Jill Susanne McCartney

Transcription

1 Disclosure of Safety Incidents Involving Pediatric Patients: A Review of Federal, Provincial, and Territorial Legislation and Related Policies of Health Care Organizations Providing Care to Pediatric Patients by Jill Susanne McCartney A thesis submitted in conformity with the requirements for the degree of Masters of Science Institute of Health Policy, Management and Evaluation Faculty of Medicine University of Toronto Copyright by Jill Susanne McCartney (2013)

2 Disclosure of Safety Incidents Involving Pediatric Patients: A Review of Federal, Provincial, and Territorial Legislation and Related Policies of Health Care Organizations Providing Care to Pediatric Patients Jill Susanne McCartney Masters of Science Institute of Health Policy, Management and Evaluation Faculty of Medicine University of Toronto 2013 Abstract Law and health policy converge with pediatric patient safety incident (PPSI) disclosure. Disclosure is vital for patient safety efforts, while respecting the decision-making autonomy of pediatric patients involves balancing parental and legal obligations with the developing independence of children. This study examined legislation potentially relevant to PPSI disclosure, along with disclosure policies from organizations providing pediatric care. Health professionals have limited legislative guidance for disclosing PPSIs and developing institutional policies. Relevant legislation is complex and varies between jurisdictions. Three jurisdictions legislatively require disclosure, including PPSI disclosure to substitute decision makers. In jurisdictions without disclosure legislation, guidance may be obtained from other legislation, including consent and capacity, substitute decision making, and child welfare. Organizations in jurisdictions with disclosure legislation may be more likely to have policies. Such policies vary between organizations. Within the policies reviewed, PPSI disclosure is based on capacity, made to a substitute decision maker, or not addressed. ii

3 Acknowledgments The completion of this thesis would not have been possible without the gracious support of Siskinds LLP, as well as André I. G. Michael, my mentor, colleague, and friend. I am very grateful to the Canadian Association of Paediatric Health Centres, particularly Elaine Orrbine and Lisa Stromquist, for kindly facilitating the collaboration for this research. I am eternally appreciative to the responding organizations and their representatives for taking the time to participate in this study. I would like to thank my invaluable supervisor, Dr. Raisa Deber, for her input and insightful comments, along with her guidance, encouragement, and support. I am thankful for my committee members, Dr. Anne Matlow and Joaquin Zuckerberg, for challenging my thinking and providing their expertise, insight, and comments throughout this process. Also, thank you to Dr. Douglas Cochrane and Gilbert Sharpe for their time and expertise as members of my thesis defence committee. I am beyond grateful for my darling baby boy, James, who was born before I was able to complete this project. I dedicate this thesis to James with hopes of inspiring a lifelong pursuit of knowledge and learning. A special heartfelt thank-you to my loving and understanding husband, Jason Hannigan, as well as my parents, Jane and Jim McCartney, for their endless support and encouragement throughout this endeavor. Thank you one and all. iii

4 Table of Contents Abstract... ii List of Tables... vi List of Appendices... vii Chapter 1: Introduction Introduction Background Problem Statement and Research Question Significance Overview of Methodology... 4 Chapter 2: Literature Review Defining Patient Safety Incidents and Disclosure The Significance of a Pediatric Population Consent, Capacity, and Substitute Decision Making Review of Relevant Literature Chapter 3: Methods Introduction Legislative Review Policy Review Ethics Considerations Chapter 4: Results of Review of Legislation Overview Age of Majority Laws Disclosure and Reporting Laws Consent and Capacity Laws Substitute Decision Making Laws Child Welfare Laws Common Law Considerations Legislation Apology Laws Common Law Considerations Legislation Privacy and Records Laws Chapter 5: Results of Review of Institutional Policies Introduction Results of Questionnaires Review of Written Policies Terminology Employed Threshold for Disclosure Timing of Disclosure Information to be Disclosed Delivery of Disclosure Information Receipt of Disclosure Information Telephone Interviews Results of Telephone Interview iv

5 Chapter 6: Discussion and Conclusion Discussion Previous Research Key Findings: Legislative Review Key Findings: Review of Institutional Policies Conclusions Recommendations Future Research Bibliography v

6 List of Tables Table 5.1: Table 5.2: Table 5.3: Table 5.4: Summary of questionnaire responses by jurisdiction Summary of questionnaire responses indicating health care organization type or services Summary of the patient safety incident terminology employed within health care institutional policies by percentage of pediatric services provided Summary of the patient safety incident terminology employed within health care institutional policies by jurisdictions with and without disclosure legislation vi

7 List of Appendices A. Correspondence Sent to Pediatric Health Care Organizations B. Correspondence of Ms. Elaine Orrbine, President and CEO of CAPHC C. Telephone Interview D. Age of Majority Laws E. Disclosure and Reporting Laws F. Consent and Capacity Laws G. Substitute Decision Making Laws H. Child Welfare Laws I. Apology Laws J. Privacy and Records Laws K. Summary of Health Care Organization Policies vii

8 1 Chapter 1: Introduction 1.1 Introduction This dissertation provides a comprehensive review of legislation, as well as policies adopted by individual health care organizations, potentially relevant to the disclosure of pediatric patient safety incidents. This study was based on a review and analysis of provincial, territorial, and federal legislation potentially relevant to the disclosure of pediatric patient safety incidents, along with disclosure policies from health care organizations providing care to Canadian pediatric patients. This introductory chapter presents the background for the study, specifies the problem for the study, describes the significance of the study, and presents an overview of the methodology used for the study. The remaining chapters of this dissertation discuss the theories and literature underlying the study (chapter 2), provide a detailed review of the methodology used (chapter 3), and present the results of the review of the legislation (chapter 4) and institutional policies (chapter 5). The final chapter of the dissertation provides a discussion of the results with concluding remarks (chapter 6). 1.2 Background The Canadian Adverse Events study estimated that adverse events, which were defined as "unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management", occur at a rate of 7.5 per 100 hospital admissions of which 36.9% are "judged to be preventable". 1 The Canadian Paediatric Adverse Events Study reported that in hospital pediatric adverse events occur at a rate of 9.2% of which 3.6% are preventable. 2 These studies have brought patient safety to the forefront for those involved in the health care system. Primary concerns following these research findings have involved improving 1 G. Ross Baker et al., The Canadian Adverse Events Study: The Incidence of Adverse Events Among Hospital Patients in Canada (2004) 170 Canadian Medical Association Journal Anne G. Matlow et al., Adverse Events Among Children in Canadian Hospital: The Canadian Paediatric Adverse Events Study (2012) 185(13) Canadian Medical Association Journal E709.

9 2 patient safety to reduce the occurrence of patient safety incidents, which includes adverse events and as well as similar incidents that do not result in patient harm. Other relevant issues include the steps to be taken to address patient safety incidents after they have occurred. Two considerations for health care providers when addressing a patient safety incident after it has occurred include reporting the event within the health care system and disclosure of the event to the patient. The Canadian Patient Safety Institute (CPSI) has considered both reporting 3 and disclosure 4 of patient safety incidents. As part of CPSI s larger paper on reporting adverse events, a review of legislation related to the reporting of adverse events was conducted in which relevant hospital policies were also considered. 5 The CPSI has also prepared guidelines to assist health care providers with the disclosure of patient safety incidents. The disclosure guidelines raise the issue of disclosure of patient safety incidents which have occurred with pediatric patients, highlighting that there are special considerations when involved with disclosure and pediatric patients that may be impacted by local legislation. The CPSI publications do not delve into the legislative and policy details of disclosure of patient safety incidents within a pediatric population. The most recent edition of the disclosure guidelines notes an absence of guidelines and legislation specifically addressing disclosure of pediatric safety incidents and suggests that assistance may be sought from recommendations relating to consent to treatment. 6 3 Canadian Patient Safety Institute, Building a Safer System: The Canadian Adverse Event Reporting and Learning System (Edmonton, AB: 2008) [CPSI Reporting System]. 4 Disclosure Working Group, Canadian Disclosure Guidelines (Edmonton, AB: Canadian Patient Safety Institute, 2008); Disclosure Working Group, Canadian Disclosure Guidelines: Being Open and Honest with Patients and Families (Edmonton, AB, 2011). 5 G. Ross Baker et al., Review of Provincial, Territorial and Federal Legislation and Policy Related to the Reporting and Review of Adverse Events in Healthcare in Canada (Edmonton, AB: Canadian Patient Safety Institute, 2007) [Baker Review]. 6 Disclosure Working Group, Canadian Disclosure Guidelines: Being Open and Honest with Patients and Families (Edmonton, AB, 2011) at 32 [CPSI 2011 Guidelines].

10 3 This study has endeavored to build upon the previous work through identification, review, and analysis of the relevant Canadian legislative framework and policies adopted by health care organizations providing care to pediatric patients. 1.3 Problem Statement and Research Question The patient safety community has recognized that the disclosure of patient safety incidents that have occurred in a pediatric population presents issues and challenges for health care organizations and professionals working with this population of patients. At the outset of this study, it was hypothesized that (1) the disclosure of pediatric patient safety incidents presents issues of law and policy for health care organizations and professionals, and (2) there is a paucity of clear guidance for health care organizations and professional when disclosing pediatric patient safety incidents. This study sought to explore the relevancy of legal and policy issues, including consent and capacity, child welfare, and substitute decision making, to the disclosure of pediatric patient safety incidents. The relevant legislation and policies were reviewed and analyzed to determine the current legal and policy framework in which disclosure is being conducted in Canada. With an understanding of the current practices, successful approaches are highlighted, and inconsistencies, concerns, and gaps are identified. 1.4 Significance Important steps towards supporting health care professionals, including pediatricians and health care organizations, with disclosure of pediatric patient safety incidents include (1) understanding the current Canadian legal framework for disclosure of patient safety incidents within a pediatric population, and (2) understanding the current practices for such disclosure within Canadian pediatric health care organizations. The information from the legislative and policy reviews conducted for this study may be useful to legislatures and policy makers to work towards developing consistency in laws and practice

11 4 relating to the disclosure of pediatric patient safety incidents, while safeguarding and respecting patient autonomy and legal rights. Consistent laws, policies, and practices for the disclosure of pediatric patient safety incidents should assist health care professionals and organizations by providing a clear understanding of expectations and requirements for disclosure of pediatric patient safety incidents while improving patient (and family, guardian, or substitute decision maker) perceptions of safety in Canadian health care for this particularly vulnerable population of patients. The importance of the issue of disclosing pediatric patient safety incidents has been raised by those involved in the Canadian patient safety community. There has been very limited work done on the specifics of the legislative framework applicable to the disclosure of pediatric patient safety incidents and the current state of related institutional policies relating to the disclosure of pediatric patient safety incidents. 1.5 Overview of Methodology A review and analysis of Canadian legislation (provincial, territorial and federal) potentially relevant to the disclosure of pediatric safety incidents was undertaken to better understand the relevant legal framework in Canada. The legislative review for this study included age of majority laws, disclosure and reporting laws, consent and capacity laws, substitute decision making laws, child welfare laws, apology laws, and privacy and records laws. Similarly, a detailed review and analysis of disclosure policies from health care organizations providing care to pediatric patients across Canada was conducted to understand the current practices of health care organizations and professionals. Participating health care organizations were the members of Canadian Association of Paediatric Health Centres (CAPHC). These health care organizations were sent written questionnaires for completion and return. The legislative and policy reviews and analyses allowed for identification of legislative and policy trends, gaps, and innovations, which are discussed. Finally, topics for further consideration and research are suggested. Chapter 2 contains a more detailed review of the methodology for the study.

12 5 This study did not involve a review of provincial policies or guidelines (unless such policies or guidelines were specifically referenced within the legislation reviewed) or codes of professional ethics. The study includes limited discussion of the common law to provide, where necessary, a context for the legislative review, but an extensive review of the common law was beyond the scope of the study.

13 6 Chapter 2: Literature Review In this chapter the concepts, terminology, and literature relevant to the disclosure of pediatric patient safety incidents are reviewed and discussed. 2.1 Defining Patient Safety Incidents and Disclosure Prior to delving into a review and analysis of legislation and institutional policies relevant to the disclosure of pediatric patient safety incidents, it is important to understand patient safety language, as well as the process for disclosure of patient safety incidents. The World Health Organization (WHO) has developed an International Classification for Patient Safety to facilitate patient safety globally through the use of consistent language. 7 The WHO s framework and terminology was adopted by the Canadian Patient Safety Institute (CPSI) in the most recent disclosure guidelines published by CPSI. 8 The use of consistent patient safety language is important as it enables health care professionals to classify like events similarly, which fosters effective communication amongst the patient safety community. 9 The WHO classification system defines 48 terms for their patient safety framework. 10 The CPSI selected four main terms, as most relevant to disclosure, to incorporate and define within their disclosure guidelines. The CPSI encourages use of these preferred terms for consistency and clarity amongst health care professionals. 11 The key terms defined within the CPSI disclosure guidelines are as follows: Patient safety incident: An event or circumstance which could have resulted, or did result, in unnecessary harm to a patient. 7 World Health Organization, Conceptual Framework for the International Classification for Patient Safety, Version 1.1, Final Technical Report (World Health Organization, 2009) [WHO Framework]. 8 CPSI 2011 Guidelines, supra note 6 at Ibid. 10 WHO Framework, supra note 7 at CPSI 2011 Guidelines, supra note 6 at 11.

14 7 Harmful incident: A patient safety incident that resulted in harm to the patient. Replaces adverse event and sentinel event. No harm incident: A patient safety incident which reached a patient but no discernible harm resulted. Near miss: A patient safety incident that did not reach the patient. Replaces close call. 12 The definitions above provide a comprehensive classification system for patient safety incidents. A patient safety incident is either a harmful incident, a no harm incident, or a near miss. Harmful incidents and no harm incidents both reach the patient. A near miss does not reach the patient. 13 These CPSI terms are used for this study. The terms error and adverse event are commonly used in patient safety literature and documents. This study, like the CPSI disclosure guidelines, avoids the use of the terms error and adverse event, and similar terms, due to the negative connotation potentially evoked through their use. 14 It is, however, recognized that health care organizations and the various Canadian legislatures have used other terminology. Where specific laws or documents are being referred to or discussed, the terminology employed in the applicable statutory documents is used. After a patient safety incident has occurred, health care professionals and organizations must consider reporting the patient safety incident, within the health care system, and disclosing the patient safety incident, to the patient or another individual such as a parent, guardian or another substitute decision maker. Disclosure is the process by which a patient safety incident is communicated to the patient or another individual such as a parent, guardian, or substitute decision maker by health care professionals. Relevant considerations for disclosure include the patient safety incidents to be disclosed, the information to be disclosed, the health care professional responsible for the disclosure discussion, and the individual to receive the disclosure information. 12 Ibid. 13 Ibid at Ibid at 11.

15 8 Health care professionals may be reluctant to disclose patient safety incidents. There may be fear of blame or ramifications, such as the patient (or the patient s family) pursuing legal action. There may be feelings of shame or denial associated with the patient safety incident. Health professionals may doubt that there will be any benefit from disclosing the patient safety incident. Health professionals may have a lack of training and resultant uncertainty about the process for disclosure. Patients are entitled to information about their medical condition and treatment. Disclosure of patient safety incidents is intended to facilitate a culture of safety through honest communication between the patient and health care professionals. 15 Pursuant to the common law, physicians have a legal duty to disclose patient safety incidents, which stems from the doctrine of informed consent. Since the doctrine of informed consent requires that patients be advised of complications which may occur, Canadian courts have held that there must be an obligation to disclose when something has actually gone wrong. Accordingly, physicians have an obligation to disclose a patient safety incident that a reasonable person would want to know. 16 The obligation of physicians to disclose patient safety incidents has also been held to flow from the fiduciary nature of the doctor-patient relationship 17, which refers to the duty of a physician to act for the benefit of a patient in matters relating to health care and treatment. 18 Effective disclosure of patient safety incidents may improve patient outcomes and satisfaction, while a lack of disclosure may lead to patient harm, misunderstandings, complaints, and litigation. A few Canadian jurisdictions have enacted legislation specifically addressing reporting and/or disclosure, which is reviewed and analyzed in chapter 4. Privacy and records laws, along with apology laws, were also considered in chapter 4 for any limitations or restrictions on pediatric patients for obtaining or being provided with the information governed by these categories of legislation. 15 Ibid. 16 Ellen I. Picard and Gerald B. Robertson, Legal Liability of Doctors and Hospitals in Canada, 4 th ed (Toronto: Thomson Carswell, 2007) at 204 [Picard]. 17 Ibid. 18 Bryan A. Garner, Editor in Chief, Black s Law Dictionary, 7 th ed (St. Paul, Minn.: West Group, 1999) at 640 [Black s].

16 9 The CPSI disclosure guidelines were developed as a tool to support Canadian health care professionals and organizations with disclosure, including development of policies and processes for communication of patient safety incidents to patients The Significance of a Pediatric Population The definition of a pediatric patient varies as between organizations. The Canadian Pediatric Society is self described as protecting and promoting the health and well-being of children and youth. 20 The American Pediatric Association is self described as being dedicated to the health and well-being of infants, children, adolescents, and young adults. 21 The upper age limit for a pediatric patient may be as old as twenty one years of age or as low as fifteen years of age. For the purpose of this study, unless defined otherwise when discussing a specific statute or document, a pediatric patient is a patient under the age of majority. The term minor describes a person who has not attained the age of majority. For the purposes of this study, the terms minor, child (children), and pediatric patient are synonymous. The age of majority is a concept that varies as between Canadian jurisdictions. All jurisdictions have legislation defining a precise age of majority, which varies between eighteen and nineteen years of age across Canada, and is analyzed in chapter 4. Other age related terms appears in the various statutes reviewed in chapter 4, including child and infant. These terms are discussed in the context of the statutory provisions in which they appear and, where available, the definition from that statutory framework is provided. Patient safety incidents involving pediatric patients, as opposed to those involving adult patients, have added complexities associated with the disclosure discussion, particularly when determining whether the disclosure is made to the pediatric patient or another individual, such as a parent, guardian or other substitute decision maker. 19 CPSI 2011 Guidelines, supra note 6 at The Canadian Paediatric Society, Protecting and promoting the health and well-being of children and youth, online: The Canadian Paediatric Society < 21 The American Academy of Pediatrics, Dedicated to the health of all children, online: The American Academy of Pediatrics <

17 10 The WHO framework describes a patient as a recipient of health care. 22 The CPSI disclosure guidelines recognize that, although the term patient is used, it may be the patient s family or another substitute decision maker receiving the disclosure information, such that these potential substitute decision makers are included within the meaning of the term patient. 23 Pediatric patients present unique legal issues, particularly in relation to their autonomy for management and decision making for health care and treatment. Aside from legislated ages of majority, there is no clear age when a pediatric patient becomes an adult patient. Rather, the transition toward adulthood occurs on a continuum towards decision making autonomy. The limits on the legal rights of minors, along with their developing mental capacity, present complex issues for health care professionals when dealing with disclosure of pediatric patient safety incidents. 24 To date, there is a paucity of guidelines and research addressing the disclosure of patient safety incidents involving pediatric patients. According to the CPSI, guidance for disclosing patient safety incidents involving pediatric patients may be extrapolated from other areas, such as laws relating to consent to treatment, i.e. if the child is sufficiently capable to make a decision about his or her health care or treatment Consent, Capacity, and Substitute Decision Making Children are a vulnerable population requiring guidance, care, nurturing, and protection. In the context of health care, a child may or may not be able to make his or her own decisions with regards to health care and treatment. Similarly, in the context of disclosure, a child may or may not be able to be the recipient of disclosure information. 22 WHO Framework, supra note 7 at CPSI 2011 Guidelines, supra note 6 at CPSI 2011 Guidelines, supra note 6 at Ibid.

18 11 Principles relating to consent to health care, capacity to make health care decision, and substitute decision making for health care may be relevant to disclosure of pediatric patient safety incidents. 26 The CPSI disclosure guidelines suggest that the requirements for disclosure may be taken from consent laws. 27 The common law and legislation governing consent to health care and treatment in Canada is reviewed in chapter 4. The legislative approaches for consent legislation vary as between jurisdictions with such legislation. The legislation may be based on a best interest test, an age requirement, or the capacity of the person. Pursuant to the common law, a mentally competent patient with capacity has the right to consent or refuse health care and treatment. A health care professional must obtain the consent of a patient before proceeding with proposed care or treatment. If a patient not competent, or lacks capacity, consent must be obtained from a substitute decision maker. In addition to obtaining consent from a patient for health care and treatment, a health care professional must ensure that the consent is informed, which refers to the obligation for the health care professional to provide adequate information to the patient regarding the benefits, risks, and alternatives the proposed care or treatment. Consent that is not informed is not rendered invalid, but a health care professional failing to obtain informed consent may be negligent. 28 Capacity relates to the mental ability to understand problems and make decisions. The circumstances under which a patient is said to have capacity to consent to health care or treatment varies as between Canadian jurisdictions, depending on whether there is legislation governing the issue or if the common law prevails. For the purpose of this thesis, a substitute decision maker is a general term used to refer to a person who has legal authority to make health care and treatment decisions for another without 26 Ibid. 27 Ibid. 28 Picard, supra note 16 at

19 12 the legal authority to make such decisions. The inability of a pediatric patient to make health care and treatment decisions may be due to age or capacity depending on the jurisdiction. Substitute decision making for incapable adults is beyond the scope of this study. Substitute decision making laws are examined in chapter 4. Examples of substitute decision makers include parents and guardians. The definitions of parent and guardian differ as between Canadian jurisdictions. Quebec, in particular, has unique terms that are used in the context of substitute decision making, including tutor and tutorship and parental authority; these terms refer to substitute decision making roles. In exceptional circumstances, if a child s health care needs cannot be met by the child, and are not being met by his or her parent or guardian, the government may have authority to intervene. The circumstances and method by which the government may intervene in making health care and treatment decision for a child varies as between Canadian jurisdictions in child welfare laws, which are examined in chapter Review of Relevant Literature There has been limited research done which addresses the complexities associated with disclosure of pediatric patient safety incidents. In general, health care professionals recognize the importance of disclosing patient safety incidents and want to disclosure such incidents, however, training may be lacking. Decisions as to whether to disclose a patient safety incident or not may be inconsistent. Recognizing a gap between recommendations for disclosure of medical errors and the actual practice of disclosure, researchers examined the knowledge and attitudes of pediatric residents, using questionnaires and focus groups, in relation to disclosure of medical errors. The researchers found that most residents considered medical errors a serious problem in the provision of health care. These residents thought medical errors should be disclosed, but recognized the task of disclosure would be difficult. Residents were consistent in their ability to identify medical errors, but were inconsistent in whether they thought a medical error should

20 13 be disclosed and the language to be used. Less than half of the residents (40%) reported receiving teaching on the disclosure of medical errors. 29 In another study, researchers did an anonymous cross sectional survey to determine pediatricians (attending and residents) attitudes and experiences communicating about errors with the hospital and patients families. Most pediatricians had been involved in an error (93%). The pediatricians supported disclosing errors to patients families: 99% would disclose serious errors, 90% would disclose minor errors, and 39% would disclose near misses. Many pediatricians had disclosed errors, both serious (36%) and minor (52%). Residents were more likely than attending physicians to believe that disclosing a serious error would be difficult (96% versus 86%). Residents were also more likely than attending physicians to want disclosure training (69% versus 56%). 30 Recognizing the discord between the desire of patients for open and honest communication and the practices of physicians when disclosing an error, combined with the complications and challenges associated with a pediatric population, another group of researchers undertook a survey of practicing pediatricians and pediatric residents on how they would disclose two different errors to a parent: (1) an insulin overdose and (2) an overlooked laboratory test resulting in hospitalization. Overall, approximately half of the respondents would: definitely disclose the error to the patient, be explicit that an error occurred using the word error, disclose the details of the event, and discuss how future errors could be prevented. Approximately one third of respondents would apologize for the error. Respondents were more likely to disclose the insulin overdose, with details of what occurred, as opposed to the overlooked laboratory test, which could easily go unrecognized by the parents. 31 Research has shown that parents want to be informed of patient safety incidents involving their children. Open and honest communication when a patient safety incident has occurred, may help to reduce the chance of parents seeking legal action. A survey of parental preferences for error 29 M. Coffey et al., Pediatric Residents Decision-Making Around Disclosing and Reporting Adverse Events: The Importance of Social Context (2010) 85 Acad Med J Garbutt et al., Reporting and Disclosing Medical Errors (2007) 161 Arch Pediatr Adolesc Med D.J. Loren et al., Medical Error Disclosure Among Pediatricians (2008) 162 Arch Pediatr Adolesc Med 922.

21 14 disclosure and reporting found that almost all parents (99%) wanted disclosure, regardless of severity. Many parents (36%) were less likely to seek legal action if the error was disclosed by the physician, although most parents would not change their decision to seek or not seek legal action as a result of disclosure (63%). 32 Parents also want to be informed of patient safety incidents regardless of whether or not their child has suffered harm. Parents also want their child included in the process of disclosure. Researchers reported the results of an assessment of parental preferences for medical error disclosure, which was conducted through questionnaires. These researchers determined that almost all parents (99%) wanted disclosure, whether there was harm or potential harm (99%) or no harm (77%). Most parents (71%) also wanted their child informed of the medical error. 33 The disclosure of pediatric patient safety incidents has been considered and discussed by a number of scholars. These scholars have emphasized the importance for health care providers to plan the details of the disclosure discussion 34, which has complexities and legal concerns specific to a pediatric population, 35 and the need to preserve trust and communication with the family through honesty and acceptance of responsibility C. Hobgood et al., Parental Preferences for Error Disclosure, Reporting, and Legal Action After Medical Error in the Care of Their Children (2005) 116 Pediatrics A.G. Matlow et al., Disclosure of medical error to parents and paediatric patients: assessment of parents attidudes and influencing factors (2010) 95 Arch Dis Child E.D. Skarsgard, Managing the adverse event occurring during elective ambulatory pediatric surgery (2009) 18 Semin Pediatr Surg T.N.K Raju, G. Suresh, & R.D. Higgins, Patient Safety in the Context of Neonatal Intensive Care: Research and Educational Opportunities (2011) 70 Pediatr Res J. E. Sullivan & J. J. Buchino, Medication Errors in Pediatrics The Octopus Evading Defeat (2004) 88 J Surg Oncol 182.

22 15 Chapter 3: Methods 3.1 Introduction The methods for this study are based on the methods used in the Canadian Patient Safety Institute (CPSI) project Building a Safer System: The Canadian Adverse Event Reporting and Learning System; 37 specifically, an appendix to the consultation paper entitled Review of Provincial, Territorial and Federal Legislation and Policy Relating to the Reporting and Review of Adverse Events in Healthcare in Canada. 38 The CPSI study examined reporting of patient safety incidents, while this study examines disclosure of pediatric patient safety incidents. Similar to the CPSI study, the data gathered for this study included legislation (provincial, territorial, and federal), institutional policies from health care organizations involved in the care and treatment of pediatric patients, and information from telephone interviews with representatives from some participating health care organizations. 3.2 Legislative Review The legislative data for this study was gathered through searches on various legislative databases. Initial searches to identify relevant categories of legislation were conducted on QuickLaw, using the following terms and parameters: adverse event, apology, child /10 capacity, child /10 consent, critical incident, disclosure /10 harm, disclosure /10 health, disclosure /10 injury, health care provider, infant /10 capacity, infant /10 consent, minor /10 capacity, minor /10 consent, near miss, quality assurance /10 health, substitute decision maker /10 health. 39 Subsequent searches were conducted on QuickLaw, CanLII, and government databases as needed to ensure completeness of results once the relevant categories of legislation were identified from the initial searches. 37 CPSI Reporting System, supra note Baker Review, supra note The QuickLaw search connector /10 (or, more generally /number) finds documents in which the two search terms appear within 10 words (or the specified number of words) of each other.

23 16 Federal, provincial, and territorial legislation (statutes and regulations) potentially relevant to disclosure of patient safety incidents in pediatric patients were identified, reviewed, and analyzed. Seven categories of legislation were identified, summarized, and considered for this thesis: age of majority laws, patient safety incident reporting and disclosure laws, health care consent and capacity laws, health care substitute decision making laws, child welfare laws, apology laws, and records and privacy laws (general, personal information, and personal health information). Age of majority laws were reviewed to understand the age at which a pediatric patient, usually referred to as a child or minor in the legislation, becomes an adult (i.e. reaches the age of majority) in each jurisdiction. Adult patients, defined as those individuals who have attained the age of majority, were outside the scope of this study. Age of majority laws were also reviewed for provisions potentially providing guidance for the interpretation of age related terms, such as minor, infant, child, adult, in other legislation within the jurisdiction being considered. Reporting and disclosure laws were reviewed to gain an understanding of reporting and/or disclosure regimes in the applicable jurisdiction. These laws were also reviewed for provisions potentially relevant to pediatric patients. Consideration was given as to: whether there were age or capacity related restrictions on disclosure and whether mechanisms for substitute disclosure were established. These laws were also reviewed for guidance as to what information should be disclosed and/or reported and any limitations on disclosure and/or reporting of information. Consent and capacity laws were reviewed for provisions dealing with the ability of pediatric patients to consent to health care. In particular, these laws were reviewed for age-related or capacity-related limitations on the ability of pediatric patients to provide consent to health care. Substitute decision making laws were reviewed to determine the process for obtaining consent to health care for pediatric patients unable to provide their own consent to health care decisions, either due to age-related or capacity-related restrictions. These laws were reviewed to identify the substitute decision maker when one was required for a pediatric patient. Two sub-categories of legislation were reviewed: (1) legislation specific to substitute decision making of pediatric patients for health care decisions and (2) legislation providing guidance on parental or guardianship roles.

24 17 Legislative provisions governing advance directives and substitute decision making for mentally incapable adults (as opposed to general capacity provisions) were beyond the scope of the review of substitute decision making laws for this study. Child welfare laws were reviewed for provisions requiring state intervention in health care decision making for pediatric patients. Consideration was given to the threshold allowing the state to intervene in the usual processes for consent to health care and treatment for pediatric patients. Apology laws were reviewed for requirements or considerations for apologies made in relation to pediatric patient safety incidents. Consideration was given as to: (1) whether apologies could be made to pediatric patients and (2) whether there were any restrictions, particularly age-related or capacity-related restrictions, as to whom the apology should be directed. Consideration was also given as to whether any specific information was, or was not, to be included in an apology. Records and privacy laws were reviewed for provisions relating to the disclosure of health care records of pediatric patients. Consideration was given to general privacy laws, personal information privacy laws, and personal health information privacy laws to determine the applicable legislation in each jurisdiction. In particular, consideration was given to whether there were any age-related or capacity-related restrictions or limitations on the ability of pediatric patients to access their health care records. In the results section, relevant aspects of these laws are summarized by each category and, where relevant, considered by jurisdiction. 3.3 Policy Review The second phase of review for this study involved an examination and analysis of disclosure policies, which were gathered through written correspondence to various health care organizations providing care to pediatric patients across Canada. A brief questionnaire was sent to each health care organization for completion and return to the researchers, along with a letter of information and consent form. The questionnaire requested a copy of any institutional policies relevant to the disclosure of patient safety incidents. The

25 18 consent form requested the name of a contact person, who was to be contacted by telephone if the questionnaire indicated that the organization did not have a disclosure policy or if clarification to the written survey was required. The participant health care organizations recruited (i.e. sent written correspondence, including a questionnaire, via ) were the members of the Canadian Association of Paediatric Health Centres (CAPHC). At the time of distribution of the questionnaires, the membership of CAPHC consisted of forty-four health care organizations providing care to pediatric patients across Canada that include tertiary, quarternary, community, and regional hospitals, rehabilitation centres, and home care provider agencies. A copy of the correspondence to be sent to the pediatric health care organizations is attached as Appendix A. As the participants recruited were all members of CAPHC, a covering letter from the President and CEO of that organization, Ms. Elaine Orrbine, was also included with the materials sent to the pediatric health care organizations. A copy of Ms. Orrbine s correspondence is attached as Appendix B. Completed questionnaires, along with any relevant policies, which were returned to the researchers were reviewed. The responses received from the participating organizations were grouped into two groups: organizations with written disclosure policies and organizations without written disclosure policies. Efforts were made to conduct a telephone interview with the contact person for organizations without written disclosure policies to obtain further information about any unwritten policies, practices, or procedures. A copy of the sample questions for the telephone interviews is attached as Appendix C. All questionnaires, policies, and telephone interview notes were de-identified using a participant coding scheme.

26 19 The completed questionnaires and policies were analyzed for trends and themes. In particular, institutional disclosure policies (including information about unwritten policies), were reviewed to ascertain information relevant to pediatric patients, including the following: What patient safety incidents require disclosure? To whom is the disclosure made when the patient safety incident involves a pediatric patient? What factors, if any, are considered in determining the recipient of the disclosure information? What information is to be disclosed? Do any patient characteristics affect what information is to be disclosed? What information is not to be disclosed? Do any patient characteristics affect what information is not to be disclosed? Who is responsible for the disclosure discussion? In the results section, a de-identified summary of the responding organizations demographic information is provided. Subsequently, the various themes discovered from the review of the various institutional disclosure policies, both exclusively pediatric and not exclusively pediatric organizations, are presented, along with relevant information obtained from telephone interviews. The themes which emerged from the completed questionnaires, institutional policies, and telephone interviews, where applicable, have been compared and contrasted with the findings from the legislative review. 3.4 Ethics Considerations Final ethics approval for this research project was obtained from the University of Toronto Research Ethics Board on June 7, Ethic approval was extended on April 30, 2012 to April 25, 2013.

27 Overview Chapter 4: Results of Review of Legislation A review and analysis of provincial, territorial, and federal legislation potentially relevant to disclosure of pediatric patient safety incidents was performed. Seven categories of legislation were identified as potentially relevant to the disclosure of pediatric patient safety incidents: age of majority laws, disclosure and reporting laws, consent and capacity laws, substitute decision making laws, child welfare laws, apology laws, and privacy and records laws. Relevant provisions from statutes in these categories of legislation are reproduced in Appendices D through J and discussed in this chapter. The discussion for some categories of legislation is subdivided by jurisdiction or legislative approach where appropriate depending on the substantive content of the legislation reviewed. 4.2 Age of Majority Laws The age of majority is the threshold at which a person becomes an adult. A person who is younger than the age of majority is a minor. Age of majority legislation in each province and territory has replaced the common law governing the issue, which was twenty-one years of age. 40 Each one of the provinces and territories has enacted legislation to establish an age of majority. The relevant provisions from these statutes are discussed in this section and reproduced in Appendix D. There is no federal legislation governing the age of majority. In four provinces (British Columbia, New Brunswick, Nova Scotia, and Newfoundland and Labrador) and all three territories (Northwest Territories, Yukon, and Nunavut) the age of majority is nineteen years of age. 41 In the remaining six provinces (Alberta, Saskatchewan, 40 David C. Day, The Capable Minor s Healthcare: Who Decides? (2007) 86(3) Can Bar Rev Age of Majority Act, RSBC 1996, c 7, ss 1 and 4; Age of Majority Act, RSNB 2011, c 103, ss 1, 2, and 8; Age of Majority Act, RSNS 1989, c 4, ss 2 and 3; Age of Majority Act, SNL 1995, c A-4.2, s 2; Age of Majority Act, RSNWT 1988, c A-2, ss 2-4; Age of Majority Act, RSNWT (Nu) 1988, c A-2, ss 2-4; Age of Majority Act, RSY 2002, c 2, ss 1-3.

28 21 Manitoba, Ontario, Quebec, and Prince Edward Island), the age of majority is eighteen years of age. 42 Within the age of majority legislation, nearly all provinces (except Manitoba, Quebec, and Newfoundland) provide that, in the absence of a definition or indication of a contrary intention, similar expressions, such as full age, infant, minor, found in other laws of the province or territory, are to be interpreted in accordance with the legislated age of majority. The relevant legislative provisions in Quebec differ from those in other jurisdictions. The Civil Code of Quebec has articles dealing with the concepts of minority and majority, which explicitly provide that upon attaining the age of majority a person has the full exercise of all his [or her] civil rights, such that the capacity of a person of full age is only limited expressly by provision of law or by a judgment. Specifically relating to minors, the Quebec Civil Code provides that a minor only exercises his [or her] civil rights to the extent provided by law. Further, where a minor cannot act alone, he or she is represented by his or her tutor for the exercise of his [or her] civil rights, unless the law or nature of the act does not allow for representation. Tutorship is established by the Quebec Civil Code to secure the exercise of the civil rights of a minor. Parents are automatically a child s legal tutors. If both parents are unable to fulfill their obligations as tutors, the tutor becomes either an individual appointed by the parents while lucid or an individual who is court appointed Disclosure and Reporting Laws At common law, pursuant to the doctrine of informed consent, physicians have been held to have a duty to disclose patient safety incidents made during the provision of health care and treatment to a patient, when it is a patient safety incident that a reasonable patient would want to know 44 and the patient is fully capable of understanding the problem and participating in making a 42 Age of Majority Act, RSA 2000, c A-6, ss 1-3; The Age of Majority Act, RSS 1978, c A-6, ss 2 and 4; The Age of Majority Act, CCSM, c A7, s 1; Age of Majority and Accountability Act, RSO 1990, c A.7, ss 1-3; Civil Code of Quebec, SQ 1991, c 64, arts , 158, 177, 178, 185, 186, 192, , 205 and 207; and Age of Majority Act, RSPEI 1988, c A-8, ss Civil Code of Quebec, SQ 1991, c 64, arts , 158, 177, 178, 185, 186, 192, , 205 and Stamos v Davies, [1985] OJ No 2625 (H Ct J) at 25.

29 22 decision 45. The duty of a physician to disclose patient safety incidents has also been considered inherent to the fiduciary nature of the physician-patient relationship. 46 Four provinces have enacted legislation that requires reporting and/or disclosure of patient safety incidents: Saskatchewan, Manitoba, Ontario, and Quebec. 47 At the federal level, there are regulations to the Food and Drugs Act that provide a scheme for reporting and recall in response to patient safety incidents relating to drugs and medical devices. 48 The relevant provisions from these statutes, describing the reporting and/or disclosure paradigm as well as any provisions specific to pediatric patients, are reviewed in this section and reproduced in Appendix E Reporting Laws: Saskatchewan Legislation in Saskatchewan establishes a scheme for the reporting of patient safety incidents to government. The legislation also requires investigation of patient safety incidents. This legislation, The Regional Health Services Act, uses the term critical incidents to describe reportable patient safety incidents arising as a result of health services provided by various organizations, including health care organizations. The legislation does not require disclosure of critical incidents to patients or their families. 49 The legislative scheme incorporates the Saskatchewan Critical Incident Reporting Guideline, which defines a critical incident as: a serious adverse health event, including, but not limited to, the actual or potential loss of life, limb or function related to a health service provided by, or program operated by, a regional health authority or health care organization Kueper v McMullin, [1986] NBJ No 89 (CA) at Vasdani v Sehmi, [1993] OJ No 44 (Ct J (GD)) at 32-33; Gerula v Flores, [1995] OJ No 2300 (CA) at The Regional Health Services Act, SS 2002, c R-8.2, s 58; The Regional Health Authorities Act, CCSM, c R34, ss 53.1 to 53.4, 53.7 to 53.8, and 53.10; Critical Incidents Regulation, Man Reg 211/2006, ss 1 and 3; Public Hospitals Act, RRO 1990, Reg 965, ss 1 and 2; An Act Respecting Health Services and Social Services, RSQ, c S-4.2, ss 8, 12, 183.1, 183.2, 233.1, 235.1, and Food and Drug Regulations, CRC, c 870, ss C to C and C ; Medical Devices Regulations, SOR/98-282, ss 59, 60, 63 and The Regional Health Services Act, SS 2002, c R-8.2, s Government of Saskatchewan, Saskatchewan Critical Incident Reporting Guideline, online: <

30 23 This guideline describes specific critical incidents that must be reported, including surgical events, product or device events, patient protection events, and care management events. The wording of the guidelines is general and contemplates the inclusion of critical incidents that were not anticipated at the time of drafting. Reporting of critical incidents is made to the Minister. Investigation of the critical incident follows reporting. Information generated by the investigation of a critical incident is protected in legal proceedings, which are defined as any civil proceeding or inquiry where evidence is given, including proceedings that may involve punishment of fine, penalty, or imprisonment. The facts of a critical incident, and information prepared for the purpose of providing care or treatment to the patient (unless that information is fully available in another record available to the patient) are not protected. This legislation does not address any specifics relating to reporting or investigating critical incidents involving pediatric patients, such as provisions relating to minors or patients without capacity Disclosure and Reporting Laws: Manitoba Legislation in Manitoba provides that various health organizations must have written procedures for reporting and disclosure of critical incidents. 51 The Act defines a critical incident as an unintended event, occurring while health services are provided to an individual, resulting in serious and undesired consequences to the individual, which are not the result of the underlying health condition or an inherent risk of the health services. The phrase serious and undesired consequences is described in the Act as including death, disability, injury or harm, unplanned admission to hospital or unusual extension of a hospital stay. The term individual is not defined in the Act. Following a critical incident, the Act requires disclosure of the critical incident. Steps must be taken to fully inform the individual as soon as possible about what occurred, the consequences as they become known, and the actions taken (and to be taken) to address the 51 The Regional Health Authorities Act, CCSM, c R34, ss 53.1 to 53.4, 53.7 to 53.8, and

31 24 consequences. The Act also requires the preparation of a record of the critical incident, which includes the same information required for the disclosure discussion with the individual. The prepared record is to be made available to the individual. The Act also requires reporting of the critical incident, usually to the Regional Health Authority. The Regional Health Authority is required to report the critical incident to the Minister (in some cases the report is made directly to the Minister). A critical review committee must be established to investigate and report on the critical incident, usually to the Regional Health Authority. The Regional Health Authority is required to report the investigation to the Minister (in some cases the investigation report is also directly to the Minister). This legislation does not specifically address issues relating to the disclosure of critical incidents to pediatric patients. A regulation to the legislation, however, provides that if the individual is a child then the parent or legal guardian is to receive the disclosure information. 52 The terms parent, legal guardian, and child are not defined within the Act or the Regulation Disclosure and Reporting Laws: Ontario In Ontario, a regulation to the Public Hospitals Act requires that hospitals have a system for ensuring the disclosure of every critical incident to the patient and reported to the hospital s medical advisory committee and administrator. 53 The Regulation defines a critical incident as an unintended event that occurs when a patient receives health care and treatment in hospital, which results in death, serious disability, injury or harm, which is not a result primarily from the patient s underlying medical condition or a known risk inherent in providing the treatment. The disclosure to the affected patient must include the material facts, the consequences for the patient as they become known, and the actions taken (and recommended to be taken) to address 52 Critical Incidents Regulation, Man Reg 211/2006, s Public Hospitals Act, RRO 1990, Reg 965, ss 1 and 2.

32 25 the consequences to the patient of the critical incident. Disclosure must occur as soon as is practicable after the critical incident occurs. When the affected patient is incapable, the disclosure must be made to a person lawfully authorized to make treatment decisions for the patient. The determination of who is lawfully authorized to make treatment decisions is made pursuant to the Health Care Consent Act, which is discussed in the section on Substitute Decision Making Laws in this chapter. 54 The Regulation also requires reporting of critical incidents to hospital s medical advisory committee and administrator. The hospital administrator must ensure that a system is in place for the critical incident to be analyzed with a plan developed for systemic steps to avoid or reduce the risk of further similar critical incidents Disclosure and Reporting Laws: Quebec There is legislation in Quebec that requires disclosure of patient safety incidents. The legislation provides that a user is entitled to be informed, as soon as possible, of any accident that occurs during the provision of health or social services, which has actual or potential consequences for the state of health or welfare of the user. The user is also entitled to be informed of the measures taken to correct the consequences suffered, if any, to prevent such an accident from recurring. 55 The Act defines the term accident as an action or situation where a risk event occurs which has or could have had consequences for the state of health or welfare of the user or others. This legislation also requires disclosure of accidents and incidents. The term incident is defined as an action or situation that does not have consequences for the state of health or welfare of a user, but the outcome of which is unusual and could have had consequences under different circumstances. 54 Health Care Consent Act, 1996, SO 1996, c 2, Sch A, s An Act Respecting Health Services and Social Services, RSQ, c S-4.2, ss 8, 12, 183.1, 183.2, 233.1, 235.1, and 431.

33 26 In addition to reporting, the Act requires that a risk management committee identify and analyze incidents or accidents, and maintain a local register of these events. The Act provides that the rights of any person under the Act may be exercised by a representative, including the holder of parental authority of a user who is a minor or the tutor of the user Reporting Laws: Federal Two regulations to the Food and Drugs Act relate to reporting of patient safety incidents. 56 These regulations require manufacturers of drugs and medical devices to report patient safety incidents in relation to their products, serious adverse drug reactions and incidents involving a device, to the Minster. These regulations also contemplate recall of drugs or medical devices and require that the details of any recall be reported to the Minister or Director. Specifically, the Food and Drug Regulations require reporting of any serious adverse drug reaction. The Regulation requires that a summary of the critical analysis be provided to the Minister. 57 The Medical Device Regulations require reporting of incidents that are related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labeling or in its directions for use, which has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so where it to recur. 58 Both of these regulations place the onus on the manufacturer to fulfill the reporting obligation when they receive a report of a patient safety incident or become aware of the information. These regulations do not address pediatric patients within the reporting and recall provisions. 56 Food and Drugs Act, RSC, 1985, c F-27; Food and Drug Regulations, CRC, c 870, ss C to C , and C ; Medical Devices Regulations,SOR/98-282, ss 59, 60, 63 and Food and Drug Regulations, CRC, c 870, ss C to C , and C Medical Devices Regulations, SOR/98-282, ss 59, 60, 63 and 64.

34 Consent and Capacity Laws Pursuant to the common law, health care professionals are required to obtain the consent of the patient prior to administering any health care or treatment. Health care or treatment undertaken without the consent of the patient gives rise to the tort of battery (application of harmful or offensive force to another). 59 Further, in addition to obtaining the consent of the patient to health care or treatment, a health care professional must ensure that the consent obtained is informed, such that the patient has been informed of the material risks, benefits, and alternatives. The failure to obtain informed consent does not render consent invalid, but may result in a finding of negligence against the health care professional. 60 The law relating to consent to health care and treatment has been codified in legislation in a number of Canadian jurisdictions. In a number of jurisdictions the consent and capacity legislation is applicable to minors (six provinces and one territory). In jurisdictions where there is no consent and capacity legislation, or the enacted legislation does provide a complete codification of the law (i.e. does not address pediatric patients), the common law governs consent issues that are not addressed in the applicable legislation. The common law position regarding informed consent to health care and treatment for adults was summarized in a recent Supreme Court of Canada: At common law, adults are presumptively entitled to direct the course of their own medical treatment and generally must give their informed consent before treatment occurs, although this presumption of capacity can be rebutted by evidence to the contrary. 61 The Court also summarized the common law mature minor doctrine: the common law has more recently abandoned the assumption that all minors lack decisional capacity and replaced it with a general recognition that children are entitled to a degree of decision-making autonomy that is reflective of their evolving intelligence and understanding. This is known as the common law 59 Malette v Shulman, [1990] OJ No 450 (CA). 60 Reibl v Hughes, [1980] SCJ No 105 (SCC) at A.C. v Manitoba (Director of Child and Family Services), [2009] SCJ No 30 at 40 [A.C. v Manitoba].

35 28 mature minor doctrine. The doctrine addresses the concern that young people should not automatically be deprived of the right to make decisions affecting their medical treatment. It provides instead that the right to make those decisions varies in accordance with the young person s level of maturity, with the degree to which maturity is scrutinized intensifying in accordance with the severity of the potential consequences of the treatment or of its refusal. 62 In Canada, pursuant to the common law, a child of any age may be capable of providing consent, or refusing to provide consent, to proposed health care or treatment, if the child has the maturity, intelligence, and capacity to understand the nature and purpose of the proposed health care or treatment, along with the ability to appreciate the reasonably foreseeable consequences of such a decision. Where a child is capable to make his or her own consent decision, parental consent is not required and the wishes of the parents do not override those of the child. The consent of the parents or guardian is required when a minor does not have the capacity to make his or her own consent decision for proposed health care or treatment. 63 Six provinces and one territory have enacted legislation governing consent to health care and treatment (British Columbia, New Brunswick, Quebec, Ontario, Prince Edward Island and Yukon). There is no federal legislation addressing the ability to consent to health care and treatment. The various statutes take varied approaches to addressing the ability of pediatric patients to consent to health care and treatment, including best interest approaches, an age-based approach, and capacity-based approaches Consent and Capacity Laws: Best Interest Approaches In British Columbia, there is legislation that specifically addresses the ability of infants to consent to health care and treatment. Pursuant to the Infants Act, infants may consent to health care as long as the health care has been explained to the infant and he or she understands the nature and consequences, along with the reasonably foreseeable benefits and risks. Also, reasonable efforts must be taken to determine that the health care is in the best interests of the 62 Ibid at Val Mol v Ashmore, 1999 BCCA 6 at 75, leave to appeal to SCC refused, [1999] SCCA No 117.

36 29 infant. 64 The term infant is not defined in the Infants Act, but the age of majority laws in the jurisdiction provide that infant is to be interpreted as a minor person. 65 In New Brunswick, the law respecting consent to medical treatment for persons who have attained the age of majority applies, in all respects, to minors who have attained the age of sixteen years. For minors that have not attained sixteen years of age, the legislation provides that they are to be treated as if they are the age of majority when, in the opinion of a legally qualified medical practitioner, they are capable of understanding the nature and consequences of the treatment and the treatment is in their best interests Consent and Capacity Laws: Age-Based Approaches In Quebec, consent to health care and treatment is codified in the Civil Code of Quebec 67 and An Act Respecting Health Services and Social Services 68. Pursuant to this legislation, health care consent for minors is to be given by the person having parental authority or the tutor. Minors who are fourteen years of age or older may give consent alone to health care that is not required by the state of his [or her] health ; however, consent of the person with parental authority or the tutor is required if the health care involves any serious risks or if it may cause grave and permanent effects Consent and Capacity Laws: Capacity-Based Approaches In Ontario, the legislation governing consent to health care and treatment applies to all persons. The ability to consent to health care and treatment is based on capacity. It does not have any age-related restrictions. A person is capable with respect to treatment if he or she is able to understand the information that is relevant to making a decision about the health care or 64 Infants Act, RSBC 1996, c 223, s Age of Majority Act, RSBC 1996, ch 7, s 1(b). 66 Medical Consent of Minors Act, SNB 1976, c M-6.1, ss Civil Code of Quebec, SQ 1991, c 64, arts 10, 14 and An Act Respecting Health Services and Social Services, RSQ, c S-4.2, ss 8 and 9.

37 30 treatment and is able to appreciate the reasonably foreseeable consequences of a decision or lack of a decision. 69 In Prince Edward Island, the legislation governing consent to health care and treatment provides that a person is capable if he or she is able to understand the information that is relevant to making the treatment decision, the information applies to his or her particular situation, and he or she has the right to make a decision. The person must also appreciate the reasonably foreseeable consequences of a decision or lack of a decision. There is no age based distinctions in the Prince Edward Island legislation; the ability to consent to health care and treatment is capacity based and every person is presumed to be capable unless it is otherwise shown. 70 The Yukon legislation governing consent to health care and treatment is also capacity based. The legislation specifically provides that it is applicable regardless of whether a person has attained the age of majority. All persons are presumed to be capable unless it is otherwise shown. Pursuant to the legislation, a person must understand the reasons for the care being proposed, the nature of the propose care, the risks and benefits of receiving and not receiving the proposed care that a reasonable person would expect to be told about, the alternative courses of care, and understand that situation and proposed care applies to him or her. 71 In Manitoba, the legislation governing consent to health care and treatment applies to all persons. The legislation provides for a presumption of capacity for all persons sixteen years of age or older; the Act further provides that persons who are under sixteen years of age are presumed not to have the capacity to make health care decisions, but the presumption is rebuttable with evidence to the contrary. The legislation provides that a person has capacity to make health care decisions if he or she is able to understand the information that is relevant to making a decision and able to appreciate the reasonably foreseeable consequences of a decision or lack of a decision Health Care Consent Act, 1996, SO 1996, c 2, Sch A, ss 4, 10, 11, and Consent to Treatment and Health Care Directives Act, RSPEI 1988, c C-17.2, ss 1, Care Consent Act, SY 2003, c 21, Sch B, ss The Health Care Directives Act, CCSM, c H27, ss 1, 2, 4, and 6.

38 Substitute Decision Making Laws Pursuant to the common law, when a pediatric patient does not have the capacity to consent to proposed health care or treatment, the consent of the parents or guardian, if the guardian is someone other than the parents, is required. 73 Most Canadian jurisdictions have enacted legislation that provides a scheme for substitute decision making for health care and treatment decisions, which is reviewed in this section to the extent that it is applicable to pediatric patients. In jurisdictions without substitute decision making legislation applicable to pediatric patients, legislation addressing parentage and guardianship for minors is considered. There is no federal legislation addressing substitute decision making for health care and treatment decisions. Legislation addressing advance directives and substitute decision making specific to people with mental or psychiatric disorders is beyond the scope of this thesis; further, legislation specific to adults is only reviewed to the extent that it provides guidance for substitute decision making for pediatric patients Substitute Decision Making Laws: British Columbia In British Columbia, the substitute decision making legislation explicitly states that it only applies to adults. This legislation is not applicable to substitute decision making for pediatric patients. 74 The Infants Act governs consent to health care and treatment for minors. This legislation suggests that when an infant is not capable of understanding the nature and consequences and reasonably foreseeable benefits and risks of health care or treatment, which is in his or her best interests, then a parent or guardian is the substitute decision maker. 75 The terms parent and guardian are not defined within this Act, but are defined in the Family Relations Act. 73 A.C. v. Manitoba, supra note 59 at The Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c Infants Act, RSBC 1996, c 223, s 17.

39 32 The Family Relations Act defines child as a person under the age of nineteen years. The term parent is defined as including a guardian and a stepparent (who meets certain conditions set out in the Act). The term guardian is defined as a person who has all the powers and duties under the Act respecting a child, including the duties involved with the person and estate of the child Substitute Decision Making Laws: Alberta In Alberta, substitute decision making for adults is governed by the Adult Guardianship and Trusteeship Act, which explicitly states that it only applies to adults. 77 Alberta does not have legislation that addresses substitute decision making for pediatric patients. In Alberta, substitute decision making for minors is affected by The Family Law Act, which provides that every child is subject to guardianship. A parent is the guardian of a child. The duties of guardianship must be exercised in the best interests of the child. A guardian is entitled to be informed of and consulted about the significant decisions affecting the child. A guardian has responsibilities including ensuring that the child has the necessities of life, such as medical care Substitute Decision Making Laws: Saskatchewan In Saskatchewan, substitute decision making is governed by The Health Care Directives and Substitute Health Care Decision Makers Act. 79 This Act is not limited to substitute decision making for adults. This legislation provides that when a person requires treatment, but does not have the capacity to make a health care decision, the nearest relative may make the health care 76 Family Relations Act, RSBC 1996, c 128, ss 1 and Adult Guardianship and Trusteeship Act, SA 2008, c A The Family Law Act, SA 2003, c F-4.5, ss 1, 19-21, and The Health Care Directives and Substitute Health Care Decision Makers Act, SS 1997, c H-0.001, ss 2, 3, 15, and 16.

40 33 decision on behalf of the person, provided that the person does not have an advance directive 80. The Act does not define the term person, but adult is defined as a person eighteen years of age or more. The Act defines capacity as including the ability to understand information relevant to a health care decision respecting a proposed treatment, to appreciate the reasonably foreseeable consequences of making or not making a health care decision respecting a proposed treatment, and to communicate a health care decision on a proposed treatment. The legislation defines treatment as anything that is done for a therapeutic, preventive, or palliative purpose related to the physical or mental health of a person. The term nearest relative is defined using a hierarchy of relations. The first listed nearest relative is a spouse (or person with whom the person cohabitates in a relationship of some permanence), followed by a parent or legal custodian or an adult son or daughter. The Act also provides that where the person requiring treatment is not an adult, the health care decision of a legal custodian, as defined in The Children s Law Act, is preferred to the health care decision of a non-custodial parent. The Children s Law Act provides further definitions of guidance for substitute decision making for pediatric patients in Saskatchewan. This legislation defines a child as anyone less than eighteen years of age who is unmarried. The term parent is defined as the mother or father of a child, born within or outside of marriage or adopted. This Act also provides guidance as to when a person is considered the mother or father of a child. A legal custodian is defined as a person having lawful custody of a child. The term custody is defined as personal guardianship of a child that includes care, upbringing, and any other incident of custody have regard to the child s age and maturity. This legislation also provides that unless a contrary intention appears in any other legislation, a reference to the guardian of a child is deemed to be a reference to the legal custodian of the child Such a directive may be made by a person 16 years of age or older who has the requisite capacity. 81 The Children s Law Act, SS 1997, c C-8.2, s 2.

41 Substitute Decision Making Laws: Manitoba In Manitoba, The Health Care Directives Act indirectly affects substitute decision making. The Act provides that every person who has the capacity to make health care decisions may make a health care directive. This legislation provides that a directive becomes effective when a person ceases to have capacity for a proposed treatment or is unable to communicate their wishes in regards to a proposed treatment. 82 This legislation does not provide a hierarchy of substitute decision makers, such as relatives, to act in the event that a person is incapable and without a proxy. The Family Maintenance Act provides guidance as to the potential substitute decision makers for a pediatric patient. The Act defines the term parent as a biological parent or adoptive parent of a child and provides for situations where a person may be declared to be the parent of a child pursuant to the Act. The Act defines a child as including a person under the age of eighteen years under parental charge. The Act provides that a person is the child of his or her parents regardless of whether he or she is born inside or outside of marriage. Further, the Act provides that the rights of parents in custody and control of their children are joint, unless they have never cohabitated since the birth of the child, in which case the rights are with the parent with whom the child resides Substitute Decision Making Laws: Ontario In Ontario, substitute decision making for health care and treatment decisions is governed by the Health Care Consent Act. If a person is incapable to make the decision for proposed care or treatment, the Act provides a hierarchy of persons who may give or refuse consent on the incapable person s behalf, including, in order of priority, a spouse or parent, a child, the children s aid society or other person who is lawfully entitled to give or refuse consent to the treatment in place of the parent (not including a parent who only has a right of access and not including a parent who is not lawfully entitled to give or refuse consent), a parent who only has a 82 The Health Care Directives Act, CCSM, c H27, ss 1-4, and The Family Maintenance Act, CCSM c F20, ss 1, 17, 18, 35.1, and 39.

42 35 right of access, a brother or sister, and any other relative. The term parent is not defined in the Act. 84 Pursuant to the legislation, a substitute decision making must, among other things, be capable with respect to making the care or treatment decision and, at least, sixteen years of age unless they are the incapable person s parent. Where there is no substitute decision maker available, the Public Guardian and Trustee shall make the decision to give or refuse consent to the proposed care or treatment. The Children s Law Reform Act provides insight into defining child and parent. Pursuant to this Act, a person is the child of his or her natural parents, whether born inside or outside of marriage. Further, adoptive parents are like natural parents. The descriptions of parent and child from this Act apply for the purposes of construing any other legislation, unless a contrary intention appears Substitute Decision Making Laws: Quebec Substitute decision making in Quebec is governed by the Civil Code of Quebec 86 and An Act Respecting Health Services and Social Services 87. The Civil Code of Quebec provides that consent to care, which is required by the state of health of a minor is to be provided by the person having parental authority or by the minor s tutor. The rights and duties of parental authority are described as custody, supervision, education, and maintenance. These rights and duties are exercised by mother and father together, unless one of the parents dies, becomes depraved of parental authority, or unable to fulfill the rights and duties, in which case parental authority is exercised by one parent. Tutorship is established by the Quebec Civil Code to secure the exercise of the civil rights of a minor. Parents are automatically a child s legal tutors. If both parents are unable to fulfill their obligations as tutors, the tutor 84 Health Care Consent Act, 1996, SO 1996, c 2, Sch A, ss 4, 10, 11, and Children s Law Reform Act, RSO 1990, c C12, ss 1, 2, and Civil Code of Quebec, SQ 1991, c 64, articles 12, 14-18, 177, 178, 185, 186, 192, 195, , 205, 207, and An Act Respecting Health Services and Social Services, RSQ, c S-4.2, s 12.

43 36 becomes either an individual appointed by the parents while lucid or an individual who has been court appointed. The Civil Code of Quebec provides that a minor fourteen years of age or older may give consent for care or treatment, when his or her state requires that he or she remain in health or social services for more than twelve hours. The person having parental authority, however, is to be informed. Further, when the required care or treatment involves a serious risk for the health of the minor, which may cause him or her grave and serious effects, the consent must come from the person having parental authority or the tutor. The Civil Code of Quebec provides that court authorization is necessary to imposed refused care or treatment on a minor who is fourteen years of age or over, except in an emergency when parental authority or tutorship is sufficient. For a minor less than fourteen years of age, consent is given by the person with parental authority or the tutor. The authorization of the court is also required if the care or treatment involves a serious risk for health or if it might cause grave and permanent effects. An Act Respecting Health Services and Social Services, which has provisions relating to consent to health care and treatment, provides that the rights under that Act may be exercised by a representative. The Act goes on to provide persons who are presumed to be representatives, including the holder of parental authority of a user who is a minor or the user s tutor. Pursuant to the Civil Code of Quebec, a person giving or refusing his or her consent for care of another person must act in the sole interests of that person and take into account as much as possible any wishes that have been expressed. If consent is provided, it must be ensured that the care is beneficial and the gravity and permanence of its effects must not be disproportionate to the anticipate benefit. The Code provides that a person who gives his consent or refuses care for another person is bound to act in the sole interest of that person, taking into account, as far as possible, any wishes the latter may have expressed. If consent is given, they must ensure that the care is beneficial, advisable in the circumstances, and that the risks incurred are not disproportionate to the anticipated benefit.

44 Substitute Decision Making Laws: Newfoundland In Newfoundland, substitute decision making is governed by the Advance Health Care Directives Act. This Act provides that where a patient lacks the competency to make a health care decision, the health care professional must determine if there is an appropriate substitute decision maker. 88 Where a patient has not made an advance directive while competent, the Act provides a hierarchy of persons who may serve as a substitute decision maker. Pursuant to the Act, a competent minor may make an advance health care directive ; the Act provides for a rebuttable presumption that persons sixteen years of age and older are competent to make a directive, while those under sixteen are not. The hierarchy of persons who may serve as substitute decision maker, in order of priority, are: spouse, children, parents, siblings, grandchildren, grandparents, uncles and aunts, nieces or nephews, another relative, or the health care professional. The term parent is not defined in the Act. The Children s Law Act provides that a person is the child of his or her natural parents independent of whether they are born inside or outside of marriage. The Act provides that a child is legally the child of adopting parents as if they were natural parents. The Act also provides that these descriptions of the relationship of parent and child are to be applied for the purpose of construing other laws in the province Substitute Decision Making Laws: New Brunswick In New Brunswick, the Medical Consent of Minors Act provides guidance for substitute decision making for pediatric patients. The Act provides that when a minor cannot consent to health care or treatment, the consent is to be provided by the parent or guardian. The Act further provides that when the consent of a parent or guardian is required by law, and it is refused or otherwise unavailable, any person may apply to a judge for an order dispensing with the consent Advance Health Care Directives Act, SNL 1995, c A-4.1, ss 2, 3, 7, 9-12, and Children s Law Act, RSNL 1990, c C-13, ss Medical Consent of Minors Act, SNB 1976, c M-6.1, ss 1-5.

45 38 The Guardianship of Children Act provides that a child includes a child whose father and mother are not married to one another. According to this Act, a parent, however, does not include the father of a child whose father and mother are not married to one another. The Act provides that the parents of a child are joint guardians of the child and may jointly appoint another person or persons to be guardian or guardians of the child. 91 The Family Services Act also provides definitions that may provide some guidance for substitute decision making. Pursuant to this Act, a person is the child of his or her natural parents, regardless of whether the child was born inside or outside of marriage. Further, an adopted child is the child of the adopting parents as if they were the natural parents. The Act also establishes a number of presumptions when a man is presumed to be the father of a child, including if the man is married to the mother of the time of the child s birth, or marries the mother after the birth and acknowledges that he is the natural father. 92 The Family Services Act provides that for the purposes of the law of the province, a person is the child of his or her natural parents, and the status as such, is independent of whether the child was born inside or outside of marriage. The Act also provides that an adopted child is the child of the adopting parents as if they were the natural parents. Further, the Act provides that, unless the contrary is proven, a man is presumed to be the father of a child in a number of circumstances, including where the man is married to the mother of the child at the time of the child s birth, the man marries the mother of a child after the birth of the child and acknowledges that he is the natural father, or the man was cohabiting with the mother of the child at the time of the birth or the child was born within 300 days after they ceased to cohabit Substitute Decision Making Laws: Nova Scotia In Nova Scotia, substitute decision making is governed by two pieces of legislation, the Personal Directives Act 93 and, in hospitals, the Hospitals Act 94. The Hospitals Act provides that if a 91 Guardianship of Children Act, RSNB 2011, c 167, ss 1, 2, and Family Services Act, SNB 1980, c F-2.2, s Personal Directives Act, SNS 2008, c 8, ss 2, 3, 9, 14, 15, 17, and Hospitals Act, RSNS 1989, c 208, ss 2, 5, 9, 52, 53, 54, 54A, 54B, 55, and 71.

46 39 provision of another provincial act conflicts with a provision in the Hospitals Act, the Hospitals Act prevails. In addition to providing a scheme for a person (no age restriction is given) with capacity to make a personal directive for future personal-care decision, the Personal Directives Act specifies a regime (which is subject to, among other things, the Hospitals Act) for substitute decision making when a person does not have a personal directive. The Act provides a hierarchy of nearest relatives who may make health care decisions for the person. A qualifying nearest relative must have been in contact with the person in the preceding twelve months, must be the age of majority, and must be willing and with capacity. If there is no qualifying nearest relative, the Public Trustee must make the health care decision. For a pediatric patient without a spouse, child, age of majority sibling, grandchild, or niece or nephew, a parent is listed as the next nearest relative, followed by a person standing in loco parentis (person standing in place of the parent), grandparent, or aunt or uncle. The Hospitals Act provides a regime for substitute decision making for persons in hospital requiring medical or surgical treatment, are incapable of consenting and without a guardian or person recognized in law to give consent. It is presumed that every adult person has capacity to make all treatment decisions for his or her health care. The term adult is not defined in the Act. Similar to the Personal Directive Act, the Hospitals Act provides a hierarchy of substitute decision makers. A parent is the substitute decision maker for a pediatric patient without a personal directive, spouse, or child. The next listed substitute decision maker is a person who stands loco parentis to the patient, followed by a grandparent or an aunt or uncle for a patient that does not have an adult sibling. A substitute decision maker must have had contact with the person in the preceding twelve months and a willingness to be the substitute decision maker. Other terms potentially relevant to substitute decision making are provided in the Maintenance and Custody Act. This Act provides that a dependent child, includes a child under the age or majority. A guardian is a head of a family and any other person who has in law or in fact the custody and care of a child. A parent is defined, in the case of a child of unmarried parents, to include a person who has been ordered to pay maintenance. The Act also provides that a parent includes the father of a child of unmarried parents, unless the child has been adopted.

47 40 The Act provides that the father and mother are joint guardians and are equally entitled to the care and custody of the child unless otherwise provided by the Guardianship Act or a court of competent jurisdiction. 95 The Guardianship Act allows for the appointment of a guardian or guardians by the person or persons having care and custody of a child Substitute Decision Making Laws: Prince Edward Island In Prince Edward Island, substitute decision making is governed by the Consent to Treatment and Health Care Directives Act. 97 The Act provides that when a health care professional finds that a person is incapable with respect to treatment a decision may be made on the patient s behalf by another person. The Act lists possible substitute decision makers in descending order of priority. For a pediatric patient without a proxy, spouse, son or daughter, or brother or sister over the age of sixteen years, the possible substitute decision makers are a guardian, parent, person who has assumed parental authority and who is lawfully entitled to give or refuse consent to treatment on the patient s behalf, trusted friend with close knowledge of the wishes or any other relative. The substitute decision maker must be at least sixteen years of age, capable with respect to the treatment, must have knowledge of the incapable patient s circumstances, and have been in recent contact with the patient. A substitute decision must act in accordance with certain principles, including the patient s best interests considering if the treatment is likely to improve the condition or well being, prevent deterioration, or reduce the rate of deterioration of the patient. The Child Status Act provides some definitions that may provide guidance for substitute decision making for pediatric patients. The Act provides that for the purposes of the law of Prince Edward Island, a person is the child of his or her natural parents, and his or her status as such, is independent of whether born inside or outside of marriage. Adoptive parents are also parents. The Act establishes a number of presumptions with regards to parentage, including that a person 95 Maintenance and Custody Act, RSNS 1989, c 160, ss 2 and Guardianship Act, SNS 2002, c 8, s Consent to Treatment and Health Care Directives Act, RSPEI 1988, c C-17.2, ss 1,

48 41 is presumed to be the parent of a child is the person was the spouse of the mother of the child when the child was born or if the person has been recognized by a Canadian court as a parent of the child. A woman who gives birth to a child is deemed to be the mother of the child, whether the woman is or is not the genetic mother of the child. The Act provides that the presumptions do not apply if they result in more than one person being the parent of the child in addition to the mother Substitute Decision Making Laws: Nunavut Nunavut does not have health care and treatment substitute decision making legislation for adult or pediatric patients. The Children s Law Act provides definitions for some terms that may provide guidance for substitute decision making for pediatric patients. The Act provides that a person is the child of his or her natural parents regardless of whether he or she was born within or outside of marriage. Similarly, when there is an adoption order, the child is the child of the adoptive parents as if they were the natural parents. These definitions apply for construing instruments and enactments of Nunavut, unless a contrary intention appears. 99 The Act further provides that are a person is presumed to be the parent of child in a number of circumstances, including where the person is the spouse of the mother at the time of the child s birth. A male person is presumed to be the father of a child in a number of circumstances, including where he was married to the mother at the time of the birth or where he married the mother of the child after the birth and has acknowledge that he is the natural father. The Act also provides that a person may apply to the court for an order dispensing with the consent of a parent to medical treatment of a minor that is required by law where the consent is refused or otherwise not obtainable. Where a court is satisfied that the withholding of the medical treatment would endanger the life or seriously impair the health of the minor, it may 98 Child Status Act, RSPEI 1988, c C-6, ss Children s Law Act, SNWT (Nu) 1997, c 14, s 2, 3, 5, 8, and 39.

49 42 by order dispense with the consent of the parent to the medical treatment. For the purposes of this particular provision in the Act, the term parent is defined to include any person entitled to give consent to medical treatment for a minor Substitute Decision Making Laws: Northwest Territories The Northwest Territories does not have health care and treatment substitute decision making legislation for adult or pediatric patients. The Children s Law Act in the Northwest Territories is similar to the legislation in Nunavut, but there are a few subtle differences. The Children s Law Act in the Northwest Territories provides identical definitions for the terms that may provide guidance for substitute decision making for pediatric patients. The Act provides that a person is the child of his or her natural parents regardless of whether he or she was born within or outside of marriage. Similarly, when there is an adoption order, the child is the child of the adoptive parents as if they were the natural parents. These definitions apply for construing instruments and enactments of the Northwest Territories, unless a contrary intention appears. 100 The legislation in the Northwest Territories does not have the gender neutral provision like Nunavut, only the provision for a male person. A male person is presumed to be the father of a child in a number of circumstances, including where he was married to the mother at the time of the birth or where he married the mother of the child after the birth and has acknowledge that he is the natural father. The Act also provides that a person may apply to the Supreme Court for an order dispensing with the consent of a parent to medical treatment of a minor that is required by law where the consent is refused or otherwise not obtainable. Where a court is satisfied that the withholding of the medical treatment would endanger the life or seriously impair the health of the minor, it may by order dispense with the consent of the parent to the medical treatment. For the 100 Children s Law Act, SNWT 1997, c 14, s 2, 3, 5, 8, and 39.

50 43 purposes of this particular provision in the Act, the term parent is defined to include any person entitled to give consent to medical treatment for a minor Substitute Decision Making Laws: Yukon In the Yukon, substitute decision making is governed by the Care Consent Act. The Act provides that a care provider must not provide care to a person without the person s consent or substitute consent, aside from exceptions established in the Act. The term care includes health care. The care provider proposing the care determines if the person is capable or incapable to give or refuse consent. This determination must be made regardless of the person s age. 101 The Care Consent Act distinguishes between care, which includes health care, and major health care, which includes major surgery, any treatment involving a general anesthetic, major diagnostic or investigative procedures, and any other health care designated by the regulations as major health care. The Care Consent Act provides for a hierarchy of person that my provide substitute consent. For a person without a proxy, spouse, or child, the list of potential substitute decision makers is a guardian if they have authority to give or refuse consent to the care, parent, grandparent, any other relative, or a close friend. The Care Consent Act defines guardian as including a person who has the right to give or refuse consent to care pursuant to the Child and Family Services Act. The term parent is not defined in the Care Consent Act. The Child and Family Services Act defines parent as including a mother or father with custody, a mother or father without custody but exercising or attempting to exercise rights of access, a mother or father providing financial support for the child, a person granted custody by a court of competent jurisdiction or by an agreement, or a person with whom a child resides and stands in place of the mother or father of the child. The term custody is defined as including the right to consent to medical treatment for the child Care Consent Act, SY 2003, c 21, Sch B, s 1, 4-13, 15, 20, and Child and Family Services Act, SY 2008, c 1, s 1.

51 Child Welfare Laws Common Law Considerations At common law, a mature minor is a minor who is capable of making his or her own health care and treatment decisions. Such a minor cannot be overridden by his or her parents or the parens patriae jurisdiction of the Court. 103 The parens patriae jurisdiction of the courts is to provide protection to those unable to care for themselves. 104 Child welfare legislation has been enacted in all Canadian jurisdictions and may provide a mechanism for a decision of a mature minor to be overridden or parental rights to be terminated, suspended, or transferred to child welfare services. The legislation in each jurisdiction sets out the circumstances for when the state, child welfare services or the court, may be able to intervene, as these details vary as between jurisdiction. Consideration has been given to the persons who may be subject to such protective intervention, the health or medical circumstances that would trigger such an intervention, and the process of the actual intervention Legislation All jurisdictions have child welfare legislation, which is discussed in the following section. There is no federal child welfare legislation, but the Criminal Code provides that a parent, foster parent, guardian or head of a family is under a legal duty to provide necessaries of life for a child under the age of sixteen years. The failure to provide the necessaries of life for a child less than sixteen years of age is an offence punishable with imprisonment. 105 The failure to provide or seek medical care has been held to be a necessity of life in some cases Child Welfare Laws: British Columbia In British Columbia, the Child, Family and Community Services Act, allows a court to make an order authorizing health care for a child in certain circumstances. The Act defines a child 103 Walker v Region 2 Hospital Corp., [1994] NBJ No 242 (CA); Val Mol, supra note Black s, supra note 18 at Criminal Code, RSC, 1985, c C-46, s R. v R.P., [2004] OJ No 5109 (SCJ) at 29.

52 45 as a person less than nineteen years of age. The court may intervene to authorize health care when a child or the parent of a child refuses to consent to health care that is, in the opinion of two medical practitioners and the court, necessary to preserve the child s life or prevent serious or permanent impairment of the child s health Child Welfare Laws: Alberta In Alberta, the Child, Youth and Family Enhancement Act, allows a court to make an order authorizing treatment for a child in certain circumstances. The Act defines a child as a person less than eighteen years of age. A child is in need of intervention when his or her survival, security or development is endangered because he or she is neglected by his or her guardian. 108 The meaning of neglected includes when a guardian is unable or unwilling to obtain for the child, or permit the child to receive, essential medical, surgical or other remedial treatment that is necessary for the health or well-being of the child. A child in need of such intervention may be apprehended by the director for the Ministry. 109 After a child has been apprehended, the director may only authorize the provision of essential medical, surgical, dental or other remedial treatment if the guardian is unable or unavailable to consent. If the guardian refuses to consent the essential medical, surgical, dental or other remedial treatment, the director must apply to the court for an order authorizing the treatment. The court may authorize the treatment when it is satisfied that the treatment is in the best interests of the child Child Welfare Laws: Saskatchewan In Saskatchewan, the Child and Family Services Act provides that a court may make an order, in certain circumstances, placing a child in the temporary custody of the Minister with the 107 Child, Family and Community Service Act, RSBC 1996, c 46, ss 1 and As defined in the Family Law Act, SA 2003, c F Child, Youth and Family Enhancement Act, RSA 2000, c C-12, ss 1, 22.1, and 22.2.

53 46 Minister having all of the rights and responsibilities of the child s parent and guardian of the person. 110 Pursuant to the Act, a child is defined as an unmarried person, less than sixteen years of age. The term parent is defined as including the mother and father of the child, a person to whom custody of a child has been granted, or a person with whom a child resides standing in loco parentis (in the place of the parent) to the child. A child is in need of protection in a number of situations pursuant to the Act, including when medical, surgical or other recognized remedial care or treatment, which is considered essential by a duly qualified medical practitioner, has not been or is not likely to be provided to the child. The term duly qualified medical practitioner is not defined within the Act. When a child is in need of protection, an application may be made to a court. If a court makes a finding that the child is in need of protection, the court may make an order regarding the custody of the child. The child may be placed in the custody of the Minister for a temporary period. If the child is placed in the custody of the Minister, the Minister has all of the rights and responsibilities of a parent and the guardian of the person for the child and may authorize health care or treatment for the child Child Welfare Laws: Manitoba In Manitoba, The Child and Family Services Act provides that a court may make an order authorizing health care or treatment for a child in certain situations. 111 The Act defines a child as a person under the age of majority. A guardian is defined as a person, other than the parent of a child, who has been appointed guardian of the person of the child by a court or to whom guardianship has been surrendered. The term parent is defined as meaning a biological or adoptive parent of a child. 110 The Child and Family Services Act, SS , c C-7.2, ss 2, 11 and The Child and Family Services Act, CCSM, c C80, ss 1, 17, 18, 18.2, 18.4, 21, 22, and 25.

54 47 A child is in need of protection when his or her life, health or emotional well-being is endangered as a result of the act or omission of a person, including when the child is in the care, custody, control or charge of a person who neglects or refuses to provide or obtain proper medical or other remedial care or treatment necessary for the health or well-being of the child or who refuses to permit such care or treatment to be provided to the child when the care or treatment is recommended by a duly qualified medical practitioner. When there are reasonable and probable grounds that a child is in need of protection, the child may be apprehended by the the director, a representative of an agency or a peace officer. A child and services agency then become responsible for the care, maintenance, education and well-being of the child. If medical or dental treatment is recommended by a duly qualified medical practitioner or dentist and the consent of the parent or guardian is required, but not available, an agency may authorize the provision of the treatment. If the child is sixteen years of age or older, the child s consent is required. If the parents or guardian of the child refuse to consent or a child sixteen years of age or older refuses to consent to recommended treatment, an agency may apply to the court for an order authorizing the treatment. A court will make an order authorizing the treatment if the court considers the treatment to be in the best interest of the child. The treatment may only be ordered by the court for a child sixteen years of age or older without the child s consent, if the court is satisfied that the child is unable to understand the information that is relevant to making a decision to consent or not consent to the treatment or to appreciate the reasonably foreseeable consequences of making a decision to consent to the treatment Child Welfare Laws: Ontario In Ontario, the Child and Family Services Act authorizes a court to make an order that a child be a ward of the society in certain situations. The Act provides that a child, absent certain exceptions, does not include those sixteen years of age or older. The term parent includes a

55 48 child s mother, a child s father as described in the Children s Law Reform Act unless it is proved otherwise, and an individual having lawful custody of a child. 112 The Act provides that a child is in need of protection in a number of situations, including when a child requires health care or treatment to cure, prevent or alleviate physical harm or suffering and the child s parent or the person having custody of the child does not provide (or refuses or is unavailable or unable to) consent to the treatment. A society may apply to a court to determine whether a child is in need of protection. If a court finds that a child is in need of protection, intervention through a court order is necessary. An order must be made in the best interests of a child. A court may order that the child be made a ward in the care for a specific period of time (not exceeding twelve months) or that the child be placed with a parent or another person, subject to supervision with terms and conditions from the court Child Welfare Laws: Quebec In Quebec, the Youth Protection Act provides that a tribunal may order specific health care or services for a child in certain circumstances. 113 Pursuant to the Act, a child is defined as a person less than eighteen years of age. The Act defines parents as the father and mother of a child or, where applicable, any other person with parental authority. The security or development of a child is considered to be in danger in a number of situations, including when a child is neglected. A child is neglected when the basic needs of the child are not met, or there is a serious risk of the basic needs not being met, by the child s parents or person having custody. Failing to provide care for the physical or mental health of a child, or not allowing a child to receive such care, is a failure to meet the basic needs of a child. 112 Child and Family Services Act, RSO 1990, c C.11, ss 1, 15, 37, 40, 47, and Youth Protection Act, RSQ, c P-34.1, ss 1, 38, 39, 46, 49, 51, 54, and 91.

56 49 Pursuant to the Act, professionals providing care or assistance to child are required to make a report to a director when they believe that the security or development of a child may be in danger. A director receiving a report may take immediate protective measures to ensure the security of the child for up to forty eight hours before making an assessment. A director must perform an assessment after receiving a report. Following an assessment, if the director is of the opinion that the security or development of a child is in danger the director may refer the matter to a tribunal for a hearing. If a tribunal concludes that the security or development of the child is in danger, the tribunal may make an order that the child receive specific health care and health services Child Welfare Laws: Newfoundland In Newfoundland, the Family Services Act provides that a judge may authorize treatment recommended by a qualified health practitioner for a child in certain circumstances. 114 The Act defines child as a person actually or apparently under the age of sixteen years. The term parent is defined to include the custodial mother, the custodial father, a custodial step-parent, a non-custodial parent who regularly exercises or attempts to exercise rights of access, and a person who is responsible for the child s care and with whom the child resides, except a foster parent. A qualified health practitioner means a physician, nurse, nurse practitioner, licensed practical nurse, dentist, or dental hygienist. Pursuant to the legislation, a child is in need of protective intervention in a number of situations, including where the child is in the custody of a parent who refuses or fails to obtain or permit essential medical, psychiatric, surgical or remedial care or treatment to be given to the child when recommended by a qualified health practitioner. If a manager or social worker believes that a child is in need of protective intervention because a parent s refusal or failure to obtain or permit essential medical, psychiatric, surgical or remedial treatment that is recommended for the child by a qualified health practitioner, the manager or social worker may bring an application before a court for an order authorizing 114 Child and Youth Care and Protection Act, SNL 2010, c C-12.2, ss 2, 10, and 30.

57 50 the treatment. Where a judge finds that a child is in need of protective intervention, the judge may grant an order authorizing the treatment recommended by a qualified health practitioner Child Welfare Laws: New Brunswick In New Brunswick, the Family Services Act provides that the custody, care and control of a child may be temporarily transferred to the Minister and the Minister may prescribe a plan considered suitable for the child. 115 Pursuant to the Act, child is defined as a person actually or apparently under the age of majority, including an unborn child, a stillborn child, a child whose parents are not married, a child to whom a person stands in loco parentis if that person s spouse is a parent of the child. The Act provides that the security or development of a child may be in danger in a number of situations, including when the child is in the care of a person who neglects or refuses to provide or obtain proper medical, surgical or other remedial care or treatment necessary for the health or well-being of the child or refuses to permit such care or treatment to be supplied to the child. If the Minister receives a report that the security or development of a child may be in danger, the Minister must take steps to investigate. If the Minister determines that the security or development of the child is in danger, the Minster must plan for the care of the child to ensure that the child s security and development are protected. A Minister must place a child in protective care in a number of situations, including if the Minister believes that it is required to protect the security or development of the child. When a child is in a protective care, the Minister must make adequate provision for the care of the child and may arrange for medical examination and treatment of the child without the consent of any person. Within five days of being in protective care, the Minister must take further steps, including applying for an order regarding the child. A hearing may also be applied for a child who was not 115 Family Services Act, SNB 1980, c F-2.2, ss 1, 31, 31.1, 32, 51, and 55.

58 51 taken into protective care, but the Minister has reason to believe that the security or development of the child is in danger. Once a matter is before a court, the court may make an order, including that the custody, care and control of the child be transferred to the Minister for a period of up to six months. The Minister may place a child under the care of the Minister in any facility considered to be appropriate for the child and may prescribe any plan considered suitable for the child Child Welfare Laws: Nova Scotia In Nova Scotia, the Children and Family Services Act provides that a court may make an order authorizing the provision of medical care or treatment for a child in certain circumstances. 116 A child is defined as a person less than sixteen years of age. A parent or guardian may include a child s mother or father, an individual having the custody of the child, an individual residing with and having the care of the child, or a step-parent. The Minister is the Minister of Community Services. Pursuant to the Act, a child is in need of protective services if he or she requires medical treatment and his or her parent or guardian does not provide, or refuses or is unavailable or is unable to consent to, the treatment. If the child is the care or custody of a parent or guardian who does not ensure the provision of medical care or treatment which is considered essential by two duly qualified medical practitioners for the preservation of life, limb or vital organs and the Minister has been notified, an application may be brought before a court. The court may make an order, including an order authorizing the provisions of the medical care or treatment Child Welfare Laws: Prince Edward Island In Prince Edward Island, the Child Protection Act provides that a court may make an order that treatment be obtained for a child Children and Family Services Act, SNS 1990, c 5, ss 3, 22, 23, 24, 30, 32, 33, and Child Protection Act, RSPEI 1988, c C-5.1, ss 1, 2, 9-11, 29, and

59 52 A child is defined as being less than eighteen years of age. The Director is the Director of Child Protection. A parent includes a birth or adoptive parent, a person who has stood in loco parentis to a child for at least a year, a legal guardian of a child, or a person responsible for the child s care with whom the child resides. Pursuant to the Act, a child is in need of protection when the child is neglected or required treatment is not obtained or provided. The Act establishes reporting obligations. When the Director receives a report and it appears that a child may be in need of protection, the Director may make an assessment to determine whether a court application is necessary. The court application results in a protection hearing and, if a child is found to be in need of protection, a disposition hearing. At the disposition hearing, the court will consider the best interests of the child and may order that the child be taken into the permanent or temporary custody of the Director or may be placed with a parent permanently or temporarily. The court may order that treatment be obtained for the child Child Welfare Laws: Nunavut and the Northwest Territories The relevant provisions of child welfare legislation in Nunavut and the Northwest Territories are the identical. 118 These Acts define child as a person who is, or appears to be, less than sixteen years of age. The term parent is defined as the person with lawful custody of a child absent certain exceptions. The Director is the Director of Child and Family Services (in the Northwest Territories, the term Director also includes a Deputy Director of Child and Family Services ). A child is considered to be in need of protection when the child requires medical treatment to cure, prevent or alleviate serious physical harm or serious physical suffering and the parent 118 Child and Family Services Act, SNWT (Nu) 1997, c 13, ss 1, 3, 7, and 31; Child and Family Services Act, SNWT 1997, c 13, ss 1, 3, 7, and 31.

60 53 does not provide, or refuses or is unavailable or unable to consent to the provision of, the treatment. If the Director has reasonable grounds to believe that a child is in need or protection because he or she requires medical treatment, the Director may apprehend the child and without delay make an application to the court for a declaration that the child needs protection and an order authorizing the medical care or treatment. The court must make a determination as to whether or not the child needs protection. Where it is determined that the child needs protection, due to the refusal or failure to provide the required medical treatment, the court must make a declaration and order that the child be provided with the medical care of treatment, if it is considered by the court to be in the best interests of the child to make such an order. The legislation provides a number of factors that may be relevant in consider what is in a child s best interest, including the child s safety; the child s physical, mental and emotional level of development and needs, and the appropriate care or treatment to meet those needs; the child s cultural, linguistic and spiritual or religious upbringing and ties; the child s views and preference, if they can be reasonably ascertained; and the effects on the child of a delay in making a decision Child Welfare Laws: Yukon In the Yukon, the Child and Family Services Act provides that a judge may make an order that a child be provided with medical treatment. 119 The Act provides that a director may apply to a judge for an order if in the opinion of two health care providers, it is necessary to provide health care to a child to preserve the child s life, prevent serious physical or mental harm, or alleviate severe pain, and no one is able or available to consent to the health care, or consent is being refused by the person responsible for the child s health care decisions, or the child if the child is capable of giving or refusing the health care. 119 Child and Family Services Act, SY 2008, c 1, ss 1, 21, and 33.

61 54 If the judge is satisfied that it is necessary to provide the health care to preserve the child s life, to prevent serious physical or mental harm, or to alleviate severe pain, the judge may make an order that, inter alia, the health care be provided, that a person be prohibited from obstructing the provision of the health care, and/or that a parent or another person deliver the child to the place where the health care will be provided. The legislation defines child as a person who is less than nineteen years of age. The legislation defines health care provider as including a medical practitioner, dentist or registered nurse. The legislation defines parent as including the mother or father of a child with custody, the mother or father of the child without custody but who regularly exercise or attempts to exercise rights of access, a mother or father providing financial support for the child, a person to whom custody of a child has been granted by a court or by an agreement, or a person with whom a child resides and who stands in place of the child s mother or father. 4.7 Apology Laws Common Law Considerations In jurisdictions without apology legislation (or prior to the enactment of apology legislation in jurisdictions with apology legislation) Canadian courts may admit statements of apology into evidence. Judges will not interpret statements of apology as admissions of liability without carefully weighing all relevant evidence. All of the legal requirements in a negligence action must still be met, including the establishment of a breach of the standard of care causing injury or harm. 120 Most jurisdictions have apology legislation. Quebec, New Brunswick, the Northwest Territories, and the Yukon do not have apology legislation. Apology legislation provides limits on the admissibility of statements of apology as evidences in various proceedings which vary by jurisdiction and are specified in the various apology statutes. 120 Dusty s Saloon, a division of A.P. Woznow & Sons Enterprises Ltd. v W.M.I. Waste Management of Canada Inc., [2001] A.J No. 108 (QB); Jordan v Power, [2002] AJ No 1080 (QB).

62 Legislation Eight provinces and one of the territories have apology legislation; there are five apology acts 121, two provinces have apology provisions within their evidence legislation 122, and one province has legislation that specifically provides for health services apologies 123. There is no federal apology legislation. Each piece of legislation defines apology as including expressions of sympathy or regret, statements 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 matter to which the words or actions relate. The purpose of these laws is to limit the use of the apology, such that it does not constitute an admission or fault or liability, does not void or impair any insurance coverage, is not taken into account in determination of fault or liability, and is not admissible in any court proceedings. The limit on what proceedings the apology is not admissible in differs between the jurisdictions. British Columbia, Saskatchewan, Manitoba, Nova Scotia and Newfoundland broadly define court to include a tribunal, arbitrator or any other person acting in a judicial or quasi judicial capacity. The apology provisions in Alberta to not apply to prosecution of offences; the legislation in Ontario does not provide protection in provincial offences or criminal proceedings; the legislation in Nunavut does not provide protection for criminal or statutory offences. The legislation in Prince Edward Island is unique in that it protects apologies made specifically in relation to incidents that occur in health care settings within the Health Services Act. It similarly defines apology, but the provisions apply to an apology made in connection with the provision of health services to any other person. 121 Apology Act, SBC 2006, c 19; The Apology Act, SM 2007, c 25; Apology Act, 2009, SO 1990, c 3; Apology Act, SNL c A-10.1; Apology Act, SNS 2008, c Alberta Evidence Act, RSA 2000, c A-18, s 26.1; The Evidence Act, SS 2006, c E-11.2, s Health Services Act, RSPEI 1988, c H-1.6, ss 26 and 32.

63 56 None of the apology laws has any provisions addressing apologies being made to minors. None of the apology laws define person or provide for age-related or capacity-related restrictions on apologizing. 4.8 Privacy and Records Laws With regards to medical records, the common law position has been articulated by the Supreme Court of Canada. A medical record is not the property of the patient. Medical records are owned by the hospital, clinic, or physician that prepares the medical record. A patient has a right of access to the information within his or her medical records. This right of access is not absolute, as a patient may be refused access in exceptional circumstances, where there is a real potential for harm to the patient or a third party. The onus is on the physician, clinic, or hospital to justify a denial of access. 124 The courts have not dealt with the issue of a minor patient accessing his or her medical records. Based on the case law, it is likely that a minor patient would have access to his or her records unless it could be established that there was a real potential for harm to the patient or a third party. The use of the term disclosure in the context of privacy and records laws refers to the release of the information from the custodian of the records, which is different than the use of the term disclosure in the context of providing information about a patient safety incident to a patient. All provinces and territories have enacted general privacy legislation. General privacy legislation applies to the collection, use, and disclosure of records, including personal information, by public bodies. There are five jurisdictions that have general privacy legislation with no privacy legislation specific to personal health information or personal information (Nova Scotia, Prince Edward Island, Yukon, Nunavut, and Northwest Territories). As stated above, general privacy legislation applies to public bodies ; hospitals are considered public bodies in the context of freedom of information legislation. These general privacy statutes each have a provision that specifically addresses the ability of minors to access information. Each of these jurisdictions draw a bright 124 McInerney v MacDonald, [1992] SCJ No 57 (SCC).

64 57 line at the age of majority, such that all minors must have a substitute decision maker ( legal custodian, person with lawful custody, guardian ) authorize access to information or consent to its collection, use, and disclosure. 125 In addition to general privacy legislation, two of these jurisdictions, Prince Edward Island and Nova Scotia, have legislation specific to hospitals. 126 In both jurisdictions, the general privacy legislation has a provision which states that in the event of a conflict with any other legislation, the general privacy legislation prevails. The hospital legislation in Prince Edward Island applies to community hospitals and provincial hospitals. This hospital legislation provides that the parent or guardian has access to health records for a patient who is not capable of making health care decisions for himself or herself. The hospital legislation in Nova Scotia applies to hospitals that are approved by the Minister. The hospital legislation provides that a patient who is not capable of giving consent in respect of that person s records and particulars may have consent given by a substitute decision maker with capacity, including a parent, a person who stands in loco parentis to the patient, an adult sibling, a grandparent, or an aunt or uncle. 127 Alberta, Saskatchewan, Ontario, Newfoundland, and New Brunswick have enacted privacy legislation that specifically addresses personal health information. In these provinces, the more specific legislation applies to personal health information, as opposed to the more general privacy legislation, which is not applicable Freedom of Information and Protection of Privacy Act, SNS 1993, c 5; Freedom of Information and Protection of Privacy Act, RSPEI 1988, c F-15.01; Access to Information and Protection of Privacy Act, RSY 2002, c 1; Access to Information and Protection of Privacy Act, SNWT (Nu) 1994, c 20; Access to Information and Protection of Privacy Act, SNWT 1994, c Hospitals Act, RSPEI 1988, c H-10.1, ss 1 and 8; Hospital Management Regulation, PEI Reg EC49/11; Hospitals Act, RSNS 1989, c 208, ss 2 and Nova Scotia has legislation specific to personal health information which received Royal Assent on December 10, 2010, which is not yet in force. 128 Health Information Act, RSA 2000, c H-5; The Health Information Protection Act, SS 1999, c H-0.021; Personal Health Information Act, 2004, SO, c 3, Sch A; Personal Health Information Act, SNL 2008, c P-7.01; Personal Health Information Privacy and Access Act, SNB 2009, c P-7.05.

65 58 Five provinces have legislation specific to personal health information. In two of these provinces (Alberta and Saskatchewan), the personal health information legislation is completely silent as to the ability of minors to access their information or consent to the collection, use and disclosure; in these two statutes are no provisions addressing age or capacity based consent. In another three of the provinces (Ontario, New Brunswick and Newfoundland), the legislation specifically provides that the ability to access or consent to the disclosure, use or collection of personal health information is capacity based; where the minor is without capacity the consent must come from the parent or guardian. In New Brunswick, minors sixteen years of age or older are treated as adults when determining capacity, those less than sixteen year of age are only able to consent where the access, disclosure, collection or use of the records is in their best interest. In Ontario, the consent for collection, use and disclosure for minors less than sixteen years of age comes from the parent or personally lawfully able to consent as the parent; those sixteen years of age or older who are incapable will have a substitute decision maker in accordance with the Health Care Consent Act provide the consent. The legislative frameworks addressing personal health information in British Columbia and Quebec are unique. These provinces each have two pieces of legislation governing personal health information. In British Columbia, there is legislation specific to personal information, as opposed to the more specific subset of that information, personal health information. The personal information legislation applies to organizations, which includes persons, but explicitly excludes public bodies. 129 Public bodies are governed by the general privacy legislation in British Columbia. 130 In British Columbia, both pieces of privacy legislation provide capacity based limits on the ability to access and consent to the disclosure, collection and use of records. The general privacy legislation provides that a parent or guardian is to consent for an incapable minor, while the personal information legislation provides that a guardian of the person is to consent for an incapable minor. 129 Personal Information Protection Act, SBC 2003, c 63, s 1 and Freedom of Information and Protection of Privacy Act, RSBC 1996, c 165, ss 4, 5, 19, and Sch 1.

66 59 In Quebec, the general privacy legislation specifically states that it applies to health service and social service institutions 131, which are also governed by legislation specific to these institutions 132 (which includes some provisions in relation to access to records), such that these two pieces of legislation work together to govern access to personal health information in Quebec. In the event of a conflict, the general privacy legislation prevails, unless explicitly stated otherwise in the other legislation. In Quebec, the general privacy legislation prohibits a minor less than fourteen years of age from obtaining their personal health information, but consent may be given by a person with parental authority. At the federal level, the privacy legislation applies to personal information and is silent on the issue of minors consenting to the collection, use and disclosure of personal information An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information, RSQ c A-2.1, ss 1, 1.1, 3, 7, 9, 14, 53, 59, 60.1, 83, and An Act Respecting Health Services and Social Services, RSQ, c S-4.2, ss 17, and Personal Information Protection and Electronic Documents Act, SC 2000, c 5, ss. 2, 4, 5, 9, 26 and 30.

67 60 Chapter 5: Results of Review of Institutional Policies 5.1 Introduction All members of the Canadian Association of Pediatric Health Centres (CAPHC), forty four health care organizations providing care to pediatric patients across Canada, were sent questionnaires. The questionnaires included a request for any written institutional policies relating to the disclosure of pediatric patient safety incidents, along with a check box description of the responding organization (Tertiary Hospital, Quaternary Hospital, Community Hospital, Regional Hospital, Rehabilitation Centre, Home Care Provider or Other), and the percentage of services provided to pediatric patients by the health care organization. 5.2 Results of Questionnaires In total, fifteen questionnaires were collected from health care organizations, which were reviewed and analyzed. Thirteen written disclosure policies were provided by participating health care organizations, while two health care organizations indicated that they did not have a written disclosure policy in place to provide, but a policy was in the process of being drafted and implemented. Questionnaire responses were received from across the country from health care organizations in British Columbia, Alberta, Saskatchewan, Ontario, Quebec, Nova Scotia, and Newfoundland. A summary of the responses received by jurisdiction is shown in Table 5.1. Table 5.1: Summary of questionnaire responses by jurisdiction Jurisdiction Number of Responses British Columbia 1 Alberta 1 Saskatchewan 2 Ontario 5 Quebec 4 Nova Scotia 1 Newfoundland 1 Total 15

68 61 Within the questionnaire, it was requested that the participating health care organization select, from options provided, a description of the facility type and services provided by the health care organizations. The responding organizations were primarily comprised of tertiary hospitals (8) and rehabilitation centres (5), but also included quaternary hospitals (2), a community hospital (1), and regional hospitals (2). A summary of the questionnaire responses indicating the health care organization type or services is shown in Table 5.2. Table 5.2: Summary of questionnaire responses indicating health care organization type or services Organization Type Number of Responses Tertiary Hospital 8 Quaternary Hospital 2 Community Hospital 1 Regional Hospital 2 Rehabilitation Centre 5 Home Care Provider 0 Other 1 Total Responses 19 Although there were only fifteen questionnaire responses in total, two health care organizations provided multiple descriptions of their organization (3 in total each, plus the thirteen other responses). The health care organization indicating other described their organization as a Regional Health Authority. Within the questionnaire, each health care organization was also asked to indicate the percentage of services provided to pediatric patients. A total of fourteen responses as to the percentage of services provided to pediatric patients were received; two of the fifteen health care organizations did not provide a percentage of pediatric services and one health care organization provided two responses (as this health care organization included an answer for each of two sites; only the percentage for the site providing solely pediatric services was included for subsequent analysis). Five health care organizations indicated that 100% of the services provided were to pediatric patients; four health care organizations provide over 90% (but less than 100%) pediatric services with one other organization providing over 50% of services to pediatric patients; the three remaining health care organizations indicating a percentage, provide less than 50% of service to pediatric patients. For some subsequent analysis, the two organizations that provided

69 62 questionnaire responses without disclosure policies were removed from these numbers (both were >50%), and these numbers were collapsed to >50% (n=8), <50% (n=3), and unknown (n=2). Health care organizations providing a written policy were asked to indicate if the policy specifically addressed patient safety incidents involving pediatric patients. Of the thirteen health care organizations providing written policies that responded to this question: seven health care organizations indicated that patient safety incidents involving pediatric patients were addressed as part of a general policy, five health care organizations indicated that patient safety incidents involving pediatric patients were addressed as part of a separate policy, one health care organization indicated that patient safety incidents involving pediatric patients were not specifically addressed in the general policy. 5.3 Review of Written Policies The written disclosure policies provided by responding health care organizations were reviewed for themes, including the patient safety terminology employed within the institutional policy, the threshold for disclosure of patient safety incidents, the timing of disclosure of patient safety incidents, the information to be disclosed, the information to be included in the disclosure discussion, the health care professional or health care professionals responsible for conducting the disclosure discussion, and the person or persons to whom disclosure is to be directed. The findings within each policy, in relation to each of the above-noted themes, are discussed below and summarized in Appendix J Terminology Employed The institutional disclosure policies were reviewed to determine the terms used to refer to patient safety incidents. As discussed in chapter 1, patient safety academics and organizations emphasizes the importance of using consistent patient safety language and advocate for the use of a standardized language to facilitate communication regarding patient safety incidents. The terms used to refer to patient safety incidents were extrapolated from the institutional policies reviewed to allow for comparison with the terminology used within other documents, including literature and legislation.

70 63 Each institutional policy was reviewed for terms defined within the policy and used to describe patient safety incidents. The following terms were found within the institutional policies reviewed: adverse event, accident, incident, harm, occurrence, sentinel event, and near miss. The findings are shown in Tables 5.3 and 5.4 below and discussed in detail within this section. Table 5.3: Summary of the patient safety incident terminology employed within health care institutional policies by percentage of pediatric services provided Patient Safety Incident Term Percentage of Pediatric Patients in Health Care Organization (n=13) All Health Care Organizations (n=13) >50% (n=8) <50% (n=3) Unknown (n=2) Adverse Event Accident Incident Harm Occurrence Sentinel Event Near Miss Table 5.4: Summary of the patient safety incident terminology employed within health care institutional policies by jurisdictions with and without disclosure legislation Patient Safety Incident Term Jurisdictions with Disclosure Legislation* Other Health Care Organizations (n=6) ON (n=3) QC (n=4) Adverse Event Accident Incident Harm Occurrence Sentinel Event Near Miss * No responses were received from health care organizations in Manitoba Adverse Event Seven disclosure policies include a definition of the term adverse event. Two of these policies are from Saskatchewan, while the remaining five are from Nova Scotia, Ontario, British Columbia, Newfoundland, and Quebec.

71 64 Six of these policies include a requirement for injury or harm as part of the definition of an adverse event ; one also includes a reasonable expectation of harm or injury. The remaining policy does not reference any requirement for injury or harm. Six of these policies include a reference to an adverse event being unexpected, undesired, unplanned, unintended, or involuntary ; the remaining policy is silent in this regard. Five of these policies include a requirement that the adverse event be from clinical or health care management or delivery, which is not related to the disease, condition, or a recognized complication. One of the other policies references that an adverse event must be associated with care or services in the health-care system, but does not distinguish from the disease, condition, or a recognized complication. The remaining policy does not reference care or treatment, but states that the adverse event must not be a recognized complication. Three policies include a reference that an adverse event may be related to an error ; two of these policies distinguish between preventable and unpreventable adverse events. Two of the policies reference that an adverse event may result from a commission or omission. The remaining two policies make no such references Accident and Incident Most of the Quebec disclosure policies use the terms accident and incident. One other policy from Ontario uses the term incident, but not accident. All four policies from Quebec include a definition of the term accident. Three of these policies also include a definition of the term incident, while the other policy only mentions the word incident within another definition. Within all four of the Quebec policies, the term accident is used to describe a patient safety incident that has or could have consequences for the state of health or welfare of the user. Within the three Quebec policies including the term incident, the term is described as a patient safety incident that does not have consequences for the state of health or welfare of a user, but the outcome of which is unusual and could have had consequences under different circumstances.

72 65 All four Quebec policies require that accidents be disclosed. Two of the Quebec policies state that incidents are subject to discretionary disclosure. One Ontario policy uses the term incident to describe patient safety incidents within the policy. The term incident is defined as an undesirable event, near miss or hazard which is caused by an unsafe act or condition that may result in physical or emotional harm. The definition states that near misses, hazards and potential incidents are all incidents that could have, but did not cause harm. This policy does not use the term accident Harm Six of the health care institutional disclosure policies contain a definition of the term harm. Two of the disclosure policies use the term harm as the primary component or concept in the policy to describe patient safety incidents. One of these policies is from an Ontario health care organization and the other is from a health care organization in Alberta. These policies do not use any other terms to reference patient safety incidents. The disclosure paradigm for each of these policies is based on the term harm. Both of these policies describe harm as being an unexpected outcome that negatively affects the patient s health or quality of life and resulted from the care, treatment, or services provided to the patient. Four other disclosure policies include definitions of harm. These policies are from health care organizations in Ontario, Newfoundland, Saskatchewan, and Quebec. Two of these policies describe harm as being unexpected or normally avoidable. All four of these policies include a reference that harm negatively affects the patient s health or quality of life. One of these policies includes a reference that harm has occurred in the course of health care treatment and is not due directly to the patient s illness ; another one of these policies includes a reference that harm may have been caused by human or system error Occurrence Two health care organizations, one from Ontario and one from Newfoundland, include a definition of the term occurrence to describe patient safety incidents within their disclosure policy. Both of these definitions describe an occurrence as an event which stems from services, products and care or services provided by the health care organization. One of

73 66 these definitions describes an occurrence as being potential or actual, while the other definition describes it as undesired or unplanned resulting from commission or omission, including close calls Sentinel Event Three health care organizations, two from Quebec and one from Ontario, have disclosure policies which contain a definition for the term sentinel event. Each one of these policies describes a sentinel event as involving death or very serious injury, or the risk of death or very serious injury. One of these policies expands the definition to include incidents and accidents, which occur at high frequencies even if they have not caused serious consequences. Two of these policies describe a sentinel event as being unexpected or unintended. Two of these policies add that sentinel events require in-depth analysis or investigation and response. The policy from the Ontario health care organization equates sentinel events to critical incidents, referencing the definition of critical incident in the Public Hospitals Act. In this disclosure policy, sentinel events require disclosure to patients as soon as practically possible Near Miss (Incident Narrowly Avoided, Close Call) The disclosure policies of six health care organizations contain definitions of near miss. Four of these policies describe the possibility of harm. Five of the definitions of near miss reference that harm is avoided due to chance, corrective action, timely intervention, being intercepted or good fortune. Five of the definitions of near miss reference harm not reaching the patient Threshold for Disclosure The institutional disclosure policies from the participating health care organizations were reviewed to determine the threshold for disclosure of patient safety incidents within each policy. In almost all of the policies, except for one, the requirement for disclosure of a patient safety incident involves harm or a negative impact on health or well-being.

74 67 Twelve of the disclosure policies provide that when harm, actual consequences for health or welfare, or injury occur, a patient safety incident must be disclosed. Nine of these policies add an additional requirement for disclosure of a patient safety incident when there is also a reasonable expectation of harm, potential consequences, potential for injury, potential clinical consequences, or an ongoing safety concern. Two of the disclosure policies state that patient safety incidents that do not harm patients, and do not have the potential to do so, do not require disclosure; both of these policies provide that disclosure is at the discretion of the Most Responsible Physician. Two policies provide that disclosure is discretionary for patient safety incidents that do not harm the patient, such as close calls and near misses ; two policies provide that patient safety incidents that do not harm the patient must be disclosed when they reach patient awareness. One health care organization policy provides that disclosure must be made even when there are no clinical consequences, if a reasonable person would want to be informed, as it may assist in planning future care for the person. The one disclosure policy that does not base the disclosure of patient safety incidents on the occurrence of, or potential for, harm is from British Columbia. This policy provides that the determination as to whether a patient safety incident is disclosed is done by the appropriate manager and appropriate health care provider. This policy provides that consultation may occur with risk management. This policy provides that disclosure of a near miss is determined on a case by case basis and disclosure may be appropriate when the patient has knowledge of the patient safety incident Timing of Disclosure As part of the review of the institutional disclosure policies, consideration was given as to the timing for disclosure of patient safety incidents, as provided by each policy. All policies include a statement to the effect that disclosure is required as soon as possible, including as soon as practically possible, at the earliest possible opportunity, and as soon as reasonably possible.

75 68 Seven policies provide that the disclosure is to be as soon as possible once the patient safety incident is identified or discovered. Five policies include an expected or ideal time requirement for disclosure of the patient safety incident. Two of these policies set the time frame from discovering or becoming aware of the patient safety incident. Three of the policies provide for a time requirement of 1-2 days ( 24 to 48 hours ); the two other policies provide a time requirement of 48 hours Information to be Disclosed As part of the review of the institutional disclosure policies, consideration was given as to the information to be disclosed during the disclosure process. A number of themes were identified among the written institutional policies, which are categorized and discussed below Facts Nine of the institutional policies provide that the facts or factual information of the patient safety incident are to be disclosed. Three of these policies emphasize that it is to be only the facts or the individuals responsible for the disclosure are to stick to the facts, such that opinions should not be discussed. Similar requirements are expressed in three other institutional policies, but the word fact is not used. These policies include statements such as all information pertaining to a patient incident is to be disclosed or that disclosure may include a description of what happened. Similarly, four of the institutional policies specifically state that disclosure should include a discussion of the nature and/or circumstances of the patient safety incident. Six of the institutional policies include a statement emphasizing that the disclosure discussion should only include information or facts known at the time or when they are known, but should not be delayed because all the facts are not known. One of these policies specifically cautions that speculation should be avoided.

76 Cause Two of the institutional policies provide that the cause of the patient safety incident should be discussed during the disclosure discussion. One policy provides that the measures taken to identify the cause should be discussed, while another provides that patients should be advised if the cause is unclear Severity, Consequences, and Outcomes Three of the institutional policies provide that disclosure should include a discussion of the severity of the patient safety incident. Similarly, another one of the institutional policies provides that the seriousness of the consequences should be discussed. Three of the institutional policies state that the patient is to be advised of any consequences or outcomes ; one of these policies adds that potential consequences or outcomes are also to be discussed. Four of the institutional policies provide that patients should be provided with information of any consequences the safety incident has had on their health or well-being. All of these policies clarify that it is to be actual and anticipated (or potential ) consequences. All of these policies clarify that any impact on the care or treatment plan is to be discussed as well Investigation Two of the institutional policies reference investigations. Both of these policies are from Ontario. One policy provides that the an overview of the investigative process should be included; the second provides that in the discussion it should be stated that the matter will be investigated. Similarly, one Quebec policy provides that information on the findings of the survey, along with the actions being implemented should be disclosed Steps When discussing steps taken or action, the institutional policies refer to either patient care or preventing the recurrence of the patient safety incident.

77 70 Two of the institutional policies provide a general statement that corrective measures or measures taken/recommended are to be included in the disclosure discussion. These policies do not indicate whether these references are in relation to health care or investigation. Eleven of the institutional policies provide that the impact on care or treatment, including recommendations or next steps, is to be discussed. Nine of the institutional policies provide that the steps taken to reduce the risk of further similar patient safety incidents, the investigation process, or improvements being implemented should be discussed Apology Seven institutional policies encourage an apology or expression of regret as part of the disclosure discussion. One of these institutional policies provides that an apology should not be conveyed until the review of the patient safety incident is complete. Another one of these institutional policies provides that there should be no legal admission of liability Questions Seven of the institutional policies provide that the opportunity for questions should be included as part of the disclosure discussion. One of these institutional policies adds that the questions may come from the patient, parent and/or legal guardians Delivery of Disclosure Information Most Responsible Health Care Professional Seven of the institutional policies provide that in the usual course the most responsible physician (or individual most responsible for the patient s care ) should be responsible for the disclosure discussion. Another institutional policy provides that, at a minimum, the most responsible physician should be included in the disclosure discussion. Four of these institutional policies further provide that the most responsible physician may decide to include other professionals if it is appropriate, such as social work or chaplain.

78 71 One of these policies provides that a hospital staff person should be present, as well as the most responsible physician. Three of these institutional policies provide that when the most responsible physician is not the most appropriate health care provider to initiate the disclosure, or if there is no treating physician, the health care team will identify an alternate to initiate disclosure. Similarly, two of these policies provide that where the patient safety incident is associated with a non-physician staff, the professional with the most thorough understanding of the accident is responsible for disclosure Hospital Administration Two of the institutional policies provide that the decision as to the professional responsible for the disclosure discussion should be facilitated by risk management or patient relations. Two other institutional policies provide that patient relations, risk management, or hospital administration may be included in the disclosure discussion Team Approach Two institutional policies provide that the disclosure discussion must be done by a team, which may include the most responsible physician and/or a representative from risk management. Three other institutional policies provide that the determination as to who will lead the disclosure discussion is determined by the appropriate health care provider or the appropriate manager Patient Preferences Four of the institutional policies provide that consideration should be given to patient preferences when determining the health care professionals that should lead the disclosure discussion. Similarly, three of the institutional policies provide that consideration should be given to whether a health care professional has an existing relationship with the patient or family.

79 Most Knowledge or Best Information Three of the institutional policies provide that the decision as to who should be responsible for the disclosure discussion should consider who has the most knowledge of the patient safety incident or who can give the best information about the patient safety incident Receipt of Disclosure Information Each one of the institutional disclosure policies was reviewed to determine the individual or individuals to receive the disclosure information. In particular, consideration was given as to when disclosure information would be given to the patient versus the patient s substitute decision maker, such as a parent or guardian in situations involving pediatric patients Capacity Based Although the wording varies, four institutional policies use capacity and/or competency as the variable for determining the recipient of the disclosure information; two of these policies specifically explain that capacity refers to capacity to make treatment decisions, while the other two policies do not explain or define capacity or incapacity. These policies state that when the patient has capacity, the disclosure of the patient safety incident should be communicated directly to the patient. One of these policies provides that, even when the patient has capacity, the disclosure should be made to the parents or legal guardians as well, unless the patient instructs otherwise. Another policy provides that if the patient has capacity, he or she may instruct that the disclosure be made to whomever he or she wishes. Similarly, these four institutional policies provide that when the patient is incapable (in two of the policies, incapable of making treatment decisions), the disclosure must be made to the substitute decision maker, such as the person lawfully authorized to make treatment decisions on behalf of the patient, the parents, the legal guardians, or the identified alternate decision-maker. One of these policies provides tha, even where the patient is capable, the parents or legal guardians should be included in the disclosure discussion, unless the health care team and parents or legal guardians are of the opinion that such inclusion is inadvisable.

80 General Four of the institutional policies provide a general statement that disclosure should be made to the patient, family, or substitute decision maker. These policies do not provide guidance as to when the disclosure is made to the patient as opposed to the family or a substitute decision maker. One of these policies adds that disclosure is to be extended to a substitute decision maker, family and next of kin as appropriately allowable under privacy policies and legislation Quebec The three institutional disclosure policies from Quebec each provide that disclosure must be made to the user, unless the user is incapacitated or less than fourteen years of age. If the user is incapacitated, the disclosure is to be made to the legal representative. If the user is less than fourteen years of age, the disclosure is to be made to the parents, guardian, or the person with parental authority. These institutional policies provide that the user should be involved in the disclosure process when the user is able to understand the information in whole or in part. If the user is fourteen years of age or more, the disclosure may be made to the family with the consent of the user. 5.4 Telephone Interviews Two of the participating health care organizations that returned questionnaires responded that their organization did not have a written disclosure policy, but noted that they were in the process of implementing a written disclosure policy. Attempts were made to arrange a telephone interview with the contact person listed for each of these health care organizations. A follow-up telephone interview was completed with the contact person for one of these health care organizations. The attempts to arrange a telephone interview with the contact person for the other health care organization were unsuccessful.

81 Results of Telephone Interview The interviewee advised that the written disclosure policy that the health care organization was in the process of implementing was in the final review. The interviewee explained that disclosure would be triggered when harm occurred. The organization was currently reviewing and considering the threshold for disclosure. The draft policy recommends disclosure for potential harm, close calls reaching the client, and ongoing safety risks. The interviewee advised that the draft policy provides that disclosure is to be made by three or four professionals to avoid overwhelming the family, including whoever is most knowledgeable of the situation. The interviewee advised that the draft policy provides that disclosure of patient safety incidents is to be made to the family or primary caregiver. The client may participate if able to consent to treatment, which is determined based on emotion maturity and cognitive ability. The interviewee did not perceive that there were any barriers to implementing the policy. The health care organization values a culture of safety and a disclosure policy goes hand in hand with such a culture. The interviewee stated that it is important not to lay blame, but have processes and staff education, along with early and open communication, to alleviate staff anxiety in relation to disclosure. The interviewee expressed the belief that following a patient safety incident the client and family have a right to know about a patient safety incident.

82 Discussion Previous Research Chapter 6: Discussion and Conclusion Previous research on disclosure of patient safety incidents within a pediatric population provides insight into the desires and attitudes of parents. These studies have demonstrated that parents want disclosure of patient safety incidents, regardless of the severity of the patient safety incident. Further, previous research demonstrates that disclosure of patient safety incidents may decrease the likelihood that the parents will pursue legal action. Previous research establishes that most parents want their child informed of a patient safety incident. Previous studies on disclosure of patient safety incidents within a pediatric population have also provided insight into the practices, knowledge, and attitudes of pediatricians, both residents and attending physicians. These studies have demonstrated that most pediatricians have been involved with a patient safety incident. Pediatric residents considered patient safety incidents a problem in health care and thought patient safety incidents should be disclosed, but recognized that disclosure is difficult. These studies have demonstrated a lack of teaching on how to disclose a patient safety incident, a lack of consistency in identifying patient safety incidents that should be disclosed, and inconsistency in what information and language should be used during a disclosure discussion. Previous research has also demonstrated that pediatricians want disclosure training. The Canadian Patient Safety Institute (CPSI) has prepared disclosure guidelines for health care professionals. The work of the CPSI recognizes the complexities associated with disclosure of patient safety incidents involving pediatric patients, including legal considerations as between jurisdictions, but these guidelines do not delve into the details of these legal issues. Important steps towards supporting health care professionals, including pediatricians and health care organizations, in meeting the desire of parents for disclosure include (1) understanding the current Canadian legal framework for disclosure of patient safety incidents within a pediatric population, and (2) understanding the current practices for such disclosure within Canadian pediatric health care organizations. Our findings from this study are within this chapter.

83 76 This study involved a review and analysis of the legislation in each Canadian jurisdiction identified as potentially relevant to the disclosure of pediatric patient safety incidents, along with institutional policies from health care centres providing care to pediatric patients in Canada Key Findings: Legislative Review The legislative review conducted as part of this study demonstrated that, although physicians have a common law duty to disclose patient safety incidents that a reasonable person would want to know, only three provinces have enacted legislation requiring disclosure (Manitoba, Ontario, and Quebec). 134 In each of these three provinces with disclosure legislation patient safety incidents resulting in harm must be disclosed (Quebec has the additional requirement that patient safety incidents with the potential for harm must also be disclosed) as soon as possible. Each of the three disclosure statutes address patient safety incidents involving pediatric patients by deferring to a parent, guardian, representative, person with parental authority, or person lawfully authorized to provide to consent to treatment for the disclosure. Each of these disclosure statutes requires navigation of a complex scheme of definitions, occasionally from other pieces of legislation within the jurisdiction, to endeavor to understand how the disclosure discussion should occur. In jurisdictions without disclosure legislation, consent and capacity legislation may provide guidance for the disclosure of patient safety incidents involving pediatric patients. 135 The laws for obtaining consent to medical care and treatment for pediatric patients may be applied with slight modifications to patients to determine if they have the capacity to receive disclosure information. Four jurisdictions (British Columbia, New Brunswick, Prince Edward Island, and Yukon), in addition to the three provinces that have disclosure legislation, have enacted consent and capacity legislation. Two of these four jurisdictions have capacity based schemes (Prince Edward Island and Yukon) to determine if a person is able to consent to health care. The other two jurisdictions (British Columbia and New Brunswick) have a best interest requirement 134 The Regional Health Authorities Act, CCSM, c R34, ss 53.1 to 53.4, 53.7 to 53.8, and 53.10; Critical Incidents Regulation, Man Reg 211/2006, ss 1 and 3; Public Hospitals Act, RRO 1990, Reg 965, ss 1 and 2; and An Act Respecting Health Services and Social Services, RSQ, c S-4.2, ss 8, 12, 183.1, 183.2, 233.1, 235.1, and Infants Act, RSBC 1996, c 223, s 17; Medical Consent of Minors Act, SNB 1976, c M-6.1, ss 1-5; Consent to Treatment and Health Care Directives Act, RSPEI 1988, c C-17.2, ss 1, 3-7; and Care Consent Act, SY 2003, c 21, Sch B, ss 1-6.

84 77 accompanying a capacity based test for pediatric patients (those less than the age of majority in British Columbia and those less than 16 years of age in New Brunswick). In jurisdictions without disclosure legislation or legislation addressing consent and capacity to consent to medical care or treatment, limited guidance may be drawn or inferred from other categories of legislation and the common law, but no clear legislative scheme or requirements for disclosure of pediatric patient safety incidents exists to guide health care professionals. Age of majority legislation is of limited assistance in providing guidance for the disclosure of pediatric patient safety incidents. It does, however, establish an age at which health care professionals may presume that the disclosure should be made directly to the patient. 136 A number of jurisdictions have apology legislation, which does not provide guidance for disclosure of pediatric safety incidents, but such legislation provides varying degrees of protection to any apology that forms part of a disclosure discussion from implying fault or negligence. 137 Some Canadian jurisdictions have legislation that provides a scheme for substitute decision making for health care and treatment decisions, which is applicable to pediatric patients. Such substitute decision making legislation, as opposed to legislation which is only applicable to adults, may provide assistance for health care providers in determining when disclosure should be made to a substitute decision maker as opposed to a pediatric patient. 138 In jurisdictions with and without substitute decision making legislation applicable to pediatric patients, legislation addressing parentage and guardianship may provide some guidance as to the responsibilities for 136 Age of Majority Act, RSBC 1996, c 7; Age of Majority Act, RSNB 2011, c 103; Age of Majority Act, RSNS 1989, c 4; Age of Majority Act, SNL 1995, c A-4.2; Age of Majority Act, RSNWT 1988, c A-2; Age of Majority Act, RSNWT (Nu) 1988, c A-2; Age of Majority Act, RSY 2002, c 2; Age of Majority Act, RSA 2000, c A-6; The Age of Majority Act, RSS 1978, c A-6; The Age of Majority Act, CCSM, c A7; Age of Majority and Accountability Act, RSO 1990, c A.7; Civil Code of Quebec, SQ 1991, c 64; Age of Majority Act, RSPEI 1988, c A Apology Act, SBC 2006, c 19; The Apology Act, SM 2007, c 25; Apology Act, 2009, SO 1990, c 3; Apology Act, SNL c A-10.1; Apology Act, SNS 2008, c 34; Alberta Evidence Act, RSA 2000, c A-18; The Evidence Act, SS 2006, c E-11.2; Health Services Act, RSPEI 1988, c H The Health Care Directives and Substitute Health Care Decision Makers Act, SS 1997, c H-0.001; Advance Health Care Directives Act, SNL 1995, c A-4.1; Personal Directives Act, SNS 2008, c 8; Hospitals Act, RSNS 1989, c 208.

85 78 these roles and who disclosure information may be communicated to in place of a pediatric patient. 139 All Canadian jurisdictions have child welfare legislation, which may provide some ancillary guidance for issues relating to disclosing patient safety incidents to pediatric patients. In each jurisdiction, this legislation provides that the state may intervene to authorize provision of health care or treatment to a child in need of protection, when the child within the legislated ages of protection. These statutes provide guidance as to the age at which a child may still be afforded protection by the state. More than half of these statutes provide that the state is to consider the best interests of the child. Similarly, more than half of these statutes require that the medical care or treatment be recommended by a health care professional. When the criteria specified by this legislation are met, a court, judge, or tribunal is either empowered to authorize the treatment or transfer custody of the child to the state, which may then authorize the treatment. 140 General privacy legislation may provide additional guidance with regards to the ability of minors to access information. A number of privacy statutes provide that patients are not able to access their information until they reach the age of majority, such that minors must have a substitute decision maker consent for the collection, use or disclosure of information. These statutes are all general privacy legislation and not specific to health information. With regards to legislation specific to health information, most jurisdictions are capacity based (4), although one provides that a person under sixteen years of age can only consent to collection, use and disclosure when it is in his or her best interest. In Quebec a bright line age 139 The Family Law Act, SA 2003, c F-4.5; The Children s Law Act, SS 1997, c C-8.2; Children s Law Act, RSNL 1990, c C-13; Maintenance and Custody Act, RSNS 1989, c 160; Guardianship Act, SNS 2002, c 8; Children s Law Act, SNWT (Nu) 1997, c 14; Children s Law Act, SNWT 1997, c Child, Family and Community Service Act, RSBC 1996, c 46; Child, Youth and Family Enhancement Act, RSA 2000, c C-12; The Child and Family Services Act, SS , c C-7.2; The Child and Family Services Act, CCSM, c C80; Child and Family Services Act, RSO 1990, c C.11; Youth Protection Act, RSQ, c P-34.1; Child and Youth Care and Protection Act, SNL 2010, c C-12.2; Family Services Act, SNB 1980, c F-2.2; Children and Family Services Act, SNS 1990, c 5; Child Protection Act, RSPEI 1988, c C-5.1; Child and Family Services Act, SNWT (Nu) 1997, c 13; Child and Family Services Act, SNWT 1997, c 13; Child and Family Services Act, SY 2008, c 1.

86 79 test is used, as those less than fourteen years of age cannot consent unless parental authority is given Key Findings: Review of Institutional Policies The review of institutional policies demonstrates that health care organizations providing care to pediatric patients have taken a proactive role in implementing policies to assist and guide health care professionals in disclosure discussions. All responding health care organizations provided a written disclosure policy or indicated that they were in the process of implementing a policy. Manitoba, Ontario, and Quebec all have disclosure legislation. There were no responses received from health care organizations in Manitoba. The disclosure policies received from Quebec health care organizations demonstrate significant similarity as between institutional policies and likeness with the Quebec disclosure legislation. The policies from the Ontario health care organizations demonstrate greater variability. Multiple responses from health care organizations were received from both Ontario and Quebec. Multiple responses were also received from health care organizations in Saskatchewan. Although Saskatchewan does not have disclosure legislation, it has reporting legislation. The two institutional policies from Saskatchewan employ similar terminology. There were six responses received from five different jurisdictions without disclosure legislation (two of these institutional policies were from Saskatchewan). These institutional policies varied significantly as between jurisdictions, particularly the terminology used within the policies, although some commonalities were found. Almost all of these institutional policies set harm as the threshold for disclosure and expected disclosure to occur as soon as possible, generally within two days. Most of the institutional policies required that the facts of a patient safety 141 Freedom of Information and Protection of Privacy Act, SNS 1993, c 5; Freedom of Information and Protection of Privacy Act, RSPEI 1988, c F-15.01; Access to Information and Protection of Privacy Act, RSY 2002, c 1; Access to Information and Protection of Privacy Act, SNWT (Nu) 1994, c 20; Access to Information and Protection of Privacy Act, SNWT 1994, c 20; Hospitals Act, RSPEI 1988, c H-10.1; Hospital Management Regulation, PEI Reg EC49/11; Hospitals Act, RSNS 1989, c 208; Health Information Act, RSA 2000, c H-5; The Health Information Protection Act, SS 1999, c H-0.021; Personal Health Information Act, 2004, SO, c 3, Sch A; Personal Health Information Act, SNL 2008, c P-7.01; Personal Health Information Privacy and Access Act, SNB 2009, c P-7.05; Personal Information Protection Act, SBC 2003, c 63; Freedom of Information and Protection of Privacy Act, RSBC 1996, c 165; An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information, RSQ c A-2.1; An Act Respecting Health Services and Social Services, RSQ, c S-4.2; Personal Information Protection and Electronic Documents Act, SC 2000, c 5.

87 80 incident, along with the consequences or outcomes, be disclosed. Greater than half of the institutional policies expected the Most Responsible Physician to conduct the disclosure discussion in the usual course, although some institutional policies contemplated participation from other health care professionals. There were significant differences as to who received the disclosure information for a pediatric patient safety incident. Four of the institutional policies based the decision as to receipt of the disclosure information on capacity of the patient, while a fifth institutional policy provided that an individual with capacity could choose who would receive the disclosure. Four other policies did not provide guidance, aside from indicating that disclosure may be made to the family or a substitute decision maker, without providing specifics as to when. Finally, the three policies from Quebec used the language from the statute and expected disclosure to a legal representative when a user was without capacity. This study demonstrates that there are few jurisdictions with disclosure laws in place. In jurisdictions without disclosure laws, it is unclear when patient safety incidents, including pediatric patient safety incidents, must be disclosed. It is also unclear what information should be disclosed, who should conduct the disclosure discussion, and to whom disclosure should be made, particularly when patient safety incidents involve pediatric patients. In jurisdictions without disclosure laws, health care professionals must navigate complex legislative schemes to obtain limited ancillary guidance for addressing patient safety incidents involving pediatric patients. This study also demonstrates that health care organizations within some jurisdictions with disclosure legislation (and reporting legislation) have more consistent institutional policies. In health care organizations in jurisdictions without disclosure legislation, and jurisdictions with less detailed disclosure laws, practices are inconsistent as between health care organizations. 6.2 Conclusions Parents want disclosure of patient safety incidents involving their children. Physicians working with pediatric patients want to disclose patient safety incidents and, further, physicians want teaching to assist with conducting disclosure discussions.

88 81 Disclosure legislation, aside from issues relating to medical devices or medication, is a matter of provincial and territorial authority. Disclosure legislation requires that certain patient safety incidents be communicated to pediatric patients or their family. Disclosure legislation provides parameters for health care professionals to address pediatric patient safety incidents. Disclosure legislation also provides guidance for health care organizations when drafting institutional disclosure policies. Although other types of legislation, particularly legislation addressing consent and capacity for health care and treatment, may provide guidance for health care professionals and health care organizations when addressing pediatric patient safety incidents, the need to make inferences and consider analogous situations may lead to confusion and inconsistent practices. It is incumbent upon the various provincial and territorial legislators to provide clear legislative guidance for the disclosure of patient safety incidents, including those involving pediatric patients. By providing such legislative guidance, consistent practices for disclosure of pediatric patient safety incidents should be facilitated for health care professionals and organizations, along with the promotion of a culture of patient safety. Legislators should build upon the previous work of the Canadian Patient Safety Institute within the disclosure guidelines of the CPSI. This study provides a review of Canadian disclosure legislation and other legislation potentially relevant to the disclosure of pediatric patient safety incidents. The study demonstrates that disclosure legislation is still relatively uncommon in Canadian jurisdictions, as only three of thirteen jurisdictions having such legislation in place. This study was limited by the number of pediatric health care organizations that chose to respond to the questionnaire. The responses received suggest that organizations with a disclosure policy may have been more likely to respond to the request for information. Further, organizations in jurisdictions with disclosure legislation, with the exception of Manitoba which had no responding organizations, may have been more likely to have a disclosure policy in place. As none of the jurisdictions without disclosure or reporting legislation had multiple responding health care organizations, the consistency of disclosure policies as between these organizations could not be considered.

89 82 In conclusion, the disclosure of pediatric patient safety incidents presents complex and challenging issues of law and policy for health care organizations and professionals. There is limited legislative guidance for health care organizations and professionals faced with having to disclose a pediatric patient safety incident or develop an institutional disclosure policy. 6.3 Recommendations With an understanding the current legislative framework, along with the current practices of health care organizations providing care to pediatric patients, further legislative efforts should be made to provide clear and consistent guidance to health care organizations and professionals to promote a culture of patient safety through consistent disclosure practices. This study suggests that enactment of disclosure legislation may encourage health care organizations to implement institutional disclosure policies. Further, disclosure legislation provides organizations with guidance for how to structure institutional disclosure policies, including guidance for addressing pediatric patient safety incidents. Institutional disclosure policies vary significantly as between organizations in different jurisdictions given differences in legislation. The CPSI disclosure guidelines provide guidance to health care organizations and professionals that is uniform across Canada. The guidelines are not law and, therefore, adherence to the guidelines by health care organizations and professionals is not required. Organizations are, however, bound by the applicable legislation in their jurisdiction and any disclosure policies must accord with such laws. Disclosure legislation is beneficial as it sets a required uniform standard for health care organizations in the jurisdiction to follow. All Canadian jurisdictions should consider enactment of disclosure legislation to promote consistency and clarity for disclosure of patient safety incidents. Further, disclosure legislation should provide specific guidance to health care professionals for the disclosure of pediatric patient safety incidence to avoid confusion and inconsistency. It would be advantageous for disclosure laws to be consistent amongst Canadian jurisdictions to provide certainty and clarity for health professionals and promote consistent practices. The responsibility for disclosure legislation is a matter for the provinces and territories.

90 83 Unfortunately, despite the guidelines from CPSI, it is unlikely that uniform practices could be legislated amongst all jurisdictions given the differences of other related laws, particularly consent and capacity legislation or lack thereof, as between Canadian jurisdictions. The issue of disclosure of patient safety incidents has not been considered by the Uniform Law Conference of Canada (ULCC), an organization which assembles experts to recommend uniform statutes for enactment by all relevant jurisdictions in Canada. The ULCC has prepared a uniform act for the medical consent of minors recommended for enactment by the provincial and territorial jurisdictions in Canada. The uniform act provides that minors who have attained the age of sixteen should be treatd as adults for medical decision making. Minors less than sixteen years who are capable may consent to medical treatment that is in their best interest. 142 The uniform act has not been adopted by all relevant jurisdictions for pediatric consent issues. Although uniform disclosure laws across Canada would be ideal, it is more practical for such laws in each jurisdiction to be based upon, and developed to accord with, existing consent and capacity laws governing the medical consent of minors and laws governing substitute decision making for minors. In jurisdictions without such legislation, disclosure laws should accord with the common law for consent to medical treatment. In jurisdictions with capacity based or best interest based approaches for consent to medical treatment for minors, disclosure legislation should provide clear guidance for assessment of capacity or determining best interests. 6.4 Future Research Further research regarding disclosure of pediatric patient safety incidents may involve qualitative studies of health care professionals involved with the enactment of institutional disclosure policies to gain an understanding of their perception of barriers and enablers to the development of institutional policies addressing disclosure of pediatric patient safety incidents. Also, further research to understand the knowledge of health care professionals of the institutional disclosure 142 The Uniform Law Commission of Canada, <

91 84 policies in place at their health care organization, including the institutional requirements for disclosure of pediatric patient safety incidents, may be beneficial.

92 85 Bibliography SECONDARY MATERIALS Baker, G. Ross et al. The Canadian Adverse Events Study: The Incidence of Adverse Events Among Hospital Patients in Canada (2004) 170 Canadian Medical Association Journal Baker, G. Ross et al. Review of Provincial, Territorial and Federal Legislation and Policy Related to the Reporting and Review of Adverse Events in Healthcare in Canada (Edmonton, AB: Canadian Patient Safety Institute, 2007). Canadian Patient Safety Institute. Building a Safer System: The Canadian Adverse Event Reporting and Learning System (Edmonton, AB: 2008). Coffey, M. et al.. Pediatric Residents Decision-Making Around Disclosing and Reporting Adverse Events: The Importance of Social Context (2010) 85 Acad Med Disclosure Working Group. Canadian Disclosure Guidelines (Edmonton, AB: Canadian Patient Safety Institute, 2008). Disclosure Working Group. Canadian Disclosure Guidelines: Being Open and Honest with Patients and Families (Edmonton, AB: Canadian Patient Safety Institute, 2011). Garbutt, J. et al. Reporting and Disclosing Medical Errors (2007) 161 Arch Pediatr Adolesc Med 179. Garner, Bryan A. Editor in Chief, Black s Law Dictionary, 7 th ed (St. Paul, Minn.: West Group, 1999). Government of Saskatchewan. Saskatchewan Critical Incident Reporting Guideline, online: < Hobgood, C. et al. Parental Preferences for Error Disclosure, Reporting, and Legal Action After Medical Error in the Care of Their Children (2005) 116 Pediatrics Loren, D.J. et al. Medical Error Disclosure Among Pediatricians (2008) 162 Arch Pediatr Adolesc Med 922. Matlow, A.G. et al. Disclosure of medical error to parents and paediatric patients: assessment of parents attitudes and influencing factors (2010) 95 Arch Dis Child 286. Matlow, A.G. et al., Adverse Events Among Children in Canadian Hospital: The Canadian Paediatric Adverse Events Study (2012) 185(13) Canadian Medical Association Journal E709. Picard, Ellen I. and Gerald B. Robertson. Legal Liability of Doctors and Hospitals in Canada, 4 th ed (Toronto: Thomson Carswell, 2007).

93 86 Raju, T.N.K., G. Suresh, & R.D. Higgins. Patient Safety in the Context of Neonatal Intensive Care: Research and Educational Opportunities (2011) 70 Pediatr Res 109. Skarsgard, E.D. Managing the adverse event occurring during elective ambulatory pediatric surgery (2009) 18 Semin Pediatr Surg 122. Sullivan, J.E. & J. J. Buchino. Medication Errors in Pediatrics The Octopus Evading Defeat (2004) 88 J Surg Oncol 182. The American Academy of Pediatrics, Dedicated to the health of all children, online: The American Academy of Pediatrics < The Canadian Paediatric Society, Protecting and promoting the health and well-being of children and youth, online: The Canadian Paediatric Society < The Uniform Law Commission of Canada, < World Health Organization. Conceptual Framework for the International Classification for Patient Safety, Version 1.1, Final Technical Report (World Health Organization, 2009). CASE LAW A.C. v Manitoba (Director of Child and Family Services), [2009] SCJ No 30 (SCC). Dusty s Saloon, a division of A.P. Woznow & Sons Enterprises Ltd. v W.M.I. Waste Management of Canada Inc., [2001] AJ No 108 (QB). Gerula v Flores, [1995] OJ No 2300 (CA). Jordan v Power, [2002] AJ No 1080 (QB). Kueper v McMullin, [1986] NBJ No 89 (CA). Malette v Shulman, [1990] OJ No 450 (CA). McInerney v MacDonald, [1992] SCJ No 57 (SCC). R. v R.P., [2004] OJ No 5109 (SCJ). Reibl v Hughes, [1980] SCJ No 105 (SCC). Stamos v Davies, [1985] OJ No 2625 (H Ct J). Val Mol v Ashmore, 1999 BCCA 6, leave to appeal to SCC refused, [1999] SCCA No 117. Vasdani v Sehmi, [1993] OJ No 44 (Ct J(GD)). Walker v Region 2 Hospital Corp., [1994] NBJ No 242 (CA).

94 87 LEGISLATION Alberta Age of Majority Act, RSA 2000, c A-6. Alberta Evidence Act, RSA 2000, c A-18. Child, Youth and Family Enhancement Act, RSA 2000, c C-12. Health Information Act, RSA 2000, c H-5. The Family Law Act, SA 2003, c F-4.5. British Columbia Age of Majority Act, RSBC 1996, c 7. Apology Act, SBC 2006, c 19. Child, Family and Community Service Act, RSBC 1996, c 46. Family Relations Act, RSBC 1996, c 128. Freedom of Information and Protection of Privacy Act, RSBC 1996, c 165. Infants Act, RSBC 1996, c 223. Personal Information Protection Act, SBC 2003, c 63. The Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181. Manitoba Critical Incidents Regulation, Man Reg 211/2006. The Age of Majority Act, CCSM, c A7. The Apology Act, SM 2007, c 25. The Child and Family Services Act, CCSM, c C80. The Family Maintenance Act, CCSM c F20. The Health Care Directives Act, CCSM, c H27.

95 88 The Regional Health Authorities Act, CCSM, c R34. New Brunswick Age of Majority Act, RSNB 2011, c 103. Family Services Act, SNB 1980, c F-2.2. Guardianship of Children Act, RSNB 2011, c 167. Medical Consent of Minors Act, SNB 1976, c M-6.1. Personal Health Information Privacy and Access Act, SNB 2009, c P Newfoundland Advance Health Care Directives Act, SNL 1995, c A-4.1. Age of Majority Act, SNL 1995, c A-4.2. Apology Act, SNL c A Child and Youth Care and Protection Act, SNL 2010, c C Children s Law Act, RSNL 1990, c C-13. Personal Health Information Act, SNL 2008, c P Northwest Territories Access to Information and Protection of Privacy Act, SNWT 1994, c 20. Age of Majority Act, RSNWT 1988, c A-2. Child and Family Services Act, SNWT 1997, c 13. Children s Law Act, SNWT 1997, c 14. Nova Scotia Age of Majority Act, RSNS 1989, c 4. Apology Act, SNS 2008, c 34.

96 89 Children and Family Services Act, SNS 1990, c 5. Freedom of Information and Protection of Privacy Act, SNS 1993, c 5. Guardianship Act, SNS 2002, c 8. Hospitals Act, RSNS 1989, c 208. Maintenance and Custody Act, RSNS 1989, c 160. Personal Directives Act, SNS 2008, c 8. Nunavut Access to Information and Protection of Privacy Act, SNWT (Nu) 1994, c 20. Age of Majority Act, RSNWT (Nu) 1988, c A-2. Child and Family Services Act, SNWT (Nu) 1997, c 13. Children s Law Act, SNWT (Nu) 1997, c 14. Ontario Age of Majority and Accountability Act, RSO 1990, c A.7. Apology Act, 2009, SO 1990, c 3. Child and Family Services Act, RSO 1990, c C.11. Children s Law Reform Act, RSO 1990, c C12. Health Care Consent Act, 1996, SO 1996, c 2, Sch A. Medical Devices Regulations, SOR/ Personal Health Information Act, 2004, SO, c 3, Sch A. Public Hospitals Act, RRO 1990, Reg 965. Prince Edward Island Age of Majority Act, RSPEI 1988, c A-8. Child Protection Act, RSPEI 1988, c C-5.1.

97 90 Child Status Act, RSPEI 1988, c C-6. Consent to Treatment and Health Care Directives Act, RSPEI 1988, c C Freedom of Information and Protection of Privacy Act, RSPEI 1988, c F Health Services Act, RSPEI 1988, c H-1.6. Hospital Management Regulation, PEI Reg EC49/11. Hospitals Act, RSPEI 1988, c H Quebec An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information, RSQ c A-2.1. An Act Respecting Health Services and Social Services, RSQ, c S-4.2. Civil Code of Quebec, SQ 1991, c 64. Youth Protection Act, RSQ, c P Saskatchewan Adult Guardianship and Trusteeship Act, SA 2008, c A-4.2. The Age of Majority Act, RSS 1978, c A-6. The Child and Family Services Act, SS , c C-7.2. The Children s Law Act, SS 1997, c C-8.2. The Evidence Act, SS 2006, c E The Health Care Directives and Substitute Health Care Decision Makers Act, SS 1997, c H The Health Information Protection Act, SS 1999, c H The Regional Health Services Act, SS 2002, c R-8.2. Yukon Access to Information and Protection of Privacy Act, RSY 2002, c 1.

98 91 Age of Majority Act, RSY 2002, c 2. Care Consent Act, SY 2003, c 21, Sch B. Child and Family Services Act, SY 2008, c 1. Federal Criminal Code, RSC, 1985, c C-46. Food and Drug Regulations, CRC, c 870. Food and Drugs Act, RSC, 1985, c F-27. Personal Information Protection and Electronic Documents Act, SC 2000, c 5.

99 Appendix A: Correspondence Sent to Pediatric Health Care Organizations 92

100 93 Disclosure of Safety Incidents involving Pediatric Patients: Policies of Health Care Organizations Providing Care to Pediatric Patients Consent Form I have read the Letter of Information, I understand the nature of the study, and I agree to participate. All questions have been answered to my satisfaction. Name of Organization (Printed): Key Contact Person / Participant (Printed): (Printed): Signature of Key Contact Person / Participant: Date: Although we are requesting contact information, information or data specifically identifying your organization will not be reported.

101 94 Questionnaire Disclosure of Safety Incidents involving Pediatric Patients: Policies of Health Care Organizations Providing Care to Pediatric Patients The following questions address any policies relating to the disclosure of patient safety incidents (adverse events, critical incidents, sentinel events, near misses 1 ) that exist in your organization: 1. Does your organization have a written policy for disclosure of patient safety incidents? yes no If you answered no to question 1, please go to question Does your policy specifically address patient safety events involving pediatric patients? yes, as part of our general policy yes, as part of a separate policy no, our general policy does not specifically address pediatric patients 3. We would appreciate if you would enclose a copy the relevant written policy (policies). Please provide the following details about your organization. 4. Description of Organization (please select the one option that best describes your organization): Tertiary Hospital Rehabilitation Centre Quaternary Hospital Home Care Provider Community Hospital Other (please describe): Regional Hospital 5. Percentage of Services Provided to Pediatric Patients: 1 The following definitions have been adapted from those of the Canadian Patient Safety Institute.

102 Appendix B: Correspondence of Ms. Elaine Orrbine, President and CEO of the CAPHC 95