Competence to Take Consent Procedure

Department of Clinical Haematology

Delegated consent procedure

Purpose

This document outlines the process whereby Clinical Haematology Specialist Registrar’s (SpR) are trained to undertake delegated consent in line with the OUH Trust Policy for the Consent to Examination or Treatment, November 2010.

Background

Section 5 of the OUH policy details ‘Who is responsible for seeking consent’. It states that ‘the health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done. He or she may be held responsible in law if this is challenged late’ (Section 5.1, pg 16). Consent is described as being delegated, when the health professional undertaking the consent does not carry out the procedure but ‘has received specialist training in advising patients about the procedure, has been assessed, is aware of his/her own knowledge limitations and is subject to audit’ (section 5.4.2, pg 17).

Clinical Haematology

Within the department, it was agreed that there are many treatments offered by the service, in which there is delegation in the consenting process. Within Haematology the word ‘treatment’ is used in place of the Trust word ‘procedure’. It was also agreed that for some treatments delegated consent is not appropriate, these include early phase research trials, peripheral blood stem cell/bone marrow harvest, DLI and donor priming or harvest. The following treatment areas have been agreed for training in delegated consent:

• Chemotherapy.
• Clinical Trials: Late phase trials
• Bone and Marrow Transplantation (BMT): Allogeneic, Matched unrelated donor (MUD), Cord, Autologous.

Training for delegated consent

The OUH policy, Appendix I (pg 90), lists the following ‘standards, which have been identified as criteria for the assessment of the competency of a health professional to obtain consent to a procedure which they themselves are incapable of performing unsupervised’.

Generic criteria:

• To have a working knowledge of the OUH consent policy
• To understand the principles and practice of consent
• To be aware of the differences between consent forms and their uses
• To understand the importance of clear, comprehensive documentation
• To be able to communicate effectively and without pressuring the patients, and to guide patients through the consent process
• To assess patients’ capacity to give consent
• To know what the steps to take where capacity is lacking
• To be able to assess possible limits to understanding and identify the means of overcoming them.

These principles are assessed in the core consent competency (Appendix 1). Assessment of this competency may take place in conjunction with any of the treatment specific competencies.

Treatment-specific criteria

• In-depth knowledge of related anatomical and physiological aspects of treatment
• Ability to clearly describe the treatment with relevant diagrams
• In-depth knowledge of, and ability to communicate, the risks and benefits of the treatment to the patient, and the degree of risk involved
• Ability to offer alternative therapies to the patient
• Awareness of information leaflets that may benefit the patient in their decision making
• Awareness of own knowledge limitations and of how to access the lead health professional responsible for the treatment if necessary.

These elements are to be covered in all training and supervision in the attaining of competence. Specific competence documents for the areas identified above are attached as appendices of this document.(Appendix: 2, 3, 4)

Generic training

• Generic consent training takes place in the Specialist Registrar (SpR) induction programme
• HTA consent training is run annually within the department
• All SpR’s undertake GCP training early in their programme
• For all competencies, trainees are required to be ARIA trained and have undertaken or are booked to undertake a chemotherapy training session, either via Oxford Brookes or a local session.

An experienced SpR is defined as, an ST4 SpR (2nd year)

Rotation to District General Hospital

The delegated consent procedure will apply to SpR’s on rotation to the district general hospitals. The SpR training lead provides liaison with these services.

Supervision

For each competency, overall supervision is to be carried out by one Consultant, whilst on rotation within that team. Where additional supervision or training is required, this should be documented on the competency form and signed off when completed. Trainees are expected to allocate time as part of the training to spend with the clinical nurse specialist or department manager (or designate) as indicated in the competency, so that there is a clear understanding of how treatments are delivered and any clinical implications.

Completed competence assessment

A separate form must be used for each ‘treatment’. The forms must be finally signed off by the supervising consultant.

The trainee is required, as per Trust policy, to send copies of the completed form to:

Consent Lead, Clinical Governance Department, John Radcliffe Hospital.

Clinical Haematology Training Lead

Clinical Haematology Quality Manager, Level 2, Cancer and Haematology Centre.

Individuals should retain a copy for their own professional profiles.

Review of competence

Because of the rotational nature of the SpR training, it may not be possible nor appropriate to review some competencies, e.g. if the SpR is no longer on the BMT rotation, it may not be relevant nor appropriate to review the competence. However, the more generic competencies are reviewed biennially. Confirmation of the competence should be documented on the original assessment form, and copies submitted to:

Clinical Haematology Training Lead

Clinical Haematology Quality Manager, Level 2, Cancer and Haematology Centre.

Individuals should retain a copy for their own professional profiles.

Audit

Compliance with this policy will be audited biennially as part of the departments audit programme.

Documents

OUH Trust, Policy for the Consent to Examination or Treatment.

B.19a, Patient consent guidelines, Department of Clinical Haematology.

GMC (2008) Consent: patients and doctors making decisions.

Authors: Dr Wale Atoyebi, Consultant Haematologist; Sandy Hayes, Quality manager, Clinical Haematology.

Review

Appendices:

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Appendix 1:

Core consent competency

Record of training and supervision of a health professional who is required to take consent for a treatment which he or she does not perform.

Level of SpR training: ST3 (1st year) and above.

Completion code: satisfactory = √; not satisfactory = x; not applicable = na

The items in this checklist relate to observed behaviour during the consent interview and ascertained by discussion afterwards.

1. Introduces self to patient/relatives and establishes rapport.

1. Ensures that the information-giving and consent-taking process is conducted with as much privacy as possible, and maintains dignity.

1. Ensures that patient is comfortable during the interview.

1. Communicates appropriately, with regards to pace, terminology and language.

1. Explains treatment in clear and simple terms.

1. Makes use of diagrams if appropriate.

1. Encourages the patient/relative to ask questions at any stage of the interview.

1. Is able to describe of the issues related to literacy competence and how to manage these.

1. Makes use of an interpreter (if applicable).

1. Makes an accurate assessment of the patient’s capacity to consent to the treatment.

1. For an incompetent adult: Is able to justify the decision that patient lacks capacity to consent to the treatment.

1. For an incompetent adult: Makes reasonable efforts to assist the patient to reach a decision; involves relatives in decision-making process (if applicable).

1. For an incompetent adult: Is able to justify that the treatment has potential benefits for the patient.

1. (BMT) For an incompetent adult: Is able to articulate the Human Tissue Authority implications and requirements.

1. Explains the treatment.

1. Explains the reasonably foreseeable risks or inconveniences to the patient.

1. Explains the intended benefits of the treatment.

1. Explains any extra procedures, which may become necessary during the treatment (e.g. Taking of blood, bone marrows etc.).

1. Ensures the appropriate patient information leaflet(s) has been given to the patient.

1. Explains the types of medication used during the treatment (if applicable).

1. Explains the alternative procedures or treatments that may be available and their potential benefits and risks ( if applicable).

1. Gives patient/relative impartial information enabling them to make their own decision to undergo the treatment- ensuring that they are aware that they may withdraw their consent at any time.

1. Is able to answer questions of patient/relatives with clarity and accuracy.

1. Seeks advice from senior colleagues if unable to answer questions.

1. Ensures patient reads and signs the consent form appropriately.

1. Asks if the patient has an Advance Directive/Living Will (e.g. Jehovah’s Witness form).

1. Demonstrates knowledge and expertise of the treatment for which the patient being consented.

1. Is able to describe what valid informed consent is.

1. Demonstrates awareness of the various factors to be taken into account when assessing the “best interests” of patients (i.e. physical, psychological, social etc.).

1. Demonstrates awareness of what constitutes a valid Advance Directive.

1. Is able to describe what to do if patient exercises his/her right to waive information.

1. Demonstrates a clear understanding of the consent process and how to complete a consent form correctly.

1. Ensures the patient is given a copy of the consent form.

1. Ensures the consent form is filed appropriately in the notes (plastic sleeve, chronological order)

1. Ensures any difficulties or complex areas of discussion are documented in the patient notes.

1. Provides patient/relative with contact details of CNS/service if has further questions.

Confirmation of competence

To be completed by supervising Consultant:

I confirm that the above Specialist Registrar has been assessed as competent to take consent, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

Where additional supervision or training has been identified, please document:

Please send copies to:

Consent Lead, Clinical Governance Department, John Radcliffe Hospital.

Clinical Haematology Training Lead

Clinical Haematology Quality Manager, Level 2, Cancer and Haematology Centre.

Individuals should retain a copy for their own professional profiles.

This competency assessment will be re-evaluated by…/…/… (Biennial)

Biennial Review of competence

To be completed by a Consultant:

I confirm that the above Specialist registrar has been reassessed as competent to take consent, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

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Appendix 2:

Competency to take consent: Chemotherapy.

Record of training and supervision of a health professional who is required to take consent for a treatment which he or she does not to perform.

Level of SpR training: ST3 (1st year) and above, when rotated into Clinical Haematology Ward or Day treatment unit.

1. The trainee must observe consent being taken for this treatment.

1. The trainee must observe/discuss the nursing management for this treatment, including a patient information/confirmation of consent session, the checking procedure, infusion and bolus treatment.

1. The trainee must be supervised taking consent for this treatment.

1. The trainee is able to demonstrate (as per OUH policy):

• Working knowledge of Trust and National Consenting policy
• Understanding of circumstances that require immediate referral to a consultant
• Comprehensive understanding and knowledge of the treatment, its specific associated risks and benefits, and of alternative treatments
• Effective communication skills
• Knowledge of correct documentation standards
• Knowledge of the relevant treatment specific patient information.

Confirmation of competence

To be completed by supervising Consultant:

I confirm that the above Specialist registrar has been assessed as competent to take consent for the treatment listed, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

Where additional supervision or training has been identified, please document:

Please send copies to:

Consent Lead, Clinical Governance Department, John Radcliffe Hospital.

Clinical Haematology Training Lead

Clinical Haematology Quality Manager, Level 2, Cancer and Haematology Centre.

Individuals should retain a copy for their own professional profiles.

This competency assessment will be re-evaluated by…/…/… (Biennial)

Biennial Review of competence

To be completed by a Consultant:

I confirm that the above Specialist registrar has been reassessed as competent to take consent for the treatment listed, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

Appendix 3:

Competency to take consent: Late phase clinical trials.

Record of training and supervision of a health professional who is required to take consent for a treatment which he or she does not perform.

Level of SpR training: ST3 (1st year) and above when working within a team undertaking late phase clinical trials.

1. The trainee must observe consent being taken for this treatment.

1. The trainee must observe/discuss the nursing management for this treatment, including a patient information/confirmation of consent session, the checking procedure, infusion/bolus treatment and by spending time with the trial specific research nurse.

1. The trainee must be supervised taking consent for this treatment.

1. The trainee is able to demonstrate (as per OUH policy):

• Working knowledge of Trust and National Consenting policy
• Understanding of circumstances that require immediate referral to a consultant
• Comprehensive understanding and knowledge of the treatment, its specific associated risks and benefits, and of alternative treatments
• Effective communication skills
• Knowledge of correct documentation standards
• Knowledge of the relevant treatment specific patient information.

Confirmation of competence

To be completed by supervising Consultant:

I confirm that the above Specialist registrar has been assessed as competent to take consent for the treatment listed, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

Where additional supervision or training has been identified, please document:

Please send copies to:

Consent Lead, Clinical Governance Department, John Radcliffe Hospital.

Clinical Haematology Training Lead

Clinical Haematology Quality Manager, Level 2, Cancer and Haematology Centre.

Individuals should retain a copy for their own professional profiles.

This competency assessment will be re-evaluated by…/…/… (Biennial)

Biennial Review of competence

To be completed by a Consultant:

I confirm that the above Specialist registrar has been reassessed as competent to take consent for the treatment listed, as per Appendix I of the OUH Trust Policy for the Consent to Examination or Treatment.

Appendix 4:

Competency to take consent: Blood and marrow transplantation (BMT).

Record of training and supervision of a health professional who is required to take consent for a treatment which he or she does not perform.

Level of SpR training: ST4 and above, when rotated into Leukaemia or Lymphoma team.

A new document should be undertaken for each treatment type.

1. The trainee must observe BMT consultations 1 & 2.

1. The trainee must undertake a draft writing of the ‘consent letter’ for the above patient.

1. The trainee must be supervised undertaking the consent process for this treatment, including consultations 1 & 2 and the draft writing of the ‘consent letter’.

1. The trainee must observe/discuss the following:

• The role and function of the BMT coordinators and CNS.

• Patient information

• The process from referral to BMT

• Management of the conditioning regime

• TBI management (delete as appropriate)

• Preparation for cell arrival, patient and environment

• First bag of frozen cells (delete as appropriate)

• First bag of fresh cells including out of hours issues(delete as appropriate)

1. The trainee is able to demonstrate (as per OUH policy):

• Working knowledge of Trust and National Consenting policy
• Understanding of circumstances that require immediate referral to a consultant
• Comprehensive understanding and knowledge of the treatment, its specific associated risks and benefits, and of alternative treatments
• Effective communication skills
• Knowledge of correct documentation standards
• Knowledge of the relevant treatment specific patient information.

Confirmation of competence