Opening Remarks

Medical Protection Society (MPS) welcomes the opportunity to respond to the Welsh Government consultation on the Statutory guidance and regulations required to implement the Duty of Candour.  

MPS is the world’s leading member-owned, not-for-profit protection organisation for doctors, dentists and healthcare professionals with over 300,000 members around the world, with almost 5,000 members in Wales. Our in-house experts assist members with the wide range of legal and ethical problems that can arise from their professional practice.  Our response to this consultation reflects both the view of Dental Protection and Medical Protection.

Summary of our response

MPS fully supports a culture of openness in the healthcare sector and we advise members that they should apologise when something goes wrong. However, we have long standing concerns that codifying this ethical principle into legislation, such as a statutory Duty of Candour being proposed by Welsh Government, fails to provide the impetus necessary for behavioural change. We believe that the statutory Duty of Candour is unlikely to be effective in ensuring a genuinely open conversation with patients when things go wrong and can lead to unintended consequences.

MPS consistently raised concerns throughout the evolution of the statutory duty of candour in England, Scotland and Northern Ireland. Similarly, we have concerns with the proposals of the Welsh Government.

A statutory duty could prove counterproductive to the development of an open learning culture in healthcare. For any statutory duty to be effective, a system will be required to monitor compliance and apply sanctions. We believe that any such system is likely to distract from the original objective of ensuring openness with patients and learning from mistakes.  This is why cultural change rather than legislation is the appropriate way of creating safe, responsive, patient centred care and high-quality communication between professionals and patients. The legislation could instead result in a ‘tick-box’ reporting culture. 

While MPS does not support the introduction of a statutory Duty of Candour; if the Welsh Government is minded and wishes to proceed, we believe that the Duty should be limited to healthcare organisations and not be imposed upon individual clinicians. We understand from the proposals that this is the case and this duty will be imposed firstly on NHS bodies.

In our view, an individual Duty of Candour is unhelpful and impractical given how healthcare is currently delivered; involving multidisciplinary teams across the healthcare organisation; and our modern understanding of medical error which takes into account the system in which practitioners operate. When something goes wrong in healthcare, the patient and/or the relatives want to not only seek information about what has occurred but also why and steps taken to mitigate this from happening again. It is the organization and not the individual practitioner which is best placed to address the range of factors leading to the adverse outcome, and to reflect on any changes introduced across the organization to stop this from happening again.

We also believe that it could be confusing for the statutory duty of candour to only apply to NHS bodies and to progressively start applying to other healthcare organisations. While we understand the aim of the government is to ensure that this is applied progressively, it could be confusing for clinicians who often work in both public and private settings.

Consultation Questions

Chapter 1 – Statutory Guidance Duty of Candour

Question 1
Is the Guidance on when the Duty of Candour applies clear?

• Yes
• No

MPS does not believe that the guidance of when the Duty of Candour applies is clear enough. When an adverse outcome occurs, it isn’t always clear from onset that the care provided was a factor or it may have been. Therefore, the chart in Annex A could lead with all adverse outcomes triggering the duty of candour as it may not be clear whether the health care provided was a factor contributing to the adverse outcome.

Question 2

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

• Yes
• No

MPS believes that the flowchart is only helpful to an extent. As stated above, it is difficult to determine as soon as an adverse outcome occurs whether the care provided was a contributing factor. We believe that the explanation of what minimum harm is can be helpful in identifying whether the Duty of Candour should be triggered but more examples may be needed in Annex B.

Question 3
Are the guidance and case studies useful in determining what is meant by harm that “could” be experienced?

• Yes
• No

MPS believes that the Guidance document at paragraph 5.3 clearly states that the duty is triggered not only where more than minimal harm has occurred but also where this could occur, providing a simple example. 

We also believe that Annex H which provides further examples is helpful. 

Question 4
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?

• Yes
• No

Yes, MPS believes that it is only reasonable to set the threshold for triggering the duty of candour at moderate harm, severe harm or death.  We feel this is the right balance and annex B is helpful in identifying what is meant by low, moderate and severe harm.

Question 5

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?

• Yes
• No

As explained above, MPS believes that  Annex B is helpful in determining the type of harm that will fall into the categories of moderate, severe harm or death.  However, more examples may be needed in the category of low/minimal harm so that there is greater clarity for clinicians aroundthis definition.   This will be helpful in deciding which incidents do and do not engage the duty of candour.

Question 6
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?

• Yes
• No

Yes, MPS believes that the examples set are clear and it is helpful to have the same case study with different outcomes for clinicians to be aware of which type of outcome would trigger the duty of candour.

Question 7
Is the relationship between the professional duty of candour that many health professionals are subject to and the statutory duty of candour clear?

• Yes
• No

MPS believes that the process of notification is clear, however it is not clear who is responsible for such notification.

As the Welsh government clearly acknowledges, there is a professional duty of candour which healthcare professionals must adhere to. However, the Welsh government is proposing to introduce a duty of candour upon NHS bodies. Who should therefore notify the patient of what has gone wrong and offer the apology? An individual clinician or the NHS body responsible for the treatment? We would welcome clarification on the duties and limitation of the individual clinician implication vs the NHS body.  

Question 8

Is the guidance on the operation of the duty of candour procedure at page 11 of the Guidance clear?

• Yes
• No

As per our response above, we appreciate the explanations on page 11 of the guidance. However, it is not clear how the statutory Duty of Candour imposed on NHS bodies would interact with the professional duty of candour which individual clinicians already adhere to.

If the Welsh government is minded to proceed with introducing a statutory duty of candour on NHS bodies, we would welcome clarification on what steps are required from individual clinicians if and when the statutory duty of candour and which steps fall on NHS organsiations to follow.  

We would also like to note that as the guidance on page 11 identifies, the professional guidance applies in more situations that the organizational Duty of Candour. While this page, as well as annex A and B, focus on the situations on when there is a statutory duty, this could be confusing for clinicians who could end up also triggering the statutory duty of candour, with associated reporting, on occasions that they may not need to, as it is their professional duty to do so. 

Question 9

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

• Yes
• No

MPS believes that the charts are helpful as an aid yet as above, it would be useful to detail who within the organization is responsible for communicating and notifying – whether in person or in writing.

Question 10

Is the guidance clear on how the duty of candour applies to commissioned
services?

• Yes
• No

MPS believes it is helpful that the clarification with regards to commissioned services is provided ie “if an NHS body enters into an arrangement for the provision of services with someone other than another NHS body, the duty to comply with the duty of candour rests with the NHS body”. It is also helpful to include the clarification with regards to the different jurisdictions and how if a local health board in Wales enters arrangements with an English provider, it is the English Duty of Candour that will apply.

Question 11
The procedure flow chart set out in Annex A1 sets the procedure to follow
when services are commissioned. Is the process clear?

• Yes
• No

Yes, MPS believes that this chart is useful and clear in determining which procedure to follow when services are commissioned. However, as in above responses,  it would be helpful to determine the obligations or requirements on individual clinicians.

Question 12

Is the guidance clear when harm to Service Users that occurs whilst waiting for
diagnostics and treatment triggers the duty of candour?

• Yes
• No

MPS believes that the guidance is slightly confusing and could benefit from further examples and clarification.

The guidance seems to suggest it is accepted that some people will deteriorate whilst on waiting lists -and gives the example of a patient waiting for a bypass who has a heart attack – DOC not engaged-.   However, the example in appendix H of a delayed colonoscopy, where a patient was subsequently found to have cancer, suggests DOC is engaged, which we believe it makes sense, but the example refers to “systemic delays”. We wonder whether the waiting list itself is a system delay and therefore we would welcome further detail and clarification in this example.

Question 13
What further clarification do you consider would be helpful for NHS bodies and Service users with regards to harm sustained whilst waiting for diagnostics and treatment?

MPS does not have any major comments on this other than perhaps including more examples.

Question 14
Is the requirement for Local Health Boards, NHS Trusts and Special Health Authorities, to publish their candour reports clear?

• Yes
• No

MPS believes that the guidance could benefit from further clarification with regards to what form the report should take or provide a template or an example of a report. There also should be more guidance on the level of detail required.

Question 15
In relation to the reporting flow chart set out in Annex G, is the process clear?

• Yes
• No

MPS believes that the process is clear although we would benefit from further detail.

Question 16

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

• Yes
• No

MPS does not have any further comments on this question.

Question 17
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?

• Yes
• No

MPS does not have a position or any comments on this question. We have selected no as the system does not allow for a n/a option.

Chapter 2 – Candour Procedure Regulations

Question 18
Is the explanation of “on first becoming aware” in the Guidance sufficiently clear to enable NHS bodies to know when the candour procedure must start?

• Yes
• No

MPS does not have any further comments on this question.

Question 19

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?

• Yes
• No

MPS believes that the guidance is not sufficiently clear with regards to who may act on the Service User’s behalf.  The guidance states “who is acting lawfully on the service users behalf” and it also mentions GDPR but this would only apply to living patients.  We believe that for those lacking capacity consideration would need to be given to acting in that persons best interests or the guidance should reference whether there is a specific piece of legislation that permits disclosure in these circumstances regardless of best interest. We question whether the regulation of the duty of candour would have this provisions and if so, this should be made clear.

Question 20
Are the provisions at regulation 7(3) which allow an NHS Body 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?

• Yes
• No

MPS does not have any further comments on this question.

Question 21
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 bodies?

• Yes
• No

MPS believes that the provisions at regulation 7(3) are appropriate and it strikes the right balance.

We believe that 7(2) is appropriate as it states reasonable steps to ensure any communication is in a manner the person can understand.

We are supportive of regulation 7(3) as we believe it actually removes further burden from the organisation as they simply need to record the reasonable attempts they have made and regs 4,5,6 then don’t apply.

Question 22
Do you agree that “in person” notification is appropriate and proportionate when informing a Service User or their representative that the duty of candour has been triggered?

• Yes
• No

MPS does not have any further comments on this question.

Question 23
Do you agree that it is appropriate and proportionate that the NHS Body has the choice of which form of “in person” notification is most appropriate, taking into account these factors above?

• Yes
• No

MPS does not have any further comments on this question.

Question 24

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?

• Yes
• No

MPS does not have any further comments on this question.

Question 25
Do you agree that “in person” notification should be followed up by a written notification?

• Yes
• No

MPS does not have any further comments on this question.

Question 26
Do you agree the requirement placed on NHS bodies to take all reasonable steps to send the written notification within two working days from the date of the in-person notification is reasonable and proportionate?

• Yes
• No

MPS does not have a position or any comments on this question. We have selected no as the system does not allow for a n/a option.

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

• Yes
• No

MPS believes that the training requirements need further qualification.

The definition of staff “involved in the provision of health care” is quite broad as arguably, anyone working for the NHS is involved in the provision of health care.  In addition to frontline workers such as nurses, doctors, physiotherapists, and managers; the Government may want to consider having training provisions for other staff such as administration staff. They may need broader training or at least an awareness of “duty of candour” as they  may discover a delay – e.g. someone missed from a waiting list-  and they are also involved in processing results or letters from the hospital. 

Question 28
What type of training do you think would be required by NHS staff in addition to the current NHS training in order for the Duty of Candour to be successful? Please provide any comments or further explanation

While MPS believes a statutory Duty of Candour would be counterproductive to an open culture in healthcare, if the Welsh Government is minded to proceed MPS agrees with the proposals that organization must ensure that all employees who carry out the Duty of Candour procedure receive training and guidance as well as support.

We are particularly concerned with how the training and support is conducted. Whilst it is obviously useful to have a policy document to refer to, practitioners need to have continuous and ongoing support, bearing in mind that there may be a significant time lag between initial training and the need to implement the Duty of Candour procedure following the occurrence of a ‘notifiable incident’.

The introduction of a formal training program and relevant policies and procedures will promote clarity and consistency amongst organisations by reducing the scope for misinterpretation of the legislation. It will assist leaders within organisations in reaching the correct decisions to ensure compliance. Also, it will allow those affected by ‘notifiable incidents’ to understand how decisions are reached.

Since it has been recognized that being candid is an advanced communication skill, adequate training will be required to support healthcare professionals who discharge this duty. Significant resources will be required to ensure that patient care does not suffer as a result of complying with the proposed legislation. This is especially a concern for small dental practices, as many dental practitioners are self-employed.

Question 29
Are the provisions related to staff support proportionate?

• Yes
• No

MPS believes that there is not enough detail in the proposals to know whether the provisions related to staff support are proportionate.

The proposals express that training modules will be developed but it does not detail those modules.  

We also note that point 8.64 express that the NHS Body “must provide a member of staff who is involved in notifiable adverse outcomes with details of service or support available”. However, we don’t think this is not sufficient as there is no details of what support is available for staff that may need to communicate adverse outcomes. The proposals also state under point 8.65 that “NHS bodies will have mechanisms in place and local support services available to pro-actively offer the appropriate provision of support and assistance to staff members through their Employee Wellbeing Service”. We welcome the inclusion of this point but it is yet to see how this will actually apply in practice.

MPS is aware of the current challenges faced by the profession and the impact the backlog and staff shortages is having on clinicians’ mental wellbeing.  As such, we believe that there is a need for a comprehensive professional led mental health support service for all healthcare staff and this may be particularly important for those who may be involved in communicating adverse outcomes.

Question 30
Do regulations 10 and 11 assist NHS bodies in establishing an effective governance structure to ensure compliance with the duty of candour procedure?

• Yes
• No

MPS does not have a position or any comments on this question. We have selected no as the system does not allow for a n/a option.

Question 31 
Do the regulations assist an organisation in providing the right level of leadership to fulfil its duty of candour responsibilities?

• Yes
• No

MPS does not have a position or any comments on this question. We have selected no as the system does not allow for a n/a option.

Question 32
Do you agree the time limits under the PTR Regulations should, when the duty of candour is triggered, run from the date of the in person notification rather than the date the NHS Body would have been notified of the incident?

• Yes
• No

MPS has no comment on this question.

Chapter 3 – Further Amendments to the PTR Regulations

Question 33
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?

• Yes
• No

MPS has no comment on this question.

Question 34
Is the link between the duty of candour and the PTR process clear in the guidance and Annex F1?

• Yes
• No

MPS has no further comment on this question.

Chapter 4 – Amendments and updates to PTR Guidance

Question 35
Are the proposed changes to the PTR Guidance in respect of the Duty of Candour and PTR Amendment Regulations clear?

• Yes
• No

MPS has no further comment on this question.

Question 36
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?

• Yes
• No

Please provide any comments or further explanation (in particular if response is no).

MPS has no further comment on this question.

Chapter 5 – Integrated Impact Assessments

Question 37
What are your views on how the proposals in this consultation might impact?

• on people with protected characteristics as defined under the Equality
• Act 201014;
• on health disparities; or
• on vulnerable groups in our society.

MPS does not have any comments on this question.

Question 38

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 favorably than English.

For example, what effects do you think there would be? How could positive effects be increased, or negative effects be mitigated?

MPS does not have any comments on this question.

Question 39
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 favorably than the English language?

MPS does not have any comments on this question.

Question 40
We have asked a number of specific questions. If you have any related issues
which we have not specifically addressed, please use this space to report them:

MPS has no further comments.

About MPS

MPS is the world’s leading protection organisation for doctors, dentists and healthcare professionals with almost 300,000 members around the world.

Our in-house experts assist with the wide range of legal and ethical problems that arise from professional practice. This can include clinical negligence claims, complaints, medical and dental council inquiries, legal and ethical dilemmas, disciplinary procedures, inquests and fatal accident inquiries.

MPS is not an insurance company. We are a mutual non-for-profit organisation and the benefits of membership of MPS are discretionary as set out in the Memorandum of Articles of Association.

Contact

Should you require further information about any aspects of our response to this consultation, please do not hesitate to contact us.

Patricia Canedo
Policy and Public Affairs Manager
[email protected]