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Informed Consent

Doc ID: 1969 Version: 09 Issue Date: 14 MAR 2019 Review Date: 14 MAR 2022 Facilitator Title: Chief Medical Officer Department: Office of Chief Medical Officer IF THIS DOCUMENT IS PRINTED, IT IS VALID ONLY FOR THE DAY OF PRINTING of 36

Policy Responsibilities and Authorisation

Department Responsible for Policy Office of Chief Medical Officer

Document Facilitator Title Chief Medical Officer

Document Facilitator Name Gary Hopgood

Document Owner Title Chief Medical Officer

Document Owner Name Gary Hopgood

Target Audience All staff

Committee Approved Policies and Guidelines Committee

Date Approved 14 December 2017

Committee Endorsed Board of Clinical Governance

Date Endorsed 21 March 2018

Disclaimer: This document has been developed by Waikato District Health Board specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at their own risk and Waikato District Health Board assumes no responsibility whatsoever.

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Policy Review History

Ver. Updated by Date Updated Summary of Changes

6.0 Nicky Haisman 3 October 2017

Roles and responsibilities section 4.0 removed. Section 9.5 Patient refusal to consent to treatment – reference to Appendix A removed. Appendix C removed.

7.0 Nicky Haisman, Tom Watson

17 November 2017

• Section 4 – added hyperlink to Health & Disability Commissioner’s Code of Rights

• Section 5 – removed reference informed consent being obtained for

• re-used single use critical item • Change age brackets where informed consent to be valid must

be given by competent patients or their legal representatives • Add to Section 8.1 Impact of age on the ability to give informed

consent exceptions include where there is a direction for medical examination ordered by the medical officer of health, public health order or order for contacts made by the District Court

• Added point on obtaining informed consent for unapproved and unregistered medicines

8.0 Gary Hopgood 7 and 23 November

2018

• Amended 1.1 Purpose to – this policy specifies Waikato District Health Board (DHB) requirements for ensuring patients are fully informed, make an informed choice and give informed consent to health and disability services. This includes the right to make an informed choice to receive or refuse treatment and to withdraw from treatment.

• Amended Section 2 Definitions Legal Guardian to add: A guardian is a person who has the duties, powers, rights and responsibilities for the child. The mother and father of a person under the age of 18 are jointly guardians, except in certain situations including: • The mother is the sole guardian (where she was neither

married to, in a civil union, or living with the father at any time during the mother’s pregnancy; or

• There is a court order appointing a different of additional guardian; or

• The child is married and lives with a de facto partner (See section 15 - 27 of the Care of Children Act 2004) • Provider definition change to: a health care provider or

disability services provider • Section 3 Policy statements – remove Right 7 Health and

Disability Commissioner Code of Consumer Rights 1996 reference

• Section 3 Policy statements added to second bullet point – the Legal representative of patients who are not competent are given sufficient information to enable them to make a voluntary decision on agreeing to refusing a treatment or procedure

• Section 3 Policy statements – bullet point 3 added – where there is no Legal representative, the process set out in right 7(4) and 7(5) of the Code of Health and Disability Services Consumer Rights 1996 (The Code of Rights) can be used.

• 4.1 Obtaining informed consent – change second bullet point to “establish a supportive environment which encourages open,

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honest and effective communication, and” • “gives sufficient information (the information that a reasonable

consumer in that consumer’s circumstances would expect to receive) to allow the patient to make an informed choice, taking into account the patient’s cultural needs e.g. information should be provided using language and examples the patient can understand (Maori Patient Advocates or interpreters may be of assistance), and;

• 4.1 Obtaining informed consent – added If the patient is incompetent and there is no legal representative, then Right 7(4) of the Code of Rights may apply (and remove – one with a legal right to give consent on behalf of the incompetent patient

• 4.1 Obtaining informed consent – added bullet point – Advanced Directive. An advanced directive is a statement made by an individual setting out the treatment they would want or not want in the event of requiring healthcare in the future in a situation where they were unable to communicate their choice. A provider must establish that:

o The patient was competent at the time the advance directive decision was made

o The decision was made voluntarily and without coercion

o The decision was an informed choice o The decision is applicable to the present

circumstances o The decision is current

• 4.1 Obtaining informed consent – change of wording for bullet point to – In cases with minimal risk you may be justified in withholding or generalising information if the patient states that he or she does not want to hear it and where providing the information may cause him or her emotional harm

• 4.3 What is sufficient information? Amended bullet point: The patient must be provided with the information that a reasonable patient, in that patient’s circumstances, would expect to receive and needs to make an informed choice and or give informed consent. It requires an understanding of the particular individual’s circumstances that may make more, less or additional information pertinent to their decision making. The onus on both counts rests with the provider. As a minimum the patient should be provided with the following:

• Added an explanation of to first bullet point • Added an explanation of to second bullet point and

also assessment of the expected risks, side effects, costs of each option

• Added consequences of not giving consent • Added new bullet point – notification of any proposed

participation in teaching or research • Added 4.4 Who is responsible for providing the information?

• The primary responsibility for ensuring the relevant essential information is provided to the patient lies with the person who is responsible for the procedure – the treating clinician

• Where it is impracticable for all information to come from the health professional conducting the procedure,

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a proxy can be used. However, this person must be sufficiently qualified and experienced to convey information to the patient in order to enable the patient to understand their condition, the proposed treatment, its intended benefits, any risks and possible side effects. It is the responsibility of the person performing a procedure to confirm that information provided by a proxy has been provided, is of an adequate standard to ensure that the patient is suitably informed, and answers any questions the patient may have

• Added 4.5 Who is responsible for obtaining informed consent? • The Provider responsible for the procedure being

performed also has the responsibility to ensure the patient’s informed consent is obtained. This must be:

o The patient’s consultant or delegate (the delegate must have an appropriate scope of practice) in the inpatient environment

o The patient’s key worker (in Mental Health Community Services)

o The patient’s primary health professional (in Community Services)

o The patient’s Allied Health professional (for Allied Health procedures)

o The patient’s nurse for nursing care • The Medical Council advises that no doctor should

obtain a patient’s informed consent when they do not feel competent to do so. This principle applies to all health professionals

• Section 5 When is informed consent required? Changes made to first bullet point adding – “Unless a lawful exception exists (refer clause 6) then”

• And added that consent must be obtained for each and any proposed treatment or procedure. And – for participation in any research activity, for the storage, preservation or use of any removed substance or body part other than outlined in Right 7 (10)

• Amendment to Section 5 separate consent must be obtained for each of the following: added – treatment of unforeseen pathology which only becomes apparent during that surgery, unless excluded under the provisions of clause 6 “When is informed consent not required”

• Section 8 change to Consent and competence. Added new bullet point – Right 7 (2) of the Code of Rights states: ‘Every consumer must be presumed competent to make an informed choice and give informed consent unless there are reasonable grounds for believing that the consumer is not competent’.

• Second 8 Consent and competence – second bullet point amended to – For informed consent to be valid, it must be given by a competent patient or their Legal Representative (see Definitions Appendix B). Table removed.

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• Section 8 Consent and competence – amend bullet point “The Provider shall make the final decision on whether to provide the proposed treatment to the patient if the patient is not competent to consent (added) and no person entitled to consent on behalf of the patient is available. In this situation, treatment may be provided as outlined in Right 7 (4)

• Section 8.1 The impact of age on the ability to give informed consent. Removed reference to section 5.1.

• Section 8.1 The impact of age on the ability to give informed consent – added new bullet point. Where there is no guardian in New Zealand, or no guardian can be found with a reasonable search, or no guardian with capacity to consent can be found, then consent may be given by a person in New Zealand who has been acting in the place of a parent

• Section 8.3 When the patient is not competent amended by removing reference to parent or legal and replacing with guardian of the child. Added to bullet point that if no such person can be found with reasonable diligence or is capable of giving consent.

• Addition to bullet point for adults (18 years and over) that it is important to determine that the power of attorney has been activated by determination of incompetence.

• Section 8.3 When the patient is not competent – removed bullet point that begins with “when a consumer is not competent to make an informed choice and give informed consent, and also sub bullet points.

• Section 9.1 Who is responsible for providing the information? And Section 9.2 Who is responsible for obtaining informed consent both removed.

• Appendix A Summary of statutory exceptions to informed consent – Abortion - update to legislation (Section 34)

• Appendix A Summary of statutory exceptions to informed consent – removal of definition of alcoholics/drug addicts

• Appendix A Summary of statutory exceptions to informed consent – addition to taking blood samples “If an enforcement officer requests a blood specimen be taken from such a patient, the medical practitioner in charge must either take the sample or organise for another medical practitioner to take a sample irrespective of whether the patient has consented to sampling or has the capacity to consent

• Appendix A Summary of statutory exceptions to informed consent – Mentally ill persons. Added provisions particular to children are defined where they differ to adults (S85, 86, 87, 88, 89, 90)

• Appendix A Summary of statutory exceptions to informed consent – bodily samples for criminal investigations (removed reference to police suspects)

• Appendix A Summary of statutory exceptions to informed consent – Welfare guardians. Change definition to wholly lacks capacity (and removed – to make or communicate a

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decision). • Appendix A Summary of statutory exceptions to informed

consent. Added Enduring power of attorney for care and welfare – protection of Personal and Property Rights Act 1988 enables a competent person to appoint an attorney to act for them in advance of incapacity.

• Appendix B Summary of statutory provisions of who can give consent. Changed definition to “mentally impaired persons who lack competence to manage their own affairs.

9 Gary Hopgood 14 March 2019

• Add new bullet point to 3. Policy Statements – and comply with obligations to assess and treat patients under the provisions of the Mental Health (Compulsory Assessment and Treatment) Act 1992

• Section 4 What is informed consent? Second bullet point reference to 5.1When is written consent required? Cross reference added to section

• Section 4 What is informed consent? Third bullet point – cross reference added to 8.3 When the patient is not competent. Advanced Directive information moved to 8.4 Advanced Directive

• Section 4.2 Documentation of the informed consent process – moved to Section 6 When is consent not required? New subsection 6.1 created

• Section 8.4 Advanced Directive – new bullet point added • Section 13 Legislative requirements – Childrens’ Act 2014

added

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Contents

1. Introduction ................................................................................................................................................ 9 1.1. Purpose............................................................................................................................................ 9

1.2. Background ...................................................................................................................................... 9

1.3. Scope ............................................................................................................................................... 9

2. Definitions .................................................................................................................................................. 9

3. Policy Statements .................................................................................................................................... 10

4. What is informed consent? ...................................................................................................................... 10

4.1. Obtaining informed consent ........................................................................................................... 11

4.2. What is sufficient information? ....................................................................................................... 12

4.3. Who is responsible for providing the information? ........................................................................ 13

4.4. Who is responsible for obtaining informed consent? ..................................................................... 13

5. When is informed consent required? ....................................................................................................... 13

5.1. When is written consent required? ................................................................................................ 14

5.2. Other circumstances requiring consent ......................................................................................... 15

6. When is consent not required? ................................................................................................................ 16

6.1. Documentation of the informed consent process .......................................................................... 16

7. How long is consent valid? ...................................................................................................................... 16

8. Consent and competence ........................................................................................................................ 17

8.1. The impact of age on the ability to give informed consent ............................................................ 17

8.2. The impact of medication on competence to consent ................................................................... 19

8.3. When the patient is not competent ................................................................................................ 19

8.4. Advance Directive .......................................................................................................................... 21

8.5. Patient refusal to consent to treatment .......................................................................................... 21

9. Responsibilities ........................................................................................................................................ 22

9.1 Informed consent forms .................................................................................................................. 22

10. Blood and blood products ........................................................................................................................ 22

10.1. Refusal of blood or blood products ................................................................................................ 22

11. Organ retrieval and use for therapeutic purposes ................................................................................... 23

12. Audit .................................................................................................................................................. 23

12.1. Indicators ....................................................................................................................................... 23

13. Legislative Requirements ......................................................................................................................... 24 13.1. Legislation ...................................................................................................................................... 24

14. Associated Documents ............................................................................................................................ 25

14.1. Associated Waikato DHB Documents ........................................................................................... 25

14.2. Other Regulations and References ............................................................................................... 25

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Appendix A Summary of statutory exceptions to informed consent ............................................................ 26

Appendix B Summary of statutory provisions of who can give consent ...................................................... 28

Appendix C Guide for use of Consent for Surgical Procedures (Investigations or Treatments) Form (RP039) 31

Appendix D Consent for Treatment/Non-treatment of the Incompetent Adult Patient ................................. 33

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1. Introduction

1.1. Purpose This policy specifies Waikato District Health Board (DHB) requirements for ensuring compliance with legal standards in ensuring patients are fully informed, make an informed choice and give informed consent to health and disability services. This includes the right to make an informed choice to receive or refuse treatment and to withdraw from treatment.

1.2. Background Waikato DHB recognises that provision of information, as part of the informed consent process, to patients about their healthcare options offers the opportunity to enhance health gain for all patients, including Māori.

1.3. Scope This policy applies to all Waikato DHB employees, independent contractors and personnel with access arrangements. All health professionals have an obligation to abide by the legal requirements relating to informed consent.

2. Definitions

Guardian A guardian is a person who has the duties, powers, rights and responsibilities for a child. The mother and father of a person under the age of 18 are jointly guardians, except in certain situations including: • the mother is the sole guardian (where she was neither married to, in

a civil union, or living with the father at any time during the mother’s pregnancy); or

• there is a court order appointing a different or additional guardian; or • the child is married or lives with de facto partner. (See section 15 - 27 of the Care of Children Act 2004)

Legal Representative For a person under 18 years: • the person’s legal guardian (usually a parent) For a person 18 years and over: • the person’s welfare guardian or • the person’s attorney appointed under an activated Enduring Power of

Attorney (for patient’s health and welfare).

Patient In this policy the word ‘patient’ is used generically to refer to consumer, client, tangata whaiora, resident.

Provider A health care provider or disability services provider.

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3. Policy Statements Waikato DHB shall implement processes that ensure that:

• Competent patients are given sufficient information to enable them to make a voluntary decision on agreeing to or refusing a treatment or procedure

• The Legal Representative of patients who are not competent, are given sufficient information to enable them to make a voluntary decision on agreeing to or refusing a treatment or procedure

• Where there is no Legal Representative, the process set out in right 7(4) and 7(5) of the Code of Health and Disability Services Consumers’ Rights 1996 (“the Code of Rights”) can be used.

• Obligations to assess and treat patients as set out in the Mental Health (Compulsory Assessment and Treatment) Act 1992 are complied with

• The provision or refusal of consent to treatment is documented in the clinical file

• It is necessary to obtain the patient’s informed consent – either verbal or written - prior to the provision of any Waikato DHB healthcare service, except:

1. for emergency situations where death or permanent disability may result if treatment is not provided immediately

2. where a Legal Representative provides consent on the patient’s behalf

3. where the treatment can be provided without consent under Right 7(4) of the Code of Rights.

4. where there is a court order allowing treatment.

• Informed consent is a process, not a single event. It involves the patient making an informed choice between the healthcare options available, including the option of refusing the service.

• Waikato DHB respects the rights of patients to refuse treatment or to withdraw their consent to treatment.

• Waikato DHB informed consent processes shall respect – and wherever possible meet - the patient’s cultural requirements.

• If you have difficulty in applying any of the principles set out in the policy or concerns about a specific matter, please seek advice from DHB Legal Services.

4. What is informed consent? • There are three key components of informed consent:

o Competence: the individual must be capable of understanding the essential nature of their condition along with the treatment proposed, its intended benefits, risks and possible side effects;

o Sufficient information: the individual has the information that a reasonable person in their position would expect to have;

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o Voluntary choice: the individual must be allowed to make a decision (either to accept or decline healthcare services) freely, without any form of coercion or constraint.

• Informed consent may be given verbally or in writing. However, written consent is lawfully required in some circumstances [refer to 5.1]

• Informed consent must be for the particular service being provided.

4.1. Obtaining informed consent

• Patients must be informed of their right to decide for themselves whether to consent, or to refuse to consent, to treatment. There are certain exceptions to this general principle which are set out in Appendix B.

• The process of seeking to obtain informed consent involves the following steps. The person(s) obtaining informed consent must:

o establish a supportive environment which encourages open, honest and effective communication; and

o give sufficient information (the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive) to allow the patient to make an informed choice, taking into account the patient’s cultural needs e.g. information should be provided using language and examples the patient can understand (Māori Patient Advocates or interpreters may be of assistance); and

o allow time for the patient to ask questions and digest the information. In some cases this may involve giving the patient an opportunity to “sleep on it” and respond at a later time; and

o obtain the patient’s (or their Legal Representative’s) verbal consent and document this in the patient’s clinical record; and if required:

o obtain the patient’s (or their Legal Representative’s) written consent using an approved Waikato DHB Consent form.

• If the patient is incompetent [refer to 8.3]

• The process of obtaining informed consent may occur during one or more appointments with the patient.

• To facilitate this process, the Provider must, wherever practicable:

o make every effort to ensure the privacy of discussions with the patient;

o respect the patient’s dignity e.g. in out-patient clinics, where practical, patients should be encouraged to dress in their own clothes and be comfortably seated before discussion of diagnosis and treatment options occurs.

o respect the patient’s cultural and personal needs e.g. support the involvement of family / whānau in discussions if appropriate (refer to Waikato DHB Best Practice guideline)

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o provide information to the patient in a language, form and manner that the patient can easily understand. Where necessary it should be translated into the patient’s own language.

o use published material where it could be helpful in providing the information needed.

o allow sufficient time for the patient to read written information, and speak with their family or friends if they wish to do so.

o advise patients that they have a right to have another person present during the discussion related to the proposed treatment or procedure.

o encourage the patient to ask questions or suggest alternative points of view.

Some patients may not want to discuss the details of a procedure. The Provider should explain to the patient that they cannot proceed with any procedure carrying significant risk without providing the information that a reasonable patient would wish to have about the procedure. In cases with minimal risk you may be justified in withholding or generalising information if the patient states that he or she does not want to hear it and where providing the information may cause him or her emotional harm.

4.2. What is sufficient information?

• The patient must be provided with the information that a reasonable patient, in that patient’s circumstances, would expect to receive and needs to make an informed choice and or give informed consent. It requires an understanding and experience of what represents a reasonable patient’s expectations and an understanding of the particular individual’s circumstances that may make more, less or additional information pertinent to their decision making. The onus on both counts rests with the provider. As a minimum the patient should be provided with the following:

o an explanation of their condition, together with any findings from investigations (tests and procedures) already carried out

o an explanation of the options available for treating their condition – important details of each option including an assessment of the expected risks, side effects, benefits, and costs of each option and any alternatives to the particular treatment proposed

o the consequences of not giving consent for the recommended option

o estimated timeframe for when they might expect to receive the service.

o discussion of any proposed participation in teaching or research

• Honest and accurate answers to all of the patient’s questions shall be given, including questions about:

o how to obtain a second opinion

o the Provider’s recommended option and why they recommend it

o the name and position of the person providing the service as soon as it is known.

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o the results of research

• Pre-prepared written information about the proposed service must be in plain English.

If there is no pre-prepared information and the patient wishes to have a written summary of the information it must be provided.

4.3. Who is responsible for providing the information?

• The primary responsibility for ensuring the relevant essential information is provided to the patient lies with the person who is responsible for the procedure – the treating clinician.

• Where it is impracticable for all information to come from the health professional conducting the procedure, a proxy can be used. However, this person must be sufficiently qualified and experienced to convey information to the patient in order to enable the patient to understand their condition, the proposed treatment, its intended benefits, any risks and possible side effects. It is the responsibility of the person performing a procedure to confirm that information provided by a proxy has been provided, is of an adequate standard to ensure is that the patient is suitably informed, and answers any questions the patient may have

• Anyone involved in the care or treatment of a patient who believes the patient is not being kept adequately informed must convey this to the clinician responsible for the patient’s care.

4.4. Who is responsible for obtaining informed consent?

• The Provider responsible for the procedure being performed also has the responsibility to ensure the patient’s informed consent is obtained. This must be:

o the patient’s consultant or delegate (the delegate must have an appropriate scope of practice) in the in-patient environment.

o the patient’s key worker (in Mental Health Community Services)

o the patient’s primary health professional (in Community Services)

o the patient’s Allied Health professional (for Allied Health procedures)

o the patient’s nurse for nursing care

• The Medical Council advises that no doctor should obtain a patient’s informed consent where they do not feel competent to do so. This principle applies to all health professionals.

5. When is informed consent required? • Unless a lawful exception exists (refer clause 6) then the patient’s informed consent

(either verbal or written) must be obtained for each and any proposed treatment or procedure. And:

o For participation in any research activity

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o for the storage preservation or use of any removed substance or body part other than as outlined in Right 7 (10)

• Separate consent must be obtained for each of the following:

o surgery

o the accompanying anaesthetic

o treatment of an unforeseen pathology which only becomes apparent during that surgery, unless excluded under the provisions of clause 6 “When is informed consent not required”

o a diagnostic test which is invasive or which involves some risk to the patient.

• In circumstances where the patient is consenting to a number of procedures within an overall treatment (e.g. ventilation of a premature baby involves a number of procedures including intubation, suction, insertion of intra-vascular lines, blood sampling etc.):

o each of the procedures must be explained and discussed with the patient or their Legal Representative

o a single composite consent is sufficient for a treatment regime, where there is the same course of treatment over time (e.g. a course of radiotherapy or chemotherapy, blood transfusion for haematological disorders, serial infusions after cancer therapy), however this must be redone if the patient’s clinical condition changes to an extent which requires a change in treatment or if the clinician has any other reasons to revisit the issue of consent, for example, a change in treatment following a less than optimal treatment (see also s7 below on how long consent remains valid)..

• A Resuscitation plan document should be completed on every patient within 24 hours of admission and patients and their families should have the opportunity to contribute to the plan discussion

• The informed consent of the family is required for a non-coronial post-mortem examination to proceed

Refer to the Waikato DHB Care of the Deceased / Tūpāpaku policy for further information relating to consent in this circumstance.

• When a patient is treated under the Mental Health (Compulsory Assessment and Treatment) Act 1992 the patient must give informed consent for procedures required to treat conditions that are not mental disorders. In these circumstances the usual consent requirements apply.

5.1. When is written consent required?

• Right 7(6) of the Code provides that written informed consent is required if:

o the patient is to participate in any research or

o the procedure is experimental or

o the patient will be under general anaesthetic or

https://intranet.sharepoint.waikato.health.govt.nz/site/pol/published/Care%2520of%2520the%2520Deceased%2520-%2520Tupapaku.pdf

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o there is a significant risk of adverse effects on the patient.

• Written consent is also legislatively required if the patient is admitted under the Mental Health (Compulsory Assessment and Treatment) Act 1992, the patient having had the treatment explained to him or her in accordance with section 67:

o (S.59:) consents in writing in order to receive treatment after the first month of a compulsory treatment order (unless treatment is approved by the psychiatrist appointed by the Review Tribunal); or

o (S.60:) when electro-convulsive treatment is ordered (unless treatment is approved by the psychiatrist appointed by the Review Tribunal); or

o (S.61:) when "brain surgery" is proposed.

• Waikato DHB also requires written consent in the following situations:

o where either the patient or Waikato DHB requests it

o where consent is given by the patient's Legal Representative

o where a medical or nursing or midwifery student is to undertake an examination or a procedure whilst the patient is under general anaesthetic or sedation

o where clinical video or photographic recordings (including digital photographs) are taken (refer to the Waikato DHB Clinical Images policy). Please note this consent is not for the treatment but to allow the photographs or video to be taken.

o where it is planned to retain any body parts that are removed or obtained in the course of a health care procedure (refer to the Waikato DHB Return or Disposal of Body Parts/Tissue/Prosthetic Devices policy)

o where transfusion of blood or blood products is required.

5.2. Other circumstances requiring consent

• Consent is required in situations beyond those set out above in 5.1 where treatment is proposed. Examples include:

o every healthcare service (treatment or procedure)

o where a student, staff member or external personnel wish to observe procedures in theatre

o where the patient’s information will be used for case studies, peer review or exemplars

o where a teacher wishes to involve the patient in a teaching or clinical demonstration session.

• Note: Consent is not required where information is used for teaching purposes and is not identifiable to the patient.

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6. When is consent not required? • There are a number of statutory exceptions to the requirements for informed consent

(see Appendix A,5).

• In an emergency situation the primary need is to treat the patient, and circumstances may make gaining informed consent impossible.

• An emergency exists when immediate action must be taken to preserve the life or health (physical or mental) of the patient. In such situations the treatment provided shall only be that necessary to correct the life- or health-threatening situation. Any further treatment shall be deferred until consent is obtained.

6.1. Documentation of the informed consent process

• If there is a consent form(s) available for the proposed treatment or procedure, this should be completed and placed on the clinical file.

• If a form is not available to document consent, the Provider is required to make clear and accurate notes about the consent process. This may include the following:

o what information was provided to the patient, when, by whom and who else was present

o questions asked by the patient and the answers given

o specific wishes of the patient

o who gave the consent i.e. whether it was the patient or the person acting on his / her behalf

o what treatment or procedure that consent was given for.

• Where the patient has declined to give their informed consent, this shall be documented in the clinical record.

7. How long is consent valid? • There are no limits placed on the length of time over which consent for treatment or a

procedure remains valid. However, a patient may change their mind and withdraw their consent at any time. The currency of consent should be checked at reasonable intervals in case it has been withdrawn or the patient’s previous consent has effectively lapsed. This is a period of time after which the proposed treatment can be considered to be “new” and no longer relates to any prior consent.

• The need to obtain new consent arises when there is a change to some relevant circumstance e.g. new information about complications of the proposed treatment; a significant change in the patient's condition, new or different treatment is proposed or where consent has been withdrawn.

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8. Consent and competence • Right 7(2) of the Code of Rights states: ‘Every consumer must be presumed

competent to make an informed choice and give informed consent, unless there are reasonable grounds for believing that the consumer is not competent.’

• For informed consent to be valid, it must be given by a competent patient or their Legal Representative (see Definitions Appendix B)

• The patient’s competence may be affected by medication, inebriation from drugs, alcohol or substance abuse, physical injuries, mental illness, or intellectual disability.

• Competence to consent shall be assessed by clinical evaluation and judgement. The treating shall determine the degree to which the patient is able to:

o understand the essential information to allow him/her to make an informed choice;

o retain that information and be able to recall it;

o use and weigh this information in the reasoning and decision-making process;

o communicate their understanding and that they reached a decision as a result of it.

• In determining competence, the focus must remain on the patient’s capacity to understand and communicate this effectively. If it is clear that the patient is competent in this regard, then the conclusion they reach must be respected. This is the case even if the Provider believes that the decision that they have made is not in the best interests of the patient. In addition to the factual information provided about their condition, the patient may choose to take additional personal factors into consideration.

• Competence shall be assessed in relation to the patient’s ability to make an informed choice and give informed consent to a particular service. (Some patients may not be competent to make a decision about some services but may be perfectly competent to give informed consent to a less complex service.)

• A patient who has diminished competence retains the right to make informed choices and give informed consent, to the extent that they are able to.

• The Provider shall make the final decision on whether to provide the proposed treatment to the patient if the patient is not competent to consent and no person entitled to consent on behalf of the patient is available. In this situation treatment may be provided as outlined in Right 7(4)

• Consent obtained by telephone can only be accepted if the Provider verifies the identity and authority of the person giving consent.

8.1. The impact of age on the ability to give informed consent

• Competence is not directly linked to age. Consent should be obtained from the patient to the extent that they are able to make an informed choice and give informed consent for the proposed treatment or services, regardless of age.

• The Guardians of a child under 16 can give informed consent on behalf of the child. In general terms, efforts should be made to obtain consent both from the child (to the

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extent that they are capable of) and the Guardian. Exceptions to this requirement are:

o if the child is fully competent to give consent

o treatment carried out in an emergency

o females of any age have the right to consent to or refuse a termination of pregnancy being carried out on themselves, provided they are competent to do so (Section 38 of the Care of Children Act 2004)

o contraceptive advice and treatment – there is no restriction on the supply of contraceptive advice or the prescribing of contraception to young people under 16 years of age

o in certain defined circumstances a child / person under the age of 16 years may be given a blood transfusion without his or her own consent or the consent of a guardian (see section 10 on Blood and Blood Products)

o the right of public healthcare clinicians to examine a child (or children) at a public school or childcare centre undersection 125 of the Health Act 1956

o where a compulsory medical examination has been ordered by the Family Court under section 49 of the Oranga Tamariki Act 1989

o where guardianship of the child has been vested in the court and the power to give or withhold informed consent rests with the court or its agent. (Section 31 of the Care of Children Act 2004).

o Where there is no guardian in New Zealand, or no guardian can be found with a reasonable search, or no guardian with capacity to consent can be found, then consent may be given by a person in New Zealand who has been acting in the place of a parent

o where the Chief Executive of Oranga Tamariki has been appointed as sole guardian of the child, consent can only be given by the Chief Executive (Section 110(2)(a) Oranga Tamariki Act 1989). A child 14 years and over may apply to the court to overturn a refusal of consent by the Chief Executive in respect of important matters that affect the child (Section 116).

• Appendix B sets out the legislative requirements relating to the age of persons who can give consent under specific circumstances.

• A child's capacity to make an informed choice may be diminished by their reaction to being in hospital or experiencing pain. While every effort should be made to support the child, their guardians' consent to the treatment will be sufficient if, for health reasons, treatment should not be postponed.

• If the child is considered competent by the Provider and there are no other concerns, then the child’s consent is sufficient to proceed with treatment.

• However, if the child’s decision is different from the Guardian’s wishes or if there are concerns about the child being coerced, then the Provider should seek advice from DHB Legal Services.

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• If the child is not considered competent to consent:

o a Guardian can consent on the child’s behalf.

o if the Guardian refuses to consent to treatment, and in the view of the doctor treatment is necessary, then there are other means of proceeding lawfully without the consent of a Guardian and these must be used. Seek advice from DHB Legal Services.

o if there is a difference of opinion about treatment between a competent child and their Guardian(s) you should seek advice from DHB Legal Services.

• Informed consent for sterilisation of an intellectually impaired child is a complex legal issue, and the legal position in New Zealand is unclear. Staff shall seek advice from DHB Legal Services in this circumstance.

8.2. The impact of medication on competence to consent

• Medication given for pain relief, in anaesthesia, or to treat psychiatric illness may impair a patient's judgement and thus their competence to consent.

• Equally, although consciousness may sometimes be impaired by medication, there is often an improvement in concentration and thinking ability with the relief of symptoms such as pain, anxiety and depression. Conversely, unrelieved pain, anxiety or depression may of themselves impair competence.

• Where practicable, discussion about treatment should take place before the administration of any medication liable to affect competence. However, consent for further treatment will sometimes be necessary from patients who have, for instance, received medication for pain relief. Sound clinical judgement must be exercised in these circumstances.

• When a patient's competence has clearly been impaired by medication, and the procedure is not urgent, recovery should be allowed before consent to further treatment is sought.

8.3. When the patient is not competent Only certain people can consent to medical treatment on behalf of an incompetent patient.

• In the case of children, section 36 of Care of Children Act 2004 applies. Consent may be given by:

o Guardian of the child; or

o if no such person can be found with reasonable diligence or is capable of giving consent, by a person in New Zealand who has been acting in the place of a parent; or if neither of the above can be satisfied, then

o by a District Court Judge or the Chief Executive of Oranga Tamariki

• In the case of adults (18 years and over), the provisions of the Protection of Personal and Property Rights Act 1988 may apply. This legislation provides for the appointment of welfare guardians and for the granting of enduring powers of attorney.

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In brief: a welfare guardian appointment is made by the Court on behalf of a person who is unable to appoint someone to look after their affairs; enduring power of attorney is granted by someone (“the donor”) to another person (“the attorney”) to enable the attorney to look after the donor’s affairs when they become incompetent. It is important to determine that the power of attorney has been activated by determination of incompetence. It is also important to confirm that the nature and extent of the welfare guardianship or power of attorney includes health care decisions. This can only be done by sighting the Court Order appointing a welfare guardian, a copy of which needs to be placed in the patient’s clinical notes.

• Neither the patient's next of kin nor any other relative has the right to consent or refuse medical treatment on the patient's behalf unless they are a Guardian, welfare guardian, or hold an activated enduring power of attorney in relation to personal care and welfare.

• No welfare guardian or person with an activated enduring power of attorney has the legal right to consent on behalf of the patient to:

o the administration of electro-convulsive treatment or

o the performance of brain surgery designed to destroy any part of the brain or any brain function or

o the patient taking part in any medical experiment (except for the purpose of saving the patient’s life or preventing serious damage to the patient’s health)

• No welfare guardian or person with an activated enduring power of attorney can refuse to consent to the provision of any standard medical treatment or procedure intended to save the patient’s life or prevent serious damage to their health.

• No Legal Representative has the right to consent to the patient’s sterilisation if the patient is incompetent only by reason of their age.

• If there is no one with a legal right to give consent on behalf of the incompetent patient, then Right 7(4) of the Code applies (refer to section 8 - Consent and Competence).

• Where a direction for medical examination has been ordered by the medical officer of health or the individual’s medical practitioner under Section 92K of the Health Act 1956

• Where a public health order to be treated for an infectious disease has been ordered by the District Court under Section 92ZA of the Health Act 1956

• Where a medical examination order has been ordered by the District Court under Section 92ZH of the Health Act 1956

• Where an order for contacts has been made by the District Court under Section 92ZJ of the Health Act 1956

• Appendix B provides a flowchart for use of Right 7(4).

• One way of knowing what the patient would have wished, is through the provision of an advance directive.

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8.4. Advance Directive

• An “advance directive” is a written or oral directive by which a patient can make choices about possible future healthcare procedures and setting out the treatment they would want or not want. They are intended to become effective only when the patient is not competent to provide informed consent.

• A provider must establish that:

o The patient was competent at the time the advance directive decision was made

o The decision was made voluntarily and without coercion

o The decision was an informed choice

o The decision is applicable to the present circumstances

o The decision is current

• If you are faced with an advance directive (written or oral) and it pertains to the patient’s proposed treatment, please seek advice from DHB Legal Services as the risks associated with incorrectly applying an advance directive can be significant.

8.5. Patient refusal to consent to treatment

• When a competent patient does not consent to all or part of treatment the Provider shall:

o explain possible risks and consequences involved in refusing treatment

o provide relevant health information, including information on continuing care requirements

o inform the patient’s responsible clinician of the patient’s refusal to consent to treatment

o reassure the patient that the decision to refuse treatment will not affect their access to future treatment

o with permission of the patient or under Section 7A of the Mental Health (Compulsory Assessment and Treatment) Act 1992 involve family / whānau, support person/s and / or advocates

o if appropriate contact the Mental Health Crisis Assessment and Treatment Team to enact the Mental Health (Compulsory Assessment and Treatment) Act 1992

o if appropriate facilitate discharge or support self-discharge (refer to the Waikato DHB Admission, Discharge and Transfer policy)

o if appropriate seek legal support from DHB Legal Services e.g. treatment of child or young person

o document the patient’s refusal to consent in the patient’s clinical record.

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9. Responsibilities

9.1 Informed consent forms All forms used for recording the patient’s informed consent shall:

• be approved by the Waikato DHB Clinical Records Committee

• be filed in the patient’s clinical record.

10. Blood and blood products • Every patient who is a potential recipient of blood or blood products (or their Legal

Representative) must be given information about the risks of blood transfusion and alternatives available. It is important that they are: o given time to read the information provided, and

o advised of any alternatives to transfusion of volunteer donated blood, if any e.g. use of patient’s own blood and

o provide with the opportunity to have their queries answered.

• The patient or their Legal Representative must give their written consent for the administration of blood or blood products to the patient.

• Where transfusion may be needed during surgery, written consent for this should be obtained by the surgical team for blood transfusions. .

• In an emergency situation where the patient cannot give consent, blood products may be given to preserve life or prevent permanent or serious injury. When the emergency situation has passed, further treatment must not be given without the consent of the patient.

10.1. Refusal of blood or blood products

• In an emergency situation where the patient lacks competence, if there is prior knowledge that the patient would not agree to blood transfusion e.g. clear and current advance directive, this must be respected unless there is good reason to believe the directive is not valid. (See also the statutory exception to the need to gain informed consent in Appendix A)

• In other situations, when a competent adult patient refuses blood or blood products, this decision must be respected. The responsible Provider must ensure that: (see 8.5 Patient refusal to consent to treatment) o the person making the decision fully understands the implications this refusal may

have on the clinical outcome, and

o the decision is not the result of any outside influence or coercion

o the decision is documented on the Waikato DHB Blood Consent form.

• Where the Provider is concerned about the legal or ethical aspects of a particular situation, the advice from DHB Legal Services should be sought.

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11. Organ retrieval and use for therapeutic purposes • The Human Tissue Act 2008 regulates the collection and use of tissue (including organs)

from cadavers.

• Prior to their death, the patient may consent to use of their tissue for organ/tissue donation or for research. The patient may also nominate a person to give or refuse consent to do so on their behalf after their death.

• In the absence of consent from a patient or their nominee, the decision can be made by the immediate family. If the immediate family is unable to reach an agreed position, there is provision for a decision to be made by a particular relative (e.g. a spouse of the deceased).

• The immediate family has the legal right to make an informed objection to the use of tissue.

• Removal of tissue for organ donation or medical research purposes should not take place if you have concerns that the deceased may have changed their mind since recording their consent or if the immediate family objects to such removal. Contact DHB Legal Services for advice on application of these principles.

• Tissue can be removed and used without informed consent under the Coroners Act 2006 or for criminal justice purposes.

• If the death is reportable to the Coroner, removal of organs for therapeutic purposes must not occur without the Coroner’s permission.

12. Audit

12.1. Indicators

• Healthcare professionals appropriately assess their patient’s competence to consent to treatment or non-treatment

• Where the patient is incompetent, a legally authorised representative is identified and consent is obtained from them or an appropriate alternative mechanism for obtaining consent is utilised

• Healthcare professionals provide their patient’s with sufficient information to enable the patient to freely make an informed choice

• The patient’s consent is recorded in a signed form or in the patient’s clinical record

• In the case of children, consent is obtained from them to the extent that they are capable of providing it

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13. Legislative Requirements

13.1. Legislation Waikato DHB must comply with the following legislation (this list is not exclusive):

• Armed Forces Discipline Act 1971

• Bill of Rights Act 1990

• Care of Children Act 2004

• Children’s Act 2014

• Contraception, Sterilisation and Abortion Act 1994

• Coroner’s Act 2006

• Crimes Act 1961

• Criminal Investigations (Bodily Samples) Act 1995

• Criminal Procedure (Mentally Impaired) Act 2003

• Crimes of Torture Act 1989

• Health Act 1956

• Health and Disability Commissioner Act 1994

• Health and Disability Commissioner Code of Consumers’ Rights 1996

• Health and Disability Services (Safety) Act 2001

• Health Information Privacy Code 1994

• Health (Immunization) Regulations 1995

• Health (Protection) Amendment Act 2016

• Health Practitioners Competence Assurance Act 2003

• Human Rights Act 1993

• Human Tissue Act 2008

• Accident Compensation Act 2001

• Intellectual Disability (Compulsory Care and Rehabilitation) Act 2003

• Land Transport Act 1998

• Mental Health (Compulsory Assessment and Treatment) Act 1992 and Amendments 1996

• New Zealand Public Health and Disability Act 2000

• Oranga Tamariki Act 1989

• Privacy Act 1993

• Protection of Personal and Property Rights Act 1988

• Substance Addiction (Compulsory Assessment and Treatment) Act 2017Vulnerable Children Act 2014

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14. Associated Documents

14.1. Associated Waikato DHB Documents

• Waikato DHB Resuscitation policy (1970)

• Waikato DHB Clinical Records management policy (0182)

• Waikato DHB Care of the Deceased / Tūpāpaku policy (0133)

• Waikato DHB Consent for Blood Components/Blood Products/Surgical Bone/Other Tissues policy (3247)

• Waikato DHB Māori Health policy (0108)

• Waikato DHB Medicines Management policy (0138)

• Waikato DHB Information Privacy policy (1976)

• Waikato DHB Disclosure of Health Information policy (1365)

• Waikato DHB Return or Disposal of Body Part/Tissue/Prosthetic Devices policy (0131) – Expired

• Waikato DHB Ethics Research procedure (5372)

• Waikato DHB Research policy (0142)

• Waikato DHB Interpreters and Translation policy (0137)

• Waikato DHB Tikanga Best Practice guideline (2118)

• Waikato DHB Towards Māori Health Gain Organisational Framework

14.2. Other Regulations and References

• Health and Disability Services Standards NZS 8134:2008

• New Zealand Medical Association Code of Ethics

• MCNZ Statements and standards for Doctors March 2011 Information, choice of treatment and informed consent

• The United Nations Convention on the Rights of the Child 1989

• The United Nations Convention on the Rights of Persons with Disabilities

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Appendix A Summary of statutory exceptions to informed consent

Abortions on persons who lack "mental capacity"

Section 34 of Contraception, Sterilisation and Abortion Act 1977 requires certain enquiries be made before an abortion is authorised to be performed on a person who lacks mental capacity to consent.

Treatment of armed forces personnel

S72 of the Armed Forces Discipline Act 1971 provides a range of circumstances where an armed forces enlisted personnel must submit to treatment if ordered to do so.

Taking blood samples to detect drink driving offences

S72, 73 and 74 of the Land Transport Act 1998 provides legal consent permitting the taking of blood samples from persons attending hospital or doctor's surgery suffering injury as a result of a motor vehicle accident. If an enforcement officer requests a blood specimen be taken from such a patient, the medical practitioner in charge must either take the sample or organize for another medical practitioner to take a sample irrespective of whether the patient has consented to sampling or has the capacity to consent

Blood transfusions for persons under 18 years

S37 of the Care of Children Act 2004 provides immunity against civil and criminal liability and disciplinary proceedings to a medical practitioner in defined circumstances; necessary to save the life or prevent permanent injury to mental, physical health and where reasonable attempts to obtain consent of a guardian have been made, or such consent has been refused.

Civil proceedings Section 44 of the Senior Courts Act provides that the High Court can order that a person submit to a medical examination where the physical or mental condition of a person party to the proceedings is relevant to any matter in question.

Contraception to persons who are mentally subnormal

S4 of the Contraception, Sterilisation and Abortion Act 1977 provides that women who are described as mentally subnormal, as defined by the Act, can be given contraceptives without their consent.

Examinations of children in public and private schools

S125 of the Health Act 1956 permits the Medical Officer of Health to enter schools and child care centres to examine children (subject to the request of the school in the case of private schools). The Officer may examine any child at the school or centre. The prior consent of the parents is not required.

Court Order – children suspected to be suffering from ill treatment, abuse or neglect

S49 and S53 of the Oranga Tamariki Act 1989 contains provisions permitting clinicians to conduct certain examinations and report to the Court without their or their parent's consent, subject to certain provisions.

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Treatment of suspected infectious disease

S77 of the Health Act 1956 empowers a Medical Officer of Health to enter any premises and examine any person believed to be suffering from, or recently exposed to, an infectious disease

Treatment of persons lacking capacity to consent

Right 7(4) of the Code of Health and Disability Services Consumers’ Rights may apply.

Mentally ill persons The Mental Health (Compulsory Assessment and Treatment) Act 1992 provides that a person, who is required to undergo assessment in terms of Part I of the Act or under an Order for compulsory treatment in terms of Part II, must comply subject to certain provisions. Provisions particular to children are defined where they differ to adults (S85,86,87,88,89,90)

Bodily samples for criminal investigations

The Criminal Investigations (Bodily Samples) Act 1995. The High Court may order the taking of blood or bodily samples from suspects in criminal investigations when suspect declines consent.

Post-Mortems The Coroners Act 2006 empowers the Coroner to require a post-mortem in certain circumstances (ss31-39).

Offence likely to cause immediate/serious injury to person/property

S41 of the Crimes Act 1961 allows restraint without consent where there is the likelihood of suicide or an offence likely to cause immediate/serious injury to any person or property.

Persons under 16 years who lack "capacity" to give consent

S36(3) of the Care of Children Act 2004 permits a guardian, person acting in place of a parent (following reasonable attempts to find the guardian), District Court Judge or Chief Executive of the Ministry for Vulnerable Children, Oranga Tamariki to give consent to any medical, surgical or dental procedure.

S31 of the Care of Children Act 2004 allows the High Court or Family Court to place a child under the Court’s guardianship. In this situation the Court or its agent can give consent to any form of medical treatment or procedure that is in that person’s welfare. Please refer to DHB Legal Services

Welfare Guardians The Protection of Personal and Property Rights Act 1988 allows the Court to appoint a Welfare Guardian to make decisions on behalf of a person 18 years of age or over who wholly lacks capacity.

Enduring Power of Attorney for care and welfare

The Protection of Personal and Property Rights Act 1988 enables a competent person to appoint an attorney to act for them in advance of incapacity.

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Appendix B Summary of statutory provisions of who can give consent

Note: The following summary is intended only as a guide. If you have any concerns, please consult DHB Legal Services.

Persons in Respect of Whom Consent can be

given

Who can Give Consent Consent to what treatment or procedure

Statutory Provisions

Persons 16 years of age or over who have capacity to give consent

Such persons can consent for themselves.

Any medical, surgical, or dental procedure.

S36(1), Care of Children Act 2004

Persons under 16 years of age who lack capacity to give consent

A guardian. In the absence of a guardian, a person in NZ who has been acting in the place of a parent. In the absence of such a person, a District Court Judge or the Chief Executive of the Ministry for Vulnerable Children, Oranga Tamariki.


S36(3), Care of Children Act 2004.

Persons under 18 years of age who lack the capacity to give consent

A guardian. In the absence of a guardian, a person in NZ who has been acting in the place of a parent. In the absence of such a person, a District Court Judge or the Chief Executive of the Ministry for Vulnerable Children, Oranga Tamariki.


S36(3), Care of Children Act 2004

Persons under 17 years of age in respect of whom agreements have been made under S139, 140, or 141 Oranga Tamariki Act 1989 for their temporary care, extended care, or the extended care of the severely disabled person.

The Chief Executive of Ministry for Vulnerable Children, Oranga Tamariki, Iwi Authority, Cultural Authority, or a Child and Family Support Service.


S149 Oranga Tamariki Act 1989.

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given



Persons under 17 years in respect of whom a medical examination is required by a Social Worker employed by the Department of Child, Youth and Family.

A parent or guardian. A medical examination other than an examination under anaesthetic or an internal examination of the anus or genitals of the young person, unless the doctor performing the examination believes the child or young person has been sexually abused and the child or young person gives consent.

S53(2), S55 Oranga Tamariki Act 1989.

Persons under 17 years in respect of whom a medical examination is required by a Social Worker employed by the Department of Child, Youth and Family.

Such persons may consent for themselves.

A medical examination involving an internal examination of the anus or genitals if the doctor carrying out the examination believes they have been sexually abused.

S55(1)(b) Oranga Tamariki Act 1989.

Persons under 18 who are not or have not been married who are "incapacitated" in respect of whom a welfare guardian has been appointed because no parent or guardian is living or in regular contact with that person and it is in their interests that a welfare guardian be appointed.

Welfare guardian Any medical treatment or procedure other than electro-convulsive treatment, brain surgery designed to change the person's character, and medical experiments not conducted to save the person's life or prevent serious illness to their health.

S12(2), (3), S18(1)(d), (e), (f) Protection of Personal and Property Rights Act 1988.

Persons under 18 who are not or who have not been married.

High Court or Family Court or duly appointed agent of the High Court or Family Court.

Any form of medical treatment or procedure that is in that person's welfare.

S31, Care of Children Act 2004

Any pregnant female of Can consent in their own The performance of an S38, Care of Children

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given



any age.. capacity. abortion on themselves. Act 2004

"Incapacitated" persons 18 years of age or over in respect of whom a welfare guardian has been appointed

Welfare Guardian Any medical treatment or procedure other than electro-convulsive treatment, brain surgery designed to change the person's character, and medical experiments not conducted to save the person's life or prevent serious illness to their health.

S12(2), S18(1)(d), (e), and (f) Protection of Personal and Property Rights Act 1988.

Mentally impaired persons who lack competence to manage their own affairs

High Court. Medical Examination by a registered medical practitioner

Senior Courts Act S14, S 44.

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Appendix C Guide for use of Consent for Surgical Procedures (Investigations or Treatments) Form (RP039)

Section A: Patient Information (1-4)

WHO? This section is completed by the health professional, with an appropriate knowledge of the proposed procedure, together with the patient. In practical terms, this will be the consultant surgeon or registrar, preferably the one who will be performing the surgery. WHERE/WHEN? Elective Surgery In the Elective Surgery Short Stay Unit or rooms, when the patient is placed on the waiting list Acute Surgery In the Emergency department, ward or clinic, prior to surgery. Note: Once Section A is completed, dated and signed by both the health professional, and the patient, the yellow copy is detached and given to the patient. The white copy is filed in the clinical notes.

Section B: Patient Consent (5 and 6)

WHO? This is completed by the patient together with any health professional of Waikato DHB, ONLY if Section A has been completed appropriately. In practice, this will be a registered or enrolled nurse, house office, registrar, or consultant surgeon. If Section A has not been completed appropriately, or if the patient has further questions that are unable to be answered by the nurse/house officer, then the registrar or consultant surgeon performing the procedure will need to be contacted to complete Section A, prior to completing Section B. WHERE/WHEN? Elective Surgery Statement of patient may be completed either prior to admission, in pre-admission clinic, or on admission (in ward or Day of Surgery Admission Unit), by patient themselves. Confirmation of consent is completed by the health professional at the time of the patient admission for procedure (in ward or Day of Surgery Admission Unit).

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Acute surgery Both statement of patient and confirmation of consent are completed prior to surgery – generally at the same time as Section A is completed, so it can be signed by same health professional (consultant surgeon/registrar performing procedure).

BLOOD PRODUCT TRANSFUSION Current blood transfusion consent form is still required in addition to the Consent for Surgical Procedures form (RP039) RETURN OF TISSUE/LIMB REQUEST If this has been requested, current Request for Return of Tissue form is still required, in addition to the Consent for Surgical Procedures form (RP039) ANAESTHETIC CONSENT Current Request for Anaesthesia care form is still required, in addition to the Consent for Surgical Procedures form (RP039). PRE-OP CHECKLIST IN WARD AND DAY OF SURGERY ADMISSION UNIT Nurse is to check that both Part A and Part B have been completed, also checking return of tissue request form is completed IF required. AT THEATRE CHECK-IN Nurse to check that both Part A and Part B have been completed, also checking return of tissue request form is completed IF required.

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Appendix D Consent for Treatment/Non-treatment of the Incompetent Adult Patient

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