Patient Safety Act
S.N.L. 2017, c. P-3.01
Newfoundland and Labrador — Consolidated Statutes
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SNL2017
CHAPTER P-3.01
PATIENT SAFETY ACT
Amended:
2022 cP-30.1 s56; 2023 c8
CHAPTER P-3.01
AN ACT RESPECTING PATIENT SAFETY AND QUALITY ASSURANCE IN THE PROVINCE
(Assented to March 21, 2017)
Analysis
Short title
Definitions
PART I
REPORTING, INVESTIGATION AND RELEASE OF INFORMATION
Patient safety indicators
Report to provincial health authority
Requirement to review and report
Reviewing close calls and occurrences
Notice to minister
Quality assurance information to minister
Release of information by minister or provincial health authority
Release of information
No retaliation
PART II
QUALITY ASSURANCE COMMITTEES AND PATIENT SAFETY PLANS
Quality assurance committees generally
Duties and responsibilities
Quality assurance activity committees
Continuing as quality assurance information
Patient safety plans
PART III
DISCLOSURE TO PATIENT
Disclosure to patient
PART IV
PROVINCIAL PATIENT SAFETY AND QUALITY ADVISORY COMMITTEE
Patient safety and quality advisory committee
Membership
Powers and duties of committee
PART V
GENERAL
Conflict
Offence
Protection from liability
Statutory review
Regulations
Ministerial regulations
Forms
SNL2015 cA-1.2 Amdt.
RSNL1990 cE-16 Amdt.
SNL2008 cP-7.01 Amdt.
SNL2006 cP-38.1 Amdt.
RSNL1990 cP-43 Amdt.
Be it enacted by the Lieutenant-Governor and House of Assembly in Legislative Session convened, as follows:
Short title
This Act may be cited as the Patient Safety
Act
2017 cP-3.01 s1
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Definitions
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 Provincial Health Authority Act
(c)
"close call" means a potential occurrence that did not actually occur due to chance, corrective action or timely intervention;
(c.1)
"correctional facility" means
(d)
"department" means the department presided over by the minister;
(e)
"health care provider" means a person who
(
i) is employed by the Provincial Health Authority
to provide a health service,
(ii)
is under contract with the Provincial 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 the Provincial 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 the Provincial 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 the Provincial 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
(o.1)
"Provincial Health Authority" means the Provincial Health Authority established under the Provincial Health Authority Act
(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)
"q uality 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 recomm
endations;
(u)
[Rep. by 2022 cP-30.1 s56]; and
(v)
"staff member"
means correctional officers and other persons employed by or under contract with the Department of Justice and Public Safety at a correctional facility.
2017 cP-3.01 s2 ; 2022 cP-30.1 s56 ; 2023 c8 s1
PART I
REPORTING, INVESTIGATION AND RELEASE OF INFORMATION
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Patient safety indicators
The Provincial 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 Provincial Health Authority
, including patient safety indicators, as prescribed in the regulations.
2017 cP-3.01 s3 ; 2022 cP-30.1 s56
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Report to provincial health authority
A report of a close call or an occurrence made by a health care provider to the Provincial Health Authority
shall be made in accordance with the regulations.
2017 cP-3.01 s4 ; 2022 cP-30.1 s56
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Requirement to review and report
Where a close call or an occurrence is reported, the Provincial Health Authority
shall review and report on the close call or occurrence in accordance with the regulations.
2017 cP-3.01 s5 ; 2022 cP-30.1 s56
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Reviewing close calls and occurrences
The Provincial 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.
2017 cP-3.01 s6 ; 2022 cP-30.1 s56
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Notice to minister
(1) The Provincial 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 Provincial Health Authority
in accordance with the regulations.
(2) The Provincial Health Authority
shall give notice to the minister of any occurrence that involves multiple patients or multiple regions in accordance with the regulations.
2017 cP-3.01 s7 ; 2022 cP-30.1 s56
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Quality assurance information to minister
The minister may direct the Provincial 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 the ministers duties and responsibilities.
2017 cP-3.01 s8 ; 2022 cP-30.1 s56 ; 2023 c8 s2
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Release of information by minister or provincial health authority
The minister or the Provincial 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.
2017 cP-3.01 s9 ; 2022 cP-30.1 s56
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Release of information
(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 personal health information about the person, 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 the following persons who have 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:
(
a) a health care provider;
(
b) a person under the authority of the Provincial Health Authority; and
(
c) a staff member.
(4.1) A person referred to in subsection (4) shall provide all information, documents or records required by the quality assurance activity committee under subsection (4).
(5) [Rep. by 2022 cP-30.1 s56]
(6) [Rep. by 2022 cP-30.1 s56]
2017 cP-3.01 s10 ; 2022 cP-30.1 s56 ; 2022 cP-30.1 s56 ; 2023 c8 s3
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No retaliation
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.
2017 cP-3.01 s11
PART II
QUALITY ASSURANCE COMMITTEES AND PATIENT SAFETY PLANS
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Quality assurance committees generally
(1) The Provincial 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 the Provincial Health Authority.
2017 cP-3.01 s12 ; 2022 cP-30.1 s56
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Duties and responsibilities
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 Provincial 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 Provincial 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.
2017 cP-3.01 s13 ; 2022 cP-30.1 s56
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Quality assurance activity committees
(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.
2017 cP-3.01 s14
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Continuing as quality assurance information
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.
2017 cP-3.01 s15
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Patient safety plans
The Provincial Health Authority
shall develop and implement a patient safety plan in the form and manner prescribed in the regulations when requested by the minister.
2017 cP-3.01 s16 ; 2022 cP-30.1 s56
PART III
DISCLOSURE TO PATIENT
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Disclosure to patient
(1) The Provincial 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) T he Provincial 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 in relation to an adverse health event under this Part.
2017 cP-3.01 s17 ; 2022 cP-30.1 s56 ; 2022 cP-30.1 s56 ; 2023 c8 s4
PART IV
PROVINCIAL PATIENT SAFETY AND QUALITY ADVISORY COMMITTEE
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Patient safety and quality advisory committee
There shall be a patient safety and quality advisory committee for the province.
2017 cP-3.01 s18
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Membership
(1)The patient safety and quality advisory committee shall consist of the following members:
(
a) the deputy minister of the department or the deputy ministers 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 the Provincial Health Authority
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.
2017 cP-3.01 s19 ; 2022 cP-30.1 s56 ; 2023 c8 s5
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Powers and duties of committee
The patient safety and quality advisory committee shall
(
a) advise on matters relating to patient safety and quality assurance within the Provincial Health Authority
(
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.
2017 cP-3.01 s20 ; 2022 cP-30.1 s56
PART V
GENERAL
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Conflict
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.
2017 cP-3.01 s21
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Offence
(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.
2017 cP-3.01 s22
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Protection from liability
(1)An action does not lie against the following for releasing information in good faith in accordance with this Act:
(
a) the minister;
(
b) the Provincial Health Authority
(
c) a person under the authority of the Provincial Health Authority
(
d) a health care provider;
(d.1)
a staff member;
(
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 the Provincial 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 the Provincial 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.
2017 cP-3.01 s23 ; 2022 cP-30.1 s56 ; 2023 c8 s6
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Statutory review
The minister shall, every 5 years, conduct a review of this Act and the regulations and consider the areas which may be improved.
2017 cP-3.01 s24
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Regulations
(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 the Provincial 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 the Provincial 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.
2017 cP-3.01 s25 ; 2022 cP-30.1 s56
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Ministerial regulations
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 the Provincial Health Authority
, including patient safety indicators, for the purpose of this Act;
(
d) prescribing patient safety indicators;
(
e) respecting the reporting requirements of the Provincial Health Authority
to the minister;
(
f) respecting the requirements for the Provincial Health Authority
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.
2017 cP-3.01 s26 ; 2022 cP-30.1 s56
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Forms
The minister may establish forms for the purpose and administration of this Act and the regulations.
2017 cP-3.01 s27
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SNL2015 cA-1.2 Amdt.
(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
2017 cP-3.01 s28
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RSNL1990 cE-16 Amdt.
(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
2017 cP-3.01 s29
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SNL2008 cP-7.01 Amdt.
(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
2017 cP-3.01 s30
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SNL2006 cP-38.1 Amdt.
(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.
2017 cP-3.01 s31
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RSNL1990 cP-43 Amdt.
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)".
2017 cP-3.01 s32
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