Response to the Welsh Government consultation on the statuary guidance and regulations required to implement the duty of candour

Our submission to the consultation, December 2022


The Welsh government ran a consultation on the Duty of Candour between the 20 September 2022 and 13 December 2022. The consultation focussed on what the Duty of Candour means for NHS organisations in Wales and how the existing ‘Putting Things Right’ regulations could be amended to integrate the Duty of Candour. 

The AOP worked closely with sector bodies to develop a response that fitted with the overarching GOC Duty of Candour guidance and helped to support colleagues at Optometry Wales to respond to the consultation.  

The Duty of Candour

The Act provides that the Duty of Candour will apply when two conditions are met:

i. firstly, a service user to whom health care is being or has been provided by a NHS organisation has suffered an adverse outcome; and
ii. secondly, the provision of health care was or may have been a factor in the service user suffering that outcome

Part 4 of the guidance describes when the Duty of Candour procedure applies.

Contact our Policy team if you have any questions: [email protected]

Q1. Is the guidance on when the Duty of Candour applies clear?

AOP response: Yes

The guidance is clear, and it is helpful that Annex H provides several examples of where the duty of Candour might apply in the case of eye care providers.

With respect to paragraphs 8.77 to 8.83 of the guidance we think it is important to differentiate and be clearer on

  • Unplanned delays in care which result in harm – eg systems delays or failures which result in avoidable harm
  • Delay without harm isn’t the same as delay with harm
  • Appropriate referral and prioritisation which due to no fault of the NHS a patient’s condition deteriorates – eg a patient unfortunately suffers from the natural progression of a disease despite appropriate triage

As set out in paragraph 8.78 it is true that in the traditional hospital model of care a service user is on a waiting list following a referral and therefore the provider has access to detailed information. It is important to note that primary care is different, in that patients might be on a ‘waiting list’ but the provider might not have the same level of background diagnostic and clinical data, only basic but proportionate triage information.

Q2. Is the flowchart at Annex A, a useful tool for determining whether the duty has been triggered?

AOP response: Yes

We believe that the flow chart at Annex A is a useful tool and the accompanying case studies will be particularly helpful for those wishing to check if the Duty of Candour applies.

Q3. Are the guidance and case studies useful in determining what is meant by harm that ‘could’ be experienced?

AOP response: Yes

Yes, we believe that the guidance and case studies are useful although some more common examples from optometry could be used.

Q4. Do you agree that setting the threshold for triggering the Duty of Candour at moderate harm, severe harm or death reaches the right balance between informing service users and not overburdening NHS providers?

AOP response: Yes

The thresholds in Annex B are consistent with similar thresholds under the duty of Candour in Scotland, England, Putting Things Right and the General Optical Council’s guidance with which registered optometrists, dispensing opticians and registered bodies corporate already comply.

These are sensible and fair thresholds to achieve safety without over escalation and, by being consistent, will minimise confusion for eye care professionals and providers and achieve better outcomes for patients and richer learnings for the NHS in all UK nations.

Q5. Does the harm framework at Annex B provide useful guidance on the type of harm that will fall into the categories of moderate, severe harm or death?

AOP response: Yes

We are pleased that Annex H contains examples of where the duty of candour might apply in eye care, but extra clarity could be added to the difference between delay without harm and with harm.

Q6. Do you consider the case study examples set out in Annex H to be sufficiently comprehensive to explain when the Duty of Candour would be generated?

AOP response: Yes

We would like some more common examples for eye care (eg a missed wet AMD on OCT). We would be happy to support CPD and further examples for our sector over time and intend to publish sector specific guidance building on these examples.

The relationship with professional duties

Q7. Is the relationship between the professional Duty of Candour that many health professionals are subject to and the statutory duty of candour clear?

AOP response: Yes

The Duty of Candour procedure

Q8. Is the guidance on the operation of the duty of procedure at page 11 of the guidance clear?

AOP response: Yes

However, many practices do not have access to, or any training to use, Datix Cymru and so will have to use alternative means of notification.

Q9. Are the flow charts at Annexes C and F1 useful as an aid to understanding how the procedure will operate?

AOP response: Yes

But, F1 is less clear and could be improved.

Commissioned services

Q10. Is the guidance clear on how the Duty of Candour applies to commissioned services?

AOP response: Yes

Q11. The procedure flow chart at Annex A1 shows the procedure to follow when services are commissioned. Is the process clear?

AOP response: Yes

Harm that occurs to service users whilst waiting for diagnostics or care from the NHS

Q12. Is the guidance clear when harm to service users that occurs whilst waiting for diagnostics and treatment triggers the Duty of Candour?

AOP response: No

The guidance is clear with respect to waiting for hospital services. However, please see our response to Question 1.

Q13. What further clarification do you consider would be helpful for NHS organisations and service users with regards to harm sustained whilst waiting for diagnostics and treatment? Please provide any comments or further explanation.

AOP response: As Q12

Annual reporting of Duty of Candour

Q14. Is the requirement for Local Health Boards, NHS Trusts, and Special Health Authorities, to publish their candour reports clear?

AOP response: Yes

Q15. In relation to the reporting flow chart set out in Annex G, is the process clear?

AOP response: Yes

Q16. Are the annual reporting dates of 30 Sept for primary care providers and 31 October for Local Health Board’s, NHS trusts and Special Health Authorities’ reasonable?

AOP response: No

We fully share Welsh Government’s sensible aim of publishing and monitoring data on the duty of candour to evaluate implementation. However, we do have some concerns about the process.

  • We are concerned about the burden on primary eye care contractors who may well have nothing to report and health boards who may well be inundated with nil returns, reducing the capacity to learn from reported incidents. Require a return only if the duty of candour has been tiggered in year would significantly reduce the administrative burdens and costs on all parties
  • Guidance should reiterate that the professional duty of candour which applies to registered healthcare professionals under the terms of their registration with the regulator is different from the duty of candour being monitored here and such data should not be reported
  • Contractor returns should not identify practitioners or patients
  • Aggregated published data should not permit contractors, practitioners or patents to be identified, even indirectly
  • Allowing only one month between Health Boards receiving returns from primary care and publishing them seems far too tight and may result in important data to be missed and/or causing confusion rather than sharing insights and supporting systems improvements. Three months would seem a more reasonable timescale for good quality reporting unless there is a serious incident which warrants more urgent publication

We will make these same arguments in the expert reference group (ERG) which we are delighted to join. However, it would be helpful if Welsh Government could make any such agreed parameters clear to the ERG in advance to streamline the workload and save time and effort.

Q17. Is it reasonable to suggest the Duty of Candour report should be aligned to the existing annual PTR report already in place to avoid duplication?

AOP response: Yes

Yes, although currently optical practices do not contribute to PTR reporting so this would be a new requirement (with accompanying burden) not covered to date in the new WGOS negotiations.

Notification of Duty of Candour

Q18. Is the explanation of 'on first becoming aware' in the guidance sufficiently clear to enable NHS organisations to know when the candour procedure must start?

AOP response: Yes

Q19. In circumstances where the service user is unable or unwilling to be notified the Duty of Candour has been triggered, are the provisions setting out who may act on the service user’s behalf sufficiently comprehensive?

AOP response: Yes

Q20. Are the provisions at Regulation 7(3) which allow an NHS organisation to record when it will not be engaging with a service user or a person acting on their behalf, either because: (i) they have made reasonable attempts to contact them and failed or (ii) where the service user has determined, they do not wish to communicate about the duty, proportionate?

AP response: Yes

Q21. Do Regulations 7(2) and 7(3) strike the right balance between the needs of service users or persons acting on their behalf and level of burden placed on NHS organisations?

AOP response: Yes

The ‘in­person notification'

Q22. Do you agree that 'in­person' notification is appropriate and proportionate when informing a service user or their representative that the Duty of Candour has been triggered?

AOP response: Yes

These matters are better dealt with in person unless the patient or carer does not wish for this. The guidance might perhaps include a hierarchy (eg for serious matters it should be face­ to ­face, non serious should be over the telephone or similar.

Q23. Do you agree that it is appropriate and proportionate that the NHS organisation has the choice of which form of 'in­person' notification is most appropriate, considering these factors above?

AOP response: Yes

Yes, although as suggested for Question 22, the guidance might provide some suggestions of a hierarchy.

The apology

Q24. Does the guidance on how to make a meaningful apology set out at section 7e and Annex E of the guidance provide sufficient information and advice to ensure a personal, meaningful apology is conveyed?

AOP response: Yes

Yes. Optical practices are used to and will have their own internal process for offering an apology or providing a solution to a patient complaint ­ Specific examples such as getting a prescription incorrect and whether that triggers a duty of candour are needed in terms of the training that will be provided, which might be supported by sector bodies.

Q25. Do you agree that ‘in­person' notification should be followed up by a written notification?

AOP response: Yes

This is useful in terms of ensuring transparency, and is necessary for anyone else taking over handling of the candour procedure and so the record is clear in case of future litigation – evidence suggests people often do not recall exactly what is said in stressful situations.

Q26. Do you agree the requirement placed on NHS organisations to take all reasonable steps to send the written notification within two working days from the date of the in­person notification is reasonable and proportionate?

AOP response: No

Two days may be too tight a timescale for many NHS organisations. Providers will need to get the communication right for the individual, which may involve taking advice of a more senior person who may not be immediately available.

Rather than setting an aim of two days which most will miss (undermining the duty), we suggest five days would be more reasonable, with three days as the target for more serious harm (permanent injury or impairment) or death.

Training and support of staff

Q27. Do the training requirements cover all the staff that require training?

AOP response: Yes

Q28. What type of training do you think would be required by NHS staff in addition to the current NHS training for the Duty of Candour to be successful? Please provide any comments or further explanation.

Online training and video scenarios would be the best for busy optical practices, with CPD points for registrants. Welsh Government might invite DOCET to produce some of these materials for registrants.

These could then be supplemented as appropriate by employer­ led team sessions (or peer sessions for those who work in smaller teams) focusing on the aims and principles of the duty, making meaningful apologies, the flow diagrams and where these can be accessed eg practice VPN and the names of whoever leads for the practice and can advise and support staff on candour issues.

AOP response: Yes

Employers will know their staff, experience and training needs best and should have flexibility in making professional judgements and providing the training necessary in accordance with the regulations, using available and accessible NHS online resources wherever possible.

Organisational governance and oversight of the Duty of Candour

Q30. Do Regulations 10 and 11 assist NHS organisations in establishing an effective governance structure to ensure compliance with the Duty of Candour procedure?

AOP response: Yes

We welcome the clarification in the regulations (11(2)(b)) and statutory guidance (8.74) around the responsible person. It would also be helpful for the guidance to be clear that, if the responsible officer is not a relevant clinician, he/she/they will ensure appropriate clinical input to the candour procedure.

Q31. Do the regulations assist an organisation in providing the right level of leadership to fulfil its Duty of Candour responsibilities?

AOP response: Yes

Duty of Candour and the PTR procedure

Q32. Do you agree the time limits under the PTR Regulations should, when the Duty of Candour is triggered, run from the date of the in­person notification rather than the date the NHS organisation would have been notified of the incident?

AOP response: Yes

Q33. Do you think changing the ‘Putting Things Right’ rules like this will cause problems? For example, do you think it would be better to not tell the person what has happened if it is in their best interest? A flow chart is available in Annex F1.

AOP response: No

Our view is that adults with capacity have a right to know when things have gone wrong even if the news is likely to be traumatising or damaging for them. For example, diagnoses and prognoses are given even when this may cause serious distress or even accelerate the poor outcome. Such situations are very unlikely to occur in eye care and, in any event, a person suffering vision loss will need support and so would have been told, to understand what was happening to them.

GOC registrants already follow the GOC Standards of Practice for Optometrists and Dispensing Opticians says health care professionals have a professional standard to “be open and honest with patients when you have identified that things have gone wrong with their treatment or care which has resulted in them suffering harm or distress or where there may be implications for future patient care” and “You must tell the patient or, where appropriate, the patient’s advocate, carer or family) that something has gone wrong.” As we have stated, regulatory standards are already applied across primary eye care and this new duty should align with those standard and avoid adding complexity.

AOP response: Yes

Duty of Candour and the PTR amendment Regulations

Q35. Are the proposed changes to the PTR guidance in respect of the Duty of Candour and PTR amendment Regulations clear?

AOP response: Yes

Q36. Do you think that the changes made to the PTR guidance are sufficient to provide clarity on how Duty of Candour interacts in the PTR procedures?

AOP response: Yes

Integrated Impact Assessments

Q37. What are your views on how the proposals in this consultation might impact? on people with protected characteristics as defined under the Equality Act 2010 on health disparities on vulnerable groups in our society.

AOP response

In theory the duty of candour should improve patient information and hence care for the whole population including those with protected characteristics. As the consultation recognises more older people are likely to be affected by virtue of the fact that they access more healthcare. This will be the case in eye care too; but they should not be positive nor negative impacts, ensuring patients are equal partners in their own care.

Impact on Welsh language

Q38. We would like to know your views on the effects that the Duty of Candour proposals would have on the Welsh language, specifically on opportunities for people to use Welsh and on treating the Welsh language no less favourably than English. For example, what effects do you think there would be? How could positive effects be increased, or negative effects be mitigated?

AOP response

Optical practices are aware of their duties under the Welsh Language Act and continue to make efforts to ensure that their patients have access and opportunity to communicate in their language of choice although this does often require having to access health board provided translation services – this should not impede the process of triggering the duty of candour and we would hope that health boards will be able to (continue to) support optical businesses in being able to offer language options to patients.

We would however have concerns about being required to submit reports or document materials in both English and Welsh, as this would add to the burden on practices. However nothing should prevent a practice from submitting reports in either language.

Q39. Please also explain how you believe the proposed Duty of Candour policy could have positive or negative effects on opportunities for people to use the Welsh language or treat it no less favourably than the English language?

AOP response: Please see Q38

As General Optical Council registered health professionals and bodies corporate, the members of Optometry Wales (including the Welsh regional optical committees and the UK profession and representative bodies) already fully support and apply the principle of candour in primary eye care.

We are pleased that Welsh Government recognises that:

  • Healthcare is complex and that, despite best efforts, it is inevitable that some people may suffer harm or near misses at some stage
  • The professional duty of candour and the statutory duty of candour have the same aims and should complement rather than duplicate one another
  • Apologising and implementing the candour procedure is good care and not an admission of negligence or a breach of statutory duty

We welcome the statutory guidance and

  • The two clear tests to trigger the new duty
  • The flexibility the guidance allows to providers and employers to make appropriate judgements about training and governance
  • The plans to produce a leaflet and video for the public – we would ask to have input to these ­either through the ERG or otherwise ­ to ensure proportionality for eye care

We do have concerns around:

  • Blanket annual reporting when exception reporting in years when the duty is triggered might save work and costs for all parties
  • The plan to implement in 2023 except for ISPs which will be in 2024 – there are major contract changes being implemented for primary eye care (as for other areas of primary care) in April 2023

This means that contractors will already be extremely busy with systems change and staff training, so this may not be the best time to implement a new duty especially given that candour already applies in primary eye care via our regulator – the General Optical Council. Would it be wiser to postpone implementation for primary eye care until 2024 when there can be more focus, as for ISPs?

  • The interrelationship with and funding for the new bronze and silver quality standards for primary eye care we have just negotiated with Welsh Government, which did not anticipate this additional duty.

The AOP would be happy to meet with Welsh Government to discuss these concerns and how they might be accommodated to find a way forward, or in the alternative to provide support via Optometry Wales if that is the preferred route for engagement.