Policy Document Control Page

Title
Title: Consent to Examination or Treatment Policy
Version: 7
Reference Number: CL2
Keywords:
Consent, Examination, Treatment, Capacity, Fraser, Competency, Parental Responsibility, Zone of Parental Control, Statement, Preferences, Wishes, Advance, Decisions, Lasting Power of Attorney, Deputies, Mental Capacity Act, Research, photography, life sustaining treatment, consent form, video recording, tissue, court of protection, refusals
Supersedes
Supersedes: Consent to Examination or Treatment Policy v6
Description of Amendment(s):
  • Policy reflects and signposts health care professionals regarding consent requirements set in the case of Montgomery v Lanarkshire Health Board (Scotland) [2015] UKSC 11. This case has provided the Supreme Court with the opportunity to firmly state that the need for “informed consent” is now part of English law. This landmark ruling clearly illustrates the Court’s growing appreciation of patients’ self-determination and ability to understand the consequences and risks of a particular treatment. Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council.
  • Significant detail added around information giving including material risks to allow patients to make informed decisions around giving or withholding consent
  • Appendix 9 updated Online Resources for Clinicians
  • Appendix 14 Revised Mental Capacity Assessment Form
  • Appendix 15 Powers of Restraint and Detention – updated guidance
  • Electronic recording of consent

Originator
Originated By: Mental Health Law Manager
Designation: On behalf of the Mental Health Law Scrutiny Group
Equality Impact Assessment (EIA) Process
Equality Relevance Assessment Undertaken by: Mental Health Law Manager
ERA undertaken on: 3rd February 2016
ERA approved by EIA Work group on: 4th February 2016
Where policy deemed relevant to equality-
EIA undertaken byMental Health Law Manager
EIA undertaken on
EIA approved by EIA work group on
Approval and Ratification
Referred for approval by: Mental Health Law Manager
Date of Referral: 10/02/2016
Approved by: Mental Health Law Scrutiny Group
Approval Date: 12/02/2016
Date Ratified by Executive Directors: 14th March 2016
Executive Director Lead: Medical Director
Circulation
Issue Date: 15th March 2016
Circulated by: Performance and Information
Issued to: An e-copy of this policy is sent to all wards and departments
Policy to be uploaded to the Trust’s External Website? YES
Review
Review Date: October 2018
Responsibility of: Mental Health Law Manager
Designation: On behalf of the Mental Health Law Scrutiny Group
This policy is to be disseminated to all relevant staff.
This policy must be posted on the Intranet.

Date posted: 15th March 2016

SECTION / TABLE OF CONTENTS / PAGE
1
/ INTRODUCTION / 5
2
/ SCOPE / 7
3
/ DEFINITIONS AND TERMINOLOGY, / 8
4
/ RESPONSIBILITIES / 9
5
/ PROCESS FOR SEEKING CONSENT / 10
  • When consent is refused
/ 13
  • Withdrawal of Consent
/ 14
  • Advance Decisions to refuse treatment
/ 14
  • Has consent been given voluntarily?
/ 16
6
/ INFORMATION / 16
  • Provision for patients whose first language is not English
/ 20
  • Access to more detailed or specialist information
/ 20
  • Access to health professionals between formal appointments
/ 20
  • Open access clinics
/ 20
7
/ DOCUMENTATION / 21
  • Completing consent forms / Electronic recording
/ 21
8
/ SEEKING CONSENT FOR ANAESTHESIA / 22
9
/ EMERGENCIES / 23
10
/ MENTAL CAPACITY ACT AND PATIENTS LACKING CAPACITY PROCESSES / 23
  • Does the person have capacity?
/ 23
  • Duration of lack of Capacity
/ 25
  • Consent of Adults who lack capacity
/ 25
  • Statements of Preferences and Wishes / Where a patient lacks capacity and continues to refuse treatment
/ 25
  • Lasting Power of Attorney (LPA)
/ 27
  • Court Appointed Deputies
/ 27
  • Independent Mental Capacity Advocates
/ 28
  • Referral to Court
/ 28
  • Withdrawing and withholding life sustaining treatment: General guidance
/ 29
  • Withdrawing and withholding life sustaining treatment: Adults and Children with Capacity
/ 30
  • Withdrawing and withholding life sustaining treatment:Adults and Children lacking Capacity
/ 31
11
/ SELF HARM / 31

12

/ TREATMENT OF CHILDREN AND YOUNG PEOPLE / 32
  • Children or Young People with capacity refusing treatment
/ 33
  • Children under 16 (the concept of Fraser Guidelines)
/ 33
  • Children Lacking Capacity
/ 34
  • Who has Parental Responsibility?
/ 35
  • Young People
/ 35

13

/ TISSUE / 37

14

/ CLINICAL PHOTOGRAPHY AND CONVENTIONAL OR DIGITAL VIDEO RECORDING / 38

15

/ IMPACT OF POLICY ON CQC REGISTRATION / 38

16

/ MONITORING / 39

17

/ IMPLEMENTATION AND TRAINING / 41
  • Training
/ 41

18

/ REFERENCES / 42
APPENDIX 1 CONSENT FORM 1 - Patient Agreement to Investigation or Treatment / 43
APPENDIX 2 CONSENT FORM 2 - Parental agreement to Investigation or treatment for a child or young person / 45
APPENDIX 3 CONSENT FORM 3 - Parental/Patient agreement to Investigation or treatment(procedures where consciousness not impaired) / 47
APPENDIX 4 CONSENT FORM GUIDANCE TO HEALTH PROFESSIONALS – To be read in conjunction with consent form 1-3 / 48
APPENDIX 5 CONSENT FORM 4 - Form for adults who are unable to consent to investigation or treatment / 49
APPENDIX 6 CONSENT FORM GUIDANCE TO HEALTH PROFESSIONALS – To be read in conjunction with consent form 4 / 51
APPENDIX 7 Questions to ask health professionals / 52
APPENDIX 8 Case Law Summary – Consent / 53
APPENDIX 9 Online Resources for Clinicians / 56
APPENDIX 10 GUIDANCE NOTE ADVANCE DECISIONS / 58
APPENDIX 11 ADVANCE DECISION TEMPLATE / 60
APPENDIX 12 GUIDANCE NOTE WRITTEN STATEMENTS / 62
APPENDIX 13 WRITTEN STATEMENT TEMPLATE / 64
APPENDIX 14 MENTAL CAPACITY ASSESSMENT FORM / 66
APPENDIX 15 BEST INTEREST CHECKLIST / 68
APPENDIX 16 MCA DECISION MAKING PATHWAY / 70
APPENDIX 17 MCA BEST INTEREST PATHWAY / 71
APPENDIX 18 GUIDANCE POWERS OF RESTRAINT AND DETENTION / 72
APPENDIX 19 SEEKING CONSENT REMEMBERING THE PATIENTS PERSPECTIVE / 75

Consent to Examination and Treatment Policy

1Introduction

1.1 Pennine Care NHS Foundation Trust is committed to ensuring patient’s legal rights are protected and they can expect healthcare professionals to work in an ethical and lawful manner. In terms of providing treatment, physical investigation and personal care, the Trust believes a patient’s autonomy to determine what happens to their body should be the paramount consideration.

1.2Although recognising that a failure to comply with the principles of consent and examination could lead to legal challenge, the overriding aim of the Trust is promoting participation and respecting a patient’s right to choose what treatments and interventions we provide to them.

1.3The purpose of this document is to provide healthcare professionals with procedures and information relating to the consent of living patients.

1.4The aim of this policy is to:

  • Ensure staff understand the legal requirements relating to obtaining consent
  • Encourage participation and respect of patient’s rights particularly relating to physical interventions and clinical procedures
  • Establish clear processes for seeking and documenting consent

1.5This policy also aims to be compliant with the legal requirement for the general principles of consent including the Trust obligations under the Human Rights Act[1]. Statute does not deal with consent although case law (‘common law’) has established that physical intervention with a patient without valid/informed consent may constitute the civil or criminal offence of assault or battery. The availability of Trust guidance in this area aims to prevent legal claims of negligence or complaints from patients either to the Trust or to professional bodies.

1.6In order to ensure that staff workin partnership with patients they must:

  • Listen to patients and respect their views about their health
  • Discuss with patients what their diagnosis, prognosis, treatment or care involves (dependent upon your role in their care)
  • Share with patients all relevant information they want or need (to allow them to make informed decisions based on a sufficient knowledge of the purpose, nature,likely effects and risks of that treatment, including the likelihood of its success andany alternatives to it. Permission given under any unfair or undue pressure is not consent.
  • Maximise patients’ opportunities, and their ability, to make decisions for themselves.
  • Respect patients’ decisions.
  • When there is doubt regarding a proposed intervention or patients consent, staff must seek further information and access legal advice from the Trust’s legal team.

1.7This policy complements (and when appropriate should be read in conjunction with) the following Trust policies available on the intranet (please note that this is not an exhaustive list and all health care professionals have a duty to ensure that the principles of obtaining valid and applicable consent or applying the principles of the Mental Capacity Act (2005) is evident in their practice in relation to providing care and treatment and intervention to patients):

  • CL1 Patient Identification Policy
  • CL5 Observation & Engagement Policy
  • CL6 Patients Absent Without Leave Policy
  • CL8 Co-Morbidity Strategy
  • CL9 Resuscitation Policy
  • CL14 Rapid Tranquilisation Policy
  • CL19 Clinical Risk Assessment & Management Policy
  • CL20 Guideline for Physical Examination & Assessment on Admission
  • CL21 Section 136 MHA 1983 - Removal to a Place of Safety Policy
  • CL25 Protocol for Mental Health Inpatient Service Users Who Require Care in the Pennine Acute Hospital
  • CL26 Policy for Seclusion, Time Out & Other Restriction of Patients Movement
  • CL27 Procedure of Venepuncture
  • CL32 Community Treatment Order Policy
  • CL36 Section 132, 132A, and 133 MHA (provision of information) Policy
  • CL39 Unified Cardiopulmonary Resuscitation Policy
  • CL42 Mental Health Services Physical Health Policy For Service Users Aged 18 Years and Over
  • CL43 Non Medical Prescribing Policy
  • CL46 Complementary Therapies Policy
  • CL48 Falls Prevention & Management Strategy
  • CL49 Mental Health Act 1983 Section 117 Policy
  • CL54 Guidance for the Management of Pornography & Sensitive Materials on In-patient Units
  • CL58 Treatment of patients subject to the Mental Health Act 1983 Part 4 & Part 4a V3
  • CL61 Admission, Entry & Exit Policy for Mental Health Ward
  • CL62 Mobile Phone Policy for Service Users and Visitors
  • CL63 Patients' Property Policy and Procedure
  • CL73 Specimens Policy
  • CL74 Management of Head, Body and Public Lice
  • CL80 Management of Scabies Policy
  • CL81 Electro Convulsive Therapy Policy
  • CL83 Research and Development Policy
  • CL87 Victims Policy
  • CL89 Clinical Audit Policy
  • CL90 Procedure for Specialist CMHN Assessments
  • CL91 Nearest Relative Policy
  • CL93 Bealey Community Discharge Policy
  • CL94 Practice Guidelines for Clinical Risk Assessment & Management Policy
  • CL95Butler Green Community Hospital Discharge Policy
  • CL97 Butler Green Enhanced Intermediate Care Admissions Policy
  • CL99 Guidance for Staff on Disclosure/Discovery of Assisted Suicide
  • CL111 Newborn Bloodspot Screening Policy
  • CL104 Children’s Speech and Language Therapy Access & Discharge Policy
  • CL106 Bealey Community Hospital Admission Policy
  • CL110 Policy for the Management of Adults with Acquired Dysphagia
  • CL112 Health of Looked After Children Policy
  • CL114 Paediatric Dysphagia Policy
  • CL115 Client Focused Physical Intervention Policy for Adults and Children (L D Directorate)
  • CO4 Confidentiality Policy
  • CO10 Incident Reporting, Management and Investigation Policy
  • CO23 Inclusive Involvement and Participation of Service Users and Carers Policy
  • CO64 Privacy & Dignity Policy
  • CO65 Guidelines for Supporting Service Users with Management of Personal Money
  • CO104 Non Access to a Clients Home/Non-attendance at Clinic Appointments Policy
  • GL1 Ear Care Guidance Including Irrigation and Otoscopy for Adults
  • GL3 Wound Care Photography Procedure
  • GL4 Nephrostomy Tube Care Guidelines for Adults and Children
  • GL5 Safeguarding Children and Domestic Abuse Guidelines (Part of Safeguarding Children Policy)
  • GL9 Earwax Clearance by Suction Guidelines
  • GL13 Continence Promotion and Management of Urinary and Faecal Incontinence for Adults
  • GL14 Trial Without Catheter (TWOC) in the Community Setting for Adults
  • GL18 Digital Rectal Examination Guidance for Adult
  • GL16 Maternal Perinatal Mental Health Guidelines for Community Services
  • GL20 The Insertion and Management of Urinary Catheters in Adult Patients Guidelines

2Scope

2.1This policy applies to all staff working for and on behalf of Pennine Care NHS Foundation Trust, including bank/agency workers.

2.2This policy covers both treatment and examination although throughout only the term treatment is used. Staff must adhere to the requirements of the policy for both types of intervention as well as the requirements and standards set by their own professional Codes of Conduct, professional membership bodies/council in relation to obtaining consent, for example, General Medical Council, Nurse and Midwifery Council, Health and Care Professionals Council.

2.3The scope of this policy does not extend to:

  • Participationin observational studies
  • The use of personal information
  • The use of organs or tissue after death

3Definitions and Terminology

3.1Consent: Consent is “the voluntary and continuing permission of a patient to be given a particular treatment, based on a sufficient knowledge of the purpose, nature and likely effects and risks of that treatment, including the likelihood of its success and any alternatives to it” (Department of Health, 2015).

3.2For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision.

  • Voluntaryconsent: This means that the decision to either consent or not to consent to treatment must be made by the person themselves, and must not be influenced by pressure from medical staff, friends or family.
  • Informed consent: This means that the person must be given all of the information in terms of what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments and what will happen if treatment does not go ahead (NHS Choices, 2015).

3.3Case law on consent has evolved significantly over recent years. Further legal developments may occur after this guidance has been issued and all healthcare professionals must remember theirduty to keep themselves informed of legal developments that may have a bearing on their practice.

3.4Capacity: A person’s capacity relates to their ability to understand the matter in question at the time and to make decisions for themselves. A person lacks capacity in relation to the matter if at the material time they are unable to make a decision for themselves in relation to the matter due to an impairment, or a disturbance in the functioning of their mind or brain (Department of Health, 2015).

3.5The Mental Capacity Act 2005: The Mental Capacity Act 2005, which came fully into force on 1 October 2007, sets out a statutory framework for making care and treatment decisions for people who lack the capacity to make such decisions themselves.The Act establishes overarching statutory principles governing these decisions, setting out who can make them and when. It also sets out the legal requirements for assessing whether or not a person lacks the capacity to make a decision.

3.6Where a person lacks the capacity to make a decision for themselves, any decision must be made in that person’s best interests. The Mental Capacity Act introduced a duty on NHS bodies to instruct an independent mental capacity advocate (IMCA) in serious medical treatment decisions when a person who lacks the capacity to make a decision has no one who can speak for them, other than paid staff. The Act allows people to plan ahead for a time when they may not have the capacity to make their own decisions: it allows them to appoint a personal welfare attorney to make health and social care decisions, including medical treatment, on their behalf or to make an advance decision to refuse medical treatment.Further guidance is available in the Mental Capacity Act (2005) Code of Practice[2].

3.7Patient: The term patient has been used throughout this policy although it is accepted other terminology may be appropriate such as service user.

3.8Healthcare Professional: The term Healthcare Professional includes all staff who may be involved in a patient’s care and has been used to encompass non-qualified staff.

3.9Must: The term must is used to indicate the requirement is a legal or overriding duty or principle. Where staff are unable to complete this requirement they must report this to their line manager and request advice as to alternative ways to comply with the legislation.

3.10Should: The term should is used where the duty or principle may not apply in all situations and circumstances, if there are factors outside the control of staff that may affect how you comply with the policy then any departures should be documented and recorded in the patients notes.

4Responsibilities

4.1The Trust Board remain responsible for ensuring appropriate consent procedures are in place. The Trust Board delegate the monitoring and responsibility of this policy to the Mental Health Law Scrutiny Group who may request the advice and involvement of other departments i.e. Audit, Medical Staffing, as necessary.

4.2The Trusts Mental Health Law Manager,and all policy holders and subject matter experts have responsibility for ensuring consent legislation is embedded within their relevant training, audit and policy requirements where consent applies. The Trusts Mental Health Law Manager has the responsibility for updating and implementing this policy on at least a bi-annual basis.

4.3Line Managers are responsible for ensuring that staff who may be delegated the role of obtaining consent are appropriately trained in respect to this policy and the consent process and that this is recorded in their supervision records. Line Managers are also responsible for reviewing consent related incidents and addressing any identified performance issues through the appropriate escalation structures.

4.4Line Managers must ensure staff under their charge are aware of this policy and the principles of seeking valid consent and that this is apparent in working practices. Any incidents or breaches of policy should be reported in accordance with the Trust Incident Reporting policy and any investigations or actions supported by Line Managers. Line Managers are also required to report any practical issues to the Trust Mental Health Law Manager to facilitate policy change if necessary.

4.5Staff including agency, contractors or anyone providing a service on behalf of the Trust in clinical and non-clinical settings have a responsibility to ensure appropriate consent is obtained and that is documented in the patient’s health records. In addition, all health care professionals are responsible for seeking valid consent for any examination, investigation, care and or treatment that they provide or carry out themselves. Where responsibility for any aspect of the consent process is delegated to another person, the overall responsibility remains with the person carrying out the procedure. In some cases, professional codes of conduct will also expect staff to work to a higher standard than the requirements of this policy and the professionals must refer to those codes for instruction. All practical issues in implementing this policy should be reported and discussed with Line Managers.A failure to comply with this policy may result in disciplinary action.