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

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.

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.

AOP response: Yes

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

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.

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.

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.

AOP response: Yes

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.

AOP response: Yes

But, F1 is less clear and could be improved.

AOP response: No

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

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.

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.

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.

AOP response: Yes

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

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.

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.

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.

AOP response: Yes

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.

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.

AOP response: Yes

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

AOP response: Yes

AOP response: Yes

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.

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.

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.