Consent to Treatment Policy for the Western Australian Health System

The Department of Health has amended the Consent to Treatment Policy for the WA Health System 2006 which outlines the process and requirements for obtaining a patient’s consent to treatment for clinicians working in WA hospitals and health services. 

Key changes to the Consent to Treatment Policy for the WA Health System (WA Consent Policy) include amendments to:

• Section 3.1 When should consent be obtained in writing
• Section 4.6 Treatment which is prohibited by law or which is prohibited unless certain requirements are met
• Section 5.3.1 What information should be provided to a patient from a culturally and linguistically diverse background or who has special needs? (including amendment to the interpreter declaration on the consent forms)
• Section 5.3.1(a) What is the role of the interpreter?
• Appendix 1 FORM A - Consent Form
• Appendix 4 Addition of FORM D – Patient Consent to Anaesthesia (general or regional)
• Appendix 7 Human Tissue and Transplant Act 1982

Additional minor changes have been made to the WA Consent Policy that do not significantly alter its content. Compliance with the Policy remains mandatory.

This policy version (2009) updates and replaces Consent to Treatment Policy for the WA Health System (2006) OD 0005/06.

A copy of the full WA Consent Policy and associated consent forms and procedure specific information sheets, are available from the Office of Safety and Quality in Healthcare website at: http://www.health.wa.gov.au/safetyandquality/

DEFINITIONS

1. Consent to treatment: includes gaining consent for a specific procedure and appropriately disclosing any material risks.
2. Health practitioner: health practitioners include doctors, nurses and allied health professionals.
3. Material risk: The High Court case of Rogers v Whittaker (Rogers v Whittaker 1992 175 CLR 479) found that a medical practitioner must ensure that a patient has been fully advised of the material risks inherent in that treatment or procedure, as well as ensuring that a patient has given appropriate consent to the carrying out of medical treatment or a medical procedure.
   A material risk is "a risk which, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it, or if the medical practitioner is or should reasonably be aware that a particular patient, if warned of the risk, would be likely to attach significance to it".
4. Treatment: treatment includes any medical or surgical management, care, therapy, test or procedure.

WHAT IS MEANT BY CONSENT TO TREATMENT?

Consent is a patient’s agreement for a health practitioner to provide treatment.  For the purposes of this policy, the consent process should be thought of as a series of steps:

1. informed decision making about what course of action to take, which includes a discussion about the pros and cons of each alternative treatment option
2. gaining consent for specific treatment, which includes the health practitioner appropriately disclosing any material risks of having the specific treatment
3. appropriate documentation and record keeping relating to the consent process.

Whether or not medical treatment is to take place is a decision for the patient, and as a matter of policy, no treatment may be performed without the consent of the patient, if the patient is a competent adult, except in narrowly defined circumstances.  Failure to obtain a patient’s consent for a procedure may result in a criminal charge of assault or civil action for battery, whereas failure to disclose material risks to a patient may give rise to civil action for negligence.

WHAT INFORMATION SHOULD BE PROVIDED TO A PATIENT?

Information should be provided to a patient with the objective of helping him/her understand his/her illness and the available treatment options.  The minimum level of information should include:

• an explanation of the patient’s condition and diagnosis
• any degree of uncertainty in the diagnosis or prognosis
• the nature of the proposed treatment, including the time required for the treatment, the likely recovery period and the likely time that the patient will be off work
• the expected benefits of the treatment
• the potential risks involved in the treatment including:
• any short or long term side effects of the treatment
• any significant long term physical, emotional, mental, social, sexual or other risks
• the risk that no benefit will be achieved
• the risk that the condition will be worse after the treatment and or procedure
• the likely outcomes of the treatment, including whether the treatment is irreversible
• outcomes which are inevitable if the treatment is performed, such as pain, altered bowel function after a cholecystectomy, removal of the umbilicus after repair of an umbilical hernia
• the likely consequences of not choosing the proposed diagnostic procedure or treatment, or of not having any procedure or treatment at all
• alternative options for investigation, diagnosis and treatment and why they are not recommended
• any costs involved in the treatment
• any follow-up treatment or care which may be required.

Requests for further information or specific anxieties expressed by the patient should be answered frankly and honestly.

DOES CONSENT HAVE TO BE OBTAINED IN WRITING?

As stated in Section 3 of this Consent Policy, no surgical operation, medical, anaesthetic, radiology or oncology procedures may be performed without the consent of the patient, if the patient is a competent adult.  Generally, the law does not require consent to be given in writing.  

An exception to this rule includes consent required under the Mental Health Act 1996 (see Section 4 of this Consent Policy).  Section 110 of the Mental Health Act 1996 requires the written approval of the Chief Psychiatrist for the provision of medical treatment to an involuntary patient or a mentally impaired accused.

It is however, the Department of Health’s policy that written consent, using an approved consent form, must be obtained for:

• surgical, medical, radiology, oncology and endoscopy treatments / procedures requiring general, regional or local anaesthesia, or intravenous sedation
• invasive procedures or treatment where there are known significant risks or complications
• sterilisation of a minor and the application of electroconvulsive therapy (special circumstances apply)
• administration of medications with known high risk complications or new unusual medications which may have risks
• drugs administered under the Special Access Scheme
• participation in clinical trials and medical research.

The absence of a completed consent form could lead to the conclusion that the procedure has not been discussed with the patient or that informed consent has not been obtained.  Therefore, in all other cases, where a health practitioner does not complete a written consent form, documentation of the consent process must be made in the patient’s medical records (as per Section 5 and 9 of this Consent Policy).

Please note there are specific requirements in relation to the consent process for anaesthesia, open access procedures, obstetric procedures and blood products (see Section 4.7 of this Consent Policy for additional information).

The use of the recommended consent forms will assist health practitioners in providing adequate and appropriate information to patients under their care during the consent process and in line with legal requirements and expectations.

Model Consent to Treatment forms for adults, minors and patients incapable of consenting to the procedure or treatment are provided at Appendices 1 to 6.

ARE THERE DIFFERENT ARRANGEMENTS APPLYING TO CONSENT?

The requirements for consent to be obtained prior to the commencement of treatment may vary depending on whether the patient is competent (adult or a mature minor), or incompetent (child or adult requiring parent or legally appointed guardian).  The following situations may require varying arrangements:

1. when immediate treatment is required to save a person’s life or prevent serious harm  (refer to Section 4.1 of this Consent Policy)
2. when treatment is provided under the Mental Health Act 1996 (refer to Section 4.2 of this Consent Policy)
3. when emergency psychiatric treatment is required (refer to Section 4.3 of this Consent Policy)
4. when medical treatment is provided under the Guardianship and Administration Act 1990 (refer to Sections 4.4(a) and 4.4(b) of this Consent Policy)
5. treatment of a minor (refer to Section 4.5 of this Consent Policy)
6. treatment which is prohibited by law or which is prohibited unless certain requirements are met (Refer to Section 4.6 of this Consent Policy).

WHO IS RESPONSIBLE FOR OBTAINING THE PATIENT’S CONSENT?

Where a health practitioner recommends or advises a patient to undergo treatment, the health practitioner is responsible for providing sufficient, appropriate information and advice to the patient to enable the patient to make his or her own informed decision as to whether to undergo the treatment.  In general, the most senior medical practitioner on the treating team is ultimately responsible for ensuring consent to treatment has been adequately obtained.

A senior medical practitioner may delegate the task of obtaining a patient’s consent to treatment to a junior medical practitioner.  However, the senior medical practitioner must ensure that the delegated practitioner is competent to undertake that task and, in appropriate cases, take reasonable steps to ensure that the patient has been properly informed and that a consent form has been completed.  The senior medical practitioner may be held responsible, where the task has not been appropriately carried out.

HOW LONG DOES THE PATIENT’S CONSENT LAST?

In principle, a health practitioner’s duty to disclose material risk and obtain a patient’s consent for treatment is a continuing obligation.  The consent process should occur before the decision is made to proceed with treatment and as close as is reasonably practicable to the commencement of the treatment process and preferably prior to admission.

Consent is considered valid until a patient withdraws consent or there is a change in a patient’s circumstances, which may include:

• improvement or deterioration in the patient’s condition
• development of new treatment options since consent was given
• progression of the disease which may have changed the therapeutic goal from “cure” to “palliation”.

It is a requirement of this Consent Policy that a patient’s clinical condition and consent must be reviewed if his or her consent was obtained more than three months prior to the treatment being performed.  Evidence of such a review should be documented in the patient’s medical record.  The previously completed form may be revalidated if the patient’s circumstances have not altered, otherwise a new consent form should be completed.  The consent process must be renewed if the period between the date of consent and the date of the procedure being performed exceeds six months.

If a patient consents to a procedure and then subsequently withdraws his or her consent, the date of withdrawal must be documented in the patient’s medical record.  It is crucial that the patient is made aware that reconsideration of treatment or withdrawal of treatment is always an option and any changes should be documented in the patient’s medical record.

WHAT EVIDENCE SHOULD HEALTH SERVICES EXPECT OF DOCTORS TO INDICATE THAT CONSENT HAS BEEN OBTAINED?

It is the responsibility of the hospital/health service to ensure that the patient’s consent has been obtained by the health practitioner at each of the following stages:

1. At the pre-admission clinic (where possible)
2. At the patient’s admission to hospital (where possible)
3. Prior to administration of pre-operative medication
4. Prior to patient’s transfer to operating theatre, diagnostic unit or medical imaging department.  

Evidence may include documentation in the patient’s medical record or production of a completed consent form.

All cases of patients arriving in the operating theatre or treatment room without valid or documented consent must be reported to a relevant Clinical Nurse Manager, Medical Director and other relevant health service administrators.

FURTHER INFORMATION

All enquiries about the Consent to Treatment Policy for the Western Australian Health System should be directed to the Office of Safety and Quality in Healthcare on (08) 9222 4080 or e-mail: safetyandquality@health.wa.gov.au

Dr Peter Flett
DIRECTOR GENERAL
WA HEALTH

ATTACHMENTS:

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Consent to Treatment Policy for the Western Australian Health System