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Knowledge hub · CQC Regulation 20
What the duty of candour means, when an incident is notifiable, what to say and write, and what happens if you get it wrong. With care home, home care and supported living examples, a free letter template and the rules in Scotland, Wales and Northern Ireland. Checked on 21 October 2026.
By the Care Sync Experts compliance team, who write duty of candour policies and incident procedures for home care, supported living and care home providers. Every rule and figure on this page was checked against the sources listed at the end of the page on .
Duty of candour is the legal duty on every CQC-registered health and social care provider to be open and honest with people when something goes wrong with their care. Under Regulation 20, when a notifiable safety incident happens, the provider must tell the person face to face, apologise, give a true account of what happened, explain what will be looked into, offer support and follow up in writing.
Nurses, doctors and other registered professionals also have a separate professional duty of candour, set by their own regulators. Saying sorry is not an admission of liability.
For a care provider, candour is two things at once: a general duty to be open at all times, and a set procedure for the more serious incidents. Most mistakes happen at the edges: deciding whether an incident is notifiable, who forms the harm opinion when there is no nurse on staff, and what goes in the letter. Use our checker or see eight care examples.
This guide covers England unless it says otherwise. It is general information, not legal advice.
| What It Is | A legal duty to be open and honest with people when something goes wrong with their care |
|---|---|
| The Law | Regulation 20, Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 |
| Who It Applies To | Every CQC-registered provider in England: care homes, home care, supported living, GPs, dentists, hospitals |
| When It Is Triggered | A notifiable safety incident: unintended or unexpected, during regulated care, causing a set level of harm |
| What You Must Do | Tell the person face to face, apologise, give a true account, explain next steps, offer support, follow up in writing |
| How Fast | As soon as reasonably practicable. No fixed number of days in the law |
| Apology | Not an admission of liability. You apologise whether or not anyone was at fault |
| Who Enforces It | CQC. Failing to give the in-person notification properly is a criminal offence: £1,250 fixed penalty or up to £2,500 fine |
| Professional Duty | Separate duty on nurses, doctors and other registered professionals, set by their regulators |
| Where | England. Scotland and Wales have their own laws; Northern Ireland has no statutory duty yet |
Source: Regulation 20; Schedule 5; CQC, Regulation 20; Compensation Act 2006, s.2.
Statutory and professional
There are two types of duty of candour. The statutory duty applies to organisations and is enforced by CQC. The professional duty applies to individual registered professionals and is enforced by their regulators. When an incident is notifiable, the professional duty alone is not enough: the provider must also follow Regulation 20.
A legal duty on the registered provider and registered manager. It has a general part (be open at all times) and a specific procedure for notifiable safety incidents.
An ethical and professional duty on each registered professional to be honest with patients, apologise and explain when something goes wrong, and to be open with colleagues and their employer.
| Feature | Statutory duty | Professional duty |
|---|---|---|
| Who it applies to | Organisations: every CQC-registered provider | Individuals: doctors, nurses, midwives, HCPC registrants and other registered professionals |
| Set by | Regulation 20 of the 2014 Regulations | Professional codes, such as the GMC and NMC joint guidance |
| Enforced by | CQC | GMC, NMC, HCPC, GDC and the other professional regulators |
| Triggered by | A notifiable safety incident that meets set harm thresholds | Anything that goes wrong and causes, or could cause, harm or distress |
| Near misses | Not in scope of the procedure | Use professional judgement on telling people |
| What happens if breached | Criminal offence for failing to notify in person, plus civil enforcement | Fitness to practise action against the professional |
Asked in courses
Official guidance recognises two: the statutory duty, set in law, and the professional duty, set by regulators. Where a course asks for three, the third is usually the general duty in Regulation 20(1) to be open and transparent at all times, as distinct from the specific procedure for notifiable safety incidents. Some courses call it the ethical or organisational duty.
Source: CQC, Regulation 20; GMC and NMC, Openness and honesty when things go wrong (updated 13 December 2024).
The law in plain English
Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 is one of CQC's fundamental standards. It came into force for NHS bodies on 27 November 2014 and for every other registered provider on 1 April 2015. It has two parts: a general duty of openness and a specific procedure.
Regulation 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.”
The criminal offence covers only 20(2)(a) and 20(3), the in-person notification. The rest is enforced through CQC's civil powers. See enforcement.
Source: Regulation 20; Regulation 2; Regulation 22; CQC, what you must do. Paragraph summaries are ours.
The trigger
A notifiable safety incident is the trigger for the duty of candour procedure. It must meet all three of CQC's criteria. If any one is missing, it is not notifiable, but you must still be open with the person.
Something in the care or treatment did not go as intended or expected. CQC says this is about the incident, not the outcome: if care went as planned, harm alone does not make it notifiable.
It happened while you were providing the care CQC registers you for, such as personal care during a visit or accommodation in a care home.
In the reasonable opinion of a health care professional, it appears to have caused death or the harm set for your type of provider. For providers other than NHS bodies, it also counts if treatment was needed to prevent that harm; NHS bodies also count harm it could cause later.
This is the point most guides get wrong. “Moderate harm” and “severe harm” only apply to NHS bodies. Care homes, home care, supported living, GPs, dentists and independent hospitals use a different list in Regulation 20(9).
Regulation 20(9) · most care providers
Notifiable if, in a health care professional's reasonable opinion, the incident appears to have resulted in, or requires treatment to prevent:
Regulation 20(8) · NHS bodies
Notifiable if, in a health care professional's reasonable opinion, the incident could result in, or appears to have resulted in:
Home care and supported living
The regulation needs the opinion of a registered health professional. Most home care and supported living teams have none on staff, so the registered manager should ask the person's GP, district nurse, a 111 clinician (not the call handler), the paramedics or the hospital team, and write down who gave the opinion, when, and what they said. Our advice: if the opinion is unclear and harm is possible, follow the procedure anyway.
An incident can be notifiable even if nobody did anything wrong. You apologise for the harm, not for blame.
If no harm happened and none is expected, the procedure does not apply. The general duty to be open still does.
An incident can qualify even if the person consented to the care.
If you discover it through a later review or audit, the duty applies from when you become aware.
Tell that provider and be open with the person. The provider where it happened runs the procedure.
Each provider keeps its own responsibilities. Agree who speaks to the person so they are not told three times.
Not sure? Answer four questions in our notifiable incident checker.
Source: Regulation 20(7) to (9); CQC, notifiable safety incidents. The “who forms the opinion” advice and the note on several providers are ours.
Free tool
Answer four questions to see whether the duty of candour procedure is likely to apply. It follows CQC's three criteria and the harm list for your type of provider. It is a guide, not a ruling: the harm test always needs a health care professional's opinion.
Think about the care or treatment itself, not only the outcome.
For example during a visit or in your care home. Include incidents where a missed or late visit, or a care plan failure, contributed.
This decides which harm list applies.
Tick all that apply, as judged by a health care professional.
Choose your provider type first.
Nothing you enter is saved or sent anywhere. Do not type personal details.
The general duty to be open applies whatever the answer. This tool is our own interpretation of the regulation and CQC guidance, not legal advice.
Source: Regulation 20(8) and (9); CQC, notifiable safety incidents.
Care examples
How the three tests and the Regulation 20(9) harm list work in real care settings. The first two follow CQC's own examples; the rest are our reading of the regulation. In every case, the harm opinion must come from a health care professional.
Care home
An OT said a resident needed grab rails before using the bath. The care plan was not updated, he slipped getting out of the bath and broke his arm, then needed full help for six weeks.
VerdictNotifiable
Why: Unexpected, during care, and it needed treatment to prevent lasting harm. This is CQC's own example under Regulation 20(9).
Also a CQC serious injury notification.
Based on CQC's guidance
Care home
A resident is found on the floor of her room in the night. Hospital confirms a fractured hip needing surgery.
VerdictLikely notifiable
Why: CQC says a fall during the accommodation part of care home care could qualify if the harm thresholds are met. A hip fracture needing surgery needs treatment to prevent lasting harm, and is likely to cause impairment or pain lasting 28 days or more.
Also a CQC serious injury notification; consider safeguarding.
Based on CQC's guidance
Home care
A care worker gives a client the blister pack meant for her husband. 111 advises A&E, where she is monitored and treated overnight.
VerdictLikely notifiable
Why: Unintended, during a care visit, and the hospital judged she needed treatment by a health care professional to prevent death or lasting harm on the 20(9) list.
Record the clinician's opinion; consider safeguarding.
Home care
A visit is dropped from the rota. The client misses his insulin, becomes unwell and is admitted to hospital.
VerdictLikely notifiable
Why: Our view: a missed visit is a failure in the care you agreed to give, and he needed hospital treatment to prevent lasting harm. CQC has not published guidance on missed visits.
Tell the commissioner if your contract requires it.
Supported living
A tenant on a soft diet is given a normal meal. Staff use back blows and call an ambulance; paramedics clear his airway.
VerdictLikely notifiable
Why: Unintended, during personal care, and treatment by a health care professional was needed to prevent death or lasting harm on the 20(9) list.
Review the SALT plan and staff training.
Home care
A client receiving four visits a day develops a category 3 pressure ulcer after skin changes were not reported.
VerdictCheck
Why: Something in the care went wrong: skin changes were not reported. Ask the district nurse whether the ulcer has caused, or needs treatment to prevent, harm on the 20(9) list, such as prolonged pain. If so, it is notifiable.
A category (grade) 3 or above ulcer can also need a CQC serious injury notification.
Home care
A client falls at night, hours after the evening visit, and is found by the morning carer.
VerdictCheck
Why: A fall when you were not providing care is usually outside Regulation 20. But if a missed or late visit, or a care plan failure, contributed, it can come within it.
Be open about anything your team did or missed.
Care home
A resident misses one dose of a routine tablet. The GP advises no action and she is well.
VerdictNot notifiable
Why: A no-harm incident: no listed harm and no treatment needed, so the 20(9) threshold is not met.
Still tell her and record it under the general duty to be open.
Source: CQC, examples of notifiable safety incidents; CQC, Registration Regulation 18 notifications. Examples 3 to 8 and their verdicts are our interpretation, not CQC's.
Step by step
Regulation 20 sets out what you must do as soon as reasonably practicable after you become aware of a notifiable safety incident. Steps 3 to 8 are the law. Steps 1 and 2 are our advice on getting there quickly.
Deal with the person's immediate needs first. Ask a health care professional whether the harm threshold is met, and write down who said what and when.
Usually the registered manager or a senior colleague the person trusts. Agree a time quickly: the law says as soon as reasonably practicable.
Face to face, as the regulation requires. Explain that something went wrong in their care. Involve family only if the person consents. If they have died, lack capacity or are under 16 and not competent, speak to the person lawfully acting for them.
Share all the facts you know so far, in plain words. Do not guess, blame individuals or wait for the investigation to finish.
Say what further enquiries you think are appropriate, such as an internal review, and when you expect to know more.
Say sorry for what happened. Offer practical and emotional support, such as an interpreter, an advocate, or details of AvMA or Cruse.
Write a record of the meeting, who was there, what was said and the support offered, and keep it securely.
Send a letter with the account, the enquiries, an apology and, once known, the results. Keep copies of everything you send.
Regulation 20(5) says the notification steps do not apply, but you must keep a written record of every attempt to contact or speak to them. CQC says you must still report and investigate the incident. Our advice: leave the door open in writing.
Myth: 10 working days
The law says “as soon as reasonably practicable”. The 10 working days often quoted came from the 10 operational days in older NHS Standard Contracts and some trust policies; it is not in Regulation 20, CQC guidance or the 2026/27 NHS Standard Contract. Wales and Scotland do set times. See the UK comparison.
Source: Regulation 20; CQC, what you must do; NHS Standard Contract. Steps 1 and 2 are our advice.
Saying sorry
Regulation 20 defines an apology as “an expression of sorrow or regret”. CQC says apologising is not an admission of liability, in health or social care, public or private, and that you must apologise for the harm whether or not anyone was at fault. Section 2 of the Compensation Act 2006 says an apology does not of itself amount to an admission of negligence or breach of statutory duty.
NHS Resolution: “We have never, and will never, refuse cover on a claim because an apology has been given.” CQC adds that it is often the lack of a timely apology that pushes people to take legal action.
Do say
Avoid
Source: Regulation 20(7); CQC, Regulation 20; Compensation Act 2006, s.2; NHS Resolution, Saying sorry.
Free template
After the in-person conversation, Regulation 20(4) says you must give or send a written notification. Many providers send two letters: one soon after the meeting, and one when the enquiries are finished. Keep a copy of every letter (Regulation 20(6)).
The law requires
Good practice (our advice)
Dear Mrs Patel,
Thank you for meeting me on 14 October. I am writing, as promised, to confirm what we discussed about the medicines you were given on the morning of 13 October.
What happened. Our care worker gave you the medicines prepared for your husband. When this was noticed, we called 111 and you were taken to hospital, where you were monitored overnight and given treatment.
What we are doing. We are reviewing how medicines are checked on each visit and will speak to the staff involved. I will share what we find by 7 November.
Our apology. I am sorry that this happened to you, and I am sorry for the worry it has caused you and your family.
If you would like support, or someone with you when we next meet, please call me on the number below.
Yours sincerely,
Registered Manager
Free download, no sign up
Page one is a fill-in letter that covers every part of Regulation 20(4). Page two is a record of the in-person conversation and a checklist of every step, so your file shows CQC exactly what you did and when.
Source: Regulation 20(3) to (6). The example letter and template wording are ours; adapt them to your service and the incident.
Inspection evidence
CQC expects to see, from registration onwards, that you understand the duty and have the training, policies and systems to meet it. At inspection it follows up incidents you have reported, speaks to staff and asks the people affected. CQC lists duty of candour under the Safe key question, in the “Learning culture” quality statement.
The list is our advice, built from CQC's guidance.
Learning culture, quality statement
“We have a proactive and positive culture of safety based on openness and honesty, in which concerns about safety are listened to, safety events are investigated and reported thoroughly, and lessons are learned…”
Changing in 2026
CQC is replacing quality statements with sector frameworks after its “Better regulation, better care” consultation. On 21 October 2026 the single assessment framework still applies. Openness after incidents stays central either way.
Source: CQC, how we regulate the duty of candour; CQC, Learning culture.
Breach
Failing to give the in-person notification Regulation 20(3) requires, with a true account, next steps, an apology and a secure written record, is a criminal offence, and CQC can prosecute without first serving a warning notice. Other failings, such as no written follow-up, no support or not keeping copies of letters, are dealt with through CQC's civil powers and can lower your rating.
£2,500
Level 4 on the standard scale, for breaching Regulation 20(2)(a) and (3).
£1,250
CQC can offer this instead of prosecution. It must be paid within 28 days.
Defence
It is a defence to prove you took all reasonable steps and exercised all due diligence.
| Date | Provider | Outcome |
|---|---|---|
| January 2019 | Bradford Teaching Hospitals NHS FT | Fixed penalty of £1,250 for a delay of about three months in apologising to a family |
| October 2019 | Royal Cornwall Hospitals NHS Trust | 13 fixed penalties, £16,250 in total |
| September 2020 | University Hospitals Plymouth NHS Trust | First prosecution: fined £1,600, plus £120 surcharge and £10,845 costs |
| April 2021 | Spire Healthcare (Leeds) | First independent provider prosecuted: fined £5,000, about £20,100 in total |
| October 2021 | West Suffolk NHS FT | Two fixed penalties of £1,250 |
| July 2022 | Premiere Care (Southern) Ltd, care home in Margate | Fined £3,300 for duty of candour failings after a resident's death, about £11,400 in total |
| December 2025 | Kettering General Hospital NHS FT | Fixed penalty of £1,250 for failing to tell a family promptly after a 13-year-old's death |
The most recent published case we found is the December 2025 fixed penalty against Kettering General Hospital. In a 2024 government call for evidence, 52% of the 261 people and organisations who responded said CQC had not enforced the duty adequately.
Source: Regulation 22; Regulation 23; Regulation 24; Schedule 5; CQC, how we regulate; CQC press releases 2019 to 2022; Northants Telegraph (February 2026); DHSC call for evidence findings (November 2024).
Common questions
Duty of care is about keeping people safe. Duty of candour is about being honest when something goes wrong. You can give good care and still breach the duty of candour by not telling someone what happened.
| Feature | Duty of care | Duty of candour |
|---|---|---|
| What it means | Act in people's best interests and keep them safe from harm | Be open and honest when something has gone wrong |
| When it applies | All the time, before and during care | All the time, plus a set procedure after a notifiable incident |
| Fault | Breach plus harm can be negligence | Applies whether or not anyone was at fault |
| Where it comes from | Common law, professional codes and the regulations | Regulation 20 and professional codes |
For learners
A model answer in your own words: duty of care means I must act in the best interests of the people I support and protect them from harm. Duty of candour means that if something goes wrong, I must be open and honest about it. They work together, because being honest when mistakes happen helps keep people safe, builds trust and helps the service learn so it does not happen again.
One incident can trigger several duties at once. Doing one does not tick off the others.
| Duty | Who you tell | What you do |
|---|---|---|
| Duty of candour (Reg 20) | The person or their representative | Tell them in person, apologise, follow up in writing |
| CQC notifications (Registration Regulations 2009, regs 16 and 18) | CQC | Report deaths (Reg 16) and serious injuries (Reg 18) without delay |
| Safeguarding (Care Act 2014) | The local authority | Raise a concern if abuse or neglect is suspected |
| Complaints (Reg 16, 2014 Regulations) | The person who complained | Investigate and respond, whether or not candour applied |
More detail: CQC statutory notifications and safeguarding adults.
Source: CQC, Regulation 20; CQC, Registration Regulation 18; Care Act 2014, s.42. The model answer is ours.
Individuals
Every registered health and care professional must be open and honest when something goes wrong with care that causes, or could cause, harm or distress. They must tell the person, apologise, offer support to put things right where possible, and explain the short and long term effects. They do not have to wait for an investigation.
| Who | Where the duty is set |
|---|---|
| Doctors, nurses, midwives, nursing associates, physician associates | GMC and NMC joint guidance, updated 13 December 2024 |
| Paramedics, OTs, physiotherapists and other HCPC professions | HCPC standard 8: be open when things go wrong |
| Dentists and dental care professionals | GDC guidance on being open and honest (2016) |
| Social workers | Social Work England standard 2.1: be open, honest, reliable and fair |
| Care workers and support workers (not registered) | No regulator, but candour is in the Care Certificate (outcome 3.1) and your employer's policy |
The professional duty is wider than Regulation 20: it covers harm or distress, and asks professionals to use their judgement about near misses. A nurse meeting their professional duty does not satisfy the provider's statutory duty.
Source: GMC and NMC joint guidance; HCPC standards; Social Work England; our Care Certificate guide.
Across the UK
Each nation has its own rules. If you run services in more than one, your policy needs a section for each. Using England's thresholds or timescales in Scotland or Wales is one of the commonest policy errors we see.
| Nation | Law | Who it covers | Harm threshold | Timescales and reporting |
|---|---|---|---|---|
| England | Regulation 20, 2014 Regulations (from 2014 and 2015) | Every CQC-registered provider, health and social care | Reg 20(8) for NHS bodies, 20(9) for everyone else | As soon as reasonably practicable. No fixed days |
| Scotland | 2016 Act and 2018 Regulations (from 1 April 2018) | All health, care and social work services, with narrow exceptions such as childminders and individual care providers with no staff | One list for all, including harm lasting 28 days. The opinion must come from a professional not involved | Explain if the procedure starts more than one month after the incident, and if the review takes more than three months; publish an annual report |
| Wales | 2020 Act and 2023 Regulations (from 1 April 2023) | NHS bodies and NHS-funded primary care. Care providers have a general duty to be open (2017 Regulations, reg 13) | Unexpected or unintended harm that is more than minimal | Written notice within five working days of the conversation; explain if notifying after 30 working days |
| Northern Ireland | No statutory organisational duty yet | Being Open framework from 1 April 2026; professional duties apply | Not set in law | A Bill is being developed; no date announced |
Source: Care Inspectorate (updated 9 October 2026); SSI 2018/57; Quality and Engagement (Wales) Act 2020, s.3; Duty of Candour Procedure (Wales) Regulations 2023; Welsh 2017 Regulations, reg 13; NI Department of Health, 19 February 2026.
2025 to 2026
Four developments care providers keep asking us about. None of them changes Regulation 20 today.
In Parliament
The Public Office (Accountability) Bill would put a duty of candour on public authorities and officials in their dealings with inquiries, inquests and investigations, with criminal offences for serious breaches. It covers NHS bodies and could reach private providers carrying out public functions. It is in House of Lords committee stage, with sittings on 12, 19 and 21 October 2026. It is not law, and it would sit alongside Regulation 20.
Government review
Findings published on 26 November 2024 from 261 self-selected responses: 54% said staff do not understand the duty, 23% said it is complied with correctly, and only 25% of health and social care workers who responded found the harm thresholds clear. Respondents gave fewer examples from social care. A final government response has not been published.
Northern Ireland
The Department of Health is developing an organisational duty of candour Bill, with no introduction date yet. The Being Open framework has applied since 1 April 2026.
CQC
CQC is moving from quality statements to sector frameworks. Regulation 20 stays a fundamental standard whatever the framework, and until the new ones start, the Learning culture quality statement applies.
Source: UK Parliament, Lords committee stage; DHSC findings (26 November 2024); NI Department of Health.
Timeline
The statutory duty came in for NHS bodies on 27 November 2014 and for all other CQC-registered providers on 1 April 2015. It followed the Francis Inquiry and the long campaign by the family of Robbie Powell, whose case exposed the lack of a legal duty to be honest with families.
February 2013
The Francis Inquiry into Mid Staffordshire recommends a statutory duty of candour for all providers
27 November 2014
Regulation 20 comes into force for NHS trusts, foundation trusts and special health authorities
1 April 2015
The duty extends to every CQC-registered provider, including all of adult social care
29 June 2015
GMC and NMC joint guidance on the professional duty of candour takes effect
1 April 2018
Scotland's organisational duty of candour starts
January 2019
CQC issues Bradford Teaching Hospitals a £1,250 fixed penalty for a delayed apology
September 2020
First duty of candour prosecution in court
June 2022
CQC clarifies that “unexpected or unintended” applies to the incident, not the outcome
1 April 2023
Wales's NHS duty of candour starts
November 2024
DHSC publishes findings of its call for evidence on the duty; GMC and NMC update their guidance in December
September 2025
The Hillsborough Law Bill is introduced; it reaches House of Lords committee stage in October 2026
December 2025
CQC issues Kettering General Hospital a £1,250 fixed penalty for not telling a family promptly
Source: CQC, background to the duty of candour; SI 2015/64; GMC and NMC joint guidance; CQC press releases; Scottish and Welsh legislation above; UK Parliament.
Watch
We write duty of candour policies that use the right thresholds for your service, train managers to run the conversation, and check your incident files the way an inspector would.
Book ConsultationEvery rule, figure and date in this guide comes from these pages or the sources named under each section, checked on 21 October 2026. Where we give our own advice or interpretation, such as the checker, the examples, the first two steps and the letter template, we say so. This guide is general information, not legal advice.
Spotted something out of date? Tell us.
Not sure if an incident is notifiable? Talk to our compliance team on 0333 577 0877.
Keep exploring with Care Sync Experts.
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All 21 CQC notifications: what to report, the deadline, how to submit, and a do I need to notify table.
The ten types of abuse, the six principles, section 42 enquiries and your CQC duties.
All 14 standards in Regulations 9 to 20A: what each requires, which apply to home care, offences and the 2026 CQC changes.
