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The Report
Volume I
Part One
Chapter 7

Chapter 7. Care Quality Commission inspection, February 2016

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Chapter 6
August 2015 to February 2016: Baby I and Baby J; concerns increase; reviews
Next
Chapter 8
February to April 2016: Baby K, Baby L and Baby M

Contents

  1. CQC is the independent regulator of healthcare in England. It was established on 1 April 2009 by the Health and Social Care Act 2008. It is an executive non-departmental public body sponsored by the Department of Health and Social Care and is accountable to Parliament through the Secretary of State for Health and Social Care.1 It is responsible for the registration, monitoring, inspection and regulation of NHS Trusts.2 Its purpose is to make sure services provided are safe, effective, compassionate and high quality.3
  2. Regulation principally consists of monitoring and inspection. Monitoring involves keeping the performance of a Trust under review through observing data, attending engagement meetings where CQC inspectors meet with representatives from the Trust, and internal CQC management review meetings where decisions are made as to any issues for investigation.4 The purpose of engagement meetings is “to enable CQC to monitor and act on patient safety concerns, monitor risk, and performance, and to seek assurance about any actions the Trust is taking to ensure safe care and treatment”.5
  3. At inspection, services provided by a Trust are assessed through five questions: are they safe?; are they effective?; are they caring?; are they responsive?; are they well led? Each of those questions is broken down into key lines of enquiry, containing questions and prompts, to be used by inspectors at inspection.6 An inspection report is prepared in which the services inspected are given one of four ratings: outstanding, good, requires improvement or inadequate.7
  4. Regulation by CQC is in accordance with the ‘fundamental standards’ below which care must never fall. This includes Regulation 12, which provides for safe care and treatment, and Regulation 13, which provides for safeguarding service users from abuse and improper treatment.8
  5. Mr Chris Dzikiti took on the role of Interim Chief Inspector of Healthcare at CQC in May 2024. He gave oral evidence to the Inquiry. His understanding was that Regulation 13 would extend to protecting patients from deliberate harm and, where a provider became aware of an allegation of deliberate harm, it was required to take appropriate action without delay. This “must include investigation and may also include referral to an appropriate body”.9
  6. CQC has power to undertake civil enforcement action, through which a registration can be cancelled, suspended or made subject to conditions.10 It can take criminal enforcement action in response to breaches of certain regulations.11 In 2016, it could issue requirement notices (now named Action Plan Requests) for regulatory breaches that did not place people at immediate risk of harm.12

Retention of documents

  1. CQC disclosed a very large number of documents to the Inquiry, including the full inspection notes for the neonatal unit and the wider Children’s and Young People’s services. However, there were specific contemporaneous documents that CQC was unable to locate. These included notes from:13
    1. a pre-inspection engagement meeting with the Countess in February 2016
    2. a meeting between CQC and the Countess in February 2016
    3. a listening event on 9 February 2016
    4. a Quality Summit meeting on 29 February 2016
    5. a Quality Surveillance Group meeting on 28 July 2016
    6. the hospital-wide consultants’ focus group meeting at the 2016 inspection14
    7. the core interviews at the 2016 inspection with:15
      1. Sir Duncan Nichol
      2. Ms Millward
      3. Ms Kelly
      4. Ms Burnett
      5. Mr Harvey
      6. the staff-side representative
      7. the Safeguarding Lead
      8. the Non-Executive Director for Quality and Safety
      9. the Complaints Lead.
  2. The CQC witnesses said there was no reason to think the documents that had not been found would contain information relating directly to the neonatal unit. CQC accepted that some may have included information relevant to the broader culture of the hospital, such as notes from the focus group meeting with hospital consultants on 17 February 2016.16 Given the content of the note of that meeting that does survive, I am satisfied that it would have included relevant information about the culture generally and, possibly, something about the neonatal unit in particular. The inability to trace such material is a significant and regrettable disadvantage to the Inquiry.
  3. CQC did not make efforts to gather the relevant material it held on the Countess until receipt of the Department of Health and Social Care letter of 13 September 2023 informing it of the need to gather material in readiness for this Inquiry. Both Ms Ann Ford, Head of Hospitals Inspections, CQC (North West) and Mr Dzikiti, on behalf of CQC, accepted that steps should have been taken to ensure documents were retained long before they received the letter. They accepted that there were several points at which CQC should have ensured the documents were properly secured. These were:
    • in July 2015, from the point of the publication of the Independent Inquiry into Child Sexual Abuse guidance17
    • in May 2017, when CQC was told that a police investigation had commenced18
    • in June 2018, when there was discussion of the police investigation at an incident coordination meeting chaired by NHS England19
    • in July 2018, when Letby was arrested; November 2020, when she was charged; and during the criminal trial from October 2022.20
  4. CQC’s record keeping was poor. Its failure to locate and retain such documents was reprehensible. CQC accepted that such failures in managing documentation may impair the families’ ability to learn what happened. It apologised to the Inquiry and to the families for this.21 I am satisfied that it has impaired my ability to establish what happened. The Inquiry was told that CQC has now completed a detailed review of its information and records management practices to evaluate its level of compliance with information governance and to make recommendations for improvement. I was told in March 2025 that the report of the review had gone to CQC’s executives.22

Disclosure

  1. The first request from the Inquiry to CQC for information was made on 6 November 2023. That resulted in two statements from CQC’s then Chief Executive, Mr Ian Trenholm, dated 12 February 2024 and 4 April 2024. A further request for documents was made on 17 May 2024. This led to CQC realising that the Inquiry required a much broader scope of information than had previously been provided.23
  2. The failure to locate and retain relevant material at these earlier opportunities, and to recognise the extent of the material that might be required, led inevitably to the loss of many documents and to the very late identification of approximately 4,000 documents relevant to the Inquiry. These were sent to the Inquiry in July 2024, less than two months before the start of the public hearings.
  3. CQC conceded it initially interpreted the Inquiry’s disclosure request too narrowly. Ms Ford accepted there had been a very significant underestimation and that the delay in providing material was unacceptable. I agree that CQC’s disclosure was neither timely nor complete, for which she apologised.24

Inspection of the Countess

  1. CQC carried out a routine inspection of the Countess between 16 February 2016 and 19 February 2016, with further unannounced visits on 26 February 2016 and 4 March 2016. Eight different services were inspected, one of which was Children’s and Young People’s services. Another was Maternity and Gynaecology. Neonatal services at the hospital were inspected as part of the inspection of Children’s and Young People’s services.
  2. As is usual with a routine inspection, CQC gave more than six months’ notice to the hospital of its arrival. It will be recalled that Ms Millward devoted the six months to preparing for the inspection, to the detriment of her risk role. In due course witnesses involved in the inspection of the neonatal unit said that they paid no attention to the self-assessment; its value was simply to inform CQC of how the Trust saw itself. That is something that could be elicited during interviews. It does not, in my view, justify requiring a Trust to spend months assessing itself.
  3. The inspection was chaired by Ms Elizabeth Childs, a specialist adviser (not employed by CQC). Ms Ford and Ms Julie Hughes, a CQC inspector, were also part of the inspection team. The inspectors responsible for inspecting Children’s and Young People’s services were led by Ms Cain, who drafted the relevant section of the inspection report, and the specialist advisers (not employed by CQC), Dr Benjamin Odeka and Ms Mary Potter. The advisers were involved only during the inspection, not in the drafting of the report.
  4. The inspection report was published on 29 June 2016. The hospital’s overall rating was ‘requires improvement’. Children’s and Young People’s services were rated ‘good’ overall and ‘good’ in the categories ‘effective’, ‘caring’, ‘responsive’ and ‘well led’. The rating for the ‘safe’ category was ‘requires improvement’; this was because of shortages of nursing staff.
  5. The report did not identify or discuss the increase in neonatal mortality at the hospital. It did not identify or discuss the recent incidents of unexpected or unexplained deaths, or any concerns of deliberate harm. There are two reasons for that. First, no one at the hospital alerted CQC to the recent incidents of unexpected or unexplained deaths. Second, although CQC had data provided by the hospital that was relevant to the question of neonatal deaths, the inspectors did not see it, nor were they aware of its existence. As a result, they did not ask questions that may have led to CQC learning about concerns about the rise in the number of deaths on the neonatal unit. Nor did they ask unprompted questions about infant mortality to gain assurance that the unit was safe. The failures were significant on all sides.

Notifiable incidents

  1. Trusts were required to notify CQC (via NHS England) of incidents that affected the health, safety and welfare of patients. Notifiable incidents included certain types of injury and abuse or allegations of abuse. There was also a requirement for CQC to be notified of the death of patients.25 NHS Trusts satisfied this obligation when submitting such information to NHS England’s National Reporting and Learning System (NRLS*).26 Such notifications to NHS England via NRLS were shared with CQC pursuant to a data-sharing agreement.27 CQC was also able to access and track notifications to StEIS,28 which records serious incidents and deaths reported by healthcare providers. Data from NRLS and StEIS was extracted by CQC and uploaded to its own system on a weekly basis.29
  2. CQC did not investigate every notifiable safety incident, nor even a selection of them. Its role was to ensure that a hospital was discharging its responsibility and carrying out all aspects of the duty of candour. It could investigate a specific incident where there were concerns about the hospital’s processes and would sample-check processes at inspection.30 CQC used the notifications from StEIS and NRLS to inform its decisions regarding regulatory activity, including inspections. Inspectors could also request further data from a Trust before, during or after an inspection to enable a more detailed analysis of notified incidents.31
  3. Ms Lyn Andrews (CQC Analyst Team Leader for the inspection of the Countess) provided a statement to the Inquiry on 20 December 2024, after all the evidence had been heard from the witnesses involved in the inspection. CQC’s then Chief Executive, Mr Trenholm, provided statements dated 12 February 2024 and 4 April 2024.
  4. In her statement, she described for the first time a number of limitations to CQC’s access to NRLS and StEIS data.32 The purpose of informing the Inquiry of this was, presumably, to show how difficult it was for CQC to monitor an NHS Trust in line with its statutory obligations. The way in which CQC went about its task was a matter for CQC. To the extent that what follows are real difficulties, responsibility for them lies squarely with CQC. Ms Andrews said, for example, that it could take a few days for the information from the electronic files received from the NHS to be transferred to CQC’s internal system. The system also depended on timely reporting and proper allocation of the severity of harm to incidents by those making a report. Incidents were recorded as ‘no harm’, ‘low harm’, ‘moderate’, ‘severe’ or ‘death’. Ms Andrews made clear that data analysts were not clinically trained; nor is it apparent that they knew the meaning of (say) ‘low harm’ when an incident had ended in death. They relied on the words used by those completing the forms and assumed they had correctly assessed the severity of harm. It is not clear that any analysis was taking place or if the information was just taken at face value.
  5. When considering NRLS incident reports, especially where datasets were large (the Countess reported more than 8,000 incidents to NRLS between February 2015 and January 2016, which was the period for analysis of NRLS reports for the inspection), it was common practice for data analysts to filter out entries marked ‘no harm’ or ‘low harm’ on the spreadsheets because it was not “viable” for them to read descriptions of every report.33 The analysts took account only of entries marked ‘moderate’, ‘severe’ or ‘death’. It is not clear that they discussed this with anyone at the hospital, nor within CQC. To a layperson (including an analyst) it appears reasonable to exclude incidents with those descriptions but, since that step was not communicated, no one knew about it. It was one of the reasons that no questions were asked about the categorisation of events. Ms Andrews said that, had there been concerns about the incident-reporting culture, analysts could have conducted an analysis of other incidents, but they did not dip sample (say) ‘no harm’ or ‘low harm’ incidents to check that they had been properly categorised.
  6. In evidence, Mr Dzikiti recognised that an alternative way of processing large amounts of information, rather than filtering out a large number of entries, would be to have more analysts analysing the data.34 Mr Dzikiti also accepted that part of CQC’s regulatory function was to consider whether patient safety incidents were being properly categorised, and that it was difficult to do that where entire categories of incidents were filtered out of the analysis.35 This was a significant shortcoming of CQC’s analytical processes.

Data analysis for the inspection

  1. CQC analysts analysed data obtained by CQC and created data packs for each of the eight core services to be inspected. These were provided to all CQC inspectors and the Trust on 2 February 2016 (draft packs were provided to the Trust on 21 January 2016 to check for accuracy).36
  2. Ms Andrews explained that basic ‘shell’ packs were created for all inspections covering the 12-month period prior to inspection. The shell packs use a standard template that a software program populates with relevant data from the CQC system, including NRLS and StEIS data. The shell packs for the Countess were created on 22 December 2015 and included data for incidents reported between October 2014 and September 2015.37
  3. Ms Andrews also noted: “[A]ny risks due to time lag were mitigated by the fuller analysis completed nearer the inspection to highlight key findings in the Intelligence Presentation … , which for this inspection included incidents reported up to 7 January 2016.” This “also would be further mitigated by up-to-date NRLS and STEIS information forming part of the additional data requests made on site by each core service lead during the inspection”.38
  4. The analysts additionally prepared an up-to-date intelligence presentation, which was delivered to inspectors and specialist advisers on 16 February 2016.39

Omission of serious incidents and the deaths of Baby A, Baby C, Baby D, Baby E and Baby I

  1. The pre-inspection packs and the intelligence presentation from the CQC analysts did not clearly identify the StEIS report in relation to Baby D. Nor did they identify at all the reports to the NRLS in respect of Baby A, Baby C, Baby D, Baby E and Baby I.
  2. The result was that the data pack for Children’s and Young People’s services stated: “No Never Events or Serious Incidents have been reported by the trust between November 14 and October 15.”40 That assertion was incorrect given the report to StEIS in respect of Baby D on 3 July 2015. CQC accepted this.41
  3. Ms Ford also accepted that the inspectors and specialist advisers for Children’s and Young People’s services had been unintentionally misled, because they did not know that there had been a serious incident.42 Mr Dzikiti agreed that the inspectors should have seen the StEIS and NRLS reports.43
  4. The intelligence presentation similarly, and incorrectly, stated in respect of Children’s and Young People’s services that there were no never events or serious incidents reported up to January 2016.44
  5. Ms Andrews said: “It was standard practice for neonatal care to be dealt with in the maternity and gynaecology data pack … [and she] would expect inspectors and SPAs [specialist advisers] to be aware of this.” She added:
    “[I]nspectors and SPAs would be provided with data packs for all core services and would be expected to have reviewed all of these … [they] would have access to all the packs (both in hard copy while on site and electronically throughout the inspection and reporting period). This means that the CYP [Children and Young People] inspection team would also have had access to the maternity and gynaecology data pack.”45

She explained that the reason for the data being reported in the maternity pack was “due to neonatology being considered under the maternity core service for the purposes of data collection and analysis”.46

  1. Whatever the ‘standard practice’ of those collecting and analysing data, it was not the approach of the inspection team. Maternity and Gynaecology was a different service from Children’s and Young People’s services, with a separate inspection team. There was no reason for the Children’s and Young People’s services team to interrogate the data from Maternity and Gynaecology, and I find that they did not do so. There was a serious gap between the understanding of the analyst team and that of the inspectors.
  2. In fact, the data pack for Maternity and Gynaecology recorded that there had been one never event (which was a maternity/obstetric event) and seven other StEIS events, all of which appeared to be maternity/obstetric rather than neonatal. The presentation for Maternity and Gynaecology noted one never event; seven serious incidents within the reporting period; and another seven reported between February 2015 and January 2016.47 The latter information does not feature in the Maternity and Gynaecology data pack and there is no indication of which incidents are referred to here.
  3. The NRLS entries in respect of Baby A, Baby C, Baby D, Baby E and Baby I were not included in the data presented by the data analysts at all, presumably because they had not analysed them. Those entries would have been filtered out by the analysts because of their ‘low harm’ categorisation.
  4. That the right information was not in front of the right people was the result of a flawed system within CQC. CQC accepted that the current system, in which neonatal services are inspected as a standalone service, not as part of Children’s and Young People’s services, is a better one. I accept that. It is highly regrettable that the need for change was not identified earlier. I can identify no good reason why neonatal data was not included in the data pack for Children’s and Young People’s services, which covered neonates. Mr Dzikiti quite properly acknowledged that neonatology data should have been addressed in the data analysis for Children’s and Young People’s services.48
  5. The evidence of the inspectors was that they were unaware of the report to StEIS in respect of Baby D.49 Ms Cain, the Lead Inspector for Children and Young People, gave evidence that she did not remember being made aware of the reports, and accepted that the data packs did not identify the StEIS report relating to Baby D or the NRLS incident reports relating to Baby A, Baby C, Baby D, Baby E and Baby I.50
  6. The failure to ensure that the inspectors and specialist advisers were aware of the NRLS entries (particularly in respect of neonatal deaths) and the StEIS report for Baby D was a significant shortcoming in CQC’s analytical process. It misled the inspectors in respect of safety incidents on the neonatal unit. It limited their ability to undertake a properly informed assessment of the ‘safe’ and ‘effective’ categories of inspection. The inspection framework requires, in the ‘safe’ category, investigation of serious incidents involving children and young people, as well as reports to NRLS categorised as ‘moderate’ or above.51 In the ‘effective’ category, it requires investigation of serious incidents and all NRLS incidents. (There is no express limitation to those that are ‘moderate’ or above and, I would add, no good reason to impose such a limit, particularly without explaining that it has been done and why.)52
  7. Mr Dzikiti accepted in evidence that members of the team inspecting Children’s and Young People’s services should have been made aware of the StEIS and NRLS incidents.53 Ms Cain’s evidence was that, if she had been provided with that information, it would have changed her preparation for the inspection: “[I]t would have been more of a focus of the inspection. There would have been more direct questions asked about mortality and morbidity.” She confirmed that this was something she would “absolutely” have investigated.54 Given that this inspection took place in February 2016, this was important evidence.

Request for further data

  1. On 15 February 2016, a senior analyst at CQC (Mr John Cunningham) sent a list of data requests to Ms Millward at the Countess on behalf of all the lead inspectors of the services being inspected.55 Eighteen of the requests were for the Children’s and Young People’s services inspection. One of these data requests (DR35) was for “[i]ncidents relating to neonates and paediatrics” in the “[l]ast 12 months”.56 Ms Andrews confirmed that the data was provided by the Countess on 16 February 2016.
  2. The spreadsheet produced was a list of 377 Datix reports covering the children’s ward and the neonatal unit.57 It had eight entries referring to deaths, two of which appear to refer to Baby A and two to Baby E. Datix forms were also listed for Baby C and Baby I. No Datix form was listed for Baby D.
  3. Ms Andrews explained that analysts would not carry out a full or further analysis unless this was specifically requested by the core service lead. Ms Andrews’ recollection was:
    “[A]nalysts did not complete any further analysis of incident data supplementary to the standard data packs or intelligence presentation for COCH [the Countess] inspection. No further incident analysis was completed by analysts for the additional incident data requested on site for COCH inspection.”58
  4. In evidence, Ms Cain agreed that she had seen the spreadsheet and that she had noted the neonatal deaths, each of which had been categorised as ‘no harm’. She said she “would have looked at every incident”.59 She said that she understood and accepted the categorisations as meaning “that no harm had occurred as a … direct result of the clinical care provided”.60 She stated: “Overall, nothing from the table of incidents appeared immediately concerning when I reviewed it in advance of the inspection.”61 Ms Cain was asked in evidence how she could be satisfied with the categorisation when in some cases the death was unexpected and unexplained. She explained:
    “The role of the inspection is not to look at … specific incidents. It’s to ensure that there is from a regulatory perspective, there is a process in place to ensure incidents like this are identified, reported, identified, investigated and lessons learnt.
    So individual examples of incidents would not be pursued. But, however as part of the inspection, evidence would be requested to ensure that that mortality and morbidity process was being followed.”62
  5. She had in fact reviewed three specific incidents (from the 377 on the spreadsheet), but could not recall which three she had reviewed.63 It is reasonable to observe that, where there were two deaths on a neonatal unit described as unexpected and without explanation, at least one of them should have been reviewed with a view to establishing that the process for categorisation was correct. Had that been done, further investigation would probably have ensued. Discussion with the Clinical Lead for Neonatology was one option. This does not appear to have happened; nor does the data appear to have been shared with the specialist advisers.
  6. CQC’s process, whereby Ms Cain, a non-clinically trained inspector, was responsible for filtering information to be provided to specialist advisers, in this case Dr Odeka, is flawed. Dr Odeka was clear in his evidence that, had he received the spreadsheet, he would have asked questions about the data.64 More importantly, however, this points to a wider systemic failure on the part of CQC.
  7. Independent of the failures by the Countess, which I shall set out, this was a significant failure on the part of CQC.

Inspection of Children’s and Young People’s services

  1. The inspection of Children’s and Young People’s services involved a walk through the neonatal unit with Ms Farmer on the first day of the inspection, and interviews with multiple members of staff over the course of the remaining days.
  2. Ms Cain accepted in evidence that she did not focus on issues concerning neonatal mortality during the inspection, and did not ask direct questions in that area because she was unaware of any concerns in respect of neonatal mortality.65 She did not discuss an increase in neonatal deaths or any concerns about unexplained or unexpected deaths with any interviewee.66
  3. There was an interview of the core service leads for Children’s and Young People’s services on 17 February 2016, attended by a number of staff members on the neonatal unit. The attendees recorded at this meeting included Dr Brearey, Dr Jayaram (who earlier that day had entered a nursery and had seen Letby fail to assist Baby K), Ms Anne Murphy, Ms Townsend, Ms Rees (who does not remember being at the meeting) and Ms Powell.67 Each of these individuals confirmed in oral evidence that they were aware of the increase in mortality rate – either from the record of neonatal deaths that Ms Powell had compiled, from the Thematic Review, initiated by Dr Brearey and convened in order to consider these deaths, or as a result of the Brigham Review, which considered obstetric care. All three inspectors for Children’s and Young People’s services attended. CQC’s position is that it was not informed about the increased mortality rate until 29 and 30 June 2016.68
  4. Dr Jayaram acknowledged that “by this stage we had had the Thematic Review several, not all of us, had the specific concern”.69 However, he stated that, “[g]iven the make-up of the number of people in the room, [the neonatal deaths and the Thematic Review] would have been a difficult — a difficult one to broach”.70
  5. The notes of the meeting indicate that there was discussion of mortality and morbidity meetings. Ms Potter’s note states: “Mortality & Morbidity meetings – 5 last year. Planned 4 this year … Neonatal depend on number of cases to be discussed.”71 Ms Cain’s note states: “Mortality & morbidity meeting. Perinatal. x8 from nnu [neonatal unit] last year x4 this year. Neonatal mortality x2 last year (dep on cases to be discussed). x2 paed [paediatric] mortality meetings. Nos fairly small.”72 These notes do not describe discussions of the detail of the meetings but show that they were only about process. The discussions confirmed that there were meetings about mortality and morbidity and how often they took place. There was nothing about what was said and no determination of the quality or content of the meetings.
  6. Dr Brearey confirmed that, in addition to attending the core service lead interview, he had a one-to-one interview with Dr Odeka.73 He did not raise the increased neonatal mortality rate nor the Thematic Review with CQC. He conceded that in retrospect he should have.74 He described his dilemma: knowing that he had provided the Thematic Review to the Medical Director and knowing they would be discussing it, he was not sure what to do. He decided to mention the mortality rate if he was asked about it.75 Dr Brearey should have told Dr Odeka about the increased number of deaths.
  7. Ms Powell confirmed that she did not raise the increased mortality rate or unexpected deaths with CQC.76 She acknowledged that she should have.77 I agree she should have. In addition to being interviewed on 17 February 2016, Ms Anne Murphy was interviewed again by CQC on 4 March 2016. This was two days after she was emailed the final version of the Thematic Review (on 2 March 2016). She did not recall raising the findings of the Thematic Review with CQC.78 I am sure she did not. She too should have done so.
  8. Ms Kelly was interviewed by CQC on 17 February 2016, and Mr Harvey was interviewed the following day. Ms Kelly accepted that, prior to the CQC interview, in July 2015 she was aware there had been an increase in neonatal mortality.79 She knew that the three deaths in June 2015 were as many (or more) deaths as there had been on the unit in one full year of the previous five years. She also accepted that she was aware of the Brigham Review in November 2015 and that it highlighted that there had been more neonatal deaths since June 2015.
  9. Ms Kelly confirmed that, on 15 February 2016, Mr Harvey had forwarded her Dr Brearey’s email with the Thematic Review.80 Ms Kelly did not mention the Thematic Review to CQC. When asked whether she should have done, she responded: “I don’t think so at that time because we had only just received it, we hadn’t a chance to digest it and in actual fact it wasn’t the full report.”81 In the context of the increased neonatal mortality rate, she accepted “we could have told the CQC more at that time”.82 Ms Kelly and Mr Harvey could and should have told CQC about the increase in the number of deaths on the neonatal unit.
  10. Mr Harvey was confident that the Thematic Review was shared with CQC before its visit in February 2016. He told the Inquiry: “[W]ith regard to the CQC, I am confident that I shared and we — we’re sort of moving on — the Thematic Review of Dr Brearey with the CQC ahead of them — their visit in February 2016.”83 This supports my view that he should have done so. However, I do not accept that he did in fact share it with CQC, before their visit or at all. His account is contradicted by Ms Millward. Ms Millward stated that, as far as she was aware, CQC had not been sent the Thematic Review in advance of the CQC inspection. She was asked directly: “Did you submit the thematic review of neonatal mortality?”. She responded: “Not at that time because that was February 2016 and obviously it was still being developed at that point … As far as I am aware, they did not see that, no.”84 She gave evidence that she had spent most of the six months leading up to the inspection preparing for it. Leaving aside the wasteful diversion of time from managing risk to preparing for an inspection of process, she is likely to be right when she says the hospital did not provide CQC with the Thematic Review.
  11. In evidence, Mr Harvey said that he could not recall any conversation with the inspectors from CQC during their inspection in February 2016. That he met them is recorded. There was obviously a conversation. If Mr Harvey made any notes, they have not survived. Whatever he said, none of the CQC witnesses had any recollection of the issue of increased neonatal mortality being raised with them, and CQC has lost any notes that may have been relevant to that issue (and many others). At that stage, Mr Harvey had not informed Mr Chambers or the Board about the increase in mortality. I am satisfied that he did not tell CQC about it. He should have done.
  12. One reason for that failure may be, as suggested by Family Groups 2 and 3, that he was seeking to cover it up. Another way of describing it is that he was putting off mentioning it in the hope that he would find an explanation for the increase in deaths that was satisfactory. Whatever the reason – and he did not give one, because he is confident he did disclose the mortality information – this was a serious failure by the Medical Director. It reveals a lack of candour. It foreshadows an approach that would repeat itself in the course of the next 18 months.
  13. Ms Cain confirmed in evidence that there was no discussion of actual mortality rates, and the topic of unexpected and unexplained deaths was not discussed.85 There was discussion of the fact that neonatal mortality meetings had not happened as frequently as the leads would have liked, but they were back on track.86 There was no discussion as to how many cases were considered at the meetings, or any themes emerging from them.87 Ms Cain could not recall any questions being asked by the inspectors relating to neonatal mortality, but she considered, in retrospect, that the discussion relating to mortality meetings should have elicited from the interviewees their concerns as to any increase in mortality.88 The chances of the discussion having that effect would have been greater had the inspectors and advisers had the relevant information and asked questions about the reasons for the mortality meetings not happening as frequently as the leads would have liked.
  14. Similarly, Dr Odeka’s view was that there was no discussion of neonatal mortality because it was not volunteered by the interviewees, and also because he did not have the data showing incidents of neonatal death.89 Ms Potter did not recall any discussion of neonatal mortality or concerns relating to it either.90
  15. An issue that was explored in evidence was the form of questions put by inspectors during interviews, and whether they were sufficient to elicit concerns that staff had but might be reluctant to volunteer. Ms Childs agreed that a question such as “Is there anything that you think you should tell us that we haven’t already covered?” would be better than an open question such as “Anything you want to say?”.91 Ms Cain’s evidence was that she would finish interviews by asking, “[I]s there anything else you think we should know, anything you would like to tell us?”.92
  16. Whilst Ms Ford could not say with certainty what was asked at interviews, she considered it standard practice to ask at the end of an interview, “Is there anything else that you would like to tell us? Is there anything that we have missed? Is there anything you want to share with us?”.93
  17. Mr Dzikiti attributed CQC’s failure to detect concerns at the hospital about neonatal deaths to the fact that staff and leadership at the Trust did not disclose them.94 I accept that is part of the story. But it is reasonable to expect an inspection team to probe what they are told by those subject to inspection. The hospital had given them the data that showed the number of deaths and the fact that some of them were unexpected and unexplained. The hospital (doctors, managers, nurses) knew they had provided that information. It was for CQC to ask questions about it. If the provision of data does not have that effect, what is the point of providing it? It is not sufficient to check that processes are in place to deal with (e.g.) deaths. I note that in respect of safeguarding, which I deal with in detail in Chapter 12, CQC found that the Countess had safeguarding policies and procedures in place and that staff “were aware of their roles and responsibilities and knew how to raise matters of concern appropriately”.95 The confidence there was misplaced. When people are asked what the process is for dealing with a particular event, they can often answer accurately. The more important next question is, what happened the last time that event occurred? That the process is used effectively should be rigorously tested if a CQC report on process is to have credibility and value.
  18. I am not confident that the CQC process, as it occurred at the Countess, is apt to find problems within a hospital. Whatever the aspiration, experience of human behaviour teaches us that, when faced with very difficult information and uncertainty, candour is not instinctive. A willingness to ask questions and probe information given should be a requirement for anyone carrying out an inspection for CQC.

What difference would it have made had CQC been informed of the increase in deaths on the neonatal unit?

  1. Ms Ford’s evidence was that, had information regarding an unexpected increase in neonatal mortality been available to the inspectors, it would have led to the issue being explored with the Trust. Assuming that this would have happened, it is likely that assurances would have been sought that the reasons for the increase were being investigated.96 It is likely that CQC would have been told about the recently held Thematic Review, the final report of which was not yet completed. Given that the inspection was directed towards whether there was an appropriate process to consider any increase in mortality rates, it is likely that the fact of the investigation would have been sufficient for CQC and nothing further would have been done.

Consultants’ focus group

  1. Amongst the focus groups held was one for consultants. It was conducted by Ms Hughes and Dr Michael Rees, a specialist adviser for CQC. Ms Hughes recalls that about 14 or 15 consultants attended, but she does not recall the individuals or their specialties.97 CQC has not found the note of that focus group.
  2. Ms Hughes made some brief notes relating to the focus group in her diary.98 The relevant part of her note states: “Themes – bullying – lack of support – staffing.”99
  3. On 7 July 2023, Ms Hughes discussed the focus group with Ms Kristin Hannaford, a CQC senior media adviser. This discussion took place towards the end of Letby’s criminal trial. The note of that discussion contains more detail than the diary, stating:
    “On 17 Feb consultant focus group Training Room 2 at 2.30pm – attended by consultants across range of services not just CYP. Some Consultants raised concerns relating to: Staffing levels / lack of staffing; Bullying culture – senior medics who talked of a lack of support from leadership team; Oppressive air at leadership level.”100
  4. Ms Hughes confirmed that this fuller account was based on her notes and what she had left in her memory of the focus group.101 She explained that what came across from the consultants at the focus group was a “general oppressive air … they didn’t feel supported to raise their concerns, they didn’t feel listened to”.102 She could not recall what concerns were being raised by the consultants, but was sure there were no specific concerns raised with her about the neonatal unit.103
  5. The note of the discussion with Ms Hannaford goes on to state: “A meeting was held with the [Trust’s] Medical Director that same day at 4.30pm and the concerns expressed by consultants were discussed.”104 Ms Hughes said in evidence that the meeting with the Medical Director, Mr Harvey, would have been an ad hoc one. She said that was the standard practice, though she could not remember the meeting.105 Mr Harvey could not remember this matter being raised with him. He said that if it had, it would have been a matter of concern since it would have marked a change from the staff satisfaction survey for 2015 and he would have acted upon it. Whatever was said in the meeting, this issue did not find its way into the CQC report.
  6. Ms Hughes was asked whether it was appropriate to raise allegations of bullying of the consultants, who had complained of an oppressive air at leadership level, with the Medical Director. Her evidence was that it was appropriate as the Medical Director carried overall responsibility for medics across the Trust and there was no one else to go to.106 This betrayed a lack of insight into how to deal with allegations of bullying. Ms Ford stated that, if the issue was not tackled by the Medical Director, then it would be raised with the Chair.107 However, Mr Dzikiti’s expectation was that this information would be discussed with someone more senior, the Chief Executive or the Chair. He commented that, where a team was reporting bullying or harassment, the most senior people in the organisation were the ideal people to have the conversation with.108 That was, presumably, the expectation of the consultants and would obviously be the right approach. In fact, the consultants’ concerns were ignored. These were serious complaints that should not have been dismissed without any discussion. They do not feature in the CQC report, nor was the Board made aware of them. This was another failure by CQC. The issue should have been explored before the conclusion could be reached that the hospital was well led.
  7. The report said: “The hospital was led and managed by an accessible and visible executive team. This team were well known to staff, visited most wards and departments regularly, and responded to issues that staff raised.”109
  8. We know from Chapter 2 that “most wards and departments” did not include the neonatal unit.

Post-inspection

  1. When the Countess eventually told CQC about the increased neonatal mortality rate on 29 and 30 June 2016, CQC should have insisted on seeing the Thematic Review and the other reviews that had been carried out. Additionally, having considered those and noted the dates upon which they had been commissioned and received, CQC should have challenged the Countess about the failure to provide the information sooner. It did not do so. CQC pointed out that it had been reassured in terms of the ongoing safety of the unit by the steps and actions that were proposed by the hospital, but accepted that it should not have been so readily reassured.110 This was a simple continuation of a non-investigative approach to inspection.
  2. I accept that until this time the relationship between CQC and the Countess was very good. A consequence of close working relationships is that they can lead to a misplaced confidence that all is well. Those conducting inspections must always approach the task with an open mind, unaffected by the results of the last inspection, and free of any bias. This means that questions should be asked about the available data and about what the staff are telling the inspectors. Most importantly, it means going beyond establishing that a process exists for a particular situation and testing whether in fact it is effective. In the absence of such testing, the inspection becomes only about the process. The outcome becomes irrelevant. This is unacceptable in an organisation with responsibility for ensuring that our hospitals are safe and effective.

Footnotes

  1. * The NRLS is now the Learn from patient safety events service.

Endnotes

  1. 1 Witness statement of Ian Trenholm INQ0012634/2/para 6

  2. 2 Witness statement of Ian Trenholm INQ0012634/2/para 7

  3. 3 Witness statement of Ian Trenholm INQ0012634/2/para 11

  4. 4 Chris Dzikiti 14 January 2025 26/5-24

  5. 5 Witness statement of Ian Trenholm INQ0017809/3/para 12

  6. 6 Witness statement of Ian Trenholm INQ0012634/13/para 61 to 14/para 64

  7. 7 Witness statement of Ian Trenholm INQ0012634/16/para 78

  8. 8 Witness statement of Ian Trenholm INQ0012634/7/para 33

  9. 9 Chris Dzikiti 14 January 2025 22/3 to 23/7

  10. 10 Witness statement of Ian Trenholm INQ0012634/17/para 83

  11. 11 Witness statement of Ian Trenholm INQ0012634/17/para 84

  12. 12 Witness statement of Ian Trenholm INQ0012634/18/para 85

  13. 13 Witness statement of Ann Ford INQ0107911/6/para 2.18

  14. 14 Witness statement of Ann Ford INQ0107911/17/para 4.13

  15. 15 Witness statement of Ann Ford INQ0108375/5/para 5.3 to 6/para 5.6

  16. 16 CQC 17 March 2025 60/14-23

  17. 17 Ann Ford 15 November 2024 12/8-12

  18. 18 Ann Ford 15 November 2024 13/6-11

  19. 19 Ann Ford 15 November 2024 14/14-23

  20. 20 Ann Ford 15 November 2024 15/10-17 and 16/20-25

  21. 21 CQC 17 March 2025 61/2-8

  22. 22 CQC 17 March 2025 61/21-23

  23. 23 Witness statement of Ann Ford INQ0102609/17/para 3.76

  24. 24 Ann Ford 15 November 2024 10/16 to 11/23

  25. 25 Witness statement of Ian Trenholm INQ0012634/27/paras 130-133

  26. 26 Witness statement of Ian Trenholm INQ0012634/27/para 134

  27. 27 Witness statement of Ian Trenholm INQ0012634/28/para 137

  28. 28 Witness statement of Lisa Annaly INQ0108742/17/para 5.6

  29. 29 Witness statement of Ian Trenholm INQ0012634/38/para 198 to 39/para 200; Witness statement of Lyn Andrews INQ0108743/7/para 34

  30. 30 Witness statement of Ian Trenholm INQ0012634/28/para 140 and 31/para 154

  31. 31 Witness statement of Ann Ford INQ0108375/2/para 2.11

  32. 32 Witness statement of Lyn Andrews INQ0108743/8/para 35

  33. 33 Witness statement of Lyn Andrews INQ0108743/12/para 48

  34. 34 Chris Dzikiti 14 January 2025 131/3-13

  35. 35 Chris Dzikiti 14 January 2025 63/23 to 64/8

  36. 36 Witness statement of Ann Ford INQ0107911/11/para 3.3

  37. 37 Witness statement of Lyn Andrews INQ0108743/4/paras 15-16

  38. 38 Witness statement of Lyn Andrews INQ0108743/10/para 41

  39. 39 Witness statement of Lisa Annaly INQ0108742/11/para 2.8.1; Witness statement of Lyn Andrews INQ0108743/6/para 26

  40. 40 INQ0101422/5/1

  41. 41 CQC 17 March 2025 76/18 to 79/22

  42. 42 Ann Ford 15 November 2024 31/3 to 32/25

  43. 43 Chris Dzikiti 14 January 2025 48/25 to 49/6

  44. 44 INQ0103620/27

  45. 45 Witness statement of Lyn Andrews INQ0108743/11/para 46

  46. 46 Witness statement of Lyn Andrews INQ0108743/11/para 43

  47. 47 INQ0103620/26

  48. 48 Chris Dzikiti 14 January 2025 57/6-10

  49. 49 Helen Cain 14 November 2024 50/11-15; Dr Benjamin Odeka 14 November 2024 98/14-20

  50. 50 Helen Cain 14 November 2024 26/1 to 27/25

  51. 51 INQ0106785/10

  52. 52 INQ0106785/19

  53. 53 Chris Dzikiti 14 January 2025 49/4-6

  54. 54 Helen Cain 14 November 2024 27/20-25

  55. 55 INQ0103249/3-5

  56. 56 INQ0103249/5

  57. 57 Chris Dzikiti 14 January 2025 58/22 to 59/6

  58. 58 Witness statement of Lyn Andrews INQ0108743/10/para 38

  59. 59 Helen Cain 14 November 2024 29/19

  60. 60 Helen Cain 14 November 2024 30/9-12

  61. 61 Helen Cain 14 November 2024 31/18-22

  62. 62 Helen Cain 14 November 2024 33/14-23

  63. 63 Helen Cain 14 November 2024 34/16-19

  64. 64 Dr Benjamin Odeka 14 November 2024 93/9 to 94/24

  65. 65 Helen Cain 14 November 2024 43/9-14

  66. 66 Helen Cain 14 November 2024 54/7-24

  67. 67 INQ0017339/206

  68. 68 CQC 17 March 2025 62/11-13

  69. 69 Dr Ravi Jayaram 13 November 2024 94/18-20

  70. 70 Dr Ravi Jayaram 13 November 2024 94/21-23

  71. 71 INQ0017339/164

  72. 72 INQ0017339/207

  73. 73 Dr Stephen Brearey 19 November 2024 192/14-21

  74. 74 Dr Stephen Brearey 19 November 2024 105/3-4

  75. 75 Dr Stephen Brearey 19 November 2024 104/1-25

  76. 76 Eirian Powell 17 October 2024 113/1-5

  77. 77 Eirian Powell 17 October 2024 115/11-21

  78. 78 Anne Murphy 21 October 2024 70/16 to 71/7

  79. 79 Alison Kelly 25 November 2024 266/12 to 268/18 and 269/25 to 270/8

  80. 80 Alison Kelly 25 November 2024 71/25 to 72/2 and 75/14-22; INQ0003140/1

  81. 81 Alison Kelly 25 November 2024 73/6-8

  82. 82 Alison Kelly 25 November 2024 271/6-7

  83. 83 Ian Harvey 28 November 2024 105/8-11

  84. 84 Ruth Millward 4 November 2024 129/5-13

  85. 85 Helen Cain 14 November 2024 55/10-15

  86. 86 Helen Cain 14 November 2024 57/12 to 58/5

  87. 87 Helen Cain 14 November 2024 58/20-25

  88. 88 Helen Cain 14 November 2024 61/12-15

  89. 89 Dr Benjamin Odeka 14 November 2024 100/20 to 102/8

  90. 90 Mary Potter 14 November 2024 130/5-11

  91. 91 Elizabeth Childs 14 November 2024 175/13-22

  92. 92 Helen Cain 14 November 2024 63/20 to 64/2

  93. 93 Ann Ford 15 November 2024 21/1-18

  94. 94 Chris Dzikiti 14 January 2025 77/1-4 and 80/8-21

  95. 95 INQ0017433/110

  96. 96 Witness statement of Ann Ford INQ0108375/5/para 4.8

  97. 97 Julie Hughes 15 November 2024 103/12-20

  98. 98 Julie Hughes 15 November 2024 109/7-12

  99. 99 INQ0017319/2

  100. 100 INQ0017319/1

  101. 101 Julie Hughes 15 November 2024 117/1-6

  102. 102 Julie Hughes 15 November 2024 112/23 to 113/2

  103. 103 Julie Hughes 15 November 2024 118/17 to 119/14

  104. 104 INQ0017319/1

  105. 105 Julie Hughes 15 November 2024 123/16-25

  106. 106 Julie Hughes 15 November 2024 124/11-24

  107. 107 Ann Ford 15 November 2024 91/16-21

  108. 108 Chris Dzikiti 14 January 2025 132/18-23

  109. 109 CQC, The Countess of Chester Hospital: Quality Report, 29 June 2016 (https://api.cqc.org.uk/public/v1/reports/7d84e4fd-bdbe-4e99-839d-df83baa36adc?20210123080129#page=2)

  110. 110 CQC 17 March 2025 62/11-23

Previous
Chapter 6
August 2015 to February 2016: Baby I and Baby J; concerns increase; reviews
Next
Chapter 8
February to April 2016: Baby K, Baby L and Baby M