Openness and honesty when things go wrong: The professional duty of candour

Encouraging a learning culture by reporting errors

23

When something goes wrong with patient care, it is crucial that it is reported at an early stage so that lessons can be learnt quickly and patients can be protected from harm in the future.

24

All health and care organisations have a duty to support their staff to report adverse incidents. Health and care organisations should have a policy for reporting adverse incidents and near misses, and you must follow your organisation’s policy.28  

28

General Medical Council (2013) Good medical practice (accessed 17 January 2022), paragraph 23

25

A number of reporting systems and schemes exist around the UK for reporting adverse incidents and near misses. 

a. Patient safety incidents in England and Wales are reported to the National Reporting and Learning System, or its replacement, the Learn from patient safety events (LFPSE) service.29, 30  

b. You must use the UK-wide Yellow Card scheme31 to inform the Medicines and Healthcare products Regulatory Agency (MHRA) about:

  1. serious suspected adverse reactions to a medicine
  2. any suspected adverse reactions to products marked with a Black Triangle symbol (▼).32 

c. Adverse incidents involving medical devices, including those caused by human error, that put, or have the potential to put, the safety of patients, health and care professionals or others at risk must be reported to the medical device safety lead in your organisation (if there is one) and the relevant national body:

  1. in England and Wales - MHRA reporting adverse incidents
  2. in Northern Ireland - Northern Ireland Adverse Incident Centre
  3. in Scotland - Health Facilities Scotland online incident reporting

d. Healthcare Improvement Scotland has a national framework,33  which aims to support health and social care services in Scotland effectively manage adverse events.

e. The Health and Social Care Board has published a procedure for the reporting and follow-up of serious adverse incidents in Northern Ireland.34 

f. In England, general practitioners and other primary medical services must submit all notifications35   directly to the Care Quality Commission (CQC).

29

NHS England Report a patient safety incident (accessed 17 January 2022)

30

The LFPSE service was launched in July 2021 and will eventually replace the NRLS. During the transition period professionals will need to identify which system their organisation is using to report incidents. Further information on the LFPSE service is available on NHS England and Improvement’s website.

31

The MHRA provides guidance for healthcare professionals, patients and the public on reporting adverse incidents with medicines and medical devices to the Yellow Card scheme.

32

New medicines and vaccines that are under additional monitoring may be marked with an inverted black triangle symbol (▼). The symbol appears in the British National Formulary (BNF), summaries of product characteristics, patient information leaflets and elsewhere.    

33

Healthcare Improvement Scotland (2019) Learning from adverse events through reporting and review: A national framework for Scotland (accessed 17 January 2022)

34

Health and Social Care Board (Northern Ireland) Procedure for the Reporting and Follow up of Serious Adverse Incidents (accessed 17 January 2022)

35

Registered providers in England are required to notify the CQC about certain incidents. For guidance see CQC’s information for providers on Notifications.

26

In addition to contributing to these systems, you should comply with any system for reporting adverse incidents that put patient safety at risk within your organisation. If your organisation does not have such a system in place, you should speak to your manager and – if necessary – raise a concern in line with our guidance.36, 37  

36

General Medical Council (2012) Raising and acting on concerns about patient safety (accessed 17 January 2022)

37

Nursing and Midwifery Council (2018) Raising concerns: guidance for nurses, midwives and nursing associates (accessed 17 January 2022)

27

Your organisation has a duty to support you to report adverse incidents and near misses routinely. If you do not feel supported to report, and in particular if you are discouraged or prevented from reporting,  you should raise a concern in line with our guidance.36, 37  

36

General Medical Council (2012) Raising and acting on concerns about patient safety (accessed 17 January 2022)

37

Nursing and Midwifery Council (2018) Raising concerns: guidance for nurses, midwives and nursing associates (accessed 17 January 2022)

28

You must not try to prevent colleagues or former colleagues from raising concerns about patient safety.38  If you are in a management role, you must make sure that individuals who raise concerns are protected from unfair criticism or action, including any detriment or dismissal. 

38

A fitness to practise panel is likely to consider a more serious sanction if there is evidence of a failure to raise a concern, or of an attempt to cover up.

29

You must take part in regular reviews and audits39, 40 of the standards and performance of any team you work in, taking steps to resolve any problems. You should also discuss adverse incidents and near misses at your appraisal.41, 42  

39

Nursing and Midwifery Council (2018) The Code: Professional standards of practice and behaviour for nurses, midwives and nursing associates (accessed 17 January 2022), section 23

40

General Medical Council (2013) Good medical practice (accessed 17 January 2022), paragraphs 22-23

41

General Medical Council (2012) Supporting information for appraisal and revalidation (accessed 17 January 2022), p8

42

The Nursing and Midwifery Council provides guidance on revalidation.

Additional duties for doctors, nurses and midwives with management responsibilities and for senior or high-profile clinicians

30

Senior clinicians have a responsibility to set an example and encourage openness and honesty in reporting adverse incidents and near misses. Clinical leaders should actively foster a culture of learning and improvement.43, 44   

43

Nursing and Midwifery Council (2018) The Code: Professional standards of practice and behaviour for nurses, midwives and nursing associates (accessed 17 January 2022), sections 16.6 and 25.2

44

General Medical Council (2012) Leadership and management for all doctors (accessed 17 January 2022)

31

If you have a management role or responsibility, you must make sure that systems are in place to give early warning of any failure, or potential failure, in the clinical performance of individuals or teams. These should include systems for conducting audits and considering patient feedback. You must make sure that any concerns about the performance of an individual or team are investigated and, if appropriate, addressed quickly and effectively.

32

If you are managing or leading a team, you should make sure that systems, including auditing and benchmarking, are in place to monitor, review and improve the quality of the team’s work.

  1. You must work with others to collect and share information on patient experience and outcomes.
  2. You should make sure that teams you manage are appropriately trained in patient safety and supported to openly report adverse incidents.
  3. You should make sure that systems or processes are in place so that:
    1. lessons are learnt from analysing adverse incidents and near misses
    2. lessons are shared with the healthcare team
    3. concrete action follows on from learning
    4. practice is changed where needed.

The organisational duty of candour

33

All health and care organisations have a duty to support staff to be open and honest with patients if something goes wrong with their care. Each of the four UK governments has considered ways to implement the organisational duty of candour, with some writing it into law (see appendix 2).