Risk assessment and the use of personal protective equipment in an emergency department: Differing perspectives of emergency and infection control clinicians. A video-vignette survey.

BACKGROUND: The use of personal protective equipment (PPE) in emergency departments (EDs) is an important defense during infectious disease emergencies. However, what counts as appropriate PPE in EDs is contentious and inconsistently implemented in practice. METHODS: An online scenario-based video survey was distributed through purposive sampling, and completed by 270 ED and infection prevention and control clinicians in Australia. A descriptive content analysis was performed on the data, and differences between groups were tested using Fisher exact test. RESULTS: Participants agreed that most items were required in both scenarios. Eye protection, mask use, and hand hygiene frequency were more contentious. Physicians were more likely than nurses, and ED clinicians more likely than infection prevention and control clinicians, to regard items or actions as optional rather than essential. Many ED clinicians, particularly physicians, regarded sequences as too time-consuming to be practical in a busy ED. DISCUSSION: Our findings likely reflect differences in professional roles, competing priorities, and risks, and highlight important contextual characteristics of EDs, such as diagnostic uncertainty, equipment inaccessibility, and resource constraints. CONCLUSIONS: To be feasible, practicable, and thereby effective, PPE guidance in the ED must be designed collaboratively with frontline ED staff, and reflects the complexities of their practice.

Exploring the safety and quality of mobile X-ray imaging in a new infectious disease biocontainment unit: an in situ simulation and video-reflexive study.

OBJECTIVES: During a precommissioning inspection of a new biocontainment centre, radiographers noted structural features of quarantine rooms that could compromise staff and patient safety and the X-ray image quality, even after significant modifications had been made to an earlier radiography protocol. The aim of this study was to explore the safety and effectiveness of the modified protocol, in the new space, and identify improvements, if required. DESIGN: A qualitative study using in situ simulation and video-reflexive methods. SETTING: A newly built biocontainment centre, prior to its commissioning in 2021, in a large, tertiary hospital in Sydney, Australia. PARTICIPANTS: Five radiographers, and a nurse and a physician from the biocontainment centre, consented to participate. All completed the study. INTERVENTIONS: Two simulated mobile X-ray examinations were conducted in the unit prior to its commissioning; simulations were videoed. Participants and other stakeholders analysed video footage, collaboratively, and sessions were audio recorded, transcribed and analysed thematically. Problems and potential solutions identified were collated and communicated to the hospital executive, for endorsement and actioning, if possible. RESULTS: Four themes were identified from the data: infection exposure risks, occupational health and exposure risks, communication and X-ray image quality. Facilitated group reviews of video footage identified several important issues, across these four areas of risk, which had not been identified previously. CONCLUSIONS: In situ simulation is used, increasingly, to evaluate and improve healthcare practices. This study confirmed the added value of video-reflexive methods, which provided experienced participants with a richer view of a familiar protocol, in a new setting. Video footage can be examined immediately, or later if required, by a broader group of stakeholders, with diverse experience or expertise. Using video reflexivity, clinicians identified potential safety risks, which were collated and reported to the hospital executive, who agreed to implement modifications.

Hospital health care workers' use of facial protective equipment before the COVID-19 pandemic, implications for future policy.

BACKGROUND: Prepandemic routine use of facial (respiratory and eye) protective equipment (FPE) by health care workers was suboptimal. Understanding factors affecting routine use would facilitate escalation to high level use during infectious disease emergencies. This study explored health care workers FPE-related knowledge, attitudes and behaviors. METHODS: Mixed methods were used in a respiratory ward and adult and pediatric emergency departments (EDs), prior to the COVID-19 pandemic. Study design and thematic analysis were based on the theoretical domains framework. Emergent themes were categorized, using the COM-B behavior model, into capability(C), opportunity(O) and motivation(M), which influence behavior(B). RESULTS: 22 emergent themes, representing factors influencing FPE use, were mapped to theoretical domains framework domains. Personal experience and departmental cultures influenced motivation. Compared with respiratory ward staff, ED clinicians were less knowledgeable about FPE; the unique ED environment and culture inhibited opportunities and motivation for FPE use. Eye protection was infrequently used. DISCUSSION: Optimal FPE use is challenged by ED care models and settings. Changes are needed to translate pandemic-related improvements into routine care of other respiratory infections. CONCLUSIONS: This study identified key determinants of FPE behavior. A review of context-specific FPE guidance for ED by infection prevention and control professionals would help to promote practicable, sustainable compliance.

Planning and executing a national point prevalence study: a blueprint for the future.

Healthcare-associated infections (HAIs) are a significant risk for patients and a burden on the health system. In 2021, the Te Tahu Hauora Health Quality & Safety Commission New Zealand Infection Prevention and Control Team undertook a national HAI point prevalence survey (PPS) across all 20 district health boards (DHBs). We describe the process that was undertaken to plan for and execute the PPS. The key stages of this project were planning, communication and engagement, piloting and then refining the process, training surveyors, delivering the full PPS, and finally, data analysis and reporting. Support for the PPS was received at a national level from clinical and non-clinical management. The sharing of this information may support other health provider groups to use similar methodology to better understand the epidemiology of both infectious and non-infectious diseases locally. It provides a useful planning strategy for those considering similar surveys.

Sources of healthcare-associated Staphylococcus aureus bacteraemia in New Zealand acute hospitals.

AIM: The primary aim of this study was to identify the source of healthcare-associated Staphylococcus aureus bacteraemia (HA-SAB) in acute district health board (DHB) hospitals to inform future national quality improvement activities. METHOD: De-identified HA-SAB event source information was submitted to the Commission from all DHBs for the period 1 January 2017 to 30 June 2021. Data was categorised and analysed to identify trends and significant sources of infection. RESULTS: There were 1,867 HA-SAB events. Of the events where S. aureus susceptibility results were reported, 159 (10%) isolates were methicillin-resistant S. aureus. The principal sources of HA-SAB were medical devices (65%), surgical site infection (10%), and organ site (8%). Ninety-five percent of medical devices were for vascular access, primarily central venous catheters (50%) and peripheral intravenous catheters (45%). CONCLUSION: This study has identified intravascular devices as significant sources of HA-SAB. Ongoing surveillance for HA-SAB source is required to identify the major risk factors and to support quality improvement activities targeting infection prevention measures and best practice related to intravascular and other medical devices.

Exploring healthcare workers' perspectives of video feedback for training in the use of powered air purifying respirators (PAPR) at the onset of the COVID-19 pandemic.

BACKGROUND: With the advent of COVID-19, many healthcare workers (HWs) in Australia requested access to powered air purifying respirators (PAPR) for improved respiratory protection, comfort and visibility. The urgency of the response at our hospital required rapid deployment of innovative training to ensure the safe use of PAPRs, in particular, a video-feedback training option to prepare HWs for PAPR competency. AIM: To explore the feasibility, acceptability, and utility of video-feedback in PAPR training and competency assessment. METHODS: Semi-structured interviews were conducted with 12 HWs, including clinicians from Intensive Care, Anaesthetics and Respiratory Medicine, at a large teaching hospital in Australia. FINDINGS: Participants believed that the use of video-feedback in PAPR training was feasible, acceptable and useful. They described a variety of benefits to learning and retention, from a variety of ways in which they engaged with the personal video-feedback. Participants also described the impact of reviewing personalised practice footage, compared to generic footage of an ideal performance. CONCLUSION: By conceptualising video-feedback using a pedagogical approach, this study contributes to knowledge around optimising methods for training HWs in PPE use, particularly when introducing a new and complex PPE device during an infectious disease outbreak.

'Like building a plane and flying it all in one go': an interview study of infection prevention and control in Australian general practice during the first 2 years of the SARS-CoV-2 pandemic.

OBJECTIVES: General practitioners (GPs) and their staff have been at the frontline of the SARS-CoV-2 pandemic in Australia. However, their experiences of responding to and managing the risks of viral transmission within their facilities are poorly described. The aim of this study was to describe the experiences, and infection prevention and control (IPC) strategies adopted by general practices, including enablers of and challenges to implementation, to contribute to our understanding of the pandemic response in this critical sector. DESIGN: Semistructured interviews were conducted in person, by telephone or online video conferencing software, between November 2020 and August 2021. PARTICIPANTS: Twenty general practice personnel working in New South Wales, Australia, including nine GPs, one general practice registrar, four registered nurses, one nurse practitioner, two practice managers and two receptionists. RESULTS: Participants described implementing wide-ranging repertoires of IPC strategies-including telehealth, screening of patients and staff, altered clinic layouts and portable outdoor shelters, in addition to appropriate use of personal protective equipment (PPE)-to manage the demands of the SARS-CoV-2 pandemic. Strategies were proactive, influenced by the varied contexts of different practices and the needs and preferences of individual GPs as well as responsive to local, state and national requirements, which changed frequently as the pandemic evolved. CONCLUSIONS: Using the 'hierarchy of controls' as a framework for analysis, we found that the different strategies adopted in general practice often functioned in concert with one another. Most strategies, particularly administrative and PPE controls, were subjected to human variability and so were less reliable from a human factors perspective. However, our findings highlight the creativity, resilience and resourcefulness of general practice staff in developing, implementing and adapting their IPC strategies amidst constantly changing pandemic conditions.

"One minute it's an airborne virus, then it's a droplet virus, and then it's like nobody really knows ": Experiences of pandemic PPE amongst Australian healthcare workers.

BACKGROUND: The SARS-CoV-2 pandemic has challenged health systems globally. A key controversy has been how to protect healthcare workers (HCWs) using personal protective equipment (PPE). METHODS: Interviews were performed with 63 HCWs across two states in Australia to explore their experiences of PPE during the SARS-CoV-2 pandemic. Thematic analysis was performed. RESULTS: Four themes were identified with respect to HCWs' experience of pandemic PPE: 1. Risk, fear and uncertainty: HCWs experienced considerable fear and heightened personal and professional risk, reporting anxiety about the adequacy of PPE and the resultant risk to themselves and their families. 2. Evidence and the ambiguities of evolving guidelines: forms of evidence, its interpretation, and the perception of rapidly changing guidelines heightened distress amongst HCWs. 3. Trust and care: Access to PPE signified organisational support and care, and restrictions on PPE use were considered a breach of trust. 4. Non-compliant practice in the context of social upheaval: despite communication of evidence-based guidelines, an environment of mistrust, personal risk, and organisational uncertainty resulted in variable compliance. CONCLUSION: PPE preferences and usage offer a material signifier of the broader, evolving pandemic context, reflecting HCWs' fear, mistrust, sense of inequity and social solidarity (or breakdown). PPE therefore represents the affective (emotional) demands of professional care, as well as a technical challenge of infection prevention and control. If rationing of PPE is necessary, policymakers need to take account of how HCWs will perceive restrictions or conflicting recommendations and build trust through effective communication (including of uncertainty).

Testing the efficacy and acceptability of video-reflexive methods in personal protective equipment training for medical interns: a mixed methods study.

OBJECTIVES: To test the efficacy and acceptability of video-reflexive methods for training medical interns in the use of personal protective equipment (PPE). DESIGN: Mixed methods study. SETTING: A tertiary-care teaching hospital, Sydney, January 2018-February 2019. PARTICIPANTS: 72 of 90 medical interns consented to participate. Of these, 39 completed all three time points. INTERVENTIONS: Participants received a standard infection prevention and control (IPC) education module during their hospital orientation. They were then allocated alternately to a control or video group. At three time points (TPs) over the year, participants were asked to don/doff PPE items based on hospital protocol. At the first two TPs, all participants also participated in a reflexive discussion. At the second and third TPs, all participants were audited on their performance. The only difference between groups was that the video group was videoed while donning/doffing PPE, and they watched this footage as a stimulus for reflexive discussion. PRIMARY AND SECONDARY OUTCOME MEASURES: The efficacy and acceptability of the intervention were assessed using: (1) comparisons of audit performance between and within groups over time, (2) comparisons between groups on survey responses for evaluation of training and self-efficacy and (3) thematic analysis of reflexive discussions. RESULTS: Both groups improved in their PPE competence over time, although there was no consistent pattern of significant differences within and between groups. No significant differences were found between groups on reported acceptability of training, or self-efficacy for PPE use. However, analysis of reflexive discussions shows that the effects of the video-reflexive intervention were tangible and different in important respects from standard training. CONCLUSIONS: Video reflexivity in group-based training can assist new clinicians in engagement with, and better understanding of, IPC in their clinical practice. Our study also highlights the need for ongoing and targeted IPC training during medical undergraduate studies as well as regular workplace refresher training.

Education and training in infection prevention and control: Exploring support for national standards.

BACKGROUND: Effective infection prevention and control (IPC) programmes comprise a hierarchy of preventive measures, one of which is appropriate use of personal protective equipment (PPE). A poor understanding of the role of PPE and sub-optimal use may fail to prevent or even increase pathogen transmission during routine care or an infectious disease outbreak. Variability in delivery and content of IPC and PPE education and training across organisations can lead to confusion, unsafe practice, and lack of confidence among clinicians. In a national survey we explored the perspectives of Australian and New Zealand IPC professionals on the value and feasibility of a national IPC training and monitoring programme to improve and standardise PPE practice and raise the profile of IPC. METHODS: A population-based online survey that examined hospital PPE training programmes was distributed to members of three major Australasian organisations representing IPC professionals. Quantitative results of the survey have been reported previously. This paper is a qualitative analysis of responses to two open-ended questions about a national approach to training in IPC and the use of PPE. RESULTS: Most respondents agreed that standardising IPC and PPE training could achieve more consistent practice nationally, supported through the provision of educational resources. Including competency in the use of PPE in mandatory IPC standards would assist in improving the practice and raising the profile of IPC more generally. CONCLUSION: The results of this study suggest that that there is support for national programmes and standards for use of PPE in Australia and New Zealand.

COVID-19 in Australia: our national response to the first cases of SARS-CoV-2 infection during the early biocontainment phase.

BACKGROUND: On 31 December 2019, the World Health Organization recognised clusters of pneumonia-like cases due to a novel coronavirus disease (COVID-19). COVID-19 became a pandemic 71 days later. AIM: To report the clinical and epidemiological features, laboratory data and outcomes of the first group of 11 returned travellers with COVID-19 in Australia. METHODS: This is a retrospective, multi-centre case series. All patients with confirmed COVID-19 infection were admitted to tertiary referral hospitals in New South Wales, Queensland, Victoria and South Australia. RESULTS: The median age of the patient cohort was 42 years (interquartile range (IQR), 24-53 years) with six men and five women. Eight (72.7%) patients had returned from Wuhan, one from Shenzhen, one from Japan and one from Europe. Possible human-to-human transmission from close family contacts in gatherings overseas occurred in two cases. Symptoms on admission were fever, cough and sore throat (n = 9, 81.8%). Co-morbidities included hypertension (n = 3, 27.3%) and hypercholesterolaemia (n = 2, 18.2%). No patients developed severe acute respiratory distress nor required intensive care unit admission or mechanical ventilation. After a median hospital stay of 14.5 days (IQR, 6.75-21), all patients were discharged. CONCLUSIONS: This is a historical record of the first COVID-19 cases in Australia during the early biocontainment phase of the national response. These findings were invaluable for establishing early inpatient and outpatient COVID-19 models of care and informing the management of COVID-19 over time as the outbreak evolved. Future research should extend this Australian case series to examine global epidemiological variation of this novel infection.

Medical interns' reflections on their training in use of personal protective equipment.

BACKGROUND: The current COVID-19 pandemic has demonstrated that personal protective equipment (PPE) is essential, to prevent the acquisition and transmission of infectious diseases, yet its use is often sub-optimal in the clinical setting. Training and education are important to ensure and sustain the safe and effective use of PPE by medical interns, but current methods are often inadequate in providing the relevant knowledge and skills. The purpose of this study was to explore medical graduates' experiences of the use of PPE and identify opportunities for improvement in education and training programmes, to improve occupational and patient safety. METHODS: This study was undertaken in 2018 in a large tertiary-care teaching hospital in Sydney, Australia, to explore medical interns' self-reported experiences of PPE use, at the beginning of their internship. Reflexive groups were conducted immediately after theoretical and practical PPE training, during hospital orientation. Transcripts of recorded discussions were analysed, using a thematic approach that drew on the COM-B (capability, opportunity, motivation - behaviour) framework for behaviour. RESULTS: 80% of 90 eligible graduates participated. Many interns had not previously received formal training in the specific skills required for optimal PPE use and had developed potentially unsafe habits. Their experiences as medical students in clinical areas contrasted sharply with recommended practice taught at hospital orientation and impacted on their ability to cultivate correct PPE use. CONCLUSIONS: Undergraduate teaching should be consistent with best practice PPE use, and include practical training that embeds correct and safe practices.

Characteristics of personal protective equipment training programs in Australia and New Zealand hospitals: A survey.

BACKGROUND: Using personal protective equipment (PPE) is one of several fundamental measures to prevent the transmission of infection and infectious diseases and is particularly pertinent in the current COVID-19 pandemic. Appropriate use of PPE by healthcare workers is, however, often suboptimal. Training and monitoring of PPE competency are essential components of an infection prevention and control program but there is a paucity of research and data on the content of such training programs across Australasia. This paper reports the results of a survey that characterised the nature of PPE training in Australian and New Zealand hospitals. METHODS: A population-based online survey was distributed to members of three major Australasian colleges representing infection prevention and control. RESULTS: Results indicate that, although training is frequently provided at orientation, many healthcare workers do not receive regular updates. Training programmes combine online and classroom sessions, but over a third do not include a practical component. The frequency of monitoring PPE competency is variable with one third of respondents indicating that no auditing occurs. PPE items used for high-level training are variable, with use of powered air purifying respirators (PAPRs) uncommon. CONCLUSION: The results of this study suggest that HCWs' confidence, competence and familiarity with PPE are a concern, which in the context of the current global COVID-19 pandemic is problematic. More research is needed into how PPE training programs could be better designed, to prepare HCWs for practice using PPE safely and confidently.

Enablers of, and barriers to, optimal glove and mask use for routine care in the emergency department: an ethnographic study of Australian clinicians.

BACKGROUND: The risk of healthcare-acquired infection increases during outbreaks of novel infectious diseases. Emergency department (ED) clinicians are at high risk of exposure to both these and common communicable diseases. Personal protective equipment (PPE) is recommended to protect clinicians from acquiring, or becoming vectors of, infection, yet compliance is typically sub-optimal. Little is known about factors that influence use of PPE-specifically gloves and masks-during routine care in the ED. METHODS: This was an ethnographic study, incorporating documentation review, field observations and interviews. The theoretical domains framework (TDF) was used to aid thematic analysis and identify relevant enablers of and barriers to optimal PPE use. RESULTS: Thirty-one behavioural themes were identified that influenced participants' use of masks and gloves. There were significant differences, namely: more reported enablers of glove use vs more barriers to mask use. Reasons included more positive unit culture towards glove use, and lower perception of risk via facial contamination. CONCLUSION: Emerging infectious diseases, spread (among other routes) by respiratory droplets, have caused global outbreaks. Emergency clinicians should ensure that, as with gloves, the use of masks is incorporated into routine cares where appropriate. Further research which examines items of PPE independently is warranted.

Clinician perceptions of respiratory infection risk; a rationale for research into mask use in routine practice.

Outbreaks of emerging and re-emerging infectious diseases are global threats to society. Planning for, and responses to, such events must include healthcare and other measures based on current evidence. An important area of infection prevention and control (IPC) is the optimal use of personal protective equipment (PPE) by healthcare workers (HCWs), including masks for protection against respiratory pathogens. Appropriate mask use during routine care is a forerunner to best practice in the event of an outbreak. However, little is known about the influences on decisions and behaviours of HCWs with respect to protective mask use when providing routine care. In this paper we argue that there is a need for more research to provide a better understanding of the decision-making and risk-taking behaviours of HCWs in respect of their use of masks for infectious disease prevention. Our argument is based on the ongoing threat of emerging infectious diseases; a need to strengthen workforce capability, capacity and education; the financial costs of healthcare and outbreaks; and the importance of social responsibility and supportive legislation in planning for global security. Future research should examine HCWs' practices and constructs of risk to provide new information to inform policy and pandemic planning.

How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative Examples.

Since 2008, the Critical Path Initiative has supported FDA's program of intramural research projects in regulatory science, with the goal of improving translation of advances in emerging sciences to the development of safe and effective medical products. Since 2011, the research of FDA's Center for Drug Evaluation and Research (CDER), including the work supported by the Critical Path Initiative, has been guided by the regulatory science needs identified in the CDER science and research needs report. In this review, the authors highlight a few of CDER'S Critical Path Initiative research projects, each addressing a different regulatory science need, to illustrate the diversity of regulatory science at CDER. They also describe elements common to these research projects, including broad collaboration with external partners, an increasing dependence on large data sets and computational models, and requirements for resources or perspectives specific to FDA.