This information was last updated by Horty, Springer & Mattern on October 26, 2018.
Minn. Stat. Ann. § 147.111. Reporting obligations
Subdivision 1. Permission to report. A person who has knowledge of any conduct constituting grounds for discipline under sections 147.01 to 147.22 may report the violation to the board.
Subd. 2. Institutions. Any hospital, clinic, prepaid medical plan, or other health care institution or organization located in this state shall report to the board any action taken by the institution or organization or any of its administrators or medical or other committees to revoke, suspend, restrict, or condition a physician’s privilege to practice or treat patients in the institution, or as part of the organization, any denial of privileges, or any other disciplinary action. The institution or organization shall also report the resignation of any physicians prior to the conclusion of any disciplinary proceeding, or prior to the commencement of formal charges but after the physician had knowledge that formal charges were contemplated or in preparation. Each report made under this subdivision must state the nature of the action taken, state in detail the reasons for the action, and identify the specific patient medical records upon which the action was based. No report shall be required of a physician voluntarily limiting the practice of the physician at a hospital provided that the physician notifies all hospitals at which the physician has privileges of the voluntary limitation and the reasons for it.
Subd. 3. Medical societies. A state or local medical society shall report to the board any termination, revocation, or suspension of membership or any other disciplinary action taken against a physician. If the society has received a complaint which might be grounds for discipline under sections 147.01 to 147.22 against a member physician on which it has not taken any disciplinary action, the society shall report the complaint and the reason why it has not taken action on it or shall direct the complainant to the board of medical practice. This subdivision does not apply to a medical society when it performs peer review functions as an agent of an outside entity, organization, or system.
Subd. 4. Licensed professionals. A licensed health professional and persons holding a residency permit under section 147.0391, shall report to the board personal knowledge of any conduct which the professional reasonably believes constitutes grounds for disciplinary action under sections 147.01 to 147.22 by any physician or person holding a residency permit under section 147.0391, including any conduct indicating that the person may be medically incompetent, or may have engaged in unprofessional conduct or may be medically or physically unable to engage safely in the practice of medicine. A licensed physician or other health professional licensed under this chapter shall also report to the board any occurrence of any adverse reaction resulting from an optometrist’s prescription, use, or administration of any legend drug. Any reports received by the board must be reported to the board of optometry. No report shall be required if the information was obtained in the course of a physician-patient relationship if the patient is a physician or person holding a residency permit under section 147.0391, and the treating physician successfully counsels the person to limit or withdraw from practice to the extent required by the impairment.
Subd. 5. Insurers and other entities. (a) Four times each year as prescribed by the board, each insurer authorized to sell insurance described in section 60A.06, subdivision 1, clause (13), and providing professional liability insurance to persons regulated by the board, shall submit to the board a report concerning the regulated persons against whom professional malpractice settlements or awards have been made to the plaintiff.
(b) A medical clinic, hospital, political subdivision, or other entity which provides professional liability coverage on behalf of persons regulated by the board shall submit to the board a report concerning malpractice settlements or awards paid on behalf of regulated persons, and any settlements or awards paid by a clinic, hospital, political subdivision, or other entity on its own behalf because of care rendered by regulated persons. This requirement excludes forgiveness of bills. The report shall be made to the board within 30 days of payment of all or part of any settlement or award.
(c) The report reports in paragraphs (a) and (b) must contain at least the following information:
(1) the total number of settlements or awards made to the plaintiff;
(2) the date the settlements or awards to the plaintiff were made;
(3) the allegations contained in the claim or complaint leading to the settlements or awards made to the plaintiff;
(4) the dollar amount of each settlement or award;
(5) the regular address of the practice or business of the regulated person or entity against whom an award was made or with whom a settlement was made; and
(6) the name of the regulated person or entity against whom an award was made or with whom a settlement was made.
The reporting entity shall, in addition to the above information, report to the board any information it possesses which tends to substantiate a charge that a regulated person may have engaged in conduct violating a statute or rule of the board.
Subd. 6. Courts. The court administrator of district court or any other court of competent jurisdiction shall report to the board any judgment or other determination of the court which adjudges or includes a finding that a physician is mentally ill, mentally incompetent, guilty of a felony, or guilty of a violation of federal or state narcotics laws or controlled substances act, guilty of an abuse or fraud under Medicare or Medicaid, appoints a guardian of the physician pursuant to sections 524.5-101 to 524.5-502 or commits a physician pursuant to chapter 253B.
Subd. 7. Self-reporting. A physician shall report to the board any personal action which would require that a report be filed with the board by any person, health care facility, business, or organization pursuant to subdivisions 2 to 6.
Subd. 8. Deadlines; forms. Reports required by subdivisions 2 to 7 must be submitted not later than 30 days after the occurrence of the reportable event or transaction. The board may provide forms for the submission of reports required by this section, may require that reports be submitted on the forms provided, and may adopt rules necessary to assure prompt and accurate reporting.
Subd. 9. Subpoenas. The board may issue subpoenas for the production of any reports required by subdivisions 2 to 7 or any related documents.
Subd. 10. Failure to report. On or after August 1, 2012, any person, health care facility, business,or organization that fails to report as required under subdivisions 2 to 6 shall be subject to civil penalties for failing to report as required by law.
§ 147.121. Immunity
Subdivision 1. Reporting. Any person, health care facility, business, or organization is immune from civil liability or criminal prosecution for submitting a report to the board pursuant to section 147.111 or for otherwise reporting to the board violations or alleged violations of section 147.091. All such reports are confidential and absolutely privileged communications.
[Minn. Stat. Ann. §153.24 et seq. contains similar language pertaining to reporting requirements for podiatrists.]
Subd. 2. Investigation; indemnification. (a) Members of the board, persons employed by the board, consultants retained by the board for the purpose of investigation of violations, the preparation of charges and management of board orders on behalf of the board are immune from civil liability and criminal prosecution for any actions, transactions, or publications in the execution of, or relating to, their duties under sections 147.01 to 147.22.
(b) Members of the board and persons employed by the board or engaged in maintaining records and making reports regarding adverse health care events are immune from civil liability and criminal prosecution for any actions, transactions, or publications in the execution of or relating to their duties under section 147.155.
(c) For purposes of this section, a member of the board or a consultant described in paragraph (a) is considered a state employee under section 3.736, subdivision 9.
§ 144.706. Citation (Reporting obligations)
Sections 144.706 to 144.7069 may be cited as the “Minnesota Adverse Health Care Events Reporting Act of 2003.”
§ 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 or outpatient surgical center 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 or 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 (2) 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.
§ 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 or other invasive procedure 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 or other invasive procedure performed on the wrong patient;
(3) the wrong surgical or other invasive 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 invasive 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 or other invasive procedure 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 injury 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 injury 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 injury 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) a patient of any age, who does not have decision-making capacity, discharged to the wrong person;
(2) patient death or serious injury associated with patient disappearance, excluding events involving adults who have decision- making capacity; and
(3) patient suicide, attempted suicide resulting in serious injury, or self-harm resulting in serious injury or death 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 injury 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 injury associated with unsafe administration of blood or blood products;
(3) maternal death or serious injury 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) death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy;
(5) stage 3 or 4 or unstageable ulcers acquired after admission to a facility, excluding progression from stage 2 to stage 3 if stage 2 was recognized upon admission;
(6) artificial insemination with the wrong donor sperm or wrong egg;
(7) patient death or serious injury associated with a fall while being cared for in a facility;
(8) the irretrievable loss of an irreplaceable biological specimen; and
(9) patient death or serious injury resulting from the failure to follow up or communicate laboratory, pathology, or radiology test results.
Subd. 6. Environmental events. Events reportable under this subdivision are:
(1) patient death or serious injury 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 injury associated with a burn incurred from any source while being cared for in a facility; and
(4) patient death or serious injury associated with the use or lack of restraints or bedrails while being cared for in a facility.
Subd. 7. Potential 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 serious injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility.
Subd. 7a. Radiologic events. Death or serious injury of a patient associated with the introduction of a metallic object into the MRI area are reportable events under this subdivision.
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. In conducting the root cause analysis, the facility must consider as one of the factors staffing levels and the impact of staffing levels on 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, data classification. (a) Adverse health events described in subdivisions 2 to 6 do not constitute “maltreatment,” “neglect,” or “a physical injury that is not reasonably explained” under section 626.556 or 626.557 and are excluded from the reporting requirements of sections 626.556 and 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 626.556, subdivision 3, or 626.5572, subdivision 16, of that determination. A mandated reporter otherwise required to report under section 626.556, subdivision 3, or 626.557, subdivision 3, or 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 sections 626.556 and 626.557 are not affected by this section.
(d) Notwithstanding section 626.556, 626.557, or any other provision of Minnesota statute or rule to the contrary, a lead agency under section 626.556, subdivision 3c, a lead investigative agency under section 626.5572, subdivision 13, the commissioner of health, or the director of the Office of Health Facility Complaints is not required to conduct an investigation of or obtain or create investigative data or reports regarding an event described in subdivisions 2 to 6. If the facility satisfies the requirements described in paragraph (a), the review or investigation shall be conducted and data or reports shall be obtained or created only under sections 144.706 to 144.7069, except as permitted or required under sections 144.50 to 144.564, or as necessary to carry out the state’s certification responsibility under the provisions of sections 1864 and 1867 of the Social Security Act. If a licensed health care provider reports an event to the facility required to be reported under subdivisions 2 to 6, in a timely manner, the provider’s licensing board is not required to conduct an investigation of or obtain or create investigative data or reports regarding the individual reporting of the events described in subdivision 2 to 6.
(e) Data contained in the following records are nonpublic and, to the extent they contain data on individuals, confidential data on individuals, as defined in section 13.02:
(1) reports provided to the commissioner under sections 147.155, 147A.155, 148.267, 151.301, and 153.255;
(2) event reports, findings of root cause analyses, and corrective action plans filed by a facility under this section; and
(3) records created or obtained by the commissioner in reviewing or investigating the reports, findings, and plans described in clause (2).
For purposes of the nonpublic data classification contained in this paragraph, the reporting facility shall be deemed the subject of the data.
§ 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.
§ 144.7068. Reports from licensing boards
(a) Effective upon full implementation of the adverse health care events reporting system, the records maintained under sections 147.155, 147A.155, 148.267, 151.301, and 153.255, shall be reported to the commissioner on the schedule established in those sections.
(b) The commissioner shall forward these reports to the facility named in the report.
(c) The facility shall determine whether the event has been previously reported under section 144.7065. The facility shall notify the commissioner whether the event has been reported previously. If the event has not been previously reported, the facility shall make a determination whether the event was reportable under section 144.7065. If the facility determines the event was reportable, the date of discovery of the event for the purposes of section 144.7065, subdivision 10, paragraph (d), shall be as follows:
(1) if the commissioner determines that the facility knew or reasonably should have known about the occurrence of the event, the date the event occurred shall be the date of discovery. The facility shall be considered out of compliance with the reporting act, and the event shall be subject to sections 626.556 and 626.557; or
(2) if the commissioner determines that the facility did not know about the occurrence of the event, the date the facility receives the report from the commissioner shall serve as the date of discovery.
If the facility determines that the event was not reportable under section 144.7065, the facility shall notify the commissioner of that determination.
§ 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.