Consent to examination or treatment

Transcription

1 Trust Policy & Procedure Consent to examination or treatment Document ref. no: PP(16)113 For use in (clinical areas): For use by (staff groups): For use for (patients): Document owner: Status: All clinical areas All health care professionals involved in the consent process Any patient undergoing any procedure for which explicit consent may be required Executive Medical Director APPROVED Purpose of this document The Department of Health document Good Practice in Consent Implementation Guide (Nov. 2001) describes model documentation developed with the aim of assisting NHS organisations to promote good practice in the way patients are asked to give their consent to treatment, care or research. This document has been produced to provide guidance to Trust clinicians on all aspects of consent practice. It is compliant with the DoH guidance while including information specific to the Trust. Local information additional to the model consent policy is indicated by an asterisk (*). Contents 1. Introduction 2 2. Documentation 3 3. Levels of Consent 5 4. When should consent be sought? 6 5. Provision of information 8 6. Who is responsible for seeking consent? Refusal of treatment Tissue Clinical photography and conventional or digital video recordings Training Document development information Distribution list/dissemination method Review Monitoring Document configuration information 18 Appendix A: 12 key points on consent: the law in England 19 Appendix B: Current Forms in Use in This Organisation 21 Consent Form 1: Patient Agreement to Investigation or Treatment 22 Consent Form 2: Parental Agreement to Investigation or Treatment for a Child or Young Person 26 Consent Form 3: Patient/parental Agreement to Investigation or Treatment (Procedures where consciousness not impaired) 29 Consent Form 4: Adults who are Unable to Consent to Investigation or Treatment 31 Source: Medical Director Status: Approved Page 1 of 52

2 Consent form 5: Consent to operative and Medical Treatment by a Patient Who Refused To Have A Blood Transfusion Appendix C: Useful contact details 37 Appendix D: How to seek a court declaration 38 Appendix E: Seeking consent: remembering the patient s perspective 39 Appendix F: Registration form for admission to the register of delegated consent 40 Appendix G: Delegated consent competency training record 41 Appendix H: Audit tool 42 Appendix i: Trust Guidance for the Level of Consent Process Required For Each Invasive Procedure 44 Appendix J: CQC regulation Introduction Why consent is crucial 1. Patients have a fundamental legal and ethical right to determine what happens to their own bodies. Valid consent to treatment is therefore absolutely central in all forms of healthcare, from providing personal care to undertaking major surgery. Seeking consent is also a matter of common courtesy between health professionals and patients. This policy 2. The Department of Health has issued a range of guidance documents on consent (see paragraph 6 below), and these should be consulted for details of the law and good practice requirements on consent. This policy sets out the standards and procedures in this Trust, which aim to ensure that health professionals are able to comply with the guidance. While this document is primarily concerned with healthcare, social care colleagues should also be aware of their obligations to obtain consent before providing certain forms of social care, such as those that involve touching the patient or client. What consent is and isn t 3. Consent is a patient s agreement for a health professional to provide care. Patients may indicate consent non-verbally (for example by presenting their arm for their pulse to be taken), orally, or in writing. For the consent to be valid, the patient must: have the capacity to take the particular decision have received sufficient information to take it not be acting under duress * Competency includes the having the mental capacity to take the decision and the information given to make the decision must be both appropriate and sufficient.(mental Capacity Act 2005) 4. The context of consent can take many different forms, ranging from the active request by a patient for a particular treatment (which may or may not be appropriate or available) to the passive acceptance of a health professional s advice. In some cases, the health professional will suggest a particular form of treatment or investigation and after discussion the patient may agree to accept it. In others, there may be a number of ways of treating a condition, and the health professional will help the patient to decide between them. Some patients, especially those with chronic conditions, become very well informed about their illness and may actively request Source: Medical Director Status: Approved Page 2 of 52

3 particular treatments. In many cases, seeking consent is better described as joint decisionmaking : the patient and health professional need to come to an agreement on the best way forward, based on the patient s values and preferences and the health professional s clinical knowledge. 5. Where an adult patient lacks the mental capacity (either temporarily or permanently) to give or withhold consent for themselves, no one else can give consent on their behalf. However, treatment may be given if it is in their best interests, as long as it has not been refused in advance in a valid and applicable advance directive. For further details on advance directives see the Department of Health s Reference guide to consent for examination or treatment (chapter 1, paragraph 19). Guidance on consent 6. The Department of Health has issued a number of guidance documents on consent, and these should be consulted for advice on the current law and good practice requirements in seeking consent. Health professionals must also be aware of any guidance on consent issued by their own regulatory bodies. Reference guide to consent for examination or treatment provides a comprehensive summary of the current law on consent, and includes requirements of regulatory bodies such as the General Medical Council where these are more stringent. Copies are available in the library [] and may also be accessed on the internet at: 12 key points on consent: the law in England has been distributed widely to health professionals working in England. This one-page document summarises those aspects of the law on consent which arise on a daily basis and is attached at Appendix A. Further copies are available in the library or from: Specific guidance, incorporating both the law and good practice advice, is available for health professionals working with children, with people with learning disabilities and with older people. Copies of these booklets are available in the library [] and on the internet at * The Reference Guide to Consent for Examination or Treatment is now the Second Edition 2009 ( 2 Documentation 1. For significant procedures, it is essential for health professionals to document clearly both a patient s agreement to the intervention and the discussions, which led up to that agreement. This may be done either through the use of a consent form (with further detail in the patient s notes if necessary), or through documenting in the patient s notes that they have given oral consent. Written consent 2. Consent is often wrongly equated with a patient s signature on a consent form. A signature on a form is evidence that the patient has given consent, but is not proof of valid consent. If a patient is rushed into signing a form, on the basis of too little information, the consent may not be valid, despite the signature. Similarly, if a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment. Patients may, if they wish, withdraw consent after they have signed a form: the signature is evidence of the process of consent-giving, not a binding contract. Source: Medical Director Status: Approved Page 3 of 52

4 3. It is rarely a legal requirement to seek written consent, 1 but it is good practice to do so if any of the following circumstances apply: the treatment or procedure is complex, or involves significant risks (the term risk is used throughout to refer to any adverse outcome, including those which some health professionals would describe as side-effects or complications ) the procedure involves general/regional anaesthesia or sedation providing clinical care is not the primary purpose of the procedure there may be significant consequences for the patient s employment, social or personal life the treatment is part of a project or programme of research approved by this Trust 4. Completed forms should be kept with the patient s notes. Any changes to a form, made after the form has been signed by the patient, should be initialled and dated by both patient and health professional. 5. It will not usually be necessary to document a patient s consent to routine and low-risk procedures, such as providing personal care or taking a blood sample. However, if you have any reason to believe that the consent may be disputed later or if the procedure is of particular concern to the patient (for example if they have declined, or become very distressed about, similar care in the past), it would be helpful to do so. (Note 1. The Mental Health Act 1983 and the Human Fertilisation and Embryology Act 1990 require written consent in certain circumstances. ) Procedures to follow when patients lack capacity to give or withhold consent * The Mental Capacity Act 2005 defines a person who lacks capacity as a person who is unable to make a decision for themselves because of an impairment or disturbance in the functioning of their mind or brain. It does not matter if the impairment or disturbance is permanent or temporary. A person lacks capacity if: they have an impairment or disturbance (for example a disability, condition or trauma or the effect of drugs or alcohol) that affects the way their mind or brain works, and that impairment or disturbance means that they are unable to make a specific decision at the time it needs to be made. Under English law, no one is able to give consent to the examination or treatment of an adult who is 16 or over who lacks the capacity to give consent for themselves, unless they have been authorised to do so under a Lasting Power of Attorney or they have the authority to make treatment decisions as a court appointed deputy The Mental Capacity Act 2005 provides healthcare professionals with protection from civil and criminal legal liability for acts or decisions made in the best interests of the person who lacks capacity. 6. Where an adult patient does not have the capacity to give or withhold consent to a significant intervention, this fact should be documented in Consent form 4 (form for adults who are unable to consent to investigation or treatment), along with the assessment of the patient s capacity, why the health professional believes the treatment to be in the patient s best interests, and the involvement of people close to the patient. The standard consent forms should never be used for adult patients unable to consent for themselves. For more minor interventions, this information should be entered in the patient s notes. Source: Medical Director Status: Approved Page 4 of 52

5 7. An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than genuine incapacity. You should involve appropriate colleagues in making such assessments of incapacity, such as specialist learning disability teams and speech and language therapists, unless the urgency of the patient s situation prevents this. If at all possible, the patient should be assisted to make and communicate their own decision, for example by providing information in non-verbal ways where appropriate. 8. Occasionally, there will not be a consensus on whether a particular treatment is in an incapacitated adult s best interests. Where the consequences of having, or not having, the treatment are potentially serious, a court declaration may be sought. See Appendix D for details of how to do this. Availability of forms 9. Standard consent forms and forms for adults who are unable to consent for themselves are reproduced in Appendix B and are available in all clinical areas. There are five versions of the standard consent form: Form 1 for adults or competent children, Form 2 for parental consent for a child or young person and Form 3 for cases where it is envisaged that the patient will remain alert throughout the procedure and no anaesthetist will be involved in their care. The use of form 3 is optional but may be thought more appropriate than form 1 in situations where patients do not need to be made aware of issues surrounding general or regional anaesthesia and do not need to make any advance decisions about additional procedures because they will be in a position to make any such decisions at the time if necessary. Form 4 For Adults Who Lack The Capacity To Consent To Investigation Or Treatment Form 5 Consent to operative and Medical Treatment by a Patient Who Refused To Have A Blood Transfusion * Young people aged 16 or 17 are presumed to be capable of consenting to their own medical treatment. It is, however, good practice to involve the young person s family in the decisionmaking process unless the young person specifically wishes to exclude them if the young person consents to their information being shared. Guidance on the use of the consent form and other documentation, to ensure correct site surgery is provided in the Trust s Safer Surgery Pathway policy (PP(299). In essence, the consent form should contain the specific procedure that is intended and this should include both the side and site of the intended surgery. Writing must be legible and in capital letters. For procedures on the digits, explicit description of the precise part/joint of the digit is mandatory as is careful marking of the same eg. mark the nail of the correct digit in addition to circling the correct joint/bone/lesion of that digit. 3 Levels of Consent Written- Consent form required 1. The patient should be given information about the procedure during a consultation prior to signing the consent form. This is to ensure the patient has time to consider the information. The information should include the risks, benefits, possible side effects and alternatives along with an information leaflet on the procedure to read through. The clinician should check with patient Source: Medical Director Status: Approved Page 5 of 52

6 that they have understood the information provided. 2. The patient then subsequently should be given consent form to sign, prior to the procedure, detailing the procedure and possible risks, so they know what they are signing for. This process is for high risk procedures Verbal Should be documented in the patient notes or patient s report 3. The patient should be given information about the procedure prior to the procedure. This is to ensure the patient has time to consider the information. The information should include the risks, benefit and alternatives, ideally with an information leaflet on the procedure to read through. 4. The process of consent should then be documented in the patient notes or patient s report, the notes do not need to be exhaustive, but should state the nature of the proposed procedure or treatment and itemise the risks, benefits and alternatives brought to the attention of the patient. Any particular fears or concerns raised by the patient should also be noted. Implied Consent Agreement with the patient that a procedure is going to be undertaken. 5. The patient may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their bloods taken. In the case of minor or routine investigations or treatments, if you are satisfied that the patient understands what you propose to do and why, it is usually enough to have oral or implied consent. This process should then be documented in the notes or report. Invasive procedures outside Theatres 6. The Level of consent required for each invasive procedure carried out within the Trust but outside Theatres or Endoscopy can be found on the Trust Intranet along with relevant patient information. (Appendix J) 4 When should consent be sought? 1. When a patient formally gives their consent to a particular intervention, this is only the endpoint of the consent process. It is helpful to see the whole process of information provision, discussion and decision-making as part of seeking consent. This process may take place at one time, or over a series of meetings and discussions, depending on the seriousness of what is proposed and the urgency of the patient s condition. Single stage process 2. In many cases, it will be appropriate for a health professional to initiate a procedure immediately after discussing it with the patient. For example, during an ongoing episode of care a physiotherapist may suggest a particular manipulative technique and explain how it might help the patient s condition and whether there are any significant risks. If the patient is willing for the technique to be used, they will then give their consent and the procedure can go ahead immediately. In many such cases, consent will be given orally. 3. If a proposed procedure carries significant risks, it will be appropriate to seek written consent, and health professionals must take into consideration whether the patient has had sufficient chance to absorb the information necessary for them to make their decision. As long as it is clear that the patient understands and consents, the health professional may then proceed. Two or more stage process 4. In most cases where written consent is being sought, treatment options will generally be discussed well in advance of the actual procedure being carried out. This may be on just one occasion (either within primary care or in a hospital out-patient clinic), or it might be over a whole series of consultations with a number of different health professionals. The consent process will Source: Medical Director Status: Approved Page 6 of 52

7 therefore have at least two stages: the first being the provision of information, discussion of options and initial (oral) decision, and the second being confirmation that the patient still wants to go ahead. The consent form should be used as a means of documenting the information stage(s), as well as the confirmation stage. * Documentation of stage 1 (the information stage) will include the health professional completing and signing the front of the consent form and providing a copy to the patient. 5. Patients receiving elective treatment or investigations for which written consent is appropriate should be familiar with the contents of their consent form before they arrive for the actual procedure, and should have received a copy of the page documenting the decision-making process. They may be invited to sign the form, confirming that they wish treatment to go ahead, at any appropriate point before the procedure: in out-patients, at a pre-admission clinic, or when they arrive for treatment. If a form is signed before patients arrive for treatment, however, a member of the healthcare team must check with the patient at this point whether they have any further concerns and whether their condition has changed. This is particularly important where there has been a significant lapse of time between the form being signed and the procedure. When confirming the patient s consent and understanding, it is advisable to use a form of words which requires more than a yes/no answer from the patient: for example beginning with tell me what you re expecting to happen, rather than is everything all right? 6. While administrative arrangements will vary, it should always be remembered that for consent to be valid, the patient must feel that it would have been possible for them to refuse, or change their mind. It will rarely be appropriate to ask a patient to sign a consent form after they have begun to be prepared for treatment (for example, by changing into a hospital gown), unless this is unavoidable because of the urgency of the patient s condition. Seeking consent for anaesthesia 7. Where an anaesthetist is involved in a patient s care, it is their responsibility (not that of a surgeon) to seek consent for anaesthesia, having discussed the benefits and risks. However, in elective treatment it is not acceptable for the patient to receive no information about anaesthesia until their pre-operative visit from the anaesthetist: at such a late stage the patient will not be in a position genuinely to make a decision about whether or not to undergo anaesthesia. Patients should therefore either receive a general leaflet about anaesthesia in out-patients, or have the opportunity to discuss anaesthesia in a pre-assessment clinic. The anaesthetist should ensure that the discussion with the patient and their consent is documented in the anaesthetic record, in the patient s notes or on the consent form. Where the clinician providing the care is personally responsible for anaesthesia (e.g. where local anaesthesia or sedation is being used), then he or she will also be responsible for ensuring that the patient has given consent to that form of anaesthesia. Where an anaesthetist is planning to perform a regional anaesthetic block whether as part of the anaesthetic technique or as a sole means of anaesthesia, it will be the responsibility of the anaesthetist to mark the site of the proposed block (correct side and site) at their preoperative visit on the ward (see Safer Surgery Policy). 8. In addition, where general anaesthesia or sedation is being provided as part of dental treatment, the General Dental Council currently holds dentists responsible for ensuring that the patient has all the necessary information. In such cases, the anaesthetist and dentist will therefore share that responsibility. Emergencies 9. Clearly in emergencies, the two stages (discussion of options and confirmation that the patient wishes to go ahead) will follow straight on from each other, and it may often be appropriate to use the patient s notes to document any discussion and the patient s consent, rather than using a form. The urgency of the patient s situation may limit the quantity of information that they can be given, but should not affect its quality. Source: Medical Director Status: Approved Page 7 of 52

8 Treatment of young children 10. When babies or young children are being cared for in hospital, it will not usually seem practicable to seek their parents consent on every occasion for every routine intervention such as blood or urine tests or X-rays. However, you should remember that, in law, such consent is required. Where a child is admitted, you should therefore discuss with their parent(s) what routine procedures will be necessary, and ensure that you have their consent for these interventions in advance. If parents specify that they wish to be asked before particular procedures are initiated, you must do so, unless the delay involved in contacting them would put the child s health at risk. 11. Only people with parental responsibility or those appointed legal guardian are entitled to give consent on behalf of a child. You must be aware that not all parents have parental responsibility for their children (for example, unmarried fathers do not automatically have such responsibility although they can acquire it). If you are in any doubt about whether the person with the child has parental responsibility for that child, please see guidance notes to Consent Form 2. 5 Provision of information 1. The provision of information is central to the consent process. Before patients can come to a decision about treatment, they need comprehensible information about their condition and about possible treatments/investigations and their risks and benefits (including the risks/benefits of doing nothing). They also need to know whether additional procedures are likely to be necessary as part of the procedure, for example a blood transfusion, or the removal of particular tissue. Once a decision to have a particular treatment/investigation has been made, patients need information about what will happen: where to go, how long they will be in hospital, how they will feel afterwards and so on. 2. Patients and those close to them will vary in how much information they want: from those who want as much detail as possible, including details of rare risks, to those who ask health professionals to make decisions for them. There will always be an element of clinical judgement in determining what information should be given. However, the presumption must be that the patient wishes to be well informed about the risks and benefits of the various options. Where the patient makes clear (verbally or non-verbally) that they do not wish to be given this level of information, this should be documented. * Patients should be informed of any "significant risk which would affect the judgement of a reasonable patient" 3. The following sources of patient information are available in this Trust: The Trust produces a wide range of patient leaflets, a number of which are now available on the Intranet in the Patient Leaflets section of this website and on the Internet on the Trust website This clinical information system has been developed to support the patient journey from primary to secondary care. All new and revised Patient Information will be produced in the same format in accordance with the Patient Information Policy and Toolkit. This toolkit (Patient Information Toolkit) and an A4 template are available on the Intranet on the Pink Book. The Template is available for staff to submit documents to the Pink Book editorial group for approval (including a patient / user group review) and publication. The final print versions of the leaflets will be in A5, fold over leaflets. The information can be produced in larger print (16pt) for the visually impaired. Arrangements can be made to convert patient information into Braille through the RNIB, this service can be accessed through PALS. In addition the Trust has RNIB approved cassette players for recording information and patient information. Source: Medical Director Status: Approved Page 8 of 52

9 Provision for patients whose first language is not English 4. This Trust is committed to ensuring that patients whose first language is not English receive the information they need and are able to communicate appropriately with healthcare staff. It is not appropriate to use children to interpret for family members who do not speak English. [] Face to face interpreters / signers / lip speakers can be accessed through PALS - these need to be booked in advance; as soon as it is identified that the patient will require the service. For out of hours (emergency) the site manager should be contacted. The Language Line is a resource available for translation, however it is important to know exactly what needs to be said / asked as this service is charged according to time. Consideration should also be given to the fact that telephone interpretation may be intimidating for patient when feeling stressed. Language Line contact tel. No Id code L Access to more detailed or specialist information 5. Patients may sometimes request more detailed information about their condition or about a proposed treatment than that provided in general leaflets. This Trust has made the following arrangements to assist patients to obtain such information: The Clinical Resource Centre and Library provides support and access to the evidence base of healthcare through the Trust website: In addition links are fostered with the public library service, as often patients will seek information there after a diagnosis. Library staff are aware of this and run training courses for public library staff to demonstrate effective use of sites such as the Cochrane Library, Medline, NeLH and OMNI (Organising Medical Networked Information). All health and social care staff in West Suffolk have the opportunity to be trained and effective access to the evidence. Links are now being developed with patient groups, the Patient Forums and PALS. Patients are also invited to contact PALS who will liaise with the appropriate clinicians. The PALS service is available from Monday Friday 9am to 5pm or out of hours by appointment. PALS can be contacted by telephone on 2555 or by bleep number 398). The Trust website also contains information on the PALS service Access to health professionals between formal appointments 1. After an appointment with a health professional in primary care or in out-patients, patients will often think of further questions which they would like answered before they take their decision. Where possible, it will be much quicker and easier for the patient to contact the healthcare team by phone than to make another appointment or to wait until the date of an elective procedure (by which time it is too late for the information genuinely to affect the patient s choice). The PALS office will liase with the appropriate clinician to help in this regard. The PALS service is available from Monday Friday 9am to 5pm or out of hours by appointment. Open access clinics 7. Where patients access clinics directly, it should not be assumed that their presence at the clinic implies consent to particular treatment. You should ensure that they have the information they need before proceeding with an investigation or treatment. Advisory leaflets or brochures should be sent to patients attending such clinics with their appointment details. Source: Medical Director Status: Approved Page 9 of 52

10 6 Who is responsible for seeking consent? 1. The health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done: it is they who will be held responsible in law if this is challenged later. 2. Where oral or non-verbal consent is being sought at the point the procedure will be carried out, this will naturally be done by the health professional responsible. However, teamwork is a crucial part of the way the NHS operates, and where written consent is being sought it may be appropriate for other members of the team to participate in the process of seeking consent. * It is usually best for the person actually undertaking the procedure on the patient to seek the patient s consent. However, you may seek consent on behalf of colleagues if you are capable of performing the procedure in question, or if you have been specially trained to seek consent for that procedure (for further details see delegated consent in Section IX) Completing consent forms 3. The standard consent form provides space for a health professional to provide information to patients and to sign confirming that they have done so. The health professional providing the information must be competent to do so: either because they themselves carry out the procedure, or because they have received specialist training in advising patients about this procedure, have been assessed, are aware of their own knowledge limitations and are subject to audit. 4. If the patient signs the form in advance of the procedure (for example in out-patients or at a preassessment clinic), a health professional involved in their care on the day should sign the form to confirm that the patient still wishes to go ahead and has had any further questions answered. It will be appropriate for any member of the healthcare team (for example a nurse admitting the patient for an elective procedure) to provide the second signature, as long as they have access to appropriate colleagues to answer questions they cannot handle themselves. * It is good practice to gain consent well in advance, giving time to respond to Patient questions and provide adequate information. Consent taken just before a procedure, if elective, may not be valid. Training for health care professionals who do not carry out specific procedures, but could potentially provide the information patients need in coming to a decision, will be arranged by the Chairman of the appropriate division or the Consultant under whose care the patient is to be treated. In the event that the health care professional cannot answer a patient s questions when confirming consent, contact should be made with the Consultant under whom the patient is to be treated. Responsibility of health professionals 5. It is a health professional s own responsibility: to ensure that when they require colleagues to seek consent on their behalf they are confident that the colleague is competent to do so; and to work within their own competence and not to agree to perform tasks which exceed that competence. If you feel that you are being pressurised to seek consent when you do not feel competent to do so, you should contact the Clinical Director or the Medical Director. Source: Medical Director Status: Approved Page 10 of 52

11 7 Refusal of treatment 1. If the process of seeking consent is to be a meaningful one, refusal must be one of the patient s options. An adult patient with mental capacity is entitled to refuse any treatment, except in circumstances governed by the Mental Health Act The situation for children is more complex: see the Department of Health s Seeking consent: working with children for more detail. The following paragraphs apply primarily to adults. 2. If, after discussion of possible treatment options, a patient refuses all treatment, this fact should be clearly documented in their notes. If the patient has already signed a consent form, but then changes their mind, you (and where possible the patient) should note this on the form. 3. Where a patient has refused a particular intervention, you must ensure that you continue to provide any other appropriate care to which they have consented. You should also ensure that the patient realises they are free to change their mind and accept treatment if they later wish to do so. Where delay may affect their treatment choices, they should be advised accordingly. 4. If a patient consents to a particular procedure but refuses certain aspects of the intervention, you must explain to the patient the possible consequences of their partial refusal. If you genuinely believe that the procedure cannot be safely carried out under the patient s stipulated conditions, you are not obliged to perform it. You must, however, continue to provide any other appropriate care. Where another health professional believes that the treatment can be safely carried out under the conditions specified by the patient, you must on request be prepared to transfer the patient s care to that health professional. * The Mental Capacity Act 2005 puts advanced decisions (living wills) on a statutory basis and they must be followed if they are valid and applicable. This means in summary: The person must be 18 or over The person must have the capacity to make such a decision The person must make clear which treatments they are refusing If the advance decision refuses life-sustaining treatment, it must be in writing (it can be written by someone else or recorded in healthcare notes), it must be signed and witnessed and it must state clearly that the decision applies even if life is at risk A person with capacity can withdraw their advance decision at any time. * Specific guidance is provided for refusal of treatment in the Trust s Jehovah s Witness policy (CG ). In addition to signing the conventional consent form, patients must also sign consent to operative and medical treatment by patients who refuse to have a blood transfusion (Consent Form 5 ). 8 Tissue 1. The legal position regarding the use of human tissue (including blood samples and other bodily fluids provided for testing) raises some difficult issues and is currently under review. Such tissue can be very valuable in education and research, and its use may lead to developments in medical knowledge and hence improvements in healthcare for all. At present, this Trust requires that patients should be given the opportunity to refuse permission for tissue taken from them during surgery or other procedure to be used for education or research purposes. The patient or the parent of the patient should indicate this as early as possible and confirm their decision on signing the confirmation of consent, page 2 of the consent form. A handwritten addendum to the consent form should be signed both by the patient and witnessed by the responsible clinician. [] The responsible clinician will discuss with the patient the possibility that tissue surplus to that required for diagnostic testing may be used for quality control, teaching or research within the laboratory. Source: Medical Director Status: Approved Page 11 of 52

12 The following procedure shall apply if the patient does not consent to tissue being used for any purpose other than diagnostic testing: The responsible clinician shall write clearly on the request form, NO OTHER CONSENT This shall apply to all tissues, including blood samples and other bodily fluids. If there are multiple tissue samples, the patient may refuse consent for any or all to be used. In accordance with Page 2 of the Consent form, this will not preclude any further necessary diagnostic tests being requested by the clinician on samples already taken. Where formal written consent is not considered necessary (e.g. phlebotomy, urine samples), patients will be made aware of the laboratory policy regarding surplus specimens. This information will be posted clearly in all Outpatient areas where patients may be required to provide a specimen. Additionally, copies of the laboratory policy will be distributed to general practitioners and other remote sites where specimens may be taken. The same procedure shall then apply if a patient requests that their sample not be used for any other purpose. Laboratory Procedure When a request form is received on which NO OTHER CONSENT is written, the following procedure will apply: The specimen container and request form will be appropriately identified. The specimen will be flagged when details are entered on the Laboratory Information Management System. (This information will be located to allow audit). The specimen will not be used for any purpose other than the diagnostic testing requested on the form. Surplus specimen will be disposed of in accordance with laboratory policy when all requested tests have been completed. Tissue samples taken for histological examination are paraffin processed and microscope slide preparations made from the paraffin blocks. These blocks and slides are archived for possible review if there are further patient episodes. These samples will be flagged as NO OTHER CONSENT if appropriate and will only be accessed where it is relevant to ongoing patient treatment or review. The policy will also be made known to other laboratories to which specimens may be referred for testing. Appropriate specimens will be flagged to ensure that the policy is adhered to at the referral laboratory. 2. Explicit consent is not necessary for public health surveillance using the unlinked anonymous method, but a well-publicised opt-out policy must apply. Any patient who does not wish involvement in anonymous public health surveillance should indicate their view. 3. Pending the outcome of the review of the law governing the use of human organs and tissue the Department of Health believes that tissue samples may be used for quality assurance purposes without requiring specific patient consent provided there is an active policy of informing patients of such use. This is essential to ensure the high quality of service which all patients have the right Source: Medical Director Status: Approved Page 12 of 52

13 to expect. Wherever possible, samples of tissue used in this way should be anonymised or pseudoanonymised. Samples Used For Quality Control Or Other Purposes Surplus samples, which may be considered for quality control or other purposes, will be flagged on the laboratory information management system. The sample will be given a code number to allow anonymity. The same data field will be used as that used to flag samples for no other consent. By this means no other consent code will prevent any other code being entered. 9 Clinical photography and conventional or digital video recordings Consent is a vital part of Clinical Photography please refer to the Photography & Video Recordings Policy Document ref. no: PP Training This policy document will be provided to every doctor in the Trust and to every health professional involved in obtaining consent to examination or treatment. Consent training will be provided as per the enclosed training matrix in Table 1 below. All health professionals will receive training in the process of obtaining consent. Training sessions for new doctors in training will be organized in the month after their arrival. Information on training sessions will be provided as part of the induction process. The nursing In-service Professional Development programme includes sessions on legal aspects of obtaining consent. Table 1 Medical 1st placement F1, F2 doctors 1st placement overseas doctors All medical staff Nursing & midwifery Nurse specialists (ONLY if consent is within their agreed job description) Other Other Practitioners (ONLY if consent is within their agreed job description) Principles of consent Induction Induction Departmental / specialty specific consent practices Specialist / departmental induction and annual update if changes in legislation occur Specialist / departmental induction and annual update if changes in legislation occur Specialist / departmental induction and annual update if changes in legislation occur Delegated consent (Non Medical) * The Trust has indicated that it is appropriate for named individuals to seek consent for a specified procedure(s) that they are not capable of performing independently. These individuals will be nominated by a named Consultant sponsor who is capable of performing that procedure(s). * It is ONLY acceptable for staff to seek delegated consent for a specified procedure if: * they are a registered clinical professional (e.g. nurse practitioner) Source: Medical Director Status: Approved Page 13 of 52

14 * they have been specially trained and assessed as competent * a registration of this training has been submitted to the Governance Department for registration on the Trust s Delegated Consent Register. A copy of the registration form is enclosed in Appendix F. If an individual (non-medical) takes consent for a procedure that they are not capable of performing independently and they do not have an entry on the delegated consent register, an incident form will be raised on the Trust incident reporting system and investigated as per Trust policy PP105 Incident Reporting and Management Policy. Delegated consent (Medical) * Doctors of FY1/2 grades do not take consent for surgery independently of their consultant. * Middle grade doctors can take consent for named common procedures at a time before they are able to perform a procedure independently by an experiential learning process comprising instruction by and observation of their practice in clinic and ward settings by their supervising consultant. * A record of this competency is kept at specialty level for each individual in training, listing which of the named common procedures they have been assessed as competent to take consent for. * The individual s e-portfolio should also contain this information. * When an individual leaves the Trust the record of this competence will be archived on the Trust s Electronic Staff record training database (Oracle Learning Management OLM) * The template for this Competency checklist is enclosed in Appendix G. * If a member of the medical staff takes consent for a procedure that they are not capable of performing independently and they do not have a record of competency, an incident form will be raised on the Trust incident reporting system and investigated as per Trust policy PP105 Incident Reporting and Management Policy. The Trust will also notify the General Medical Council (GMC) of any individual who has obtained consent without the authorisation to do so via the GMC-required form found at Details of any referral to the GMC will be documented within the investigation summary. * Patient consent in the emergency setting is a combined discussion with the consultant who decides an operation is needed and explains the indications and complications to the patient, and the completion of the consent form which may be delegated to a more junior but appropriately trained doctor. 11 Document development information a. Rationale for main recommendations This model documentation has been developed as part of the Department of Health s good practice in consent initiative, as promised in the NHS Plan, with the aim of assisting NHS organisations to promote good practice in the way patients are asked to give their consent to treatment, care or research. Source: Medical Director Status: Approved Page 14 of 52

15 b. References: Good practice in consent implementation guide. Department of Health, Nov Mental Capacity Act 2005 Code of Practice. c. Development of the guideline Changes compared to previous document Clarification of procedures for delegated consent Section on consent for other invasive procedures Compression of Consent Form 4 to single page and updated information on IMCA Clarification in relation to filling out the consent form and preoperative marking Inclusion of an audit tool for monitoring compliance to the policy Amendments to the consent form to ensure that all aspects of consent can be obtained. Additions / amendments to the previous form are as follows: addition of a box to indicate consent for the use of tissue for teaching / research. addition of a box to indicate consent for the use of medical photography for teaching / research. Policy for Consent for the use of Tissue (both from surgery and at post mortem) policy. This will draw upon the Department of Health current guidance and new legislation (Ref?) d. Statement of evidence This policy is developed from the Department of Health model policy. Guidance on the use of this model states that it has been designed to encourage the addition of local information where indicated. The layout of the policy has not been changed, as the guidance also states that this should be preserved in order that staff moving between NHS organisations can know exactly where to look for particular information within the policy. Local information additional to the model consent policy is indicated by an asterisk * e. Contributors and peer review The initial version of this policy PP(02)113 was written by Mr Bedford, Orthopaedic Surgeon who was appointed by the Medical Director to lead in implementing the new policy. Consultation took place with appropriate clinical and management staff assisted by the members of the Revised Consent Policy Implementation Group. The Consent Implementation Group, chaired by a General Manager, produced an updated version in Multidisciplinary membership of this group enabled a group process to review and amendment. The Consent Policy was amended in November 2008 to take into account the Mental Capacity Act 2005, since then the DH has clarified the position in a guidance of July 2009 (Reference Guide to Consent for Examination or Treatment, 2nd edition).this sets out how the wording of Source: Medical Director Status: Approved Page 15 of 52

16 Trust consent policies should be changed in both the document and the consent forms themselves. The Trust's 2010 documentation was updated to comply with the latest guidance. The 2010 version also added into the consent forms a form of words agreed with the lead for photography, Giles Arbon, to address the possibility of photographs or video being taken in the hospital as part of the patient's treatment. Similarly a section was added in 2010 to cover the use of tissue taken from patients as agreed with the Pathology lead consultant Dr Dada. The section on Training was updated in 2010 to reflect the processes in the trust for training those staff who take consent for procedures that they are not able to undertaken. This describes the training in place and how the competency is recorded. Appendix A: 12 key points on consent: the law in England was updated in the 2011 version to include a clarification of the role of IMCAs (Independent Mental Capacity Advocates) at the request of the Clinical Standards Committee membership The section on Training was further updated in 2012 to clarify the process for reporting to the GMC Use of an additional form for use by Jehovah s Witnesses 12. Distribution list/dissemination method The policy document will be disseminated to all clinical areas in the Trust through the Trust standard process. The policy will also be available on the Trust intranet. A copy will be available to all healthcare professionals involved with the process of obtaining consent. 13. Review This policy will be reviewed in 2 years. Earlier review may be required in response to exceptional circumstances, organisational change or relevant changes in legislation or guidance 14. Monitoring Compliance to this policy will be assessed by means of an annual audit (using the audit tool in Appendix H). The audit will be undertaken by doctors in training and coordinated centrally by the Governance and the Trust lead for Consent, the Clinical Director for Surgery and will result in a report to the Clinical Safety & Effectiveness Committee (CSEC) presented by the Trust lead for Consent. This report will include an action plan to address areas of non-compliance. The regular six monthly Consent report to the CSEC will monitor progress to this plan. The audit report will monitor compliance with the policy, as follows Aspect of compliance being monitored Monitoring method Individual responsible for monitoring Process for obtaining consent Audit of health records Clinical Director for Surgery Process for discussion and provision of information to patients to support their decision making, including risks, benefits and Audit of health records Clinical Director for Surgery Frequency of monitoring activity Committee which receives monitoring report Committee responsible for ensuring actions are completed Annual CSEC CSEC Annual CSEC CSEC Source: Medical Director Status: Approved Page 16 of 52

17 alternatives where appropriate Process for recording that consent has been given Audit of health records Clinical Director for Surgery Annual CSEC CSEC Procedure-specific training on consent for clinical staff who are not capable of performing the procedure, but who are authorised to obtain consent for that procedure register of staff who are authorised to obtain consent for that procedure and a record that they have received training Clinical Director for Surgery Annual CSEC CSEC Follow up where an individual has obtained consent without the authorisation to do so Review of incident forms for every case identified in annual audit of health records. Head of Patient Safety Annual CSEC CSEC Notification to the GMC via the required form, of any individual who has obtained consent without the authorisation to do so Review of incident investigation documentation for every case identified in annual audit of health records Executive Medical Director Annual CSEC CSEC A review of additions to the Trust register of delegated Consent will include assurance that appropriate training has been provided and will form part of the regular six monthly Consent report to the CSEC 15 Document configuration information Author(s): Justin Alberts Clinical Director, Rosemary Smith, General Manager Other contributors: Governance, Giles Arbon, Trust Photography lead Dr M Dada Pathology lead. Approvals and Clinical Safety and Effectiveness Committee endorsements: Consultation: Surgical Directorate Clinical Governance Steering Group Issue no: 7 File name: Consent policy PP113 Supercedes: PP(11)113 Equality Assessed Yes Implementation This document will be widely circulated within the Trust, including all heads of department and Ward Managers and will be made availability on the Trust s Intranet and Internet sites. A copy will also be sent to all consultants and made available to junior doctors at induction. Relevant changes will be brought to the attention of staff during circulation. Monitoring: (give See Section 8. Monitoring brief details how this will be done) Source: Medical Director Status: Approved Page 17 of 52

18 Other relevant PP105 Incident Reporting and Management, CG Jehovah s Witness, policies/documents PP223The Mental Capacity Act 2005 and the Independent Mental Capacity Ad & references: (IMCA) Policy and Guidance (Patients Wills) Trust s Safer Surgery Pathway policy (PP(299) Additional Information: Source: Medical Director Status: Approved Page 18 of 52

19 Appendix A: 12 key points on consent: the law in England When do health professionals need consent from patients? 1. Before you examine, treat or care for adult patients with capacity you must obtain their consent. 2. Adults are always assumed to have the mental capacity unless demonstrated otherwise. If you have doubts about their capacity, the question to ask is: can this patient understand and weigh up the information needed to make this decision? Unexpected decisions do not prove the patient is incompetent, but may indicate a need for further information or explanation. 3. Patients may have the capacity to make some health care decisions, even if they do not have the capacity to make others. 4. Giving and obtaining consent is usually a process, not a one-off event. Patients can change their minds and withdraw consent at any time. If there is any doubt, you should always check that the patient still consents to your caring for or treating them. Can children give consent for themselves? 5. Before examining, treating or caring for a child, you must also seek consent. Young people aged 16 and 17 are presumed to have the capacity to give consent for themselves. Younger children who understand fully what is involved in the proposed procedure can also give consent (although their parents will ideally be involved). In other cases, some-one with parental responsibility must give consent on the child s behalf, unless they cannot be reached in an emergency. If a child with capacity consents to treatment, a parent cannot over-ride that consent. Legally, a parent can consent if a child with capacity refuses, but it is likely that taking such a serious step will be rare. Who is the right person to seek consent? 6. It is always best for the person actually treating the patient to seek the patient s consent. However, you may seek consent on behalf of colleagues if you are capable of performing the procedure in question, or if you have been specially trained to seek consent for that procedure. What information should be provided? 7. Patients need sufficient information before they can decide whether to give their consent: for example information about the benefits and risks of the proposed treatment, and alternative treatments. If the patient is not offered as much information as they reasonably need to make their decision, and in a form they can understand, their consent may not be valid. Source: Medical Director Status: Approved Page 19 of 52

20 8. Consent must be given voluntarily: not under any form of duress or undue influence from health professionals, family or friends. Does it matter how the patient gives consent? 9. No: consent can be written, oral or non-verbal. A signature on a consent form does not itself prove the consent is valid the point of the form is to record the patient s decision, and also increasingly the discussions that have taken place. Refusal of treatment 10. Adult patients with capacity are entitled to refuse treatment, even when it would clearly benefit their health. The only exception to this rule is where the treatment is for a mental disorder and the patient is detained under the Mental Health Act A pregnant woman with capacity may refuse any treatment, even if this would be detrimental to the fetus. Adults who do not have the capacity to give consent 11. No-one can give consent on behalf of an adult who is 16 or over who lacks the capacity. However, you may still treat such a patient if the treatment would be in their best interests. Best interests go wider than best medical interests, to include factors such as the wishes and beliefs of the patient when they had capacity, their current wishes, their general well-being and their spiritual and religious welfare. People close to the patient may be able to give you information on some of these factors. Where the patient has never had the capacity, relatives, carers and friends may be best placed to advise on the patient s needs and preferences. 12. If a patient who lacks capacity has clearly indicated in the past, while they had the capacity, that they would refuse treatment in certain circumstances (an advance refusal ), and those circumstances arise, you must abide by that refusal. This summary cannot cover all situations. For more detail, consult the Reference guide to consent for examination or treatment, available from the NHS Response Line and at Independent Mental Capacity Advocates (IMCAs) should be used to contribute information on a patient s best interests when they do not have any relatives/informal carers and important decisions need to be made. When a patient lacks capacity and has no family or informal carers, an IMCA must be involved if an NHS body is proposing to provide, withhold or stop serious medical treatment. IMCAs can also be used if there are safeguarding issues, or disagreements amongst family members about the patients best interests. In Suffolk, the IMCA service is provided through VoiceAbility. The referral form to instruct an IMCA is attached as an Appendix to The Mental Capacity Act 2005 and the Independent Mental Capacity Advocate (IMCA) Policy and Guidance (PP223) and can be found on the IMCA Suffolk website: They can also be contacted by phone: Source: Medical Director Status: Approved Page 20 of 52

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22 Appendix B: Current Forms in Use in This Organisation Consent Form 1: Patient Agreement to Investigation or Treatment Consent Form 2: Parental Agreement to Investigation or Treatment for a Child or Young Person Consent Form 3: Patient/parental Agreement to Investigation or Treatment (Procedures where consciousness not impaired) Consent Form 4: Form for Adults who are Unable to Consent to Investigation or Treatment Consent form 5: Consent to operative and Medical Treatment by a Patient Who Refused To Have A Blood Transfusion Some Specialties such as Breast have procedure specific consent forms All forms are in use at A4 size reproduced in the following pages at 50% actual size. Source: Medical Director Status: Approved Page 22 of 52

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36 Consent Form 5 Source: Medical Director Status: Approved Page 36 of 52

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38 Appendix C: Useful contact details Governance Department 3994 Head of Patient Safety and Effectiveness ext 3057 Admin Manager (for advice on court orders) ext 3829 West Suffolk Local Research Ethics Committee (Secretary) ext 3014 Patient Advocacy Liaison Support (PALS) (answerphone out of hours) ext 2555 Interpreter services (Language Line) Id code L25092 Signing (contact PALS) ext 2555 Hospital Liaison Committee for Jehovah s Witnesses D.P. Andrews R.F. Veazey Mobile Fax Source: Medical Director Status: Approved Page 38 of 52

39 Appendix D: How to seek a court declaration 1. A court declaration is usually required only when there isn t consensus on the patient s capability of understanding and ability to give consent to examination or treatment. Each case will be different but one example may be where the patient isn t able to consent at the time of treatment but has submitted previously (or the relatives are holding) an Advanced Directive (Living Will). The validity of the Living Will will need to be checked. See Trust policy PP052 - Patients Wills. 2. Further information on Advanced Directives can be obtained from the Department of Health s Reference guide to consent for examination or treatment (chapter 1, paragraph 19). Advice in the Trust is available from the Administration Manager on ext 3829 during office hours or through the Site Manager (bleep 652). Source: Medical Director Status: Approved Page 39 of 52

40 Appendix E: Seeking consent: remembering the patient s perspective Source: Medical Director Status: Approved Page 40 of 52

41 Appendix F: Registration form for admission to the register of delegated consent Details of staff member to be added to register: Name of staff member Grade of staff Staff department / specialty Consultant sponsor Procedure(s) to be consented. Details: Procedure name(s) Specific exceptions Training date* *Please attach details of training to support this form. Source: Medical Director Status: Approved Page 41 of 52 Issue date: March 2016 Valid until date: Dec 2017 Document reference: PP(11)113

42 Appendix G: Delegated Consent Competency Training: Procedures in (insert directorate/specialty) Name of delegate Grade.. By signing below, the delegate is confirming that the assessor has explained the nature of the procedures listed, the risks and benefits, the possible consequences and any alternative treatments, and that the delegate accepts responsibility for obtaining consent on the assessor s behalf. By signing below, the assessor is confirming that the delegate has been fully informed about the procedures listed, the risks and benefits, the possible consequences and any alternative treatments, and that the delegate can obtain consent for the procedures on the assessor s behalf. Procedure Name Delegate s signature Date Assessor s signature Date Delegated consent involves taking consent for a procedure for which the individual is not able to undertake the procedure independent Source: Medical Director Status: Approved Page 42 of 52 Issue date: March 2016 Valid until date: Dec 2017 Document reference: PP(11)113

43 Appendix H: Consent Form Audit November 2015 Ward Speciality:. Auditor:. Audit date: Instructions to the Auditor The consent form will normally be located alongside the correct site surgery form (on pink paper) in the patient s record. Use a new audit form for each patient and include all patients on the ward on the audit day. Answer all questions as required, marking answers clearly. Please return completed forms to the Governance Office (x2752). Patient CRN: Intended procedure:. Procedure date:. Elective Emergency 1) Is a consent form present in the patient s record? Yes No 2) Which consent form was used? ( tick form used 1. Patient Agreement 2. Parental Agreement To Treat Child or Young Person i) Is there evidence in the patient s record of discussion with parent/guardian? Yes No 3. Patient / Parental Agreement (consciousness not impaired) 4. Adults Unable To Consent i) Is there evidence in the patient s record of discussion With relatives etc.? Yes No 5. Other Specialty Procedure Specific Form. Title: 3) Was the appropriate consent form used? Yes No 4) Are the patient s details recorded? 5) Are the responsible health professional s details recorded? 6) Is the name of the procedure recorded? Yes legible Yes legible Yes legible Yes illegible No Yes illegible No Yes illegible No Questions for Consent Forms 1, 2 and 3: (If auditing Consent Form 4 go to Q28) Statement of Health Professional 7) Have the intended benefits been recorded? Yes legible Yes illegible No 8) Have the risks been recorded? Yes legible Yes illegible No 9) Has an information leaflet been provided? Yes No 10) Has the responsible health professional signed the form? 11) Has the responsible health professional dated the form? 12) Has the responsible health professional printed their name? 13) Has the responsible health professional recorded their job title? No declined Yes legible Yes illegible No Yes legible Yes illegible No Yes legible Yes illegible No Yes legible Yes illegible No Source: Medical Director Status: Approved Page 43 of 52 Issue date: March 2016 Valid until date: Dec 2017 Document reference: PP(11)113