Be it enacted by the Lieutenant-Governor and
House of Assembly in Legislative Session convened, as follows:
Short title
1. This
Act may be cited as the Patient Safety
Act.
Definitions
2. In
this Act
(a) "adverse health event" means an
occurrence that results in an unintended outcome which negatively affects a
patient's health or quality of life;
(b) "board of trustees" has the same
meaning as the word "board" in the Regional Health Authorities Act;
(c) "close call" means a potential occurrence
that did not actually occur due to chance, corrective action or timely intervention;
(d) "department" means the department
presided over by the minister;
(e) "health care provider" means a
person who
(i) is employed by a regional health authority to provide
a health service,
(ii) is under contract with a regional health
authority to provide a health service, or
(iii) receives funding or payment from the
government of the province to provide a health service and provides that health
service under the authority of a regional health authority but does not include
a person who provides a health service that is excluded under the regulations;
(f) "health service" means an
observation, examination, assessment, care, service or procedure in relation to
a patient that is carried out, provided or undertaken by or under the authority
of a regional health authority and includes
(i) health screening, protection and promotion,
(ii) continuing and long term care,
(iii) community health services,
(iv) mental health and addiction services,
(v) community supports and home care,
(vi) treatment of illness and injury,
(vii) hospital care,
(viii) evaluation, research and quality assurance,
(ix) diagnostic services,
(x) ambulance services, and
(xi) those other services or procedures prescribed
in the regulations;
(g) "minister" means the minister
appointed under the Executive Council Act
to administer this Act;
(h) "morbidity and mortality rounds"
means a review of a health service provided to a patient or a group of patients
by a group of health care providers within a unit, program or specialty in
order to provide recommendations to improve the quality of health services;
(i) "occurrence" means an undesired or
unplanned event that does not appear to be consistent with the safe provision
of health services;
(j) "patient" means a person who is receiving
or who has received a health service;
(k) "patient safety indicator" means a
measure that provides information about close calls and occurrences in the provision
of health services or quality assurance activities that are known to reduce
harm to patients;
(l) "patient safety plan" means a plan
developed by a regional health authority focused on improving safety,
preventing outcomes which negatively affect a patient's health or quality of
life and promoting safer care of patients;
(m) "peer review" means a review by peers
or subject matter experts undertaken for the purpose of improving the quality
of health services provided by a health care provider or a group of health care
providers by identifying areas for practice improvement;
(n) "personal health information" has the
same meaning as in the Personal Health
Information Act;
(o) "personal information" has the same
meaning as in the Access to Information
and Protection of Privacy Act, 2015;
(p) "quality assurance activity" means an
activity carried out, provided or undertaken by or under the authority of a
quality assurance committee, the purpose of which is to study, review, investigate,
assess or evaluate the provision of health services, either ongoing or case
specific, in order to make recommendations to improve
(i) medical or hospital care, the provision of health
services or medical research, or
(ii) programs relating to health services,
and includes morbidity and mortality rounds,
peer reviews, quality reviews and reviews of health services;
(q) "quality assurance activity committee"
means a committee established under paragraph 13(a);
(r) "quality assurance committee" means a
committee established under section 12;
(s) "quality assurance information"
means information in any form that is
(i) provided to or generated for a quality
assurance committee or a quality assurance activity committee,
(ii) provided to or generated for the purpose of
carrying out a quality assurance activity,
(iii) generated for the purpose of producing patient
safety indicators,
(iv) generated in the course of carrying out a
quality assurance activity, or
(v) contained in a report or notice made under section
4 or 7,
but does not include
(vi) information contained in a record, such as a
hospital chart or a medical record, that is maintained for the purpose of documenting
health services provided to a patient,
(vii) the fact that a quality assurance activity committee
met or that a quality assurance activity was conducted, and
(viii) the terms of reference of a quality assurance activity
committee;
(t) "quality
review" means a process to assess the quality of a health service provided
or the causes and contributing factors associated with a close call, occurrence
or adverse health event and to make recommendations; and
(u) "regional health authority" means a
regional health authority established under the Regional Health Authorities Act.
PART I
REPORTING, INVESTIGATION AND RELEASE OF INFORMATION
Patient safety
indicators
3. A
regional health authority shall compile and report information concerning the
quality of health services carried out, provided or undertaken by or under the
authority of the regional health authority, including patient safety indicators,
as prescribed in the regulations.
Report to
regional health authority
4. A
report of a close call or an occurrence made by a health care provider to a
regional health authority shall be made in accordance with the regulations.
Requirement to review
and report
5. Where
a close call or an occurrence is reported, the regional health authority shall review
and report on the close call or occurrence in accordance with the regulations.
Reviewing close
calls and occurrences
6. Every
regional health authority shall establish a process for reviewing close calls
and occurrences for the purpose of reducing or mitigating the risk of further
similar close calls or occurrences in accordance with the regulations.
Notice to
minister
7. (1) A
regional health authority shall give notice to the minister of an adverse
health event that arises during the provision of a health service carried out,
provided or undertaken by or under the authority of the regional health
authority in accordance with the regulations.
(2) A regional health authority shall give notice
to the minister of any occurrence that involves multiple patients or multiple
regions in accordance with the regulations.
Quality assurance
information to minister
8. The
minister may direct a regional health authority to provide to the minister
quality assurance information that does not include personal information or personal
health information in the form that the minister directs for the purpose of carrying
out his or her duties and responsibilities.
Release of information
by minister or regional health authority
9. The
minister or the regional health authority may release information and any
related recommendations made by a quality assurance activity committee that do
not include personal information or personal health information.
Release of information
10. (1) The
Access to Information and Protection of
Privacy Act, 2015 does not apply to the use, collection, disclosure,
release, storage or disposition of, or any other dealing with, quality
assurance information.
(2) Notwithstanding the Personal Health Information Act or another Act or law, a person may
release any information to a quality assurance activity committee.
(3) Notwithstanding subsection (2) or another Act
or law, a person shall not disclose, release or access quality assurance information,
even where it contains his or her personal health information, except as
permitted under this Act.
(4) For the purpose of carrying out its duties and
responsibilities under this Act, a quality assurance activity committee may
require a health care provider or a person under the authority of a regional
health authority who has information, or the custody or control of a document
or record, relating to a close call or an occurrence being reviewed or investigated
to provide the information, document or record in accordance with the regulations.
(5) If a close call or an occurrence involves more
than one regional health authority, the quality assurance activity committees
established to review or investigate it may share information, documents and records
with each other to the extent necessary to properly carry out their duties and
responsibilities.
(6) For the purpose of subsection (5), a document
or record may contain personal information or personal health information.
No retaliation
11. A
person shall not dismiss, suspend, discipline, demote, harass or otherwise
disadvantage or penalize
(a) an individual where the individual has
released information to a quality assurance activity committee; or
(b) a health care provider where the health care
provider reported a close call or an occurrence.
PART II
QUALITY ASSURANCE COMMITTEES AND PATIENT SAFETY PLANS
Quality assurance
committees generally
12. (1) Every
regional health authority shall establish and maintain a quality assurance committee
in accordance with the regulations.
(2) The membership, composition, structure and
terms of reference of every quality assurance committee shall meet the
requirements prescribed in the regulations.
(3) A quality assurance committee shall report to
the board of trustees of its regional health authority.
Duties and responsibilities
13. A
quality assurance committee shall
(a) establish or designate quality assurance
activity committees to carry out quality assurance activities in order to
maintain or improve the quality of health services carried out, provided or
undertaken by or under the authority of the regional health authority;
(b) monitor and report to the board of trustees on
the quality of health services carried out, provided or undertaken by or under
the authority of the regional health authority;
(c) consider and make recommendations to the board
of trustees respecting patient safety and quality improvements;
(d) maintain confidentiality of all quality
assurance information with which it has been provided or to which it has access
unless otherwise provided in this Act or the regulations; and
(e) carry out any other duties and responsibilities
prescribed in the regulations.
Quality assurance
activity committees
14. (1) The
membership, composition, structure and terms of reference of every quality
assurance activity committee shall meet the requirements prescribed in the regulations.
(2) A quality assurance activity committee shall
(a) make recommendations and report on the quality
assurance activities carried out by the committee in accordance with the regulations;
and
(b) maintain confidentiality of all quality
assurance information with which it has been provided or to which it has access
unless otherwise provided in this Act or the regulations.
Continuing as quality
assurance information
15. Quality
assurance information collected by or for a quality assurance committee or a
quality assurance activity committee continues to be quality assurance information
after
(a) the committee is no longer in existence or no
longer being maintained or operated; or
(b) the entity that established the committee no
longer has the authority to establish or maintain the committee.
Patient safety
plans
16. A
regional health authority shall develop and implement a patient safety plan in
the form and manner prescribed in the regulations when requested by the
minister.
PART III
DISCLOSURE TO PATIENT
Disclosure to patient
17. (1) Every
regional health authority shall establish a policy for ensuring that an adverse
health event is disclosed to the affected patient in accordance with the
regulations.
(2) A regional health authority shall disclose the
following information relating to an adverse health event to the patient affected
by the adverse health event in accordance with the regulations:
(a) the facts of the adverse health event and any
new or otherwise unknown facts as they become known;
(b) the consequences to the patient as they become
known;
(c) the details of the health services provided to
the patient as a result of the adverse health event; and
(d) any recommendations from quality assurance
activities respecting the adverse health event.
(3) Where a patient is deceased or lacks the capacity
to understand the nature and consequences of an adverse health event, the disclosure
required to be provided under subsection (2) shall be provided to a person
authorized by the regulations to receive information on the patient's behalf.
(4) The policy referred to in subsection (1) shall
include a requirement to record the fact that information has been provided to
the patient or a person referred to in subsection (3) and to record the details
of the information that was provided in the patient's health record.
(5) Notwithstanding subsection 10(3), this Act
does not apply to the disclosure or release of quality assurance information by
a patient or a person referred to in subsection (3) where the quality assurance
information was disclosed to him or her in relation to an adverse health event
under this Part.
PART IV
PROVINCIAL PATIENT SAFETY AND QUALITY ADVISORY COMMITTEE
Patient safety
and quality advisory committee
18. There
shall be a patient safety and quality advisory committee for the province.
Membership
19. (1) The
patient safety and quality advisory committee shall consist of the following
members:
(a) the deputy minister of the department or his
or her designate; and
(b) not more than 12 other persons appointed by
the minister which shall include
(i) 2 patient representatives,
(ii) not more than 2 officials of the department
who are responsible for patient safety and quality assurance,
(iii) one or more vice-presidents of regional health
authorities responsible for patient safety and quality assurance,
(iv) one or more patient safety physicians, and
(v) those other persons the minister considers
appropriate.
(2) The minister shall designate one member of the
committee to be the chairperson.
Powers and duties
of committee
20. The
patient safety and quality advisory committee shall
(a) advise on matters relating to patient safety
and quality assurance within regional health authorities;
(b) consider and make recommendations to the
minister respecting any matter referred by the minister;
(c) measure, monitor and assess patient safety indicators
and the quality of health services;
(d) identify effective practices and make recommendations
to improve patient safety and the quality of health services;
(e) assist in implementing and evaluating patient
safety and quality assurance improvements;
(f) consult and engage with regulatory bodies of
health professions where appropriate;
(g) report annually to the minister on its
activities; and
(h) undertake other activities as prescribed in
the regulations.
PART V
GENERAL
Conflict
21. In
the event of a conflict between a provision of this Act or the regulations and
a provision of any other Act or regulations, this Act and the regulations
prevail unless this Act or the regulations specifically provide otherwise.
Offence
22. (1) A
person who accesses, discloses or releases quality assurance information
contrary to this Act or the regulations is guilty of an offence and is liable
on summary conviction to a fine not exceeding $5,000 and,
in default of payment, to a term of imprisonment not exceeding 3 months, or to
both a fine and imprisonment.
(2) A person who contravenes section 11 is guilty
of an offence and is liable on summary conviction to a fine not exceeding
$5,000 and, in default of payment, to a term of imprisonment not exceeding 3
months, or to both a fine and imprisonment.
Protection from liability
23. (1) An
action does not lie against the following for releasing information in good
faith in accordance with this Act:
(a) the minister;
(b) a regional health authority;
(c) a person under the authority of a regional
health authority;
(d) a health care provider;
(e) an employee of the department;
(f) a quality assurance committee;
(g) a participant of a quality assurance activity;
and
(h) a person who provides information to a quality
assurance activity committee.
(2) An action does not lie against a member of a
quality assurance committee, a quality assurance activity committee or a
patient safety and quality advisory committee for releasing in good faith quality
assurance information to the minister or a regional health authority for the
purpose of improving or maintaining the quality of health services carried out,
provided or undertaken by or under the authority of a regional health authority.
(3) An action does not lie against a person for releasing
in good faith information to reduce or eliminate a significant risk of bodily
harm if it is reasonable in the circumstances.
Statutory review
24. The
minister shall, every 5 years, conduct a review of this Act and the regulations
and consider the areas which may be improved.
Regulations
25. (1) The
Lieutenant-Governor in Council may make regulations
(a) governing notice and the reporting of close
calls, occurrences and adverse health events and prescribing the information
that shall be included in a notice or report;
(b) governing the notice to be given to the
minister by a regional health authority regarding an occurrence involving multiple
patients or multiple regions including prescribing the time within which notice
shall be provided and prescribing the information that shall be included in a
notice;
(c) respecting the review, investigation and
reporting of close calls, occurrences and adverse health events;
(d) respecting the appointment of members, terms
of office of members, operating procedures, composition, structure and terms of
reference of quality assurance committees, quality assurance activity committees
and the patient safety and quality advisory committee;
(e) respecting the use, disclosure and release of
quality assurance information;
(f) respecting how a quality assurance activity committee
may require a health care provider or a person under the authority of a
regional health authority who has information, or the custody or control of a
document or record, relating to a close call or an occurrence being reviewed or
investigated to provide the information, document or record to the committee;
(g) respecting the disclosure of adverse health
events to a patient including the persons to whom an adverse health event may
be disclosed on behalf of a patient who lacks capacity or is deceased;
(h) defining a word or expression used but not defined
in this Act; and
(i) generally, to give effect to the purpose of
this Act.
(2) The Lieutenant-Governor
in Council may, in addition to or instead of regulations made under this section,
adopt by reference and constitute as regulations the whole or part of
provisions of a code adopted or standards fixed with or without modification,
and including amendments to the code or standard of an organization acceptable
to the minister.
(3) A certificate of the
minister that a document is a copy of a code or standard referred to in subsection
(2) or an extract from, a modification of, or an amendment to, a code or
standard is without further proof presumptive evidence of the content of that
code, standard, extract or amendment.
Ministerial regulations
26. The
minister may make regulations
(a) prescribing which services or procedures are health
services for the purpose of this Act;
(b) excluding health services for the purpose of subparagraph
2(e)(iii);
(c) governing the compilation and reporting of
information concerning the quality of health services carried out, provided or
undertaken by or under the authority of a regional health authority, including
patient safety indicators, for the purpose of this Act;
(d) prescribing patient safety indicators;
(e) respecting the reporting requirements of a
regional health authority to the minister;
(f) respecting the requirements for regional
health authorities to report to the public on matters relating to patient
safety and the quality of health services including patient safety indicators;
(g) governing the duties and responsibilities of
quality assurance committees and quality assurance activity committees including
record keeping requirements and reporting requirements;
(h) prescribing the activities to be undertaken by
the patient safety and quality advisory committee;
(i) respecting patient safety plans including the
factors to be considered in developing them, their content and the manner in
which they are developed, published and released;
(j) defining a word or expression used but not defined
in this Act; and
(k) generally, to give effect to the purpose of
this Act.
Forms
27. The
minister may establish forms for the purpose and administration of this Act and
the regulations.
SNL2015 cA-1.2 Amdt.
28. (1) Subsection 102(3) of the Access to Information and Protection of
Privacy Act, 2015 is amended by deleting the word "or" at the end
of paragraph (a), deleting the period at the end of paragraph (b) and
substituting a semi-colon, and by adding immediately after paragraph (b) the
following:
(c) any information contained in a report or
notice made under section 4 or 7 of the Patient Safety Act; or
(d) any information, including a record, that is
prepared for the use of, or collected, compiled or prepared by, a committee
referred to in subsection 8.1(1) of the Evidence Act for the purpose of
carrying out its duties.
(2) Schedule A of the Act is amended by adding
immediately after paragraph (m) the following:
(m.1) sections 10 and 15 of the Patient Safety Act;
RSNL1990 cE-16 Amdt.
29. (1) Paragraph 8.1(1)(a) of the Evidence Act is repealed and the
following substituted:
(a) "legal proceeding" means any civil
proceeding, inquiry, arbitration, judicial inquiry or proceeding in which
evidence is or may be given before a
(i) court, tribunal, board or commission,
(ii) person or committee, including a disciplinary
committee, mandated to review the clinical competency of a health care provider
of a regional health authority established under the Regional Health Authorities Act, or
(iii) committee, including a disciplinary committee,
of a governing body of a regulated health profession,
and includes an action or proceeding for the
imposition of punishment by way of fine, damages or penalty for the violation
of an enactment but does not include an inquiry ordered under the Fatalities Investigation Act, the Provincial Offences Act or the Public Inquiries Act, 2006;
(2) Subsections 8.1(2) to (4) of the Act are
repealed and the following substituted:
(2) This section applies to the following committees:
(a) a quality assurance committee as defined under
the Patient Safety Act;
(b) a quality assurance activity committee as
defined under the Patient Safety Act;
and
(c) the Child Death Review Committee under the Fatalities Investigations Act.
(3) The following shall not be disclosed in or in
connection with a legal proceeding:
(a) a report, statement, evaluation,
recommendation, memorandum, document or information, of, or made by, for or to,
a committee to which this section applies; and
(b) a report or notice made under section 4 or 7 of
the Patient Safety Act.
(4) Where a person appears as a witness in a legal
proceeding, that person shall not be asked and shall not
(a) answer a question in connection with
proceedings of a committee to which this section applies;
(b) produce a report, evaluation, statement,
memorandum, recommendation, document or information of, or made by, for or to,
a committee to which this section applies; or
(c) produce a report or notice made under section 4
or 7 of the Patient Safety Act.
SNL2008 cP-7.01 Amdt.
30. (1) Paragraph 58(1)(c) of the Personal Health Information Act is
amended by deleting the word "or" at the end of subparagraph (ii) and
by adding immediately after that subparagraph the following:
(ii.1) preparing or providing a report or notice under
section 4 or 7 of the Patient Safety Act,
or
(2) Subsection 78(3) of the Act is amended by deleting
the word "or" at the end of paragraph (a), by deleting the period at
the end of paragraph (b) and substituting a semi-colon and the word
"or", and by adding after that paragraph the following:
(c) information contained in a report or notice
made under section 4 or 7 of the Patient
Safety Act.
SNL2006 cP-38.1 Amdt.
31. (1) Subsections 12(2) and (3) of the Public Inquiries Act, 2006 are repealed
and the following substituted:
(2) Notwithstanding subsection (1) but subject to
subsection (4), a rule of law that authorizes or requires the withholding of records,
documents or other things or a refusal to disclose information, on the grounds
that the disclosure would be injurious to the public interest or would violate
Crown privilege, does not apply in respect of an inquiry under this Act.
(3) Notwithstanding subsection (1) but subject to
subsection (4), a person shall not refuse to disclose information to a
commission or a person authorized by a commission on the grounds that the
disclosure is prohibited or restricted by another Act or regulation.
(2) Section 12 of the Act is amended by adding
immediately after subsection (3) the following:
(4) Notwithstanding another provision of this
section, subsections (2) and (3) do not apply to quality assurance information
as defined in the Patient Safety Act
in a proceeding in which evidence is or may be given before a committee of a
governing body of a regulated health profession.
RSNL1990 cP-43
Amdt.
32. Schedule
C of the Public Service Commission Act
is amended by inserting immediately after the statutory appointment reference "Optometry Act, 2012, subsections 9(1)
and 27(4) with respect to ministerial appointments" the statutory
appointment reference "Patient
Safety Act, subparagraph 19(1)(b)(i)".
©Queen's Printer