Chapter 4. Risk and Patient Safety Department

The purpose of a department for risk and patient safety is to identify risks and take steps to enhance patient safety in response. The department at the Countess neither identified the risk nor took steps to protect patients until after the deaths of Baby O and Baby P. The department failed in its fundamental task to enhance patient safety.
In 2014, the Risk and Patient Safety Department comprised a small team of 10 to 12 people. By June 2016, this had risen to approximately 30 staff.¹ From March 2014, Ms Millward was Head of Risk and Patient Safety at the hospital. She reported to Ms Sian Williams, Deputy Director of Nursing.² Ms Millward was a nurse who had qualified in 1997.³ She began the Risk role on a temporary basis in March 2014, being substantively appointed from 2015.⁴ Between 2004 and 2011, Ms Millward had worked as the Quality Improvement Facilitator in the hospital’s Risk and Patient Safety Department. Following this role, she worked as a matron, before returning to the Risk Team as the Head of Risk and Patient Safety.⁵
In her evidence to the Inquiry, Ms Millward was keen to emphasise that her job title was “a little bit misleading as to the level of influence”.⁶ She asserted that she did not have ultimate responsibility for risk, but that her responsibilities were focused on designing and delivering systems and processes for risk management, advising on whether matters needed to be escalated to the Executive Team via the Executive Risk Register⁷ and attending QSPEC meetings.⁸ The Risk and Patient Safety Department also took the lead on matters such as inspections by CQC. It was the evidence of Ms Millward that the CQC inspection of the hospital was her “priority” in February 2016.⁹
This was telling evidence. Ms Millward’s role as Head of Risk and Patient Safety, and that of the department she led, was to enhance patient safety. She was keen to emphasise her responsibility for systems, processes and inspections. However, reporting systems, risk registers, committee structures and even submission to outside inspection do not in themselves protect patient safety. What is needed is that those in the key roles within risk and patient safety continually seek to expose what the risks to patient safety are and address the question of what actions need to be taken to reduce these risks.
Within the Risk and Patient Safety Department, there were identified Risk and Patient Safety Leads associated with the different divisions and services within the hospital. From December 2013 to February 2016, the Risk and Patient Safety Lead for Women and Children, to whom risks and patient safety incidents occurring on the neonatal unit were referred, was Ms Peacock.¹⁰
Ms Peacock, in her role as Risk and Patient Safety Lead for Women and Children, covered neonatology, midwifery, gynaecology and paediatrics. Ms Peacock had qualified as a registered general nurse and a sick children’s nurse in 1985, and as a midwife in 1987. She had experience working as a nurse on a neonatal unit. Having subsequently qualified as a solicitor in 2010 and worked as a solicitor in clinical negligence, Ms Peacock then moved to a role as Clinical Risk Manager within a hospital. Her appointment at the Countess was her second post in a risk-related role within a hospital setting.¹¹ She was one of a small number of Risk and Patient Safety Leads at the hospital, who between them reviewed the risk and patient safety issues arising in the different divisions and specialties within the hospital.¹²
The purpose of Ms Peacock’s role, as she accepted in her evidence, was to improve patient safety.¹³ She did this by managing Datix incidents, identifying trends and attending incident review meetings.
Ms Peacock explained in her evidence that incidents were broadly investigated in the following ways:¹⁴
- ‘No harm’ incidents (where despite an error no harm was caused to the patient) were managed at local level and dealt with by the ward manager or lead consultant.
- Serious incidents, which involved some level of harm, had a Situational Background Assessment Recommendation (SBAR). In the neonatal unit, Dr Brearey’s clinical assessment would usually form the basis of the SBAR.
- SBARs were escalated to the Serious Incident Panel and Ms Millward or Ms Peacock would usually make the recommendation to the Serious Incident Panel.
- The Serious Incident Panel would then meet and make decisions about further investigatory steps, such as reporting the matter to the Strategic Executive Information System (StEIS) and thus triggering a more in-depth investigation.
Ms Peacock was a member of the Women and Children’s Care Governance Board,¹⁵ the purpose of which was to bring together those working within obstetrics and gynaecology and representatives from the Paediatric Department, including the neonatal unit. Her role included preparing a quarterly report of incidents for the Board.¹⁶ The minutes of the Women and Children’s Care Governance Board meetings were sent to Ms Kelly.¹⁷ A baby death by a natural cause would not be escalated to the meetings but would be received by the Board in a yearly report. A sudden and unexpected neonatal death would be discussed in a perinatal mortality meeting and later escalated to the Women and Children’s Care Governance Board.¹⁸ As I said earlier in this Report, the Women and Children’s Care Governance Board was introduced because maternity and neonatal care were now in different divisions. This might fairly be described as a sticking plaster remedy for a structural problem. Ms Millward observed that this “confused their process”.¹⁹ It is not apparent that she sought to do anything about that. The meetings of the Women and Children’s Care Governance Board were not, generally, well attended.
Ms Peacock also attended the Neonatal Incident Review Group. These meetings were usually attended by Ms Powell, Dr Brearey, Ms Hayley Cooper (Griffiths), the Countess’s Royal College of Nursing Representative and a neonatal pharmacist. The group aimed to hold meetings fortnightly and would review Datix incidents and medical notes.²⁰
When Ms Peacock left her employment at the hospital on 15 February 2016, Ms Janet McMahon, also a midwife, temporarily took over the role.²¹ In May 2016, Ms Annemarie Lawrence was appointed as Risk Midwife, a permanent full-time replacement for the Risk and Patient Safety Lead role, covering maternity, obstetric, neonatal and paediatric services.²²
Between Ms McMahon’s time in the temporary role and Ms Lawrence’s appointment, the name of the role of Risk and Patient Safety Lead for the Women and Children’s Division (itself an outdated title) had been changed to Risk Midwife, although the role continued to cover neonatal and paediatric services as well as maternity and obstetrics. Ms Millward’s view was that the role always had a predominant focus on maternity services, and the new title reflected this. She explained that the name change was prompted by national guidance on maternity safety released in 2015/16. Ms Millward accepted that the name Risk Midwife signalled externally that the maternity guidance was being taken seriously, and the occupant of the role would respond to the national guidance. Significantly, she sought to emphasise that “at no point was this going to be a withdrawal of support for paediatrics, neonatology”. Ms Millward did however accept that the decision to change the name of the role to Risk Midwife was made without consulting paediatrics and neonatology.²³ In her view, the support provided to paediatrics and neonatal services would be the same.²⁴ It follows therefore that this was either a cosmetic change of title to give the impression externally that the new maternity guidance was being taken seriously, despite nothing changing, or it was a real change, signalling a shift in approach. In fact, the support provided to the neonatal unit was considered inadequate by Dr Brearey and he expressed that view very clearly in June 2016 (see Chapter 14).²⁵
The Risk and Patient Safety Department had systems and processes for identifying and addressing risk within the hospital. Underpinning these was a Datix risk management system, intended to record all incidents where unnecessary harm had been caused to patients. The most significant incidents reported on the Datix risk management system were referred for consideration by a Serious Incident Panel. Incidents that were, after consideration by the panel, categorised as serious incidents requiring fuller investigation were then reported to StEIS.
The Datix risk management system was intended to be integrated with, and to inform, a system of risk registers, which recorded identified risks within a particular hospital division. Risks that were identified as relevant to the neonatal unit would be recorded on the Urgent Care Risk Register, as the neonatal unit fell within the hospital’s Urgent Care Division. The most serious risks recorded on these divisional registers would be entered in the Executive Risk Register, which would be reviewed by the Corporate Directors Group.²⁶
According to Ms Millward, daily, weekly and monthly meetings would be held to consider ongoing risks.²⁷ Ms Millward’s role also involved attending the meetings of QSPEC, which sat just below Board level. In her evidence, Dr Susan Gilby (Medical Director and then Chief Executive of the Countess from 2018) described this as the most important subcommittee in most hospitals. It is usually called the Quality and Safety Committee. She said: “[T]hey look at data, and they receive reports surrounding patient and staff, safety and experience.”²⁸

In evidence, Ms Millward described her role on QSPEC as “providing oversight of our Serious Incident investigations”.²⁹

Ms Millward’s evidence was that the correct escalation route for matters of patient safety occurring within the neonatal unit was first to raise the issue at neonatal unit meetings and thereafter raise it with the Urgent Care Division. The most serious safety issues were referred to QSPEC or the Corporate Directors Group.³⁰
Despite, or perhaps because of, all these reporting systems, risk registers and committees, the Risk and Patient Safety Department failed promptly to identify as a risk the increased mortality on the neonatal unit in 2015. Neither did they ask the key question: why were these deaths happening? Not only as a department did they fail to identify the problem, even when Dr Brearey started to raise concerns about the deaths from his clinical perspective, they failed to ensure that the issue of increased neonatal mortality and its cause was discussed by the relevant committees or appropriately raised with the Executive Team. Most significantly, the Risk and Patient Safety Department failed to take prompt and appropriate steps to protect patients.
A phrase that was used by many witnesses to the Inquiry was an inability or reluctance to ‘think the unthinkable’, referring to the possibility that a member of clinical staff could be deliberately harming patients. It was, above all, for the Risk and Patient Safety Department to consider such a possibility. Even when presented with a chart that highlighted Letby’s presence on duty for seven of the eight deaths in 2015,^* the department took no steps to ensure that this was investigated promptly and treated as a matter of patient safety; that is, risk to babies. In so far as the risk of deliberate harm by a member of staff was even acknowledged, it appears to have been considered as a matter for HR rather than an issue of patient safety.³¹
Dr Gilby took over as Chief Executive in 2018. In her assessment, the risk management framework and strategy fell “significantly below” what she would have expected.³²

Datix risk management system

Central to the way in which the hospital sought to identify risks and address them to enhance patient safety was the Datix risk management system. It was the responsibility of the managers of wards or units to ensure that incidents were recorded on the Datix risk management system. Staff received mandatory training on Datix reporting every two years.³³
The reporting of incidents on the Datix risk management system was determined by whether ‘unnecessary harm’ had been caused. The hospital’s Policy for the Reporting of Incidents set out that “an event or circumstance which could have resulted, or did result, in unnecessary damage, loss or harm to patients” should be reported on the Datix risk management system.³⁴
The hospital’s Policy for the Reporting of Incidents set out an “incident grading system” to be used on any Datix report.³⁵ This grading system was intended to record the actual degree of harm suffered by the patient as a direct result of the patient safety incident. The practical impact of this was that the harm grade for a neonatal death, where there was no identifiable error in the care at the time, would be graded as ‘no harm’.
With the exception of Baby O and Baby P, whose deaths were reported on the Datix risk management system by Ms Powell with the most severe grading, “Result: Actual Harm – Death (caused by the Incident)”, all the other babies on the indictment who died on the unit were graded contemporaneously at the minimum level: “Result: No Harm – None (no harm caused)”.³⁶
Datix entries were filled in by the person, usually a member of clinical staff, who acted to report the incident.
As Ms Peacock observed in her evidence, the effectiveness of the Datix risk management system was “dependent on having a good reporting culture”.³⁷ If an incident was not recorded on the system, there was no deeper investigation into the incident.
Ms Peacock’s successor in the role, Ms Lawrence, expressed the view that the Datix risk management system provided “an open and transparent way of improving the safety and culture of a hospital”.³⁸ However, she stated that staff on the unit, including consultants, registrars and nurses, did not report incidents “freely” and instead sought to corroborate with one another whether there was a need to complete a Datix report.³⁹ Her perspective was that clinicians regarded the reporting of incidents as “punitive”.⁴⁰ However, this was not terminology or sentiment that was reflected in the evidence of nurses or doctors.
All neonatal deaths were reported to Ms Peacock via the Datix risk management system. Ms Peacock explained that, sometimes, Ms Powell would also call her to report a death. Upon being informed of a death, Ms Peacock would visit the neonatal unit and review the medical records with Dr Brearey. This happened for every death.
Datix reports were completed in respect of the deaths of Baby A, Baby C, Baby D, Baby E, Baby I, Baby O and Baby P. Parents were not made aware of the Datix report in respect of their baby’s death; nor were they made aware of any meeting about the death of their baby until the criminal trial or when they received disclosure from the Inquiry.
Mother A and B told the Inquiry in relation to Baby A’s death: “I wasn’t even aware that a Datix form had been completed.”⁴¹ Mother C stated she had never seen the Datix report prior to being shown it in oral evidence.⁴² Mother D told the Inquiry she was not aware Serious Incident meetings or any other meetings had taken place about Baby D.⁴³ Mother E and F was not aware that a Serious Incident Panel meeting regarding Baby E’s death had taken place.^{† 44}
Mother I said: “I now understand that a report called a ‘Datix’ was created on 01/10/2015 about our baby’s collapse on 30/09/2015. I was not told about this at the time and would not have known what a Datix report was. I had no idea there were any meetings or discussions about her collapse.”⁴⁵ She was also not aware of a Datix report created in relation to Baby I’s collapse on 13 October 2015,^{‡ 46} and told the Inquiry: “I understand that a Datix report was created on 23/10/2015 about our baby’s death. As with the other Datix reports, I wasn’t told about this at the time.”⁴⁷
Mother O, P and R told the Inquiry: “As far as the Datix reports are concerned, I did not know they existed until we saw them in the criminal trial.”⁴⁸ Father O, P and R stated: “[W]e had never seen the Datix reports before the trial. I didn’t even know they existed until the trial. The trial was the first time we saw them.”⁴⁹
As the trigger for a Datix report was a clinical event that could have (or had in fact) resulted in ‘unnecessary damage’, an unexplained collapse of a baby on the neonatal unit (unattributed at the time to any error in clinical treatment) would not normally lead to a report under the policy.
No Datix reports were completed in respect of the unexplained or unexpected non-fatal collapses pursued on the indictment. However, apart from Baby G, Baby K and Baby L, each of the surviving babies named on the indictment had a Datix report created about them in respect of some identifiable event in their care. The parents were not informed about these Datix reports.
Ms Peacock informed the Inquiry that “generally speaking collapses weren’t Datixed”.⁵⁰ A non-fatal collapse would be recorded if there was an identifiable issue with equipment or a staff member’s competency, but not otherwise. She acknowledged that this was “a flaw in the system” but noted:
“[I]f they reported every collapse on Datix, it would be its own industry, I think. However, in this situation, I would have thought it was relevant for us to be notified of the collapses, which we weren’t.”⁵¹

Ms Peacock accepted that she never raised this with Ms Millward or Dr Brearey at the time.⁵²

Ms Millward’s evidence was that unexpected neonatal collapses should have been reported as clinical incidents, but that this did not occur in practice. She accepted in evidence that the requirement to record such incidents was not formally conveyed to staff.⁵³ However, Ms Millward said that the fact the collapses of Baby B and Baby F^§ were not reported on the Datix risk management system meant that, in her view, “the fuller scope and understanding of what was happening in the unit wasn’t there”.⁵⁴
Ms Millward asserted in her evidence to the Inquiry that the issues with incident reporting were twofold:⁵⁵
- Not enough Datix reports were completed.
- The quality of the information on the Datix system was limited.
The Datix risk management system had a pick list (drop-down menu) of incident categories, which included a sub-category titled ‘expected and unexpected death’. Ms Millward’s evidence was:
“[T]he use of the pick list and the category or subcategory as an unexpected death was not particularly helpful because it is not telling me what has contributed to the incident, what element of the patient’s care or treatment you want us to look into, what element of the treatment you are concerned about.”⁵⁶

The practical effect of this was, she said, that it was not easy to understand what the concern or incident related to without seeking more information from the incident reporter.

Ms Millward asserted that “the use of the pick lists meant that there was quite a narrow focus at the time so as I say you would tend to see the same sorts of incident types being reported”.⁵⁷
Ms McMahon, who, as noted above, temporarily took over from Ms Peacock as Risk and Patient Safety Lead covering the neonatal unit, pointed out in her evidence two flaws that she perceived with the Datix risk management system:
- The grading of harm incidents was subjective because staff reporting incidents had the discretion to grade an incident ‘no harm’, ‘moderate harm’ or ‘severe harm’. It was common for the Risk Team to investigate the incident and change it to more “realistic categories”.⁵⁸
- The Datix system was live and could be repeatedly updated. This made it difficult to identify when changes had been made: “the only way to see when the change has been made is to get the audit trail so you can print out a copy that shows every date and time a change has been made”.⁵⁹
Despite the perceived shortcomings of the system, all the deaths of the babies who were named on the indictment were promptly reported on the Datix risk management system. Whilst it may be that further detail should have been supplied in the Datix entries, the number of Datix reports of neonatal deaths should have been sufficient to alert the Risk and Patient Safety Department to the fact that there was an increase in mortality on the neonatal unit. This should have prompted a full and early investigation of potential causes of the increase in neonatal deaths.
Ms Millward’s view was that the lack of Datix reporting of collapses meant that “the fuller scope and understanding of what was happening in the unit”⁶⁰ was not understood. However, this has to be seen in the context of the fact that, when presented with a list that identified eight neonatal deaths in 2015, indicating that Letby had been on duty for seven of the eight deaths, no proactive steps were taken by the Risk and Patient Safety Department to make further investigations. That there was not a “fuller scope and understanding of what was happening in the unit” was not due to a failure in the Datix risk management system – it was due to a failure to investigate.

Serious Incident Panel, 2 July 2015

By July 2015, whatever the flaws in the Datix risk management system, it was plain that there had been three neonatal deaths in very short succession during the month of June 2015.
On 26 June 2015, Ms Millward emailed the Serious Incident Panel members, including Ms Kelly and Mr Harvey, to invite them to a meeting of the panel on 2 July 2015 to discuss three neonatal deaths (of Baby A, Baby C and Baby D). She explained that “child death is no longer included as a Serious Incident by definition [in the SI Framework or on StEIS], however it may be reported as a serious incident under another category e.g. medication error”.⁶¹
As set out in Chapter 3 (paragraph 3.124 onwards), Dr Brearey, Ms Peacock and Ms Powell had carried out a case note review of the deaths of Baby A, Baby C and Baby D. In addition, Dr Brearey had produced a report that included details of the annual neonatal mortality data for the Countess for the previous seven years (ranging from four deaths per year to one death per year). This report was referred for discussion to the Serious Incident Panel meeting on 2 July 2015.
In evidence, Mr Harvey confirmed that he was invited to the Serious Incident Panel meeting on 2 July 2015, but he “was on leave and hadn’t received — or didn’t receive the email in a timely fashion and wasn’t at the meeting for the conversations [on 2 July 2015]”.⁶²
The Panel meeting took place on 2 July 2015. Its purpose was to discuss the deaths of Baby A, Baby C and Baby D.⁶³ Ms Kelly was the only executive in attendance, although decisions were for the Executive Team. Ms Fogarty (Head of Midwifery) was at the meeting. She had been involved in the obstetric secondary review of the deaths of Baby A, Baby C and Baby D, and noted in respect of each baby that there were no maternity issues. Also at the meeting were Dr Brearey, Ms Millward, Ms Peacock and Ms Sian Williams.⁶⁴ Dr Brearey’s recollection is that Ms Powell was also at this meeting.⁶⁵ I think he is wrong about that. She is not recorded as present and no one else refers to her as present either. She cannot remember whether she was there or not. Dr Brearey and Ms Powell had many conversations and it is likely that they spoke on a different occasion.
Ms Millward said that the aim of the meeting was to review the three cases with a view to reporting any of them to StEIS, thus triggering a more in-depth investigation. Serious incidents that are reported to StEIS lead to notification of the relevant commissioner in the NHS about the incident.⁶⁶
Ms Millward explained that the Serious Incident Framework has three criteria for reporting to the local commissioning group:⁶⁷
1. any act or omission that has led to serious harm or death
2. never events (a list of incidents that should never happen)
3. a broad category relating to system deficiencies in the delivery of care or service failures.
NHS England’s Serious Incident Framework policy, dated March 2015, sets out that:
“[S]erious incidents are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response.”⁶⁸

It also provides that serious incidents in the NHS include the unexpected or avoidable death of one or more people. This sentence has a footnote which specifies that the unexpected or avoidable death must have been caused or contributed to by weaknesses in care or service delivery.⁶⁹ Despite this, Professor Sir Stephen Powis, National Medical Director, NHS England, asserted in his evidence to the Inquiry: “[A]t the time the definition did include … unexplained or unexpected death, that could not be explained by a particular omission or a particular act.”⁷⁰

No one at the meeting had been present at any of the deaths or collapses of Baby A, Baby C and Baby D. Although neither Dr Harkness nor Dr Jayaram had recorded the rash on Baby A at the time, others had done so but this issue did not feature in the meeting, nor in Dr Brearey’s review. No questions were asked about which doctors and nurses were on duty with a view to asking the people involved whether they had any recollection and any concerns. Had that been done, the issue of the rashes/skin mottling may have been identified. It was only just over a week since the registrars had raised their worries about the rashes (and they had been referred to the senior clinicians’ meeting on 29 June 2015). That should have prompted some questions. The fact that these collapses and deaths were all sudden and unexpected did not, at that stage, cause a more inquisitive approach. Nor did it prompt anyone at the meeting to consider the Pan-Cheshire Guidelines for the Management of Sudden Unexpected Death In Infants and Children (SUDIC) (the Pan-Cheshire Guidelines),⁷¹ due to a widespread misunderstanding that the multi-agency referral that should have been triggered did not apply where a neonatal death occurred in a hospital setting (see Chapter 12). It is probable that the mistaken belief that the death of Baby A may be attributable to the medical condition of Mother A and B, and that the cause of death was bowel obstruction in respect of Baby C, led to an acceptance that no further investigation was needed. Ms Millward explained that, during the Serious Incident Panel meeting, Dr Brearey and Ms Fogarty asserted that for Baby A and Baby C’s deaths “it was likely that their clinical condition was more attributable to the death … it was progression of the clinical illness that the children had rather than an incident”.⁷² I understood her to mean that there were clinical explanations for the deaths of Baby A and Baby C, and so there was no need for a StEIS report.
The belief at that time was that Baby D had died of sepsis. Concern had been expressed that there had been a delay on the maternity ward in starting the process of induction, there had been a delay by the paediatric senior house officer in identifying subtle signs of sepsis in the early stage of Baby D’s life and so moving her to the neonatal unit, and there had been a delay in administering antibiotics. For those reasons, the death of Baby D was referred to StEIS.
Baby B’s collapse was not discussed at the meeting. In evidence, Ms Fogarty said that in her view it should have been. She acknowledged that the commonality of the rashes seen in Baby A, Baby B and Baby D at the time of collapse was not mentioned. She went on to say that “there was no clinical, no detailed clinical information given” in the meeting.⁷³ Ms Fogarty’s view of the meeting was that “with hindsight, really what should have happened is there should have been a total review of all three cases by someone external from the Trust”.⁷⁴
I accept that hindsight may lead, reasonably, to that conclusion.
Ms Millward’s evidence was that all the attendees contributed to the discussion. She confirmed that her role was to advise on the options, “but the final decision whether or not a case would go for a Serious Incident investigation would sit with the Executive”.⁷⁵ This was Ms Kelly. Apart from referring Baby D to StEIS, it was decided that there would be no further investigation.⁷⁶ Ms Fogarty confirmed that “[t]hat decision was made by the Director of Nursing”.⁷⁷
Ms Millward conceded in evidence that “the three deaths could have been considered as a Serious Incident” as a “collective review of the three deaths and more of a systems process review of the neonatal unit” under the third broad category.⁷⁸ She said that, in 2015/16, the Trust’s approach to the Serious Incident Framework “was narrow, the largest focus was of course upon the acts or omission criteria. The third section, as I say, which talks around systems failures, that wasn’t really something that was considered at that time.”⁷⁹ She accepted she should have considered the third option.⁸⁰ Whilst the third option was systems failure and would have justified a report to StEIS on that basis, it was the view of Sir Stephen that three deaths of vulnerable children should have been reported to StEIS as a cluster.⁸¹
Dr Brearey said that during the meeting they discussed the fact that “three deaths in a short period of time, this was unusual. This amounted to what would be our normal annual mortality rate.”⁸² Ms Kelly’s reaction was that “we’ll have to keep an eye on it”.⁸³ In oral evidence, Dr Brearey said he understood that Ms Kelly was “alluding to the fact that, you know, we would have to keep our eye on things going, going forwards in the future”.⁸⁴ Ms Kelly’s evidence was to the same effect. They would be keeping an eye on the mortality rate; it was not a reference to Letby. I find that there was no discussion about Letby at this meeting.
Dr Brearey was asked whether he thought the cluster of Baby A, Baby C and Baby D’s deaths should have been reported to StEIS as a Serious Incident. He acknowledged that he had not thought of it (he was not familiar with the process, and had received no training). He said that in retrospect it would have been reasonable to report the cluster.⁸⁵ He stated that “[i]t would have led to greater scrutiny” and resulted in family involvement, external reporting and increased objectivity.⁸⁶ This would have been particularly important because the families were not included in the local investigations at the hospital.
On 3 July 2015, Ms Peacock completed the StEIS report for Baby D and copied it, as required, to the regional commissioning group.⁸⁷ There was a full case review by the obstetric team and by the neonatal team. The two teams met separately and wrote their reports separately; the reports were then put together under the heading ‘Case Review’. Ms Fogarty stated that “[w]ith hindsight definitely, that, that should have been done” for Baby A and Baby C.⁸⁸
Once the post-mortem results in respect of Baby D had been received, a further meeting was held on 12 October 2015 of the obstetric and neonatal teams (Dr Joanne Davies, a consultant in obstetrics and gynaecology, Dr Newby, Ms Fogarty, Ms Powell and Ms Peacock). They reviewed the post-mortem results then reviewed the care of mother and baby in light of those results. They acknowledged, as in the main body of the review, the delays in beginning induction, in transfer to the neonatal unit and in the administering of antibiotics. They decided that antibiotics should be administered to women in labour after Preterm Prelabour Rupture of Membranes.^¶ They noted that the (junior) paediatrician had not identified risk factors for sepsis and had delayed transfer to the neonatal unit, but that antibiotics had been commenced within the recommended time limit. They also set out other changes in practice, not directly relevant to the death of Baby D but directed to improving practice generally. See further details about Baby D in Chapter 3.
The case review for Baby D (also described as a root cause analysis) was sent by the Countess to Wirral Clinical Commissioning Group (CCG), who considered it at their meeting on 14 December 2015. The group concluded that no further investigation was required.
Following the Serious Incident Panel meeting, Ms Kelly emailed Dr Brearey to say she was happy to meet if he wanted to discuss anything. He did not take Ms Kelly up on this invitation. He reflected in oral evidence: “[I]n retrospect, it was an opportunity where I could have come back to her with, you know, a suggestion of how we are going to keep an eye on it going forwards.”⁸⁹ Whilst this may be the case, I have no reason to think such a discussion would have made any difference in light of what did happen later.
There is no evidence that Mr Harvey ever asked what had happened at the meeting or that he sought any follow-up.
Barely a month later, Baby E died. A Datix report was opened by Letby on 4 August 2015 and recorded an “[u]nexpected death following GI [gastrointestinal] bleed. Full resus [resuscitation] unsuccessful.”⁹⁰

Footnotes

* Up to 23 October 2015.
† It is worth noting that a Serious Incident Panel meeting is triggered by a Datix report. Thus, if the parents were not informed about the meeting, it is highly unlikely they were informed about the report.
‡ Please note that these Datix reports are not about Baby I’s collapses in and of themselves. The reports concern incidents at the time of the collapses, such as an antibiotic administration error and delayed treatment of emergency blood.
§ On 9/10 June 2015, Baby B collapsed. On 5 August 2015, Baby F suffered from hypoglycaemia and collapsed.
¶ This decision was taken although it was not yet National Institute for Health and Care Excellence (NICE) guidance.