DGD12-044 Standard Operating Procedure Consent and Treatment: Capacity and Substitute Decision Maker Purpose This Standard Operating Procedure (SOP) outlines the processes to assist Health Directorate staff to seek consent from a substitute decision maker for consumers when they are assessed as not having the capacity to provide consent for themselves. Scope This SOP applies to all Health Directorate staff who are involved in obtaining consent from consumers and provides information relating to: Decision-making capacity for consent Assessment of a consumer’s capacity to make consent decisions Obtaining valid informed consent from a substitute decision maker, and Meeting requirements of the Guardianship and Management of Property Act 1991. This SOP should be read in conjunction with the Health Directorate Consent and Treatment policy and associated SOPs: Consent and Treatment SOP Consent and Treatment: Children or Young People SOP. The term capacity is used in this document to mean a person is capable of: Understanding the nature and effect of decisions about consent and has demonstrated that they have this understanding Freely and voluntarily making decisions about consent Communicating the decisions verbally or non-verbally, and Retaining the information, their decision and their consent. Procedure An adult consumer is presumed to have the capacity to make decisions about their health care except where it is shown by a clinical assessment that they do not. Refer to Attachment 1: Determination of who can provide consent as a Substitute Decision Maker Flowchart. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 1 of 13 DGD12-044 Even when a consumer makes a decision that a health professional disagrees with it does not mean the consumer lacks capacity to consent. Consumers with capacity to consent have the right to make decisions even if the decision they make is likely to result in harm to themselves and even their death. 1. Capacity to consent A consumer’s capacity to give valid informed consent can be demonstrated by five specific functional abilities to: Express a choice Understand information relevant to health care decision-making and demonstrate their understanding Appreciate the significance of that information for their own situation, especially concerning their illness and the probable consequences of their health care options Use relevant information to come to a decision, and Ability to retain the information, their decision and their consent. Consumers need to demonstrate all five abilities to give informed consent. 1.1 Factors that may impact on capacity to consent Factors that may impact on the capacity of a consumer to consent include: Being under the influence of alcohol or other drugs, including prescribed and non-prescribed medication and prohibited substances Dementia Delirium Progressive neurological disease Intellectual disability Communication disability Brain injury Mental illness or mental dysfunction including psychosis, depression, hypomania and some anxiety states Pain Emotional shock Fatigue Panic and fear, and Illness itself. The capacity of a person with mental illness will often fluctuate with episodes of illness and even when they are unwell their capacity may not be impaired. The presence or history of mental illness should not automatically lead to a conclusion that the person does not have capacity to consent to health care. 1.2 When is assessment to determine capacity to consent necessary All consumers are considered to have the capacity to consent until it is demonstrated that they do not. If during the general care of the consumer, or discussions with them, Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 2 of 13 DGD12-044 there is an indication the consumer may not have the capacity to consent, a specific clinical assessment should be undertaken. Consumer compliance is not to be considered the same as giving informed consent. The senior treating medical officer is ultimately responsible for assessment of a consumer’s capacity to make a valid informed consent decision. They may seek advice from other medical officers, nursing and allied health staff to assist them in their decision. The type of assessment required to determine someone’s capacity will vary depending on the type of decision being made. After completing an assessment of capacity to consent, the questions, answers and the senior treating medical officer’s decision must be documented in the consumer’s clinical record. 2. Other ways consumers can outline their wishes regarding medical treatment Other ways consumers who have the capacity to make decisions can outline their wishes regarding medical treatment for when they no longer have the capacity to make decisions for themselves are: 2.1 Health Directive A Health Directive contains instructions that consent to or refuse specified medical treatment or treatment which may occur in the future. Health Directives become effective in situations where the consumer doesn’t have the capacity to make health care decisions for themselves. A Health Directive is legally binding and must be followed. It doesn’t apply where the consumer has or regains capacity to consent. Note: If a consumer makes a Health Directive and then appoints an attorney, under an Enduring Power of Attorney, who is authorised to make health care decisions; the Health Directive is revoked (Medical Treatment (Health Directions) Act 2006, Section 19). 2.2 Advance care planning Advance care planning is a process enabling a consumer to express and document their wishes about future health care in consultation with their health care providers, family and other important people in their lives. An advance care plan is designed to guide substitute decision makers when the consumer loses the capacity to make health care decisions for themselves. Where the consumer has outlined their wishes these must be taken into consideration in consent situations, however an advance care plan is not legally binding. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 3 of 13 DGD12-044 2.3 Advance agreement for Mental Health consumers An advance agreement is written by the consumer when they are capable of providing valid informed consent. It provides details of the consumer’s preferred clinical treatment to be administered in the event of deterioration in their mental state such that they are unable to provide valid informed consent. It is intended that Mental Health clinical managers collaborate closely with consumers during the development of advance agreements. An advance agreement provides a guide to relevant medical staff and other health professionals, health providers and the family and support people. Where the consumer has outlined their wishes these must be taken into consideration in consent situations, however an advance agreement is not legally binding. 3. Substitute Decision Makers: Where it has been identified that an adult consumer does not have the decision-making capacity to provide consent to treatment or procedures themselves the following substitute decision makers can provide consent in specific situations: The Attorney under an Enduring Power of Attorney Guardian, when appointed Health Attorney Public Advocate of the ACT when appointed guardian, and the Chief Psychiatrist or Community Care Coordinator (where there are issues relating to mental health or mental dysfunction and the consumer is under a Mental Health Order). To determine who can provide consent as a substitute decision maker refer to the flowchart at Attachment 2. For any substitute decision maker, evidence of their authority to consent needs to be sighted and confirmation of having done this needs to be documented in the clinical record. 3.1 Enduring Power of Attorney A consumer who has decision-making capacity may appoint someone else as an attorney under an Enduring Power of Attorney. This provides authority for the attorney to make personal, financial or medical decisions as specified on the consumer’s behalf, in the event the consumer no longer has decision-making capacity. An appointed attorney under the Enduring Power of Attorney can provide consent on behalf of the consumer. Note: If a consumer makes a Health Directive and then appoints an attorney, under an Enduring Power of Attorney, who is authorised to make health care decisions; the Health Directive is revoked (Medical Treatment (Health Directions) Act 2006, Section 19). 3.2 Legal guardians A legally appointed guardian, as defined in the Guardianship and Management of Property Act 1991, must make decisions in the consumer’s best interests. Additionally, Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 4 of 13 DGD12-044 the protected person’s wishes (as far as they can be determined) must be addressed – unless a decision made in accordance with such wishes is likely to significantly adversely affect the person’s protected interests. A legal guardian can give consent for a medical procedure or other treatment if so appointed, excepting ‘prescribed medical procedures’ as defined in legislation. Consent cannot be given by a legal guardian in some situations including: Where consent would override a decision outlined in a valid Health Directive Consent to procedures defined as a ‘prescribed medical procedure’ such as: o Abortion o Reproductive sterilisation o Hysterectomy o A medical procedure concerned with contraception o Removal of non‐regenerative tissue for transplantation to the body of another living person o Treatment for psychiatric illness, electroconvulsive therapy or psychiatric surgery. Refer to Section 4 for further information, and Withdrawal or withholding of medical treatment. 3.3 Health Attorneys A Health Attorney may provide consent to treatment when the consumer has: Impaired decision making ability and Has not appointed someone to have enduring power of attorney with regard to medical treatment, and When a legal guardian has not been appointed for consent to medical treatment. Listed in order of priority, a Health Attorney can be either a: Domestic Partner (i.e. spouse) Carer, not including carers employed to care for the consumer, and a Close relative or friend. Staff can ask for consent from someone from the above list whom they believe is the person best able to represent the views of the consumer and is readily available. In accordance with the Guardianship and Management of Property Act 1991 staff are not required to seek the views of more than one Health Attorney. The Health Attorney must be formally appointed by a medical officer before they can provide consent. The use of a Health Attorney must be documented in the clinical record using the Health Attorney for Consent to Medical Treatment form available on the Clinical Forms Register. Consent provided by the Health Attorney is valid for six months only. There are certain situations where staff must refer matters of consent to the Public Advocate of the ACT. These are where the health professional believes treatment should occur and: Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 5 of 13 DGD12-044 The Health Attorney who has been asked to provide consent does not consent to a recommended medical procedure and is believed to not be acting in the best interests of the consumer, or Before obtaining consent from the Health Attorney believed to be best able to represent the views of the consumer, staff become aware that any of the other possible Health Attorneys object to the giving of consent. The Office of the Public Advocate contact is: 02 6207 0707. 3.4 Public advocate Health professionals must contact the Public Advocate of the ACT to provide or withhold consent in the following circumstances: If they have concerns that decisions made by a substitute decision‐maker are not being made in the best interests of the consumer, and In the absence of a Health Directive, an appointed Health Attorney, Guardian, or Enduring Power of Attorney. Consent can be obtained by contacting the Office of the Public Advocate during business hours. If consent is required outside of business hours, a procedure or treatment may only proceed if it is an emergency, otherwise the procedure or treatment must not proceed until the emergency guardianship order is in place. The Office of the Public Advocate contact is: 02 6207 0707. 3.5 Telephone consent provided by substitute decision makers: Wherever possible, consent to treatment should be obtained through face-to-face conversation with the substitute decision maker. However, in certain circumstances when consent is requested, the substitute decision maker may not be in the presence of the consumer and can’t see the consumer’s physical condition or affected part or side of the body for themselves. Where there is no reasonable alternative at the time, a substitute decision maker may provide consent over the telephone. For example: When a surgical procedure is urgently required to treat traumatic injury, and During an elective treatment or procedure previously consented for, an additional treatment or procedure is deemed necessary at that time. The consent and information about the process used to gain consent must be documented in the clinical record. Refer to the Consent and Treatment SOP for further information about minimum requirements for documenting consent. 4. When mental health issues affect capacity 4.1 A consumer with mental illness can have the decision-making capacity to consent to medical or surgical treatment. The principles of valid informed consent apply to all mental health consumers; they can participate in all aspects of their health care and exercise their rights to consent to or decline health care. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 6 of 13 DGD12-044 If a consumer is assessed as not having capacity to consent due to their mental illness, the substitute consent provisions of the Guardianship and Management of Property Act 1991 and outlined in Procedure items: 1 – 4 apply for all: General medical or surgical conditions (except for psychiatric treatment or psychiatric surgery). 4.2 Psychiatric treatment If a consumer who is unable to provide informed consent appears to require psychiatric treatment, application must be made to the ACT Civil and Administrative Tribunal (ACAT) for a Psychiatric Treatment Order. Legal guardians or Attorneys cannot consent to psychiatric treatment on behalf of a consumer. An ACAT Order is required before psychiatric treatments can be provided to consumers who are deemed unable to consent. 4.3 Electroconvulsive Therapy (ECT) Consent to ECT may be voluntary or under an ECT order. A consumer for whom ECT is recommended must have the nature and purpose of the therapy explained by a medical officer who will not perform the therapy. Emergency provision of ECT can only be authorised by the Chief Psychiatrist. There is a specific consent form for ECT that must be used. The consumer’s signature on the consent form must be witnessed by a person who has no financial interest in the consumer’s affairs. A new consent form is required if the course of ECT goes beyond nine treatments as specified within the Mental Health (Treatment and Care) Act 1994. Involuntary ECT needs to be applied for through ACAT and needs to have a current psychiatric order in place as well (or applied for concurrently). Evaluation Outcome Measures Consumers provide valid informed consent wherever it is required. All forms used to document written consent are endorsed for use by the Health Directorate and comply with this policy and associated SOPs. Method Documentation of consent audits overseen by the Governance Health Service Standard Group. Related Legislation and Policies Legislation Age of Majority Act 1974 Children and Young People Act 2008 Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 7 of 13 DGD12-044 Civil Law (Wrongs) Act 2002 Guardianship and Management of Property Act 1991 Health Practitioner Regulation National Law (ACT) Act 2010 Health Records (Privacy and Access) Act 1997 Health Regulation (Maternal Health Information) Act 1998 Medical Treatment (Health Directions) Act 2006 Medicare Australia Act 2005 Mental Health (Treatment and Care) Act 1994 Powers of Attorney Act 2006 Public Advocate Act 2005 Road Transport (Alcohol and Drugs) Act 1977 Transplantation and Anatomy Act 1978 (2.2, 2.3, 2.5) Policy Clinical Record Management Policy Clinical Record Documentation SOP Release or Sharing of Clinical Records or Personal Health Information SOP Consent and Treatment Policy Consent and Treatment SOP Consent and Treatment: Children or Young People SOP Guidelines for Assessment of Decision Making Capacity by ACRS Psychologists SOP Consumer and Carer Participation Framework Consumer Feedback Standards: Listening and Learning Elective Surgery Access Policy Patient Identification: Correct Patient, Correct Site, Correct Procedure Policy Patient Identification: Correct Patient, Correct Site, Correct Procedure Standard Operating Procedure General Practitioner – Hospital Access and sharing of Clinical Information within CHHS – policy General Practitioner – Hospital Access and sharing of Clinical Information within CHHS - SOP Standards ACHS EQuIP 5: 1.1 Consumers/patients are provided with high quality care throughout the care delivery process. 1.1.3 Consumers/patients are informed of the consent process, and they understand and provide consent for their health care. 1.6 The governing body is committed to consumer participation. 1.6.2 Consumers/patients are informed of their rights and responsibilities. 3.1.5 Documented corporate and clinical policies and procedures assist the organisation to provide quality, safe health care. National Safety and Quality Health Service (NSQHS) Standard: Governance for Safety and Quality in Health Service Organisations Partnering with Consumers Patient Identification and Procedure Matching Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 8 of 13 DGD12-044 Definition of Terms Capacity The term capacity is used in this document to mean a person is capable of: Understanding the nature and effect of decisions about consent and communicating the understanding verbally or non-verbally Freely and voluntarily making decisions about consent Communicating the decisions verbally or non-verbally, and Retaining the information, their decision and their consent. The type of assessment required to determine someone’s capacity will vary depending on the type of decision being made. Carer People who provide unpaid care and support to family members and friends who have a disability, mental illness, chronic condition, terminal illness or general frailty. Carers include parents and guardians caring for children. Chief Psychiatrist Is appointed by the Minister and has the following functions under the Mental Health (Treatment and Care) Act 1994, Section 112: Provision of treatment, care, rehabilitation and protection for persons who have a mental illness, and Reporting and making recommendations to the Minister with respect to matters affecting the provision of treatment, care, control, accommodation, maintenance and protection for persons who have a mental illness. Clinical Activity Clinical activities improve, maintain or assess the health of a person in a clinical situation and may include invasive and non-invasive procedures (including those performed in settings other than the operating room). Some examples are: Invasive - taking a specimen of blood - giving medication via an intravenous, intramuscular or subcutaneous route - inserting intravenous access, or - performing a surgical procedure, including a procedure performed in medical imaging. Non-invasive - interventions such as evaluating, advising, planning (E.g. dietary education, physiotherapy assessment, crisis intervention, bereavement counselling, a procedure in medical imaging) and giving medication. Common law (Also known as case law) Law developed by judges through decisions of courts/tribunals rather than through legislation. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 9 of 13 DGD12-044 Consumer In this document the term ‘consumer’ refers to patients, consumers and clients under the care of the Health Directorate. Enduring Power of Attorney An attorney, appointed under and Enduring Power of Attorney, who authority comes into affect when the principal (authoriser) ceases to have capacity. In the ACT, an individual can complete an Enduring Power of Attorney to appoint someone else (the attorney) to make their personal or medical decisions in case they are unable to decide for themselves because of an accident or an illness. Guardian A person who has the right and duty to protect another person, his/her property and rights. Guardianship and management orders are made by the ACT Civil and Administrative Tribunal. In emergency situations, the Public Advocate of the ACT is appointed guardian of last resort to make decisions on the person’s behalf. Health Directive A Health Directive contains instructions that consent to, or refuse, specified medical treatment or treatment which may occur in the future. Health Directives become effective in situations where the consumer doesn’t have the capacity to make health care decisions for themselves. An Health Directive is legally binding and must be followed. It doesn’t apply where the consumer has or regains capacity to consent. (Medical Treatment (Health Directions) Act 2006) Health Professional There are two Acts which define ‘health professionals’: the Medical Treatment (Health Directions) Act 2006 (ACT) and the Health Practitioner Regulation National Law (ACT) Act 2010. For the purpose of this document a ‘health professional’ includes all doctors, dentists, nurses and allied health professionals engaged the Health Directorate to care for consumers. Informed consent A person gives consent based upon an appreciation and understanding of the facts and implications of an action. The person must be given the relevant information and have the capacity to understand it. Valid consent is based on the fundamental legal principle that the law protects the integrity and autonomy of the person. Consent for a procedure or treatment is valid if: The consumer has the capacity to give consent Full information on risks, benefits and alternatives has been provided and understood, with understanding demonstrated The consent is given freely, and The consent is specific to the procedure. Medical officer A conditionally registered or unconditionally registered medical practitioner employed by, or contracted to, the Health Directorate. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 10 of 13 DGD12-044 Mental dysfunction Means a disturbance or defect to a substantially disabling degree, of perceptual interpretation, comprehension, reasoning, learning, judgement, memory, motivation or emotion. Mental illness Means a condition that seriously impairs (either temporarily or permanently) the mental functioning of a person and is characterised by the presence in the person of any of the following symptoms: a. Delusions b. Hallucinations c. Serious disorder of thought form d. Severe disturbance of mood e. Sustained or repeated irrational behaviour indicating the presence of the symptoms referred to in a, b, c or d. Prohibited substance A substance to which the medicines and poisons standard, schedule 9 applies. Schedule 9 substances are generally illegal substances that are subject to misuse, for example, cannabis or heroin. Senior medical officer A medical officer, salaried or contracted, who has clinical privileges and who is not required to work under supervision, with the exception of doctors appointed to Area of Need specialist positions who are required to have a supervisor. Treatment Medical or surgical management of a consumer (including any medical or surgical procedure, operation, examination and any prophylactic, palliative or rehabilitative care) normally carried out by, or under the supervision of a Health Professional. Treating medical officer Medical officer who is delegated responsibility for all or part of the care of a consumer. The treating medical officer may be a junior medical officer or senior medical officer and may not be the admitting senior medical officer. Treating Team The treating team includes all service providers (located within, or external to the ACT) who provide a service for the ACT Government Health Directorate involved in diagnosis, care or treatment for the purpose of improving or maintaining the consumer’s health for a particular episode of care (Health Records (Privacy and Access) Act 1997). Voluntary Mental Health Consumer A person who has is receiving treatment but is not under an Emergency Detention or Psychiatric Treatment order/Community Care order or any other order under the Mental Health (Treatment and Care) Act 1994. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 11 of 13 DGD12-044 Involuntary Mental Health Consumer A person who is subject to an Emergency Action, or an Emergency Detention Order (ED3 or ED7) or a Psychiatric Treatment Order, or a Community Care Order under the Mental Health (Treatment and Care) Act 1994. References RACCS SOP Guidelines for Assessment of Decision Making Capacity by ACRS Pyschologists Guidelines for Health Care Professionals Including Medical Practitioners and Dentists. (1999) Office of the Public Advocate of the ACT Australian Capital Territory Government Informed Consent for Health Care Treatment. (1999). Office of the Public Advocate of the ACT. Australian Capital Territory Government Guide to Informed Decision-making in Healthcare. (2011) Queensland Health. Queensland Government Guidelines for Medical Practitioners on Providing Information to Patients. (2004) National Health and Medical Research Council (NHMRC) (www. nhmrc.gov.au) Attachments Attachment 1: Determination of who can provide consent as a Substitute Decision Maker Flowchart Associated SOPs Consent and Treatment SOP Consent and Treatment: Children or Young People SOP Disclaimer: This document has been developed by Health Directorate, specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever. Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 12 of 13 DGD12-044 Attachment 1: Determination of who can provide consent as a Substitute Decision Maker Flowchart Is this an emergency? I.e. The procedure is both necessary to prevent serious harm or death and cannot be delayed YES Proceed without consent YES Proceed with verbal/written or other indication of consent documented YES Proceed in accordance with the advice of the appointed Enduring Power of Attorney YES Proceed in accordance with the advice of the guardian YES Proceed in accordance with the advice of the Health Attorney NO Is the consumer able to give valid informed consent? NO Have you sighted a current Enduring Power of Attorney that authorises decisions for health care? (Check with family/significant other/GP) NO Have you sighted a current guardianship order? (Check with family/significant other/ GP NO Is there a Health Attorney available? NO In business hours, telephone the Office of the Public Advocate on 6207 0707 to discuss the need for an Emergency Guardianship Order OR visit www.publicadvocate.act.gov.au and download the application form Note: A valid Health Directive overrides any Substitute Decision Maker unless a consumer makes a Health Directive and then appoints an attorney, under an Enduring Power of Attorney, who is authorised to make health care decisions; the Health Directive is revoked (Medical Treatment (Health Directions) Act 2006, Section 19). Doc Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 13 of 13