Transcript of Module 3 Public Hearing on 19 September 2024.
(10.00 am)
Ms Carey: My Lady, may we have, please, Dr Gee Yen Shin sworn, Professor Dinah Gould sworn and Dr Ben Warne sworn.
Dr Ben Warne
DR BEN WARNE (affirmed).
Professor Dinah Gould
PROFESSOR DINAH GOULD (affirmed).
Dr Gee Shin
DR GEE YEN SHIN (affirmed).
Questions From Lead Counsel to the Inquiry for Module 3
Lady Hallett: Are the three of you all right? I’m sorry, the box isn’t intended for threesomes.
Ms Carey: Can I introduce all three of you in turn.
Can I start with you, Dr Shin, I believe you are the Director of Infection Prevention and Control at UCLH in London, informally known as a DIPC, if I can introduce more acronyms. You are a consultant virologist at the University College Hospital’s Foundation Trust and have been so since 2018; is that right?
I think during the pandemic you were interim DIPC and then, since 2021, have been continuously in that role.
Would you mind saying “Yes”.
Dr Shin: Yes, that’s correct.
Ms Carey: Thank you. So that anyone who is following online can hear and, indeed, our stenographer, who is off site.
Dr Shin: That is all correct.
Ms Carey: Thank you.
I think you were heavily involved in many aspects of the Covid response of the trust, and you are also a member of the UK Advisory Committee on Dangerous Pathogens; is that correct?
Dr Shin: That’s correct.
Ms Carey: We may come to HCIDs later.
You have worked for Public Health England formally between 2013 and 2018 and have co-authored various Covid papers. Can I ask you, during the pandemic, were you working on the wards in the hospital or in the background, as it were?
Dr Shin: I was working in non-clinical areas.
Ms Carey: All right, okay.
Professor Gould, may I come to you. You are a registered nurse and nurse educator; is that correct? I think you taught for many years the scientific aspects of the curriculum to undergraduate nurses and other health professionals. You have undertaken a PhD exploring hand hygiene, use of PPE and other matters. You’ve conducted research into how IPC is taught in the undergraduate programmes and, indeed, at one stage you belonged to a group known a the Cochrane Effective Practice and Organisation of Care group and you were on the World Health Organisation’s Technical Advisory Group for hand hygiene?
Professor Gould: That’s correct, and I’m still on those two groups.
Ms Carey: Thank you.
Can I ask you about your role during the pandemic. Is this right, that, as we entered the pandemic, you were not in fact on the nursing register; is that correct?
Professor Gould: I was on the temporary nursing register.
Ms Carey: Did you make efforts – we’ve heard a little bit about that – to go back onto the temporary register once there was the call out for assistance?
Professor Gould: Yes, as soon as the call came out because I’d only just come off the permanent register. So I went back on the temporary register as soon as it was possible.
Ms Carey: Thank you. Were you, in fact, deployed during the pandemic?
Professor Gould: No, I would like to have been but I was never asked to, so I did work in the background.
Ms Carey: Did they tell you why you weren’t able to be deployed?
Professor Gould: No, I never received any information individually from the Nursing and Midwifery Council, just generic emails.
Ms Carey: Thank you.
Dr Warne, finally to you, you are a consultant in infectious diseases and general medicine at Cambridge University Hospital’s NHS foundation trust; is that correct?
Dr Warne: That’s correct.
Ms Carey: You trained as a registrar in infectious diseases from 2015 to 2024 and have recently finished a post as an academic clinical lecturer in infectious disease at the Department of Medicine at Cambridge University.
Dr Warne: That’s correct.
Ms Carey: I think during 2017 to 2021, you were a clinical research fellow at the university using pathogen genomics to study common infectious diseases of public health significance; what did you do, Dr Warne?
Dr Warne: So it was using genomics and traditional epidemiology to study important pathogens, including influenza and SARS-CoV-2 and how they spread in hospitals, as well as antibiotic resistance mechanisms.
Ms Carey: Of significance to us, I think during 2020 to 2021, that academic year, you were the clinical lead for the university’s asymptomatic Covid-19 screening programme?
Dr Warne: That’s correct.
Ms Carey: May I ask you about your time during the pandemic. Did you work on the front line, if I may put it like that?
Dr Warne: So during the first wave of the pandemic, I went back to the hospital to work on preparations for the pandemic, guidelines, et cetera, but I wasn’t a frontline clinician for the majority of that time. I continued to do out of hours on-call work from June 2020 and then returned back to full-time clinical work at the end of 2021, when I was caring for Covid patients directly.
Ms Carey: Thank you very much.
May I start actually where we normally end up and ask you, please, in turn for a headline recommendation, and I would like you, if I may, just to tell us what it is, briefly why, and I suspect, as we go through your evidence, the reasons why, I hope, will become more obvious.
Can I start with you, Dr Shin. If you could recommend one thing for her Ladyship to consider that might help in the event of a future pandemic what would it be?
Dr Shin: It would be really important to review and improve the NHS estate, particularly in ventilation and isolation capacity. The reason why this is important is because, in facing any epidemic or future pandemic, if the legacy inadequacies of our NHS estate across the country, which in some places is very old, if that is not improved, we will face the next emergency with the same difficulties that we encountered this Covid pandemic.
Ms Carey: Thank you.
Professor Gould?
Professor Gould: I think that, throughout the four nations of the UK, we should have guidelines for infection prevention and control that everybody knows about, that everybody can access, that people believe in and want to put in place and can put in place and understand why they’re doing it.
Ms Carey: Thank you.
Dr Warne?
Dr Warne: I would advocate for the rapid expansion of testing capacity in the UK, both for testing symptomatic people and asymptomatic individuals. In the event that we have another pandemic which involves any kind of asymptomatic transmission, it is vitally important for infection control that we know who those individuals are, and that requires expansive – different types of testing capacity and also that the results of that are linked to large national databases, so we can properly understand and address the problem.
Ms Carey: We heard the chief nursing officers for different reasons advocate for the same thing when they gave evidence.
Can I just deal with your report. Helpfully, you have divided up the task between you and there are lead authors for various parts of the chapters and it will be to those that I turn and ask you to respond to. Can I urge you not to all jump in, no matter how tempting it may be, but if there are important matters after the lead author has given their answers, feel free then to perhaps add different perspectives to the matters that we will be examining.
I think you make the observation that, broadly speaking, between the three of you, your expertise covers IPC, nursing, education and training, obviously infectious diseases, public health virology and managing those outbreaks and you have written about matters within your collective experience and expertise and I think you’ve also seen Professor Beggs’ report and he, likewise, had seen yours.
Also this, just so that you know, we have been referring to it as Covid, rather than SARS-CoV-2, if you can manage to do that, that would be greatly appreciated.
May I turn to you, Dr Shin, firstly, for a brief summary of how pre-pandemic respiratory viruses impacted the healthcare, so we have an overview of where we were before we entered and then what happened when we got into the pandemic, and if it helps you I’m at paragraph 1.5 in your report.
Dr Shin: Thank you. So the NHS is used to seeing a seasonal winter challenge from multiple respiratory viruses, particularly respiratory syncytial virus, influenza or flu, A and B, each winter and also some other non-respiratory viruses like norovirus, which causes a gastrointestinal illness. And this occurs very regularly and predictably every winter, approximately in that order, and this causes a major challenge for acute parts of NHS hospitals, our emergency department, our acute wards, sometimes intensive care and, of course, all of these have infection prevention and control, IPC, challenges to them, which we are reasonably well, you know, practised in dealing with.
Part of the response includes a pre-emptive seasonal flu vaccination for all staff, for vulnerable patients in the population, diagnostics and preparing pathways for these kinds of patients.
Ms Carey: Let me just pause you there, can I just ask you, we’ve not actually looked at RSV, respiratory – how do I pronounce the second word –
Dr Shin: Syncytial.
Ms Carey: – syncytial virus; what is RSV?
Dr Shin: It’s a common, globally-distributed virus which particularly affects young children, infants, and also we now know older adults, and adults with chronic lung disease and it can lead to hospitalisation, in some cases intensive care and, sadly, globally, it does cause thousands of deaths globally. In UK that’s less common.
Ms Carey: So there is a background of dealing with the flu epidemics that hit us most winters.
Dr Shin: Yes.
Ms Carey: You mentioned there that the vaccine take-up can impact the impact of the flu vaccine on the numbers in hospital. I think you also say whether social distancing, the mutation of the particular flu virus, they all depend on how badly hit the hospitals are; is that correct?
Dr Shin: Yes. So the severity of each winter’s flu epidemic does vary year to year and that is affected by multiple factors, for example the characteristics of virus strain, how well matched the virus is to the vaccine, vaccine uptake and many other factors, which I won’t go into too much detail here. But it does vary year to year, some years are very severe, some years less.
So you mentioned social distancing. Actually, with flu, we don’t traditionally apply social distancing that much something which is a feature of this pandemic.
Ms Carey: Can I pause you there because I think you make the point in your report that, during the winter of 2020 into 2021, the non-pharmaceutical interventions actually suppressed flu cases that year.
Dr Shin: Yes, I think that was a general observation that in that winter, the first winter of the pandemic, Covid really dominated, and we saw most of the other viruses in far lower frequency than we did before, and that’s probably linked to, for example, lockdown and the various public health restrictions that influenced that significantly. But it was a remarkable change in epidemiology in that winter.
Ms Carey: I think you say that regular infection prevention and control challenges of dealing with RSV, for example, flu and TB, meant the NHS had some experience of IPC countermeasures. Was that isolation, cohorting, those kind of things?
Dr Shin: All of those and PPE.
Ms Carey: And PPE, right.
Lady Hallett: Can you just say in one sentence what cohorting means for those who might not have followed?
Dr Shin: So cohorting – when you have sufficient number of cases of, for example, flu, then you can put them into a bay or, indeed, a ward if it gets that many. Many trusts or hospitals would have had, for example, a flu ward. In paediatrics, it’s common to have an RSV ward because when you have sufficient numbers then that area then becomes, you know, an infection area, which is dealt with differently to other wards.
Ms Carey: We are familiar with some IPC definitions but, Professor Gould, can I ask you about the World Health Organisation’s definition of IPC, and I think you set it out in your report as follows:
“The World Health Organisation defines IPC as a ‘practical evidence-based approach preventing patients and healthcare workers from being harmed by avoidable infections’.”
A fairly common sense definition, if I may put it like that; do you agree?
Professor Gould: Yes, that’s correct.
Ms Carey: We have heard a little about source control, and is this right, it means preventing the spread of infection from an individual who is known or suspected to be a potential source of infection, and that can include things like having the infected person in a single room, isolating them, decontaminating the room or the ward, and using masks?
Professor Gould: That would be correct.
Ms Carey: PPE we’re familiar with, I won’t ask you about that. You do help in your report, though – and if it helps you, Professor Gould, at paragraph 1.18 – in relation to the make-up of IPC teams. I think you say that there are specialist teams employed in most countries in the UK. Can you just tell us who makes up an IPC team?
Professor Gould: The infection control team will be led either by a doctor or a nurse. It will consistent of usually a medical microbiologist, it will include a virologist, it will include specialist nurses, it will probably include nurses who are specifically engaged in surveillance and audit, it will very likely, particularly in a large NHS Trust, would involve nurses who particularly have an educational role, and people will be co-opted on to the team in the case of particular need. So if there was an outbreak of food poisoning, for example, the catering staff would be there, but they wouldn’t be there all of the time. If there was a problem with ventilation then the hospital engineers would be there. So there’s a core team and there would be additional people as well.
Ms Carey: You mention in your report what are called IPC link nurse schemes. What are they, please?
Professor Gould: Infection prevention and control link nurses are members of the general ward team, so they would be a member of the team who looked after patients or worked in an outpatient department in the usual way but they would have an additional responsibility: they would act as ambassadors for infection prevention and control, they would have a liaison role, they would provide the communication channels between the infection prevention specialist team and ordinary people on the wards, and they would usually have some particular education or training for that. Not every organisation will have them –
Ms Carey: I was going to ask.
Professor Gould: – but many, many do.
Ms Carey: Are they across only England or UK-wide?
Professor Gould: Oh, they would be UK-wide.
Ms Carey: Thank you. Can we look at perhaps the arrangements for the leadership of IPC teams across the four nations. I think obviously in England there is the director, the DIPC, as Dr Shin is. In Scotland they have – the leader of the IPC team is called the infection control manager; is that correct?
Professor Gould: Yes.
Ms Carey: In Wales, leadership for IPC is undertaken by a senior nurse with expertise in IPC.
Professor Gould: Yes.
Ms Carey: And in Northern Ireland, I think you say in the report:
“We could not locate any publicly available information on IPC team leadership for Northern Ireland.”
Professor Gould: I looked as far as I could but I could find nothing in writing, and I have no contacts in Northern Ireland, whereas I do – I worked in Wales for eight years so I have contacts in Wales, I have contacts in England, I do have some contacts in Scotland, but I have no contact in Northern Ireland to ask.
Ms Carey: Whatever nomenclature is given to the person in charge leading the team, does effectively the director, the manager and the senior nurse with expertise in Wales, are they all performing roughly the same function, do you know?
Professor Gould: They’re performing roughly the same function, but their remit would vary a little bit, because in Wales they have health boards instead of NHS trusts, and the health boards would include some community staff as well. So the person, the nurse in charge, would have a community role, whereas somebody in a large NHS Trust would have a role just to do with the acute trust.
Ms Carey: I ask you this because there is a query by those who represent the Welsh bereaved as to whether the absence of a DIPC, a director, in Wales, might have detrimentally affected implementation of IPC guidance. Are you able to opine on that?
Professor Gould: I worked in Wales between 2012 and 2019, and Wales is a small country and that is advantageous because you can know people in it the way you can’t in a larger country, I used to go to a lot of meetings to do with infection prevention specialists and I would say the quality of the service that was offered by the people in charge of the services was very good. The fact that they didn’t have the title of DIPC didn’t make any difference, they performed the same role.
Ms Carey: Perhaps a question for you, Dr Shin, in practice does your oversight of IPC matters include consideration of non-clinical staff as well as clinical staff?
Dr Shin: It is – yes, my role is really to protect the patient and staff safety. Putting staff safety aside, it includes all staff, clinical and non-clinical, if that’s what you’re asking.
Ms Carey: Thank you.
A slightly different matter, the characteristics of Covid, and for you, Dr Warne. We have heard from Professor Beggs, so we’re familiar with contact, direct, indirect, fomite, call it what you will, droplet and aerosols, I won’t ask you about that, but can I just ask you very briefly about transmissibility and the reproduction number. I suspect her Ladyship’s heard about this in earlier modules but, for the purposes of Module 3, could you just help us please with how transmissibility is commonly expressed as the R number?
Dr Warne: Absolutely. So in terms of infection control measures, the transmissibility is a key feature of consideration for – when you’re talking about infection control measures. So the R number is the number of – if you had an infected individual, it’s the number of people in a vulnerable population you would expect to be infected coming into contact with that person.
So, for Covid, early in the pandemic the estimate was that it was around 2.5 in – and for other pathogens that can vary. It’s roughly the same number for influenza and other respiratory viruses. It’s far higher for conditions like measles, lower for tuberculosis, and so on. And that influences the control measures we would take.
Ms Carey: I think you say though in your report that it’s important to note that the transmissibility or the R value is an estimate and the true transmissibility depends on the setting.
Dr Warne: Exactly right. So the R0 is quoted in population-level studies but obviously the individual circumstances in which a patient finds themselves on the ward in hospitals, that will influence the R number, the transmissibility, if the pathogen has an opportunity to spread and there are different ways to facilitate that.
Ms Carey: Is there a higher or a lower R number in the hospital settings?
Dr Warne: It could potentially be higher. It really depends on the setting. So if you were to put a patient isolated into a side room, in principle it would be lower, but we don’t really think about the R number in terms of these individual settings, it’s more of a population-level measure.
Ms Carey: Some other terminology we might be considering throughout your evidence, the infection fatality rate, please, what is that?
Dr Warne: It’s the number of people who get the infection who subsequently died. So it’s the true number. So the problem we have with Covid is that we know that there are a number of people who are asymptomatic, who – where they’re never identified as being a true case. The difficulty there is it’s very difficult to always identify all of the asymptomatic cases so they’re often not included when you’re quoting rates of infection. More commonly quoted to be the case fatality rate –
Ms Carey: Slow down a tiny bit, please.
Dr Warne: Okay.
Ms Carey: Tell us about that.
Dr Warne: So the case fatality is where you have confirmed cases, where you know that you have the infection. So that doesn’t include asymptomatic individuals, but it’s much easier to get that information from nationally collected data on confirmed cases, confirmed infections.
Ms Carey: Thank you. For our purposes, hospitalisation fatality rate.
Dr Warne: This is the proportion of people who are hospitalised with Covid who subsequently died. Again, that’s only a subset of all the people who catch Covid, is the ones in hospital.
Ms Carey: I think you go on to say – look, in your report, into the fatality rate, and there’s a graph I’d like us to put up on screen.
Can I have, please, INQ000474282_18. Already there, thank you very much.
You’ll have to help me, Dr Warne, with this. What does the top graph show and what is the point that is trying to be depicted by this graph?
Dr Warne: So the top graph shows the hospitalisation fatality rate. So this is the proportion of people with Covid in hospital who subsequently die.
Ms Carey: Right.
Dr Warne: So we can see that with the purple line, that’s the original variant of the virus.
Ms Carey: You’ve called it wild type but is that what came out in January to March 2020?
Dr Warne: Exactly right.
Ms Carey: All right.
Dr Warne: You can see that the hospitalisation fatality rate peaks at over 40%, so over 40% of people hospitalised with Covid in that time would have died.
Ms Carey: So that is – yes, thank you very much, that is April 2020 there. Then it falls throughout the summer effectively. The dotted line running down, what does that signify?
Dr Warne: So that’s the point at which the vaccination campaign was launched in the UK, so in December 2020.
Ms Carey: Thank you.
Then we can see it rise slightly, then there’s the emergence of a black line on the graph, which I think you say is the weighted indicate – what’s the weighted indicator?
Dr Warne: So at this point we have two variants circulating in the UK at the same time, the original wild-type virus and the emergence of the Alpha variant, and that black weighted line shows the definition of those two as the wild type numbers went down and the Alpha numbers went up.
Ms Carey: Then if we look at Alpha just before December 2020, the hospitalisation fatality rate is at 40% and then begins to drop as we pass through 2021, and then we get to June, or thereabouts, 2021 and the emergence of Delta.
Now, that’s got a lot lower hospital fatality rate. Can you help as to why that is?
Dr Warne: So you’ve noticed before that that there are two waves of Alpha.
Ms Carey: Oh, yes.
Dr Warne: The Alpha hospitalisation fatality rate falls. There are multiple reasons. Probably the most important was the introduction of vaccination, as well as other things including effective treatments for Covid that weren’t there previously, but vaccination is probably the most important.
Ms Carey: Then it rises slightly, and then towards the end of December 2021 into February 2022 we’ve got the emergence of Omicron.
Dr Warne: Yes, so each of these variants have lower fatality rates associated with them.
Ms Carey: Going back to the beginning, then, in April 2020, can you help at all as to why the hospitalisation fatality rate is as high as it is in April 2020?
Dr Warne: So it’s a number of things. First, we had an unvaccinated population, all of whom were vulnerable to the infection. The virus itself was probably more pathogenic, it was more likely to cause severe disease and death. So the Omicron variant is very different in that regard to the original wild-type virus, as well as other factors, including an absence of effective treatment, and there are differences in the patient populations that were admitted, but they’re all contributing.
Ms Carey: Okay. Then the bottom graph, please, is the effective infection fatality rate. What is that graph demonstrating to us?
Dr Warne: This is all of the people – an estimate of all of the people that were infected with Covid, what proportion of those ultimately died. So it peaked at just over 1% with the wild type early in the pandemic, but like the graph above it, each subsequent wave of virus appeared to have a lower fatality rate, so fewer people died with subsequent variants.
Ms Carey: I think you make the observation in your report that obviously if you are asymptomatic, or indeed minimally symptomatic, don’t feel that unwell, if I can put it like that, you can still transmit the virus as we have heard. You say this:
“The proportion of asymptomatic infections varies depending on the immune status of the individual, but a meta-analysis of studies published in 2020 estimated this figure at approximately one third of all cases in unvaccinated individuals.”
Can you just put that into layman’s terms for us.
Dr Warne: So a meta-analysis is where you take multiple studies and group them together to try to get a better idea of an estimate of a number. So that number of roughly a third of people from different studies with different methods comes to this conclusion that roughly one in three people who catch Covid are asymptomatic.
So the relevance of that for IPC is that it means that anybody coming into your hospital who don’t have any symptoms may be carrying Covid, they may be potentially capable of spreading the virus.
Ms Carey: Yes, and before testing it’s almost impossible to work out if the person is infectious or not?
Dr Warne: Exactly right.
Ms Carey: Incubation periods we did briefly look at with Professor Beggs, but I think you say there that data from the pandemic showed the incubation period was – from time to – catching the virus and developing symptoms, anything from between 1 and 14 days, so you could be asymptomatic for as long as two weeks.
Dr Warne: Exactly right.
Ms Carey: But the average was five days. Again, presenting a problem for visitors, patients, staff alike, coming into hospitals.
Dr Warne: Absolutely, so you could potentially be in hospital for two weeks before you – having caught the virus in the community and potentially spread it from that point onwards. Which is very difficult to try to work out from an infection control point of view where that infection originally came from.
Ms Carey: Now, there was knowledge, as we know, of asymptomatic infections being possible early on and evidence emerging as we went through the pandemic about the role of asymptomatic transmission, but do you think that future guidance should assume there will be asymptomatic transmission unless and until the contrary is proven?
Dr Warne: Absolutely. So we know that there is asymptomatic transmission of a range of respiratory viruses, including influenza, including RSV. I think that there is much less with SARS, and MERS prior, but until proven otherwise, I think we should assume that there will be a substantial proportion of asymptomatic transmission.
Lady Hallett: Are you saying, Dr Warne, that that should have been the case, given the state of knowledge when the pandemic hit us?
Dr Warne: So we knew that there were high rates of asymptomatic influenza and, although we discussed before in this Inquiry about the importance of preparing for an influenza rather than a coronavirus pandemic, the likelihood that you have asymptomatic influenza is equally likely. So I think that we should definitely have been preparing for it and should prepare for it in a future pandemic.
Lady Hallett: Thank you.
Ms Carey: We have become familiar with standard IPC measures and transmission based precaution but, can I just ask you this, I’m asked to ask you about Professor Beggs’ conclusion that hand hygiene has a modest effect in preventing Covid-19 transmission and whether, I think probably you, Professor Gould, agree with that conclusion or any of you if you disagree with it. Start with you, Professor.
Professor Gould: I would agree with it. Direct contact was not found to be the major – not considered to be the major route of spread, so hand hygiene is always going to be important but would not, in this case, be the major route.
Ms Carey: Dissent from either of you two gentlemen?
Dr Warne: No, I agree with that.
Dr Shin: I agree but I think there were a few words there that were important. IPC is not just about Covid obviously, so we have to be conscious of all the other infectious threats. For that reason, hand hygiene is extremely important, as Professor Gould has just said, so I broadly agree, with that small caveat.
Professor Gould: Could I just add, we would be concerned with the spread of Covid but we wouldn’t want inadvertently to give the patients MRSA or any other infection. So hand hygiene is always good.
Ms Carey: No, it’s always important.
Lady Hallett: Can I just check what your final word was because I missed it and I think the stenographer missed it, Professor Gould. You said hand hygiene is important but not – I think I know what the word was.
Professor Gould: Wasn’t the major route.
Lady Hallett: Thank you.
Ms Carey: Thank you.
We are familiar with airborne contact droplet, and the like, so I won’t ask you to go through those again. Can I just ask you about FRSMs, though. Is this right, that they have effectively sometimes a dual role as source control and/or as PPE; is that a fair way of putting it?
Dr Shin: I think they’re used as source control, for example historically in operating theatres surgeons will wear them to protect the patient from – and especially the operating field – from any droplets from that surgeon. They can be used – they’re not technically PPE –
Ms Carey: Yes, we know.
Dr Shin: – but they are deployed in that way, so with that small distinction, important distinction, they have been used as a form of PPE but officially and technically they’re not classified as PPE.
Ms Carey: Understood, save that all the IPC guidance talks about them in the context of PPE, but we take the technical distinction that there is. For these purposes, obviously it can protect you from getting blood on you if someone is bleeding but, equally, if you’re coughing and sneezing, it can help prevent the larger droplets going out into the environment.
Dr Shin: Yes, as I think a number of witnesses have said in written and verbal that any form of face covering provides some protection, so FRSMs can provide modest protection for the wearer.
Ms Carey: Thank you. Dealing with masks and respirators, we’re familiar with FFP3. Can I just ask about FFP2 or N95, as it’s also been referred to. Is that a type of mask that is commonly used in the UK?
Perhaps is that to you, Dr Shin, or you, Dr Warne?
Dr Shin: I can start. So FFP2 or N95 is commonly used in other countries, notably the United States but some European countries. It is available in the United Kingdom but we don’t have any tradition in the NHS of using FFP2. We tend to use FFP3 because it provides a slightly higher level of protection.
Ms Carey: I think in the report it says the type of respirator is designed to reduce the exposure of the wearer to respiratory particles by 95% when properly fit tested, compared to no mask; is that correct?
Dr Shin: I think for FFP3 it may be higher than 95%. So FFP2 is also known as N95, that’s where the figure comes from, but I think we’re talking about fine margins here.
Ms Carey: Fine. Whether it’s FFP2 or FFP3, it provides a higher level of protection than wearing no mask at all, understood.
Dr Shin: Yes, I think that’s clearly true.
Ms Carey: Now, fit testing, can I ask about that, please. There are two ways, as I understand it, of fit testing and is this a matter that you can help us with, Professor Gould, or is it for you, Dr Warne?
Dr Warne: I’m happy to talk to it, or Dr Shin.
Ms Carey: Either of you.
Help us with what is quantitative fit testing and it’s at paragraph 1.59 in your report.
Dr Shin: So there are two main methods of conducting fit testing, which is a requirement by the Health and Safety Executive, before using FFP3 as PPE. The qualitative method requires the user to, once having donned a well fitting respirator, to show that when a scent, for example, is placed close to the user, that they cannot detect that scent, which means that there is a good seal and protection and those particles cannot breach that PPE.
That’s suitable for probably low volume – you know, low volume usage. But –
Ms Carey: Do you mean when lots of people don’t need to be fit tested?
Dr Shin: When you only have to test a few people, basically, and there is no real urgency, that’s a reasonable approach and one which my hospital used, for example. But, in the context of an emergency like the pandemic, we have to scale up fit testing to a very, very massive degree, then that becomes impractical, and there is a method called the quantitative method which used complex equipment and you need to train personnel to do that and that becomes – that is a method which is more easily scalable for this pandemic situation, for example, and most trusts would have used that method.
Ms Carey: Can I ask, what about the person who may not have a sense of smell: how is fit testing conducted in those circumstances?
Dr Shin: I think that would need the quantitative method and the qualitative method, relying on scent detection, would, in that case, clearly not work, which the irony is that Covid produced anosmia or loss of sense of smell in a number of people. So that was another reason why the quantitative method, needing specialist equipment, was favoured.
Ms Carey: Just help me, is this specialist equipment available in most hospitals, are you able to give us an indication about how widely available it is?
Dr Shin: I don’t know specifically if I can give you a best guess, my best guess is that most trusts probably didn’t have this equipment or, if they did, very, very – you know, only in one or two examples. So I think – I suspect during the pandemic most trust hospitals would have had to purchase more equipment and/or outsource. There were some companies which could do this as an outsourced service.
Ms Carey: And you need trained people available to do the fit test?
Dr Shin: Absolutely.
Ms Carey: All right. The fit test results, as I understand it, have to be recorded; is that correct?
Dr Shin: Well, they should be, I mean, if you want to have a robust process, once again, the logistical aspect of all this is very important. If you don’t have a proper record then, as an employer, you can’t get assurance, as a member of staff, you can’t assurance that you know exactly which mask fits you and that you need that mask available. So we have records for many reasons. The hospital has to assure itself that sufficient numbers of staff in relevant areas have been fit tested and so, obviously, we record for the staff that we know, for those staff they need this type of mask, for these staff we need that type of mask. So accurate records, I would suggest, are really quite important.
Ms Carey: Help us, how long does it take to do a fit test?
Dr Shin: Approximately 15 minutes, 15/20 minutes, and the difficulty there is that, if you don’t pass on one type of mask, you then need to be tested on another type of mask. So that adds to the time.
Ms Carey: Understood.
We are familiar that fit checking is a different process and, is this right, it’s effectively designed to check the seal?
Dr Shin: Once you have found a mask which fits that person, they use that particular type of mask, don it, and it’s just basically breathing in to make sure you feel that there is a seal and there is no air leakage.
Ms Carey: Thank you.
May I ask you, please, Dr Shin, about a document INQ000427339, please, at page 5. I just want to look at some of the practicalities of how they played out. This is a document from Leicester NHS Trust, and it’s dated 30 April and, in short, it sets out some of the challenges that that trust was going through in fit testing their staff and what they did to try and deal with that, and a proposal that they made.
So that’s the background, and I think, if we just look there at 3.0, “What has Changed?”, the trust was saying to the board that:
“… the NHS supply chain has been unable to provide a consistent stock of masks. In practice, this means we have had very limited stock of FFP3 on which staff have previously been tested. Under the current supply chain conditions, no Trust has any control over the types of mask that are provided.”
Drilling into that, you might have type A mask one week and type B mask comes in next week and no-one has been fit tested on the type B mask?
Dr Shin: That is possible.
Ms Carey: “[Public Health England] guidance has changed a number of times in recent weeks and has meant we have used up some supply in fit testing groups of staff where a surgical is now considered …”
Then they go through the deliveries that are expected to come in and it was the next bit really:
“Currently we have seven different types of mask in stock approximately 2,000 staff who require repeated fit testing as the mask type changes. Each test takes between 15 and 30 minutes. Even with our now increased fit testing offer over 7 days per week, it would take a number of weeks to test all staff on all available masks.”
I know we’re looking at a Leicester problem but is that an uncommon problem or do you think this is replicated across other trusts in other parts of the UK?
Dr Shin: I think every NHS hospital had huge challenges in getting their, you know, many thousands of staff fit tested with the multiple different types of masks and the logistical challenges would have been huge and we had similar problems. It was a massive logistical challenge, training challenge, it was a very difficult –
Ms Carey: Well, if we go down the page to 4.0, what have they done, that trust, to maximise fit testing? They purchased ten PortaCount machines, which is the quantitative test, reducing the time from 30 to 15; they worked with colleagues to acquire additional fit testing kits; they established a team of staff trained to undertake the fit testing clinics; they identified areas where testing should be prioritised; and, indeed, vulnerable staff, with underlying health conditions, were fit tested and provided with the PPE.
So they did a number of things but, if we go over the page, please, to page 6 – thank you – this is where they ended up:
“The purpose of this paper is to inform the board that following discussion and approval at a strategic and tactical response level, the trust has made a move away from compulsory fit testing for all types of FFP3.
“We have emphasised the need for a fit check at the time of donning the PPE …”
But, essentially, they wanted sign-off to move away from the need to fit test; is that how you read this document?
Dr Shin: That is how –
Ms Carey: Now, I know there is going to be controversy about this, given that you are required to fit test. If you go over the page, please, to page 7, they received what was called compliance advice and they had taken steps to try and mitigate the testing situation, including they considered the least harm that would be obtained by releasing FFP3 national emergency stock. They set out there, effectively, that they acknowledge this is not in line with the standard practice outside a pandemic situation, but they considered it was consistent with the requirement under the Health and Safety at Work Act to ensure, so far as is reasonably practicable, the health and safety and welfare at work, and they noted that:
“… we would not expect staff to work in Covid positive areas without fit testing.”
So I just raise that so we can look at the interplay between the health and safety legislation and actually how it panned out on the ground, and then they asked the board to derogate from the usual requirements to fit test and revert back to fit testing as soon as supply issues – do you think that’s an extreme example, Dr Shin, or does it demonstrate, actually, what trusts were having to do, particularly in April 2020, when there were supply chain issues?
Dr Shin: So this is the only example I know where there has been applied but, as they said in this document, I think they’ve put a lot of thought into this in an extremely difficult and challenging situation, which they’ve described well. They’ve tried to mitigate risk as much as possible, so I think I can understand how they got to this position that they made and I think that they took lots of reasonable steps to try and mitigate the risk, and I think reflecting on the Health and Safety Executive guidance or instruction, that’s written in the cold light of day for a non-pandemic situation, and this is in early 2020, as we’ve heard, in the face of a rising tide of a very dangerous, lethal virus, so they were – like many hospitals, and I wouldn’t be surprised if this wasn’t the only one, I’m sure other trusts had lots of difficult discussions – and I think it’s a very well reasoned rationale for changing their position to what we would like in ideal circumstances because we were not in ideal circumstances.
Ms Carey: No, understood. I want to ask you about those who fail a fit check and need something other than an FFP3 mask and you include in your report reference to powered air purifying hoods. Clearly, staff who couldn’t find either suitably sized or it failed for reasons of beards or face shape, whatever the position may be, could use a powered hood. You say this in your report:
“For these healthcare workers, such hoods were the only viable respiratory PPE option.”
You say this:
“This was understood before the pandemic but a very large number of NHS staff would fail their first fit test for a variety of reasons.”
Can you give us an indication of why people might fail it? Obviously beards, face shape but what are the other reasons that are commonly encountered.
Dr Shin: Actually, I would say that beards are probably not the most common, so I know colleagues who shaved their beards during the pandemic. But one really significant problem, which is one of the recommendations actually, is that we found that, basically, these masks were designed for, you know, stereotypical face size, if we can call it that, and shape and many of our staff just don’t have the – you know, looking around the room, even, you see people have different shaped faces, especially women and persons of other ethnicities and we found that in our workforce, and I think we said in our paper, and it’s well known, most nurses – more than 80% of nurses are female and in the NHS we have a lot of – a very diverse workforce, especially in London we have a particularly diverse NHS workforce, and we just found in practice, when we were scaling up this fit testing, that a lot of the people who failed their fit testing on a number – one mask or more, were female and of another ethnic – non-white ethnic background. And that’s one of the recommendations that that needs – that situation needs to be improved.
Ms Carey: I appreciate that a lot of the staff had never had to have been fit tested or needed to wear RPE but, given that it was known, if I understand you correctly, pre-pandemic that there wasn’t enough masks to fit the variety of face shapes that we encounter, can you help at all as to why there wasn’t provision in place for being able to scale up lots of different types of masks.
Dr Shin: I think basically the practice – this is one of the areas where our practice in the NHS changed dramatically during the pandemic. We just – before the pandemic we would only have had FFP fit testing for very specific – as I think we did mention in our report, for example, critical care, for example, respiratory medicine and other areas similar to that and infectious diseases wards, where there’s a reasonable expectation that patients with infections like TB and HCIDs could be seen.
So that means this testing was only done in a very select few areas, whereas in the pandemic because of the scale of it, it eventually it expanded to most acute areas of acute hospitals and indeed perhaps most clinical staff. So it was a question of what was needed before the pandemic was very different.
Ms Carey: Understood.
Can I change topic and turn to you, Dr Warne, and included in the report is a section entitled “Controversies surrounding the transmission route of Covid and the implications for PPE”, and if it helps you, Doctor, I’m at 6.10.
Can I ask to be called up on screen page 64 of the report, it’s INQ000474282_0064. Would you be able to highlight the five bullet points, because, if I may say, this rather encapsulates the areas of controversy that we have been dealing with. You say:
“However, there has been disagreement in the scientific and medical communities, and a changing evidence base during the course of the pandemic, related to:
“[Firstly] Whether the simple size threshold of 5 microns is accurate when considering which particles are aerosolised.
“Which medical procedures are at increased risk of generating aerosols (AGPs).
“Whether aerosolised particles can be produced in the absence of AGPs (for example through talking, coughing, sneezing, and singing).
“What is the contribution of aerosol transmission for Covid-19 in comparisons to other routes in a hospital setting.
“How the above relates to implications for IPC guidance.”
In a nutshell, we have been considering some of that already and I don’t want to revisit old ground but did you hear some of yesterday’s evidence from Professor Susan Hopkins?
Dr Warne: Some of it, yes.
Ms Carey: I would like to ask you, please, about FFP3 versus – and it’s my word, not anyone else’s – efficacy of FRSMs. I think you perhaps go back in time, please, to your paragraph 6.12 because, as I understand it, for a long time now there has been a distinction in IPC guidance, whether it’s flu, MERS, coming on to Covid, drawn between FRSMs for routine care and respirators for AGPs; is that correct?
Dr Warne: That’s correct, yes.
Ms Carey: That’s been pre-existing, I think you say, since at least 2007?
Dr Warne: Yes.
Ms Carey: The flu pandemic guidance was based on the assumption that flu was droplet and so, again, FRSM was recommended for routine care, respirators for AGPs. Can I ask you this: why do you think respirators are recommended if it was not thought that, in a clinical context, they necessarily offered a higher degree of protection than FRSM?
Dr Warne: Is this related to aerosol-generating procedures?
Ms Carey: Well, no, not necessarily. Yesterday we heard from Professor Hopkins, and I asked her this:
“Do you agree that where there is an accepted risk of aerosol transmission FFP3 should be recommended?”
She didn’t agree with that. She said it was complicated, and she said that evidence was weak that FFP3s protected more than FRSMs, and it made us ponder why, if the evidence was weak, there has been, running throughout the guidance, this distinction between FRSMs in one context and respirators in another.
So that’s the genesis of the controversy and I’d like your help with how we’ve ended up in this position, if you’re able to help us.
Dr Warne: A lot of the evidence for this comes from SARS, so it’s about 20 years old. There is no high-quality evidence, as we would understand it, so in future modules we talk about vaccines, talk about drugs and effective treatments that undergo high quality randomised control trials, so evidence which is considered to be of a high quality and is robust.
Those kind of studies are very uncommon in infection control measures so we rely on, essentially, look-back exercises, retrospective observational studies where some people had one type of infection control intervention and another group had another.
So, in SARS, there were a number of very small studies looking at people who had surgical masks or respirators or no PPE at all, and the evidence from SARS, based on those small studies, is that some PPE is much better than none, but very few of them actually compared respirators with surgical masks.
There were two studies, they’re incredibly small, and those very small studies, which are by the authors’ admission of poor quality, essentially are the only basis – the only scientific basis at the start of this pandemic by which – is quoted in guidance both of pandemic flu preparedness and other guidance at the start of this pandemic, the rationale for using surgical masks for routine clinical care above respirators.
Ms Carey: So is a lack of high-quality trial evidence that respirators are more effective than FRSM, is that –
Dr Warne: That’s right because there is essentially no high-quality evidence.
Ms Carey: Right, but there is other evidence because we heard from Professor Beggs about the studies done in lab conditions.
Dr Warne: Absolutely.
Ms Carey: What about observational studies, if that be the right – are there any other studies that help at least try and ascertain whether respirators are better than FRSMs?
Dr Warne: There’s certainly been a lot, as the pandemic has progressed, observational studies which show that FFP3 respirators or other types of respirator are associated with lower risk of transmission, particularly to healthcare workers, which are the group we’re talking about. None of – again, they are being criticised because the methodology is not rigorous, they often rely on retrospective observational data, there are chances of bias, and so on.
But that’s the quality of the evidence that we’re relying on and the laboratory style evidence, what we know a priori, you know, what we know about the first principles of these aerosols and how they’re generated, has contributed to a body of evidence that’s open to interpretation.
Ms Carey: If there is this lack of high-quality trial evidence, can you help why it is that we’ve ended up now, for a number of years, with a distinction nonetheless being drawn between FRSM in routine care and respirators for AGP procedures; why have we been following this for two decades?
Dr Warne: I think part of it is entrenchment that IPC measures are very slow to change. So once you have a standard which is establish, 15, 20 years ago, there is very little change that happens with IPC measures, particularly at any kind of pace, so “That’s what we’ve always done, that’s what we’ll continue to do”.
Ms Carey: I saw Professor Gould nodding there. As someone who has been involved in the educational side of things, do you have a view about what Dr Warne’s just told us?
Professor Gould: I think, by tradition, infection prevention people are very traditional and they are not very forward-thinking people, they tend to be backward-thinking people, they tend to be, “We’ve always done it this way and it’s the safe way and so we’ll carry on doing it the safe way”. They don’t think it for any malicious reason; people don’t dare to change.
So there are some entrenched things that we do and we do them because we’ve always done them because we just don’t dare to change. We always wear masks in operating theatres because we always have. Some kinds of surgery, it’s probably very unlikely that transmission of infection would occur by that route but we still wear them just to be sure.
Ms Carey: Can I ask you this, though, that her Ladyship will see, as we go through, and may indeed have an indication of it already, there are a number of calls from people like the BMA, the Royal College of Nursing, the TUC, for increased usage of FFP3 masks. Why is there this demand for FFP3 if, in fact, it makes, certainly in terms of the clinical trial evidence, little difference to the protective quality over FRSMs; why is there the call for it?
Dr Warne: There is certainly a perception among healthcare workers that the respirators provide more protection than surgical masks?
Ms Carey: Do you think that’s basically because, if you look at them, one is blue and loose fitting and the other one is tighter and is more robust material?
Dr Warne: I think that is a big – evidently a contribution to it but a lot of healthcare professionals do follow the evidence or they are associated with professional bodies that review the evidence on their behalf and there are, as you mentioned, trade unions, Royal College of Physicians, other bodies, where their view on the evidence was that FFP3 masks or other respirators would have provided protection to those healthcare workers.
Ms Carey: What did you wear, Dr Warne, when you were on the wards?
Dr Warne: So initially, as was the guidance and as I even advocated at the start of the pandemic, in line with national guidance, I would have worn a surgical mask, as we have done for previous flu winters. Our trust is one of a number across the UK that moved towards respirators based on evidence that we had that respirators provided more protection for our staff and so, as the pandemic progressed, we switched to using respirators for healthcare workers caring for confirmed Covid – confirmed or suspected Covid-19 patients.
Ms Carey: And, presumably, respirators in areas where AGPs were being performed?
Dr Warne: Yes, throughout.
Ms Carey: Can I ask you this, then: if there were sufficient supplies and a healthcare worker just would prefer to wear a respirator because it made them feel safer – forget whether the lab or the science proves it – do you think that is something that should have been enabled, had the supplies been there?
Dr Warne: If I was in this position in, you know, March 2020, I think that it would be difficult to say. With the benefit of hindsight and in future pandemics, the answer would be yes, depending on which patient group I was looking after. So for confirmed Covid patients, absolutely; for others it’s more unclear.
Ms Carey: Can I ask you this then, please, Dr Warne, based on the lack of high-quality trial evidence but the other laboratory trial evidence or the observational studies, does it come to this: do we know from the data whether FFP3 would have reduced the number of cases of Covid-19 in healthcare workers?
Dr Warne: So we don’t know that for sure. I suspect it would have reduced it by a proportion of cases but there are other factors that contribute to healthcare workers acquiring Covid-19. So that relates to compliance with PPE, and whether they would have tolerated these kind of respirators, an acknowledgement that transmission to healthcare workers came from sources other than Covid-19 patients, including other healthcare workers, and that there were issues with other issues regarding training and other compliance issues with PPE that need to be taken into consideration.
Ms Carey: Given that answer, do we know from the data whether FFP3 wearing would have reduced the number of hospital-acquired infections, whether acquired by the healthcare worker or acquired by the patient?
Dr Warne: The majority – as we will come to later – of patient healthcare-associated infections comes from other patients. So the use of FFP3 respirators by healthcare workers is unlikely to have substantially changed the number. It may have done a small amount.
Ms Carey: Would you recommend that the current IPC guidelines are updated to recommend routine use of FFP3?
Dr Warne: For the care of patients with confirmed respiratory –
Ms Carey: Or respiratory virus?
Dr Warne: Yes, I would.
Lady Hallett: I think Dr Shin wanted to say something.
Ms Carey: So sorry. Yes, Dr Shin.
Dr Shin: I broadly agree but I think we also take into account the pathogenicity of the virus we’re talking about. For example, if it was rhinovirus, which is the common cold virus, then I wouldn’t advocate FFP3 for that. But, yes, Covid and flu and potentially other viruses, like parainfluenza virus, there are four types, immunocompromised patients can be quite seriously ill with that, so I think there’s a bit of a nuance here, basically.
Ms Carey: Understood.
May I turn to AGPs, which we’ve touched on, and I’m at paragraph 6.4, which I think is you, Dr Warne. Can I just ask you this: we are aware that there was, during the pandemic, an independent high-risk AGP panel set up by, I think, the Chief Medical Officer, which it reported to in due course. But I think you say at the outset that there is little scientific consensus on which procedures are aerosol generating. Can you just help us: why is there no consensus about this?
Dr Warne: So there are a number of medical procedures involving the airway or involving the upper GI tract, the mouth, the oesophagus, and so on, which potentially are at risk of producing aerosols and, therefore, are potentially a higher risk to healthcare workers in the vicinity of those procedures being performed. There is little – some of those procedures, there is little consensus on which ones produce an aerosol and why they produce an aerosol, so if, for example, a number of these procedures are associated with aerosol generating, potentially because they cause coughing, so endoscopy, et cetera, which as evidence has come through the pandemic and been reviewed by Professor Beggs, I think, last week, that coughing is in itself probably an aerosol-generating event.
Ms Carey: Yes, I think you make the point in the report that tracheal intubation, ie putting the tube in, produced very low quantities of aerosolised particles but extubation, I presume taking the tube out, particularly when the patient coughed, produced detectable aerosols which was 15-fold greater than a normal cough.
Is it quite common, when they’re taking the tube out, for a patient to effectively cough it up? I don’t mean that quite as grossly as it sounded.
Dr Warne: Yes.
Ms Carey: I see.
Cardiopulmonary resuscitation, there has been conflicting guidance, I think you say, between the IPC cell and other organisations in the UK as to whether that should or shouldn’t be an AGP. Can you just summarise the competing arguments, if you like?
Dr Warne: So resuscitation guidance in the UK is provided by the Resuscitation Council. One of the complications with resuscitation attempts is that they are essentially a series of interventions. So the actual chest compressions, potentially intubation, line insertion, some of which are potentially aerosol-generating procedures and some of them aren’t.
When the initial list of AGPs was produced at the start of the pandemic, cardiopulmonary resuscitation was not on it and that led to conflicting guidance produced from the IPC cell, from NHS and PHE, and the Resus Council. So the Resus Council advised the use of respirators in all resuscitation attempts and that conflicted with guidance produced by the other bodies.
Ms Carey: May I just ask you about CPR. To the layperson, one might think of someone putting their hands on a person’s chest. Does that produce aerosols or do we know if it does?
Dr Warne: So what you’re essentially doing is forcing somebody to breathe. In any resuscitation attempt in hospital you would have a lot of people there doing different tasks often simultaneously, so when you have chest compressions coming on the chest, you would also have somebody trying to intubate the patient, to put a tube down, doing other procedures simultaneously. So while some of those procedures, including intubation, are, you know, concerned with aerosol-generating procedures, it’s difficult to disassociate chest compressions, intubation, et #cetera, because they’re all happening at the same time.
Ms Carey: I think, my Lady, we’re going to hear from a number of the different parties there that Dr Warne mentioned, so I’ll leave that topic there.
I think just, finally, Dr Warne, your paragraph 6.50, where you looked at a number of studies that were trying to work out which procedures were more aerosol generating, and what was the outcome at paragraph 6.50?
Dr Warne: So, as I mentioned, a number of these procedures are associated with coughing, and some of these laboratory studies that you refer to show that it’s coughing that produces more aerosols. Anything that induces coughing, whether that’s an intubation or if it’s a physiotherapist trying to induce coughing to help somebody clear their chest, these are all likely to be associated with aerosol generation.
Ms Carey: What about if it’s not something being done to you that produces the coughing but you’re just coughing because you’ve got Covid and you don’t feel very well?
Dr Warne: So the evidence from these studies, which wasn’t available at the start of the pandemic, is that coughing is, in and of itself, likely to produce as much or more aerosol than many of the procedures on the list of AGPs.
Ms Carey: So if it is right to draw a distinction between FFP3 and AGPs, actually it’s not a great distinction because, on that basis, you should be having FFP3 around anyone who’s coughing.
Dr Warne: Yes, bear in mind that two in three people who come to hospital with Covid present with coughing that’s a high proportion of – that’s a high risk, just on the general ward.
Ms Carey: My Lady, it’s a little early but I’m moving on to IPC guidelines and quite a large body of the report, and turning to Professor Gould. So I wonder if that might be a convenient moment or I can carry on, if you wish, and deal with some of it.
Lady Hallett: No, I’m sure the stenographer will be grateful, given some of the words that our experts have been using.
Ms Carey: Yes.
Lady Hallett: Right, I shall return at 11.20.
Ms Carey: Thank you very much.
(11.03 am)
(A short break)
(11.20 am)
Lady Hallett: Ms Carey.
Ms Carey: Thank you.
Can we turn, please, to chapter 3 in the report, and I think, Professor Gould, these questions are mainly going to be directed at you. I understand that people are finding it difficult to hear, so – I know it’s not much space – could you perhaps move your chair forward a little bit. And if anyone can’t hear, I’m sure we’ll get a message.
Professor Gould, I suppose some background, really, it’s your page 38 that we’re starting at.
We’ve heard reference already in the Inquiry to the National Infection Prevention and Control Manual, the NIPCM, which was first published in Scotland but has subsequently been rolled out across the UK. It was adopted, I think, in Wales first, is that correct, in 2018?
Professor Gould: Yes.
Ms Carey: In England pre-pandemic it was Public Health England guidelines were used; is that correct?
Professor Gould: A combination of guidelines were used, including Public Health guidelines.
Ms Carey: Thank you. Then England moved to the NIPCM in April 2022; is that correct?
Professor Gould: Yes.
Ms Carey: In Northern Ireland, Public Health Agency guidelines applied pre-pandemic. They updated their manual in 2023 and based the update on the NIPCM; is that correct?
Professor Gould: That’s correct.
Ms Carey: I just want to check this: notwithstanding that NIPCM is either the manual or underpins the manuals in the respective countries, I’m asked to ask you whether you are aware that the NIPCM for England has its own governance structure, notwithstanding that it’s based on the NIPCM Scotland; were you aware of that?
Professor Gould: Yes.
Ms Carey: Thank you. Just for the record, we are aware that the UK IPC guidelines were published in the name of all four public health agencies and the Department of Health and the NHSE.
At the outset, can I ask you whether you think, in your experience, consultation with stakeholders is important when developing guidelines such as IPC guidelines.
Professor Gould: Very important indeed, because the stakeholders are the people who – they will include the staff who will have to put them into place, and they will include the patients who will have to have them used on them, and the patients’ families, and other groups with specific information that would wish to feed into guidelines. So stakeholder involvement would be essential.
Ms Carey: At what stage would you recommend that there should be stakeholder engagement?
Professor Gould: From the outset, if at all possible.
Ms Carey: In the room drafting the guidelines, as it were?
Professor Gould: Yes.
Ms Carey: How practical is that? Clearly in pre-pandemic times there may be more leeway in terms of pressures of time.
Professor Gould: I think these days it would be more easily done by previously, because people would do it by video conferencing. So it would be, these days, more practical.
Ms Carey: Compliance or otherwise with the guidelines and the role of regulators, can we just consider that, please. I think you say in your report at paragraph 3.14 that:
“The regulatory bodies … play an important role in ensuring that adequate IPC standards are in place.”
But I just want to be clear about what is mandatory, what is guidance, what is the sanction if you don’t follow IPC guidance.
So could I start with England, please. I think you said England is mandatory.
Professor Gould: Mandatory means that you have to do it, so you would have to show that you had – you would have to be able to demonstrate to the regulatory bodies that you had the guideline in place and that people knew what it was and where it was and how to find it. But making sure that they followed everything on it would be another story, because they would have to have the time, the resources and all the other things that is necessary. If the hand hygiene gel is not there, you cannot use it.
Ms Carey: We’ve seen I think in some of the IPC guidance the words “must be used”, indicating a sort of mandatory, but what happens if you don’t follow the guideline?
Professor Gould: If the regulatory body comes and you are not adopting the guidelines or you are seen not to be adopting the guidelines then you will be penalised.
Ms Carey: In Scotland you set out that the NIPCM manual has a disclaimer on it and it reads as follows:
“When an organisation, for example health and care setting, uses products or adopts practices that differ from those stated in [the manual], that individual organisation is responsible for ensuring safe systems of work including the completion of a risk assessment approved through local governance procedures.”
I think there’s also that wording I think on the bottom of the English NIPCM. Not mandatory, then, you can deviate from it providing you’ve got a safe system of work including, for example, a risk assessment. Is that how I should read that?
Professor Gould: Yes. Healthcare is dynamic, new products, new ways of working are introduced all the time, guideline development is complex, it is time consuming, even if you do it by video conferencing, and you can’t mandate for every occasion. So if you were going to introduce new equipment or a new way of doing something, you would have to be able to demonstrate that you had thought about infection prevention before you did it, and you could argue that what you were doing was safe and sensible.
Lady Hallett: Just before you go on, Ms Carey, I may have misunderstood. I thought you said the English guidance was mandatory but the Scottish had the disclaimer, but then you added: but the English guidance also has a disclaimer.
Ms Carey: It does have a disclaimer on the bottom of it, but it does say this “should be adopted as mandatory”. So perhaps that’s not entirely – let me read it out for clarity’s purposes, so the website on the NIPCM on the NHS England website states that NIPCM:
“… should be adopted as mandatory guidance in NHS settings or settings where NHS services are delivered, and the principles should be applied in all [healthcare] settings.”
That’s how it reads. But I think there is the caveat added, I will find it at some point in a convenient break.
Can I park England for a second and ask you about Wales, please. I think you say this: the web pages for the NIPCM in Wales state that the manual, and indeed there’s a care home manual, “are considered best practice”.
Professor Gould: Yes, guidelines are considered best practice, the best way of doing things. They don’t talk about mandatory so much on the Welsh guidelines.
Ms Carey: No. So how does one enforce best practice?
Professor Gould: It would sometimes be very difficult, but then it would be difficult in any – whichever nation you were in if you didn’t have the time or you didn’t have the resources to put the guideline in practice. If you didn’t have the right equipment then it would be very hard wherever you worked. And that would be the same in Wales and anywhere else.
Ms Carey: In Northern Ireland, the webpages state:
“Healthcare organisations may adopt this advice and guidance in Health and Social Care Trusts, Primary Care, Private Clinics and Voluntary sectors …”
So clearly, there, discretionary, not mandatory?
Professor Gould: The Northern Ireland manual says substantially less than the other three manuals, and it’s harder to draw inferences from them about what is expected, except that they are clearly drawn from the Scots ones.
Ms Carey: Do you think that that’s helpful?
Professor Gould: It would depend how much guidance you wanted, it would depend how confident you were.
Ms Carey: Variation, then, in the terminology used across the four nations. Do you think that leads to an inconsistency of approach between the four countries?
Professor Gould: There could be slight inconsistencies, and certainly it is confusing when the manual says that it’s mandatory and there is a disclaimer there as well. That is – that’s difficult.
Ms Carey: In addition to the NIPCM and the equivalents thereof, can you also have local guidelines?
Professor Gould: You can have local guidelines that are adopted from the national guidelines, but then there are other guidelines as well as the national infection prevention and control manuals.
Ms Carey: Yes, there are a number of guidelines I think we may look at produced by various societies, royal colleges and the like, understood.
Professor Gould: Yes.
Ms Carey: Can you help with this: we know that during the pandemic the regulator stopped visiting healthcare settings in particular hospitals; do you think that had an effect on whether IPC measures were being properly undertaken and conducted? Is that something you can help us with, Professor Gould?
Professor Gould: I think Dr Warne might be better, in a better position.
Dr Warne: I think it’s very difficult to say, because any kind of visit from the regulators produces additional burden and stress on these departments, who are already incredibly under pressure. I think there are other ways that you could measure infection control interventions and compliance, but, bearing in mind the guidance was changing frequently, I’m not sure how useful that would have been. It’s beyond my area of expertise.
Professor Gould: I can remember examples from clinical practice. I was doing a research project throughout the Covid period and I was particularly speaking to people on the surgical wards. They said that parts of their ward had been commandeered for other purposes, so the room in which they normally did surgical dressings – this was a complex plastic surgery ward, patients were at very high risk of infection, with very severe consequences if they became infected – the room which they reserved for doing the dressings in had been changed into a room where computers were present to record epidemiological data, so the dressings were being done at the bedside and locally the nurses thought that there were more infections result of that, and ergonomically it was more difficult to do those dressings. I don’t have any hard evidence of the infection rates but that example struck – to me it was a very interesting example and it stuck in my mind.
Ms Carey: The development of the guidelines, and I think you set out a summary and then I’ll work backwards, if I may, but, Professor, you say this:
“Guideline development is time-consuming … [it is not practical] in an emergency such as a pandemic when information is needed as soon as possible.”
And I think you set out in your report there are a number of ways of drafting the guidelines but there’s two I’d like to look at in particular, which is a literature review-based guideline and a rapid review-based guideline.
So taking a literature review first of all, what is a literature review?
Professor Gould: A literature review is a summary of all that has been written on a subject. There are different sorts of literature reviews, but in this case people would be talking about a systematic literature review, which is one in which all sources of evidence have been considered.
Ms Carey: How long does that take?
Professor Gould: It can take a very long time, depending on the amount of literature that has been written. So on a topic like hand hygiene – and I’ve been involved in the writing of hand hygiene guidelines – when an enormous amount has been written, it can take you over a year. You can speed the process up if you have to, remembering that guideline development need not necessarily be a full-time occupation, often people do it alongside – you know, it’s something you do alongside your job very often, or you might work in the university and you might do it as part of your academic activities, but practitioners will be involved in it as well.
Ms Carey: A rapid review?
Professor Gould: A rapid review is supposed to be based on the literature but is streamlined, it’s an accelerated process.
Ms Carey: How long does a – I hesitate to use “average rapid review”, if there be such a thing, but how long would a rapid review take?
Professor Gould: It’s defined as something you would do in about three months, but rapid review, some are much more rapid than others. A lot, again, would depend on how much had been written. In some areas, you know, in the case of Ebola, in the Ebola guideline development, in which I was not personally involved, not very much was written, and so there wasn’t actually very much to review, so looking at what had been written would have occurred much more rapidly.
Ms Carey: I’ve made reference there to manuals and guidelines and indeed guidance, and help us with what distinction, if any, there is between those things. Perhaps start with a guideline. How do you perceive a guideline to be defined?
Professor Gould: A guideline is usually considered to be a general outline of what should be achieved. It’s usually supposed to represent best practice, you know, what you would do under ideal circumstances for everybody to avoid unwarranted variations in practice so that all patients are treated the same.
So deviation from a guideline ought to be possible if you had to. For example, if a new way of doing something evolved, if a new piece of equipment was evolved, you would look at the guideline but you would use the guideline to inform what you did, remembering that the guideline couldn’t be updated every five minutes.
A manual is – infection prevention experts appear to use the word “manual” and “guideline” much more interchangeably and synonymously, but in lay parlance a manual would be a how-to-do-it thing, rather like a recipe, rather than general principles. So a manual would tell you the different stages of a procedure and what you were doing.
Ms Carey: Is there any difference that you can determine between a guidance and a guideline?
Professor Gould: As far as I can see, and I have tried to find the difference between them, they are used synonymously.
Ms Carey: Now, help us, please, if you wouldn’t mind, Professor, with your paragraph 4.4 where you set out the WHO criteria for developing IPC manuals, which I think came in in 2018.
Can we perhaps put it on the screen. It’s INQ000474282_42, excuse me.
If we could go to the bottom of that page, and paragraph 4.4, I think the definition is set out. That’s it, there we are:
“The WHO has published criteria for developing IPC manuals … The WHO criteria state that ‘The manual is not intended to be a prescriptive list of “must do’s”. Instead, it provides a stepwise approach to implementation based on the evidence and experience of worked in a number of settings and introduces examples and ideas from healthcare facilities [from] around the world which can be used by IPC leads/focal persons and teams within health care facilities’.”
Can you help, what is a stepwise approach?
Professor Gould: Well, first of all I would like to point out that this manual was written with low-income countries more in mind than with high-income countries, but it seemed quite important to write about manuals, given the title of the guidance that we have in the UK. But step by step would indicate there was more directive behind it rather than a guideline. So this kind of a manual I think would be telling you how to put a guideline in place. It would be saying, you know, you have to involve stakeholders, you have to go through these processes, but it wouldn’t be, I think, like a recipe book, remembering that these manuals would have to apply in Africa, in other parts of the world that would be very different.
Ms Carey: Thank you.
You say:
“The WHO advocates … a clear summary of its core components, identification of barriers and practical solutions …”
And then this:
“… and the importance of ‘winning hearts and minds’ …”
And you say:
“The phrase ‘winning hearts and minds’ is used to describe …”
Is that a quote?
Professor Gould: Yes.
Ms Carey: “… the ‘convincing narrative’ that must be put in place …”
Why is it a question of winning hearts and minds?
Professor Gould: Because emotionally and intellectually people need to accept that the guideline genuinely does represent best practice, that it is based on evidence that is of the best quality where that evidence exists, and people have to want to do it and they have to feel emotionally able to do it. If they’re given a guide – if people are instructed to do something and they feel that it’s not right, then they still may not follow it, they may improvise, they may do something different, or they may simply not adopt the guideline at all.
Ms Carey: When dealing with something, though, as fundamental as infection prevention and control, I understand the desire to win the hearts and minds battle but is it not just a case of “Do what you’re told because that’s what the guidance tells you to do”?
Professor Gould: People don’t behave like that, sometimes they can’t follow the guidance if they don’t have the right equipment anyway.
Ms Carey: There are, as we alluded to earlier, a number of guidelines produced by NICE, professional bodies, the UK IPC cell. You say in your report there are differences in the way that various bodies produce and generate guidelines, and we’ve touched on already the use of randomised control trials and why they are considered the gold standard. Are they relevant when it comes to looking at the UK IPC cell guidelines or not?
Professor Gould: They’re relevant, but infection prevention interventions are public health interventions. Randomised control trials were developed to test pharmacology interventions such as vaccines, such as drugs, and there the intervention is aimed at individual people, whether the person getting the drug gets better or otherwise, is protected by the vaccine or otherwise, whereas infection prevention and control guidelines are really public health interventions. And it’s much more difficult to subject those to randomised controlled trials. You can do it, but there will be more flaws.
Ms Carey: You were speaking now about the kind of evidence that might underpin a guideline and I think you say this in your report:
“Professional groups view evidence differently. Medical staff tend to be interested in how evidence has been generated and value evidence derived from the findings of randomised controlled trials. Nurses appear to be more interested in how evidence can be used to support practice. They appear to place less emphasis on how it is generated than doctors …”
Does that not cause a slight disconnect when one thinks about winning hearts and minds? The nurses just want to be told what to do but the doctors want to understand how we’ve ended up in this position?
Professor Gould: I don’t think nurses necessarily want to be told what to do, I think that they do like to think, but I think one does have to look at the difference between the preparation of medical staff and nursing staff.
Medical staff have a much longer preparation time, they learn much more about epidemiological matters, they learn much more about evidence-based practice and research. A medical degree takes five or six years to complete. A nursing degree takes three years, and half of that is spent in practice placements, the other three years (sic) is theory.
There is input on evidence-based practice in a nursing course, but it cannot be at the same high level that doctors have, and nurses don’t necessarily have the scientific background always. This is a generalisation. But it is quite a lot harder, I would say, to teach evidence-based practice to nurses than to doctors, and I have done both. In my last job at Cardiff University I taught the medical students evidence-based practice. Since the pandemic I have taught nurses evidence-based practice. It is actually quite a lot harder with nurses because you have to provide much more background material.
Ms Carey: Understood.
There are, is that correct – or there is, I should say, WHO guidance on how to produce guidelines during an emergency; is that correct?
Professor Gould: There are.
Ms Carey: I think you said in your report that effectively they have “specific recommendations” as to how guidelines should be produced:
“According to … international standards, [it] should take place in two stages.”
What are those two stages, please?
Professor Gould: First of all you should do a systematic review or a review of the literature as far as you can, if that literature exists, remembering it may change as the situation evolves. And secondly, you should develop the guidelines from the review of the evidence, such as it is.
Ms Carey: Translating that to the Covid, though, pandemic, where we’re having a novel pathogen, how, practically, would that happen in these circumstances?
Professor Gould: It will be challenging. It was a challenge. I think that – well, it was a novel challenge, but not unprecedented, because the World Health Organisation guidelines are devised not just to look at pandemics, but any kind of emergency, so in the case of upset of infrastructure to do with earthquakes or whatever, they’re designed for that as well. But I think one has to realise that in an emergency situation, information is unfolding very quickly, which is why rapid reviews are often used. But the World Health Organisation does – and other organisations are very clear about the fact that rapid reviews should not replace full-scale systematic reviews when time and resources allow.
Ms Carey: A shortcut may be taken at the start of a pandemic, then –
Professor Gould: Yes.
Ms Carey: – but with the knowledge that in due course you should be conducting a more full-scale review.
Professor Gould: Yes.
Ms Carey: Is there any guidance as to how soon after the rapid review the full-scale review should take place?
Professor Gould: Yes, the organisations are fairly clear about that: they say that after three months you should update a rapid review and the systematic review should be available in a year. The World Health Organisation say that there should be an interim report as well.
But remembering also that when you do a review of the literature, that review is done electronically; it is possible to update the review at any time, you would simply have to run it again.
Ms Carey: Can I ask you, please, about challenges to sort of implementation of guidelines. I think you’ve already told us that successful uptake depends on the front line believing in the guidelines, presumably being clear in the guidelines, and you make the point that guidelines that refer you to another guideline or another website are not helpful, particularly in a pandemic.
Were there examples of that that you can think of in the IPC guidelines at the start?
Professor Gould: There were lots of complaints throughout the pandemic that the guidelines changed, and of course that made it very difficult for people, but some of that was inevitable. For example, at the beginning of the pandemic, people genuinely did feel that there was a strict dichotomy between droplet spread and aerosol spread, which I think there was – well, I know that there was evidence that there was no such dichotomy but it was widely held that there was. More work was done throughout the pandemic and the guidelines had to be updated accordingly.
Ms Carey: You say this:
“Guidelines that instruct the user to take an additional action or decision are equally unlikely to meet health professionals’ needs. This is another common feature of IPC guidance. All too frequently users are instructed to make a ‘risk assessment’ …”
Now, we’ve touched on it already in relation to the Scottish NIPCM, for example, but help us, why is it not helpful to tell people to conduct a risk assessment if that would help keep them safe?
Professor Gould: If people had the skills and the knowledge and the expertise to do a risk assessment, that would be fine. But they might not have, or they might be so anxious that they couldn’t be thinking rationally. There is risk assessment, I think, at an organisational level, when people have time to reflect among one other, and there is a risk assessment that you do at the bedside, when you’re all on your own, in a novel situation, the guideline is in your head but there are all sorts of things going on and you may not be able to follow it. So reading in a guideline “Go away and do a risk assessment” is not always very helpful to people.
Ms Carey: Do you think that the IPC guidelines that recommended a risk assessment were useful?
Professor Gould: I think that’s a very broad question. I think sometimes they were probably useful and sometimes not, depending on who was reading them.
When I was doing work for this, I put myself in the position of thinking what it would be like if I was still a ward sister in charge of a ward right at the front, and I think it would be very difficult. Some of the staff would be confident at doing a risk assessment, and some others would not.
I noticed that in his expert statement, Dr Barry Jones said it’s particularly difficult with aerosol-generating procedures because, after all, the person at the bedside can’t count the number of virus particles that are present, they can’t see them and they can’t smell them either, and so that makes life very difficult. That would be true of other hazards such as radioactivity in healthcare as well, it’s not just unique to infection, but you are asking people to cope with the unknown. And remember that not all people at the front of – at the bedside are going to be qualified professionals who have –
Ms Carey: Well, quite.
Professor Gould: – who have had any infection prevention –
Ms Carey: We have heard already that some of the IPC guidance, I think it’s in January 2022, included reference – and that was the seasonal guidance, not just Covid-specific – included reference to IPC measures that should be taken whether the virus was wholly airborne or predominantly airborne. Do you think reference to “wholly” and “predominantly” is helpful to the nurse at frontline?
Professor Gould: Well, they’re vague terms, you can’t really quantify them.
Ms Carey: Speaking of which, may I ask to be put up on screen, please, INQ000421245, and the language used, because we have an answer to your Ladyship’s query.
This is the NIPCM for England, and if we could just scroll down, it says the aims are to:
“• provide an evidence-based practice manual for … those involved in care provision in England and should guidance in NHS settings or settings where NHS services are delivered and the principles [that] should be applied …”
If you go down to the “Audience and target groups”, there is further reference to “should be applied”.
And if we could go over the page to page 2, and at the bottom of the page I think it is:
“When an organisation, eg, an NHS trust, uses products or adopts practices that differ from those stated in this manual, it is responsible for ensuring safe systems of work, including the completion of a risk assessment approved through local governance procedures.”
So not dissimilar to the disclaimer on the bottom of the Scotland one.
I suppose it comes back to her Ladyship’s question: how helpful is it to have, on the face of it, what looks like mandatory guidance but then a disclaimer on page 2? Is that useful, is it confusing?
Professor Gould: Potentially, of course, it is confusing, but I think you have to have the disclaimer because healthcare is dynamic, because new ways of doing things, new equipment, are introduced, and no guideline can ever cover every eventuality, something different is always going to happen, something unique or – you can’t – you could take all day, you could take all year, you cannot cover for every eventuality.
Ms Carey: Having looked at some of the terminology and the advantages and disadvantages of having mandatory and a disclaimer allowing for a deviation from practice, do you think that the guidelines were effective at ensuring that black, Asian and minority ethnic healthcare workers understood the need for good infection prevention and control guidelines and took into account their perspectives?
Professor Gould: Well, I think again that’s a very broad question because much depends not just on people’s ethnicity but on people’s professional backgrounds and on the procedures that they are doing. So somebody – I mean, people’s ethnicity did affect their susceptibility to infection, and there’s no getting away from that, but a lot would depend on what those people were doing, whether they were qualified professionals, whether they were unqualified professionals and what kind of setting they were working in. So I think you can’t just look at ethnicity, you’ve got to look at all those other things as well.
Ms Carey: I asked you about engagement with stakeholders and didn’t specify which, but do I assume that that would include within those, those within – healthcare workers within black, Asian and minority ethnic –
Professor Gould: Yes, they would.
Ms Carey: Yes.
May I ask you about a slightly different topic, and something that we’ve heard about called the GRADE framework, but we haven’t really looked at it yet, and it’s at your paragraph 4.36.
It might be helpful to just put that up on screen, actually, but you say:
“A structured approach is advocated when formulating guideline recommendations. Ideally it should involve the use of an evidence-to-decision-framework.”
Could we put up, please, INQ000474282_49, which is Professor Gould’s report.
Paragraph 4.36, at the bottom there:
“A structured approach is advocated …”
Then there is reference to:
“The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) … [being] the most widely used framework.”
And it identifies four levels of evidence: very low, low, moderate and high.
Can you help us with GRADE and how evidence might be upgraded or downgraded and how it impacts with the guidelines?
Professor Gould: Yes. If you look at the evidence that’s come out of the literature review, you have to have a method of – you can’t just look at the literature review and pick out individual points and say “Well, I like that and so I’m going to put that in my guideline”. It has to be auditable. So people have to know how you reached your conclusion, it has to be clear to other people, it has to be transparent to everybody taking part and to the people who are going to use that guideline and have it used on them.
You would look at the guideline, the guideline might say: everybody needs to wear a high-grade face mask. That would be based on the findings of high-quality evidence, just supposing, supposing it existed. But then it might be very difficult to provide everybody with a high-quality face mask because they might just not be available. So you would downgrade that recommendation, but you would have to say why.
Some recommendations might not be acceptable to all people, and so you would have a discussion in your group, in your discussion group, about why you thought that something wouldn’t be acceptable, and that would be where stakeholders would come in. Stakeholders might say: well, this would be desirable but ordinary people won’t do this because of whatever reason.
So you can upgrade or downgrade your recommendation, but you have to show how you reached that conclusion.
Lady Hallett: Could you speak a little more slowly, please.
Professor Gould: Yes, I’m so sorry.
Lady Hallett: It’s all right, no, we all do it.
Ms Carey: A show your working?
Professor Gould: Yes, you have to show how you got there.
Ms Carey: Now, you say some recommendations might not be acceptable to all people. Can you think of an IPC measure where there might be unacceptability to some people?
Professor Gould: Yes. IPC guidelines state that alcohol hand rub should be used in the clinical situation to prevent the spread of bacteria and viruses, but if somebody touched something very dirty they might emotionally think it would be nicer to use soap and water, so they might very well do that instead of using alcohol hand rub.
There have been cases where new policies of infection prevention and control have been introduced into NHS trusts, people have introduced a new disinfectant, and people have said “No, I like the old one and I’m going to bring in the old one from home”, and people do.
Ms Carey: You make the point in your report that no matter how rigorously undertaken systematic reviews are, they might not yield the required evidence.
Professor Gould: They might not.
Ms Carey: So how are guidelines drafted and come into being where there isn’t a body of evidence following a literature review?
Professor Gould: Where there isn’t a body of evidence then you would rely much more on expert opinion. And if you can’t have the results of randomised controlled trials, you would go lower down in the hierarchy of evidence to look at retrospective cohort studies, as we’ve heard already, or you might look at case series analyses, but even where those – they may not exist, they very likely don’t in the case of infection prevention, so you would call on professional experts and lay stakeholders who had had experience of the infection and ask those people for their expert opinion. But expert opinion is not the same as evidence.
Ms Carey: So turning to the Covid pandemic then and the guidelines at the start, are you able to help us with – there’s guidelines that came out in March 2020, and put the HCID ones to one side from January, but by March 2020 were those guidelines based on literature reviews or rapid reviews, can you help?
Professor Gould: They were based on rapid reviews.
Ms Carey: And in your opinion, was that an acceptable practice given the emergency nature of the situation we were in?
Professor Gould: At the beginning of the pandemic I think there was no help but to use rapid reviews, people had to use the information that was there and they used information from pre-existing respiratory infections, predominantly SARS and MERS. But as the pandemic wore on, then I think that those rapid reviews could have been better updated. What happened was that rapid reviews were generated a lot of the time or were added to, but no full-scale systematic reviews took place.
Ms Carey: When do you say that should have happened?
Professor Gould: Well, according to the guidelines that come from the World Health Organisation and other organisations, after about 12 months.
Ms Carey: That would take us to March 2021, where we would have been through wave 2.
Professor Gould: Yeah.
Ms Carey: Is there any merit, do you think, in the guidelines being reviewed in the summer of 2020 when there was a lull, my word, perhaps not the scientific one, between wave 1 and wave 2 starting?
Professor Gould: If there was a lull it would have been a good opportunity for people to have used their time, if they had any, to produce guidelines or to think about guidelines.
Ms Carey: Can I ask you, please, about ARHAI Scotland and rapid reviews, and I think you are aware that they had conducted a number of rapid reviews, and some of those rapid reviews were appended to IPC cell minutes.
Professor Gould: They were.
Ms Carey: Did you have any concerns about the use of ARHAI rapid reviews being used by the UK IPC cell?
Professor Gould: I had reservations about it, because of the way that those rapid reviews were undertaken, and they weren’t updated as they should have been.
Ms Carey: Help us with that, what were your concerns? Why did you have them about the ARHAI rapid reviews?
Professor Gould: They were undertaken in a manner that wasn’t very comprehensive or systematic. They were undertaken predominantly by one or two people. A limited amount of – when you do a review of the literature, you look at a number of databases. Many databases exist. They looked at a restricted number of databases and some of the databases that were omitted were ones that would have contained key information, particularly about transmission.
Stakeholder – I mean, I could talk for quite a long time. Stakeholder opinion doesn’t – as far as I could see, wasn’t taken into consideration. It would be difficult in the middle of a pandemic to include stakeholders, but something could have been done.
The presentation of the guidelines was quite difficult as well. That was perhaps not such a problem with the IPC cell as it was for people trying to put the guidelines into practice.
Ms Carey: In your report, I won’t go to it, but you set out at table 1 at page 54 summaries of evidence and recommendations that ARHAI Scotland rapid reviews produced. Can I ask you this, though: I think you said that there is little detail that was provided about the processes used by ARHAI Scotland to search the literature, select the works, critique them, resulting in a lack of the convincing narrative that the WHO guidance advocated. It resulted in maybe a lack of trust expressed by health professionals themselves and their representative bodies.
Professor Gould: Yes. If a review isn’t – if guidelines and reviews are not undertaken in a systematic way, if they take place quickly in a piecemeal way, they’re more likely to contain bias, they’re more likely to be influenced by other factors than the ones that we’re looking at and health professionals did realise that, they did realise that shortcuts had been taken. Some shortcuts are more permissible than others and it’s not a very good idea to go on repeating the same shortcuts and I think that people thought that more comprehensive literature should have been reviewed and they would have had more faith if they didn’t.
Having said that, I think it would be fair to say that people’s reactions were often very emotional but, nevertheless, intellectually, people didn’t always trust the guidelines.
Ms Carey: That brings me on to your work, Professor, I think, in 2021, when you were commissioned by the Royal College of Nursing to conduct an independent review of IPC guidelines. Help us with what were you asked to look at and why were you asked to look at the guidance.
Professor Gould: I was asked by the Royal College of Nursing, the RCN, specifically to look at the ARHAI guidelines. I wasn’t asked to look at anything from NERVTAG, I wasn’t asked to look at anything from the IPC cell, I was specifically asked to look at the most recent ARHAI guideline, which was the one that was produced in February that year, I think 5 February, and I was asked to look at it in detail and to look at the methods that were used to construct it.
Ms Carey: When you looked at it, what did you conclude?
Professor Gould: It didn’t look like – it didn’t resemble what I was expecting.
Ms Carey: In what way?
Professor Gould: It wasn’t of the quality that I would have expected, given it certainly wasn’t of the quality of systematic review, but it wasn’t of the quality of a well conducted accelerated review either. The methods weren’t described in any very great detail and it was very hard for me to work out exactly how the information contained in it had been reached.
Ms Carey: Can I ask you this: I understand the arguments you make about driving, effectively, the reader to the conclusion that it makes, but do you think perhaps there is an overfocus here on how you get there; if it gets the right result does it matter in an emergency how you get there?
Professor Gould: But in an emergency you don’t know what the right result is, so you don’t know.
Ms Carey: So, in relation to the ARHAI Scotland review, do you think they got to the wrong result because they hadn’t followed the right process?
Professor Gould: Some of the time I think that they did.
Ms Carey: How did that affect, if at all, the UK IPC cell guidance?
Professor Gould: It would be hard to know, because I looked at the IPC guidance in the documents that I was sent, but it would be hard to look at how they were – a lot of it documented conversations that appeared to have taken place very quickly. In looking at them, I never found any detailed discussion. I didn’t find any evidence that people have said, “Oh, we looked at the ARHAI guidance on such and such a day and we have been through it and we’ve reached this conclusion”. A lot of it seemed to be off-the-cuff decisions, I might be wrong because I wasn’t there, but that is the impression that I get.
Ms Carey: That brings me on to a rebuttal of the RCN report that you had undertaken, which was issued, I think, by NHS NSS, so National Services Scotland, and I think they were critical of your report, saying it incorrectly assumes that the UK IPC guidance is based on the ARHAI rapid review, and the rebuttal also stated that the RCN report incorrectly asserts that Scotland’s NIPCM is based on rapid review methodology, “The origin of this statement is unclear”.
Can you help disentangle the rebuttal from what you were asked to do and what actual happened.
Professor Gould: The rebuttal didn’t really make a great deal of sense to me because I had been asked to look at the ARHAI guidance, I hadn’t been asked to look at any other, but also it itself appeared to contain, well, incorrect information because never in the work that I wrote for the Royal College of Nursing did I even mention the word “manual”. I didn’t mention the national infection prevention and control manuals, I wasn’t asked to and I didn’t mention them.
Ms Carey: Crossed purposes or crossed wires maybe?
Professor Gould: Well, the impression that I got was that somebody had looked at what I had written and had taken fright and decided that they didn’t like it very much. The rebuttal was quite brief but a lot of it didn’t make a lot of sense to me.
Ms Carey: Do you think, having been on the inside of this, that, forget the rights and wrongs, but the arguing about whether who was right and who was wrong was a distraction to those who were actually trying to bring in better protection for healthcare workers?
Professor Gould: I think it probably was.
Ms Carey: Standing back, then, taking your observations about systematic reviews, rapid reviews, the need for clear guidance, in the event of the next pandemic that’s novel and there isn’t an evidence base, what would be your sort of summary of how IPC guidance should be developed?
Professor Gould: It would be a good idea to have thought about what might happen before the eventuality. So it would be a good idea to be able to draw upon a panel of people who could produce this guidance and could produce it rapidly.
Now, rapid reviews are problematic because nobody agrees what is a good one. Three organisations globally, internationally, have written about rapid reviews and their views are more or less all the same, and they all recognise that shortcuts can be taken but they don’t endorse any of the shortcuts.
We would probably benefit if people could have a greater debate about what makes a good rapid review and what doesn’t. The situation is complicated because what might be permissible in one situation might be not such a good idea in another. Looking at, you know – one of the criteria of a rapid review is that you only look at publications in one language. That probably doesn’t matter all that much because most people aim to get their publication in an English journal and most journals, wherever they’re produced in the world, are actually published in English, which many people don’t realise.
But restricting the number of databases in the case of Covid probably did matter. So I think you would want to be aware – the panel of people doing this would need to be aware of the shortcuts of rapid reviews and there would have to be a group of people who were able to jump off the mark very quickly and produce guidance very swiftly, and you would need a panel of stakeholders that you could refer to as well.
Ms Carey: Well, I was going to ask that. So who do you say should be on the panel?
Professor Gould: You’d have to have, obviously, people who are guideline developers, who are technically expert, but you would need to have technical experts in the type of infection as well that you thought it was, and you would need to have people there who were going to put the guidelines into practice, which would be practitioners in the various groups, and patients and families as well, lay representatives, and people from the professional bodies.
Ms Carey: Why do you include in it the patients and families?
Professor Gould: Because they’re going to have the guidelines used on them, and they deserve a voice.
Ms Carey: Thank you, Professor.
Can I turn to some challenges in the implementation of guidance, and I think this is your area of the report, Dr Shin, and I’m in chapter 12, if it helps you.
We’ve obviously already considered with Professor Gould just there some of the terminology and how helpful or otherwise that is, but can I go back to basics and, when a new guideline came out, was that communicated to the trust, the hospital and then, indeed, the staff who had to implement it?
Dr Shin: So there was a now well rehearsed method, so it came out, basically, from a national body, be it NHS England or UKHSA or PHE. It would then be – in England it would then be transmitted to a regional organisation, for example, NHS England London for example, and then to the NHS Trust within that region, say London, for example, and then to –
Ms Carey: So it goes national, regional –
Dr Shin: Then hospital.
Ms Carey: We saw yesterday a CAS communication, a central alerting system. Is that how you were alerted to the fact guidance was coming?
Dr Shin: That’s one method, we’ve had some recently, but there are other methods too, for example, IPC networks. Another complication is that in England NHS systems are now organised in bodies called integrated care systems, of which London has five, for example, and that’s another way of cascading information.
So in terms of cascading, there is no reason to be concerned about that because information would definitely get cascaded. Once it reaches hospital then it would arrive on, for example, something like my desk or my colleagues and be cascaded internally within – mainly within senior leadership and then we discuss how we can implement that, whether we can implement that and also when, and then we communicate we work closely with our communication colleagues, make sure it gets cascading out through the formal communication method, which might be email, daily bulletins, but also through professional networks within the hospital, for example matron huddles, through all staff or, for example, all consultant emails, that kind of thing.
Ms Carey: So pausing there, if you got some guidance that came out on a Friday afternoon, and we’ve heard a number of examples of that, indeed we saw one coming out at 4.43 on a Friday, what do you practically do as the DIPC?
Dr Shin: Get a large cup of coffee, I think!
This was a feature which many, many witnesses and many of my colleagues at the time we – it did occur quite frequently, I’m not quite sure why it has to come out on a Friday. It was difficult because, on a Friday, everybody is preparing to go home so we would stay and deal with it and have those conversations I’ve described as quickly as we can, and then probably deal with it more completely on Monday morning to generate a plan on how we would cascade that.
Sometimes the guidance was quite urgent and it would – maybe really important, new information came out and we would have to cascade it as best we can potentially on a Friday evening.
Ms Carey: So we were looking yesterday at the acute shortages guideline, when there was a shortage of gowns, and that came out at 4.43 on a Friday afternoon. How did you get that down to the staff that weekend?
Dr Shin: That kind of example would be done with difficulty. We would have, you know, on-call teams, site management, in our hospital, I’m sure in many others, there are weekend operational meetings, which I attended during the pandemic, and we just have to use every method we can to get the message out. But that Friday afternoon/evening is just not a good time to disseminate this kind of guidance.
Ms Carey: I don’t know if there is ever a good time to disseminate the acute shortages guidance.
Dr Shin: On those particular examples I can understand but a lot of time, when you look at the guidance, it was not clear to me and many of my colleagues why it was so urgent it had to come out on a Friday afternoon but that example you gave, yes, I can see why that’s –
Ms Carey: Would it have made a difference if it came out at 9.00 am on a Monday morning in the pandemic?
Dr Shin: For that particular example, that would have come out whenever the need arose but there were other times where there were changes in, I don’t know, pathways, for example, and why that was so urgent to come out on a Friday afternoon was not always clear.
Ms Carey: Do you think it would have made a difference to you on the ground if it had come out on a Monday morning?
Dr Shin: It just would have made implementation easier and been less stress for all staff and maybe less stress, less confusion, because one of the things we discussed was how can we get this out clearly to the right people at the right time and, if you’re doing it all in a rush, in a panic on Friday afternoon when, you know, emergency departments are often, traditionally quite busy anyway, and also staffing – staffing at the weekends and evenings is less, it’s just not a good time to implement guidance. But when it is urgent like the example you gave, then that’s understandable.
But the short answer, yes, just not – just don’t do it on a Friday afternoon, basically.
Ms Carey: I think we’ve got that message.
Help us with this, though, putting aside when the guidance came out, there were clearly lots of different pieces of guidance, and do you think that having so many iterations of the guidance was confusing or is it just something that has to happen as science evolves and supplies evolve and the guidance changes?
Dr Shin: I mean, in a way, the answer is all of the above. If the evidence changes significantly, as we’ve heard, then it’s right and proper to create, to generate and cascade correctly formatted guidance. But there was some – in reviewing the documents in our report, in preparing for this, there were occasions when new iterations came out it was quite hard to see the differences, and later on in the pandemic it was highlighted which bits changed but sometimes the changes were quite subtle, so it did beg the question sometimes: why is this version needed?
Ms Carey: Can you give an example? If you can’t –
Dr Shin: I can’t give a specific one but sometimes –
Ms Carey: – can you have a think over lunch and we might return to that?
Dr Shin: Potentially, potentially.
Ms Carey: The reason I ask is this: there’s a question mark for a number of core participants, about having so many versions of the guidance might have made it confusing for the staff having to implement the guidance. Do you have any observations on that comment?
Dr Shin: Yes, you see it also in non-Covid examples as well, where we disseminate guidance it’s quite common for people to print it out and stick it on a wall in the ward. So you can easily see how you can easily end up with an old version. So we tend to discourage – well, officially we discourage printing, we disseminate everything – everything is electronic these days, as we discussed, but on wards where it’s busy, having a notice on the wall is one way of communicating to staff but that can easily become out of date.
Ms Carey: I think you were made aware of a problem in Wales where, at some point during the pandemic, actually Public Health England guidance started coming out on a Thursday but Public Health Wales guidance came out the following Friday, causing an unnecessary level of anxiety through the staff because they weren’t sure whether the Thursday guidance was then going to be made to come in in Wales.
Do you have any views about whether there should be a unified approach to the announcement of new IPC guidance?
Dr Shin: Between devolved administrations, do you mean? That I find it hard to comment on but I can give you examples, even within England or within London, where if there’s cascading of slightly different rates, we have – you know, many colleagues have maybe partners or family members or friends who work in other hospitals and they may have implemented at a different rate or speed and also differed in the degree to which they adopted the guidance and that has – a lot of has – related to PPE, for example, and that has led to difficult conversations about, “Well, the hospital down the road is doing it this way, why are we doing it another way”, or “They did this last Thursday and why are we doing this on Tuesday”.
So those kind of conversations, so I think a bit more uniformity of the way it’s cascaded would be helpful but I’m not saying that that happened by any design. Probably it was more done by accident.
Ms Carey: How did you deal with that?
Dr Shin: So coming back to the integrated care system, one example where this was helpful was that we had a network with IPC of DIPCs, and I’m sure there were other professional groups as well. So when one of these major guidance changes arrived, we would quickly – well, basically email each other or phone each other and say “This is what’s come, this is the recommendation, how are you going to deal with this”. That didn’t mean that we all had to adopt the same thing at the same time but it was helpful to be aware that another hospital might do it slightly differently, so that when we get that feedback from staff to say, well, that hospital is doing it differently, we’re aware of it and we have some kind of logical reasoning, hopefully, to explain the difference.
Ms Carey: I wanted to ask you about feedback actually because, if you got feedback that a guideline had come out but wasn’t helpful, didn’t work in practice, is there any system in place for you relaying back to NHS England in this example “That just doesn’t work for us”?
Dr Shin: We – again, so this is for – if I can call it ICS because it’s quicker.
Ms Carey: Integrated care system.
Dr Shin: Yes, integrated care system, ICS.
We had some mechanisms through links with NHS England and UKHSA to feed back but, when we did that, we did that with not much expectation that it would change anything but just for feedback that we felt this was difficult to implement, but if – in each hospitals we made decisions – coming back to look at risk assessment – made decisions about to what extent we can implement that guidance.
Ms Carey: Can I ask a slightly broader question. We looked at some of the problems the terminology used in IPC guidance can cause, “predominantly”, “wholly”, and the like, but do you think that routes of transmission do have a role in IPC guidance and it may be one that all three of you would like to consider but, starting with you, Dr Shin, do you think it should set out, we think it’s droplet borne or maybe aerosol borne or might be contact?
Dr Shin: I think differentiating for contact transmission and the other methods, the other routes of transmission, that is an important distinction. I think many of us would be aware, perhaps everyone’s aware, that the WHO’s advocating for more simple nomenclature, so just airborne, moving away from, as we’ve heard, the very complicated technical difference between droplets and aerosols and particle sizes, et cetera, which Professor Beggs’ report has an excellent summary of.
So I think contact versus airborne would be a useful distinction. Talking about being clinically entrenched, I grew up as a virologist with droplet and aerosol and I think that actually particles are of different sizes, so that is not – it is valid to talk about that, from a virological perspective and maybe an academic perspective.
But, from the point of view of deploying this on the wards in our hospitals, I think a simplification of nomenclature would be helpful to avoid the confusion and all the unnecessary debate and, you know, confusion on the front line would be the last thing we want.
So, even though I’ve got reservations about moving to just calling it airborne, I think, from delivering good IPC practice, protecting staff and patients, moving to the terminology of airborne is a reasonable compromise and step to take to try and avoid confusion that we’ve experienced in this pandemic.
Ms Carey: Professor Gould, can I ask you, since you’re an educator of people that have to use the IPC guidance, do you have any views on this?
Professor Gould: I think simplification would be a good thing, particularly remembering that many people who deliver care on the frontline are unqualified support staff in any case and they will not have had any formal preparation in infection prevention at all. So a simplification would be very useful.
Ms Carey: Given, though, that we have standard IPC measures and then transmission based, doesn’t there need to be some reference to the mode of transmission?
Professor Gould: Yes, I think that there does. Whether something is spread by direct contact or through the air is important, and remembering also that most infections that are spread in hospital that cause problems on a day-to-day measure are spread predominantly by hands and by contaminated surfaces.
Ms Carey: Any agreement or disagreement from you?
Dr Warne: I do agree and I would just add that we’ve laid out in the report that there are downsides of wearing respirators. So for pathogens where there is no risk of an airborne route, so for example MRSA, we should have separate contact and airborne precautions.
Ms Carey: Well, can I turn to adherence or lack thereof, and I think this may still be you, Dr Shin, in paragraph 12.7 in the report. I think set out there that there was, anecdotally, reports of incomplete adherence to recommended RPE by clinical staff. You acknowledge that it would have varied greatly across the NHS, but the reasons for that might include lack of training, variable quality of the training, perceived lack of PPE supply in the organisation, lack of confidence in the recommended PPE, and you say there varying social pressure to adhere to PPE policy.
What did you mean by that?
Dr Shin: I think the best way to respond to that is that I think missing off that list, an important factor affecting adherence, was basically the discomfort related to RPE, and I think that would be a big factor. I find it ironic that, when we had lower levels of expected face coverings or PPE or RPE, when there was pressure to move to respirators and then we respond to that and when we did change to respirators because our ventilation was poor, there was then push-back asking us to move in the other direction because people were finding RPE so uncomfortable.
It’s physically uncomfortable, it’s tight, breathing is difficult, communication is difficult and, as we’ve said in our report and I don’t know if we’re coming onto it separately, specifically, but, you know, quite a few staff experienced skin –
Ms Carey: Yes.
Dr Shin: – lesions, you know, pressure sores, where you’ve got prolonged apparatus on your face, quite tight, and it can – and quite a few staff experienced this – lead to pressure sores on the nose, which is very uncomfortable, risk of infection and it could be potentially quite serious.
So I think those are the factors and many staff reported feeling headaches after prolonged usage, which you can understand why that affected adherence. But, you know, it was kind of a lose/lose. When we had lower standards of RPE, there was pressure to move up and then when we adopted it, there was pressure to move down.
Ms Carey: Would you say lose/lose or being caught between a rock and a hard place?
Dr Shin: Lose/lose, yes, rock and hard place.
Ms Carey: In the report, you set out that there was a survey conducted in 2020 of over 1,000 UK healthcare workers. They found self-reported adherence to PPE to be 80%. Adherence was greater in the older healthcare workers in situations where PPE supply was good and where PPE training was perceived to be good.
Do you have any observations on why it would be that older healthcare workers were more adherent than the younger ones?
Dr Shin: I think this brings us to another factor, influence adherence. As we’ve heard earlier today, it was also linked to the perceived risk to the user. So we quickly knew in the pandemic that older persons were at greater risk of more severe disease and age was a significant – I think it’s over 50 was the cut-off, so it doesn’t surprise me that older staff, who felt at a greater perceived risk themselves, had a greater adherence to RPE.
Ms Carey: We have referred a number of times now to challenges in rolling out IPC, and I think you reference in the report the size of the IPC teams, and I’m at your paragraph 12.12, but I think you say in your experience large teaching hospitals tend to have IPC teams of adequate size and expertise in non-pandemic times, but even those relatively well-resourced IPC teams were stretched during the period.
Give us an example perhaps of your hospital, Dr Shin, how big is the IPC team in your hospital, in your trust?
Dr Shin: So in my trust, we have – well, there’s myself, we have a nurse-led team, approximately 15 – it does change from time to time, approximately 12 to 15 nurses of varying seniority, from very senior to colleagues who have just joined us – I’m glad they have joined us. We also have, I think, probably the relative luxury of an epidemiologist, who only deals with IPC matters, who was very helpful generating data during the pandemic, but also before the pandemic on non-Covid matters. We also have, for example, analysts – I’ve talked about analysts, data analysts, who deal with audit data, surgical site infection data, so not necessarily Covid related.
In addition we have subject matter experts, we have two infection control doctors, who are consultant microbiologists and infectious disease physicians, and we have support from consultant virologists, so my colleagues in virology. So it’s quite a sizeable –
Ms Carey: How many people is that trying to roll out – how many patients have you got in your trust, give us a –
Dr Shin: We have approximately between 1,000 and 1,100 beds. It does fluctuate slightly so it’s approximately 1,100 beds.
Ms Carey: It gives us an idea.
There are obviously challenges during the pandemic to the supply and distribution –
Lady Hallett: Sorry, just before you go on to that.
Dr Shin, you’re a large London teaching hospital, so dare I say I’m going to assume that the NHS other hospitals around the country aren’t quite as well staffed by IPC experts, or …
Dr Shin: I mean, it would be proportionate but I think we are relatively well resourced and I think most London teaching hospitals have similar resource. I’m sure it would vary a lot but I think there will be smaller non-teaching hospitals which have maybe disproportionately smaller teams. So I think there will be quite a lot of variation across the country but I can’t speak to exact details.
Lady Hallett: Thank you.
Ms Carey: Challenges in relation to supply and distribution, and I think you say, between the three of you, you have no personal experience of PPE supplies not arriving or being exhausted in your NHS trusts, you’re not aware of any examples of specific NHS trusts running out of PPE. Some specific products ran out, if I understand it correctly, but alternative PPE was sought and supplied.
But you are aware of the concerns outside of your trusts – I see nods from both you and Dr Warne – and can I ask you please about a survey conducted, I think, by the BMA, the RCN and the Royal College of Physicians, and could we have up on screen, please, INQ000474282_128.
Could we highlight figure 14, please. I’d just like your help, Dr Shin, with what the survey found. I think it was conducted in 2020 and it set out the findings of the different, three different groups contributing to this. Do I take it that, if we take eye protection, that in high-risk environments the Royal College of Nursing reported that 22% of the people responding had difficulties obtaining eye protection? Am I reading that correctly?
Dr Warne: That’s correct, that’s – the respondents came from frontline healthcare workers, so the nursing team in that regard, yeah.
Ms Carey: Then it speaks for itself, going down, in a high-risk environment; what do you understand that to mean, an AGP hotspot?
Dr Warne: Exactly.
Ms Carey: Right. Seemingly no issues with face masks in high –
Dr Warne: I suspect that was because it wasn’t included in the survey or, no, actually, in that particular regard because respirator masks would have been recommended rather than face masks, hence it’s not relevant to that.
Ms Carey: There were reports of difficulties with respirator masks across all three contributors to varying degrees. No training on safe donning and doffing – putting on and taking off – as a problem. Then a distinction drawn between an environment with possible or confirmed cases, presumably to mirror the distinction in the IPC guidance; is that how you read it?
Dr Warne: Yes, so this has been people caring for confirmed or possible Covid cases but not in an AGP environment.
Ms Carey: There, there were reports of insufficient PPE in relation to eye protection across all three contributors, plus now UNISON had responded to parts of the survey. Face masks and indeed problems with gloves. Again, some gaps there. Do you take the gaps because they weren’t asked in the survey?
Dr Warne: Because at that time these items of PPE were not recommended for routine use in these environments.
Ms Carey: Yes, correct, thank you. So, although you don’t have personal experience of supply issues, clearly there were reports of them from a number of significant bodies representing healthcare workers.
Just can I ask you anecdotally, if I may, did you hear reports from your colleagues in other hospitals and trusts, Dr Warne, of difficulties?
Dr Warne: Yes, so, first of all, there was always a perception that the supplies of PPE were always low, they were particularly resilient in each trust but in certain trusts, including mine, there were no reports that they completely ran out. The Royal College of Physicians and others have released information about the variable quality, some of which was perceived to be not fit for purpose that was supplied. This is from the first wave of the pandemic, in particular, in March and April 2020.
And the reports on social media and various other outlets, both anecdotal and systematically collected by these organisations and others showed concerns that frontline healthcare workers felt that the availability or quality of the PPE, or the training associated with it, was not adequate.
But the detail on that is lacking. We don’t know – the definitions here are unclear and, as referenced in the report, the National Audit Office, who surveyed some NHS providers, stated that the supply chains to those trusts – the PPE never ran out. So it’s unclear why there is this disconnect between what the procurement chain is saying and what the frontline healthcare workers are saying.
Lady Hallett: Can I go back to what the human chain, as you call it, was saying about your fellow professionals. You said that there was a perception the supplies were always low, and I missed it and I think the stenographer missed it, did you say there weren’t reports of anyone completely running out or there were reports of hospitals –
Dr Warne: So I can’t speak for any other trusts; I’m not aware of any PPE shortages of any particular items in my trust but certainly there was perception of other healthcare workers at other trust that there was lack of availability on the frontline.
Ms Carey: Dr Warne, you mentioned quality issues there and it’s touched on in the report because, at paragraph 12.18, there was concern about some of the flu pandemic stockpile and the quality of FFP3 respirators. I think the report says this:
“The national stockpile had been built up over several years for the next pandemic. Unfortunately, many NHS hospitals reported that these masks were in poor physical condition and could not be used. For example, some of the masks had begun to partially disintegrate. [There was] visible deterioration of the fabric and elastic head straps of these masks.”
I think you wanted to add some context to that, Dr Shin?
Dr Shin: Yes, just reflecting on re-reading the report, that’s probably an overly black and white description. On reflection, we’re aware that some trusts were in receipt of supplies of these pandemic stockpile respirators, which were of acceptable standard and were used but it reminded me and my colleagues that one of the controversies at the time was that a lot of the stock was actually time expired and many recipients found that new expiry date stickers had been applied which undermined confidence in that PPE.
Ms Carey: So it said it’s expired in 2015 and here you were in March 2020 with a new stamp on it?
Dr Shin: Yeah.
Ms Carey: Was it communicated to healthcare workers that, although a new stamp had been applied, it was therefore approved? Had that message got through?
Dr Shin: I recall some communications about that but how clear that was I’m not certain.
Ms Carey: Just finally on this topic, we have been looking at problems in relation to masks and other PPE but can I ask you about respiratory hoods. I think you say there that there is a challenge in relation to those; what are the challenges in relation to respiratory hoods?
Dr Shin: So there are multiple challenges. Again, coming back to logistics, trusts and hospitals probably had very small numbers of them, if any, and they would have had to have purchased potentially significant numbers. We bought a few hundred, and everyone – so was everyone else. That’s one challenge. (2) you would need to, you know, train staff on how to use them. They’re actually quite a complicated piece of equipment, they have, you know, a hose to a pump and a filter with a power supply, so they’ve got bulk, they’re heavy and, if you look at them, they basically surround the head, so that’s not good for communication, from verbal, maybe even non-verbal communication, and if – and they’re often used, for example, in critical care, as an example, I’m aware of their being used quite widely.
In that setting, where people – they’ve got lots of very sick, acutely ill patients, deteriorating patients, any impediment to communication between team members is probably not ideal at all.
Ms Carey: I think you say they need to be cleaned after each use –
Dr Shin: Absolutely.
Ms Carey: – and they need to be maintained, not just cleaned?
Dr Shin: Exactly. So all of these things, when – you know, you can view these PAPR hoods as the solution to this problem of staff not getting fit tested or unable to find a mask, but although they bring that PPE protection for that episode of giving a patient care, they bring with them a lot of attendant behind-the-scenes challenges which are not evident when you first reach for this as a solution.
Ms Carey: Yes.
My Lady, I’m moving on to a different topic.
Lady Hallett: Yes, of course.
Ms Carey: Would that be a convenient moment for lunch?
Lady Hallett: I shall return at 1.35.
Once Ms Carey has finished with her questions, obviously there are questions coming from core participants, could I ask each advocate who has been given permission to ask questions to work out which expert would be best able to deal with their questions, otherwise the questions are going to come at the experts and we’re not going to know who is meant to be answer –
Ms Carey: If I can assist I’ll happily do so.
Lady Hallett: If you can. It’s just that it might be easier for the experts and easier for me.
Ms Carey: Quite, yes.
Lady Hallett: Thank you. 1.35, please.
(12.36 pm)
(The short adjournment)
(1.35 pm)
Lady Hallett: Ms Carey.
Ms Carey: Thank you, my Lady.
I think, Professor Gould, I’m turning to you next, and questions in relation to educating the workforce about infection prevention and control, and they are in chapter 10 of the report, for those who are following in the paper copy.
Can I ask you firstly about nurses. Do they have IPC training during their degree or any of the practical stages of their learning?
Professor Gould: They do. In the nursing and midwifery regulations that cover basic nurse education, pre-registration nursing education, infection prevention has to be covered and then they get practical experience of it in the clinical areas.
So they will get classroom practice, but what they will get in the practice areas depends quite a lot on where they go.
Ms Carey: Quite.
I think you said in your report that the NMC, the regulator curriculum, does not provide specific details of what aspects of IPC should be included or when or how; is that correct?
Professor Gould: That’s correct.
Ms Carey: So, with your experience, can I ask you, how does that play when you are trying to teach the nurses?
Professor Gould: With difficulty, because you never know who’s been exposed to what, and very often what people have seen in the clinical placements isn’t reflected in what the university teaches.
Ms Carey: Do you think there should be an attempt by the regulator to standardise what IPC is taught and how?
Professor Gould: A degree of standardisation would be helpful because then you would know that the basics had been covered.
Ms Carey: And the basics, in terms of the Covid pandemic, what would you have in mind for a respiratory virus on the next time there’s a pandemic?
Professor Gould: The basics for any infection prevention and control teaching that anybody would have, whether related to respiratory infection or anything else, would be you would have to teach people about the chain of infection. So you would need to teach them where the infection comes from, where the reservoir of it is, whether it’s other people or the environment, how it escapes from that source, how it’s spread, how it gets into the next host, and the damage it does there. Because if you know the chain of infection you know how it can be broken: by hand hygiene, by wearing PPE, by a combination of things.
Ms Carey: Do you know why there isn’t a degree of standardisation or reference to this in the NMC curriculum?
Professor Gould: I don’t.
Ms Carey: Okay, fine.
Healthcare assistants, can I ask you about any training they receive in relation to IPC?
Professor Gould: It would very much depend on where they were. It would depend on the organisation for which they worked, it would depend on the enthusiasm of the local infection prevention teams and the other people they come into contact with, and it would depend quite a lot on how motivated they were. Some can be very interested and know a lot, others much less.
Ms Carey: Do you think there is a need for any degree of standard training in relation to healthcare assistants?
Professor Gould: Yes, it would be useful.
Ms Carey: Would that be a matter for their regulator?
Professor Gould: They don’t –
Ms Carey: They’re not regulated –
Professor Gould: They’re not regulated –
Ms Carey: No, I was trying to think –
Professor Gould: Not in this country. Some other countries, but not in the UK.
Lady Hallett: Can I just ask, before we go further down this line, was there any effect, causal effect, in the pandemic as a result of this lack of standardisation or regulation? Because, you know, this is all about the impact of the pandemic, so I just think we need to be careful about what, in a perfect world, the training would consist of and whether there was a causal effect because there wasn’t standardisation of training.
Professor Gould: I think if you inform people, if you inform people properly, you can allay their fears. So if people had had some knowledge and had known about where to go and get it, that would have been helpful.
Lady Hallett: Thank you.
Ms Carey: Thank you.
I think you say there have been arrangements for – IPC education and training have been updated since the pandemic –
Professor Gould: They have.
Ms Carey: – and you set those out in your report. Indeed they’re different in all four nations of the UK, but I don’t need to ask you about that.
Can I ask you about, though, non-clinical staff and any education and training that they receive, porters, cleaners and the like; are you aware of any IPC training for them?
Professor Gould: When somebody moves to a new employer – when somebody begins to work in healthcare first of all, they have to have induction training, and that is the same for all staff, whether they’re qualified or unqualified. So what they make of it would depend on the way that it’s put across, and on how relevant it’s made to be.
Ms Carey: Okay.
Can I turn to a different topic, please, and could I have up on screen INQ000502072.
It’s the timeline of some of the changes to the IPC guidance. I make it clear it’s not every change to IPC guidance.
Dr Shin, can I ask you just very briefly about high-consequence infectious diseases. It’s at chapter 6 in your report, but given that you were on the ACDP it may be you don’t need to turn up the pages.
There are specific rules, as we understand it, that pertain to HCIDs; is that correct?
Dr Shin: That’s correct.
Ms Carey: We know it was classified in January and then declassified on 19 March 2020.
Dr Shin: Yes.
Ms Carey: Is this right, the rules include FFP3 to be worn, and indeed I think there’s a whole kit of PPE.
Dr Shin: Yes.
Ms Carey: There are only a small number of HCID units across the UK.
Dr Shin: There are a few specialised units and there were some, if I can call it, less specialised units, but, partly due to the pandemic, the number of HCID units in total has increased but the two units of – I think referred to as high-security units are at the Royal Free, which has been there for quite a long time, and I think now Liverpool. There are some other units which can handle airborne HCIDs, for example St Thomas’ is one example, so they can handle very severely ill respiratory virus cases, for example if there was a MERS coronavirus. So there is a network across the UK.
Ms Carey: Were you part of the ACDP when the decision was taken to declassify HCIDs?
Dr Shin: I was not in that meeting.
Ms Carey: All right. But are you aware of the reasons why it was declassified?
Dr Shin: In broad terms.
Ms Carey: All right. Can you just outline that to us in broad terms, please.
Dr Shin: So my understanding is that it was a decision not indicating that there was a change to the severity of the infection but it’s more linked to the fact that basically HCIDs framework is there for us to handle unusual imported cases, for example a suspected Ebola or a suspected Lassa fever or avian flu, et cetera, for small numbers of sporadic cases.
Quite clearly from – by March and April 2020 we were facing a large pandemic and very large-scale infection, which was not what the HCID network was designed for. So it was not the right approach to the situation as it was evolving at that time.
Ms Carey: I think you say later on in your report that, from your perspective, initially classifying Covid as an HCID was an example of the precautionary principle in practice; do you agree with that?
Dr Shin: Very much so. The HCID precautions are very stringent and it’s basically – when we say something is an HCID or we suspect a patient of having it, it’s basically like a red alert to tell everyone: this patient, this case, needs an extraordinary response.
Ms Carey: Can I ask you this, please: once Covid was declassified, was there anything to do with the – did the declassification decision have anything to do or prevent the IPC guidance recommending FFP3?
Dr Shin: I don’t think I have enough knowledge to answer that question –
Ms Carey: Fine.
If we look at the timeline: clearly 10 January, there, there’s the HCID precautions.
13 March, so just before it was declassified, there was some guidance that recommended airborne precautions in hotspots where AGPs are being conducted, and then FRSMs for routine care. And then Covid was declassified.
I think in your report you make the point that at the time the decision was taken to declassify it as an HCID, it was possible to separate that decision from the need to retain enhanced PPE if considered appropriate.
I’m reading from your paragraph 6.9 if that helps.
Dr Shin: I think the question of what happened with the PPE is, you know, a difficult one which – you know, was – probably the entirety of this module perhaps, and the exact decision-making for that was – I’m not that privy to.
Ms Carey: All right, fine, thank you very much.
I can take that timeline down, thank you very much.
May I turn to another topic though that you did deal with in the report, and that of visiting guidance. Clearly it’s a difficult decision, but can you just help, do I understand it correctly that even outside of the pandemic there have been visiting restrictions imposed in relation to other viruses? Help us with that, please, just give us some examples.
Dr Shin: So, for example – the most obvious example of when visiting is restricted would be during an outbreak, for example of flu, of norovirus, even measles and other infections, so in that case restrictions are brought in to protect anyone entering that ward, which would include visitors and members of the public, who could then be put at risk, and we tried to avoid that as much as possible.
Ms Carey: So they could be solely to prevent visitors coming to specific ward. Have you known them to prevent people coming to the hospital in its entirety?
Dr Shin: Not in my working life.
Ms Carey: All right.
We know, however, there were visiting restrictions preventing visitors save for three at the beginning, exceptional circumstances, end-of-life care, when the woman was in labour, and I think a parent accompanying a child or a baby that was requiring treatment.
Can I ask you about that decision. It obviously has caused a great deal of upset.
Dr Shin: Yes, and we – I think everyone working in the NHS understands the reasons why that’s caused so much controversy and upset, but the decision-making to restrict visiting in that manner and to only allow those specific circumstances, especially end-of-life care and paediatric – neonates, newborn babies and in labour, that was done really to protect members of the public and visitors.
So a balance had to be struck somewhere and where the balance lay was – in those particular circumstances it was felt that the risks of infection were outweighed by the benefit of having – you know, allowing the family, for example, to be there when a patient – end of life, obviously that is a very major life event, obviously, and the other examples. So that was where the line was drawn.
Ms Carey: Yes.
Dr Shin: But I think some form of control was reasonable, logical and I think the right – probably the right decision. As we keep saying, we were facing this new rapidly-rising infection with high mortality we’ve seen and, you know, a very dangerous foe, so to take stringent measures at the beginning was I think, on reflection, a reasonable step to take.
Ms Carey: There may be a distinction drawn by many between a visitor and a carer, carers providing help to feed the patient, communicate with the patient. Do you think perhaps there should have been more acknowledgement in the exceptions to the visiting restrictions to let carers attend on their loved one?
Dr Shin: I think there could have been, so especially if the carer is somebody who is already living with the patient –
Ms Carey: Quite.
Dr Shin: – coming with Covid, for example, they already had the same exposures and risks already. So I think that is reasonable to say that a carer in that situation could be allowed in and I’m sure lessons will be learned about that scenario.
Ms Carey: It was my fault, it was a bad question, because I actually wanted to ask you whether a carer should be let in, whether a loved one or someone who comes in and routinely provides care for – would you draw a distinction if they’re providing care and they know the patient well?
Dr Shin: So late – maybe perhaps later in the pandemic, we – forgive my hospital example, we have, you know, like many other trusts, have elderly care with a lot of dementia patients, and in that setting we have been quite flexible in allowing carers and relatives to come in to see those patients with dementia, for example, because that helps reduce confusion, disorientation, distress, et cetera. I don’t know if that’s an adequate answer to your question.
Ms Carey: I suppose really it was whether, in the event of another pandemic, we widen the exceptions to the visiting restrictions to allow carers to come in for people with dementia, for example, or those with learning disabilities, and take a slightly more purposive approach and be less restrictive.
Dr Shin: Do you mean carers who are not family members?
Ms Carey: Yes.
Dr Shin: I see. I think you could argue that, because if they’re seeing patients, say, daily, and they’ve got the same exposure anyway, I think that is something that could be looked into.
Ms Carey: All right, thank you.
Can I take it that you do not consider it reasonable to have patients wearing FFP3?
Dr Shin: I think given all the difficulties we have discussed about FFP3 logistics and provision to healthcare workers testing mask types and all of those challenges, I think that’s one good argument against that.
In addition we’ve also mentioned the discomfort of wearing FFP3 masks, so it’s – I think respirators should be used when they are absolutely necessary and for visitors – for short-term visitors or for patients who are already unwell, et cetera, I think an FRSM would be a reasonable measure in that case. And even – FRSMs, even that are not tight fitting, et cetera, to wear one for, say, 24 hours apart from when you’re eating and drinking, it’s also quite uncomfortable, so, you know, we always try to take steps to reduce discomfort in our patients.
Ms Carey: I think you looked into the impact that a range of interventions had on the first wave, and there was a study conducted that concluded that sustained visiting restrictions were likely to have reduced nosocomial transmission but its implementation was likely of less impact than other IPC measures such as universal mask wearing and isolation of infected healthcare workers.
So is that potentially a study that supported the implementation of visiting restrictions?
Dr Shin: I would say so but it also illustrates the fact that with IPC it requires the application of multiple measures.
And we also, just to give another example, before the pandemic, a number of trusts use visitor restrictions for neonatal intensive care units, because if they bring siblings in, who often have other respiratory viruses, that poses a risk to the babies in that unit. So that’s another pre-pandemic example where some form of visitor restriction was applied.
Ms Carey: Can I – it might be a question for you, Dr Warne, but thinking about the patient on the ward in end-of-life situation, where visiting restrictions were either severely limited or we have heard examples where there were no visitors allowed, can you help from your experience how the staff communicated with the families of the loved ones of a dying patient?
Dr Warne: So I worked in a department where it was the job of the doctors every afternoon to update relatives who weren’t able to visit the ward. And that formed a significant proportion of their working day. I think it was one of the most difficult aspects for doctors working in that environment during the pandemic.
This is something we just do not normally do. We usually would update people – relatives who have had the opportunity to see their loved ones in a ward setting and be able to update them in person. Doing it by telephone was an incredibly impersonal experience for many people and, I think, quite distressing for junior doctors and other healthcare workers.
Ms Carey: Finally this, I’m asked to ask about a slightly different scenario where there is a cultural importance among a number of communities, in particular among black, Asian and minority ethnic communities who rely on social networks for healing and whether there should be a relaxation, I suppose, on the visiting restrictions to allow members of those communities to visit.
Do any of you have experience of trying to deal with people from those communities being prohibited from coming in and seeing their loved ones? Do you think we should expand the numbers of visitors to try and incorporate communities like that that have that cultural importance?
Dr Warne: I don’t think I have any direct experience, particularly based on ethnicity. I think that we haven’t talked about ways that we could make that experience safer, apart from the use of FFP3 masks. So, ideally, we would, for example, have people in end of life in side rooms, away from other patients, away from other potential sources of infection, which might make it safer for visitors coming to the hospital, and there are potentially other ways that we could do that to make that experience safer for the other visitors, as well as staff and other patients. But I’ve not seen any systematic studies by which that’s been studied and which we can provide evidence for today.
Lady Hallett: I think also that’s an extraordinarily difficult territory to work out how you would say a particular group, because in Northern Ireland I was told that a great deal of importance is placed on end-of-life care and death and funeral rites. I’m not sure I can go down that path, Ms Carey.
Ms Carey: No, there may be lots of people wanting exceptions to the visiting restrictions and I suspect that reality comes as where is the line drawn. It was drawn in this pandemic with end-of-life care, women in labour and babies and children, and the question is really is the line drawn there or slightly differently in the next time?
Yes, Dr Shin?
Dr Shin: I think this would be really difficult because let’s say a four-bedded bay, a Covid bay, and you would say to one set of relatives “You can come in because you’re from a certain background”, and the patient opposite can’t. That would be extremely inequitable and difficult to implement and difficult to defend, I think.
Ms Carey: Understood.
We mentioned there other IPC measures and so can I ask you about this, Dr Shin, and it’s in section 9 of your report, and you deal there with a number of measures that now we are quite familiar with in the Inquiry.
I’ll deal with testing separately, if I may, but I think you said that, clearly, there’s a variety of interventions that were taken to try and reduce transmission of Covid but there is variation in the breadth and quality of the evidence underlying these measures. Can you help us with what you were meaning there?
Dr Shin: I think that certain measures like, for example, social distancing, which I think probably were quite effective but getting the evidence for that in a real world setting is difficult. Although you said testing would be managed – handled separately, that was a very important IPC strategy to use – utilise testing and surveillance testing of asymptomatic patients and staff was a really important revolution when it arrived.
Ms Carey: There was, I think, as you set out at paragraph 9.2, that whatever the individual contribution, it’s likely that a combination of approaches were effective in reducing transmission. Is it right that UKHSA did a modelling study that concluded that the combination of interventions used to reduce nosocomial transmission between March 2020 and July 2022 averted 400,000 infections in patients and 410,000 infections in healthcare workers?
Based on that study, did you therefore conclude it’s likely that the combination will be needed again in the event of a future pandemic?
Dr Shin: Is that to me?
Ms Carey: Yes, or either of you.
Dr Warne: Yes, I think that it’s highly likely you will need a combination of different measures. The study points out that it’s quite difficult to pull out the relative contribution of each measure and its importance because they were often introduced together. It’s highly likely we will need a wide range of interventions again in any future pandemic.
Ms Carey: One of the measures we spoke of there was the social distancing and I would like to ask about the practicalities of that in the hospital. What about in staff-only areas: how easy or otherwise is it to have social distancing in staff-only areas?
Dr Shin: So I did work on groups which dealt with this and I think it was feasible. So, as you know during lockdown, many of the non-clinical staff worked from home and technology allowed that to happen quite efficiently and when we started having staff return to the office, we just worked out what was the staffing density which would comply with social distancing requirements, and we worked out, you know, staff had rotas saying “You come in on these days”, and in the end we would make sure we exceed that number, which would breach social distancing.
In addition, for example, most meetings which were previously all face to face, like this, we moved very quickly to online meetings and so, again, technology helped with that measure. So for non-clinical areas I think social distancing was actually quite achievable.
Ms Carey: And presumably used up areas in the hospital estate that might have been given over for lecture theatres, that kind of arrangement.
Protecting clinically vulnerable staff. I think it’s right that you say that if the staff were on the shielded patient list then, clearly, they had to stay at home. What about those staff who weren’t on the shielded patient list but who otherwise had vulnerabilities, they were either clinically vulnerable or had other comorbidities; what was the position in relation to them?
Dr Shin: So in that intermediate group, if I can call it that, some of the measures used were, for example, deploying them to non-Covid wards. So, as we’ve discussed, we would have Covid wards and non-Covid and acute areas and non-acute pathways and, for those higher-risk staff, they would be deployed to either wards which were areas where staff and patients were well screened and with no expected Covid patients and/or, for example, outpatients.
Ms Carey: Would the staff who are vulnerable but not on the shielded patient list, would they be risk assessed to work out the safest place in the hospital, the least unsafe place in the hospital that they could go?
Dr Shin: Yes, we were basically told to do risk assessments for, I think, all staff actually but that was a very big exercise run by occupational health and others to risk assess – I think it was all staff and that helped decide where it was safe or not safe for them to work.
Ms Carey: You said in the report certainly those with other risk factors, such as male gender, older age, as we’ve looked at, being of black, Asian and minority ethnic background, with chronic diseases like diabetes/asthma, it was potentially quite a large cohort of vulnerable people that had to be risk assessed. I didn’t ask: how long does it take to be risk assessed?
Dr Shin: So if I give you an example, in my own trust we had a pro forma, which I think was probably shared at least regionally, and that needed probably a meeting of some kind between the line manager and the member of staff to go through and, if anything was uncertain or complicated, that would go to occupational health but it was basically a tick-box pro forma, leading to – I think it was a score and the – because the OH team is quite small and there is no way – we have more than 11,000 staff, so our small OH team can’t do that. So it was devolved to local management to do that.
Ms Carey: I think you make the point that the roll-out of the vaccine in early 2021 reduced the risk to a number of NHS staff, including clinically vulnerable, and that coupled with adjustments, the risk assessments, redeployment areas, was a measure that was included to try and help keep them safe from Covid.
Can I ask about the impact on occupational health, we haven’t considered that yet within the Inquiry. Just help us: how big a team is an occupational health team?
Dr Shin: That varies a lot and, during the pandemic, our occupational health department had a lot of high staff turnover.
Ms Carey: Right.
Dr Shin: Considering the size of my trust and my experience working in other trusts, occupational health teams tend to be relatively quite small, surprisingly small, and they have, as I said, a lot of – a high staff turnover, especially, if I give a specific example of medical staff, I find the turnover there very, very high and often they’re part-time as well.
So I think for many trusts they would struggle to provide adequate OH coverage in normal times, and we’ve quoted, I think, one paper which we found where one of the occupational health doctors, or a team of them, said their workload increased 20-fold during the pandemic. How they cope with that, I don’t know.
Ms Carey: I won’t go through all of the other ways that attendance was reduced in hospitals. Some of them are obvious like the use of remote appointments, working from home.
Can I ask about blue and green pathways. I think some might be red and green, depending on which nation or indeed which region that we’re talking about, but was the idea to keep non-Covid patients away from Covid patients; how easy in practice though was that to bring into effect?
Dr Shin: So, as you said, the nomenclature changes so we have different colour codes, for example. Basically, it’s about separating acute patients, acutely ill patients from elective patients coming for surgery, for example, or diagnostic, radiology scans, that kind of thing.
In many hospitals, as we said, I think many hospitals have multiple sites, so that starts to make it become feasible and that’s what we did. So our main site, which had an emergency department, was clearly, probably not suitable or ideal for an elective pathway and we moved some of them to other sites which didn’t have an emergency department. So, I think each trust would have been very different and I’m sure the experience across the UK – the principle was to separate the acutely unwell patients, especially Covid patients, from the well, elective patients.
Ms Carey: So if, once there was a reinstatement of elective surgery and treatment, I think you said there a negative PCR was required two days before the planned elective procedure and, if obviously it was negative the procedure could go ahead and, if positive, the treatment cancelled or the surgery cancelled?
Dr Shin: Postponed.
Ms Carey: Thank you.
Clearly though, within the two days, one could be negative on the day you take the test but catch Covid then the next day. How was that managed, if at all, for those coming back for an elective procedure?
Dr Shin: That’s a very difficult eventuality which we did see and that was hard to manage. If I remember correctly, we also had, for some patients, a rapid PCR on the day of the procedure, literally hours before the procedure, because we were able to – once testing was scaled up, as Dr Warne mentioned the importance of scaling up testing – when we had sufficient rapid testing capability patients may even come in, say, two, three, four hours before the procedure to get a final PCR and if that’s green – negative, then they can go ahead.
And that – although that gave some reassurance, it was also really stressful for the patient but, as you said and as we’ve described, the incubation period being quite long, there is no guarantee that they would then not subsequently develop Covid and we were aware of that but all we wanted to show was that, on the day of the procedure, that they didn’t have detectable Covid at that time.
Ms Carey: I think you make the point in your report that the roll-out of the rapid testing in particular gave reassurance to immunocompromised patients who were obviously worried about coming to hospital and contracting Covid.
I suppose that really brings us on to testing and I suspect turning to you, Dr Warne, there is various, I think, basics we may need to cover.
Can I start, please, with a summary of the differences between PCR tests and lateral flow devices? If it helps you it’s 9.3 in the report.
Dr Warne: Those are two different ways of testing for Covid. So, normally, a nose and throat swab, for both methods, the PCR test is a molecular test for looking for the specific RNA – the specific part of the virus, which is very accurate. So we’re looking specifically for Covid and it’s got a high sensitivity. So it’s picking up a large amount of the true positives.
Lateral flow tests, which we probably all know and love, have a similar principle to a pregnancy test, you can take them at home, they’re much easier and faster to get a result, but they’re less accurate. So while they’re useful for screening, for certain purposes, they had probably less utility as a diagnostic test in hospital.
Ms Carey: Can we just be clear about the use of the term “sensitive” here; what does it mean in the way that you’re using it?
Dr Warne: So all the people who genuinely have Covid what proportion of those patients will it detect. So, for the PCR, we’ll be picking up over 95% potentially, if the swab is taken properly; lateral flow tests, there is a much wider quoted range, so from 40% up to 90% plus.
Ms Carey: So there are pros and cons to each, if I may put it like that?
Dr Warne: So the PCR test, depending on how you do it, if it’s being done in a main laboratory, you might get a result 24 hours later. As newer, rapid diagnostic testing platforms came on later in the pandemic, you might get the result in within an hour. Lateral flow test is very quick but less accurate.
Ms Carey: Clearly testing played a role initially in the pandemic to confirm that the patient had, in fact, got Covid because I think you make the point in the report that a number of the symptoms alone – coughing, sneezing, feeling unwell – are capable of being any number of different diseases or viruses.
Turnaround times, can you help us with, once the rapid Covid test came in, what was the turnaround time for those tests?
Dr Warne: So potentially less than an hour from the point that the test is being done.
Ms Carey: I think you say in your report easy to use and they could be deployed to areas in the hospital near the patient.
Dr Warne: Exactly right.
Ms Carey: Then if a patient came in for a procedure, had a rapid test and tested positive, were they literally sent home?
Dr Warne: If they were otherwise well, then yes. I tend to follow national guidance on self-isolation et cetera.
Ms Carey: Then cleaning of the areas where they had been, and the like, understood, right.
Can I ask you about testing of healthcare workers, and I think there was testing but you say in your report, at paragraph 9.25:
“Routine symptomatic testing or asymptomatic screening for respiratory virus infections in healthcare workers was not performed in the UK prior to the pandemic.”
Is that correct?
Dr Warne: Yes.
Ms Carey: So, once testing came in, it was new to healthcare workers, as much as it was to the rest of us?
Dr Warne: In the sense that, yeah, you’re testing people who don’t otherwise need to come into hospital, absolutely.
Ms Carey: You make the point that during March and April 2020 there was a large increase in PCR testing for Covid across the UK, and then we know there are various dates when different people were tested, including differences between symptomatic and asymptomatic. I think you said in the report that, for asymptomatic, there was a pilot of testing in March to May 2020; can you help with that?
Dr Warne: So a number of trusts recognised early on the importance of asymptomatic screening for healthcare workers or diagnostic testing. So, firstly, they recognised that some of our healthcare workers would be asymptomatically carrying and potentially transmitting the infection to vulnerable patients, other healthcare workers. They also recognised that, following government advice to self-isolate, if you had any of these symptoms, that a large proportion of those would not have Covid, they would have one of the other conditions, and you were potentially losing a large amount of your workforce who did not have Covid. So, therefore, the importance of distinguishing those that did and did not have Covid was really important to ensure that you were isolating the right healthcare workers and the others can return to work.
Ms Carey: Yes.
Dr Warne: But that wasn’t widely available, it was piloted in a small number of trusts, particularly those who had more testing capacity, potentially more academic laboratories to help to support testing capacity.
Ms Carey: Do you know was that rolled out, even though it was a small pilot was UK-wide or was this England only; can you help?
Dr Warne: I’m aware of a number of pilots that were conducted in England. I’m not sure about the rest of the UK. When lateral flow tests were much more widely available later in the pandemic, they were rolled out to everybody, all healthcare workers across the four nations, implemented in slightly different ways.
Ms Carey: You make reference in your paragraph 9.26, Doctor, to a modelling study that has shown that periodic testing of healthcare workers has a small effect on the number of hospital acquired Covid-19 cases in patients but reduces infection in healthcare workers by as much as 37%, which results in, as you say, only a small proportion of staff absences.
Just help us put that into the real world.
Dr Warne: You might come on to this in a moment but the majority of patient’s hospital acquired infections were acquired from other patients during the pandemic, whereas with healthcare workers, there was a lot of healthcare worker to healthcare worker transmission. So by understanding who was asymptomatically infected in your healthcare workers and isolating them effectively, you reduced that healthcare worker to healthcare worker transmission and, therefore, helped to prevent healthcare worker infections.
Ms Carey: I think in your report, as we’ve looked at the potential pros and cons, if I can call it that, between lateral flow devices and PCR tests, you say there has been no comparison made between the testing approaches and, therefore, their relative contribution and, indeed, cost as an IPC measure remains poorly studied.
Why is it important for there to be a comparison between testing approaches?
Dr Warne: They have big cost implications that each of them has different advantages and disadvantages, depending on how you use them, and there are a number of different commercially available tests, or tests available in any kind of way. So making direct comparisons between lateral flow tests, of which there are many, many brands, and PCR tests, of which there are different approaches, is very difficult to do.
Also the frequency, so how often you’re testing, if you’re testing once a week, you know, you have an entire week in which to develop symptoms, you might get missed. Doing it every day or even multiple times a day is perhaps impractical for a variety of reasons.
So to understand this to the best that we can, for any future pandemic, we probably need to do more work and, as technology advances and new diagnostics are available, they too will need to be appraised in any future pandemic and this is an area of great and quite rapid scientific development.
Ms Carey: It brings me on to transmission of Covid in hospitals and your chapter 11, please. I think you make the point at the outset that there is a focus on the transmission of Covid within hospitals, obviously because we want to keep people safe in hospitals, but I think some of the data that we’re going to look at is only available in hospitals or the majority of it is only available in hospitals; why is that?
Dr Warne: There’s a number of different reasons. So firstly, the hospitals we have high-quality data on where a patient is at any one time, or indeed a healthcare worker, and they are essentially in your hospital for a long period of time, you have their test results that you can link that information to, you have a large amount of information about those individuals and, therefore, can study them and how they transmit within the hospital. That’s much less easy to do in primary care where the patients are only there for very short periods of time or in social care, where perhaps you don’t collect that information or can tie it to their test results in the same way.
Ms Carey: Understood.
Dr Warne: I would say that there is an historic bias towards infection control studies in secondary care in hospitals and that primary care/social care are much less well studied and published on.
Ms Carey: You make the point that healthcare-associated transmission was a feature of hospitalised cases for SARS, I think, and MERS. What about flu?
Dr Warne: The evidence base for flu is much smaller. There was an increasing evidence base that hospital transmission of flu was important, and we have data from our own trust and from other hospitals in the UK, from the years prior to the pandemic, which showed that flu was probably an underappreciated hospital associated infection.
Ms Carey: Okay.
Dr Warne: The quoted numbers are very variable depending on the type of hospital.
Ms Carey: But it’s not new that people go into hospital, nonetheless contract a virus?
Dr Warne: No, or indeed any other hospital-associated infection.
Ms Carey: All right. In relation to Covid, I think you said that the first study on Covid-19 was published from Wuhan in February 2020; is that correct? And it stated that 41% of all cases identified in patients and healthcare workers were hospital-acquired infections. So early on in the pandemic, we were aware that there was the possibility of Covid transmitting in this way.
Can I ask you about your paragraph 11.3 though, and can you just set out for us why it is challenging to work out the location where SARS or Covid is acquired?
Dr Warne: The main reason relates to the incubation period which we talked about right at the start of today’s hearing. So the time from somebody catching Covid and then to developing symptoms ranges from two to 14 days, the average being approximately six days at the start of the pandemic. That means that if you developed symptoms of Covid on day 6 of an admission, you had an essentially 50/50 chance of acquiring it in hospital or in the community, and in that preceding six days you may have moved several areas in the hospital, the preceding 14 days you may have had a number of different exposures in the community. It’s often very difficult to tie down exactly the point at which you would have acquired Covid.
By comparison, influenza the average incubation period is about a day, one to two days, so a much shorter space of time for us to look back and say, “Where was the patient, who did they come into contact with, how do we investigate and manage this problem?”
Ms Carey: That brings us on to – can I have on screen, please, INQ000474282_103 and table 2. I’d like to look at the way in which Public Health England assigned the likelihood of an infection being in hospital, against that background of the incubation period.
My Lady, we touched on this briefly yesterday with Professor Hopkins and some of the data and I skated through what the definitions were.
With your help, Dr Warne, can you help us with HOHA or hospital onset definite healthcare associated?
Dr Warne: These are patients that tested positive 15 days or more into their admission, so beyond the longest possible incubation period of the virus. So they acquired it in hospital.
Ms Carey: Probable healthcare associated?
Dr Warne: So these are patients who tested positive between days 8 and 14 of their admission, where the balance of probability is that they acquired it in hospital but not for definite.
Ms Carey: Right. Then indeterminate?
Dr Warne: So this is where people tested positive from day 3 to 7 of admission, so where initially the balance of probability was that it was acquired in the community.
Ms Carey: Right. Community onset possible healthcare associated: help us with the definition there?
Dr Warne: So these are patients who tested positive within two days of being admitted that had recent by been discharged from hospital. So, very early in the pandemic, it became clear that a number of people were being readmitted to hospital, having acquired their Covid on their prior admission, going into the community and coming back. This category was intended to capture those patients.
Ms Carey: Understood. Then community onset community acquired?
Dr Warne: So these are people who tested positive in the first two days of their admission but had not had any prior healthcare contact.
Ms Carey: So you have effectively got reasonable certainty at the top end and reasonable certainty at the bottom end of the table but slightly greyer areas depending on the day of testing in the middle. Understood.
Now, translating that to the data that there is no relation to Covid, can you just help with some advantages of those definitions and then some disadvantages or caveats to those definitions?
Dr Warne: So the advantage is that that kind of data can be collected at a national level at scale because there are national databases of hospital admissions and discharges and there are national databases of testing. If you put those two together, suddenly you have data from all the admissions in the country and you can use that to compare hospitals, regions, interventions over the course of the pandemic, so at a surveillance level it’s helpful.
The disadvantages are that it works less well on an individual level. If you want to know when an individual caught Covid, you can’t necessarily use this unless it’s in those extreme ends of community or hospital onset. It’s also limited by things like testing availability: if there is a delay in testing for any reason then you may be put into the wrong category by mistake. Also limitations on, finally, the definition of indeterminate being seven days. As the pandemic progressed the newer variants had a shorter incubation period –
Ms Carey: Right.
Dr Warne: – so went down from probably around six days at the start to about three and a half days with Omicron, which meant that you would be miscategorising a lot of people as community acquired who more likely would be hospital acquired.
Ms Carey: Understood. All right, can I ask you this: these were categories used by Public Health England were there similar categories and definitions applied across the UK?
Dr Warne: There were indeed, there were some slight caveats, and the example is that, in Scotland, I understand that they did not use the possible healthcare associated – community onset possible healthcare associated because they could not easily or readily identify preceding admissions in those patients. So there are some slight nuances but, overall, they were consistently used across the UK to the best of my knowledge.
Ms Carey: With the definitions in mind, the caveats in mind though, I think you in the report tried to estimate the number of hospital acquired SARS-CoV-2 infections. Can I ask you about your summary please at paragraph 11.17.
I think, essentially, having set out a number of different studies and the like, you said estimates of the proportion of Covid infections acquired in hospital ranged between 5 to 20% of all Covid-19 cases identified in acute hospitals; is that correct? It’s quite a wide range there.
Dr Warne: Yes.
Ms Carey: But doing your best, did you come to the conclusion that, overall, it was highly likely that the true number of patients who contracted a hospital-acquired Covid infection in the UK was well over 100,000?
Dr Warne: Yes.
Ms Carey: Are you able to help us with sort of what was like the lowest estimate and what could be the highest estimate, based on the modelling studies that you looked at?
Dr Warne: So the lowest proportion that’s quoted in these studies – and this is a combination of big national datasets and smaller individual hospitals, and everything in between – the lowest that it’s come to is 5%, the highest is 20, but some modelling estimates are actually much higher than that because we don’t take account, for example, of people who catch Covid but don’t develop symptoms until they get into the community. So in some studies it’s even higher than that 20% figure.
Ms Carey: When you say well over 100,000?
Dr Warne: Data from NHS England, which is included in the pack for this hearing states that in England alone, up until June 2021 there were 65,000 hospital acquired infections, either falling into the first two categories, the definite or probable, and that’s only up until June 2021 and only in England. So I think that both national data and the data from this, the estimates from this, converge on that figure of being well in excess of 100,000 people.
Ms Carey: If we think about – I don’t know if you heard Professor Hopkins’ evidence yesterday in relation to some Public Health England data that looked – that found that between March 2020 and April 2021, for hospital onset definite healthcare associated figures, they were nearly 30,000, of which 9,854, almost a third of those people died.
Dr Warne: Yes.
Ms Carey: That’s just to sort of try and bring the two strands together.
In the report, with that sort of headline figure in mind, you looked at variation by patient population. It’s at your paragraph 11.15, but help us with some of the variations that were noted across the patient populations.
We were aware of age –
Dr Warne: Yes, so age is an important factor that they were more likely to have hospital-acquired infections. The type of hospital affected the proportion of healthcare-associated infections. So, for example, those in community hospitals, excepting community cases of Covid, had an overall lower proportion, whereas mental health trusts, community trusts, where patients are resident for longer and they wouldn’t generally admit community-acquired cases, in turn had a higher proportion.
But also patients with a higher number of comorbidities were also more likely to have a hospital-associated infection.
Ms Carey: In that regard you say that they are more likely “the proportions of patients with a Charlson index”.
I don’t know what that is. Could you help us?
Dr Warne: The Charlson index is a well established term used in epidemiology. It’s a simple scoring system where the more comorbidities you have, the higher your score. So, for example, you might get a set number of points for a cancer diagnosis or diabetes, and the more comorbidities you have the higher your score.
Ms Carey: All right.
So if you are old, more risk of contracting it in hospital, co-morbid – at higher risk, understood, and depending on, potentially, where you were a patient, at higher risk?
Dr Warne: Yes.
Ms Carey: We looked yesterday, and I don’t need to look at it with you, but geographical variations existed, certainly in terms of England. The outcomes of patients with healthcare-acquired Covid, I think you say it’s challenging to work out the outcomes. Can you help us with your summary at paragraph 11.26?
Dr Warne: Yes. So the crude, so in terms of outcomes that we measure, mortality is the one that we can most readily measure and it’s the one that’s been most widely reported. The mortality in people with hospital-acquired Covid at the start of the pandemic was very high, in excess of 40% in some weeks. Some studies that found that if you adjusted for other things that dispose you to severe Covid, like age, like comorbidities, actually that adjusts out to be the same as a community-acquired infection, it’s just that our hospitals are full of people who are older, vulnerable, have comorbidities.
Ms Carey: So it’s very difficult to work out the outcomes I think for the reasons.
What about – I think in your report you included some data from Scotland. Are you able to summarise that for us and what you could tell us about the outcomes?
Dr Warne: Yes. So we have peer-reviewed studies published from England, Scotland and Wales which look at issues of hospital-associated infection, so if we look at – so it’s in paragraph 11.21 here, that’s where they quote that if you adjust for age and morbidity, actually the mortality in patients with hospital-associated Covid isn’t necessarily different from community-acquired. They also point out that – in subsequent – no, apologies, that’s a separate study.
Ms Carey: I was just looking at the Scottish data.
Dr Warne: In figure 12 in this report.
Ms Carey: Yes.
Dr Warne: This was the point I was wanting to make. That the mortality, the number of patients that died of hospital-acquired infection changed over the course of the pandemic. So while it was very high with the original variant of the virus, with each subsequent new variant, Alpha, Delta, Omicron, the mortality for each of these different categories reduced.
Ms Carey: Can you help us with why that might be or the reasons why?
Dr Warne: It’s probably a combination of things. There was a significant drop in mortality associated with vaccination, once the vaccines were rolled out. There also appeared to be – each subsequent variant to an extent was less virulent than the prior one, so less likely to cause severe disease.
Ms Carey: I think you said in the report that there was an ARHAI study that found that inpatients who had been vaccinated with either one, two, or three or four doses had lower odds of death within 28 days compared with those who had not been vaccinated.
Dr Warne: Yes.
Ms Carey: Understood.
I think those are dealing with outcomes of patients. Can I ask you about infections of healthcare workers that were in hospitals, please. Again, can we look at the summary of your conclusions and then perhaps work back and look at some of the examples.
What were you able to ascertain in relation to Covid infections acquired in hospital by healthcare workers?
Dr Warne: So the rates of infection – a number of studies have shown that the rates of infection in healthcare workers are higher than the general population, and that this is associated with higher rates of staff absence, and that that is a combination of the direct infections with the virus but also due to other issues, so exacerbations of mental health, a range – stress, burn-out related to Covid-19.
Ms Carey: Go on. Did you want to add something?
Dr Warne: Not yet.
Ms Carey: All right.
So higher rates of infection in healthcare workers than in the general population, and I think there are various studies that you have set out. There was a particular study done though by the Nuffield Trust on staff absences, and I want to be clear about whether that deals with staff absences over the pandemic because of the pandemic, as in directly people got Covid, or were a consequence/byproduct of the pandemic.
Can you have a look, please, at your paragraph 11.29 and help us with what the Nuffield Trust found?
Dr Warne: So this is a report which looked at staff absences in the UK pre – during the pandemic, and they show data in figure 13 from 2014 up until mid-2022. What they show is that pre-pandemic there were staff absences that peaked every winter and that these were between 4 and 5% of staff at any one time, likely an underestimate because of under-reporting.
With each wave of the pandemic, the first and second wave, there was a spike in absences.
Ms Carey: Yes.
Dr Warne: Likely they attribute to direct infection of the virus, but then with the advent of Omicron that – the rates were persistently increased, they didn’t go back to their normal baseline. And the report gives a number of reasons for this, including the direct effect of Covid or Covid complications, chest infections, but also higher rates of mental health problems, burn-out, stress, and a range of other conditions which are perhaps not directly related to the infections caused by Covid but a lot of the side effects of the pandemic.
Ms Carey: So if I understand you correctly, is it possible to say then that where there is an absence, whether it’s because the person’s got sick from Covid or it’s – do we know whether they have gone off sick because of the stress, they’ve burnt out, can you draw that distinction from the data alone?
Dr Warne: There are problems with the way that it’s reported, et cetera, but if you look at paragraph – sorry, (e) here, they suggest that as much of that – that rates due to infection, cough, flu-like illnesses up – increased to 27% compared to 10% in pre-pandemic times, but mental health increased 26% over the same period. So it’s probably a combination of different factors.
Ms Carey: I’m asked to ask you this, whether there is a link between the high rates of infection in healthcare workers and the failure to recognise airborne transmission of Covid.
Are you able to opine on that at all or is it simply not possible to say?
Dr Warne: Would you mind repeating the question?
Ms Carey: Yes, it was: is there any link between the high rates of infection in healthcare workers and the failure to recognise airborne transmission of Covid prior to early 2022?
Dr Warne: I think it’s a very complicated area to address, and later in the report we address the various ways by which healthcare workers may become infected.
I don’t – there are a number of different steps between the recognition that Covid may be airborne through to rates of healthcare worker absence, and that path is quite complicated, so I don’t think it’s direct –
Ms Carey: Is there any data that would suggest there is a link between higher rates of Covid infections acquired in hospital for healthcare workers and a rise in community infections?
Dr Warne: The other way round is true, that if there are higher rates in the community there are higher rates in healthcare workers.
Ms Carey: Acquiring it in hospital. That’s what I was trying to get at, it’s my fault.
Dr Warne: No, I see. So the data that – isn’t really included in the report, and that I’ve read, suggests that the chance of healthcare worker infections – acquiring it in the community is higher at times of high community prevalence. When community prevalence falls and you have persistent transmission in hospital, the chance of getting it in hospital is higher.
Ms Carey: The sources of transmission, please, in hospital. In your report you separate individual factors from environmental factors. Can I ask you about, firstly, individual factors. It’s at your page 123.
Obviously there’s a number of ways one can acquire the infection but what are the individual factors, please?
Dr Warne: For patients or for healthcare workers?
Ms Carey: Dealing with patients firstly.
Dr Warne: So we know the majority of patients who acquired Covid in hospital are infected by other patients. One of the major issues is not recognising a patient who developed Covid while they were in hospital, and spreading it before their diagnosis was made.
We know that on arrival to the hospital, sometimes if there was limited isolation capacity in assessment areas, that people with Covid and without Covid would be cohorted together in the same space while they were awaiting test results to guide them towards either a Covid ward or a non-Covid ward.
We know there are patients who did not present with typical symptoms of Covid, where a diagnosis was not considered. So, for example, particularly in elderly populations, they may present with atypical symptoms like diarrhoea or gastrointestinal symptoms rather than the classic fever, cough, breathlessness.
And we have alluded to it before, but the asymptomatic rates are incredibly important in patients, in staff and potentially in visitors.
Ms Carey: You separated the individual factors between patients and healthcare workers. Is there anything you would like to say about healthcare workers and the individual factors or is that more the environmental factors?
Dr Warne: So the same applies to healthcare workers, the rates of asymptomatic or presymptomatic infection in potential transmission. There’s a – I think a phenomenon that happened during the pandemic where people with perhaps mild symptoms who were able to come to work felt they were duty bound to do so to try to not let down their teams, their colleagues and because they felt compelled to do work for the pandemic. Particularly people who had minimal symptoms or very mild symptoms of Covid.
Ms Carey: Is that the phenomenon known as –
Dr Warne: As presenteeism.
Ms Carey: Presenteeism, as opposed to absenteeism. So trying to do the right thing, essentially, but actually bringing in – potentially –
Dr Warne: Potentially.
Ms Carey: – the virus. Understood.
Any environmental factors?
Dr Warne: Anything that facilitates meeting of people in hospital where there are ineffective controls. So one of the major things is about ventilation and the age of the NHS estate, so you’re – with poor ventilation, so that Covid can potentially remain in the air and the environment for prolonged periods of time.
Many NHS hospitals have a limited amount of side-room capacity, which makes isolation very challenging. We have a number of old-fashioned hospital wards where they have large open bays with large numbers of patients in them, which can, again, facilitate the transmission of the virus, as well as a variation in IPC practices that we’ve already discussed and how well they’re utilised.
And Dr Shin has mentioned earlier on that towards the end of the first wave of the pandemic we got better at staff break-out areas and providing non-clinical areas and how they should be worked. I think that at the start of the pandemic we were less effective at that.
Ms Carey: Okay.
Dr Warne: And that sometimes – these – particularly staff areas are less well ventilated, can be quite cramped.
Ms Carey: I was going to ask you about is there any data or anything you can add about what we know about transmission in non-clinical areas?
Dr Warne: So we know that it happens, we know that – so this is areas where we might have office space, for example, or break-out areas. It’s very difficult to try to get that kind of information because we don’t have the same level of data that we do about patient movements, but we have identified clusters of healthcare workers who don’t work in clinical areas who have transmitted the virus between them, so it’s certainly possible, as you would find in social settings in the community as well.
Ms Carey: I think you make the point in your report that there are certain occupational groups that had higher rates of healthcare workers infections, notably domestic services staff, nurses and healthcare assistants.
Can you help as to why there was certain groups of staff that had higher rates of healthcare-acquired Covid?
Dr Warne: So some of them were exposed more to Covid-19 patients, so these are people that work in acute specialties, in front – in emergency department, for example, in acute medicine, you would receive Covid-19 patients. There is an observation which has been replicated on multiple instances that higher rates were observed in healthcare workers from minority ethnicity, even accounting for the job role which they undertook, and there were rates that were higher in, as you mentioned, domestic services staff, nurses, healthcare assistants, porters, people who had frequent direct contact with patients.
Ms Carey: Do you know if there was any data dealing with healthcare-acquired infections for migrant workers?
Dr Warne: I’m not aware that specifically differentiated migrant workers from other types of working.
Ms Carey: We have looked at patients, looked at healthcare workers; what about the role of visitors in transmitting the virus and adding to the burden of Covid being acquired in hospitals?
Dr Warne: So the level of data and quality studies we have on visitors is much, much, much lower than we have for patients and for healthcare workers, partly because, as I mentioned, we have good data on who our patients are, where they are, when they get tested. The same is true with healthcare workers when we introduced staff screening. But we keep no records of who visits our patients, we don’t know what happens to them after they leave the hospital, and therefore it’s very difficult to be able to understand the role that they have in transmission events.
Ms Carey: Clearly if the visitors are asymptomatic, harder still to determine any data. Understood.
May I just deal with a couple of discrete topics before returning to the recommendations that you all made at the beginning of your evidence. I’m asked to ask you whether you would – could particularise the precautions that should have been recommended for healthcare workers for patients that are infected or suspended to be infected with Covid.
I don’t know who feels best qualified to answer that, but I think essentially I want to know what you would have recommended in the IPC guidance to protect those looking after infected or suspected infected patients.
Dr Warne: Is that with particular regard to PPE?
Ms Carey: Yes, I would have thought so.
Dr Warne: I think we … I can imagine this particularly refers to FFP masks.
Ms Carey: Yes.
Dr Warne: I think we’ve already said that – I’m of the view that the balance of evidence as we have it now is that FFP respirators would provide more protection for healthcare workers than surgical masks.
In addition to the wide range of other measures that were taken in terms of PPE, isolation, I would point out, because it hasn’t quite come up yet, is that although patient to healthcare worker transmission is important, in – there is also an enormous contribution of healthcare worker to healthcare worker transmission, where FFP3 masks would not be recommended, and the majority of that actually happens in non-Covid clinical areas where FFP3 masks aren’t routinely worn.
Ms Carey: Just thinking about that practically, is that healthcare to healthcare in a staff room or in a canteen; is that the kind of thing that you’re speaking of?
Dr Warne: We don’t know. Potentially in staff areas, potentially in canteens, potentially in a car on the way to work, potentially in a clinical area where, you know, PPE was not used or at least to the same extent in the direct care of patients. It’s not clear where that happens. But we know from genomic epidemiology studies that people who work together on the same ward, healthcare workers can trans – or part of the same transmission network where the virus is transmitted among healthcare workers in that clinical area – or they can’t specify exactly where on the ward that happened, or in – outside the ward setting.
Ms Carey: Can I return to the precautionary principle, and I think to you, Dr Shin.
Clearly it’s an approach to trying to mitigate the risks of the virus. You spoke about HCID being an example of the precautionary principle in practice, but by reference to your paragraphs 12.43 onwards, do you have any observations about the use of the principle or overuse of people demanding the precautionary principle? Help us please with your observations.
Dr Shin: I think in retrospect, you know, I think it’s now clear that – well, in my mind – that Covid is transmitted through the airborne route. So with that in mind, I would agree with the earlier response that FFP3 would be what I recommend.
In terms of precautionary principle, I think it is part of our recommendation that in a future pandemic that we would suggest that before PPE steps down you need evidence that that would – is a safe step to take, rather than step down and – as evidence mounts that you should have RPE, then do it that way, which is what happened in this case. So I think if we were faced with a similar situation, which I hope we’re not for a long time, then we would suggest that – we can understand why there are loud voices calling for precautionary principle for PPE and I think that would be more – all of our workforce would be more reassured if that precautionary principle was applied in a future emergency so that we only step down PPE when evidence showed that that was reasonable and safe to do so.
Ms Carey: So where there is an absence of evidence about the route of transmission, start with the highest level of protection and as you work out the routes, as the evidence emerges, then make a decision to step down if that’s appropriate. Is that it?
Dr Shin: I think that’s probably our consensus view.
Ms Carey: All right.
Can I return to lessons learned, your conclusions and recommendations, please. I would like to ask you about a few recommendations that you set out in your report before coming back to the ones that you spoke of this morning. I’m not going to go through them all but can I ask about recommendation A, and you subdivided those into various categories, and it’s recommendation A(v), you say:
“We are aware of variations in PPE adherence across the NHS and even within NHS organisations … The best quality PPE will not help protect staff if they do not use it, or [don’t] use it properly. We recommend that in a future pandemic or … epidemic … IPC training is sufficient quality to inform [healthcare workers] the threat posed, what PPE to use, why and when.”
It may be your remit, Professor Gould, but why are you – how is that going to be sort of achieved, is essentially what I wanted to ask.
Professor Gould: Could you repeat the –
Ms Carey: Yes, if you have a look, please, at your page 134, and recommendation A(v) – and if it’s not you, one of the doctors, I know, will step in, but …
Professor Gould: It wasn’t my particular recommendation.
Ms Carey: But if we’re trying to get staff to adhere to PPE, clearly training is a part of that, and would that go back to training from the get-go when people are trying to become nurses, healthcare assistants –
Professor Gould: Yes, people would need adequate training so that one could build on it later on when they come into practice.
Ms Carey: And what about those who are already practising?
Professor Gould: They would need updates.
Ms Carey: Yes.
Professor Gould: And they would need regular updates.
Ms Carey: And is there a sort of continuing professional development regime that could accommodate?
Professor Gould: There should be. And of course it has been renewed with the new recommendations – the new educational approaches to do with the launch of the national manuals. A lot, I would suspect, probably still depends on the particular organisation where people work.
The other thing is that with equipment that people don’t use very often, they have to be refreshed very often how to use it because people reasonably – quite reasonably – forget, so they would have to have regular updates.
Ms Carey: We referred there to nurses and other members of clinical staff having training. What about training for non-clinical staff? Is that realistic? How practical is that?
Professor Gould: It would depend on the degree of – it would depend on what they did, but if people are going to come into contact with patients then, yes, they would require training. People who never see a patient, it would not be relevant to them.
Ms Carey: What about outsourced workers?
Professor Gould: Could you give me an example?
Ms Carey: It was one of the questions I was asked to ask while I was on my feet, so no, but I would imagine those that aren’t trained within the NHS. As I understand it a number of workers working in healthcare aren’t employed by NHS trusts but are outsourced from agencies and the like. I’m just trying to think about practicalities of training for that cohort of staff.
Professor Gould: I would think that people like agency nurses. Many – many NHS organisations have what they call bank staff, which will be people who work on a regular or irregular basis but they draw on the same people. Those people should have training.
Many years ago I was a bank nurse myself and people did receive training before they were able to join the scheme, and in an ideal world they would have updating.
But it also needs to be pointed out that many people who do agency work and bank nurse work are employed full-time elsewhere and would be – they would have, you know, a regular job as well, so they would receive their updating there.
Ms Carey: Thank you.
There was a recommendation at D for a single source of official IPC guidance to be available throughout the UK, and the first question I suppose really is: what is meant by a single source?
Professor Gould: Well, the principles of infection prevention are the same everywhere. The principles of breaking the chain of infection are the same everywhere, so it would be sensible to have one single source instead of dividing up efforts and producing multiple sources.
Ms Carey: Given that health is devolved though, I suspect the question really is how achievable is that, given that each nation is responsible for their own healthcare systems.
Professor Gould: Well, I think that people in those four nations do speak to one another, so I would think that that probably wouldn’t be out of this world. I think it would be achievable.
Ms Carey: Is it necessary, given that the NIPCM either is the manual or is the manual upon which the other guidelines are based, do you still think that it is necessary to have a single source of IPC guidance?
Professor Gould: I suppose I have a nice tidy mind, so – but, in fairness, the manuals don’t try to propose different principles, so I think that you would want a degree of commonality between all of them, it wouldn’t do if they all looked differently, and of course people do move between the nations that they work in.
Ms Carey: Your recommendation E, Professor, I think, may in part align with your recommendation for guidelines to win hearts and minds. You asked for education and training for all staff, and I think we’ve covered the reasons for that. But given everything we’ve discussed today, is there anything particular that you think would help win the hearts and minds and help the guidelines to be more closely followed and more bought into, for want of a better phrase?
Professor Gould: Education for people before they come into their professional roles in the universities is not particularly good. I know more about nursing because I am a nurse, but I did try very hard when writing the documents to find out about the other professional groups. So I tried to find out what physiotherapists are taught, remembering that physiotherapists do a lot of respiratory interventions and would be in the firing line, and it was very hard indeed to find somebody who could tell me about the physiotherapy curriculum, and that was true of many of the other professions.
So it does worry me that we don’t know or we can’t easily get hold of what people are taught. It would be, I think, an advance if people had a better basis for infection prevention in pre-registration training. I know that there is a lot of variations between universities and the number of hours that are put in.
Ms Carey: Thank you.
One of the other recommendations, recommendation J, is that you recommend there should be a single UK-wide organisation or process with oversight of healthcare-associated infection.
I don’t know if this is your remit, Dr Warne, but what was envisaged by that recommendation?
Dr Warne: All of the – to be able to understand infection prevention and control we need to understand the numbers, the surveillance, the numbers of hospital-acquired infections, the interventions which may be used to reduce them. That requires collation of a wide range of data sources, literature reviews we’ve already discussed as – in a rapidly moving field, and decision-makers and people who produce guidelines, that needs a consistent unified process, even if it’s slightly different people or different groups of people who do each of those things, to ensure that that guidance is consistent and the best quality that we can provide.
Ms Carey: Finally you, Dr Shin, earlier this morning you advocated for better understanding of ventilation in hospitals. We haven’t touched on it, but we’re aware of HEPA filters, UV lights, where it’s not possible to tear down a roof and install new ventilation. Why is it that you have proposed as your headline recommendation better research and better understanding of the role of ventilation?
Dr Shin: So it was ventilation and isolation. But in terms of ventilation, this being a respiratory virus, that was obviously a very significant risk factor for the NHS. Many hospitals are old and are not well suited to face such a – a threat like this, so in the future it would be much better if we can – ideally, long term, hospitals should have improved ventilation in general, as you hinted. We know that’s difficult. So there are short-term solutions, for example portable HEPA-filtered air filtration units are one possible short-term measure. And in Professor Beggs’ report, he talks about an ultraviolet – a high-mounted ultraviolet filtration system, which looks to me, as a non-engineer, like it might be something feasible to retrofit to some high-risk ward areas in hospitals.
So I think risk mitigation measures should be looked at to make sure that our environments are safer, but I don’t want to lose sight of increased isolation capacity as part of the recommendation as well.
Ms Carey: Yes.
Apart from building more hospitals, I was just trying to think about how, practically, you could recommend that – you say:
“We recommend that the overall NHS isolation capacity should be increased over the next 5-10 years …”
Apart from the rebuilding programme, how else might that be achieved?
Dr Shin: So we are trying to do something like this at the moment with limited resources. What might be possible is for certain ward designs – which are very open plan, open layout – which might be convenient for peacetime, but in a pandemic situation that is a risk, so it could be possible to increase segmentation within the ward, which is kind of a halfway house, to full isolation, but it would probably reduce risk.
So instead of having, like, three or four bays, having, you know, a domino effect of infections, you may be able to contain it, say, in one bay, rather than allow it to spread further.
So I think we’d have to – I think we should look at all of our hospital estate and say: what can we reasonably do in a short space of time and also long term?
Ms Carey: Thank you very much.
My Lady, those are all the questions I have for the experts.
Lady Hallett: Thank you very much.
I hope you were warned that we have another break in the afternoon, but I promise you the next session will be the last and you will be gone this evening.
So I will return at 3.10.
Ms Carey: Thank you, my Lady.
(2.55 pm)
(A short break)
(3.10 pm)
Ms Peacock: I ask questions on behalf of the Trades Union Congress.
I would like to address the infection risk associated with specific healthcare roles. In your report in section 11, and in Dr Warne’s evidence today, it has been explained that certain occupational groups had higher rates, most notably domestic services staff, nurses and healthcare assistants, and you also mention porters and certain therapist roles.
Dr Warne has mentioned in evidence the influence of having more exposure to Covid-19 patients, and in your report in section 10 Professor Gould, as the lead author, explains that nurses and healthcare assistants provide most of the frontline care: it is here that the risk of spreading and contracting Covid is highest.
My question, however, focuses specifically on domestic services staff and porters. Are you able to identify any aspect of the role or the working conditions of domestic service staff and porters which may contribute to the higher rates identified?
I think it’s for Dr Warne, but perhaps also Professor Gould.
Dr Warne: So I am not aware of any report that specifically addresses that exact question, but we know that the majority of healthcare worker infections that are attributed to patient transmission are in non-Covid clinical areas, and what those staff members that you’ve mentioned have in common is that they move between clinical areas. So, for example, the role of a porter is to take patients between clinical areas – part of their role is to move between different clinical areas with patients.
So – and we know that staff that move between clinical areas, from other studies, are at higher risk of acquiring Covid. So that is potentially one route but, again, I have not seen any specific study that has addressed that.
I might pass it on to my colleagues: have you noticed or seen any …?
Professor Gould: I’ve never seen anything written about that. I would agree with what has been said. I can’t think of any other logical reason. These people are – you now, they are peripatetic, they go around the hospital. They would also come into contact with visitors in general hospital areas, and that might have some contributory effect.
Ms Peacock: Thank you.
Just to perhaps drill down into what could be a potential other area just to test it: if workers within a particular role have less access, for example, to training on IPC measures, to IPC guidance or to PPE, could that also be a feature of higher infection risk in a particular role?
Dr Warne: So, perceived lack of access to PPE and lack of training has been identified as a risk factor for healthcare worker infection in the first wave, but that’s based on self-reporting of training and self-reporting of PPE access.
So, again, I’m not necessarily aware of any studies that have systematically looked at that.
Professor Gould: No, neither have I.
Ms Peacock: Thank you.
Building on some of the evidence today around the essential role of IPC leads and teams and the importance of clearly communicating guidance to workers, are there any additional challenges faced in reaching non-clinical staff who were not directly employed by the trust? So, for example, outsourced and agency cleaners and porters.
Professor Gould has mentioned bank staff receiving training, but where the staff are not employed by the NHS but by another company, such as a company providing cleaning staff, as far as you’re aware, does that introduce additional challenges in ensuring they hear about updates to guidance or specific plans for approaching IPC within that hospital?
Professor Gould: It would be a complication, but most reputable cleaning companies would provide trained staff, so they will be trained as cleaners and they would be trained with infection risks.
Ms Peacock: And to your knowledge, how good is – apologies.
Dr Shin: Just to add to that, I think it’s a particular consideration with outsourced staff and the groups you’ve mentioned, and we have some of those, and the communication cascades, which we talked about earlier today, is – a lot of it’s by email and our emails are nhs.net, and whether staff not employed by our trust get those nhs.net emails I’m not certain, and that could be an area where the communication is not as efficient as we’d like, potentially. But I don’t know for certain that’s the case. But I’m sure that would vary a lot from hospital to hospital.
Ms Peacock: And to your knowledge, is there sufficient oversight of the training and the guidance and these emails that are being provided? Could that be improved upon?
Dr Shin: So the emails I’m talking about are really highlighting to staff that there’s a change to guidance which are usually often put on our hospital intranet, which is accessible to our staff, meaning primarily NHS employed staff, and the level of access to those online resources in our hospital for the outsourced staff I’ve mentioned, again I’m not – I don’t have enough knowledge to date to answer that question now.
Ms Peacock: So is it a fair summary that there may be additional challenges to getting messages and training to these staff, and there might not be the right level of oversight as to what information and updates they are receiving?
Dr Shin: That is a possibility.
Ms Peacock: I’m grateful, my Lady, those are my questions.
Lady Hallett: Thank you very much, Mrs Peacock.
Ms Weeraratne.
Questions From Ms Weereratne KC
Ms Weereratne: Thank you.
Good afternoon. I ask questions on behalf of Welsh bereaved families. Many members of this group experienced loss of loved ones through nosocomial infection.
My first question is on the precautionary principle, which I believe should be addressed to Dr Shin. You considered that – and we were taken to it by CTI – at paragraph 12.42 of your report onwards.
At 12.43 you say that the precautionary principle is an approach to risk mitigation in the face of potentially serious threats amid scientific uncertainty.
Following on from, that you say at 12.45 that it is harder to apply the precautionary principle when the threat is on a massive scale because it risks exhausting supplies of PPE for which the precautionary principle advocates.
Now, I know you have made some recommendations, which you have also already been taken to, in relation to the declassification of the pathogen and HCIDs and commensurate levels of PPE, but I’m asking you about 12.45, leaving aside HCIDs, and more broadly.
So my question is: do you agree that, firstly and put simply, assessing a risk or threat and uncertainty in scientific evidence and applying the precautionary principle, that is a different and prior process to the drafting of suitable IPC guidance to meet that risk; would you agree?
Dr Shin: I think I agree with what you’ve said, yes. We’ve said in the previous session that we would, in a future pandemic, support the precautionary principle and only step down measures like PPE and other IPC measures when evidence – there’s evidence that that’s safe to do so.
But, as we said – and you just highlighted that section of the report – if and when the risk we’re trying to control is on a massive scale like in this pandemic and we face supply challenges that we’ve discussed earlier today, then it may be impractical to do that, even though that’s what is recommended and what everyone intends –
Ms Weereratne: Yes.
Dr Shin: – to do so.
Ms Weereratne: I’m so sorry, I’ve only got limited time, so I’m just going to jump back to my question, and that’s really that: whilst there’s a relationship between PPE supplies at some point and the risks that’s assessed, but my question was that at the point of assessing the risk and the uncertain scientific evidence, that that is a prior process to considering suitable IPC guidance to meet the risk, including availability of PPE.
Dr Shin: I’m not sure how you can separate the availability of the PPE. If you make guidance which cannot be implemented, and –
Ms Weereratne: So that’s the guidances, I’m saying a separate process to the risk assessment. Risk assessment comes first, and then you turn to guidance and availability of PPE.
Dr Shin: Yes.
Ms Weereratne: Would that be right? Two stages, in effect.
Dr Shin: That’s a fair assessment, but then we’ve also heard today that even if guidance is published there is often, you know, a caveat at the end saying there can be local risk assessment which may affect how this is applied locally, for example.
Ms Weereratne: Yes, so we’re then looking at application of the principle. I was looking more at the actual risk assessment prior to the application or the implementation.
Dr Shin: Yes.
Ms Weereratne: So there was a two-stage process. I think you have agreed with me, Dr Shin, I’m going to move on.
Dr Shin: I think I’m generally agreeing with what you’re saying, yes.
Ms Weereratne: Thank you so much. Because again, once the precautionary principle applies because there’s a serious threat – and I think you said there’s – you described it earlier today as facing a rising tide of a very dangerous, lethal virus in early 2020 – and then the uncertain science, then you look at what measures and steps are appropriate and available to guard against that risk that’s identified. A slightly different way of putting the same point.
Dr Shin: I think we’re agreeing.
Ms Weereratne: Yes, okay.
So let me then move on, then. So if you end up in a position where there precautionary principle clearly applies, but you require a level of protection through PPE that’s known to be in short supply, I think you will agree – because I’m going to quote something that you have written – that policymakers have a responsibility to be transparent about decision-making, including whether logistical challenges or resource constraints have influenced their decisions. Is that right?
Dr Shin: Again, I think we’re broadly agreeing here.
Ms Weereratne: Good. Well, I do quote that from your recommendation, actually, so I’m expecting and hoping that you agree.
Dr Shin: On that point, I think a point we’re trying to make is that when guidance et cetera is produced, we’ve argued for greater transparency in how that’s arrived at and also who’s involved in drawing up that guidance. So, again, I think we’re broadly speaking on the same page.
Ms Weereratne: Yes, I think that’s right, but – so I call it the honesty principle, which is I’m going to ask you: does it lead to less confusion and better understanding all round for practitioners and governments to have that kind of openness and transparency?
Dr Shin: Yes.
Ms Weereratne: Thank you.
So I’m going to move on, then, to my next question, which is – hopefully in time – at paragraph 9.27, which is Dr Warne.
In that paragraph, Dr Warne, that –
Dr Warne: Yes.
Ms Weereratne: – applies to guidelines for the roll-out of asymptomatic staff testing using lateral flow devices, and that was published by the NHS in November 2020, making twice-weekly screening available for all NHS staff and acute hospitals across the UK.
You see that?
Dr Warne: Yes.
Ms Weereratne: So, however, it appears that in Wales asymptomatic staff testing was not in fact started until the middle of March 2021, and possibly not as late as July 2021 in some areas.
So the question is: do you agree that this delay in implementation exposed patients to the risk of infection from healthcare workers?
And in asking that question, I bear in mind what you’ve said about the transfer of infection from healthcare workers to healthcare workers and patients to patients in your earlier evidence.
Dr Warne: So I think they would have increased the risk of transmission from healthcare workers – asymptomatic healthcare workers to patients. The absolute increase in numbers may have been small in comparison to other routes of transmission, but there is an increased risk.
Ms Weereratne: An increased risk, thank you very much.
Again to you, Dr Warne: on hospital-acquired infection rates, at paragraph 11.16.3 of your report you provide some statistics about hospital onset cases during the first wave in England, represented by 5.3% of all laboratory confirmed Covid cases.
Are you with me?
Dr Warne: Yes.
Ms Weereratne: And in Scotland, being 6.4% of all confirmed cases, and in Wales being 10.5% of all laboratory confirmed Covid-19 cases.
Dr Warne: Yes.
Ms Weereratne: Again understanding that you have expressed some caution on that data in that paragraph, and noting what you say about the lower proportion in England, do you have any theory or hypothesis as to why, by this measure at least, the rates of hospital-acquired Covid-19 were so much higher in Wales?
Dr Warne: So that may be a reflection of the studies, the way they were conducted, rather than a true reflection of the number of hospital-acquired infections in Wales. That’s why I’m reluctant to draw a direct comparison between the three devolved nations in that regard, because there are a number of different factors that may influence it.
Ms Weereratne: All right. So are you able to consider what range of factors might affect the figure in Wales?
Dr Warne: So, first, obviously it’s potentially true that there was a genuinely higher rate of hospital-acquired infection in Wales and that may reflect, for example, the community-acquired infection rates across Wales which were, I believe, lower in the first wave than they were in other parts of the UK, therefore the proportion of hospital-acquired infections would appear larger. It’s difficult without having the full data, and there’s probably a number of factors that could influence that. So again I would draw – I would be very careful in drawing direct comparison between those three figures.
Ms Weereratne: Thank you.
My Lady, I have one short question.
So I’ve one final question to Professor Gould, in that case, and it’s on training, Professor Gould.
So at paragraph 12.10 of your report you cover the need obviously for PPE training to be of a good standard. Our question is this: do you have any specific recommendations for this to include in particular points on the changing scientific picture to ensure buy-in to the guidance to promote staff compliance in that way?
Professor Gould: You would have to have regular communication with the staff to tell them about the changes in scientific thinking and regular continuing professional development and there should be refresher UPS and there always have been refresher updates in infection prevention, I think in the past perhaps they haven’t been as good as they might have been throughout all the four nations, but I think there is greater awareness now, so I think in future there will be greater awareness on CPD, continuing professional updating, and people will be more likely to buy into it, because now they’ve had the experience of going through a pandemic, and they know that this is not just theoretical stuff that we expect people to know, it directly affects their wellbeing and that of patients.
Ms Weereratne: Just to be clear, that also applies to the changing scientific picture?
Professor Gould: Thank you very much.
Lady Hallett: Thank you very much.
Ms Sen Gupta.
Questions From Ms Sen Gupta KC
Ms Sen Gupta: Thank you.
I represent the Frontline Migrant Health Workers Group, and our clients’ members include outsourced workers within the NHS system, such as agency nurses, cleaners, porters, security guards, medical couriers and drivers that were not directly employed by the NHS.
Dr Shin, we have been given to ask some specific questions about testing, of healthcare workers rather than patients. You were referred earlier to paragraph 9.27 of the report, and I’m going to take you back to that. In that paragraph, you state:
“Guidelines for the roll-out of asymptomatic staff testing using lateral flow devices were published by the NHS in November 2020, making twice weekly screening available to all NHS staff in acute hospitals across the UK.”
Just earlier in your oral evidence you referred to NHS employed staff. The reference in that paragraph of your report to NHS staff is a reference to those employed by the NHS, isn’t it?
Dr Warne: So that paragraph was written by me, rather than Dr Shin, so perhaps if I may answer it, if that’s okay.
Ms Sen Gupta: Yes, of course.
Dr Warne: I’m not aware of the exact eligibility criteria for lateral flow testing that was rolled out as part of those recommendations, so I’m afraid I don’t know if that applied to people working within NHS institutions who were employed outside of NHS employment.
Ms Sen Gupta: So you don’t know whether it was extended to outsourced workers?
Dr Warne: I’m afraid I don’t, no.
Ms Sen Gupta: I’m grateful, thank you.
During the relevant period of this module, March 2020 to June 2022, outsourced workers who were sick and unable to work because, for example, they were self-isolating, were only entitled to statutory sick pay of £94.25 per week. Do you agree that this low level of statutory sick pay provided a disincentive to test because of the resulting loss of work if required to self-isolate?
Lady Hallett: I’m sorry, which question is this that I’ve approved, Ms Sen Gupta?
Ms Sen Gupta: It’s in relation to the disincentive to test. I’ve broken it down, my Lady, into two parts. The numbering has changed in terms of our spreadsheet, I am afraid.
Lady Hallett: Could you answer the question: is there a possibility that if you may be financially affected if you test positive that you may not want to take the test, it’s a disincentive? Forget about the level of statutory sick pay because that may not be for me.
Dr Warne: So we know that staff uptake when offered screening was not 100% and we know that there are a variety of different reasons why people chose not to participate in screening programmes. I don’t know – I don’t have any expertise in reasons for that or indeed on the financial situation of people in the situation that you describe and, therefore, I can’t comment on whether that would have influenced their decision to participate in screening programmes or not.
Dr Shin: I have some limited experience of this, so I recall some discussions along those lines. The short answer to your question is it could be a disincentive to testing but my recollection of discussion, at least locally, was that that was recognised by the hospital leadership and NHS system leadership and I think steps were taken to try and reduce that disincentive. The details of that I’m not certain of but I recall that this area was recognised and discussed because staff took it – it affects the hospital because we can’t recruit – we can’t get staff to come on and to work as agency staff, bank staff for that reason, because they fear impact on their income, which is completely understandable. Exact steps, I can’t recall, but it was recognised and steps were taken to reduce that disincentive but I can’t give you further detail on that.
Ms Sen Gupta: Thank you.
In terms of regular testing, do you agree that regular testing was a valuable IPC tool throughout the pandemic?
Dr Warne: It wasn’t available immediately at the start of the pandemic. Where it was available and when it was available, I think it was useful tool, IPC tool, and it became perhaps less useful, for a variety of reasons, the later the pandemic went on. But I think that it is a very valuable tool and, if I might, all people who work or visit hospital sites, they are potentially capability of catching or transmitting Covid. So I think it’s critically important that all staff members who are there should be treated in the same way with regards to testing and IPC measures wherever possible.
Ms Sen Gupta: Thank you.
Dr Warne, at paragraph 9.25 of your report you refer to the availability of testing in March and April 2020. Do you agree that in March and April the limiting factors for testing were capacity and cost?
Dr Warne: There are more things to that. So whilst capacity and cost were certainly key features, there was also elements about technical expertise required, both to generate these testing platforms but also to roll them out, they require special – you need a supply of testing kits in addition to the testing capacity, which means you actually have to have swab in your hand. You also need the organisational structure by which to implement this. It’s incredibly complicated.
Ms Sen Gupta: Finally, do you agree that, as at March 2020, any suggestion that regular testing is of no value would be wholly incorrect?
Dr Warne: Apology, would you mind repeating the question?
Ms Sen Gupta: Not at all. Do you agree that, as at March 2020, any suggestion that regular testing is of no value would be wholly incorrect?
Dr Shin: I think we need more information, we need more detail on that question. Regular testing of who and in what circumstance; do you mean staff or patients, asymptomatic?
Ms Sen Gupta: Outsourced workers.
Dr Shin: Outsourced workers.
Dr Warne: So we know that by early March 2020, Covid was prevalent in the UK, and it was affecting wide varieties of people in the community in different groups at different levels across the different regions of the UK. I think that, if we had the capacity that asymptomatic screening of healthcare workers working in hospital, if it was available, in retrospect would have been useful but I think there are so many different factors to consider when making that statement, I’m not sure I can wholly agree or disagree with that statement.
Ms Sen Gupta: Thank you. Thank you, my Lady.
Lady Hallett: Thank you very much, Ms Sen Gupta.
Right, Mr Wagner wearing the hat for Clinically Vulnerable first, I think.
Questions From Mr Wagner
Mr Wagner: Correct. Thank you.
Good afternoon, my name is Adam Wagner and I act for Clinically Vulnerable Families, a group that represents people who are clinically vulnerable, clinically extremely vulnerable and their families.
So my first question is for, I think, Dr Shin. I want to ask you about paragraph 4.51 of your report, please, and this is with reference – this is a part of the report where you’re referring to aerosol-generating procedures, and you say there:
“Much less attention is paid to the risk posed by natural respiratory aerosols exhaled by patients, healthcare workers and visitors, despite the fact that these aerosols vastly outnumber those produced by AGPs, [that’s aerosol-generating procedures] and potentially pose a greater infection risk, the much higher risk of infection associated simply by occupying the same indoor space as that occupied by somebody who is infected suggested the routine use of RPE would have offered a higher degree of protection.”
Dr Shin, am I asking the right expert the question about this section?
Dr Shin: So the quotation there is a direct reference there to the report from Clive Beggs, who gave evidence to the Inquiry last week.
Mr Wagner: Yes, and I think it’s agreeing with Professor Beggs?
Dr Shin: Yes.
Mr Wagner: So, Dr Shin or Dr Warne, whoever wants to answer the question, Dr Shin, said in evidence, you were asked about FFP2 and FFP3 masks, as compared to nothing, as compared to no measures, and you agreed, you said it was clearly true that a higher level of protection would be offered by those interventions. Just considering the risks of respiratory aerosols exhaled by patients and visitors, so members of the public, and the FFP2 and FFP3 masks, would it, in your view, have helped for there to have been clear public guidance about the benefits of FFP2 and/or FFP3 masks, so that when the public entered healthcare settings, potentially with Covid or potentially at risk of Covid, they would be better educated on the benefits of those masks and be able to make informed choices about what they do?
Dr Shin: Sorry, for members of the public?
Mr Wagner: Yes, so people visiting hospitals or patients.
Dr Shin: I’m not sure I fully understand the question because we’re never going to offer visitors, if that’s what you’re talking about, FFP2 or 3.
Mr Wagner: Yes.
Dr Shin: Maybe I’m not understanding the question correctly.
Mr Wagner: I was going to come onto that in a moment, but in relation to – I think it was Dr Warne who just said, in response to the earlier question, that members of the public brought Covid into hospital settings, quite often logically. So if a member of the public is coming to the hospital, and I extend the question in this way: if they brought their own FFP2 or FFP3 mask and they wanted to wear it, leaving aside mandating, just it was their choice to wear it, would you agree that that should be facilitated because it helps protect them and the people around them?
Dr Warne: So there is clear evidence that wearing face coverings reduces the risk of transmission and there is evidence that FFP2 and 3 masks provide more protection in that regard, predominantly from the wearer coughing – you know, really transmitting virus in that way.
I’m not sure, at a community level, what the evidence would be, whether they can comment on that, bearing in mind that these would be non-fit-tested FFP2 and FFP3 masks and the variety of other considerations for community settings. But certainly there is clear benefit of wearing face masks when visiting hospital.
Mr Wagner: I think you have also said that FFP2 and 3 are better, you know, obviously including if fit testing and making sure you’re wearing them in the right way, so if a person turns up, the member of the public, with one of those better masks and says “I want to wear it”, is there any reason why you wouldn’t allow them to wear it or give them, for example, a surgical mask instead.
Dr Warne: So speaking from my own hospital, I’m not aware that we would have asked a visitor to change from FFP2/3, should they be wearing one, to an FRSM, and I’m not aware of any hospital which would have taken that position, if that’s what you’re implying by your question.
Mr Wagner: It’s the evidence of some of the Clinically Vulnerable Family group that that’s exactly what happened, that they came into hospital and were told, “No, no, you’ve got to wear the sort of hospital issued surgical mask, rather than the mask that you’ve come in with”.
Just following on from that, you know, talking about a clinically vulnerable group, so people who know that they are immunosuppressed, or whatever the reason they would be particularly vulnerable to Covid, would you agree that it would be important to allow them or facilitate them to wear better quality masks if visiting a healthcare setting when potentially there is a high risk of Covid transmitting to them?
Dr Shin: I think answering the question today, I’d say, yes, it’s reasonable that they continue to wear that mask. Now, what our position would have been in 2020 is a different story. One thing I do recall is that we asked visitors to wear – if they were provided with an FRSM for example to put on a new FRSM because we don’t know how long – could that mask have been but I will confess I’ve never come across even a report of a visitor arriving with FFP2 or 3 or being asked about that, not that I get asked about every single incident at our front door but I think the basis of your question, I think, is it’s reasonable that if you’ve got a vulnerable visitor coming, for them to wear an FFP2 or 3, it’s a reasonable thing and I can’t think of a good reason to stop them doing that.
Dr Warne: I would add to that I think we also need to consider safer ways of vulnerable patients and healthcare workers entering the hospital environment through a range of other measures, of which, you know, PPE, potentially, is one of them. Again, it’s a poorly studied area and one I think that’s been highlighted by the pandemic that we need to take more of an interest in.
Mr Wagner: Are there any measures that you could recommend, simple measures that might help those clinically vulnerable people coming to healthcare settings?
Dr Warne: So two examples spring to mind, one is dialysis patients and the other is haem-oncology patients, so patients who need to access health services for life-saving treatment, and various mechanisms were used during the pandemic to try and provide those hospital attendances in as safe way as possible, through, for example, staggered appointment times, greater social distancing in waiting rooms, guiding patients directly into clinic rooms, rather than being in open waiting areas, et cetera, and we should be looking at restarting that package of measures in the event of a further pandemic, as soon as possible, for our vulnerable patients.
Mr Wagner: What about the healthcare staff wearing respirator masks when they’re dealing with those immunosuppressed or clinically vulnerable patients, would that be another way you might think you could reduce the risk of them getting Covid-19 or some other respiratory virus?
Dr Warne: So, potentially, the evidence base is much less clear, particularly for the valved FFP3 masks where, when you exhale, you’re potentially releasing material out. So I’m not aware of any studies that have looked at that particular risk. In the event that a patient is wearing an FFP3 mask non-fit tested, and a staff member is doing the same, what is the risk to those patients – to those individuals. Theoretically, obviously, it would be lower but I can’t quantify that risk in comparison to other measures we might take.
Mr Wagner: Thank you.
I want to ask you secondly about testing and I think this is for Dr Warne. You have spoken about lateral flow testing and about other kinds of testing. Is it a one-stop shop or do you think repeat testing, testing after admission of a patient, might help mitigate that risk of, you know, long incubation of the virus?
Dr Warne: So we know that more frequent testing is more likely to pick up asymptomatic or pre-symptomatic cases. So the more frequently you do it, theoretically, the less likely you are to – the more likely you are to identify those patients early and to prevent them from transmitting, up to a certain point. The practicalities become one of logistics, about how frequently you can test people and, certainly, in our hospital, we were doing it more than just on admission; we were doing it at intervals during the course of their admission as well, in an attempt to try to mitigate that.
Mr Wagner: Do you think, looking back, repeat testing after admission could have been used more effectively across the NHS to reduce transmission one way or the other?
Dr Warne: It’s difficult to assess because, in doing that, you immediately reduce your testing capacity or screening capacity for other purposes. It is a finite resource that needs to be managed in the best way possible and this is where some modelling interventions have been able to try to find that sweet spot where you can provide the most benefit to the greatest number of patients and healthcare workers. It’s not a straightforward question.
Dr Shin: I’ll just add to that. In fact, in reality, in my hospital, which has a large number of vulnerable patients, we did actually have weekly PCR testing for a long period and, in fact, even to this day, in our haematology-oncology population, the most vulnerable, we maintain once-weekly surveillance PCR testing in our inpatients.
Mr Wagner: Thank you. Just one final question. In relation to false negatives, is there any evidence of common causal factors that might lead to false negatives and if there anything that could be done if there is evidence of that kind to reduce the number of false negatives or false positives?
Dr Warne: It depends on the testing platform that’s being used. So there is, for example, evidence that if you don’t get enough sample when do the nasal swab, if you don’t put it in far enough or get enough material on it, that that can lead to false negatives. That’s an issue about training or educating people how to use those tests. Then there are the intrinsic features of the test itself, some of them have better sensitivity, fewer false negatives than others.
Mr Wagner: Thank you.
Lady Hallett: Thank you, Mr Wagner.
Mr Simblet?
Mr Simblet: My Lady, the questions you approved on behalf of the Covid Airborne Transmission Alliance have already been answered in the course of this afternoon, so I’m not going to ask those questions, thank you very much.
Lady Hallett: Thank you very much, Mr Simblet, very grateful.
You’re back up, Mr Wagner.
Mr Wagner: A bit of a gap, I have to open my computer again.
I’m also acting for a different core participant, the pregnancy, baby and parenting organisations, which are a coalition of 13 charities that deal with those kinds of issues, so I’m just going to ask you a couple of questions, please, on their behalf.
So, first of all, I think this is a question for Dr Shin, it’s about visitors guidance. Dr Shin, do you agree, as a general proposition, that it’s much harder to strike a reasonable balance with visiting restrictions during a pandemic if there isn’t clear national guidance to help achieve that balance?
Dr Shin: Yes.
Mr Wagner: Following the same logic, would you agree that, without clear national guidance, it would be much harder for trusts to strike a reasonable balance in relation to maternity and neonatal services?
Dr Shin: Yes. The short answer, yes.
Mr Wagner: I’d like to ask you about paragraph 8.22 of your report, please, where you say:
“Overall, taking into account the exceptions made for special circumstances, like end-of-life care, maternity services, patients with cognitive impairment, et cetera, and the fact that visiting guidance evolved to be more flexible over time, we believe a reasonable balance was struck but with variation in local practice that contributed to differing experience.”
Just a point of clarification: when you say maternity services, did you include early pregnancy services or were you focusing on childbirth itself?
Dr Shin: From my perspective, we were focusing more around childbirth.
Mr Wagner: Yes. So would it be right to say that, when you were reaching that conclusion that a reasonable balance was struck, you weren’t considering early pregnancy services, so such as attending early pregnancy scans with a partner?
Dr Shin: Again, from my perspective, when we were writing that, I was really focusing on the childbirth phase of pregnancy.
Mr Wagner: Were you including in that neonatal services? You did mention it before –
Dr Shin: We mentioned it separately. Sorry, we didn’t mention – I thought it was explicit but, for neonatal intensive care units, it was quite common to have a more flexible approach and I think we said that – you know, for example parents – many hospitals have accommodation, even, for parents to stay overnight, so that they could stay near or with their babies.
Mr Wagner: So the national guidance for maternity and neonatal services wasn’t issued until December 2020, so that’s nine months after March 2020. Do you agree that in the interim, there was a vacuum in relation to that area of the hospital services.
Dr Shin: My recollection of that, this wasn’t the focus of all my workload in the pandemic period, so I can’t answer that specifically for my hospital. What I do know is that neonatologists around the country work in large networks, in regional networks and national, so I would assume there’s a lot of communication about this very point. But I wasn’t privy to those.
Mr Wagner: Would you agree that, going back to my initial question, the fact there wasn’t national guidance until December 2020 would have left individual trusts probably quite inconsistently applying what they thought was the best option?
Dr Shin: Yes, potentially, but, as I mentioned, neonatology units work in networks so I think there would’ve been very quickly, hopefully – I presume a very quick arrival at some reasonable consensus about this because I’m aware that they do work very closely together as networks.
Mr Wagner: Sure, but that’s not actually something you studied for – and didn’t take evidence on that for the purpose of this report?
Dr Shin: And it’s not something I had any direct experience of.
Mr Wagner: No. No.
So just sticking on visiting guidance, and just looking at 8.14 of your report, where you say the extent and consistency with which these restrictions were and should be put in place across different clinical areas is unclear, we assume that most, if not all, NHS hospitals followed relevant national NHS visiting guidance in the four nations.
On what basis did you make that assumption? What was the evidential basis of assuming that most, if not all, NHS hospitals followed the relevant national guidance?
Dr Shin: I think I bring you to the early preamble in the report where we say we can talk about our own experience and also in our regions perhaps, but we can’t, you know, really answer for the entire – the experience of people across the entire country, and also if we looked for evidence and couldn’t find it, then we couldn’t include that, so we were applying the precautionary principle in a way to that paragraph that, to the best of my knowledge, that was the case but we can’t speak for every trust in the country. And also devolved administrations, as we said before, we don’t have strong links, for example, with Northern Ireland. In some cases, we said in the report – for some aspects of the report, pertaining to other parts of the country, so that was the reason for the wording of that.
Mr Wagner: But wouldn’t the precautionary principle have meant that you applied the other way: that without evidence of their being a sort of majority who applied national guidance, you just couldn’t say anything about it?
Dr Shin: Yes, it was linked to the fact we can’t always cover all aspects of pandemic response in all parts of the country.
Mr Wagner: Yes, and there is evidence – this is the final point I want to make – from the 13 organisations that I represent and their stakeholders that there was very inconsistent application of principles, if I can put it like that, before that December 2020 national guidance. Is that something that you can speak to or not?
Dr Shin: Well, I’m not aware of that evidence that you’ve mentioned.
Dr Warne: No, I think it’s important that we start – as I said earlier in the hearing, I think that it’s important that we start to think more about visiting as an understudied area, and one that always takes third place to patient and healthcare worker care, but one that we should consider further in future pandemics. I’m not sure how best to do that, but I think that the reports produced by the organisations you represent are probably a good way of starting that process now.
Mr Wagner: I think it was you, Dr Warne, who mentioned earlier – you were talking about carers being a sort of special category of visitors where they’re providing care to the individuals – it may have been Dr Shin actually, but would you put, in relation to neonatal care or maternity services, the parents of the child, of the baby, in a similar category as carers, rather than just, sort of, visitors?
Dr Warne: So I think that there are a number of different visiting groups of visitors that you could include. You have to consider – and it’s important to consider them, including carers and – and whether I’d include them in the caring group or not is a bit unclear because, you know, some people might say they fit more into the role of parents or paediatric considerations.
You have to take – I’m a bit cautious around maternity services because we know that there are some pandemics that have happened in the recent past where pregnant women and people in the immediate post-partum period are at increased risk of severe disease. So swine flu, for example, I clearly remember looking after pregnant women, who were otherwise fit and well, in intensive care with a disease that was widely considered to be relatively mild.
So we have to take each pandemic on its own merits, and I think that we should take these considerations now but we need to be careful how we apply them to any future pandemic.
Lady Hallett: Thank you, Mr Wagner.
Mr Wagner: Thank you.
Lady Hallett: Ms Mitchell.
Questions From Ms Mitchell KC
Ms Mitchell: I appear as instructed by Aamer Anwar & Company on behalf of the Scottish Covid Bereaved. I think my questions are probably most suited to Professor Gould, but if I’m not right in that, please do intervene.
My first question is in relation to the practicalities of IPC, particularly as it relates to visitors.
In your report you identify that there are practicalities which have to be overcome, for example patients taking off masks because they need to eat. One of the practical examples that was given to us repeatedly by the Scottish Covid Bereaved was examples of seeing visitors and perhaps people from various different wards coming out of the hospital to smoke or to get some air or both, mixing with one another and then going back separately to the wards.
Do you agree, when we go forward and look at IPC in the future, that any guidance needs to emphasise the movement of people not only within the hospital but from within the hospital to outside and back again?
Professor Gould: I think that it would be a very reasonable area to look at and to consider, but I don’t have any hard figures about what was – it’s not something I’ve seen written about very much.
I’m aware very much that in many hospitals in many European countries, patients spend more time outside of the hospital than they do in it, if they’re mobile, and it apparently makes no difference on infection rates.
Ms Mitchell: Well, that’s very –
Professor Gould: But that’s not in relation to Covid, that is in relation to healthcare-associated infection more generally. But I think it’s an important and interesting point that you bring, and I think that it probably should be given consideration in future guidelines.
Ms Mitchell: Moving on, the evidence of Dr Warne earlier on said that you’ve no records of who visits patients, and what you’ve already said in relation to visitors perhaps already answers this next question, but was there any work done to ascertain if visitors were adhering to IPC guidelines when they were visiting?
Professor Gould: Not that I’m aware of, no. It wasn’t an area, again, that received a great deal of attention.
Ms Mitchell: The reason I ask that is that the implementation and the differences between implementation of IPC visiting guidelines were noticed by the Scottish Covid Bereaved, and they considered that there was significant differences in between different hospitals, even in between different wards, as to how those policies and procedures were implemented and, as a result of that, it has caused significant upset and significant concern to the Scottish Covid Bereaved, for example, a number of end-of-life visits weren’t permitted during 2020, there was an inconsistency in approach of things like how many people could visit, for how long and what setting, what protection they can wear.
First of all, my question is: do you accept that there was a wide variation in the implementation of IPC guidance?
Professor Gould: Certainly there were variations reported among healthcare staff, but I’m not aware of anything written very much about visitors. That may be my ignorance but I have not read very much about that.
Ms Mitchell: Again, would that point to an area of IPC that should be considered more –
Professor Gould: I think it would be a good idea to consider it more in the future, yes.
Ms Mitchell: Thank you.
Finally, and sort of moving on from the point that you’ve just made there, I was so interested to hear about your hearts and minds argument to engage people in these sorts of policies.
Would having one set of guidelines that we could say to people these are being implemented consistently and uniformly be a good idea to ensure compliance to make people think “I’m doing this and other people are doing the same thing”?
Professor Gould: We could never ensure compliance, because we don’t live in that kind of a world, but if people know why they are doing something, and agree with it, I think you would be more likely to have their hearts and minds, yes.
Ms Mitchell: I’m obliged, my Lady, those are our questions.
Lady Hallett: Thank you very much, Ms Mitchell.
I think that completes the questions that people wanted to ask. I am really grateful to you. I don’t know if it’s easier sharing the burden after a long day of intensive questioning or whether it’s harder, I don’t know, but thank you all very much indeed for all your help in preparing the report and for all your help today, I’m very grateful to you.
(The witnesses withdrew)
Lady Hallett: Right, it’s 10.30 on Monday.
Ms Carey: It is.
Lady Hallett: On whatever day of September it is.
Ms Carey: The 23rd, my Lady.
(4.00 pm)
(The hearing adjourned until 10.30 am on Monday, 23 September 2024)