6. 
  9.16     (c) The protections and immunities applicable to voluntary 
  9.17  reports under section 626.557 are not affected by this section. 
  9.18     (d) Notwithstanding section 626.557, a lead agency under 
  9.19  section 626.5572, subdivision 13, is not required to conduct an 
  9.20  investigation of an event described in subdivisions 2 to 6. 
  9.21     Sec. 5.  [144.7067] [COMMISSIONER DUTIES AND 
  9.22  RESPONSIBILITIES.] 
  9.23     Subdivision 1.  [ESTABLISHMENT OF REPORTING SYSTEM.] (a) 
  9.24  The commissioner shall establish an adverse health event 
  9.25  reporting system designed to facilitate quality improvement in 
  9.26  the health care system.  The reporting system shall not be 
  9.27  designed to punish errors by health care practitioners or health 
  9.28  care facility employees. 
  9.29     (b) The reporting system shall consist of: 
  9.30     (1) mandatory reporting by facilities of 27 adverse health 
  9.31  care events; 
  9.32     (2) mandatory completion of a root cause analysis and a 
  9.33  corrective action plan by the facility and reporting of the 
  9.34  findings of the analysis and the plan to the commissioner; 
  9.35     (3) analysis of reported information by the commissioner to 
  9.36  determine patterns of systemic failure in the health care system 
 10.1   and successful methods to correct these failures; 
 10.2      (4) sanctions against facilities for failure to comply with 
 10.3   reporting system requirements; and 
 10.4      (5) communication from the commissioner to facilities, 
 10.5   health care purchasers, and the public to maximize the use of 
 10.6   the reporting system to improve health care quality. 
 10.7      (c) Reports, analyses, and corrective action plans 
 10.8   submitted under section 144.7065, subdivisions 1 and 8, shall be 
 10.9   afforded the protections and immunities set forth in section 
 10.10  145.64, subdivision 1, paragraph (b). 
 10.11     Subd. 2.  [DUTY TO ANALYZE REPORTS; COMMUNICATE 
 10.12  FINDINGS.] The commissioner shall: 
 10.13     (1) analyze adverse event reports, root cause analyses, 
 10.14  reports, and corrective action plans to determine patterns of 
 10.15  systemic failure in the health care system and successful 
 10.16  methods to correct these failures; 
 10.17     (2) communicate to individual facilities the commissioner's 
 10.18  conclusions, if any, regarding an adverse event reported by the 
 10.19  facility; 
 10.20     (3) communicate with relevant health care facilities any 
 10.21  recommendations for corrective action resulting from the 
 10.22  commissioner's analysis of submissions from facilities; and 
 10.23     (4) publish an annual report: 
 10.24     (i) describing, by institution, adverse events reported; 
 10.25     (ii) outlining, in aggregate, root cause analyses, 
 10.26  findings, and corrective action plans; and 
 10.27     (iii) making recommendations for modifications of state 
 10.28  health care operations. 
 10.29     Subd. 3.  [SANCTIONS.] (a) The commissioner shall take 
 10.30  steps necessary to determine if adverse event reports, root 
 10.31  cause analyses, findings, and corrective action plans are filed 
 10.32  in a timely manner.  The commissioner may sanction a facility 
 10.33  for: 
 10.34     (1) failure to file a timely adverse event report under 
 10.35  section 144.7065, subdivision 1; or 
 10.36     (2) failure to conduct a root cause analysis, to implement 
 11.1   a corrective action plan, or to provide the findings of a root 
 11.2   cause analysis or corrective action plan in a timely fashion 
 11.3   under section 144.7065, subdivision 8. 
 11.4      (b) If a facility fails to develop and implement a 
 11.5   corrective action plan mandated by the commissioner under 
 11.6   subdivision 2, the commissioner may suspend, revoke, fail to 
 11.7   renew, or place conditions on the license under which the 
 11.8   facility operates. 
 11.9      Subd. 4.  [DATA.] A facility is not required to report data 
 11.10  on individuals.  Data on individuals that are maintained in the 
 11.11  adverse health event reporting system are confidential data on 
 11.12  individuals as defined in section 13.02, subdivision 1, or as 
 11.13  protected nonpublic data to the extent the data do not identify 
 11.14  individuals. 
 11.15     Sec. 6.  [144.7069] [INTERSTATE COORDINATION; REPORTS.] 
 11.16     The commissioner shall report the definitions and the list 
 11.17  of reportable events adopted in this act to the National Quality 
 11.18  Forum and, working in coordination with the National Quality 
 11.19  Forum, to the other states.  The commissioner shall monitor 
 11.20  discussions by the National Quality Forum of amendments to the 
 11.21  forum's list of reportable events and shall report to the 
 11.22  legislature whenever the list is modified.  The commissioner 
 11.23  shall also monitor implementation efforts in other states to 
 11.24  establish a list of reportable events and shall make 
 11.25  recommendations to the legislature as necessary for 
 11.26  modifications in the Minnesota list or in the other components 
 11.27  of the Minnesota reporting system to keep the system as nearly 
 11.28  uniform as possible with similar systems in other states. 
 11.29     Sec. 7.  [APPROPRIATIONS.] 
 11.30     $....... is appropriated from the general fund to the 
 11.31  commissioner of health for the biennium beginning July 1, 2003, 
 11.32  for the purposes of sections 1 to 6.