Royal College letter to Ian Harvey
5 Sep 2016
[...]
Action required — Case review
The Review team agrees, from the information received, that the pattern of recent deaths and the mode of deterioration prior to death in some of them appears unusual and
needs further enquiry to try to explain the cluster of deaths.
This was not possible within the terms of reference for the review or from the information received. To this end we recommend that, alongside the HR investigation, a detailed
forensic casenote review of each of the deaths since July 2015 should be undertaken, ideally using at least two senior doctors with expertise in neonatology / pathology in order to determine all the factors around the deaths. The casenotes and electronic records should ideally be paginated to facilitate reference and triangulation. This investigation should include as a minimum the following elements
a) a full systematic chronology for each case including all interventions, and details of nursing and medical observations and activity
b) a view on whether escalation of each case at an earlier stage to involve more senior opinion locally or more expert opinion from a regional centre would have potentially made a difference to the outcome
c) examination (with the relevant paediatric pathologist) of the post mortem findings and any additional information available on their files
which might identify cause of death, including rare conditions such as air embolism and severe metabolic derangement
d) details of all staff with access to the unit from 4 hours before the death of each infant. Ancillary and facilities staff should be included
e) Consideration of any other 'near miss' cases with similar chronology /presentation where the child survived.
We have identified four individuals with appropriate expertise and experience who may be prepared to take on the casenote work swiftly for you on a private basis. I will advise these separately and continue to seek alternatives.
Please don't hesitate to get in touch if any of the above requires further clarification.
https://thirlwall.public-inquiry.uk/wp-content/uploads/thirlwall-evidence/INQ0003120.pdf
Ian Harvey letter to Dr Hawdon, consultant neonatologist
5 Oct 2016
Thank you for accepting our instructions to carry out a review of case notes and associated records relating to 13 neonatal deaths and four' near misses' from the Countess of Chester Hospital NHS FT.
These instructions follow from an invited review by the Royal College of Paediatrics and Child Health.
The review team agreed that the pattern of recent deaths and the mode of deterioration prior to death in some of them appeared unusual and needed further enquiry to try to explain the cluster of deaths. They did not feel that this was possible within the terms of reference for the review. They recommended that a detailed
forensic case note review of each of the deaths from July 2015 be undertaken. They also recommended that the investigation should include as a minimum the following elements:
a) a full systematic chronology for each case including all interventions, and details of nursing and medical observations and activity
b} a view on whether escalation of each case at an earlier stage to involve more senior opinion locally or more expert opinion from a regional centre would have potentially made a difference to the outcome
c) examination (with the relevant paediatric pathologist) of the post mortem findings and any additional information available on their files
which might identify cause of death, including rare conditions such as air embolism and severe metabolic derangement
d) details of all staff with access to the unit from 4 hours before the death of each infant. Ancillary and facilities staff should be included
e) Consideration of any other 'near miss' cases with similar chronology /presentation where the child survived.
We understand that as part of this review you may need to consult with a Neonatal Pathologist.
https://thirlwall.public-inquiry.uk/wp-content/uploads/thirlwall-evidence/INQ0012066_01-03.pdf
Dr Jane Hawdon, consultant neonatologist
Letter to Ian Harvey 29 Oct 2016
With regards to your instructions:
a)
Were I to carry this out for each case, each case would take 10-12 hours and I would not have the capacity to do this alongside my other reporting commitments, it would be extremely costly for the Trust, and I do not consider would yield on investment. Rather, I have prepared a synopsis of key events and issues, focussing particularly on events preceding and during episodes of collapse or demise. I have applied MBRRACE-UK methodology to standards of care.
b) I agree this is an important aspect and I have commented on this where relevant.
c) Given that many cases had coroner's post mortem and
these results were not available to me, I am not in a position to consult with a perinatal pathologist. Neither woud I be in a position to contract with a pathologist. I suggest that once you are in receipt of my report and the coroner's PM reports, you instruct an independent perinatal pathologist.
d)
I am not in a position to perform this. This should be commissioned locally and for relevant cases the review should include the period before a collapse, or series of collapses, rather than the period before death.
e)
I can only consider the cases that you have supplied. I note that the twin of I&S I&S had a similar course but I was not supplied with his records.
I suspect you have copied the suggested terms of reference for an overall investigation suggested by RCPCH, one element of which was independent case review by a neonatologist.
It would be useful to review copies of SI reviews and reports for these cases, and findings of the CDOP panel and triangulate findings with my independent review. Was this cluster noted and investigated at the time by the Trust or coroner? Has the pattern persisted?
https://thirlwall.public-inquiry.uk/wp-content/uploads/thirlwall-evidence/INQ0003358.pdf
Ian Harvey from transcript of evidence to the Inquiry
Q. Do you know what a forensic pathologist does?
A. I can surmise, yes.
Q. Well, they are qualified as pathologist but they have got a specialist skill in investigating and excluding crimes, and the reason it is a specialist area is because it's difficult to identify crimes and there are particular types of investigations that are done, particular checks on the body, particular investigations which they conduct, which ordinary pathologists don't; you are aware of that?
A. Yes.
Q. Are you also aware that, in order to do those investigations, they require a history, they require information. In other words, they are given circumstances of how the body was found, who the person was with, what might be a possible cause of the criminal activity: that makes obvious sense you to?
A. Yes.
Q. Dr McCormack actually mentioned forensic pathology in the meeting on the 30th [June 2016] because he was concerned that the Royal College, which you were talking about, weren't going to be able to do the kind of investigation that was required. Again, looking back, do you recognise that this required forensic pathology in order to rule out a crime?
A. In retrospect, yes, that was an opportunity missed.
Q. Just to be clear: the Royal College were instructed and they did a service review. That, in fact, not only didn't look at the medical notes but it didn't examine whether a potential crime had taken place, did it?
A. I -- in my statement, I think I have covered this, insofar as,
in commissioning the review, I got the Terms of Reference or the Terms of Reference were incomplete and I -- I got that wrong. It should have been specific with regard to a Casenote Review. I anticipated that the College would be reviewing the individual cases. Given that they were being commissioned on the basis that we were concerned about an increased mortality, I found it difficult to imagine that they wouldn't be reviewing those cases as the basis of their review, and we had prepared all the documentation for them to do that to be told, "Well, no actually that's not part of it".
So that the review that they did, no, wasn't in a position to fulfil that brief, hence the subsequent Jane Hawdon review.
Q. Yes, so to be clear, it wasn't in a position to understand why the children had died because it wasn't incorporating a Casenote Review –
A. Yes.
Q. -- and it certainly wasn't in a position to understand if they died as a result of a crime because that is a step even further than a standard Casenote Review, that requires a forensic consideration?
A. Potentially, I would say.
Q. Not potentially, that is exactly what is required?
A. Well, I suppose it depends on the mechanism of assault or death and the obvious example would be for collapse in the case of Child F. The results were in the notes. You know, we would have known that there was insulin, so that there was certain potential.
Q. They might have spotted something untoward that could have been a crime, it is fair to say, but
the Royal College of Paediatrics and Child Health don't investigate crimes, do they?
A. No.
Q. No.
A. But on the basis that I had alerted them to a concern about one member of staff and the association with her and the review going ahead, there seemed to be an acceptance that that was a reasonable path to follow, and I would point out that the paediatricians also, I think, reviewed the Terms of Reference that we had drawn up and felt that they were reasonable and appropriate for what we were doing in that circumstance.
Q. Well, the Terms of Reference looked like they considered everything.
A. Well, that that was the intention, yes.
Q. But, in fact, it is not a Casenote Review and they didn't consider criminal activity, as you have accepted?
A. It, it -- it didn't end up as a Casenote Review, although I imagine that it was going to be because I couldn't foresee how they could fulfil their brief, based on the premise, without doing that.
Q. But just to be clear, the report that was produced as a result of that review could not be relied on to exclude the possibility that the children had been harmed?
A. No.
Q. The same really must apply to Dr Hawdon's examination and Dr McPartland's examination, because first of all, Dr Hawdon, in respect of five of the deaths -- or four, and I am sure you will be asked about why that may have changed -- couldn't find an explanation. So, by definition, she hadn't found a crime or excluded a crime. She was in the same position, really, as Child A's pathologist was: it was unascertained.
So that had not excluded Lucy Letby harming them?
A. No.
Q. Dr McPartland was not a forensic pathologist, so she, by definition, couldn't investigate a crime and exclude it definitively, although, as you have said, she might have found some evidence that could incriminate?
A. Yes, and, as an example, I had a conversation -- or exchanged emails or had a conversation as well with regard to the possibility of air embolus, that having been raised, and was informed by her that she would fully expect that their postmortem would have picked up the presence of an air embolus.
Q. Yes, but to be absolutely clear, she was not a forensic pathologist –
A. No.
Q. -- and she was not briefed to investigate criminal activity?
A. No, she was a specialist paediatric neonatal pathologist.
Q. So as all these investigations are being pursued throughout the course of 2016 and into 2017,
the upshot is that none of them, in fact, exclude the possibility that had been raised on 29 and 30 June 2016 that Lucy Letby harmed the children: none of them?
A. No, which is why we ended up subsequently going to the police.
Q. Well, I will come back to that.
You presented a paper to the board on 10 January 2017, INQ0003518, it'll come up; do you remember this?
A. Yes.
Q. You discussed the Royal College Review but you don't make clear that it hadn't addressed the Consultants' concerns, correct?
A. Correct.
Q. You also, without naming them, I think, mentioned Dr Hawdon and Dr McPartland because they are the secondary reviewers, one doing a case review, the second with specialist expertise on pathology and, again, of course,
you don't mention and couldn't have mentioned that they hadn't excluded a crime because they hadn't; is that correct?
A. Correct.
Q. During this meeting -- and I can take you to the notes of the substantive meeting, I think you are familiar with them but, for reference, it's INQ0003237 --
Mr Chambers repeatedly dismissed the concerns of the Consultants as being unsubstantiated. Now, the reality was that they had not, in fact, been directly investigated and excluded as possibilities. You have already accepted that?
A. They had been excluded to the extent of the reviews that we had carried out. I will accept that not to the level of a forensic, yes.
Q. Well, the reviews had not looked for a crime and they had not excluded a crime, had they?
A. The reviews hadn't been specifically commissioned to look for a crime. But I suppose we had anticipated that, in the event that there had been a malicious act, that there would have been evidence found in the course of those reviews.
Q. Well, you have a scientific background. If you have a hypothesis that needs testing, you have to direct your research to that hypothesis. The hypothesis was: Lucy Letby has murdered or killed these children through mechanism unknown, investigate it, please. Royal College, Dr Hawdon, Dr McPartland, or some other person, needed to actually investigate that directly, didn't they?
A. I don't think the time that these were commissioned we were in a position to say that this is suspected murder. […]
Q. So when you attend the board and present your paper, you are reassuring them that proper investigations have taken place and that, as a result of those investigations, Mr Chambers is allowed to say to the board, in front of you, without correction, that the allegations against the nurse are unsubstantiated. And you would go even further, collectively as an Executive, and advise them that Lucy Letby should be supported in her return to the unit. That's completely unacceptable, isn't it?
A. I would only say that that was the view based on the evidence that we had at that time.
Q. It wasn't –
A. -- with -- on retrospect, yes. And as, you know, I -- I have now repeatedly said I regret that we didn't contact the police in June/July 2016.
Q. Just focusing on that.
It doesn't require retrospect. You were in a meeting, advising the most senior people in your Trust to support you putting someone back in the unit who had not been investigated for potential crimes. That is an extraordinary failure on your part, do you accept that?
A. I believe that I was making these statements in good faith, based on the evidence that I had available to me at that time.
Q. What evidence did you have that Lucy Letby had not killed those children?
A. It was the fact that nothing had been specifically raised in the course of the College review, Dr Hawdon's review, in discussing with Dr McPartland, with regard to the previous postmortems, that some of the babies had had.
Q. Well –
A. I accept, with retrospect, that that is incomprehensive. That is with the benefit of knowing how things came out. But this was a series of investigations, a series of reviews and a statement that was made in good faith at that time.
Q. Mr Harvey, I'm struggling to understand the logic of your answers. You have accepted, as I have taken you through them, that the Royal College Review, Dr Hawdon's review, Dr McPartland's review did not exclude a crime on the part of -- crimes committed on the part of Lucy Letby. In this meeting it is being presented that there is no substantive evidence to that allegation and it is being recommended that she go back to the unit on that basis. That was wrong as an assertion and it was dangerous and irresponsible. The logic of that is impossible to disagree with.
A. I'm sorry. I'm sorry –
Q. Do you want me to take you through it again?
A. Well, no. I'm sorry, I apologise. I didn't hear a question.
Q. You had investigated, using the Royal College, Dr Hawdon, Dr McPartland whether or not there may have been some medical cause for these children's deaths. They had not identified a definitive theme, but none of those investigations, as you have accepted, excluded the possibility that Lucy Letby had killed the children; you've accepted that already.
A. I accept that they didn't go to the level of a forensic investigation and, in hindsight, that was incorrect.
Q. They did not exclude a crime.
A. They certainly didn't highlight one. I can't say that they excluded.
Q. They did not exclude a crime, did they? Any of those reviews did not exclude the possibility the children had been killed deliberately?
A. Nor did they actually bring anything out to suggest that there had been any malicious act in, in any of those.
Q. Well, in those circumstances, finally,
I put to you that it was irresponsible and dangerous to return Lucy Letby to the unit because you could not be confident, as the Medical Director of the hospital responsible for patient safety at the Countess of Chester, that Lucy Letby would not harm children again?
A. I would have to accept that, with retrospect, yes, it would have been a risk -- well, more than a risk for her to have gone back on to the unit.
Q. One which should never have been countenanced?
A. Looking at this no.
https://thirlwall.public-inquiry.uk...024/11/Thirlwall-Inquiry-28-November-2024.pdf
highlighting added by me.
