DGD12-044 Policy Consent and Treatment Policy Statement Health Directorate health professionals must obtain a consumer’s valid informed consent before beginning any clinical activity, treatment or procedure, except when: The consumer is unable to provide informed consent and then it is sought from an appropriate substitute decision maker, or Urgent medical treatment is required to save a consumer’s life or prevent serious harm and the consumer is not able to provide consent to the required treatment at the time through a lack of capacity, (e.g. because the consumer is unconscious). 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. Written and verbal consent, and the information provided to the consumer must be documented in the clinical record. The Standard Operating Procedures (SOPs) associated with this policy provide all Health Directorate staff with the information required to assist in meeting legal obligations when seeking valid informed consent: Consent and Treatment Consent and Treatment: Children or Young People Consent and Treatment: Capacity and Substitute Decision Makers. Purpose Informed decision-making is essential for consumer-centred care. Consumers have the right to decide whether or not they wish to receive health care. Good practice in gaining informed consent includes communication of the benefits, risks and alternatives of treatment, taking into account the consumer’s personal circumstances, beliefs, and priorities including: Temperament, attitude and level of understanding Cultural and linguistic diversity Influences that are non‐medical but may have an impact, or Communication and/or cognitive difficulties. DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 1 of 7 DGD12-044 Failure to obtain a consumer’s consent to health care may result in a criminal charge of assault or civil action for battery. In addition, failure to inform a consumer about the related risks may give rise to civil action for negligence. Scope This policy and the associated Standard Operating Procedures (SOPs) are the overarching documents for consent processes that apply to all Divisions, Branches and Units within the Health Directorate. Principles: Valid informed consent When seeking valid informed consent staff must: Satisfy themselves that the consumer has the capacity to consent to treatment and that the consumer’s decision-making capacity is not impaired by therapeutic or other drugs, or alcohol, and Ensure that: Consent is specific to the relevant clinical activity, treatment or procedure Appropriate and sufficient information on the risks, benefits and alternatives is provided The consumer is able to clearly understand the information as it is provided in verbal or non-verbal means which they can understand, and Consent is voluntarily given and once given is properly recorded. Length of time consent is valid Consent is considered valid until the consumer withdraws their consent or there is a change in their circumstances, which may include: Unplanned or unexpected improvement or deterioration in the consumer’s condition Identification of new risks or side effects associated with the recommended treatment Development of new treatment options since consent was given, or Progression of the disease, which may have changed the therapeutic goal – for example from ‘cure’ to ‘palliation’. Wherever there is a delay between the consumer giving consent and the provision of treatment, staff need to assess whether circumstances have changed and whether a new consent discussion is required. Changes to consent must be documented in the consumer’s clinical record when this occurs. Consent to Collection and Sharing of information Health Directorate staff are also responsible for ensuring consumers are aware that when they receive care in, or attend a Health Directorate facility, the information relating to their care will be kept by the Health Directorate and may be shared with members of their treating team as necessary, including their nominated General Practitioner (GP). Consumers have the right to decline to have their information shared at any time. DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 2 of 7 DGD12-044 Refer to Health Directorate policy documents relating to clinical records management and sharing of personal information for further information Roles & Responsibilities Executive Directors of Divisons, Branches and Units are responsible for ensuring there are strategies in place relating to consent within their areas for: Communication Training and/or orientation, and Evaluation and continuous improvement. Managers are responsible for: Ensuring that staff are able to access, interpret and apply this document and are provided with education related to this policy and associated SOPs. All Health Directorate staff who obtain consent should be aware of: The principles of valid informed consent Consumer rights The nature of the clinical activity, treatment or procedure the consumer is being asked to consent to including the likelihood and degree of possible harm Required consent procedures including rules applying to: o Emergencies and particular procedures o Decision‐making by substitute decision makers o Documentation requirements o Legal and ethical considerations and risks, and o Relevant legislation, policies and standards. 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, Policies and Standards Legislation Age of Majority Act 1974 Children and Young People Act 2008 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 DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 3 of 7 DGD12-044 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 SOP Consent and Treatment: Children or Young People SOP Consent and Treatment: Capacity and Substitute Decision Makers 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) Standards Std 1: Governance for Safety and Quality in Health Service Organisations Std 2: Partnering with Consumers Std 5: Patient Identification and Procedure Matching DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 4 of 7 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. 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. Consumer In this document the term ‘consumer’ refers to patients, consumers and clients under the care of the Health Directorate. 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. DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 5 of 7 DGD12-044 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. Substitute Decision Maker 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: Health Attorney The Attorney, under an Enduring Power of Attorney Guardian, if approved Public Advocate of the ACT if 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). 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 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). References 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 DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 6 of 7 DGD12-044 Guidelines for Medical Practitioners on Providing Information to Patients. (2004) National Health and Medical Research Council (NHMRC) (www. nhmrc.gov.au) Attachments N/A Associated SOPs Consent and Treatment SOP Consent and Treatment: Children or Young People SOP Consent and Treatment: Capacity and Substitute Decision Makers 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. DGD Number DGD12-044 Version 2.0 Issued October 2012 Review Date October 2015 Area Responsible QSU Page 7 of 7