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Office of the Revisor of Statutes

Key: (1) language to be deleted (2) new language

                            CHAPTER 99-S.F.No. 1019 
                  An act relating to health; establishing a reporting 
                  system for adverse health care events; amending 
                  Minnesota Statutes 2002, section 145.64, subdivision 
                  1; proposing coding for new law in Minnesota Statutes, 
                  chapter 144. 
        BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
           Section 1.  [144.706] [CITATION.] 
           Sections 144.706 to 144.7069 may be cited as the Minnesota 
        Adverse Health Care Events Reporting Act of 2003. 
           Sec. 2.  [144.7063] [DEFINITIONS.] 
           Subdivision 1.  [SCOPE.] Unless the context clearly 
        indicates otherwise, for the purposes of sections 144.706 to 
        144.7069, the terms defined in this section have the meanings 
        given them. 
           Subd. 2.  [COMMISSIONER.] "Commissioner" means the 
        commissioner of health. 
           Subd. 3.  [FACILITY.] "Facility" means a hospital licensed 
        under sections 144.50 to 144.58. 
           Subd. 4.  [SERIOUS DISABILITY.] "Serious disability" means 
        (1) a physical or mental impairment that substantially limits 
        one or more of the major life activities of an individual, (2) a 
        loss of bodily function, if the impairment or loss lasts more 
        than seven days or is still present at the time of discharge 
        from an inpatient health care facility, or (3) loss of a body 
        part. 
           Subd. 5.  [SURGERY.] "Surgery" means the treatment of 
        disease, injury, or deformity by manual or operative methods.  
        Surgery includes endoscopies and other invasive procedures. 
           Sec. 3.  [144.7065] [FACILITY REQUIREMENTS TO REPORT, 
        ANALYZE, AND CORRECT.] 
           Subdivision 1.  [REPORTS OF ADVERSE HEALTH CARE EVENTS 
        REQUIRED.] Each facility shall report to the commissioner the 
        occurrence of any of the adverse health care events described in 
        subdivisions 2 to 7 as soon as is reasonably and practically 
        possible, but no later than 15 working days after discovery of 
        the event.  The report shall be filed in a format specified by 
        the commissioner and shall identify the facility but shall not 
        include any identifying information for any of the health care 
        professionals, facility employees, or patients involved.  The 
        commissioner may consult with experts and organizations familiar 
        with patient safety when developing the format for reporting and 
        in further defining events in order to be consistent with 
        industry standards. 
           Subd. 2.  [SURGICAL EVENTS.] Events reportable under this 
        subdivision are: 
           (1) surgery performed on a wrong body part that is not 
        consistent with the documented informed consent for that 
        patient.  Reportable events under this clause do not include 
        situations requiring prompt action that occur in the course of 
        surgery or situations whose urgency precludes obtaining informed 
        consent; 
           (2) surgery performed on the wrong patient; 
           (3) the wrong surgical procedure performed on a patient 
        that is not consistent with the documented informed consent for 
        that patient.  Reportable events under this clause do not 
        include situations requiring prompt action that occur in the 
        course of surgery or situations whose urgency precludes 
        obtaining informed consent; 
           (4) retention of a foreign object in a patient after 
        surgery or other procedure, excluding objects intentionally 
        implanted as part of a planned intervention and objects present 
        prior to surgery that are intentionally retained; and 
           (5) death during or immediately after surgery of a normal, 
        healthy patient who has no organic, physiologic, biochemical, or 
        psychiatric disturbance and for whom the pathologic processes 
        for which the operation is to be performed are localized and do 
        not entail a systemic disturbance. 
           Subd. 3.  [PRODUCT OR DEVICE EVENTS.] Events reportable 
        under this subdivision are: 
           (1) patient death or serious disability associated with the 
        use of contaminated drugs, devices, or biologics provided by the 
        facility when the contamination is the result of generally 
        detectable contaminants in drugs, devices, or biologics 
        regardless of the source of the contamination or the product; 
           (2) patient death or serious disability associated with the 
        use or function of a device in patient care in which the device 
        is used or functions other than as intended.  Device includes, 
        but is not limited to, catheters, drains, and other specialized 
        tubes, infusion pumps, and ventilators; and 
           (3) patient death or serious disability associated with 
        intravascular air embolism that occurs while being cared for in 
        a facility, excluding deaths associated with neurosurgical 
        procedures known to present a high risk of intravascular air 
        embolism. 
           Subd. 4.  [PATIENT PROTECTION EVENTS.] Events reportable 
        under this subdivision are: 
           (1) an infant discharged to the wrong person; 
           (2) patient death or serious disability associated with 
        patient disappearance for more than four hours, excluding events 
        involving adults who have decision-making capacity; and 
           (3) patient suicide or attempted suicide resulting in 
        serious disability while being cared for in a facility due to 
        patient actions after admission to the facility, excluding 
        deaths resulting from self-inflicted injuries that were the 
        reason for admission to the facility. 
           Subd. 5.  [CARE MANAGEMENT EVENTS.] Events reportable under 
        this subdivision are: 
           (1) patient death or serious disability associated with a 
        medication error, including, but not limited to, errors 
        involving the wrong drug, the wrong dose, the wrong patient, the 
        wrong time, the wrong rate, the wrong preparation, or the wrong 
        route of administration, excluding reasonable differences in 
        clinical judgment on drug selection and dose; 
           (2) patient death or serious disability associated with a 
        hemolytic reaction due to the administration of ABO-incompatible 
        blood or blood products; 
           (3) maternal death or serious disability associated with 
        labor or delivery in a low-risk pregnancy while being cared for 
        in a facility, including events that occur within 42 days 
        postdelivery and excluding deaths from pulmonary or amniotic 
        fluid embolism, acute fatty liver of pregnancy, or 
        cardiomyopathy; 
           (4) patient death or serious disability directly related to 
        hypoglycemia, the onset of which occurs while the patient is 
        being cared for in a facility; 
           (5) death or serious disability, including kernicterus, 
        associated with failure to identify and treat hyperbilirubinemia 
        in neonates during the first 28 days of life.  
        "Hyperbilirubinemia" means bilirubin levels greater than 30 
        milligrams per deciliter; 
           (6) stage 3 or 4 ulcers acquired after admission to a 
        facility, excluding progression from stage 2 to stage 3 if stage 
        2 was recognized upon admission; and 
           (7) patient death or serious disability due to spinal 
        manipulative therapy. 
           Subd. 6.  [ENVIRONMENTAL EVENTS.] Events reportable under 
        this subdivision are: 
           (1) patient death or serious disability associated with an 
        electric shock while being cared for in a facility, excluding 
        events involving planned treatments such as electric 
        countershock; 
           (2) any incident in which a line designated for oxygen or 
        other gas to be delivered to a patient contains the wrong gas or 
        is contaminated by toxic substances; 
           (3) patient death or serious disability associated with a 
        burn incurred from any source while being cared for in a 
        facility; 
           (4) patient death associated with a fall while being cared 
        for in a facility; and 
           (5) patient death or serious disability associated with the 
        use of restraints or bedrails while being cared for in a 
        facility. 
           Subd. 7.  [CRIMINAL EVENTS.] Events reportable under this 
        subdivision are: 
           (1) any instance of care ordered by or provided by someone 
        impersonating a physician, nurse, pharmacist, or other licensed 
        health care provider; 
           (2) abduction of a patient of any age; 
           (3) sexual assault on a patient within or on the grounds of 
        a facility; and 
           (4) death or significant injury of a patient or staff 
        member resulting from a physical assault that occurs within or 
        on the grounds of a facility. 
           Subd. 8.  [ROOT CAUSE ANALYSIS; CORRECTIVE ACTION 
        PLAN.] Following the occurrence of an adverse health care event, 
        the facility must conduct a root cause analysis of the event.  
        Following the analysis, the facility must:  (1) implement a 
        corrective action plan to implement the findings of the analysis 
        or (2) report to the commissioner any reasons for not taking 
        corrective action.  If the root cause analysis and the 
        implementation of a corrective action plan are complete at the 
        time an event must be reported, the findings of the analysis and 
        the corrective action plan must be included in the report of the 
        event.  The findings of the root cause analysis and a copy of 
        the corrective action plan must otherwise be filed with the 
        commissioner within 60 days of the event. 
           Subd. 9.  [ELECTRONIC REPORTING.] The commissioner must 
        design the reporting system so that a facility may file by 
        electronic means the reports required under this section.  The 
        commissioner shall encourage a facility to use the electronic 
        filing option when that option is feasible for the facility. 
           Subd. 10.  [RELATION TO OTHER LAW.] (a) Adverse health 
        events described in subdivisions 2 to 6 do not constitute 
        "maltreatment" or "a physical injury that is not reasonably 
        explained" under section 626.557 and are excluded from the 
        reporting requirements of section 626.557, provided the facility 
        makes a determination within 24 hours of the discovery of the 
        event that this section is applicable and the facility files the 
        reports required under this section in a timely fashion. 
           (b) A facility that has determined that an event described 
        in subdivisions 2 to 6 has occurred must inform persons who are 
        mandated reporters under section 626.5572, subdivision 16, of 
        that determination.  A mandated reporter otherwise required to 
        report under section 626.557, subdivision 3, paragraph (e), is 
        relieved of the duty to report an event that the facility 
        determines under paragraph (a) to be reportable under 
        subdivisions 2 to 6. 
           (c) The protections and immunities applicable to voluntary 
        reports under section 626.557 are not affected by this section. 
           (d) Notwithstanding section 626.557, a lead agency under 
        section 626.5572, subdivision 13, is not required to conduct an 
        investigation of an event described in subdivisions 2 to 6. 
           Sec. 4.  [144.7067] [COMMISSIONER DUTIES AND 
        RESPONSIBILITIES.] 
           Subdivision 1.  [ESTABLISHMENT OF REPORTING SYSTEM.] (a) 
        The commissioner shall establish an adverse health event 
        reporting system designed to facilitate quality improvement in 
        the health care system.  The reporting system shall not be 
        designed to punish errors by health care practitioners or health 
        care facility employees. 
           (b) The reporting system shall consist of: 
           (1) mandatory reporting by facilities of 27 adverse health 
        care events; 
           (2) mandatory completion of a root cause analysis and a 
        corrective action plan by the facility and reporting of the 
        findings of the analysis and the plan to the commissioner or 
        reporting of reasons for not taking corrective action; 
           (3) analysis of reported information by the commissioner to 
        determine patterns of systemic failure in the health care system 
        and successful methods to correct these failures; 
           (4) sanctions against facilities for failure to comply with 
        reporting system requirements; and 
           (5) communication from the commissioner to facilities, 
        health care purchasers, and the public to maximize the use of 
        the reporting system to improve health care quality. 
           (c) The commissioner is not authorized to select from or 
        between competing alternate acceptable medical practices. 
           Subd. 2.  [DUTY TO ANALYZE REPORTS; COMMUNICATE 
        FINDINGS.] The commissioner shall: 
           (1) analyze adverse event reports, corrective action plans, 
        and findings of the root cause analyses to determine patterns of 
        systemic failure in the health care system and successful 
        methods to correct these failures; 
           (2) communicate to individual facilities the commissioner's 
        conclusions, if any, regarding an adverse event reported by the 
        facility; 
           (3) communicate with relevant health care facilities any 
        recommendations for corrective action resulting from the 
        commissioner's analysis of submissions from facilities; and 
           (4) publish an annual report: 
           (i) describing, by institution, adverse events reported; 
           (ii) outlining, in aggregate, corrective action plans and 
        the findings of root cause analyses; and 
           (iii) making recommendations for modifications of state 
        health care operations. 
           Subd. 3.  [SANCTIONS.] (a) The commissioner shall take 
        steps necessary to determine if adverse event reports, the 
        findings of the root cause analyses, and corrective action plans 
        are filed in a timely manner.  The commissioner may sanction a 
        facility for: 
           (1) failure to file a timely adverse event report under 
        section 144.7065, subdivision 1; or 
           (2) failure to conduct a root cause analysis, to implement 
        a corrective action plan, or to provide the findings of a root 
        cause analysis or corrective action plan in a timely fashion 
        under section 144.7065, subdivision 8. 
           (b) If a facility fails to develop and implement a 
        corrective action plan or report to the commissioner why 
        corrective action is not needed, the commissioner may suspend, 
        revoke, fail to renew, or place conditions on the license under 
        which the facility operates. 
           Sec. 5.  [144.7069] [INTERSTATE COORDINATION; REPORTS.] 
           The commissioner shall report the definitions and the list 
        of reportable events adopted in this act to the National Quality 
        Forum and, working in coordination with the National Quality 
        Forum, to the other states.  The commissioner shall monitor 
        discussions by the National Quality Forum of amendments to the 
        forum's list of reportable events and shall report to the 
        legislature whenever the list is modified.  The commissioner 
        shall also monitor implementation efforts in other states to 
        establish a list of reportable events and shall make 
        recommendations to the legislature as necessary for 
        modifications in the Minnesota list or in the other components 
        of the Minnesota reporting system to keep the system as nearly 
        uniform as possible with similar systems in other states. 
           Sec. 6.  Minnesota Statutes 2002, section 145.64, 
        subdivision 1, is amended to read: 
           Subdivision 1.  [DATA AND INFORMATION.] (a) Except as 
        provided in subdivision 4, data and information acquired by a 
        review organization, in the exercise of its duties and 
        functions, or by an individual or other entity acting at the 
        direction of a review organization, shall be held in confidence, 
        shall not be disclosed to anyone except to the extent necessary 
        to carry out one or more of the purposes of the review 
        organization, and shall not be subject to subpoena or 
        discovery.  No person described in section 145.63 shall disclose 
        what transpired at a meeting of a review organization except to 
        the extent necessary to carry out one or more of the purposes of 
        a review organization.  The proceedings and records of a review 
        organization shall not be subject to discovery or introduction 
        into evidence in any civil action against a professional arising 
        out of the matter or matters which are the subject of 
        consideration by the review organization.  Information, 
        documents or records otherwise available from original sources 
        shall not be immune from discovery or use in any civil action 
        merely because they were presented during proceedings of a 
        review organization, nor shall any person who testified before a 
        review organization or who is a member of it be prevented from 
        testifying as to matters within the person's knowledge, but a 
        witness cannot be asked about the witness' testimony before a 
        review organization or opinions formed by the witness as a 
        result of its hearings.  For purposes of this subdivision, 
        records of a review organization include Internet-based data 
        derived from data shared for the purposes of the standardized 
        incident reporting system described in section 145.61, 
        subdivision 5, clause (q), and reports submitted electronically 
        in compliance with sections 144.706 to 144.7069.  
           (b) Notwithstanding paragraph (a), a review organization 
        may release nonpatient-identified aggregate trend data on 
        medical error and iatrogenic injury and a facility may file the 
        reports, analyses, and plans required by sections 144.706 to 
        144.7069 without violating this section or being subjected to a 
        penalty under section 145.66 and without compromising the 
        protections provided under sections 145.61 to 145.67 to the 
        reporter of such information; to the review organization, its 
        sponsoring organizations, and members; and to the underlying 
        data and reports.  
           (c) The confidentiality protection and protection from 
        discovery or introduction into evidence provided in this 
        subdivision shall also apply to the governing body of the review 
        organization and shall not be waived as a result of referral of 
        a matter from the review organization to the governing body or 
        consideration by the governing body of decisions, 
        recommendations, or documentation of the review organization. 
           (d) The governing body of a hospital, health maintenance 
        organization, or community integrated service network, that is 
        owned or operated by a governmental entity, may close a meeting 
        to discuss decisions, recommendations, deliberations, or 
        documentation of the review organization.  A meeting may not be 
        closed except by a majority vote of the governing body in a 
        public meeting.  The closed meeting must be tape recorded and 
        the tape must be retained by the governing body for five years. 
           Sec. 7.  [ADVERSE HEALTH CARE EVENTS REPORTING SYSTEM 
        TRANSITION PERIOD.] 
           (a) Effective July 1, 2003, limited implementation of the 
        Adverse Health Care Events Reporting Act shall begin, provided 
        the commissioner of health has secured sufficient nonstate funds 
        for this purpose.  During this period, the commissioner must: 
           (1) solicit additional nonstate funds to support full 
        implementation of the system; 
           (2) work with organizations and experts familiar with 
        patient safety to review reporting categories in Minnesota 
        Statutes, section 144.7065, make necessary clarifications, and 
        develop educational materials; and 
           (3) monitor activities of the National Quality Forum and 
        other patient safety organizations, other states, and the 
        federal government in the area of patient safety. 
           (b) Effective July 1, 2003, facilities defined in Minnesota 
        Statutes, section 144.7063, subdivision 3, shall report any 
        adverse health care events, as defined in Minnesota Statutes, 
        section 144.7065, to the incident reporting system maintained by 
        the Minnesota Hospital Association.  The association shall 
        provide a summary report to the commissioner that identifies the 
        types of events by category.  The association shall consult with 
        the commissioner regarding the data to be reported to the 
        commissioner, storage of data received by the association but 
        not reported to the commissioner, and eventual retrieval by the 
        commissioner of stored data. 
           (c) The commissioner shall report to the legislature by 
        January 15 of 2004 and 2005, with a list of the number of 
        reported events by type and recommendations, if any, for 
        reporting system modifications, including additional categories 
        of events that should be reported. 
           (d) From July 1, 2003, until full implementation of the 
        reporting system, the commissioner of health shall not make a 
        final disposition as defined in Minnesota Statutes, section 
        626.5572, subdivision 8, for investigations conducted in 
        licensed hospitals under the provisions of Minnesota Statutes, 
        section 626.557.  The commissioner's findings in these cases 
        shall identify noncompliance with federal certification or state 
        licensure rules or laws. 
           (e) Effective July 1, 2004, the reporting system shall be 
        fully implemented, provided (1) the commissioner has secured 
        sufficient funds from nonstate sources to operate the system 
        during fiscal year 2005, and (2) the commissioner has notified 
        facilities by April 1, 2004, of their duty to report. 
           (f) Effective July 1, 2005, the reporting system shall be 
        operated with state appropriations. 
           Presented to the governor May 23, 2003 
           Signed by the governor May 27, 2003, 6:06 p.m.