Bill 40 - An Act Respecting Health Quality and Patient Safety

BILL 40

An Act Respecting Health Quality and Patient Safety

His Majesty, by and with the advice and consent of the Legislative Assembly of New Brunswick, enacts as follows:

Health Quality and Patient Safety Act

1( 1) The heading “Definitions” preceding section 1 of the Health Quality and Patient Safety Act, chapter 21 of the Acts of New Brunswick, 2016, is repealed and the following is substituted:

Definitions and interpretation

1( 2) Section 1 of the Act is amended

(a) by renumbering the section as subsection 1(1);

(b) in subsection (1)

( i) in paragraph (a) of the definition “patient safety incident” by striking out “patient” and substituting “patient or occurs on the property of a health care organization”;

( ii) by adding the following definitions in alphabetical order:

“Advisory Committee” means the New Brunswick Quality of Care and Patient Safety Advisory Committee established under section 2.1. (comité consultatif)

“critical event” means a patient safety incident that creates an ongoing safety risk to patients and that (événement critique)

(a) was serious, including an incident

( i) resulting in a symptomatic outcome,

( ii) requiring that the patient receive a major medical or surgical intervention or life-saving intervention,

( iii) shortening the patient’s life expectancy, or

( iv) causing the patient major, long-term or permanent harm or loss of function,

(b) is considered to have contributed to or resulted in a patient’s death, or

(c) in the case of a regional health authority, contributed to or resulted in serious harm to the patient and is, according to the Minister, a never event in hospital care in Canada.

“harm” means an adverse outcome to a patient (préjudice)

(a) identified by clinical observation, assessment or a report by the patient or the patient’s family, and

(b) that resulted in, or could have resulted in, the patient requiring health products, services, treatments, interventions or restorative actions.

“incident report” means a record that sets out the facts of a patient safety incident. (rapport d’incident)

“Minister” means the Minister of Health and includes any person designated by the Minister to act on the Minister’s behalf. (ministre)

“multiple-patient event” means a patient safety incident involving one or more related events that (événement affectant plusieurs patients)

(a) contributes to, or results in, harm to or the death of multiple patients, or

(b) could have contributed to, or resulted in, harm to or the death of multiple patients, and the health care organization determines that there is an ongoing safety risk to the patients involved.

“performance indicator” means a standardized measure of health system performance, developed in accordance with recognized methodologies, that quantifies and evaluates a specified aspect of health quality and patient safety, establishes a desired direction of performance and enables comparison within or between organizations or other entities, programs, departments, services or populations for the purposes of monitoring, reporting and improving health system outcomes. (indicateur de rendement)

“personal health information” means personal health information as defined in the Personal Health Information Privacy and Access Act. (renseignements personnels sur la santé)

“personal information” means personal information as defined in the Right to Information and Protection of Privacy Act. (renseignements personnels)

“quality assurance information” means information, including personal information and personal health information, that is collected in an incident report or prepared in the course of a quality review or after a quality review by a health care organization but does not include information that is retained for the purpose of documenting health services provided to a particular patient in a patient’s health record. (renseignements utilisés aux fins d’assurance de la qualité)

“quality improvement activity” means an activity to assess, investigate, evaluate or improve the quality and safety of health services. (activité d’amélioration de la qualité)

“quality improvement plan” means a quality and safety of health services plan that is developed through an evidence-based process with an emphasis on accountability, transparency and collaboration and that sets out quality improvement activities. (plan d’amélioration de la qualité)

“quality improvement report” means a report that sets out the progress and results of quality improvement activities implemented in the previous year as part of the quality improvement plan. (rapport d’amélioration de la qualité)

“quality review” means a process that is conducted to examine the factors that contributed to a patient safety incident or other incident referred to in subsection 3(4). (examen de la qualité)

“quality review report” means a report that is prepared after a quality review that sets out the facts of the patient safety incident or other incident referred to in subsection 3(4) and recommendations to improve the quality and safety of health services but does not contain personal information or personal health information. (rapport d’examen de la qualité)

“surveillance information” means microdata with respect to a patient safety incident or quality concern, including personal information and personal health information, that is (renseignements de surveillance)

(a) contained in an information system, or any other system, and

(b) collected, used, disclosed or retained for the purposes of contextualizing, monitoring, detecting and tracking trends in the quality, safety and experiences of or with respect to health products, services, treatments and interventions across a system or organization.

1( 2) For the purposes of paragraph (b) of the definition “critical event”, a patient safety incident is considered to have contributed to a person’s death if the health care organization makes that determination on a balance of probabilities.

1( 3) Section 2 of the Act is amended

(a) by repealing subsection (1);

(b) in subsection (2) by striking out “committee” and substituting “committee whose sole purpose is to ensure quality of care and safety of patients”;

2( 3) A quality of care and safety of patients committee shall perform the duties and functions set out in this Act and the regulations.

(d) by repealing subsection (4).

1( 4) The Act is amended by adding after section 2 the following:

New Brunswick Quality of Care and Patient Safety Advisory Committee

2.1 The Minister shall establish and maintain a New Brunswick Quality of Care and Patient Safety Advisory Committee with the powers and duties prescribed by regulation.

1( 5) Section 3 of the Act is repealed and the following is substituted:

3( 1) As soon as the circumstances permit after a patient safety incident occurs, the member of the staff of the health care organization who discovered the incident shall submit an incident report to the health care organization.

3( 2) If an incident report is submitted to a health care organization, the health care organization may conduct a quality review.

3( 3) Despite subsection (2), in the case of a patient safety incident that is a multiple-patient event or a critical event, the health care organization shall conduct a quality review.

3( 4) If an incident occurs that could have resulted in a patient safety incident and the health care organization determines that there is an ongoing safety risk to patients, the health care organization may conduct a quality review.

3( 5) After a health care organization conducts a quality review, the health care organization shall

(a) prepare a quality review report, and

(b) submit the quality review report to the quality of care and safety of patients committee.

3( 6) A health care organization shall notify the quality of care and safety of patients committee on the completion of a quality review.

3( 7) Subject to subsection (8), in the case of a patient safety incident that involves two or more health care organizations, the health care organizations may conduct a joint quality review, prepare a joint quality review report and submit the joint report to the quality of care and safety of patients committees involved.

3( 8) In the case of a patient safety incident that is a multiple-patient event or a critical event and that involves two or more health care organizations, the health care organizations shall conduct a joint quality review, prepare a joint quality review report and submit the joint report to the quality of care and safety of patients committees involved.

3( 9) If a quality review report is submitted to the quality of care and safety of patients committee under this section, the committee shall review the report, approve recommendations in the report and notify the board of directors of the health care organizations involved of the approved recommendations.

1( 6) The heading “Notice to patient” preceding section 4 of the Act is repealed and the following is substituted:

Disclosure to patient

1( 7) Section 4 of the Act is repealed and the following is substituted:

Disclosure to patient

4( 1) As soon as the circumstances permit after a patient safety incident occurs, the health care organization involved shall notify the patient if

(a) the patient safety incident contributed to or resulted in harm to the patient, or

(b) the health care organization determines that there is an ongoing safety risk to the patient.

4( 2) A health care organization who provides notice to a patient under subsection (1) shall disclose, when the information is available,

(a) the relevant facts of the incident,

(b) the health products, services, treatments, interventions and restorative actions, if known, that the patient requires as a result of the incident, and

(c) the approved recommendations of the quality of care and safety of patients committee if a quality review is conducted.

4( 3) The health care organization may notify a patient involved in a patient safety incident of any quality improvement activities that were developed as a result of the incident.

4( 4) For the purposes of subsections (2) and (3), the health care organization may disclose information to the patient’s decision-making assistant, decision-making supporter or representative in accordance with the Supported Decision-Making and Representation Act, the patient’s substitute decision-maker in accordance with the Personal Health Information Privacy and Access Act or the patient’s attorney for personal care in accordance with the Enduring Powers of Attorney Act.

1( 8) The Act is amended by adding after section 4 the following:

Improvement of quality and safety of health services

4.1( 1) In accordance with the regulations, a health care organization shall

(a) submit a quality improvement plan to the Minister,

(b) carry out the quality improvement activities set out in the quality improvement plan, and

4.1( 2) A health care organization shall carry out any quality improvement activity required by the Minister.

4.1( 3) A health care organization shall comply with any standard established by the Minister and any principles, standards and policies that the Minister imposes on the health care organization.

4.1( 4) The Minister may approve funding payments for quality improvement activities and may give directives with respect to the funding payments, impose terms and conditions on the funding payments and change, remove or impose new terms and conditions.

4.1( 5) If a health care organization is not in compliance with this Act or the regulations or any applicable principles, standards or policies, the Minister may withhold all or part of funding payments until the health care organization is in compliance.

Risk to public

4.2( 1) As soon as the circumstances permit after a patient safety incident or an incident referred to in subsection 3(4) occurs, a health care organization shall notify the Minister if the incident may

(a) have significant implications on the health system as a whole or on an interjurisdictional scale,

(b) be reasonably perceived as a threat to public safety, or

4.2( 2) If a health care organization notifies the Minister under subsection (1), the health care organization shall submit to the Minister, as soon as the circumstances permit, a plan for the investigation, disclosure and mitigation of the risk to the public.

Discretion of the Minister

4.3 The Minister may determine the form and manner of submitting a plan or report under this Act and the time within which updates to a plan or report shall be submitted.

1( 9) Section 5 of the Act is amended by striking out “organization or a quality of care and safety of patients committee in connection with a patient safety incident or other incident referred to in section 3” and substituting “organization, a quality of care and safety of patients committee or the Advisory Committee in connection with a patient safety incident or other incident referred to in subsection 3(4)”.

1( 10) The heading “Confidentiality of information” preceding section 6 of the Act is amended by striking out “information” and substituting “information − health care organization and quality of care and safety of patients committee”.

1( 11) Section 6 of the Act is repealed and the following is substituted:

6( 1) Quality assurance information and surveillance information collected by a health care organization or a quality of care and safety of patients committee is confidential and shall not be disclosed to any person.

6( 2) Despite subsection (1), a health care organization

(a) may disclose to any person

( i) an incident report,

( ii) a quality review report,

( iii) a quality improvement report,

( iv) a performance indicator, and

( v) surveillance information that does not contain personal information or personal health information,

(b) may disclose to health regulatory bodies quality assurance information that does not contain personal information or personal health information, and

( i) to the Minister, on the request of the Minister, any surveillance information that the Minister considers appropriate to improve the quality of care and safety of patients,

( ii) to an organization, or other entity determined by the Minister, surveillance information that the Minister considers appropriate to improve the quality of care and safety of patients in accordance with the regulations,

( iii) to a quality of care and safety of patients committee of another health care organization quality assurance information for the purposes of a joint quality review,

( iv) to the Advisory Committee, in accordance with the regulations, quality assurance information and surveillance information, and

( v) in the case of a public inquiry into a patient safety matter, to public commissions quality assurance information that does not contain personal information or personal health information.

1( 12) The Act is amended by adding after section 6 the following:

Confidentiality of information − Advisory Committee

6.1( 1) Quality assurance information and surveillance information collected by the Advisory Committee is confidential and shall not be disclosed to any person.

6.1( 2) Despite subsection (1), the Advisory Committee may disclose to any person, in accordance with the regulations,

(a) a quality improvement report, and

(b) a performance indicator.

Right to Information and Protection of Privacy Act

6.2 If this Act is inconsistent or in conflict with a provision of the Right to Information and Protection of Privacy Act, this Act prevails.

1( 13) Section 7 of the Act is repealed and the following is substituted:

Inadmissibility of evidence

7 Except on the trial of a person for an offence in respect of the person’s sworn testimony, a statement, an opinion or advice made or evidence given, orally or in writing, by that or any other person under this Act or the regulations is not admissible in evidence against any person before The Court of King’s Bench or an administrative body, at an inquiry or in any other proceedings.

1( 14) Section 8 of the Act is repealed and the following is substituted:

Apologies

8( 1) In this section, “apology” means an expression of sympathy or regret, a statement that one is sorry or any other words or actions indicating contrition or commiseration, whether or not the words or actions admit or imply an admission of fault in connection with the incident to which the words or actions relate.

8( 2) A person may make an apology in connection with a patient safety incident or other incident referred to in subsection 3(4), and the apology

(a) does not constitute, in law, an express or implied admission of fault or liability by the person in connection with the incident,

(b) despite any wording to the contrary in any contract of insurance or indemnity and despite any other Act or law, does not void, impair or otherwise affect any insurance or indemnity coverage for any person in connection with the incident, and

8( 3) Despite any other Act or law, evidence of an apology by a person in connection with a patient safety incident or other incident referred to in subsection 3(4) is not admissible in any civil proceeding, administrative proceeding or arbitration as evidence of the fault or liability of any person in connection with the incident.

1( 15) The Act is amended by adding after section 9 the following:

Administration

9.1 The Minister is responsible for the administration of this Act and may designate one or more persons to act on the Minister’s behalf.

1( 16) Section 10 of the Act is amended

(a) by adding before paragraph (a) the following:

(0.a) prescribing types of harm for the purposes of the definition “harm” in subsection 1(1);

(0.b) prescribing categories and subcategories of patient safety incidents;

(b) in paragraph (b) by striking out “and establishing procedures of the committees”;

(b.1) prescribing powers and duties of a quality of care and safety of patients committee;

(b.2) providing for membership to the Advisory Committee, including the size and composition of the committee;

(b.3) prescribing powers and duties of the Advisory Committee;

(d) by repealing paragraph (c);

(e) by repealing paragraph (d);

(f) by adding before paragraph (e) the following:

(d.1) respecting a quality improvement plan, including the content of the plan and the time within which the plan shall be submitted;

(d.2) respecting a quality improvement report, including the content of the report and the time within which the report shall be submitted;

(d.3) authorizing the Minister to exercise discretion in extending the time within which a quality improvement plan or a quality improvement report shall be submitted;

(d.4) prescribing information that a health care organization is required to disclose to the Advisory Committee, or authorizing the Minister to exercise discretion in determining the information, and authorizing the Minister to exercise discretion in determining the time within which the information shall be provided;

(d.5) prescribing situations in which a health care organization is required to provide notice to the Minister and to the public on risks to the public relating to quality and safety of health services and the process for providing notice;

(d.6) prescribing performance indicators, the process for reporting the performance indicators and to whom the performance indicators shall be reported;

(d.7) respecting quality assurance information and surveillance information, including the collection, use, disclosure and retention of the information;

Regulation under the Health Quality and Patient Safety Act

2( 1) New Brunswick Regulation 2018-60 under the Health Quality and Patient Safety Act is amended by adding after section 2 the following:

Health care organizations

2.1 A health care organization shall

(a) manage the collection, use, disclosure and retention of quality assurance information and surveillance information,

(b) disclose to the Advisory Committee, within the time established by the Minister, any quality assurance information that the Minister considers appropriate and that does not contain personal information or personal health information,

(c) disclose to the Advisory Committee, within the time established by the Minister, any surveillance information that the Minister considers appropriate, and

(d) monitor and report to the board of directors of a health care organization on the implementation of quality improvement activities.

2( 2) Section 3 of the Regulation is amended by adding after subsection (2) the following:

3( 3) The quality of care and safety of patients committee shall establish and maintain a written terms of reference approved by the chief executive officer and shall make it available to any person on request.

3( 4) The quality of care and safety of patients committee shall perform the following duties:

(a) collaborate with other quality of care and safety of patients committees to carry out joint quality reviews;

(b) review quality review reports and approve recommendations in the reports to improve the quality and safety of health services; and

(c) report to the board of directors of a health care organization the relevant facts of a patient safety incident and the approved recommendations.

2( 3) The Regulation is amended by adding after section 3 the following:

New Brunswick Quality of Care and Patient Safety Advisory Committee

3.1( 1) The Advisory Committee shall consist of

(a) an executive or director from each health care organization who oversees and is responsible for

( i) quality of care and safety of patients,

( ii) patient engagement or patient experience, and

( iii) patient safety incident management, and

(b) at least one patient or family member or caregiver of a patient.

3.1( 2) The chair of the Advisory Committee shall be the Executive Director for Acute Care Services at the Department of Health or the Executive Director’s designate.

3.1( 3) The administrator of the Advisory Committee shall be the health care consultant for quality of care and safety of patients for the Department of Health.

3.1( 4) The Advisory Committee shall establish and maintain a written terms of reference and shall make it available to any person on request.

3.1( 5) The Advisory Committee shall provide recommendations and advise the Minister on issues related to quality of care and safety of patients.

2( 4) The Regulation is amended by adding after section 4 the following:

Disclosure to patient

4.1 A health care organization shall, on request, disclose to a patient involved in a patient safety incident the incident report free of charge.

2( 5) The heading “Report” preceding section 5 of the Regulation is repealed and the following is substituted:

Quality review report

2( 6) Section 5 of the Regulation is amended by striking out “its report” and substituting “a quality review report”.

2( 7) The Regulation is amended by adding after section 5 the following:

Quality improvement plan and report

6( 1) A health care organization shall submit a quality improvement plan for the upcoming fiscal year to the Advisory Committee annually.

6( 2) The plan shall be submitted within 40 business days after the last day of the fiscal year.

6( 3) The health care organization shall provide updates to the plan when requested by the Minister.

6( 4) A health care organization shall submit a quality improvement report to the Advisory Committee annually.

6( 5) The report shall be submitted within 40 business days after the last day of the fiscal year.

6( 6) Before the end of a fiscal year, a health care organization may make a written request to the Minister to extend the time within which a plan or report shall be submitted under this section, and the Minister may grant an extension, in the discretion of the Minister.

2( 8) The Regulation is amended by adding after section 6 the following:

Surveillance information

7( 1) A health care organization shall maintain an incident management reporting system and collect, use, disclose and retain surveillance information through the incident management reporting system using standardized definitions and taxonomy as determined by the Minister and set out in Health Care Quality and Patient Safety Data Reporting and Analytics in New Brunswick, as amended.

7( 2) A health care organization shall collect, use and retain health care associated infection data in accordance with the Public Health Agency of Canada standards.

7( 3) A health care organization shall disclose surveillance information to the Minister in accordance with Health Care Quality and Patient Safety Data Reporting and Analytics in New Brunswick, as amended.

7( 4) A regional health authority shall disclose surveillance information through the Discharge Abstract Database to the Canadian Institute for Health Information’s National Ambulatory Care Reporting System in accordance with Health Care Quality and Patient Safety Data Reporting and Analytics in New Brunswick, as amended.

7( 5) A regional health authority shall disclose surveillance information through the incident management reporting system to the Institute for Safe Medication Practices Canada’s Canadian Medication Incident Reporting and Prevention System in accordance with Health Care Quality and Patient Safety Data Reporting and Analytics in New Brunswick, as amended.

Commencement

3( 1) Subsection 7(4) of New Brunswick Regulation 2018-60 under the Health Quality and Patient Safety Act, as enacted by subsection 2(8) of this Act, comes into force on April 1, 2027.

3( 2) Subsection 7(5) of New Brunswick Regulation 2018-60 under the Health Quality and Patient Safety Act, as enacted by subsection 2(8) of this Act, comes into force on December 1, 2027.