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Statutes of Newfoundland and Labrador 2017


CHAPTER P-3.01

AN ACT RESPECTING PATIENT SAFETY AND QUALITY ASSURANCE IN THE PROVINCE

(Assented to March 21, 2017)

Analysis


        1.   Short title

        2.   Definitions

              PART I
REPORTING, INVESTIGATION AND RELEASE OF INFORMATION

        3.   Patient safety indicators

        4.   Report to regional health authority

        5.   Requirement to review and report

        6.   Reviewing close calls and occurrences

        7.   Notice to minister

        8.   Quality assurance information to minister

        9.   Release of information by minister or regional health authority

      10.   Release of information

      11.   No retaliation

              PART II
QUALITY ASSURANCE COMMITTEES AND PATIENT SAFETY PLANS

      12.   Quality assurance committees generally

      13.   Duties and responsibilities

      14.   Quality assurance activity committees

      15.   Continuing as quality assurance information

      16.   Patient safety plans

              PART III
DISCLOSURE TO PATIENT

      17.   Disclosure to patient

              PART IV
PROVINCIAL PATIENT SAFETY AND QUALITY ADVISORY COMMITTEE

      18.   Patient safety and quality advisory committee

      19.   Membership

      20.   Powers and duties of committee

              PART V
GENERAL

      21.   Conflict

      22.   Offence

      23.   Protection from liability

      24.   Statutory review

      25.   Regulations

      26.   Ministerial regulations

      27.   Forms

      28.   SNL2015 cA-1.2 Amdt.

      29.   RSNL1990 cE-16 Amdt.

      30.   SNL2008 cP-7.01 Amdt.

      31.   SNL2006 cP-38.1 Amdt.

      32.   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)  "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)".