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Regulation 20: Duty of candour

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  • Organisations we regulate

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20

The intention of this regulation is to ensure that providers are open and transparent with people who use services and other 'relevant persons' (people acting lawfully on their behalf) in general in relation to care and treatment. It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.

The regulation applies to registered persons when they are carrying on a regulated activity.

CQC can prosecute for a breach of parts 20(2)(a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action. See the offences section of this guidance for more detail.

The regulation in full

20.—

  1. Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.
  2. As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must—
    1. notify the relevant person that the incident has occurred in accordance with paragraph (3), and
    2. provide reasonable support to the relevant person in relation to the incident, including when giving such notification.
  3. The notification to be given under paragraph (2)(a) must—
    1. be given in person by one or more representatives of the registered person,
    2. provide an account, which to the best of the registered person's knowledge is true, of all the facts the registered person knows about the incident as at the date of the notification,
    3. advise the relevant person what further enquiries into the incident the registered person believes are appropriate,
    4. include an apology, and
    5. be recorded in a written record which is kept securely by the registered person.
  4. The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person containing—
    1. the information provided under paragraph (3)(b),
    2. details of any enquiries to be undertaken in accordance with paragraph (3)(c),
    3. the results of any further enquiries into the incident, and
    4. an apology.
  5. But if the relevant person cannot be contacted in person or declines to speak to the representative of the registered person —
    1. paragraphs (2) to (4) are not to apply, and
    2. a written record is to be kept of attempts to contact or to speak to the relevant person.
  6. The registered provider must keep a copy of all correspondence with the relevant person under paragraph (4).
  7. In this regulation—
    "apology" means an expression of sorrow or regret in respect of a notifiable safety incident; "moderate harm" means—
    1. harm that requires a moderate increase in treatment, and
    2. significant, but not permanent, harm;
    "moderate increase in treatment" means an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care);
    "notifiable safety incident" has the meaning given in paragraphs (8) and (9);
    "prolonged pain" means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
    "prolonged psychological harm" means psychological harm which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;
    "relevant person" means the service user or, in the following circumstances, a person lawfully acting on their behalf—
    1. on the death of the service user,
    2. where the service user is under 16 and not competent to make a decision in relation to their care or treatment, or
    3. where the service user is 16 or over and lacks capacity in relation to the matter;
    ‚Äč"severe harm" means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, including removal of the wrong limb or organ or brain damage, that is related directly to the incident and not related to the natural course of the service user's illness or underlying condition.
  8. In relation to a health service body, "notifiable safety incident" means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—
    1. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition, or
    2. severe harm, moderate harm or prolonged psychological harm to the service user.
  9. In relation to any other registered person, "notifiable safety incident" means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional—
    1. appears to have resulted in—
      1. the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user's illness or underlying condition,
      2. an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,
      3. changes to the structure of the service user's body,
      4. the service user experiencing prolonged pain or prolonged psychological harm, or
      5. the shortening of the life expectancy of the service user; or
    2. requires treatment by a health care professional in order to prevent—
      1. the death of the service user, or
      2. any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).

Guidance

Component of the regulation

Providers must have regard to the following guidance

20(1) Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.

  • Providers must promote a culture that encourages candour, openness and honesty at all levels. This should be an integral part of a culture of safety that supports organisational and personal learning. There should also be a commitment to being open and transparent at board level or its equivalent, such as a governing body.
  • Providers should have policies and procedures in place to support a culture of openness and transparency, and ensure that all staff follow them.
  • Providers should take action to tackle bullying and harassment in relation to duty of candour, and must investigate any instances where a member of staff may have obstructed another in exercising their duty of candour.
  • Providers should have a system in place to identify and deal with possible breaches of the professional duty of candour by staff who are professionally registered, including the obstruction of another in their professional duty of candour. This is likely to include an investigation and escalation process that may lead to referral to their professional regulator or other relevant body.
  • Providers should make all reasonable efforts to ensure that staff operating at all levels within the organisation operate within a culture of openness and transparency, understand their individual responsibilities in relation to the duty of candour, and are supported to be open and honest with patients and apologise when things go wrong.
  • Staff should receive appropriate training, and there should be arrangements in place to support staff who are involved in a notifiable safety incident.
  • In cases where a provider is made aware that something untoward has happened, they should treat the allegation seriously, immediately consider whether this is a notifiable safety incident and take appropriate action.

20(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must– (a) notify the relevant person that the incident has occurred in accordance with paragraph (3) and

20(3) The notification to be given under paragraph (2)(a) must–

(a) be given in person by one or more representatives of the registered person,

(b) provide an account, which to the best of the health service body's knowledge is true, of all the facts the registered person knows about the incident as at the date of the notification,

(c) advise the relevant person what further enquiries into the incident the registered person believes are appropriate,

(d) include an apology, and

(e) be recorded in a written record which is kept securely by the registered person.

  • When a notifiable safety incident has occurred, the relevant person must be informed as soon as reasonably practicable after the incident has been identified. Providers who are subject to the NHS Standard Contract should be aware that the standard contract requires that the notification must be within at most 10 working days of the incident being reported to local systems, and sooner where possible.
  • All staff working within a provider must have responsibility to adhere to that organisation's policies and procedures around duty of candour, regardless of seniority or permanency.
  • Regulation 20 defines what constitutes a notifiable safety incident for health service bodies and other providers. It includes incidents that, in the reasonable opinion of a healthcare professional, could result in, or appear to have resulted in, the death of the person using the service or severe harm, moderate harm, or prolonged psychological harm. These terms are defined in the regulation – paragraph 8 for health service bodies and paragraph 9 for other providers (see above).
  • Where the degree of harm is not yet clear but may fall into the above categories in future, the relevant person must be informed of the notifiable safety incident in line with the requirements of the regulation.
  • Providers are not required by the regulation to inform a person using the service when a 'near miss' has occurred, and the incident has resulted in no harm to that person.
  • There must be appropriate arrangements in place to notify the person using the service who is affected by an incident if they are aged 16 and over and lack the mental capacity to make a decision about their care or treatment, including ensuring that a person acting lawfully on their behalf is notified as the relevant person.
  • A person acting lawfully on behalf of the person using the service must be notified as the relevant person where the person using the service is under 16 and lacks the mental capacity to make a decision regarding their care or treatment.
  • A person acting lawfully on behalf of the person using the service must be notified as the relevant person, upon the death of the person using the service.
  • Other than the situations outlined above, information should only be disclosed to family members or carers where the person using the service has given their express or implied consent.
  • A step-by-step account of all relevant facts known about the incident at the time must be given, in person, by one or more appropriate representatives of the provider. This should include as much or as little information as the relevant person wants to hear, be jargon free and explain any complicated terms.
  • The account of the facts must be given in a manner that the relevant person can understand. For example, providers should consider whether interpreters, advocates, or other communication aids should be used, while being conscious of any potential breaches of confidentiality in doing so.
  • Providers must also explain to the relevant person what further enquires they will make.
  • Providers must ensure that one or more appropriate representatives of the provider gives a meaningful apology, in person, to relevant persons. An apology is defined in the regulation as an expression of sorrow or regret.
  • In making a decision about who is most appropriate to provide the notification and/or apology, the provider should consider seniority, relationship to the person using the service, and experience and expertise in the type of notifiable incident that has occurred.

20(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must–

(b) provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

  • Providers must give the relevant person all reasonable support necessary to help overcome the physical, psychological and emotional impact of the incident. This could include all or some of the following:
    • Treating them with respect, consideration and empathy.
    • Offering the option of direct emotional support during the notifications, for example from a family member, a friend, a care professional or a trained advocate.
    • Offering help to understand what is being said, for example, through an interpreter, non-verbal communication aids, written information, Braille etc.
    • Providing access to any necessary treatment and care to recover from or minimise the harm caused where appropriate.
    • Providing the relevant person with details of specialist independent sources of practical advice and support or emotional support/counselling.
    • Providing the relevant person with information about available impartial advocacy and support services, their local Healthwatch and other relevant support groups, for example Cruse Bereavement Care and Action against Medical Accidents (AvMA), to help them deal with the outcome of the incident.
    • Arranging for care and treatment from another professional, team or provider if this is possible, if the relevant person wishes.
    • Providing support to access the complaints procedure.

20(4) The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person containing—

(a) the information provided under paragraph (3)(b),

(b) details of any enquiries to be undertaken in accordance with paragraph (3)(c),

(c) the results of any further enquiries into the incident, and

(d) an apology.

  • Providers must ensure that they give written notification to the relevant person following the notification that was given in person, even though enquiries may not yet be complete.
  • The written notification must contain all the information that was provided in person, including an apology, as well as the results of any enquiries that have been made since the notification in person.
  • The outcomes or results of any further enquiries and investigations must also be provided in writing to the relevant person through further written notifications, if they wish to receive them.

20(5) But if the relevant person cannot be contacted in person or declines to speak to the representative of the registered person –

(a) paragraphs (2) to (4) are not to apply, and

(b) a written record is to be kept of attempts to contact or to speak to the relevant person.

  • The provider must make every reasonable attempt to contact the relevant person through all available means of communication. All attempts to contact the relevant person must be documented.
  • If the relevant person does not wish to communicate with the provider, their wishes must be respected and a record of this must be kept.
  • If the relevant person has died and there is nobody who can lawfully act on their behalf, a record of this should be kept.

20(6) The registered provider must keep a copy of all correspondence with the relevant person under paragraph (4).

  • Providers must keep a record of the written notification, along with any enquiries and investigations and the outcome or results of the enquiries or investigations.
  • Any correspondence from the relevant person relating to the incident must be responded to in an appropriate manner and a record of communications should be kept.

 

Last updated:
14 April 2015