Abstract
Mari Rosser examines the operation of the National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011. She comments on the intention behind the National Health Service Redress measure passed by the Welsh Government in 2008 and reviews how successful this has been in delivering an effective complaint handling process. She highlights the areas where she considers that the process is not working as it should be.
Keywords
More than a decade on from devolution, there are now four very different health services operating in the United Kingdom. Views on the emerging differences vary; some suggest that the differences – such as free prescriptions for Welsh patients and the forthcoming ‘opt-in’ system for organ donation – are ‘breeding envy’ amongst English National Health Service (NHS) users. Others suggest that the Welsh NHS is underperforming in comparison particularly in areas such as waiting lists, such that Welsh patients have more reason to be dissatisfied with their NHS than their English, Scottish and Irish counterparts.
There has been no lack of negative press reporting around the Welsh NHS over recent months. The summer of 2013 saw the departure of part of the management team at Betsi Cadwaladr Health Board; November 2013 saw the announcement of a public enquiry in relation to events at Princess of Wales Hospital Bridgend and most recently in February 2014 Sir Bruce Keogh, the NHS Medical Director in England wrote to his Welsh counterpart Dr Chris Jones expressing his view that data on death rates in six Welsh hospitals was worrying but not adequate to ‘form a view’.
The Welsh Government sees the negative headlines, some generated by English Conservative Government, as politically motivated attempts to ‘drag the Welsh NHS through the mud’. 1 However, not all of the criticism has been from opposing political parties. In November 2013, the then outgoing Public Services Ombudsman for Wales, Mr Peter Tyndall, reporting on the significant increase in the number of health issues referred to his team, said that there was ‘lack of challenge’ currently structured into the health service in Wales, the effect of which was that we have ended up with bodies where the external scrutiny needed to be more significant because there was insufficient internal scrutiny. 2
This commentary from Mr Tyndall is all the more disappointing given that the Welsh Government, unlike its English counterpart has sought to innovate in its approach to NHS complaints and has tried to lead the way by introducing NHS Redress arrangements which are yet to see light of day in England.
The NHS Redress measure passed in 2008 was a significant landmark of Welsh legal history as the Assembly’s first measure to reach the statute book. Former Welsh Health Minister Edwina Hart introduced regulations to the measure in 2011 declaring that it was her intention that the legislation should result in a Welsh NHS ‘investigating once, investigating well’. 3 The NHS (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 (the Regulations) were intended to put in place a transparent, honest and candid patient centric process which would ‘replace the current two stage complaints process of local resolution and independent review with a simpler, one stage process for looking into all concerns, run by highly trained teams of people based in the NHS organisation. This will include looking at the situation to see if the NHS organisation is legally at fault and whether compensation should be offered so that the NHS learns lessons from them. The number of such cases is likely to be small, but it is important that they are included so that the NHS learns lessons from them. It is also important to give the message that people should not have to fight legal cases if an issue can be sorted out locally’. 4
In the consultation process which followed the publication of the first draft of the Regulations, many expressed reservations that the culture within the NHS was insufficiently open and transparent to fairly implement a system which essentially provided that the NHS organisation must scrutinise itself. In her statement to the Assembly which followed the consultation responses on 6 May 2010, Edwina Hart stated ‘in particular, comments were received on the independence in the process, both in terms of the future of independent review, but also how patients can receive assurance that their concerns are being investigated fairly and promptly at a local level’.
The process – How putting things right should be working
The Regulations essentially introduced one process for dealing with complaints and claims of modest value referred to as ‘concerns’. Whilst they apply in whole to Welsh NHS hospitals, they apply only in part to primary care providers such that general practitioner (GP) practices only need to implement those parts of the Regulations which deal with the investigation of a concern and do not have to implement the parts of the Regulations dealing with compensation. The term used for the process covered by the Regulations is ‘Putting Things Right’. The application of the Regulations includes cases involving children and individuals who lack capacity.
Timescales
A concern must be notified no later than 12 months – following the incident giving rise to the concern or 12 months after the date when the concern came to the notice of the person notifying it. There is discretion to extend that time frame but for no later than three years from the incident or three years from the date of knowledge (Regulation 15).
The investigation
The NHS body must then acknowledge receipt of the concern no later than two working days after the day on which it is received and in that acknowledgement it must offer to discuss with the person who notified the concern, the manner in which the investigation of the concern will be handled. The NHS body should also explain that advice and support are available through the Community Health Council Independent Advocacy Service.
It is then the NHS body’s responsibility to investigate the matters raised in the concern in a manner which appears to that body to be the most appropriate to reach a conclusion in respect of the matters raised thoroughly, speedily and efficiently.
Qualifying liability
Under Regulation 23 if an NHS body receives a concern which includes an allegation that harm has or may have been caused, that triggers an obligation on the part of the NHS body to consider whether there is a likelihood of a qualifying liability arising such that it needs to consider whether redress should be offered in accordance with Part 6 of the Regulations.
Under the Regulations ‘qualifying liability’ is defined as ‘a liability in tort owed in respect of, or consequent upon, personal injury or loss arising out of or in connection with breach of a duty of care owed to any person in connection with the diagnosis of illness, or in the care or treatment of any patient:
in consequence of any act or omission by a health care professional; and which arises in connection with the provision of qualifying services’.
Reporting
Unless the redress arrangements apply (as provided above), the NHS body must prepare a written response to the concern within 30 working days. That response must summarise the nature and substance of the matter or matters raised in the concern and it must describe the investigation undertaken in accordance with the Regulations. It must contain copies of any expert opinions that have been obtained and the relevant medical records. If appropriate, it should contain an apology and should identify any action that has been taken as a result of the outcome of the investigation. It should advise the individual who notified the concern of the right to report the matter to the Public Services Ombudsman for Wales and it should also, in the event that the concern originally included an allegation that harm has or may have been caused, give a view as to the reasons why it is determined that there is no qualifying liability.
The Regulations provide that the response should be given within 30 working days, but if it cannot be given then a reason must be given for the delay and the response must be sent as soon as reasonably practicable and within six months beginning on the day upon which the NHS body received notification of the concern. If exceptional circumstances mean that the six-month period cannot be adhered to then again the person who notified the concern must be told the reasons for that delay and advised as to when a response can be expected.
If, as a result of its preliminary investigation, the NHS body comes to the conclusion that there is or may be a qualifying liability, then it must produce an interim report describing why it so concludes. This report should contain any relevant medical records and advise the person who notified the concern of the availability of free legal advice which will be available in the continuing investigation as to whether there is a qualifying liability and/or the procedure which will apply in order to determine the appropriate form of redress. Again, the time limit with regard to production of this interim report is 30 working days beginning on the day on which the NHS body received notification of the concern. If the NHS body is not able to provide an interim report, it must give reasons for the delay and provide the report within six months or, in exceptional circumstances as soon as reasonably practicable but not later than 12 months from the date that the NHS body received notification of the concern.
Limitation
During the period when the concern is subject to investigation under redress (Part 6), the limitation period applicable under the Limitation Act 1980 is suspended for the period beginning with the date when the initial concern was received by the NHS body.
Redress
Where the NHS body has determined that a qualifying liability exists or may exist, the Regulations provide that legal advice will be available to either advise on any offer of redress which has been made in accordance with the Regulations or in relation to the obtaining of reports from jointly instructed experts. The legal advice is paid for by the NHS body in accordance with a legal fees framework contained in the guidance 5 to the Regulations and it may only be sought from firms who have one partner or employee who is a member of the Law Society Clinical Negligence Panel or the AvMA Clinical Negligence Panel.
Forms of redress under Regulation 27 comprise:
Making an offer of compensation in satisfaction of any right to bring civil proceedings in respect of a qualifying liability; The giving of an explanation; The making of a written apology; The giving of a report on the action which has been or will be taken to prevent similar cases arising.
The compensation which may be offered in accordance with Regulation 27 can take the form of entering into a contract to provide care or treatment or financial compensation or both. Although it is a provision of the Regulations, it is unclear if there has been any case to date where a contract to provide care or treatment has been offered.
The financial limit for compensation awarded under redress is £25,000 (to include general and special damages). It should be noted that the guidance 5 to the Regulations provides that it is for the NHS body to investigate quantum. The legal fees framework in the guidance document does not allow fees in respect of the investigation of quantum. The fees are limited to obtaining the necessary medical reports to establish breach of duty and causation, to quantify the claim and obtain Court approval if necessary.
If it is decided that an offer should be made, the person who notified the concern and/or his/her legal representative must be advised that they should respond to the offer within six months of the date it was made.
Is putting things right working as it should be?
Whilst there have been some positive outcomes, the experience of patients who have instructed Hugh James is that NHS bodies are regularly breaching the Regulations. It is not possible to outline each and every difficulty encountered here as these are so varied, particularly as there is a lack of consistency of approach throughout each of the seven Welsh health boards. However, there are some failings which are common to all of the NHS bodies in Wales and which are militating against the transparency, honesty and candour which were intended to be at the heart of this process. These are not only causing patients to become disheartened and frustrated with the process but, more seriously, may well mean that patient safety issues are being left unaddressed such that future patients are left at risk of avoidable harm.
Delays
It is of course appreciated that detailed investigations into serious incidents can take some time, but it is difficult to understand why there are such extensive delays across each of the seven health boards in providing responses.
The experience at Hugh James in dealing with over 200 cases is that only a small percentage of them are compliant with the time scales set. The majority are falling outside of the deadlines with some clients having waited in excess of 18 months.
Delays are encountered at each stage of the dialogue with the NHS body, particularly in those cases where the medicine or the law is complex. Even in the most serious cases, including those involving fatalities, children and the elderly, there is a striking lack of urgency.
Lack of patient involvement
Under Regulation 22(4), the NHS body is specifically required at least to offer to discuss with the patient and his or her representative, the manner in which the concern will be investigated, the availability of advocacy and support services and the time scales for the investigation. In the experience of Hugh James, the investigations are carried out by the NHS body without the patient’s input or involvement beyond the initial notification of the concern.
In the experience of Hugh James, once the concern is notified, patients will hear nothing in response other than an acknowledgement (and usually not within the two-day time frame) and then a series of letters apologising for the ongoing delay before eventually a response is received outlining the outcome of the NHS body’s investigation in relation to its own standard of care. As a result, the response given often fails to adequately address the issues raised in the concern. Responses also regularly fail to comply with the Regulations in relation to the prescribed content.
Lack of detailed investigation of quantum
If the NHS body determines that there is a qualifying liability and hence an offer of compensation should be made, the amount of compensation offered to the patient should be assessed in the same way in which the Court would assess the value of the claim. In the experience of Hugh James, in those cases in which an offer of redress is made, the NHS body rarely carries out a detailed investigation into the value of the claim. Patients are not being asked to provide details of the way in which their injuries have affected them, whether they continue to suffer problems and whether they have suffered any financial losses as a result of their injuries. In some cases, very low offers have been made – the offer has been rejected on legal advice and lawyers have subsequently been able to reach a much higher settlement for their clients outside of the redress arrangements because they, rather than the NHS body, have carried out the appropriate investigations. Of course, there may well be patients who have accepted offers and waived their right to bring civil claims, without taking legal advice and without proper investigation of the value of their case. Unless these cases are properly investigated before offers are made, there is a real risk of patients not being fairly compensated.
Independence
Many expressed concerns regarding the independence of this process at the time that the Regulations were first laid. Under the Regulations, the NHS body is required to determine whether there is a qualifying liability and it is only in those cases where there is a qualifying liability, on the NHS body’s own determination, that the patient is entitled to free legal advice and a more detailed investigation, which may include the joint instruction of independent experts.
In the experience of Hugh James, and in that of many other specialist clinical negligence practioners, the bar for determining whether a qualifying liability exists or may exist is being set too high. Only those cases where a qualifying liability is obvious are being dealt with at the second stage, i.e. the redress stage of the process. NHS bodies seem reluctant to accept that there are many cases in which there may be a qualifying liability requiring a more detailed investigation and, as a result, those cases are dealt with in much the same way as they were dealt with under the old complaints procedure. The redress part of the procedure under Part 6 is not being utilised as often as it should be. This is perhaps not surprising given that in the first stage of the investigation, the NHS body is effectively acting as defendant, judge and jury and there appears to be little change in terms of culture within the NHS complaints investigation, despite the best intentions of the Welsh Government when the Regulations were introduced.
What next?
The events at Mid Staffordshire NHS Foundation Trust and the subsequent recommendations of Robert Francis QC following his public enquiry into those events have brought issues around patient safety into very sharp focus both in England and in Wales. Prime Minister David Cameron and his Minister for Health Jeremy Hunt are constantly berating the Welsh Government, alleging that it has not got its house in order as far as the Welsh NHS is concerned. There is some evidence for underperformance and increasing expression of public concern.
One of the recommendations which Robert Francis QC suggested was key to the avoidance of a repeat of the experiences at Mid Staffordshire was effective complaints handling by NHS bodies with prompt and thorough investigation of the complaint which in turn is properly and effectively communicated to those providing care.
It was clearly the Welsh Government’s intention to introduce an effective complaint handling process when it introduced the Regulations in 2011. Sadly, the reality is that the Regulations are not consistently adhered to by NHS bodies and this situation has, to date, been tolerated.
By far the biggest flaw with the Regulations, as was anticipated from the outset, is that they fail to provide for a level of independent scrutiny. This would address not only the operational issues such as compliance with timescales etc., but also whether the Regulations are truly being applied fairly and with the interests of the patient in mind.
How can the Welsh Government’s aim of investigating once and investigating well be best achieved? One solution may be the increased involvement of Community Health Council complaints advocates. Whilst an independent complaints advocacy service for patients is available in Wales, it is fair to say that there is currently a lack of awareness amongst the general public of the role of that Community Health Councils play, such that the Community Health Councils are currently involved only a small percentage of Welsh NHS complaints. With increased publicity for the Community Health Council advocacy service within hospitals and in GP practices, one might see increased uptake of the Community Health Council’s advocacy service in the investigation of concerns. This may result in more robust challenges to refusals on the part of Welsh NHS bodies to embark on an investigation of whether there is or may be a qualifying liability.
It is important also to consider the increasing numbers of concerns alongside the resources which both the NHS bodies and Community Health Councils have available to them to deal with the concerns presented. Given the significant delays encountered, despite the good intentions of the Welsh Government, adequate resources have not been available to allow the effective implementation of Putting Things Right on a local and national level. Given the increasing pressure on the public purse, we are unlikely to see increased resources being made available. That being so, it is important that we see a simple, consistent and standard approach to implementation of the Regulations across all of the Health Boards and Community Health Councils in order to maintain quality. It cannot be helpful that all concerns, regardless of the seriousness of the issue, should be managed in the same way. It may be preferable to have a system which categorises a concern and attempts to match time and resources to the complexity of the issues raised within it: ‘the guidelines concerning ‘Grading of Concerns’ should be re-written with this in mind’. 6
The Welsh Government is to be applauded for leading the way with NHS Redress and there remains great potential for the Welsh population to be better off as a result of Welsh Government innovation in this area. However, things have gone wrong in the implementation of these arrangements and these difficulties need to be addressed urgently. In February 2014, The Welsh Health Minister Mark Drakeford announced
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a three-month review of Putting Things Right. The review was led by Keith Evans, the former Chief Executive and Managing Director of Panasonic UK and Ireland supported by Andrew Goodall, Chief Executive of Aneurin Bevan Health Board.
The terms of reference of the review included: Review the current process to determine what is working well and what needs to improve; Consider if there is sufficiently clear leadership, accountability and openness within the process; Identify how the NHS in Wales can learn from other service industries; Consider the wider cultural ‘patient’ service ethos and how staff are supported to deal with patient feedback; Identify how the NHS can demonstrate it is learning from patient feedback.
The report from the review entitled ‘Using the Gift of Complaints’ 8 was published in 2014. The report highlights many of the issues raised in this article, including the adequacy of resources available; inconsistent application of the Regulations across Health Boards and insufficient patient focus. The strong message from the report is that the NHS is missing the opportunity to learn valuable lessons presented from the ‘Gift of Complaints’. The report’s authors make no less than 109 recommendations for improvement of the process.
Since the report’s publication, the National Assembly’s Health and Social Care Committee has written to the Health Minister Mark Drakeford setting out 11 key issues that it wants the Government to consider in relation to the ‘Using the Gift of Complaints’review.
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These include:
The introduction of an independent regulator; Accountability in strengthening of leadership within the Health Boards; Monitoring of complaints handling; Recording of informal incidents or complaints; Support for staff including feedback; Making complaints data available; Improve response times to complaints.
Reports in the media suggested that the Welsh Government would set out its formal response to the review in the autumn following a period of wider engagement. 10
It is hoped that the Welsh Government will seize the opportunity to get this process right so that the NHS learns from the invaluable information contained within complaints of patients, such that errors can be avoided and the risk of avoidable harm reduced.
Footnotes
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Conflict of interest
None declared.
