Following further information coming to light after the coroner’s inquest concluding on 31 March 2022, Dr C raised her concerns with the CQC about her foster son’s care, but it has not adequately addressed the issues she raised with it.
35. Dr C told us: ‘Since the inquest concluded I have had to write to the CQC at least four times. This is because they have not addressed most of the points I have raised in my letters. They will not enforce the regulations despite clear breaches and have not been clear about their process for investigation of the breaches I have raised’.
36. As Dr C was not satisfied with the CQC’s reply to her concerns, she wrote again and told it: ‘There is substantial new evidence that has come to light through the inquest, and the coroner’s findings highlighted in her summing up and Prevention of Future Deaths Report. I highlighted some of this evidence in my previous letter and I summarise the concerns I have raised that are not addressed in your reply’.
37. In her final reply to the CQC Dr C told it: ‘The CQC response to my requests for information have been obstructive from the onset. My initial complaint letter to the CQC in 2018 was treated as a Freedom of Information request and this has compounded the lack of transparency we have faced. If information had been shared or my insight sought the CQC may well have taken a critical and objective view rather than a supportive view to the narrative that the […] Trust promoted after Child A died. This whole process has left me with the view that the CQC is protecting the interests of the organisation it regulates rather than the interests of the people it should be serving’.
38. In its complaint replies the CQC told Dr C: ‘Whilst you have requested a formal complaint be raised about CQC, the scope of the issues the National Complaints Team (NCT) can consider are in relation to the standard of service provided by us as an organisation but the team do not handle complaints about the services we register, and nor do they review the judgements and evidence our Inspection Teams make or consider concerning a registered service. This is because such matters will, as in this case, have already been subject to professional and legal oversight’.
39. It also told Dr C: ‘You have also asked CQC to disclose the information that we hold about Child A. As you have previously been advised, data protection law does not apply to this information, but CQC remains subject to the common law duty of confidentiality. We have previously shared much of the information about Child A that we hold with you. The remaining information about Child A that we hold was shared with CQC by other parties for the purposes of our regulatory role. After consideration we have decided that, in the absence of a legal duty of disclosure, it would not be appropriate to make further disclosure of records obtained from other parties’.
Our findings
40. We know Dr C contacted the CQC following Child A’s death and told it his was a sudden and unexpected death and she had serious concerns that this had happened due to failures to provide Child A with basic care and safe equipment.
41. We can see Dr C returned to complain to the CQC following the conclusion of the coroner’s inquest and publication of the Regulation 28 report. Dr C set out the failings the coroner had identified in the report and told the CQC she felt it should pursue prosecutions for these failings. Dr C also referred to the CQC’s previous decision not to share information with her or take further action on her concerns.
42. On 19 July 2022 the CQC sent a further complaint reply. This was because Dr C returned to the CQC with further questions asking why it had not considered bringing a criminal prosecution following the publication of the Regulation 28 report. In this reply the CQC told Dr C Section 90 of the Health and Social Care Act 2008 prevented the CQC from bringing a prosecution against the Trust, as the events had taken place more than three years ago.
43. To consider if what the CQC told Dr C it did with the information she gave it was in line with relevant standards, we have considered the CQC’s guidance ‘Responding to information from individuals about their experiences of care’.
44. This policy sets out how the CQC should consider and act on information received from individual members of the public, individual health and social care professionals and individual members of CQC staff about the quality of care they have experienced or observed at named health and social care services in England. It includes information about how to handle both concerns and positive feedback, as both inform CQC’s work.
45. The policy sets out that the CQC does not have the power to investigate or resolve complaints about care received on behalf of individuals. Instead, it sets out that the CQC will assess any information provided, then ensure this information is handed over to the relevant inspector for them to review the information.
46. We can see that the CQC took the relevant action as set out in its policy as it explained to Dr C that, following the Regulation 28 report, it could not reconsider taking enforcement action as the statutory time limit had passed.
47. Section 90 of the Health and Social Care Act 2008 sets out that the CQC may bring criminal proceedings within a period of 12 months from the date on which evidence sufficient in the opinion of the prosecutor to warrant the proceedings came to the prosecutor's knowledge, but no such proceedings can be brought more than three years after the commission of the offence.
48. We can see that as the date of Child A’s death was in May 2017 and the Regulation 28 report was published on 15 May 2022, any information contained in the report was only published five years after Child A’s death. Therefore, it is clearly outside the statutory three-year time limit for a prosecution to be possible. The Act setting out this time limit does not allow for any extension beyond the three-year time limit, for any reason.
49. We can therefore see that in advising Dr C that it could not consider taking enforcement action following the publication of the Regulation 28 report, the CQC has acted in line with our ‘UK Central Government Complaint Standards’, which say it should give clear references to any relevant legislation relevant to its decisions.
50. We have also considered if how the CQC dealt with Dr C’s complaint is in line with its own complaint procedure. To do this we have considered CQC guidance on ‘How to complain about the CQC’. This guidance sets out how the CQC will deal with a complaint. The guidance states the CQC will listen to the person complaining, be polite and helpful, and deal with their complaint fairly.
51. We can see the CQC replied to Dr C’s complaint and answered the questions she asked in her follow up letters. Although it did not always give Dr C the answers she wanted, we can see it did explain its position and explain why it could not now take any enforcement action.
52. It also apologised when it reflected that it could have done some things differently, having reviewed the matter and with the benefit of hindsight. This is in line with the CQC’s commitment in its publicly available information ‘How to complain about the CQC’. This says when the CQC investigates a complaint, it will recognise if it could have done things better.
53. As well as reflecting on its complaint handling the CQC has also reflected on the impact of its complaints process and how it discharged its role in the consideration of the information it received from Dr C about Child A and the Trust. The CQC concluded that: ‘This experience has served as a lesson in empathy, communication, and understanding, prompting us to be more introspective and thoughtful in similar future events’.
54. We can see that when Dr C returned to the CQC it could have been clearer in its initial complaint replies by more promptly advising Dr C about the time limit for enforcement action to be considered. This would have made it clearer that it could now not consider taking enforcement action due to the time that had passed. However, we do not see that this omission is so significant as to indicate a failing, as the CQC did ultimately provide that information and explain why it was so important in this case, after Dr C asked it for further information.
55. We find no indications of maladministration with how the CQC dealt with Dr C’s complaint. Therefore, we do not uphold this aspect of the complaint.
Dr C believes the CQC should have reconsidered its position and taken enforcement action, as new information had become available to it.
56. Dr C told us: ‘Child A's death was due to serious breaches of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 at the Trust, which the CQC is responsible for enforcing. However, they took no such action’.
57. In her complaint to the CQC Dr C told it: ‘I expect the CQC to use its full powers to enforce the Health and Social Care Act Regulations and given the very serious breaches which led to Child A’s death, I believe the CQC has grounds to do this through prosecution. There have been numerous breaches of the most serious nature which have resulted in avoidable harm’.
58. Following the conclusion of the coroner’s inquest, Dr C wrote to the CQC. She told it: ‘On conclusion of the inquest the medical cause of death given was obstruction of the airway through external compression. The coroner determined that Child A died following entrapment by a loose cot bumper causing death by way of airway obstruction. The coroner was satisfied that the Trust failed to properly secure the cot bumper appropriately and in so doing failed to keep Child A safe in his cot’.
59. She also told it: ‘The Trust completed the statutory notification of death for the CQC on the day of Child A’s death. This was not an accurate notification and contained false information. In section 6, which asks are there any concerns relating to the use of medical devices, they wrongly ticked no. Child A was trapped in his specialist cot by a padded panel and as the coroner states in her PFD the padded board was initially found across his neck and that it required force by either one or two nurses for it to be pushed down to be removed. In section 7 where they are asked to describe the circumstances of the death, they wrongly state that he had been checked every 15 minutes overnight and no concerns were raised. They gave a description that Child A had been found sat up with a cot bumper across his chest area. This is not described accurately at all as the next sentence states, carer asked R/N (registered nurse) to help reposition him, which is more suggestive of the padded panel just being in the way or resting on him. The truth was that when Child A was found he was trapped by the padded panel’.
60. In its complaint replies the CQC told Dr C: ‘In this case the CQC coordinated with the police following Child A’s death. The police concluded on the evidence available at that time that no criminal offences falling within their wider criminal jurisdiction had been committed and they did not carry out any further investigation. As stated above, the CQC gathered further evidence during our monitoring functions including the information received from the Trust, our inspections, the initial conclusion of the post-mortem investigation and the coroner’s preliminary findings. The outcome of the initial post-mortem investigation was inconclusive as to the part that the cot bumper may have played in Child A’s death. The view of the coroner at the pre-hearing inquest in 2018 was still in the investigatory stages and no new conclusive pathologist evidence was available at that time’.
61. It also told Dr C: ‘The CQC is bound by strict time limits for prosecution. Pursuant to section 90 of the Health and Social Care Act 2008 any prosecution has to be brought within 3 years of a prosecutable offence occurring. As such, in this case, the limitation period expired in March 2020. Unfortunately, the outcome of the coroner’s enquiries concluded beyond the limitation period in March 2022 and so the concerns raised in the Regulation 28 report and any evidence that might flow from the Inquest cannot be used to form the basis of an investigation by the CQC with a view to criminal prosecution’.
Our Findings
62. We can see that, following Child A’s death on the morning of 17 May 2017, the Trust completed the required statutory notification and informed the CQC about the death of a person using its service. The circumstances of the death given in the statutory notification were described as: ‘Registered nurse and carer went into child's room at 8.15 am to give him his medications. Carer noted that the child was sat up in the corner of his cot with the cot bumper across his chest area. Carer asked R/N to help reposition him. Cot sides were dropped, and R/N moved the bumper and found the child was pale, cold and unresponsive. Emergency call initiate. Complete assessment of ABC undertaken. Airway completely blocked by child’s tongue, no signs of breathing, no capillary refill, pupils fixed and dilated. 999 services contacted, decision made not to commence CPR as death had obviously occurred over 10 minutes ago. Staff undertake 15-minute checks of all children overnight and had not raised any concerns’.
63. We know that the police attended the scene and the information they shared with the CQC did not reach the threshold for any joint work under the agreed Memorandum of Understanding. The Memorandum of Understanding sets out the protocol for liaison and effective communication between the CQC and the police. The CQC told us that its understanding was that the police attended the service as routine and did not identify any suspicious circumstances. Therefore, it did not invoke the Memorandum of Understanding in place between the CQC and the Police.
64. We can see there is nothing to suggest the CQC should have taken any further action immediately after the incident. It received the statutory notification from the Trust, and the police did not report any suspicious circumstances, so the evidence available to it and the guidance in place did not indicate it needed to take further action at that point.
65. Dr C has told us she contacted the CQC in November 2017 and felt like the concerns she was expressing were effectively closed down by the CQC, as it informed her it could not disclose anything as she had no parental responsibility. Dr C has told us she felt the response from the CQC about her information was defensive and she feels her concerns should have been listened to. We appreciate that as someone who cared a great deal for Child A, this was very frustrating to her.
66. The CQC told Dr C it was in contact with the Trust, and it was keeping the CQC updated as it undertook its own investigation of the circumstances surrounding Child A’s death. The CQC also told Dr C there would be an inquest into Child A’s death and confirmed that it had very recently conducted an inspection at the Trust.
67. On 20 December 2017 the Trust completed its own Root Cause Analysis (RCA) investigation. On reading this report, much of it refers to the fact that staff had not properly completed overnight checks and there needed to be clearer guidelines in relation to these checks being carried out. Although the report goes into some depth in relation to the overnight checks, other issues are covered in less detail.
68. An RCA investigation report is a detailed document that outlines the process of identifying and addressing the underlying cause or causes of a problem or incident. As well as giving details of event leading up to the incident and factors contributing to it, it should make any relevant recommendations for preventing similar incidents in the future.
69. The RCA described that staff found Child A in a sitting position in the corner of his cot with a padded cot bumper resting against his chest. The report also states that the Trust collated and reviewed staff statements but did not give a summary of what these statements said. We also note that the report mentioned that staff had raised concerns regarding the cot used, as the padded cot sides were removable.
70. The root cause listed in the report said: ‘The Coroner’s Office verbal telephone update outlined ‘This is an undetermined cause of death which would appear to be natural. There was no sign of trauma, neglect and no skeletal involvement’.
71. We can see the next update the CQC received from the Trust was on 1 May 2018. The CQC inspector called the registered manager to discuss updates. The call note for that call says: ‘Call to the registered manager for overview of the service and update following adjourned coroner's hearing. Adjourned until June 18 for further information, coroner now considering death by negligence although pathologist could not confirm that a cot bumper found on the deceased child contributed to the death’.
72. We consider this to be a new and significant update, partly because the RCA had stated the coroner had previously believed the death to be natural. However, the coroner’s position had clearly changed, and it was now considering whether neglect had played a part in Child A’s death. This is the first time the issue of neglect had been mentioned and is a considerable change from the previous update.
73. On 3 August 2018 the CQC received another update from the Trust. The call note relating to this update says: ‘The coroner is considering the possibility that the cot bumper was instrumental in the cause of death, the post-mortem did not find any evidence to suggest that this was the case. The coroner was critical that the fact that Child A was found with the cot bumper on top of him, wasn’t included in the Trust’s internal investigation initially, their rationale was due to the findings in the post-mortem. The Trust have accepted this should have been included and they will review the investigation to include the cot bumper and update policies accordingly. The registered manager will update CQC as necessary’.
74. We consider that this was another new and significant update, as this was the first time it had been suggested that the cot bumper was instrumental in the cause of death. Before this update it had only been reported to the CQC that the cot bumper had been resting on Child A when he had been found. For the coroner to now suggest that the cot bumper may have been instrumental in his death is a significant change of circumstances.
75. From the update the Trust gave the CQC, we cannot see that there was clear information to explain why there has been such a fundamental change of view from the coroner. In our view, this new update should have prompted more consideration to look at what may have led to this change of position. By this point we can see that the initial picture of the incident had changed considerably.
76. We understand the initial notification and information from the police did not raise any concerns and there is no suggestion the CQC should have taken action to prosecute at the time. However, since that time the CQC had received a complaint from Dr C, and the RCA report that identified staff had raised concerns about the cot the Trust was using. Together with the two new and significant updates from the Trust in relation to the coroner’s investigation, we can see by this point the picture of what may have happened to Child A had changed and suggested a serious error may have occurred.
77. This is emphasised by the eventual conclusions of the Regulation 28 report, which concluded that Child A’s cause of death was due to obstruction of the airway through external compression. We understand the report was completed outside the statutory time limit for a prosecution to be considered. However, all the above updates the CQC received were within the statutory three-year time limit for it to consider enforcement action.
78. To understand the role of the CQC inspector receiving the updates we asked the CQC to provide us with any information relating to the role and responsibilities of the person receiving the updates from the Trust. It told us: ‘Their role is to review any information received relating to a service, to follow up any enquiries with the service where required, to share information with any relevant teams internally or externally, to risk assess information received and progress for review via appropriate processes where needed e.g. MRM, enforcement, inspection planning etc’.
79. To establish what further consideration should have been given to the updates we have considered the CQC guidance contained in the ‘Inspectors handbook Enforcement’ and the CQC ‘Enforcement decision tree guidance’.
80. The introduction to the Inspector’s handbook says: ‘This handbook is to support inspectors and registration inspectors when they are undertaking enforcement action. Enforcement is every inspector’s job, and this handbook sets out what it looks like in practice when concerns are escalated’.
81. Within the introduction section it also says: ‘The enforcement policy and decision tree set out the decision-making process, and the different forms of enforcement action that we may take, which include prosecution, the service of warning notices and fixed penalty notices. The decision tree should also be used during a management review meeting’.
82. The section in the guidance that relates to Management Review Meetings (MRMs) says: ‘MRMs are triggered when we become aware of incidents and events which may constitute a breach in regulations and we conduct an initial assessment by reviewing all the relevant information and consider what response may be appropriate from the full set of options available’.
83. The guidance goes on to say: ‘The MRM will assist you in reaching a decision about the next course of action to take, with the benefit of the right input and expertise from others. They ensure that there is a documented rationale for all decisions, using a clear decision-making process and providing an audit trail to show how decisions were reached. The MRM process is highly important as part of all enforcement decisions and actions, and it is a basic responsibility to follow the process and document it’.
84. The introduction to the CQC Enforcement Decision Tree says: ‘The enforcement decision tree is at the core of how CQC applies its enforcement policy. The decision tree describes the process that guides CQC’s decision on the use and selection of enforcement powers. By setting a structured decision-making process, it drives consistency and proportionality’.
85. The guidance sets out that the decision tree has four stages: 1. Initial Assessment.
2. Legal and evidential review.
3. Selection of the appropriate enforcement action.
4. Final review.
86. The initial assessment sets out the options when the CQC becomes aware of incidents or events that could warrant enforcement action. The options at this stage include: • Carrying out a focused or comprehensive inspection • Gathering more information • Referring the concern or sharing the information of concern with another public body • Progressing to stage 2 of the decision tree and considering what enforcement action to take.
87. From the information available to us, there is nothing to suggest the CQC gave any further consideration to completing an enforcement decision tree or organising an MRM to discuss the possibility of taking any enforcement action following any of the new and significant updates listed above. We consider that the updates mentioned above were so significant that they should have prompted some action to at least give consideration if any further action was necessary. Therefore, we find that by not doing so the CQC failed to follow the relevant guidance in this case.
88. In the information the CQC supplied in response to our requests it told us: ‘Whilst the updates provided information regarding the coroner’s concerns there was no new evidence received that would indicate the requirement to proceed with a criminal enforcement case i.e. No new evidence of provider level failure. The requirements to proceed with criminal enforcement for a breach in reg 12 were not met at this point’.
89. We understand that the updates received on their own may not provide enough evidence to proceed with criminal enforcement action. However, it should have at least prompted some consideration of how this new information may affect previous decisions made. Whilst the CQC says the information itself was not enough to decide on enforcement action, in our view it should have acted in line with the above guidance in exploring the matter further. We consider that it was premature to conclude that no enforcement action would result from an MRM or new enforcement tree, as carrying out those actions may have identified evidence that meant the CQC should move to the next stage of the enforcement process.
90. As the CQC took no action following receiving these new and significant updates, there was no prospect of finding the evidence needed to progress to the next stage of the enforcement process. We consider that this was a missed opportunity to further assess the issues being raised in this case to decide whether any further action would be appropriate.
91. The decision tree itself sets out the first stage of the process is to conduct an initial assessment to consider what response is appropriate from the full set of options available. From the information available to us, we can see the only decision tree completed in this case was on 17 May 2022 following the publication of the coroner’s Regulation 28 report. At this point, although the decision tree was completed, there was no prospect of the CQC taking enforcement action as the three-year time limit for criminal prosecution had now passed.
92. As no decision tree was actioned following new information coming to light via these significant updates, this meant no MRM was arranged. The guidance in relation to when an MRM can be called says one can take place at any point. It also says: ‘During the MRM discussions will be held about all information presented along with a review of all the responses considered until a decision is made on what is the most appropriate action to take’.
93. With the information we have available to us, we can see that this missed opportunity to use the decision tree and take forward an MRM when new and significant information came to light was a failure to follow the CQC enforcement process. Therefore, we uphold this aspect of the complaint.
94. In her complaint Dr C told us how she has been affected by the lack of any enforcement action by the CQC. She told us the process had caused her added frustration, stress and anxiety, at an already extremely difficult time for her and her family. Dr C also told us that she feels she has never had any kind of justice for what happened to Child A. Dr C feels the CQC’s lack of enforcement action when new information became available to it means she will never now get the justice that Child A deserved, and that because the CQC waited until it was too late to act means the prospect of some kind of justice has been taken away from her.
95. We can see that the injustice Dr C feels is directly linked to the failure of the CQC to have taken steps to consider new information in line with its enforcement guidance. If the CQC had acted on new information that we can see was significant, we cannot give any view on the balance of probabilities as to whether it would have taken forward any prosecution or enforcement action at that time.
96. However, it would have followed a clear and transparent process that would have reassured Dr C that it was taking what happened to Child A very seriously and that its decision making was robust. It has also left Dr C not knowing if enforcement action may have been taken within the statutory time limit if the significant new information had been properly considered at the time it was received. In not following that process, the CQC has caused her avoidable frustration and distress. We have therefore thought about what the CQC should do to put things right.