2007 Minnesota Statutes

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, 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/HLA-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;
(7) patient death or serious disability due to spinal manipulative therapy; and
(8) artificial insemination with the wrong donor sperm or wrong egg.
    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 or serious disability associated with a fall while being cared for in a
facility; and
(5) patient death or serious disability associated with the use or lack 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; 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, 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, neither a lead agency under section 626.556, subdivision 3c, or 626.5572,
subdivision 13 , the commissioner of health, nor the director of the Office of Health Facility
Complaints is 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.
(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.
History: 2003 c 99 s 3; 1Sp2003 c 14 art 7 s 85; 2004 c 186 s 1; 2007 c 41 s 1-3