COVID-19 transmission in hospitals: Management of the risk - a prospective safety investigation

Date Published:

Theme:

  • Hospital care,
  • Coronavirus (COVID-19)

A note of acknowledgement

The investigation would like to thank the NHS staff, patients and families that gave their time to assist with the investigation, providing open and honest accounts of events to support learning and improve patient safety. The investigation would like to note its gratitude for their efforts in allowing rapid access to enable investigation activities to take place, and for engaging with and responding to the investigation within condensed timescales.

Executive Summary

Introduction

This prospective patient safety investigation looks at how the healthcare system operates to minimise the likelihood of patients catching coronavirus (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19) on acute hospital wards. Transmission of COVID-19 can cause serious illness and death.

HSIB identified evidence to suggest that people were being admitted to hospital without signs of COVID-19 and by the time they were discharged, or soon after, they had contracted COVID-19.

Hospital acquired infections – also referred to as nosocomial infections – are significant both because of the effect on the health of patients and staff and the risk of transmission between patients and staff. Fear of contracting COVID-19 can deter people with healthcare needs from attending hospital, and healthcare staff who contract COVID-19 or are required to isolate can be absent from work for prolonged periods, often at a time of maximum strain on the workforce.

NHS response to COVID-19

The investigation recognises the unprecedented response the NHS has been required to deliver due to the COVID-19 pandemic. The investigation has heard evidence of the significant organisational and personal impact of COVID-19 and the exceptional efforts that have been necessary to manage the healthcare system response.

HSIB aim to improve patient safety through effective and independent investigations that do not apportion blame or liability. This investigation does not intend to provide any criticism of the NHS response to the COVID-19 pandemic. The investigation instead seeks to provide a prospective view of actions that may help to facilitate an enhanced response in the face of continuing COVID-19 pressures.

The national investigation

The investigation focused on understanding the national situation regarding nosocomial transmission during July and August 2020. The intention was to assist the NHS as it prepares itself for the coming autumn/ winter period and any longer-term implications of responding to COVID-19.

The investigation identified six reference trusts that represented a range of geographical locations, socioeconomic conditions, building and environmental conditions and local population ethnicity. Observations and interviews were conducted with staff at all levels within these trusts as well as national system leaders and patient focus groups. Data analysis software and an established investigation methodology were used to corroborate and triangulate the findings from multiple sources.

There is rapidly developing knowledge of COVID-19 and how best for the healthcare system to respond. The number of reference trusts was selected to allow the investigation the broadest possible basis for evidence to be collected within the available reporting timeframe and resources available. HSIB considers it has struck an appropriate balance by providing information that may be beneficial to the various different layers of the healthcare system in a timescale that would enable a practical response.

The investigation fieldwork was completed between 13 July and 28 August 2020. A draft report was shared for consultation with the relevant stakeholders on 16 September 2020 so that they could carry out a factual accuracy check to ensure the validity of the investigation findings.

The terms of reference were as follows:

  1. Consider how national guidance aimed at reducing nosocomial transmission reflects the accepted international scientific knowledge as stated by the government’s Scientific Advisory Group for Emergencies.
  2. Identify the environmental and other systemic factors that help or hinder efforts to manage the risk of nosocomial transmission of COVID-19 on acute hospital wards.
  3. Identify the implications of the findings for prevention and mitigation measures within hospitals.

The investigation report presents findings, national safety recommendations and safety observations that may help to assist the NHS in its future response to COVID-19. The investigation report presents the voice of healthcare staff and members of the public to represent the key themes identified following analysis of the evidence collected.

The investigation report also includes key findings from the investigation analysis that may assist local NHS trusts in immediately identifying:

  • Factors influencing the risk of nosocomial transmission.
  • Questions to prompt considerations of what action may be taken to mitigate this risk.

The investigation acknowledges that its findings and recommendations are potentially complex and therefore the timescales in which it is possible to put them into practice may differ.

Some recommendations will have an impact on the response to COVID-19 over the short to medium term, while other recommendations will aid the healthcare system in its response to future rises in COVID-19 activity and other potential large-scale system responses to infectious disease.

Findings

Guidance

  • Although there has been an increase in collaborative working there remains a lack of clarity regarding national responsibilities, ownership, and process for the development of national infection prevention and control (IPC) guidance.
  • Current key national guidance does not fully reflect the range of mitigation measures suggested within the principles of the hierarchy of controls (an approach that sets out measures to mitigate risk ranked by their effectiveness).
  • Current national and local guidance and initiatives have focused on the role of personal protective equipment (PPE) as a mitigation strategy.
  • It has been challenging for the NHS to develop, interpret and implement guidance due to the volume of guidance disseminated and the speed at which guidance updates have been required.
  • At local level, the need to interpret the volume of guidance requires the use of additional organisational resources.
  • There has been a lack of consistency across some guidance which creates challenges in implementation. Testing and capacity factors
  • Access to sufficient patient and staff testing (Pillar 1 testing) and rapid testing plays a key role in how effectively NHS trusts can manage operational capacity.
  • Rapid testing will help to facilitate appropriate cohorting (grouping together) and isolation of patients.
  • Strategies used to manage the first wave of COVID-19 based on reduced elective (planned) activity, and the subsequent reduction of bed occupancy, may not be available in a future peak in COVID-19 activity. • Some reference trusts were seeking to procure and deploy inhouse testing facilities.
  • There was no regular surveillance testing of staff in the reference trusts outside of the Public Health England SIREN (Sarscov2 Immunity and Reinfection Evaluation) study.
  • The potential risk of asymptomatic staff transmission (transmission by staff who are not showing COVID-19 symptoms) was not always well understood in the reference trusts.
  • There was little evidence of a national strategic approach to address how trusts might overcome the obstacles faced when attempting to implement national guidance on patient testing. Personal protective equipment (PPE) and infection prevention and control factors (IPC)
  • Current PPE supply levels were satisfactory in the reference trusts.
  • Some reference trusts had concerns that there may be challenges to PPE provision in any further peak in COVID-19 activity.
  • A lack of clarity and changing guidance on PPE use created anxiety for staff, patients and families.
  • Clinical activities in hospitals could be restricted because of the provision of different types of FFP3 (filtering facepiece class 3) respirator masks, which required repeated fit testing for staff.
  • In the reference trusts, cleaning regimes had focused on public and ward areas and this increased workload had required trade-offs in cleaning other areas.
  • IPC specialists have taken a key role in the response to COVID-19, but availability of this type of expertise was variable across the reference trusts. There is a national lack of IPC staff and shared understanding of their role and national IPC requirements.
  • Staff experienced difficulties in following PPE guidance where it contradicted training and cultural expectations of staff and families.
  • Proactive management of IPC and PPE risks may help to alleviate future pressures from additional increases in COVID-19 activity.

Environmental factors

  • The design of the hospital estate (buildings and other infrastructure in clinical and nonclinical environments) impacted on the reference trusts’ ability to comply with IPC guidance and take mitigation efforts to reflect the higher levels of the hierarchy of control.
  • Hospital design does not always account for how staff are required to interact in non-clinical areas and the way in which these interactions may increase the risk of nosocomial transmission.
  • The flow and layout of staff work activities and equipment create additional transmission risks.
  • All the reference trusts needed to reconfigure their estate and bed numbers to comply with IPC guidance.
  • Considerations about the design and use of hospital ventilation systems are an emerging factor in mitigating the risk of COVID-19 transmission.
  • Controlled entry/exit points and controlling the flow of people around hospitals helped to build patient confidence and mitigate transmission risk.
  • A consistent national approach to barriers and signage may increase public confidence and mitigate transmission risks.

Staff factors

  • Staff who engaged with the investigation reported significant fatigue and emotional distress associated with COVID-19 activity.
  • Staff fatigue and emotional distress may impact on the NHS’s ability to mitigate against nosocomial transmission of COVID-19 and its ability to respond to a further rise in COVID-19 activity.
  • The reference trusts had developed staff health and wellbeing initiatives to assist with the emotional impact of COVID-19 activity.
  • National approaches had been developed to help NHS staff to access support services.
  • Across the NHS there was a lack of a national strategic focus on adapting work systems to mitigate the risks associated with staff fatigue.

Organisational factors

  • The organisational response to COVID-19 has required significant adaptability in NHS systems and leadership.
  • The COVID-19 response has facilitated an increased role of leadership on the frontline.
  • The response to COVID-19 required the reference trusts to increase their tolerance for organisational risk to ensure rapid response to emerging COVID-19 concerns.
  • There has been rapid organisational technological development to facilitate the response to COVID-19.
  • There was limited evidence of how technological developments had been used to address COVID-19 transmission risk in clinical areas.
  • There were recognised benefits of networked and regional working to support trusts to mitigate the impact of challenges faced by hospitals with less agile infrastructure.

Recommendations and observations

HSIB acknowledges that the safety recommendations identified by the investigation may require action over the short, medium and longer term.

HSIB makes the following safety recommendations

Safety recommendation R/2020/095:

It is recommended that the Department of Health and Social Care, working with NHS England and NHS Improvement, Public Health England, and other partners as appropriate, develops a transparent process to co-ordinate the development, dissemination and implementation of national guidance across the healthcare system to minimise the risk of nosocomial transmission of COVID-19.

Safety recommendation R/2020/096:

It is recommended that NHS England and NHS Improvement:

  • supports additional capacity for testing for NHS patients and staff (Pillar 1 testing)
  • facilitates the accessibility of rapid testing for NHS trusts, as soon as an increase in rapid testing supplies becomes available.

Safety recommendation R/2020/097:

It is recommended that NHS England and NHS Improvement:

  • develops a national intensive infection prevention and control (IPC) safety support programme for COVID-19 which focuses on leadership, IPC technical support, education, practice, guidance and assurance
  • develops a national IPC strategy which focuses on developing IPC capacity, capability and sustainability across the NHS in England.

Safety recommendation R/2020/098:

It is recommended that NHS England and NHS Improvement reviews the principles of the hierarchy of controls in its health building notes (HBN) and health technical memoranda (HTM) for the design of the built environment in existing and new hospital estate to reduce the risk of nosocomial transmission.

Safety recommendation R/2020/099:

It is recommended that NHS England and NHS Improvement responds to emerging scientific evidence and shared learning when reviewing guidance for NHS trusts on the role of hospital ventilation systems in nosocomial transmission.

Safety recommendation R/2020/100:

It is recommended that NHS England and NHS Improvement investigates and evaluates the risks associated with the potential impact of staff fatigue and emotional distress on nosocomial transmission of COVID-19. Safety recommendation R/2020/101: It is recommended that the Department of Health and Social Care reviews and identifies the mechanisms which enabled regional and local organisations to adapt and respond with agility during the pandemic. This should inform the development of a strategic approach to national leadership models at times of crisis and under normal conditions.

Safety recommendation R/2020/102:

It is recommended that NHSX considers how technology can assist in mitigating nosocomial transmission in the ward environment with regard to:

  • the use of digital communication technologies in assisting with the deployment of staff and the dissemination and circulation of key information
  • the increased use and availability of personal computing devices and electronic health record systems.

HSIB makes the following safety observations

Safety observation O/2020/075:

It may be beneficial to analyse data collated on asymptomatic staff infection rates to consider how this may impact on mitigation strategies to reduce the risk of nosocomial transmission.

Safety observation O/2020/076:

It may be beneficial to have greater consistency in the provision of FFP3 respirator masks to assist in their response to COVID-19.

Safety observation O/2020/077:

It may be beneficial to reconsider the design of ward work systems and equipment layout to mitigate the risk of nosocomial transmission.

Safety observation O/2020/078:

It may be beneficial if interventions aimed at reducing the risk of nosocomial transmission more closely consider non-clinical areas in which staff are required to work or gather.

Safety observation O/2020/079:

It may be beneficial to facilitate shared learning across the NHS so that effective strategies that have been adopted by local NHS organisations for the management of staff fatigue and emotional wellbeing can be shared.

Safety observation O/2020/080:

It may be beneficial to evaluate the change in organisational risk tolerance to consider the potential future impact on NHS governance and regulation processes.

1 Background and context

1.1 This is a prospective safety investigation which sought to understand how NHS guidance, structures and processes are currently designed to reduce the risk of nosocomial transmission of COVID-19. Nosocomial is the scientific term for an infection which is thought to have occurred in a hospital setting. The coronavirus disease (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. For ease of reference, this report refers to COVID-19 throughout as encompassing both terms.

1.2 The investigation focused on understanding the national situation during July and August 2020, with the intention of assisting the NHS as it prepares itself for the coming autumn/ winter period. At the time of publication, the NHS is facing a resurgence of COVID-19 infection rates, in conjunction with a potential seasonal increase in demand created by traditional winter illnesses.

1.3 The investigation recognises the unprecedented response the NHS has been required to deliver during the COVID-19 pandemic. The investigation has heard evidence of the significant organisational and personal impact caused by COVID-19 and the exceptional efforts that have been necessary to manage the healthcare system’s response.

1.4 The aim of the investigation was to understand the NHS’s position in relation to which risk reduction measures are recommended for nosocomial transmission of COVID-19, how these have been reflected in guidance, and practical considerations relating to how these measures are implemented.

1.5 This investigation is not intended to criticise the NHS response to the COVID-19 pandemic. Instead it aims to provide a prospective view of actions that may help to facilitate an enhanced response and help the NHS to further improve its services in the face of continuing COVID-19 pressures.

1.6 To understand the position of the NHS during this period it is necessary to briefly set out the context in which the NHS response to the coronavirus pandemic has developed.

1.7 The first cases of COVID-19 in the UK were confirmed on 31 January 2020 and the first death was reported on 5 February 2020 (BBC News, 2020a; BBC News, 2020b). By 7 March 2020, there were 316 confirmed cases of COVID-19 in the UK and a further four people had died. On 11 March 2020, the World Health Organization (WHO) declared a pandemic (World Health Organization, 2020a). The pandemic continued to progress rapidly and on 23 March 2020 the Prime Minister announced a full lockdown across England.

1.8 From 12 March 2020 until the introduction of community testing in early April 2020, there was no way of confirming whether an individual was infected with COVID-19 unless they were unwell enough to be admitted to hospital. This same period saw the number of cases of COVID-19 increase rapidly, reaching a peak in the third week of April, although high numbers of new cases and deaths continued throughout May (GOV.UK, 2020). By June 2020, the number of new cases had decreased and the number of deaths reported continued to fall (GOV.UK, 2020).

1.9 Concerns about patients becoming infected with COVID-19 during hospital admission began to emerge into the public domain in mid-May 2020. On 13 May 2020, the COVID-19 Clinical Information Network produced a paper for the Scientific Advisory Group for Emergencies (SAGE) and the New and Emerging Respiratory Virus Threats Advisory Group, which collated clinical data from hospital admissions. This report suggested that approximately 20% of patients were reporting symptoms of COVID-19 seven days following admission (COVID-19 Clinical Information Network, 2020), indicating possible nosocomial transmission. The BMJ reported that doctors were ‘deeply concerned at the number of patients becoming infected with COVID-19 in NHS hospitals in England’ (Lacobucci, 2020).

1.10 Subsequently, published research used a definition of nosocomial infection as ‘infection occurring 14 days following admission’ to hospital. These reported rates were stated at 12.5% (Carter et al., 2020). NHS England and NHS Improvement has identified patients who are diagnosed with COVID-19 seven days after admission as a ‘probable healthcare associated COVID-19 inpatient infection’ and require a root cause analysis to be completed for every incidence of nosocomial infection (NHS England and NHS Improvement, 2020a).

1.11 In addition, the transmission of COVID-19 by asymptomatic individuals (people who are not showing symptoms of the illness) is not well understood. There is limited evidence on the rate of asymptomatic transmission; estimates suggest the rate could be as low as 16% or as high as 41% (Byambasuren et al., 2020).

1.12 A precise understanding of nosocomial infection rates for COVID-19 remains very difficult to ascertain, as different definitions of nosocomial infection for COVID-19 are used. At the time of writing, there was no publicly available data to provide evidence of the scale of nosocomial of COVID-19 in the NHS in England. (DELVE Initiative, 2020, Appendix B).

1.13 The investigation requested data from Public Health England and NHS England and NHS Improvement to assist with understanding the rate of nosocomial transmission between July and August 2020. Both organisations explained the methods they used to collect and represent surveillance data for nosocomial infection. However, data on nosocomial transmission rates between July and August 2020 was not made available to HSIB for consideration or publication.

Modes of transmission of COVID-19

1.14 The understanding of how transmission of COVID-19 occurs continues to grow. Current understanding suggests that the three key modes of transmission are: droplets via people within close proximity, contact via surfaces, and aerosol via airborne particles (see figure 1) (Environment and Modelling Group, 2020).

Fig 1 Modes of transmission of COVID-19

1.15 Evidence regarding airborne transmission of COVID-19 emerged as the pandemic progressed and scientific understanding of the virus developed. On 29 March 2020, the WHO commented that in respect of COVID-19, there was the possibility of airborne transmission in very specific circumstances, which included aerosol generating procedures (AGPs) (World Health Organization, 2020b).

1.16 The WHO updated this guidance on 9 July 2020, when it considered whether the virus may be spread through airborne transmission not associated with AGPs. Although the WHO accepted that scientific modelling had suggested that this could occur, it concluded that further research was required (World Health Organization, 2020b).

Risk management

1.17 SAGE advises that a risk management approach should be adopted to minimise the transmission of COVID-19. The Health and Safety Executive guidance on risk management requires organisations, in consultation with staff, to identify, analyse and evaluate risks (Health and Safety Executive, n.d.a; Health and Safety Executive, 2017).

1.18 The greater the consequence and the higher the likelihood of a hazard occurring, the greater the risk and need for controls (preventative actions or methods) to minimise or mitigate the potential for harm (Health and Safety Executive, 2017).

1.19 The concept of a hierarchy of controls is commonly used to describe the properties associated with controls. Certain methods of control provide more protection and are more effective than others. The hierarchy of controls approach implies those controls at the top of the hierarchy are likely to be more effective at managing risks than those lower down (see figure 2) (Health and Safety Executive, n.d.a; National Institute for Occupational Safety and Health, 2020).

1.20 The hierarchy has been supported for use in healthcare internationally (Centres for Prevention of Disease Control and Prevention, 2010) and specifically in response to the risks posed by COVID-19 in healthcare settings (Joint Commission, 2020; Queensland Government, 2020). However, these controls may be more challenging to implement due to practical limitations (such as time and cost) in how they can be incorporated into the healthcare system in the short term.

Fig 2 The hierarchy of controls relevant to the transmission of COVID-19 in hospitals based on evidence provided by SAGE

Elimination: Redesign the activity such that the risk is removed or eliminated.

Substitution: Replace the activity with an activity that reduces the risk. Care is required to avoid introducing new hazards from the substitution.

Engineering controls: Design measures that help control or mitigate risks, such as barriers, guards and so on. Priority should be given to measures that provide collective protection rather than those that just protect individuals or a small group of people.

Administrative controls: Identifying and implementing the procedures to improve safety, such as undertaking risk assessments, preparing and communicating mitigating procedures, and increasing signage.

PPE: Personal protective equipment: local kit to mitigate the risks to those exposed to the hazard. People must be familiar with the function and limitation of each item of PPE for this to be an effective measure. Ideally, PPE is only considered after all previous measures higher in the hierarchy are identified as not being fully effective in controlling the risks.

1.21 The evidence from SAGE includes consideration of the design of the physical environment, clinical processes and pathways, minimising movement, and promoting consistency in allocation of staff (Scientific Advisory Group for Emergencies, 2020).

1.22 The infection prevention and control (IPC) guidance available to the investigation was updated during the period of the investigation (Public Health England, 2020a; Public Health England, 2020b). The IPC guidance is issued jointly by the Department of Health and Social Care, Public Health Wales, Public Health Agency Northern Ireland, Health Protection Scotland, National Services Scotland, Public Health England and NHS England. The IPC guidance is currently published on the Public Health England website.

1.23 The IPC guidance updated on 20 August 2020 (Public Health England, 2020b) includes definitions of high-risk, medium-risk and low-risk patient pathways to help trusts respond to different levels of COVID-19 transmission risk.

1.24 High-risk categories include patients with confirmed COVID-19 status or patients who are showing symptoms of or are suspected of having COVID-19, including those that have been triaged/clinically assessed and are awaiting test results. Medium-risk categories include individuals who are asymptomatic and are awaiting a COVID-19 test but have been triaged/clinically assessed. Low-risk categories include patients who are triaged/clinically assessed to have no symptoms and have a negative COVID-19 test.

2 Involvement of the Healthcare Safety Investigation Branch

2.1 Healthcare Investigation Safety Branch (HSIB) identified transmission of COVID-19 in hospitals as a priority for investigation, due to concerns about the number of patient and staff deaths from the virus and the significant percentage of infections estimated to be associated with hospital admission.

2.2 Given the potential for future rises in COVID-19 infection, it was agreed that an investigation should be undertaken, and a report published, within a shorter timescale than other HSIB national investigations. This was intended to assist the various systems of the NHS in implementing any appropriate action ahead of further waves of the pandemic.

Decision to investigate

2.3 Following preliminary information gathering, HSIB’s Chief Investigator authorised a full investigation based on the HSIB patient safety risk criteria.

2.4 A summary of the analysis against the HSIB investigation criteria is given below.

  • Outcome impact – what was, or is, the impact of the safety issue on people and services across the healthcare system?

2.5 Transmission of COVID-19 can cause serious illness and death. The number and rate of nosocomial infections is unknown, however it is acknowledged as an issue that requires greater understanding (NHS England and NHS Improvement, 2020a).

2.6 Healthcare worker infections are significant both because of the effect on their personal health, the risk of transmission to patients, and because they lead to loss of healthcare providers for prolonged periods (when infected and when required to isolate), often at the time of maximum strain on the workforce, leading to reduced healthcare provision for patients (DELVE Initiative, 2020).

2.7 Fear of hospital-associated COVID-19 can also deter people with clinical need from attending hospital. This can result in their conditions deteriorating and can potentially limit their treatment options.

  • Systemic risk – how widespread and how common a safety issue is this across the healthcare system?

2.8 Large clusters of infections have been publicly reported in three acute care hospitals in England across multiple regions. At the time of writing, one outbreak involved multiple clusters of infection, including patients and healthcare workers (DELVE Initiative, 2020). NHS England and NHS Improvement told the investigation that “deep dive” investigations were underway at specific trusts that reported higher nosocomial transmission rates.

  • Learning potential – what is the potential for an HSIB investigation to lead to positive changes and improvements to patient safety across the healthcare system?

2.9 A national investigation could provide insight into how known risks of transmission are reflected within the guidance and how they are currently being managed with reference to the hierarchy of controls (see figure 2). This could highlight other approaches to mitigate the risk of transmission and shift the focus from individual compliance to environmental and engineering design.

Investigation scope

2.10 The investigation fieldwork was completed between 13 July and 28 August 2020. The investigation terms of reference were to:

  1. Consider how national guidance aimed at reducing nosocomial transmission reflects the accepted international scientific knowledge as stated by the Scientific Advisory Group for Emergencies (SAGE).
  2. Identify the environmental and other systemic factors that help or hinder efforts to manage the risk of nosocomial transmission of COVID-19 on acute hospital wards.
  3. Identify the implications of the findings for prevention and mitigation measures within hospitals.

Methodology

2.11 The investigation reviewed the key guidance and supporting documentation relevant to NHS trusts on managing the risk of transmission of COVID-19, in use between July and August 2020 (see section 3, table 1). This involved a review of guidance to determine the extent to which the breadth of mitigation strategies, suggested within SAGE and Data Evaluation and Learning for Viral Epidemics (DELVE) Initiative evidence, has been represented within NHS guidance.

2.12 The investigation used publicly available data from the Office for National Statistics to identify six trusts across England in locations that represented a range of geographical locations, socioeconomic conditions and local population ethnicity. These trusts are referred to in this report as ‘reference trusts’.

2.13 The investigation also used publicly available information from NHS sources to consider the age of hospital infrastructure. The six reference trusts included a range of hospital buildings and environments constructed between 1900 and 2020.

2.14 Acute medical wards were selected as the target healthcare environment as they were considered most likely to capture a breadth in typical healthcare work and patient care activities consistently across all six sites. Targeting acute wards also allowed the investigation to focus on areas where there was the potential for uncertainty about patients’ COVID-19 status.

2.15 The Systems Engineering Initiative for Patient Safety (SEIPS) (see figure 3) was used as a framework for the standardised evidence collection tools used in the investigation. Carayon et al (2006) and Holden et al (2013) suggest that the SEIPS framework provides a way to understand the relationship between the structures, processes and outcomes of healthcare systems.

Fig 3 The Systems Engineering initiative for Patient Safety (SEIPS)

2.16 The investigation completed observations and interviews with staff in key roles at each of the reference trusts. National system leaders were also interviewed who were able to provide authoritative comment on system level issues. The investigation worked with HSIB’s Citizens’ Partnership [1] to hold two on-line focus groups for patients and families; with the majority believing their relative had contracted COVID-19 in a hospital setting.

2.17 The evidence collected was uploaded into data analysis software. A thematic coding framework, based upon the SEIPS model, supported the analysis to identify key themes and findings emerging from the evidence.

2.18 The text and quotations from healthcare staff presented in the investigation report are representative of the themes identified through analysis and following corroboration and triangulation of evidence across multiple sources.

2.19 The draft report was shared with stakeholders via HSIB’s factual accuracy checking process on 16 September 2020. The report findings were subsequently verified with each reference trust and stakeholders involved within the investigation.

2.20 The investigation methodology is outlined in Figure 4 and presented in more detail in Appendix A.

2.21 During the period of the investigation, on 18 August 2020, the Secretary of State for Health and Social Care announced that Public Health England (PHE) would be replaced by a new organisation, the National Institute for Health Protection. This created some practical challenges for the investigation as it considered the role of PHE in any future peak in COVID-19 activity.

2.22 The investigation report (section 5) also includes key findings from the SEIPS analysis that may assist local NHS trusts in immediately identifying considerations, in the context of the hierarchy of controls, to help thinking on further steps available to control transmission.

2.23 In a response to the draft investigation report on 13 October 2020, NHS England and NHS Improvement confirmed to HSIB that they were in the process of undertaking a range of safety actions. These are set out in more detail at Appendix B.

Fig 4 Investigation approach

3 National guidance and local implementation of national guidance

3.1 National guidance

3.1.1 Because COVID-19 is a novel virus, the management of the pandemic has required rapid learning regarding the modes and rates of transmission, and clinical requirements for treatment. This has required unprecedented and frequent modifications to guidance as evidence evolved.

3.1.2 The volume and frequency of changes to guidance is clear from the evidence found within policy and guidance trackers (Health Foundation, 2020; NHS England and NHS Improvement, 2020b). This has created unique challenges for healthcare in terms of adapting and learning how to accommodate the proliferation of guidance quickly and effectively.

3.1.3 This investigation has reviewed the guidance in the context of the evidence provided by the Scientific Advisory Group for Emergencies (SAGE). The investigation focused on how current guidance is suited to the continuing mitigation of the risk of transmission in hospitals. This is with a view to identifying where additional adaptations to guidance may assist in the response to any further rise in COVID-19 activity.

3.1.4 The Data Evaluation and Learning for Viral Epidemics (DELVE) Initiative and SAGE produced papers on the transmission and mitigation of COVID-19 (DELVE Initiative, 2020). These papers present the international scientific knowledge that has come to light throughout the pandemic. The evidence is presented in the context of the hierarchy of controls (see figure 2), which lists the most effective to least effective mitigation strategies for the reduction of the transmission of COVID-19.

3.1.5 The investigation considered to what extent current key pieces of national guidance, and supporting documents, reflected the factors identified to mitigate transmission within the DELVE and SAGE papers. The investigation identified and reviewed key sources of guidance and supporting documentation (Appendix A) referred to most commonly by NHS trusts, including:

  • ‘Considerations for acute personal protective equipment (PPE) shortages’ (Public Health England, 2020c) (this guidance was withdrawn on 16 September 2020)
  • ‘Operating framework for urgent and planned services in hospital settings during COVID-19’ (NHS England and NHS Improvement, 2020c)
  • ‘Infection prevention and control board assurance framework’ (NHS England and NHS Improvement, 2020d)
  • ‘COVID-19: infection prevention and control guidance’ (Public Health England, 2020a)
  • ‘COVID-19 safe ways of working’ (Public Health England, 2020d)
  • ‘Recommended PPE for healthcare workers by secondary care inpatient clinical setting, NHS and independent sector’ (Public Health England, 2020e)
  • ‘COVID-19: guidance for the remobilisation of services within health and care settings’ (Public Health England, 2020b).

3.1.6 The investigation completed a mapping exercise to compare the breadth of mitigation strategies suggested within SAGE and DELVE evidence to those set out in these seven documents. Table 1 indicates how frequently each mitigation strategy can be identified within the guidance.

Table 1 Frequency of mitigation strategies in key documents reviewed by the investigation

3.1.7 The investigation found that national guidance had predominantly focused on the provision and use of PPE to mitigate against the risk of nosocomial transmission. This may represent a practicable approach to the urgent need to respond to a pandemic. Section 4.2 covers PPE factors in more detail. However, national guidance included fewer considerations for mitigations that are recognised as being higher within the hierarchy of controls (and therefore deemed more effective) (see figure 2).

3.2 Local implementation

3.2.1 The investigation team developed a checklist of the mitigation strategies outlined by SAGE evidence. This was used to record observations during visits to the reference trusts.

3.2.2 This approach helped the investigation to identify where measures outlined by SAGE had been implemented and where difficulties arose in putting these measures into practice. It also highlighted the frequency with which strategies placed higher

Fig 5 Elimination and substitution mitigation measures

within the hierarchy of controls were observed compared to those at the lower end.

3.2.3 The majority of the reference trusts were able to implement ‘elimination’ measures (see figure 5), such as stopping visitors to the hospital and providing homeworking facilities for staff who did not need to be physically present in the hospital. In some trusts, people were not able to access certain areas without a temperature check to confirm they did not have a raised temperature, which may be an indicator of COVID-19.

3.2.4 The investigation found that some ‘substitution’ mitigation measures (see figure 5) were difficult for the reference trusts to achieve. Due to the practicalities of providing patient care, it was not feasible to move to outdoor working. ‘Loud’ activities (activities that result in people talking loudly or shouting, for example) may result in increased droplets and aerosols being generated from the mouth. The investigation observed patients coughing, which could be considered to be a ‘loud’ activity. The investigation also observed patients in assessment areas who were confused and shouting. Where these patients were found to be suffering from delirium, it would have been very difficult for staff in the environment to stop or mitigate against this behaviour.

3.2.5 The investigation found that some staff groups were able to reduce the time they spent in an environment, for example by reducing the duration of in person meetings. There were also instances where reference trusts were able to use technology to replace face-to-face interactions. A common example was the rapid implementation of the ‘Attend Anywhere’ software application, which enables outpatient clinics to be run virtually.

3.2.6 The investigation found that changing working patterns to assist clinical staff to work in a cohort (group), either by keeping staff to one ward or area or keeping the staff together shift to shift, proved difficult. The reference trusts explained that they had encountered numerous situations in which staff members had become unwell with symptoms, were asymptomatic and tested positive or were required to isolate due to a member of their household having symptoms or testing positive. This led to a fluctuation in the number of available staff which meant that staff cohorting was difficult to achieve.

3.2.7 The investigation heard examples of cleaning, portering and catering staff being separately allocated to either high-risk or low-risk areas. This enabled nonclinical staff to manage the risk of nosocomial transmission between these areas.

3.2.8 Engineering mitigation measures (see figure 6) seek to control risk through the design of physical environments or objects. The investigation found that many engineering mitigation measures identified by SAGE were not advised in national guidelines. This is reflected in observations within the reference trusts. Good maintenance of sanitation and drainage systems was the only measure implemented by most of the hospitals. The investigation found that this was likely due to the lack of availability of some technologies within the NHS and challenges posed by existing infrastructure. However, Public Health England (PHE) explained that the lack of inclusion of ultraviolet light and hydrogen peroxide vapour decontamination (HPC) was appropriate due to a lack of strong evidence for its effectiveness.

Fig 6 Engineering mitigation measures

3.2.9 The investigation observed limitations in how administration mitigation measures could be put in place (see figure 7). It was very difficult for staff to maintain social distancing in clinical and nonclinical areas due to limitations in the physical environment and the layout of the equipment needed to complete care tasks. For example, the investigation observed multiple examples where staff were required to cluster in specific ward areas because of the position of phones, computers, medical notes and medication trolleys.

Fig 7 Administration and PPE mitigation measures

3.2.10 The investigation did not observe any one-way systems in place on any of the wards visited. Such systems appear challenging to implement, especially for wards that are required to share facilities with adjoining wards. The reference trusts were able to reduce the number of occupants in an area and provide additional alcohol gel (hand sanitiser) and appropriate hand-washing facilities. The remaining administration mitigation measures focus on training and behaviours. The investigation observed variable application of these measures.

3.2.11 Figure 8 shows the PPE mitigation measures observed at the reference trusts. All the trusts had made it a requirement to wear face masks in line with national guidance. The investigation did not observe respirator face masks in use because it did not observe any clinical areas or procedures where this was necessary. Protective clothing (such as disposable aprons and gloves) were also available and in use.

3.3 Development and dissemination of guidance

3.3.1 The investigation found that there had been a need to constantly develop national guidance to respond to the emerging risks of COVID-19 infection. This posed a significant challenge in how guidance was developed and disseminated.

Fig 8 PPE mitigation measures

3.3.2 The investigation identified that the need for rapid guidance change may be an inevitable consequence of managing a novel virus (Kearsley and Duffy, 2020). Senior leaders explained that “trusts have to understand that any delay to guidance being issued can be questioned; why the delay?!” and that a failure to issue new knowledge to the healthcare system in a timely way could be open to criticism if this impacted on staff and patient safety. There was also a personal and professional desire among senior staff to ensure that they acted on knowledge about how to improve safety and to make sure this was communicated.

3.3.3 The reference trusts acknowledged and understood the need for guidance to be regularly updated to continually improve practices that may mitigate against the risk of infection: “…the fact that it is a novel virus means that the guidance…changes so frequently.” Trusts told the investigation that their central point of contact for dissemination of NHS guidance was NHS England and NHS Improvement.

3.3.4 However, in addition to this, a range of other guidance documents arrived via different routes. Typically, this included guidance from royal colleges and professional bodies: “…some stuff would come in directly…a lot of the college stuff came in to the medical director.” This could create difficulties due to guidance being provided from a variety of sources: “…there was quite a lot [of guidance] and trying to sort through it all…made it hard…none of it married up.”

3.3.5 The reference trusts explained that it felt that they were receiving “five lots of guidance a day – and five’s probably an underestimate”. Trusts also expressed frustration that it was “very common that guidance was issued late on Friday. So common that we assigned extra on-call arrangements to deal with guidance and comms arising from it”. National policy changes made late in the working week made it challenging for trusts to quickly implement large-scale changes. This was because many non-clinical staff and support services do not routinely work over a seven-day week and may not routinely be present in hospitals over the weekend.

Interpreting guidance

3.3.6 The reference trusts reported that they had struggled to interpret some guidance because of lack of clarity in relation to updates and ease of ability to translate guidance into practical actions. They had to invest significant staff time and resource in ensuring guidance could be considered and quickly disseminated to staff.

3.3.7 One reference trust explained that “some of the guidance, you know, very broad multifactorial, multi-settings, all the rest of it. Okay… how do we interpret that then at the local site level in the context of what the systems can actually do?”.

3.3.8 One example offered to the investigation related to guidance provided on the use of face coverings in hospitals. The investigation found that this guidance was initially communicated on 5 June 2020 by the Secretary of State for Health and Social Care (Public Health England, 2020f) with the intention that face covering requirements would be in place by 15 June 2020 to allow hospitals to get stocks and plans in place.

3.3.9 However, comments from the reference trusts showed the potential confusion and concern expressed by staff and patients where such communications were not clearly understood: “…so that came out over the weekend, and it was from Monday morning everybody needs to wear a mask from entering the hospital as well. So that made it extremely hard for people, on that weekend, trying to set up and getting every entrance set up with masks so that you had got them there for staff coming in. We were getting a lot of complaints around that from our staff and some of our patients that [PPE] wasn’t available for them in some areas.”

3.3.10 Challenges with interpreting and implementing guidance had led to the need for individual reference trusts to commit significant time and resource into interpreting and acting on the guidance being provided to them. Trusts were eager to stress that: “…the ability to disseminate and deploy the guidance at that point becomes about how well written and clear the guidance is and ensuring it’s not contradictory, and I would hope that, given the learning, we would be clearer in the guidance that we receive.”

3.3.11 All the reference trusts described a similar process in senior leaders “working very closely with a number of clinicians to pull together local clinical guidance which assimilated and contextualised that into a clinical working guideline that we could operationalise. That was really helpful and really valuable…but I think it could be done at a national level, at a slightly higher level”.

3.3.12 For guidance to be effective, it must be written and presented in a way that enables staff to understand and implement the required interventions. Usability issues are attributed to non-adherence in many industries. These issues might include lack of clarity on the actions required by the guidance, or the presentation of large amounts of text which makes it more difficult to see modifications to previous guidance and procedures. User-centred design principles can support the development of guidance to ensure the intended user has been considered and that the presentation of information assists understanding, prioritisation and interpretation of information (Chartered Institute of Ergonomics and Human Factors, 2020a; Health and Safety Executive, 1999). Risk management and consistency of guidance

3.3.13 The investigation observed that the need to quickly update and distribute guidance resulted in unintended consequences for the reference trusts. Although national bodies were required to rapidly distribute guidance to ensure emerging knowledge was shared with the system, this impacted on local trusts who were tasked with ensuring guidance could be implemented in practice.

3.3.14 The reference trusts told the investigation that they felt more could have been done at a regional level to assist in the interpretation of guidance: “… what would…have been helpful from my point of view was if they’d actually done more coordination of the various trusts.” National leaders also reflected that there was a “need to be clear where changes have been made and where possible, [make] no change”.

3.3.15 Local NHS trusts are required to take ownership of the need to implement guidance; if trusts did changes in practice or additional resources to ensure it could be implemented.

3.3.16 The investigation was told of examples of competing advice given within national and professional guidance. This created logistical problems for the reference trusts in considering which guidance to implement and created anxiety and frustration among staff.

3.3.17 One common example the investigation found related to guidance about whether resuscitation should be considered an aerosol generating procedure (AGP): “…the clinicians followed the Resuscitation Council guidance and the Resuscitation Council has been really clear about the risk from chest compressions and the aerosol…PHE has taken a very purist view of, well, it’s not an AGP…but we all know the chaos of a resus [resuscitation] and there’s bodily fluids and vomit…In practice, I think at best 90% of the country is going with the Resuscitation Council, I think ignoring PHE, but it’s still absolutely unresolved.”

3.3.18 PHE told the investigation that PPE would be expected to be worn during resuscitation, however the level of PPE worn would depend on the situation. PHE clarified that the issue of whether chest compressions would be considered to be an AGP was discussed at New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) COVID-19 meetings on 27 March, 9 April and 17 April 2020. This led to the publication of the NERVTAG consensus statement on cardiopulmonary resuscitation (Public Health England, 2020g) which supported that chest compressions or defibrillation were not linked to a significantly increased risk of COVID-19 transmission (Public Health England, 2020b).

3.3.19 Within the reference trusts, the investigation found a varying approach to decisions about which guidance would be followed. Some trusts explained that they always sought to adopt national-level IPC guidance. However, they reflected that this had led to challenges where national and professional guidance were not consistent, causing disagreement and conflict with certain professional groups.

3.3.20 One reference trust explained: “…we went for what we would consider was the safest, so if a college said something…and [IPC guidance] said it wasn’t, we would treat it as [what the college said]. You might be accused of wasting stuff [PPE supplies] but you weren’t putting staff at risk.”

3.3.21 This approach required a local, dynamic risk assessment that ultimately determined what level of guidance has been adopted across each reference trust. The investigation found that trusts’ risk tolerance could vary depending on their relative size and scale, with smaller trusts often feeling more vulnerable to challenge if they were to depart from national NHS guidance.

3.3.22 The investigation found that the management and impact of national guidance had a fundamental effect on the confidence and anxiety levels of staff at local level. Some staff expressed concerns that changing guidance on required levels of PPE left them feeling scared or uncertain when caring for patients, as previously required levels of PPE were downgraded. Staff told the investigation that often “friends and family were concerned” for their welfare when this occurred.

3.3.23 Changes in guidance also created challenges for organisational leaders and IPC specialists. These were often the staff who were required to disseminate changing guidance to the workforce and they often felt the impact of the anxiety this could cause: “…when staff are continuously questioning whether you’re really looking after their welfare, then that does get to you.”

3.3.24 Senior national leaders accepted that there continued to be difficulties in how national guidance could be prepared and issued to the NHS, in the face of the exceptional circumstances presented by the pandemic. The investigation was told that senior leaders had “never seen policy being developed by so many players” and that this had made it “harder to develop”. Senior leaders acknowledged that “there was an inability for a single national message linked to professional guidance. That needed resolving really and is still a contention”.

3.3.25 The need for input from across the healthcare system was recognised as “necessary to ensure guidance is taken up”. Senior leaders reflected on this issue: “How do we get everybody into the same tent? The bigger the tent the better.”

3.3.26The investigation found that different national system leaders had a contradictory understanding of which national body took ownership of the IPC guidance. PHE told the investigation that the IPC guidance was jointly issued as official guidance by the Department of Health and Social Care, Public Health Wales, Public Health Agency Northern Ireland, Health Protection Scotland, National Services Scotland, PHE and NHS England and NHS Improvement. PHE understood that NHS England and NHS Improvement would take the lead in developing this guidance in England and PHE provided the platform for sharing the guidance. NHS England and NHS Improvement told the investigation that PHE published and owned the guidance and it considered PHE to ultimately be responsible for its final content.

3.3.27 It was unclear how different parts of the system interacted to ensure consistency and ownership of the guidance and how shared goals and priorities were identified. The investigation was not able to clearly identify the structures and processes that may ensure greater integration of decision making across the system.

3.3.28 The investigation team heard evidence at the national level of the system that these challenges had been acknowledged. The investigation was told that the most recent update to IPC guidance had included a more collaborative approach, including engagement and representation from the Academy of Medical Royal Colleges. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/095:

It is recommended that the Department of Health and Social Care, working with NHS England and NHS Improvement, Public Health England, and other partners as appropriate, develops a transparent process to co-ordinate the development, dissemination and implementation of national guidance across the healthcare system to minimise the risk of nosocomial transmission of COVID-19.

4 Factors impacting on the risk of nosocomial transmission of COVID-19 on acute hospital wards

4.1 Testing and organisation capacity factors

“The idea is that with our own in-house testing we’d have all the results back within two or three hours. That’s an absolute game-changer…so we can stream patients much more effectively.”

Associate Director for Improvement

Patient testing

4.1.1 The investigation found that testing of patients was a key task that impacted on the reference trusts’ ability to respond effectively to the pandemic. The investigation found that trusts’ ability to test was a significant influence on the healthcare system’s ability to optimise performance and the safety of those required to use or work within the system.

4.1.2 In the reference trusts, patient testing regimes were in place in line with national guidance (NHS England and NHS Improvement, 2020a). This included patient testing on admission, again five to seven days after admission, and prior to discharge to vulnerable settings. However, the investigation was told of frustrations about the timeliness of test results being returned.

4.1.3 Some reference trusts explained that they may wait “between 24 and 48 hours” for Pillar 1 test results (tests for those with a clinical need and health and care workers) to be returned. These trusts were typically reliant on test results being processed by regional testing centres where they would send patient samples. The investigation was told by national leaders and identified from published research that testing capacity was an issue that impacted on the timeliness of test results being returned (Wise, 2020).

4.1.4 In addition, all the reference trusts had access to a number of rapid testing samples. The investigation was told that rapid testing of patients (routinely involving test results that were returned within 90 minutes), both on admission to hospital and during their stay, enabled a more dynamic risk assessment of a patient’s COVID-19 status to be undertaken.

4.1.5 However, the reference trusts suggested that rapid tests were in limited supply and supplies had reduced further during the course of the pandemic: “Originally, we had 35 [per day] and I think it has gone down to about 25 now just because the reagents [the substances used in the tests] aren’t available.”

The investigation saw that the number of available rapid tests often did not meet the demand created by hospital admissions – for example one reference trust had 11 tests available per day but reported over 50 admissions to one of its two assessment units alone. The reference trusts understood that limitations in rapid testing were due to international supply and demand issues relating to the availability of the test reagents.

4.1.6 The way in which rapid tests were prioritised varied between the reference trusts. Different trusts prioritised rapid tests for different patient groups, including emergency surgical admissions, emergency maternity cases and suspected COVID-19 admissions. Where and how rapid testing should be prioritised was a significant decision for trusts to manage and created tension between operational and clinical teams.

4.1.7 In response, some reference trusts proceeded with business cases to purchase their own in-house testing systems to enhance testing capacity. One trust explained that this would provide “testing capacity for 800 tests a day and that should be sufficient for all of our own or most of our own needs, plus or minus depending on where we get to with staff testing”. In house testing enabled trusts that had been required to send test samples to external laboratories to access test results more quickly.

4.1.8 Some of the larger reference trusts that already had in-house testing available were able to support smaller trusts with testing capacity based on existing local networks and relationships.

Impact on hospital capacity

4.1.9 The reference trusts explained to the investigation the significant impact that delays in confirming the COVID-19 status of patients had on the ability to manage patients in hospital.

4.1.10 The reference trusts explained that they often “had suspected COVID-19…patients…still waiting for the test results to come back” in ward areas. Some family members described receiving relatives’ test results several days after testing (and in some cases after a relative’s death). This posed a challenge in effectively segregating patients with a positive result from COVID-19 negative patients.

4.1.11 Staff told the investigation that accurate early identification of COVID-19 positive patients was important to ensure appropriate cohorting within ward environments. In terms of mitigating transmission risk, cohorting would be placed high within the context of the hierarchy of controls (see figure 2), as it aims to eliminate the risk of nosocomial transmission through segregation of COVID-19 positive patients.

4.1.12 This was a particular concern in the high-risk and medium-risk patient groups (see 1.23 to 1.24), where patients without a confirmed COVID-19 positive status may be located in the same clinical environment as patients with either a positive or yet-to-be-confirmed COVID-19 status.

4.1.13 In response to this, one reference trust developed a four-part COVID-19 identification protocol. The trust identified COVID-19 positive and COVID-19 negative patients, but separated patients with an unknown COVID-19 status into ‘suspected’ and ‘unsuspected’ (based on clinical indications) to further assist in how patients could be placed in cohorts to avoid any transmission risk. “…actually a degree of separation of those patients just helps provide a little bit of extra protection for patients when we’re in the position where we can cohort them separately.”

4.1.14 In addition, some reference trusts told the investigation that patients awaiting a test result were sometimes required to be moved into the hospital system prior to test results being returned, either due to the demand on COVID-19 related admission areas or based on the clinical needs of the patient. This provided a further challenge should any patient subsequently return a positive COVID-19 test following admission to a nonCOVID-19 area.

4.1.15 Families told the investigation how decisions about where their relatives were placed in hospital could be distressing. The investigation was told about vulnerable patients, who had been shielding at home, having to be placed in bay areas on wards where patients were still waiting for their COVID-19 status to be confirmed. Families sought to ensure that their relatives would be kept in a side room but had been told that this was not always possible due to the demand on hospital services and lack of side rooms being available. Often families considered that the overall problem of patients being placed in areas with non-confirmed COVID patients was caused by delays in test results being returned.

4.1.16 The importance of testing and clinical diagnosis of a patient’s COVID-19 status was reiterated by all the reference trusts. They acknowledged that “the fact that all patients are now tested and repeat tested completely changes the equation. We weren’t at that stage at all, so that certainly helps”.

4.1.17 The investigation found that although testing of patients was identified as a national priority in IPC guidance issued on 9 June 2020 (NHS England and NHS Improvement, 2020e), trusts’ level of success in implementing this national guidance depended on local infrastructure and capacity.

4.1.18 The potential for timely Pillar 1 testing and rapid testing has a big influence on trusts’ ability to ensure patients are protected and streamed to an appropriate clinical area. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/096:

It is recommended that NHS England and NHS Improvement:

  • supports additional capacity for testing for NHS patients and staff (Pillar 1 testing)
  • facilitates the accessibility of rapid testing for NHS trusts, as soon as an increase in rapid testing supplies becomes available.

Strategies to manage capacity issues

4.1.19 Although many clinical activities continued during the first wave of the pandemic, the reference trusts all reported a significant reduction in planned activity and hospital attendances which allowed them to free up space and staff.

4.1.20 The reference trusts explained that the response to the first wave had been facilitated by reduced activity and bed occupancy levels, and the ability to redeploy clinical staff between services to support the COVID-19 response: “…the bed base was really unoccupied with occupancy at less than 40 per cent.” This additional capacity enabled the separation of patients suspected or confirmed as having COVID-19, ward moves to be facilitated, and some clinical areas to be given over to staff activities. One trust explained how in order to manage the first wave there were “10 respiratory consultants who stopped all clinics to work the wards. Doesn’t feel [like we] could do that again”.

4.1.21 The investigation found that staff had significant concerns about how any further peak in COVID-19 activity could be managed alongside the need to return to specified NHS activity levels and respond to winter pressures. One reference trust explained: “…as we get into winter, it is going to become increasingly difficult because, in effect, anyone with flu or a sniffle we are going to be treating as having COVID-19 and that is going to paralyse us as the NHS, and of course that is the importance of having rapid turnaround, near-patient testing.”

4.1.22 One reference trust acknowledged: “…there comes a tipping point in any organisation that when you have got a certain number of COVID-19 patients in, it will start to cause problems and that tipping point will be different depending on your estates, your staffing models and the sort of patients that are coming in the front door.”

4.1.23 The investigation was told that at this point further trade-offs would be necessary between IPC requirements and patient need in order for trusts to meet these competing demands on their services. The reference trusts were eager to ensure that this was not a trade-off between patient safety and operational targets but acknowledged that it may be “a clinical risk tradeoff between COVID-19 and other health needs”.

4.1.24 Some reference trusts already had concerns that the need to step up operational activity would require trade-offs to be made against nosocomial transmission risks, such as the need to open up additional bed capacity in patient bays where it may then become difficult to comply with IPC requirements. The investigation observed that this had already been required in one trust where an increase from two beds to three beds in a four-bed patient bay had been required to meet increased demand. This allowed the trust to comply with IPC guidance but meant that efforts to create additional mitigation via increased distance and limiting patient capacity in bays were compromised.

4.1.25 Ways to optimise local and regional healthcare estates to balance, with equal priority, both capacity and measures to minimise the risk of nosocomial transmission need to be considered. The constraints of the built environment suggest certain estates or wards are less capable of cohorting patients. An improved understanding of how trusts can best utilise the full range of their estate and how regional networks can work together on provision that can minimise nosocomial transmission may be helpful. The adoption of operational modelling as routine practice to understand how to optimise capacity and manage change would help the healthcare system to anticipate and respond to resurgent COVID-19 pressures (Currie et al., 2020). Knowledge of staff transmission risk

4.1.26 The investigation found that reference trusts had seen varying impacts from staff infection rates and they did not share a consistent understanding about the potential risk of staff transmission and infection, and the potential impact on patient transmission.

4.1.27 One reference trust explained: “… this is something that we fought with quite a lot, around getting that message that it is not just patients that are at risk and we aren’t immune. Even though we work close together all the time and we get that, there is asymptomatic carriage and we needed to be more aware of that.”

4.1.28 The investigation observed that considerations around staff-to-staff transmission, or staff-to-patient transmission, often related to whether reference trusts had experienced outbreaks that could be tracked back to a member of staff. The investigation observed a variable approach to staff testing across the reference trusts.

4.1.29 Some reference trusts had responded to identified staff outbreaks by rolling out wider testing regimes in outbreak areas. One trust explained that “all staff were tested (48) over three days. All came back positive apart from the ward manager”. Other trusts had introduced wider antibody testing regimes to try and identify the prevalence of staff infection: “…so we have [antibody tested] just about 4,300 of our 5,000 staff… that is running…about 12/13% [positive].” COVID-19 antibody tests indicate past COVID-19 infection, but the future significance of having antibodies, including possible immunity to reinfection, is at present unknown. Some of the reference trusts explained that staff testing was accessed in the same way as wider public testing; if staff displayed symptoms, they would attend a public testing centre or occupational health service for a test.

4.1.30 NHS England and NHS Improvement (2020e) advises that testing capacity available to trusts should be used to test all staff with symptoms of COVID-19. In addition, any surplus NHS testing capacity should be used for ‘routinely and strategically testing asymptomatic’ staff. This approach of regular and routine surveillance testing for asymptomatic staff was proposed by some interviewees and was raised as a measure that may improve families’ confidence.

4.1.31 PHE told the investigation that any form of surveillance testing needs to consider an understanding of the possibility of prolonged positive results in staff who have recovered from their infection but may still return a positive COVID-19 test result. Without a clear understanding and protocols to manage the risk of potential false positive results, this could have implications for NHS staffing levels if staff who are not an infection risk are required to stay away from work.

4.1.32 Many of the reference trusts reflected on the potential limitations of further routine, local staff testing, including capacity issues and the nature of tests, which “are still at the moment fairly invasive tests”. NHS England and NHS Improvement told the investigation that new tests currently being evaluated for possible deployment in the NHS would include less invasive measures, such as using saliva and mouth washings. Due to the limitations on staff testing, the reference trusts had focused testing on specific high-risk areas for transmission and on protected patient pathways. The trusts were aware of the PHE SIREN study [2] and had directed staff to testing via this initiative in line with NHS England and NHS Improvement advice.

4.1.33 The investigation was told that the potential role or wider benefits of surveillance testing are currently not well understood. However, opinion increasingly supports the implementation of surveillance testing of asymptomatic staff (Francis Crick Institute, 2020). Expanding surveillance testing to staff could provide additional data to help trusts mitigate the risk of nosocomial transmission. This may be difficult to implement in practice due to limitations in testing volume and capacity.

4.1.34 NHS England and NHS Improvement told the investigation that it is involved in ongoing work with the UK government to expand testing capacity very significantly and to deploy mass testing, including for surveillance purposes (Appendix B). Further work to consider the potential benefit of surveillance testing on nosocomial transmission should take place to ensure resources are targeted in the most effective way.

4.1.35 On 12 October 2020, the testing of asymptomatic staff in areas with high COVID-19 infection rates was announced during a national briefing from the UK government (Appendix B). A programme of asymptomatic staff surveillance testing would be valuable in helping to further identify the potential number of asymptomatic carriers within the NHS and its impact on the management of nosocomial transmission. HSIB makes the following safety observation

Safety observation O/2020/075:

It may be beneficial to analyse data collated on asymptomatic staff infection rates to consider how this may impact on mitigation strategies to reduce the risk of nosocomial transmission.

4.2 Personal protective equipment (PPE) and infection prevention and control (IPC) factors

“The power of cleaning was critical to the effectiveness of limiting transmission.”

Estates lead

Availability of PPE

4.2.1 The use of appropriate PPE by staff was considered a key priority by reference trusts and helped to protect both staff and patients from infection. The provision of PPE was a constant pressure that was considered by the reference trusts to have an ongoing impact on the response to the pandemic. 4.2.2 Some reference trusts explained that they had sufficient PPE supplies. Staff who spoke with the investigation did not have any immediate concerns about PPE supplies and felt that this situation had significantly improved as the pandemic progressed. Some families were also confident in the PPE supplies they observed: “…the hospital had plenty of PPE; I was offered lots [of PPE] and felt pretty safe in that regard.”

4.2.3 However, the investigation found that ensuring sufficient PPE supplies had often involved the need for reference trusts to quickly anticipate and respond to shortages within local organisational networks. Some trusts had worked collaboratively to move to regional solutions that helped to reduce variability and increase consistency in the type of PPE supplied. One trust described that they “did better than average…partly because our procurement guys were driving round…doing swapsies…mutual aid and all that sort of thing”. The investigation was told of many similar examples where mutual aid was provided across organisations.

4.2.4 The investigation was also made aware of aid being provided via non-NHS organisations, for example where universities assisted in developing and manufacturing face masks and where a local education system donated unneeded paper towels to a trust.

4.2.5 Other reference trusts still had concerns about their ability to access appropriate levels of PPE should there be a further increase in COVID-19 activity. This anxiety meant that trade-offs were observed to try and ensure sufficient supply would continue into winter: “…making sure that where you can now, for instance, cut back on [PPE] in the nonCOVID-19 areas…so you’ve got stock when you do require it because otherwise we’ll struggle again like we did in March, and we’re hoping to make sure we’ve got it all available.”

4.2.6 The reference trusts told the investigation that it was important to have clarity and understanding about NHS procurement processes, and any difficulties in procurement, to ensure that they could effectively plan for any future rise in COVID-19 activity. A proactive approach to consider how best to reduce these risks to as low as reasonably practicable should continue to be adopted (Health and Safety Executive, n.d.b). This should include consideration of how additional resilience may be created through adaptations to current procurement practices.

4.2.7 The investigation saw that supplies of surgical face masks were available for use by staff and the public at each reference trust; routinely these were placed at all entrance/exit points and at regular points in the ward environment.

4.2.8 The investigation also observed that the reference trusts had supplies of disposable aprons and gloves. However, changes in product suppliers had meant that new supplies of gowns and gloves did not always fit into existing ward PPE stations. The investigation observed how this had led to disposable gowns being loosely draped over handrails to ensure staff could access them easily.

4.2.9 The reference trusts reported frequent problems in receiving a consistent supply of FFP3 respirator masks. Trusts reported that FFP3 respirator mask suppliers changed frequently and that they “had no control over what was coming to us”.

4.2.10 With each change in supplier, the regulatory requirement to ‘fit test’ staff with masks arose. This is a formal test that takes around 15 minutes to complete and ensures the mask provides appropriate protection for the staff member.

4.2.11 All the reference trusts reported that “fit testing was a problem” and that the requirement to frequently test staff for different mask supplies created significant additional work. In addition, when supply lines changed, staff sometimes discovered that new masks did not fit correctly. This meant they could not use the new FFP3 respirator masks. This limited the range of clinical activities these staff members could engage with and increased the demand on other staff.

HSIB makes the following safety observation

Safety observation O/2020/076:

It may be beneficial to have greater consistency in the provision of FFP3 respirator masks to assist in their response to COVID-19.

4.2.12 The reference trusts understood the national and international pressures on the supply of FFP3 respirator masks. However, they told the investigation that they did not feel supported by regulators and other national organisations in understanding the challenges they faced.

4.2.13 One reference trust sought support from regulators to help risk assess FFP3 respirator fit testing but reported being told that it was not the regulator’s role to provide support. Another trust described having “some really threatening letters from the colleges…saying that everybody must be fit tested on them and reminding us that we could be prosecuted if staff weren’t fit tested”. In both instances, the trusts accepted the role of regulators and the colleges in seeking to protect staff and uphold good practice. However, there was frustration that the approach taken did not reflect the reality of the unprecedented situation presented by COVID-19.

4.2.14 The investigation found that the potential lack of understanding of the reality of the situation on the frontline created additional pressures on local trusts and national organisations to balance the risks to staff and the public with their existing obligations to comply with and enforce regulations, in the context of the significant challenges posed by the pandemic.

4.2.15 The investigation found that this created tension between local and national elements of the system that may be repeated if further difficult decisions are required during any future rise in COVID-19 activity. A shared understanding of and approach to these challenges may ensure a consistent, system-wide approach to balancing these risks and pressures.

Use of PPE

4.2.16 PPE plays an important role in managing the risk of nosocomial infection (Public Health England, 2020b). The investigation observed that the majority of staff in the reference trusts complied with PPE requirements in clinical areas, particularly in the use of FFP2 (filtering facepiece class 2) respirator masks. The investigation also saw that the majority of patients being transferred around the hospital and the limited number of visitors allowed on the hospital sites used face masks in line with guidance. A number of staff reported feeling “naked” without a face mask and that use of masks had become part of everyday workwear and culture within the trusts.

4.2.17 Families told the investigation that they were sometimes confused about what level of PPE they could expect staff to wear. IPC guidance (Public Health England, 2020b) identifies that different levels of PPE are necessary in different clinical environments and this guidance has changed on a number of occasions during the course of the pandemic. Families explained that this could cause anxiety as they were often not sure if staff were wearing appropriate levels of PPE. This was particularly the case for families who had experienced the higher PPE levels expected in intensive care units who then met staff wearing reduced levels of PPE in other clinical environments.

4.2.18 The reference trusts told the investigation that they believed the use of face masks had been linked to a drop in nosocomial transmission. The investigation was unable to access data to support this assertion. However, face mask use could not mitigate the risk of transmission from patient to patient, or between staff in areas where masks may need to be removed, such as eating areas and changing rooms.

4.2.19 The investigation observed some instances where staff had not followed guidance. In one example, staff had been required to remove masks to eat lunch but had not been able to socially distance due to the constraints of the environment. In another example, the investigation observed a staff member helping a patient who they found had slipped out of bed, without donning appropriate PPE.

4.2.20 Current training requires staff to don PPE before assisting patients. However, this may still remain counterintuitive to staff in highly emotive circumstances where a weight of previous training has provided a different focus.

4.2.21 One family member told the investigation that she appreciated steps staff had taken contrary to guidance. A nurse on the ward saw that she was very distressed and hugged her to try and comfort her. Another family member regretted not removing their PPE to hold their relative before they died.

4.2.22 However, another family member told the investigation about an occasion when a doctor removed their mask in order to communicate sensitive information about their relative’s care. On that occasion the family member explained how this made her anxious and she hoped that the doctor would replace their mask.

Cleaning

4.2.23 The investigation was told of significant efforts that had been made to increase cleaning in hospitals to help mitigate the risk of transmission. One reference trust felt that “the power of cleaning was critical to the effectiveness of limiting transmission”. This reflected the national advice and published guidance (Public Health England, 2020b).

4.2.24 Another reference trust told the investigation that they now completed 2,000 ward cleans in the same time period as they would normally expect to complete 300 ward cleans. All trusts reported similar increases in the frequency and level of cleaning. This included wider use of cleaning products that were previously only used in specific clinical areas, such as chlorine-based cleaning products.

4.2.25 The investigation observed increased cleaning levels in clinical areas in the majority of the reference trusts, and cleaning staff reported this as their priority, with cleaning efforts often focused on “bays and patient areas”. Efforts had also been made to clean high-contact areas, such as main entrances and exits. However, trusts reflected that this had required a trade-off in some circumstances; increasing cleaning levels in some areas meant they had to reduce them in others. These included some staff and non-clinical areas, such as staff break rooms or storerooms.

4.2.26 The need for such trade-offs creates the potential for other transmission risk areas that may not be clearly identified by patient- and public-facing risk assessments.

Role of infection prevention and control (IPC) specialists

4.2.27 The investigation observed the important role that specialist IPC and microbiology staff played in responding to the pandemic. In some reference trusts, these staff had played key roles in providing in situ training to staff on PPE and IPC measures to help mitigate against infection: “…their daily role was to walk round all of the wards and departments and do on-the-spot training and let staff have a go putting on and taking off the PPE.”

4.2.28 In other reference trusts IPC activities had relied more on guidance posters and adherence to previous education. The investigation found that this often reflected the resource available within trusts, with one trust explaining that “it’s very difficult to recruit infection control nurses. I’ve been looking for [one] for the last 12 months and we’ve even been through an agency and headhunted and we can’t find anybody”.

4.2.29 The investigation found that reference trusts reported vacancies for IPC staff and challenges in recruitment. The investigation was told by national and regional leaders that there was no formal education pathway into IPC roles and a variable level of competence and expertise existed within staff already employed in these posts. National leaders reflected that there may have been a gradual degradation in IPC capacity and standardisation of expertise within the NHS.

4.2.30 The investigation was told that both rapid response and longer-term solutions were being considered by NHS England and NHS Improvement senior managers to respond to this issue. In the short to medium term, a response focusing on the IPC needs arising from the COVID-19 pandemic would be beneficial.

4.2.31 Although it would take longer to implement, a longer-term national operational approach to IPC would provide a clear process and transparency to the development and distribution of national IPC guidelines and the development of professional pathways and qualifications for IPC staff. The investigation identified that a national operation manual, such as is already in place in Scotland (NHS Scotland, 2012) may assist this work. The investigation was told that a similar approach was planned for the NHS in England and any future COVID-19 activity would benefit from a shared approach to IPC, that could be supported by this work. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/097:

It is recommended that NHS England and NHS Improvement:

  • develops a national intensive infection prevention and control (IPC) safety support programme for COVID-19 which focuses on leadership, IPC technical support, education, practice, guidance and assurance
  • develops a national IPC strategy which focuses on developing IPC capacity, capability and sustainability across the NHS in England.

4.3 Environmental factors

“Some areas of the hospital are better suited to really, really, really good infection prevention than others, just because of…the age and layout.”

Associate Director for Improvement

Age of the hospital estate

4.3.1 The investigation observed that the age, quality and utilisation of the hospital estate was an important factor in determining how the risk of transmission could be mitigated. The estate in which patients were cared for, and staff worked, varied significantly across the reference trusts, and throughout the wider NHS. This created limitations for trusts and staff in responding to the risk of transmission.

4.3.2 The reference trusts told the investigation about the benefits of newer ward environments and how they had helped to reduce the risk of transmission when compared with older ward environments: “…in the new build you’ve got…side rooms all with en suite facilities. In the old build it’s not quite so luxurious… we have side rooms that don’t have en suite toilets…patients have to share facilities.”

4.3.3 The investigation heard several examples where older hospital estate had been linked to an increased risk of transmission. For example, one trust told the investigation: “…some areas of our estate where we’ve had…two outbreaks…the estate is pretty old. So, there are four-bedded bays, limited toilet facilities, the bays don’t have any doors on them.”

4.3.4 Some reference trusts were able to maintain social distancing while four beds remained in a patient bay. In other trusts, some patient bays had been reduced to two or three beds to ensure that IPC guidance could be appropriately followed to mitigate the risk of transmission, particularly in medium-risk areas. One trust explained that “we have removed 90 beds from the bed base for IPC and we’re reluctant to put the beds back”. This directly impacted on the capacity available to treat patients, as highlighted above (see 4.1.19 to 4.1.25).

4.3.5 The storage of the removed beds on hospital corridors limited the ability to social distance in some other areas and created a further difficulty for the reference trusts.

4.3.6 The reference trusts with newer hospital estate where there were more side rooms worried about this resource being overburdened. One trust with newer hospital estate explained that they had “a huge number of side rooms and I know others aren’t that fortunate, but we will quickly run out if we are waiting for tests”.

4.3.7 Health building notes (HBN) give best practice guidance on the design and planning of new healthcare buildings and on the adaptation or extension of existing facilities. Health technical memoranda (HTM) give comprehensive advice and guidance on the design, installation and operation of specialised building and engineering technology used in the delivery of healthcare. In the long term, a greater integration of the hierarchy of controls into such guidance will help the NHS to prepare for future infectious disease outbreaks and increase the capacity of the healthcare estate to aid in the response to nosocomial transmission. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/098:

It is recommended that NHS England and NHS Improvement reviews the principles of the hierarchy of controls in its health building notes (HBN) and health technical memoranda (HTM) for the design of the built environment in existing and new hospital estate to reduce the risk of nosocomial transmission.

Ventilation systems

4.3.8 The World Health Organization (2020) advised that there was the potential for airborne transmission of COVID-19. One reference trust explained that “the only defence against this is dilution or air changes”. However, trusts reported that they had been working in a context of emerging, uncertain evidence about the potential for ventilation to mitigate COVID-19 transmission. They also reported that their existing ventilation systems made it difficult to put mitigation measures in place.

4.3.9 All the reference trusts had taken measures to consider how ventilation impacted on potential airborne transmission (Department of Health, 2007a; Department of Health, 2007b.) but this posed a “massive challenge” to estates teams. Some trusts felt that they had received “very limited information on the ventilation stuff and around how we would actually deliver that” from national organisations.

4.3.10 The investigation found that existing guidance assisted the NHS in understanding how ventilation systems could mitigate against known nosocomial risks. However, because evidence about the transmission of COVID-19 is still emerging, this had limited the ability to develop specific formal guidance on how mechanical ventilation systems could help to mitigate transmission risk.

4.3.11 Although some specific clinical areas (for example, operating theatres) had specialist ventilation systems in place, the majority of the reference trusts relied on fresh air ventilation via air circulating around the hospital.

4.3.12 The investigation heard examples of specific difficulties that the reference trusts encountered when considering how such ventilation systems may impact on the transmission of COVID-19. One trust explained that the main vent for the hospital expelled air onto “one of the external walkways for staff” and that this area had to be closed off. Another estates lead explained how similar issues affected where COVID-19 positive or suspected patients could be treated within the hospital, as the ventilation system was shared among multiple wards over multiple floors.

4.3.13 On many wards, patient areas had windows that allowed daylight in and aided fresh air ventilation when windows were opened. One estates staff member explained that “back in the day [wards] were designed predominantly as naturally ventilated spaces…so we’ve been encouraging people to open windows…as much as we could”. However, this should be balanced against other potential risks relative to patient safety.

4.3.14 The investigation found no consistent approach or guidance to help trusts understand whether daylight and ventilation could help in mitigating the risk of COVID-19 transmission within the ward environment. Decisions were made about whether blinds, windows, and room or bay doors were open in patient areas based on patients’ preferences and the need for patients to be kept comfortable and safe. Staff told the investigation that relying on open windows for ventilation could create practical problems associated with patient safety.

4.3.15 The ventilation systems of the majority of the reference trusts could not be easily repurposed. Trusts explained that many older ventilation systems were “never designed to be a high efficiency particulate air (HEPA) filtered system [a type of system that captures a high proportion of airborne particulates]” and this limited their ability to adapt these systems to address airborne transmission.

4.3.16 NHS England and NHS Improvement (2020f) described the communication channels developed to share learning on the impact of ventilation, in response to this emerging challenge. This learning included informal guidance, which had been made available to NHS trusts as knowledge had developed in this area.

4.3.17 As new knowledge emerges about the possible impact of ventilation systems on COVID-19 nosocomial transmission there will be a need to ensure consistency in understanding and actions across the NHS, and for relevant guidance to be clearly and consistently disseminated as soon as possible. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/099:

It is recommended that NHS England and NHS Improvement responds to emerging scientific evidence and shared learning when reviewing guidance for NHS trusts on the role of hospital ventilation systems in nosocomial transmission.

Staff environments

4.3.18 Some reference trusts had observed issues with staff compliance with PPE requirements in non-clinical areas. One trust told the investigation that “staff still gather around without PPE in staff rooms and communal areas”. Some families reported seeing staff without PPE in “staff areas” and this impacted on how safe they felt in hospital. Often, these examples were found in non-clinical areas where staff gathered, such as staff break areas.

4.3.19 The investigation observed limited mitigation strategies in the design of the physical environment, and in staff work patterns, to enable staff to take breaks in environments which reduced the risk of transmission. Typically, due to limited time available to take a break, staff would need to use small rooms adjacent to their clinical environment, with a lack of opportunities to increase levels of ventilation. The investigation has highlighted that staff social and emotional pressures pose a threat to the sustainability of the workforce and the ability to respond to any further rise in COVID-19 activity (see section 4.4).

4.3.20 Often the size and layout of staff environments did not allow social distancing to take place. The investigation observed a number of staff environments and ward corridors that were not wide enough to maintain a two-metre distance among staff. This was a particular challenge in staff break rooms and kitchen areas where staff may need to congregate to take breaks or in which ward meetings may take place.

4.3.21 Access to ventilation and natural light was also observed to be a problem in specific staff areas visited by the investigation. The majority of these areas were located on the interior of ward spaces, with no access to daylight or windows to aid ventilation. This increased the risk of transmission.

4.3.22 The investigation undertook a ward mapping exercise to gain an insight into the ward environment, track the movement of staff and assist in highlighting areas where staff may be forced to gather in order to complete tasks. The investigation found that mitigation of the risk of nosocomial transmission through the design and layout of ward environments and workflow was not always considered. Figure 9 shows key ‘hotspots’ – areas of higher density of staff movement and ward-based activities that created the greatest challenge for social distancing and minimising high-contact areas.

4.3.23 The investigation observed that, as may be anticipated, the majority of activity on the ward took place around a central nurses’ station. Many wards were still reliant on fixed computer and telephone terminals to enable staff to access IT systems and communicate about patient care. In addition, medical records were often stored at central points in wards, encouraging staff to return regularly to these areas. This influenced where staff were forced to gather on wards in order to complete key tasks and the investigation observed examples where staff were not able to comply with social distancing requirements due to these limitations.

Fig 5 Fig 9 Key ‘hotspots’ identified by ward mapping

4.3.24 The investigation observed some local adaptations that had been made to mitigate this risk. This included approaches to mitigating the risk associated with regular use of specific equipment and machinery by multiple staff members. For example, one reference trust had moved equipment to a more open space at one end of a ward to avoid the need for staff to cluster in more confined environments. Another trust ensured medical records were distributed more evenly throughout the ward.

4.3.25 The investigation found that areas of high staff activity and movement reduced the ability to maintain IPC practices. This could be improved by considering technological solutions to mitigate the need for staff to cluster in ward areas or share equipment as frequently.

4.3.26 Design of the physical layout of spaces and equipment can determine how people interact and behave in an environment. The use of design to enable social distancing, recognising the number of people and activities required within a similar timeframe, would support implementation of IPC guidance (Chartered Institute of Ergonomics and Human Factors, 2020a).

4.3.27 Healthcare has not traditionally considered how physical design can support safety and performance (Hignett et al., 2010). Reliance on posters, training and changes of behaviour to ensure adherence to guidance are weak interventions compared to physical redesign to ensure work is completed in the desired sequence and correct way.

HSIB makes the following safety observation

Safety observation O/2020/077:

It may be beneficial to reconsider the design of ward work systems and equipment layout to mitigate the risk of nosocomial transmission.

Safety observation O/2020/078:

It may be beneficial if interventions aimed at reducing the risk of nosocomial transmission more closely consider non-clinical areas in which staff are required to work or gather.

Environmental adaptations

4.3.28 The investigation observed that some limited adaptations had been made to alter the layout and structure of some wards. This routinely included the installation of additional hand-washing facilities in general ward areas and restricting some access points to ensure that a single point of access onto a ward could be maintained where possible.

4.3.29 The investigation also observed how some small-scale estate works could assist in altering the layout of the ward. In one reference trust, the doors to patient bays had been relocated so that patients could access toilet facilities without having to go into the ward corridor.

4.3.30 The reference trusts had taken steps to create separate high-, medium- and low-risk ward areas. The investigation observed that in some trusts entire floors could be dedicated to a single category of patient, while in others separation had to be maintained on a ward-toward basis.

4.3.31 Some reference trusts had created systems to separate the flow of patients considered to be in high-risk or low-risk categories as they moved around the hospital. The investigation observed examples such as the use of dedicated ward corridors and elevator systems to ensure separation of these patient groups.

4.3.32 Outside of the ward environment, the investigation observed additional steps the reference trusts had taken to limit the risk of transmission. These included limiting entry and exit points for staff and patients and creating additional barriers in patient waiting areas to try and maintain social distancing.

4.3.33 However, in some circumstances, this type of approach was challenging owing to the lack of available infrastructure to ensure separation and because the design of hospital buildings did not allow such adaptations to be made. Changes in the way people were expected to move around hospitals had also created unexpected problems in hospitals that had not been designed to be used in this way. For example, in one hospital where the flow of people was controlled by having one entrance and one exit, a staff member said: “I got…phone calls off people trapped in corridors and rooms because they couldn’t get out of any of them.”

4.3.34 Some reference trusts had also introduced signage in public areas to indicate where one-way systems were in place or where staff were required to walk on specific sides of corridors. National leaders explained that “for £600 we had template designs made as PDF with print colourway so that individual trusts could send off for printing locally”. The investigation was told that this saved potentially thousands of pounds in separate design costs. Signage and efforts to ensure people travelled to the right place along a controlled route also assisted wayfinding (Department of Health, 2006) and social distancing. The investigation heard how approaches to sharing such knowledge may be facilitated by existing online platforms that bring together NHS estates professionals so that best practice can be shared.

4.3.35 However, such signage was not in place in all the reference trusts. Some trusts were unaware that pre-designed templates were available and explained that they had felt the need to engage local designers and printers to create signage. The investigation did not observe a consistent approach to signage in any of the trusts.

4.3.36 Standardised and effective signage design can significantly impact the effectiveness and likelihood of adherence to information and control movement of large volumes of people. Central design and production processes are advised to result in more effective and economical signage (Design Council, 2012).

4.3.37 Families told the investigation that they felt more confident when they could see visible indications that it was harder for people to access hospitals. Many families said they felt safer due to the use of restricted entrance/ exit points and the use of staff at these points to help provide PPE and advice, and felt that these systems had improved over time.

4.3.38 Some families reported seeing a lack of physical measures in place in the hospital environment that could mitigate transmission. One family member said that they “didn’t see any barriers in the emergency department to help with separation”.

4.3.39 Some families also did not perceive that COVID-19 and non-COVID-19 areas were appropriately separated. In one example, a family member explained how both COVID-19 and non-COVID-19 areas shared the same floor in a hospital. This had led to concerns that staff from these areas may share common facilities and could move freely between the areas. One family member queried “why one of three hospitals in [their local trust] couldn’t have been a ‘clean’ hospital” where patients not suspected of COVID-19 could be admitted for care.

4.4 Staff factors

“I think the last six months really have been the hardest six months I’ve ever been through in 25 years.”

IPC lead

Workforce sustainability

4.4.1 The investigation spoke with a range of staff at national, regional and local levels within the NHS. These staff expressed significant concern about the sustainability of the workforce in the next few months as staff have frequently been required to work longer hours in order to meet demand.

4.4.2 Both clinical and non-clinical staff at all levels reported extreme levels of fatigue. One reference trust told the investigation: “People are knackered and have been working way above and beyond.” For example, one trust reported significant additional work for hospital estates and domestic teams; staff had undertaken “96 ward moves in 18 weeks” which they estimated as being “10 years’ worth of work”.

4.4.3 The ability of NHS trusts to respond to a further increase in COVID-19 activity may be compromised without access to sufficient and suitable staff resources. For example, this may impact on the ability to meet the additional demand for cleaning or whether staff can remain in consistent teams as recommended by IPC guidance (Public Health England, 2020b).

Staff cohorting

4.4.4 IPC guidance (Public Health England, 2020b) suggests that where possible teams of staff should be assigned to care for patients in a particular risk category or being treated in particular clinical areas. The investigation was told that there were significant challenges in cohorting (grouping) staff that could provide care in specific clinical environments to mitigate the transmission risk.

4.4.5 The reference trusts explained that they had encountered numerous situations in which staff members either became unwell with COVID-19 symptoms, were asymptomatic and tested positive, or were required to isolate due to a member of their household having symptoms or testing positive.

4.4.6 Furthermore, the investigation also found concerns among the reference trusts about the physical and emotional impact on staff being on duty for long periods. At the time of the investigation this made cohorting of clinical staff impossible.

Impact of staff fatigue and emotional distress

4.4.7 The reference trusts explained how medical and nursing staffing rotas had been amended to increase staff numbers to help in the response to COVID-19: “…the medical rotas were completely rejigged so that you had more senior decision makers around the clock which helped ensure that only those patients who really needed to be in hospital were admitted.”

4.4.8 However, there was concern that this approach may not be sustainable in returning NHS services to pre COVID-19 activity levels or in responding to any further rise in COVID-19 activity. One trust explained: “… people…committed themselves to really tough rotas. Nobody took any leave…Do we need to have such intense rotas? We probably do, but it has really exhausted people.” At a trust where medical rotas had been amended to meet the increased demand, a staff member explained that the rotas “have gone back to normal because I guess that’s not sustainable”.

4.4.9 The investigation found few examples of clinical and nonclinical rotas being altered to address the risk of staff fatigue. The majority of wards the investigation visited required nursing staff to work 12-hour shift rotations. Some staff explained how these shift rotations had become harder owing to the increased demands on the healthcare system and increased need to wear a range of PPE, often in ward environments that were warm and may be poorly ventilated. However, other staff preferred to continue these work patterns as it offered more time away from work once they had completed their weekly shift rotation.

4.4.10 Shift patterns are recognised as having a key part to play in work-induced fatigue. PPE is also recognised as increasing levels of heat stress and contributing to fatigue (Health and Safety Executive, n.d.c; Matthews et al., 2000; Medicines and Healthcare products Regulatory Agency, 2020). Information is available to help trusts to consider how to balance the risks associated with staff fatigue and organisational capability (Health and Safety Executive, 2020).

4.4.11 Fatigue is acknowledged to influence attention levels, increase risk of error and lead to performance degradation (Folkard et al., 2005). Reference trusts identified that relying on individual staff resilience was not an effective or sustainable approach to ensuring the resilience of their hospitals to deliver effective care. Instead, there was a growing appreciation that organisational capability stemmed from a range of other factors and not just the physical and mental capabilities of the staff within the healthcare system.

4.4.12 Staff at all levels of the NHS who engaged with the investigation reported that working during the pandemic had a significant emotional impact. Some reference trusts reported that they had identified some “real emotional issues” among staff. One trust told the investigation: “…we had some significant mental health issues that we picked up from staff members… someone attempted suicide because they were so distressed by all of this.” Another staff member told the investigation: “I look back and think, “How on earth did we do that?” but it was at some personal cost to people, so we have a lot of people who are, I would say, still in a genuine recovery period and it has impacted staff health and wellbeing, so we have people with very high stress levels.”

4.4.13 The investigation spoke with clinical and non-clinical staff who had been reassigned to other duties at short notice as part of the pandemic response, often with ‘on the job’ training. Many staff had also been required to work in unfamiliar clinical environments. This had often required staff to relocate to unfamiliar ward environments at short notice or adapt ways of working to balance efficiency against the risk of transmission. The investigation heard that staff “found the ward moves really tough. It was trying to get used to the unfamiliarity which was hard”.

4.4.14 Staff told the investigation that they would normally be able to meet with colleagues to discuss stressful or distressing experiences. This helped them to cope with the demands of their role and helped protect their mental health. However, restrictions introduced to reduce transmission of COVID-19 in non-clinical environments had affected where and how staff could gather, significantly reducing opportunities to talk to colleagues in person.

4.4.15 Anxiety can impact on people’s ability to safely perform work or may lead to staff absences due to mental health concerns. Such absences may further limit NHS trusts’ ability to respond to increased demands that may be caused by further increases in COVID-19 activity. A reduced workforce inhibits adherence to IPC staff cohorting strategies, which provide controls at the higher levels within the hierarchy of controls.

4.4.16 The investigation observed a range of initiatives that had been developed to support staff wellbeing in the reference trusts. The investigation was told that these measures did make staff feel supported by leaders and were valued by staff. By addressing issues considered to influence staff absence, fatigue and the sustainability of the workforce, the initiatives attempted to manage the risks of nosocomial transmission.

4.4.17 However, the investigation understood that many initiatives observed at local level were not available to staff working in organisations at regional or national level, due to these staff being required to work remotely.

4.4.18 NHS England and NHS Improvement told the investigation that, alongside the local response, there had been a co-ordinated national response to help staff to access remote emotional support. This has included offering services such as a dedicated website (www.people.nhs.uk), smartphone applications and dedicated helplines. In total, up to mid-September 2020, these services had been accessed nearly half a million times.

4.4.19 The investigation observed how proactive monitoring of occupational health and human resources data had helped some reference trusts to identify trends in staff sickness. This enabled additional support to be directed to affected areas. This approach may allow trusts to mitigate further impacts on staff and manage the risk of ensuring a consistent and sufficient workforce, to support adherence to guidance and respond to increases in workload.

4.4.20 The investigation found that, at a national level, there was an emerging understanding of the emotional distress experienced by staff at all levels of the NHS. The investigation was told that NHS England and NHS Improvement is developing a further national response to support all staff, which includes utilising expertise in mental health trusts and making this expertise available to NHS staff. It is also considering how to include specific support for its own staff in health and wellbeing programmes.

4.4.21 These risks are likely to continue in the short to medium term and the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/100:

It is recommended that NHS England and NHS Improvement investigates and evaluates the risks associated with the potential impact of staff fatigue and emotional distress on nosocomial transmission of COVID-19.

HSIB makes the following safety observation

Safety observation O/2020/079:

It may be beneficial to facilitate shared learning across the NHS so that effective strategies that have been adopted by local NHS organisations for the management of staff fatigue and emotional wellbeing can be shared.

4.5 Organisational factors

“It was just we’re doing it, everybody just got together… that’s the bit that was a real positive for us…people just forgot their organisational allegiances and just did the right thing.”

Estates Director

Organisational adaptability

4.5.1 The investigation heard a range of positive stories from reference trusts about the way in which the pandemic had brought services together to operate effectively in responding to COVID-19. One trust’s comments reflected this: “…we implemented a massive amount in a really, really short space of time because everybody was focused on COVID-19, weren’t they? Normally you have got multiple competing priorities where [COVID-19] actually made it easier.”

4.5.2 The reference trusts explained how they had developed mechanisms to allow them to become adaptive and flexible in the face of challenges posed by the pandemic. These included changes in formal leadership and staffing and governance structures to facilitate more rapid action and to increase capacity. The investigation was also told how complex contractual arrangements for the management of hospital estates were able to be proactively managed to enable more effective and timely modifications within the hospital environment.

4.5.3 The investigation observed how clinical and non-clinical leadership had adapted to support the response to the pandemic. The investigation found that mechanisms for engagement with frontline staff had improved across trusts, including more regular communications updates and senior staff presence on the frontline.

4.5.4 Many senior leaders in the reference trusts explained that leadership practices had changed and the pandemic had required them to be “connected with the frontline all the time and we were sensitive to frontline staff”. The investigation was told that this had facilitated more effective two-way communication and dissemination of critical information: “…we walked the floor so you get the messages back…and you feed that back into the decision making... We learnt quite quickly what messages weren’t getting through in either direction.”

4.5.5 Another change in leadership practice was the development of increased seven-day working and on-call arrangements among senior staff; this had continued throughout the pandemic. The investigation also heard of examples of practical steps reference trusts had taken to increase flexibility in how they responded to emerging information. One trust told the investigation how they had “restructured our trust management team meetings to be shorter but to happen more frequently so that we can get more agile decision making”.

4.5.6 The experiences of the first wave had allowed the reference trusts to develop and embed practices that could assist in response to any future peak in COVID-19 related activity. One trust the investigation: “…everyone knows that in the event of a peak, second wave, whatever, the tactical arrangements will be stood straight back up. So those things will happen in a heartbeat as opposed to us having to work it out the previous time.”

4.5.7 This was echoed by national leaders who were confident that structures developed during the peak of the pandemic would better facilitate the response to any future rise in COVID-19 activity.

Risk tolerance

4.5.8 The investigation found that there had been a need for rapid adaptations within the reference trusts to enable them to respond to the pandemic. This had seen a trade-off in levels of consultation, assurance and governance systems usually in place to embed systems.

4.5.9 All the reference trusts reflected that the pandemic had required a change in trusts’ tolerance for risk. This required the reference trusts to undertake local and dynamic risk assessments to ensure that action could be taken to mitigate nosocomial transmission risks in advance of national guidance, or where no national guidance or support was yet available: “…some of the things were done on the core principle of if you just want to run a safe site, if there’s a mitigation you can take in the absence of guidance, do what seems sensible.”

4.5.10 This included the need to circumvent or reimagine existing governance processes to enable more rapid decision making. This had become a key enabler to the reference trusts responding to the pandemic, and the trusts’ views are reflected in one staff member’s comment: “…generally, what we have seen…is a much higher tolerance of risk across the board – in every function, I will be honest.”

4.5.11 Often, tasks that had previously involved significant time and planning were required to be completed at short notice. A common example was where ward moves had been required within the reference trusts. The investigation was told that under normal circumstances this would typically take many months of planning and multiple levels of governance approval. However, a far more rapid process had been required to support capacity levels and reduce nosocomial transmission risk during the pandemic. For example, one trust explained: “…a consultant came and sat in my office on a Friday afternoon, about one or two o’clock…saying, “I think we should open up a COVID-19 palliative care ward.”…by 5.30pm we had moved all the patients…so in four hours we had set up a ward. [That was] just stunning.”

4.5.12 The investigation was told of concerns about the potential impact of this change in the tolerance of risk. One reference trust explained: “…we’ve looked at it from a COVID-19 risk perspective, not from a global patient or system or organisational risk perspective and that’s the change we’re going to have to make. That will mean some difficult decisions around when the risks to other patients, or the risk to the organisation or the system, are greater than the risk of COVID-19 nosocomial spread.” Another trust echoed this, saying: “…there was a good, quick ability to [get things done]...I think people see it as bureaucracy, but actually I don’t see governance as bureaucracy, I see it more as doing it properly.”

HSIB makes the following safety observation

Safety observation O/2020/080:

It may be beneficial to evaluate the change in organisational risk tolerance to consider the potential future impact on NHS governance and regulation processes.

4.5.13 The investigation found that national organisations had also been required to be adaptive in their approach to risk. In the early stages of the pandemic response, decision making was “quite reactive”. However, the investigation identified that structures had now been created to ensure that senior leaders could “proactively risk assess decisions that are now being made”. Decision making structures included representation from both national and regional representatives across the healthcare system.

4.5.14 Further organisational learning is required at local, regional and national levels to consider how fast-moving change was accomplished and to judge the trade-offs required, to assist in understanding any future approach to the development and implementation of technological solutions.

4.5.15 Unlike other industries, a formal safety management system is not a regulatory requirement for healthcare (Chatburn et al., 2018; Dixon-Woods et al., 2014; Vincent et al., 2013). The concept of risk management in healthcare is not currently aligned to other safety-critical industries.

4.5.16 Other safety-critical industries routinely mandate a safety management system to engage expertise in risk management and human factors. This is to ensure a proactive approach is applied and maturity is demonstrated in their approach to safety.

4.5.17 In the absence of a formal safety management system, it is possible that the method by which some trusts have been able to successfully adapt their practices and leadership models to ensure an effective response to the pandemic may be lost. Work to consider how NHS trusts have been able to adapt would allow learning to be embedded in the healthcare system to help mitigate against future circumstances that may create similar demands. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/101:

It is recommended that the Department of Health and Social Care reviews and identifies the mechanisms which enabled regional and local organisations to adapt and respond with agility during the pandemic. This should inform the development of a strategic approach to national leadership models at times of crisis and under normal conditions.

Technological advancements

4.5.18 The investigation observed a rapid increase in the use of technology within the reference trusts during the pandemic. One trust told the investigation that its use of technology had “moved on three years” due to the pandemic. The investigation heard that this was seen as a positive by many trusts who considered that they would be able to adapt their ways of working in the long term to help support greater IT integration. However, it did pose challenges in terms of organisational culture due to the speed of IT implementation.

4.5.19 Increased use of IT allowed the reference trusts to mitigate the COVID-19 infection risk by moving non-clinical staff to home working arrangements and facilitating IT-led solutions within the hospital environment (see figure 2). A common example across the reference trusts was a shift to video conferencing to facilitate staff meetings and information sharing: “Everybody embraced [video conferencing], we put video room conferencing kits into as many rooms as we could so that the Execs when they had [their] meeting in the morning they weren’t all needing to be in the room, they could socially distance.”

4.5.20Ad hoc technical solutions were also used to ensure staff could stay up to date with key messages within the reference trusts. As frontline staff had limited opportunities to access computers or email, the investigation was told of alternative means by which messages had been distributed: “We’ve got a closed [social media] group, we’ve got [messaging apps], so [messages] did go out through a variety of forums.” The investigation was told that many of these informal communication systems were not normally encouraged within NHS organisations. However, the pandemic had revealed the gap in similar fast and accessible communication platforms being available within the NHS.

4.5.21 The investigation also observed some increased use of technology within the ward environment. This included use of existing systems that were adapted to COVID-19 activity to better manage and integrate patient care. One reference trust had altered its electronic bed management system to “designate wards as either red, yellow or green”, including specific bays in wards, to assist bed management teams in placing patients in high, medium and low COVID-19 status categories. However, the investigation did not observe an increase in the use or availability on wards of patient- and clinician-focused technology. The use of such technology could further mitigate against the risk of transmission by allowing alternative approaches to patient care and staff interaction to be developed. As a result, the following safety recommendation is made:

HSIB makes the following safety recommendation

Safety recommendation R/2020/102:

It is recommended that NHSX considers how technology can assist in mitigating nosocomial transmission in the ward environment with regard to:

  • the use of digital communication technologies in assisting with the deployment of staff and the dissemination and circulation of key information
  • the increased use and availability of personal computing devices and electronic health record systems.

4.5.22 In light of restrictions on visiting, the reference trusts had all developed additional ways to ensure patients could interact with their families and be supported during their stay in hospital. For example, technology had been used to help patients to communicate with their families, such as the use of video conferencing and other technological solutions. One trust explained how they had “implemented a solution where staff could securely send copies of the patient’s diary to the relatives and they could communicate”.

4.5.23 The increased use of technology had been facilitated by increased national investment and local efforts. One reference trust told us of efforts to create a “production line” that deployed administrative staff to help assemble laptops and put together equipment packages that could then be used to facilitate home working.

4.5.24 However, the investigation also heard of issues that impacted on how successfully technology could be implemented to help mitigate the risk of transmission. Existing network capacity and technological integration were identified as a “limiting factor” by some trusts.

4.5.25 Other reference trusts reported that the complexity of existing systems also placed limits on the integration of new technology and resource: “… when you work in a complex environment like we have… there’s a Heath Robinson mix of systems across the whole organisation. So bringing in extra people and resources isn’t necessarily a quick fix because it takes months to learn the individual areas. We have put in additional resources, there are no two ways about it, but it is not always the answer.” These issues posed a challenge in terms of how successfully trusts could use technological advancements to help mitigate the impact of COVID-19 and the risk of transmission.

Organisation size and healthcare networks

4.5.26 The size of the reference trusts and the resources available to them had a fundamental impact on their ability to adapt and respond to the pandemic. The larger trusts, and those where strong existing regional structures were in place, reported a more collaborative approach in their response. This created more opportunities to segregate patients across larger estates or to work in collaboration with other providers to pool resources. One trust explained how they had “worked hard to provide a partnership…so that the health and care environment works as one” to try and extend the benefits of this approach across the wider care system.

4.5.27 However, smaller reference trusts faced challenges where this type of resource and support was not available. One trust told the investigation that “if you end up with a small hospital anywhere in the country that runs into problems, it has to be picked up by everybody around it”. Where local and regional networks were not as well developed, smaller trusts were at risk of being overwhelmed without additional support. The development of the Nightingale hospitals provided regional confidence in the availability of additional critical care capacity, but noncritical care capacity remained a potential area for concern in advance of any future rise in COVID-19 activity.

4.5.28 Operational modelling can simulate different scenarios to enable decision makers to understand how hospital systems can perform better in response to public health emergencies. This approach is currently underused within the NHS and may assist in decisions about how best to use the available NHS infrastructure (Currie et al., 2020; Pitt et al., 2009). Rapid national learning is required to understand the level of existing risk held by each NHS trust relative to its capability to manage public demands and IPC requirements.

Information gathering

4.5.29 The investigation found that the reference trusts wanted to develop proactive, data-led approaches that may assist them in anticipating any peak in COVID-19 activity in the community or within the hospital environment.

4.5.30 One reference trust explained that it had been able to bring together incident reporting and sickness absence data to try and provide an overview of where potential staff COVID-19 cases were increasing: “…in our [daily] incident control meeting… workforce is a key part of that. We…highlight if there’s any areas that are seeing an increased number of staff off sick so that we can start to escalate that early and look at what we need to put in to support that area.” Other trusts explained that such an approach was difficult due to differences in reporting systems in use across the trust.

4.5.31 There was perceived to be a lack of central data collection systems that may help to inform “a single clear view” of anticipated activity levels to enable the reference trusts to prepare their response. One trust explained how a centralised data system could feed into “a workable regional escalation plan that recognises that the level of COVID-19 in the general circulation within your community [may be used to] dictate a different response potentially in organisations”.

4.5.32 A range of data was collected from the reference trusts by PHE and NHS England and NHS Improvement. NHS England and NHS Improvement required trusts to provide daily data on a range of metrics with regard to COVID-19 activity. However, the rationale for collecting this data and how it was used was not well understood by all trust staff.

4.5.33 One reference trust expressed: “…often we are collecting things and saying, “What the heck do they want this for? What do they want us to put in the hours for?” and it just felt like feeding the beast.” In some reference trusts, staff perceived data collection as an additional burden on organisational resource, staffing and time, and did not have a clear understanding of the benefits it provided.

4.5.34 PHE told the investigation that there were barriers associated with existing, pre-COVID-19 data collection systems to identify nosocomial infections. Historically these systems did not always enable real-time learning about nosocomial transmission.

4.5.35 PHE told the investigation how it had tried to achieve more timely reporting. The methodology assimilates data from existing healthcare systems to identify probable nosocomial COVID-19 cases. However, this still creates a time lag for reviewing and providing the data on COVID-19 nosocomial transmission.

4.5.36 PHE told the investigation of recent collaborative work it was undertaking with NHS England and NHS Improvement. This aims to provide local trusts with data on the prevalence of nosocomial COVID-19, to address the existing time lag associated with the reporting of nosocomial transmission.

4.5.37 The investigation was told that NHS England and NHS Improvement has developed a data collection system. It is a manual data entry system completed by trusts that helps to provide real-time information about the number of cases of COVID-19 identified in hospital, and the time from admission to positive test.

4.5.38 The NHS England and NHS Improvement data can be accessed by trusts and regions to identify increases in the number of infections and take any urgent action required.

4.5.39 The investigation found that there was a lack of shared understanding between the reference trusts and NHS England and NHS Improvement on the need for this data to be collected, its usefulness and the practicality of this data collection. A shared understanding may facilitate discussions regarding which data is the most beneficial to influence local responses to COVID-19 activity. Confidence in the dataset may promote earlier safety interventions from trusts when pre-set thresholds have been triggered.

5 Potential control measures for the transmission of COVID-19 in hospitals

The investigation identified a desire among the reference trusts to develop a greater understanding of the factors that may influence the risk of nosocomial transmission. The investigation committed to sharing its findings with trusts to assist in developing this understanding.

This section presents the systemic factors identified during the investigation that may help in the development of further understanding about how the risk of nosocomial transmission may be mitigated in hospital environments.

Each table presents the findings of one of the components represented within the work system of the Systems Engineering Initiative for Patient Safety (SEIPS) framework (see 2.16). NHS trusts may find this framework useful to assist in the assessment of local work systems to consider how the risk of nosocomial transmission can be further mitigated and reduced.

The investigation found that a number of factors reported by the reference trusts may help control the risk of nosocomial transmission.

The questions are presented in a descending order to reflect their level of effectiveness in the context of the hierarchy of controls, as suggested by the Scientific Advisory Group for Emergencies (2020).

5.1 People

Factors influencing the risk of nosocomial transmission

5.2 Equipment

Factors influencing the risk of nosocomial transmission

5.3 Task

Factors influencing the risk of nosocomial transmission

5.4 Environment

Factors influencing the risk of nosocomial transmission

5.5 Organisation

Factors influencing the risk of nosocomial transmission

6 Summary of findings, safety recommendations and safety observations

Healthcare Safety Investigation Branch (HSIB) acknowledges that the safety recommendations identified by the investigation may require action over the short, medium and longer term.

HSIB makes the following safety recommendations

Safety recommendation R/2020/095:

It is recommended that the Department of Health and Social Care, working with NHS England and NHS Improvement, Public Health England, and other partners as appropriate, develops a transparent process to co-ordinate the development, dissemination and implementation of national guidance across the healthcare system to minimise the risk of nosocomial transmission of COVID-19.

Safety recommendation R/2020/096:

It is recommended that NHS England and NHS Improvement:

  • supports additional capacity for testing for NHS patients and staff (Pillar 1 testing)
  • facilitates the accessibility of rapid testing for NHS trusts, as soon as an increase in rapid testing supplies becomes available.

Safety recommendation R/2020/097:

It is recommended that NHS England and NHS Improvement:

  • develops a national intensive infection prevention and control (IPC) safety support programme for COVID-19 which focuses on leadership, IPC technical support, education, practice, guidance and assurance
  • develops a national IPC strategy which focuses on developing IPC capacity, capability and sustainability across the NHS in England.

Safety recommendation R/2020/098:

It is recommended that NHS England and NHS Improvement reviews the principles of the hierarchy of controls in its health building notes (HBN) and health technical memoranda (HTM) for the design of the built environment in existing and new hospital estate to reduce the risk of nosocomial transmission.

Safety recommendation R/2020/099:

It is recommended that NHS England and NHS Improvement responds to emerging scientific evidence and shared learning when reviewing guidance for NHS trusts on the role of hospital ventilation systems in nosocomial transmission.

Safety recommendation R/2020/100:

It is recommended that NHS England and NHS Improvement investigates and evaluates the risks associated with the potential impact of staff fatigue and emotional distress on nosocomial transmission of COVID-19.

Safety recommendation R/2020/101:

It is recommended that the Department of Health and Social Care reviews and identifies the mechanisms which enabled regional and local organisations to adapt and respond with agility during the pandemic. This should inform the development of a strategic approach to national leadership models at times of crisis and under normal conditions.

Safety recommendation R/2020/102:

It is recommended that NHSX considers how technology can assist in mitigating nosocomial transmission in the ward environment with regard to:

  • the use of digital communication technologies in assisting with the deployment of staff and the dissemination and circulation of key information
  • the increased use and availability of personal computing devices and electronic health record systems.

HSIB makes the following safety observations

Safety observation O/2020/075:

It may be beneficial to analyse data collated on asymptomatic staff infection rates to consider how this may impact on mitigation strategies to reduce the risk of nosocomial transmission.

Safety observation O/2020/076:

It may be beneficial to have greater consistency in the provision of FFP3 respirator masks to assist in their response to COVID-19.

Safety observation O/2020/077:

It may be beneficial to reconsider the design of ward work systems and equipment layout to mitigate the risk of nosocomial transmission.

Safety observation O/2020/078:

It may be beneficial if interventions aimed at reducing the risk of nosocomial transmission more closely consider non-clinical areas in which staff are required to work or gather.

Safety observation O/2020/079:

It may be beneficial to facilitate shared learning across the NHS so that effective strategies that have been adopted by local NHS organisations for the management of staff fatigue and emotional wellbeing can be shared.

Safety observation O/2020/080:

It may be beneficial to evaluate the change in organisational risk tolerance to consider the potential future impact on NHS governance and regulation processes.

7 Appendices

Appendix A - Investigation methodology

7.1 HSIB aim to improve patient safety through effective and independent investigations that do not apportion blame or liability. The process of evidence collection and analysis has integrated the safety science of human factors to ensure a systems approach. The methodology was subject to scrutiny by HSIB internal governance mechanisms.

Investigation methods

7.2 The investigation completed review of the key guidance and supporting documentation relevant to NHS trusts on managing the risk of transmission of COVID-19, between July and August 2020 (Table 1). This involved a review of guidance to determine the extent to which the breadth of mitigation strategies, suggested within Scientific Advisory Group for Emergencies (SAGE) Data Evaluation and Learning for Viral Epidemics (DELVE) evidence, has been represented within NHS guidance.

7.3 The investigation utilised publicly available data from the Office of National Statistics to identify six reference trusts across England in locations that represented a range of: geographical locations, socioeconomic conditions and local population ethnicity. The selection criteria aimed to ensure the trusts were representative of NHS hospitals within England.

7.4 The investigation also utilised publicly available information from NHS sources to consider the age of hospital infrastructure. The six reference trusts included a range of hospital buildings and environments constructed between 1900 and 2020.

7.5 Acute medical wards were selected as the target healthcare environment as they were considered most likely to capture a breadth in typical healthcare work and patient care activities consistently across all six sites. This also allowed the investigation to focus on areas where there was the potential for uncertainty about the COVID-19 status of patients.

7.6 The Systems Engineering Initiative for Patient Safety (SEIPS, figure 3) was used as a framework for the standardised evidence collection tools used in the investigation (Carayon et al., 2006) and (Holden et al., 2013) suggest that the SEIPS framework provides a way to understand the relationship between the structures, processes and outcomes of healthcare systems. This approach was piloted prior to the investigation and all investigators were made familiar with the evidence collection tools prior to trust visits. Investigation fieldwork was completed between 13 July and 28 August 2020.

7.7 The investigation completed a range of ward observations, including completion of a standardised checklist to consider whether mitigation measures were visible on wards that reflected the hierarchy of controls proposed by SAGE. In addition, the investigation also completed ward mapping exercises to track staff movement in the ward environment and identify where areas at higher risk of facilitating transmission may exist.

7.8 The investigation adopted a standardised approach to the individuals selected for interview. This included a deliberate strategy to interview from board to ward. Interviews included a range of staff at the trusts who were sufficiently senior to make decisions about an organisation’s response to the pandemic. These local leaders were able to provide authoritative and reliable comment during interview and all staff provided their experience of working through the pandemic.

7.9 Staff within key roles in each of the trusts were interviewed. This included senior medical, nursing, infection prevention and control, operational, facilities, estates, and IT staff. The investigation completed 45 interviews with staff across the six reference trusts. In addition, a range of informal and opportunistic interviews were also completed with staff at all six trusts during visits to observe the acute ward environment. At national level, the investigation interviewed system leaders who were able to provide authoritative comment on system level issues. These included representatives from the Department of Health and Social Care, NHS England and NHS Improvement, Public Health England and the Academy of Medical Royal Colleges.

7.10 To fully understand the nosocomial transmission of COVID-19, the investigation sought the experiences of patients, or their families, who were in hospital during the pandemic.

7.11 The investigation worked with HSIB’s Citizens’ Partnership to decide how best to engage with patients and their families. The investigation held two on-line focus groups. Twelve individuals attended across the two focus groups; all had a relative that had died from COVID-19, with the overwhelming majority believing their relative had contracted COVID-19 in a hospital setting.

7.12 All interviews and focus groups were either digitally recorded or comprehensive notes were taken. Transcripts were made of all digital recordings to assist in thematic analysis. These provided insight into the work and challenges associated with managing the transmission of COVID-19.

7.13 The evidence collected through observations, interviews, and guidance documents, was uploaded into data analysis software. This was interrogated, based on principles familiar to the management of qualitative information, to understand key mitigation strategies currently applied across the healthcare work system to reduce the three modes of transmission.

7.14 A thematic coding framework, based upon the SEIPS model, supported the initial analysis of the investigation evidence. This framework was expanded to capture the emergent themes grounded within the evidence from all levels of the healthcare system. An independent HSIB investigator that had not been involved in the evidence collection process assisted in the analysis to provide further scrutiny.

7.15 The emergent themes from the investigation were identified and findings have been drawn from this evidence. The text and quotations presented in the investigation report are representative of the themes identified through analysis, following corroboration and triangulation of evidence across multiple sources.

7.16 The draft report was shared with stakeholders via HSIB’s factual accuracy checking process on 16 September 2020. The report findings were subsequently verified with each trust and stakeholders involved within the investigation via the HSIB factual accuracy checking process.

Investigation team

7.17 The core HSIB investigation team consisted of five staff all with a knowledge of healthcare systems.

These included experience and skills in the following areas:

  • healthcare investigation
  • human factors
  • law and regulation
  • clinical practice.

7.18 In addition, a further three HSIB investigators were also involved in fieldwork and evidence collection. HSIB internal governance processes provided further scrutiny of the findings, recommendation and observations set out in the report. This included further review by two senior HSIB investigators, two senior clinicians, the Director of Investigations, and the Chief Investigator.

Limitations of the investigation

7.19 HSIB committed to completing this investigation as soon as possible in order to help in a response to an increase in COVID-19 activity during the autumn/winter period. This required an agile approach to completing the investigation within a shortened timeframe.

7.20 The approach to the selection of the trusts was aimed at ensuring they were representative of characteristics considered relevant to the transmission of COVID-19 in hospitals. For example, infrastructure design, geographic location, and population demographics. There were limitations on trusts that could be selected owing to local lockdowns and practical limitations on the investigation team.

7.21 The number of reference trusts was selected to allow the investigation the broadest possible basis for evidence collected within the available reporting timeframe and resources available. The findings are consistent across the reference trusts and should be applicable across the healthcare system.

7.22 The investigation was aware that other types of health and social care settings may equally benefit from a similar level of scrutiny. Healthcare staff also told the investigation of the value of such an approach in considering mental health and primary care settings. This was not possible due to the limited time and resources available to the investigation. However, the findings and considerations for local organisations identified in this report (Section 5) may assist in the consideration of nosocomial transmission risks in other healthcare settings.

7.23 The investigation team was not provided access to quantitative data relevant to nosocomial transmission or hospital performance. The investigation has relied upon the analysis of qualitative evidence.

Appendix B – NHS England and NHS Improvements comments on 13 October 2020

In a response to the draft investigation report on 13 October 2020, NHS England and NHS Improvement confirmed to HSIB that they were in the process of undertaking the following safety actions:

  • Data on nosocomial transmission rates would begin to be published on a weekly basis, following sign off from local NHS trusts. Nosocomial data will be reviewed to allow targeted investigation of known nosocomial hot-spots.
  • Asymptomatic testing of NHS staff would begin in hospitals under Tier 3 restrictions and where there is seen to be a high-prevalence of nosocomial transmission.
  • Rapid testing will continue to be rolled out for patient admissions via emergency departments.
  • NHS England and NHS Improvement will ask trusts to focus on the turnaround times for COVID-19 tests as a quality indicator.
  • There will be reinforced messaging about wearing face masks in hospital, including (when feasible) the use of face masks by patients.
  • There will be consistent messaging to all healthcare staff on ‘hands, face, space’ - inside and outside of hospitals which will highlight the role professional accountability in adhering to guidance.
  • NHS trust boards will be asked to review the infection prevention and control board assurance framework every month, as a minimum.
  • Regional teams from NHS England and NHS Improvement will share local lessons learnt amongst NHS trusts.

8 Glossary

Aerosols/aerosol particles Small droplets which are less than 5 microns in diameter, also known as airborne particles.
Aerosol generating procedure (AGP) Aerosol generating procedure – a medical procedure that releases droplets from the patient’s respiratory tract into the environment.
Cohort/cohorting A cohort is a group of people with a shared characteristic. Cohorting means grouping together.
Cohorting (staff) When staff care for one specific group of patients and do not move between different patient cohorts.
Cohorting (patients) Patient cohorts may include, for example, high-risk, medium-risk or low-risk patient groups in an area (room, bay, ward) in which two or more patients (a cohort) are placed. A cohort area should be physically separate from other patients.
COVID-19 Clinical Information Network (CO-CIN) The body that collates clinical information about people in hospital with COVID-19 and provided reports to both SAGE and NERVTAG.
Data Evaluation and Learning for Viral Epidemics (DELVE) A multidisciplinary group convened by the Royal Society to analyse data related to the pandemic to support learning.
Droplet particles Droplets which are between 5 and 10 microns in diameter – usually produced by coughing or sneezing.
FFP3 respirator mask Filtering facepiece class 3 respirator mask. This is a type of mask that offers the highest level of protection and must be fit tested to ensure the mask is sealed to the wearer’s face.
Fit test A series of steps to ensure a FPP3 respirator mask is suitable for the user, fits their face properly and provides the necessary protection.
New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) The group that provides scientific data regarding COVID-19 to the Chief Medical Officer which fed into SAGE.
Nosocomial transmission The transmission of an infection in a healthcare setting. This includes transmission from patient to patient, staff to patient, patient to staff and staff to staff.
Personal protective equipment (PPE) Personal protective equipment – equipment such as masks, gloves, eye, protection and gowns worn to prevent COVID-19 infection. There are different levels of PPE offering different levels of protection.
Pillar 1 testing In the UK, COVID-19 tests are carried out through a number of different routes. Pillar 1 refers to swab testing in Public Health England labs and NHS hospitals for those with a clinical need, and for health and care workers.
Public Health England SIREN study SIREN (Sarscov2 Immunity and Reinfection Evaluation) is a research study investigating whether healthcare workers who have previously been infected with COVID-19 are immune to re-infection.
Scientific Advisory Group for Emergencies (SAGE) The group that provides scientific and technical advice to the government to inform policy during the pandemic.
Systems engineering An approach to understanding how people, facilities and processes interact within complex systems to understand how the system may or may not achieve its goals.

9 Endnotes

[1] The Citizens’ Partnership makes sure the patient and public perspective is at the heart of everything HSIB does.

[2] SIREN is a National Institute for Health Research urgent public health priority study which has a primary objective of determining if prior COVID-19 infection in healthcare workers confers future immunity to reinfection. It will also allow organisations to estimate the prevalence of COVID-19 infection in healthcare workers and use this information to determine wider staff testing.

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