Minnesota Legislature
Office of the Revisor of Statutes
Minnesota Session Laws - 2003, Regular Session
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.
Official Publication of the State of Minnesota
Revisor of Statutes