First Session, 48th

General Assembly

66 Elizabeth II,

BILL 70

AN ACT RESPECTING PATIENT SAFETY

AND

QUALITY ASSURANCE IN THE PROVINCE

Received and Read the First Time .................................................................................................

Second Reading .................................................................................................................................

Committee ..........................................................................................................................................

Third Reading .....................................................................................................................................

Royal Assent ......................................................................................................................................

HONOURABLE JOHN

HAGGIE

Minister of Health

and Community Services

Ordered to be printed by

the Honourable House of Assembly

EXPLANATORY NOTE

This Bill would enact the Patient Safety Act to improve patient

safety and quality assurance processes in the province by providing a framework

for reporting and investigating close calls, occurrences and adverse health

events.

A BILL

AN ACT RESPECTING PATIENT SAFETY AND QUALITY

ASSURANCE IN THE PROVINCE

Analysis

Short title

Definitions

PART

REPORTING, INVESTIGATION AND RELEASE OF INFORMATION

Patient safety indicators

Report to regional 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

regional health authority

Release of information

No retaliation

PART

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

PROVINCIAL PATIENT SAFETY AND QUALITY ADVISORY COMMITTEE

Patient safety and quality advisory

committee

Membership

Powers and duties of committee

PART

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

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) "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; 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

(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

(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

(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

(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

(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

(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

(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

(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

(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.

(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 ,

(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.

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)".

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