Posted: 28 March 2012
CQC: The value of consent
Consent is a key part of the CQC guidance. Continuing her series, Seema Sharma looks a what it means for dental practices
The Care Quality Commission expects dental practices to gain and review valid consent to the examination, care, treatment and support patients receive. Outcome 2 therefore requires practice providers (owners) to:
• Ensure consent is sought by a practitioner capable of imparting sufficient knowledge to ensure the patient makes an informed decision
• Ensure options, risks, benefits and fees are discussed
• Ensure all care provided is in the patient’s best interest
• Respect the patient’s autonomy, choice and free will
• Know the correct procedures for obtaining consent from children and patients who lack capacity.
Consent: Consent is a patient’s agreement to an action based on knowledge of what the action involves and its likely consequences.
Valid consent: For consent to be valid it must be specific, informed and normally be given by the patient or a parent or guardian if the patient is under 16.
Express consent: (Also known as explicit consent) Consent which is given orally or in writing. For example for an examination or treatment, or for the processing of personal information.
Implied consent: Consent that can be inferred if the patient has been given information, knows he/she has the right to object, and has not objected. For example when a patient has been informed that their information is to be disclosed to another provider through a referral process, and they do not object. This can also be indicated by compliant actions, such as when a patient indicates agreement to an examination by lying in the dental chair and opening their mouth. Care must be exercised in extending this to treatment as an open mouth does not necessarily mean that the patient has understood what the dentist has proposed to do or the reasons why.
Informed consent: Consent obtained after a full explanation of the nature, purpose, options, benefits and risks of proposed procedures in language that the patient understands (using an interpreter and visual aids where necessary). The patient should have time to think about their consent decisions and ask questions in order to arrive at a balanced judgement of whether to proceed or not.
Specific consent: Specific consent means that the patient consents expressly to each of the procedures to be undertaken. An agreement to undertake a course of treatment without knowing what is to be done is not specific consent. Examples include consent for higher risk procedures such as whitening, root treatments, extractions, implants, sedation and complex care such as orthodontics or smile makeovers.
There is landmark case law on the subject of consent that is beyond the scope of this article but a summary can be requested from the author (Bolam test, Bolitho Judgement). When in doubt, advice should be sought from the dentist’s defence organisation.
Gaining consent is an ongoing process, not a form-filling exercise or a specific event, and effective communication is vital. The patient’s comprehension is an essential element in the validity of consent and the onus is on the dentist to be satisfied that the patient has understood the treatment to be carried out and the consequences of not having the treatment. Other than for the most routine procedure such as an examination, for which implied consent may be adequate, valid consent must be obtained.
When developing a care plan, the issues that are known to be the most PROBABLE causes of future complaints or litigation should be documented in a personalised care plan (Table 1).
|TABLE 1: 'PROBABLE' PERSONALISED CARE PLAN|
B Balanced judgement
L Long-term impact
Co-diagnosis: A process of co-diagnosis ensures that patients are informed and involved in decision making, that they arrive at their own final decisions, and that is clearly documented that the final care plan is mutually agreed. This is the most fundamental requirement for satisfying a dentist’s ethical and legal obligations.
Material risks: Dentists must warn patients of any substantial or unusual risks and their consequences. For example the possibility of nerve damage in oral surgery procedures, perforation or instrument breakage in endodontics, failure of implants, crowns or bridges.
Autonomy, choice, free will and valid consent: Dentists have a moral obligation and ethical principle to respect a person’s autonomy and right to self-determination. For consent to be valid, patients should make their own choices of their own free will. Any treatment or intentional physical contact with the patient undertaken without consent may amount to assault and a breach of the patient’s human rights and/or lead to a serious professional misconduct case with the General Dental Council, or even prosecution.
Managing expectations: It is important to manage patient expectations around all aspects of dental care. The patient should be given a realistic explanation of the benefits of proposed care, a statement of all costs associated and clear information about what is being provided privately or on the National Health Service.
Copies of care plans and estimates may be used to record consent, but it is important that they accurately reflect that the patient has agreed to the proposed care, all necessary explanations have been given and a signature has been obtained. The key component of consent is patient information and involvement, and confirmation that the person has understood the care they are consenting to, and that they continue to consent at each visit.
Taking care with consent
Time to reflect: It is good practice to leave a period of time between obtaining consent and commencing treatment, particularly when it is expensive or extensive, or where there are multiple options to consider. The most foolproof way is to obtain consent when the treatment plan is drawn up and then to record re-affirmation of consent at subsequent visits.
Consent is more than a signature: Obtaining a signed statement from the patient instructing the dentist to carry out the treatment and absolving the dentist from any stated adverse consequences may not be a valid defence in court or before the General Dental Council.
Consent under duress: Patients must be given sufficient time to consider and understand the information that they are given about proposed treatment, to ask any questions that they still need answers to and to come to a decision. Consent is not valid if it is obtained under duress.
Treatment which is not in the patient’s best interest: Sometimes a dentist might be asked to carry out treatment that conflicts with the dentist’s judgement, and is not in the patient’s best interest. Dentists have a responsibility to act in the patient’s best interests. Procedures that cause permanent damage to the dentition should not be undertaken, or if the clinical or cosmetic benefits do not outweigh the potential drawbacks.
Battery: Failure to obtain consent to care can constitute an assault and there is also a possibility of action under the Human Rights Act 1998.
All people aged 16 and over are presumed in law to have the capacity to consent to surgical, medical or dental treatment unless there is evidence to the contrary (Family Law Reform Act 1969). In circumstances where a child is unable to give consent, the practitioner must identify and involve the person with parental responsibility. An adult relative without parental responsibility cannot give consent to the treatment. If the parent cannot be contacted then treatment should only proceed in exceptional circumstances, for example where the child is in pain and the treatment is undertaken to alleviate it.
If the unusual circumstance arises where the child refuses family involvement, their right to confidentiality must be respected, but children below 16 are not deemed to be automatically legally competent to give consent unless they have ‘sufficient understanding and maturity to enable them to understand fully what is proposed’ (known as Gillick competency or Fraser competency - see information box below) and this depends on the intervention proposed. Advice should be sought from the practitioner’s indemnity provider. It will ordinarily be for the practitioner to decide whether the child satisfies these criteria of competence.
|Gillick vs West Norfolk and Wisbech Area Health Authority (1985)|
|This case ruled against mother Mrs Gillick who sought a declaration that prescribing contraception was illegal because the doctor would commit an offence of encouraging sex with a minor, and that it would be treatment without consent as consent vested in the parent. The judgement was that a child under 16 was able to consent if he or she understood the nature of the treatment, its purpose and hazards.|
A young person who has the capacity to consent to straightforward, relatively risk-free treatment may not necessarily have the capacity to consent to complex treatment involving high risks or serious consequences, so families of children should be involved in decisions about their care, unless there is a very good reason for not doing so.
Patients lacking capacity
Patients lacking capacity/competence under the Mental Capacity Act 2005. The Act has five key principles:
1. We must begin by assuming that people have capacity. ‘A person must be assumed to have capacity unless it is established that he/she lacks capacity.’
2. People must be helped to make decisions. ‘A person is not to be treated as unable to make a decision unless all practicable steps to help him/her to do so have been taken without success.’
3. Unwise decisions do not necessarily mean lack of capacity. ‘A person is not to be treated as unable to make a decision merely because he/she makes an unwise decision.’
4. Decisions must be taken in the person’s best interests. ‘An act done, or decision made under this Act for or on behalf of a person who lacks capacity must be done, or made, in his/her best interests.’
5. Decisions must place as few restrictions on freedom as possible. ‘Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.’
The Mental Capacity Act Code of Practice also includes an important ‘two-stage test of capacity’:
1. Is there an impairment of, or disturbance in, the functioning of the person’s mind or brain? If so:
2. Is the impairment/disturbance sufficient that the person lacks capacity to make a particular decision?
A person lacks capacity to make a particular decision if they cannot do any of the following:
• Understand information relevant to the decision
• Remember information long enough to make the decision
• Weigh up information relevant to the decision
• Communicate the decision by talking, sign language, or any other means.
A key principle of the Mental Capacity Act is that decisions made on behalf of a person who lacks capacity are made in the person’s ‘best interests’. People who make decisions on other people’s behalf are known as ‘decisionmakers’ and must follow the ‘best interests’ checklist in section 5 of the code of practice.
|CQC The Mental Capacity Act 2005 Guidance for Providers|
|Mental Capacity Act 2005 Code of Practice|
|GDC Principles of Consent|