Can Pharma Quality Go High Tech?

"There were questions of how to handle tech transfer, factory and site acceptance tests, and regulatory inspections when the world was no longer travelling," he says. Since July, Stracquantanio says, usage of the platform has expanded by a factor of 17, and new site deployments by a factor of ten. The company is now using the remote approach with all major global regulatory agencies. Since Catalent hosts or performs more than 500 audits each year, new technology has allowed Catalent to keep pace, while observing social distancing requirements, Montano adds. Live facility tours are filmed with a 360-degree camera, and 3-D tours with a 3-D mapping camera, says Sandy Immerman, vice president of Information Technology (IT), Pharma Services. [...]this year, Immerman says, Thermo Fisher has hosted multiple regulatory inspections and more than 125 client audits, focusing efforts on current good manufacturing practice (CGMP) activities in work that has involved FDA, the European Medicines Agency, which issued formal guidance on the use of this technology last May (3), the Russian Ministry of Health (MoH), and the Swedish Medical Products Agency.

IMPROVING PATIENT SAFETY THROUGH THE ESTABLISHMENT OF A PHARMACIST-LED BLOOD MONITORING CLINIC FOR JAK INHIBITORS IN RHEUMATOLOGY

BackgroundJanus kinase inhibitors drugs (JAKi) are novel small molecule medications known to cause abnormalities such as elevations in hepatic transaminases, decreases in neutrophil and lymphocyte counts and elevations in cholesterol and creatinine kinase. Blood monitoring is recommended and dose adjustments are advised if abnormalities arise. Recent warnings by the EMA and MHRA have highlighted the importance of monitoring these medications.Timely review and management of patients on JAKi drugs is difficult to maintain with increasing workload amongst the rheumatology team. A baseline audit (2020) demonstrated that hospital blood monitoring guidelines for JAKi drugs were not being followed. The rheumatology multidisciplinary team met and utilised Quality Improvement methodology including fish and driver diagrams to address this. This led to the creation of a pharmacist-led JAKi blood monitoring clinic.ObjectivesTo establish a pharmacist-led rheumatology blood monitoring clinic for the JAKi drug class in order to: increase patient safety with increased compliance to blood monitoring, save consultant/nurse time, improve communication with primary care on the frequency of blood testing required, increase patient understanding of the importance of blood monitoring with JAKi drugs, reinforce counselling advice such as risk of infections, shingles and thrombosis and promote medication adherence.MethodsThe clinic was established in March 2021. Patients commencing JAKi drugs are referred to the pharmacist-led clinic by the medical team. The pharmacist contacts the patient by phone following delivery of their medication. The patient is counselled on their new medication and dates for blood checks are agreed. A letter is sent to the patient and their GP providing this information. The patient is booked into virtual telephone appointments and bloods are monitored every month for the first 3 months and every 3 months thereafter. Any change or abnormality in blood results are flagged early in the patient's treatment and if necessary, discussed with the consultant. Adjustments are made to the patient's dose if appropriate.ResultsIn order to evaluate the benefit of the pharmacist clinic a re-audit of compliance with blood monitoring (March 2021- September 2022) was carried out alongside a patient satisfaction postal survey (August 2022).A total of 58 patients were sampled in the re-audit. The re-audit found an increase in compliance in blood monitoring since the introduction of the pharmacist clinic. 98% of patients had their full blood count performed at 3 months compared to 56% in audit 1 and 95% of patients had their lipid profile completed at 3 months compared to 15% in audit 1 (Table 1).A patient satisfaction survey (N=62, response rate 48%) found that 28 (93%) patients either agreed or strongly agreed that they were more aware of the importance of attending for regular blood monitoring when prescribed JAKi therapy as a result of the clinic.The pharmacy team made several significant interventions (self-graded Eadon grade 4 and 5). For example by improving medication adherence, detecting haematological abnormalities that required JAKi dose reduction, identifying patients suffering from infection requiring intervention including shingles and Covid-19.Table 1.Comparison of audit results pre (Audit 1) and post (Audit 2) clinic establishmentAudit 1 (N=48)Audit 2 (N=58)Number of patients with full blood count completed at weeks 4, 8 & 1227 (56%)57 (98%)Number of patients with lipid profile completed at week 127 (15%)55 (95%)Number of patients LFTs completed at weeks 4, 8 & 1226 (54%)54 (93%)ConclusionIntroduction of the pharmacist-led clinic has increased patient safety by ensuring compliance with blood monitoring as per hospital guidelines. The clinic has paved the way for improved communication with primary care teams and has provided patients with extra support during their first months on treatment with their JAKi. It has also expanded the role of the rheumatology pharmacy team and saved nursing and medical time.Acknowled ementsI wish to thank the SHSCT Rheumatology team for all their help, support and guidance with this project.Disclosure of InterestsNone Declared.

Geographic Information Systems for Facilitating Audits of the Urban Built Environment

Data collection and large-scale urban audits are challenging and can be time consuming processes. Geographic information systems can extract and combine relevant data that can be used as input to calculation tools that provide results and quantify indicators with sufficient spatial analysis to facilitate the local decision-making process for building renovations and sustainability assessment. This work presents an open-access tool that offers an automated process that can be used to audit an urban area in order to extract relevant information about the characteristics of the built environment, analyze the building characteristics to evaluate energy performance, assess the potential for the installation of photovoltaics on available building rooftops, and quantify ground permeability. A case study is also presented to demonstrate data collection and processing for an urban city block, and the relevant results are elaborated upon. The method is easily replicable and is based on open data and non-commercial tools.

The impact of risk-taking and auditor characteristics on value creation in pre-Covid 19 and post-Covid 19 pandemic: MRN

PurposeThis study aims to investigate the impact of risk-taking and auditor characteristics on value creation in companies listed on the Tehran Stock Exchange. In addition, it investigates the moderator role of auditor characteristics in the impact of risk-taking on value creation, especially in pre-Covid 19 and post-Covid 19 pandemic.Design/methodology/approachThe information about 199 company in 2014–2021 was examined. In the present study, in accordance with the related theoretical literature and the importance of auditor specialization, auditor tenure and auditor reputation, these factors were considered as the auditor characteristics.FindingsThe present findings based on the generalized least squares (GLS) method showed that risk-taking positively affects the value creation. The auditor characteristics (auditor specialization, auditor tenure and auditor reputation) have a significant positive effect on the value creation. Furthermore, the auditor characteristics enhance the impact of risk-taking on value creation. The results of generalized method of moments method and robust regression analysis are consistent with the GLS results. To take into account the Covid-19 conditions, the data were divided into pre-Covid-19 and post-Covid-19 years. The results showed that auditor characteristics moderate the impact of risk-taking on value creation in pre-Covid 19 and post-Covid 19.Originality/valueThe study highlights the role of auditor characteristics in the value creation, especially in the emerging market. Given that Covid-19 has seriously damaged global economic well-being and has put companies at a double risk, the present findings can be useful for managers, investors and the international community, and help company managers make risk-taking policies and select auditors with appropriate characteristics.

Performing Remote Audits During a Pandemic

For medical devices, FDA has published a "Remote Auditing Pilot Program" document outlining a voluntary pilot programme for remote auditing of processes, the Medical Device Single Audit Program (MDSAP) as part of the audit of a medical device organization (2). An important aspect of this pilot is the use of technology that facilitates remote audits, including: * Videoconferencing * Web-based meeting systems with screen sharing capability * Teleconferencing in conjunction with e-mail * Smart glasses or optical mounted head displays * Secure fileshare repositories * Remote 'read only' access to automated systems, such as electronic quality management systems (e.g., to view standard operating procedures [SOPs], deviations, electronic batch records, video recordings from the operational area, etc.). The meeting, which was moderated by Janet Woodcock, the US Food and Drug Administration's (FDA')s director of the Center for Drug Evaluation and Research, was conducted to align global regulations and approaches to clinical trial management, drug supply issues, and pharmacovigilance during the pandemic (1).

Lifestyle audits in South Africa – overrated or X-factor?

PurposePresident Cyril Ramaphosa, in his 2018 State of the Nation Address, stated that "Thieves who are stealing public funds should be arrested and prosecuted”, and called for lifestyle audits of public-sector employees. The gross misuse of COVID-19 relief funds by public officials indicated the urgent need to execute these audits as an anti-corruption measure. This paper aims to provide a review of the existing state of affairs with regard to the application of lifestyle audits in South Africa.Design/methodology/approachThis paper critically analyses the literature available on the current position of South Africa concerning lifestyle audits in the public sector, based on the mandates of some of the anti-corruption agencies that could be responsible for the conducting and processing of such audits.FindingsSouth Africa has only recently seen a framework for applying lifestyle audits, developed by the Department of Public Service and Administration. Although these first steps in developing a standard practice are laudable, the practical process of dealing with misconduct and/or criminal matters remains to be seen. It is recommended that South Africa consider a legislative approach to dealing with unlawfully obtained wealth by either criminalising the act of illicit enrichment (per the United Nations Convention Against Corruption) or creating an Unexplained Wealth Order, as seen, for example, in the UK.Originality/valueSouth Africa is in dire need of addressing corruption in the public sector. Despite lifestyle audits being called for, the lack of proper implementation is negating any positive outcomes. Therefore, alternative solutions should be investigated.

Analysis Of the Effectiveness of Risk- Based Internal Audit Implementation: A Case Study: Acces la Success

Background: Risk Based internal audit is a control and supervision activity carried out by internal auditors using the output of risk management. Purpose: The purpose of this study was to obtain a comprehensive understanding of the implementation of risk based internal audit at BPJS Ketenagakerjaan. Internal auditors need to know about risk management and risk maturity to identify key areas that require immediate supervision and follow-up. Method: This research is a case study qualitative research with a descriptive approach. Data was collected by means of interviews, observation and documentation. The analysis technique using triangulation is to collect data, reduce and draw conclusions. Results and findings: Researchers found that Social Security Agency while in Indonesian term is Badan Penyelenggara Jaminan Sosial (BPJS) Ketenagakerjaan as an institution that is mandated to manage labor social security membership fees and implement good governance and manage business risks. The risk management output is then used as the basis for conducting an internal audit. Discussion: BPJS Ketenagakerjaan carries out risk management to identify risks, identify areas that have potential risks and carry out risk profiling. This makes it easier for internal auditors to carry out the internal audit process. Impact: The results of risk management make it easier for auditors to identify risks and identify specific areas so that internal audits can run effectively and efficiently.

Financial Aspects of Maintaining Business Activities in the Face of Unexpected Changes

In the context of the war, the external environment is characterized by a growing level of uncertainty. Rising energy prices, the closure of airspace in Ukraine, rising inflation, a 30% decline in GDP in 2022, and the destruction of infrastructure as well as supply chains have necessitated adjustments to the company's operations and changes to its financial plan. The research aims to assess the financial aspects of doing business in the face of unexpected changes. The research methodology is based on the case study of a company that supplies energy resources to Ukraine. The main research methods used are in-depth interviews with the staff to assess the existing strategy, employee motivation system, efficiency of the organizational structure, and financial aspects of the company's activities. The results demonstrate that an important stage in the development of a financial plan in wartime is the audit of business activities. It includes an understanding of the current state of the organizational, financial, and human aspects of the company's functioning. An in-depth interview with the company's personnel shows the level of effectiveness of the interaction of all these aspects of the business. Changes in the financial system involve organizational changes: company structure, motivation system, customer interaction, and service improvement. The study shows that the interaction of organizational, financial, and motivational components contributed to the synergy of the company's resources and their mobilization in the face of the growing risks of a company's crisis. Financial planning by business segments and precision in the distribution of employees' responsibilities increases the level of motivation and involvement of staff in all business processes. Moreover, the distribution of centers and areas of responsibility should be linked to the incentives and motives of employees.

Strive to prescribe and do no harm

AimsPrescribing medication is a common intervention and hence prescribing errors are not uncommon events. From the literature 13% of paediatric prescriptions contain errors1 and recently it was estimated that 66 million of the 237 million prescription errors had potentially clinically significant outcomes.2 This has been highlighted following a recent critical incident and, as part of the learning recommendations;a multidisciplinary team (MDT) approach was formed to improve departmental prescribing education. The aim was to reduce the number of prescribing errors, therefore reducing harm to patients, and improving patient care. This was achieved through the joint efforts of trainees and ward pharmacist by developing robust evidence-based teaching not only at induction but as rolling sessions throughout the year which, due to COVID-19 restrictions, was delivered virtually. In conjunction there was also a revision of the induction paediatric prescribing test, regular review of the number of prescribing error incidents and drug chart audits with cycle completion and implementation of changes. The teaching programme and audits were started in December 2020 and are on-going.MethodsFrom December 2020 to May 2021, audits were undertaken initially using the RCPCH Paediatric Prescribing Error tool.3 We later revised the audit tool to also include the standards defined in our hospital inpatient prescribing policy. 30 random drug charts from across three paediatric inpatient wards were analysed every month with the aim to achieve greater than 90% in each standard (taking into account a baseline level of human error) and then to maintain this over time. To achieve this, learning from the audit was fed back to all members of the team via regular electronic and visual/verbal reminders and the teaching programme was amended to include troublesome topics. Adverse incidents were reviewed and teaching from this was also included in the teaching programme.ResultsSince December 2020, it took six months for the number of incidents due to prescribing errors to reduce from 14 in six months (December 2020-May 2021) to 10 in six months (June-November 2021). Audit results showed that since December 2020 we were scoring >90% in 3 out of the 10 domains. Three months into the teaching programme this improved to 4 out of 10 of the domains and at six months, 6 out of 10 domains. When re-audited with our revised audit tool, we achieved >90% initially in 10 out of 16 domains and then consistently maintained our standards across 11–12 out of 16 domains over a four-month period (October 2021-January 2022).ConclusionsThis project has shown that despite a global pandemic, a combination of innovation, education, technology, multidisciplinary skills and MDT working can implement and embed change to improve patient safety. When considering the bigger picture, we recognise this is a small part of the larger systemic processes that can influence medication errors and that with perseverance, we can aim to reduce the risk of adverse events due to medication errors and therefore provide the best care for our patients.ReferencesGhaleb MA, Barber N, Franklin BD, et al. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child 2010;95;113–118.Elliot RA, Camacho E, Jankovic D, et al. Economic analysis of the prevalence and clinical and economic burden of medication error in England. BMJ Quality & Safety 2021;30:96–105.RCPCH Paediatric Prescribing Error Audit Tool. https://qicentral.rcpch.ac.uk/medsiq/safe-prescribing/paediatric-prescribing-error-an-audit-tool/

Precision medicines in practice: the connection between CFTR modulators and deranged liver enzymes

Background and AimFor most of the 83 years since acknowledging cystic fibrosis (CF) as a separate disease entity, treatment has primarily focused on symptomatic relief.1 Following the discovery of the CFTR gene, efforts have been made to produce therapies to target the underlying dysfunctions caused by CFTR mutations.2 Moderate transaminase elevations are commonly observed in CF patients. Severe transaminase elevations have been observed in patients taking CFTR modulators in clinical trials with the initial STRIVE trial revealing that treatment discontinuation was commonly due to an increase in hepatic enzymes.3 Consequently, liver function test (LFTs) monitoring is recommended for all patients before commencing therapy, every three months for the first year and annually thereafter. This audit aims to assess the compliance of LFT monitoring in clinical practice for paediatric patients initiated on CFTR modulators, evaluate the incidence of liver-related adverse effects, and examine trends between the CFTR modulator used and the clinical significance of LFT derangements, and determine if there are any sex-related correlations.MethodsPatient data, including date and age on treatment initiation, gender, LFT results at baseline (AST, ALT, ALP, GGT and total bilirubin), first derangement since initiation and monitoring frequency were extracted from the clinical system Meditech®, pseudonymised and analysed. There were 91 records of patients being treated with a CFTR modulator. Some patients were on more than one CFTR modulator as treatment can be switched if eligible. For the purpose of the audit after consultation with the local CF clinical team, a two-month deviation outside of the recommended monitoring frequency was considered non-compliant. LFT derangements were classified as clinically significant if the result was higher than 3 times the upper limit of normal (ULN).ResultsOur study found that most patients (50/91 – 54.9%) on CFTR modulators in the tertiary centre did not have their LFTs monitored following the recommended guidelines. A statistically significant increase in LFT abnormalities from pre- to post- intervention with a CFTR modulator was observed (p=0.015). Kaftrio®/Kalydeco® (3/20 – 15%) and Orkambi® (1/29 – 3.4%) were the only CFTR modulators that led to patients developing clinically significant derangements (>3x ULN). Additionally, a greater proportion of females (24/51 – 47.1%) than males (15/40 – 37.5%) had abnormal LFTs within the tertiary centre contrary to previous epidemiological studies where males have been documented to have a greater risk of abnormal LFTs. However, the strength of this association was negligible (φ =0.096, p=0.360).ConclusionIn conclusion, the tertiary centre's compliance with LFT monitoring guidelines for patients initiated on CFTR modulators was substandard. Most records of treatment initiation occurred during COVID-19, which impacted monitoring as many hospitals suspended routine clinical work to limit the spread of the infection in high-risk groups. Time constraints limited the audit during the data extraction period;therefore, results should be interpreted cautiously. In the absence of the COVID-19 pandemic a re-audit process should include patient lifestyle data and consider other medication regimens that could potentially alter LFTs. Introducing a blood clerk would enable the CF unit to monitor LFT changes more efficiently.ReferencesGuimbellot J, Taylor-Cousar JL. Combination CFTR modulator therapy in children and adults with cystic fibrosis. The Lancet Respiratory Medicine 2021;9:677–679.Lopes-Pacheco M. CFTR Modulators: The Changing Face of Cystic Fibrosis in the Era of Precision Medicine. Frontiers of Pharmacology 2020;10:1662.Gavioli EM, Guardado N, Haniff F, et al. A current review of the safety of cystic fibrosis transmembrane conductance regulator modulators. Journal of Clinical Pharmacy and Therapeutics 2021;46:286–294.

Análisis de los criterios de revelación financiera por efectos de la pandemia por COVID-19 de empresas cotizadas chilenas y peruanas

Esta pesquisa qualitativa permitiu analisar e descrever a natureza das revelações em notas aos estados financeiros anuais de 2019 e intermédios de 2020, em firmas chilenas e peruanas listadas no contexto de pandemia por COVID-19, sob o marco da teria institucional. Os resultados do estudo confirmam que o nível de revelação sobre o impacto da COVID-19 não cumpre com todos os critérios da normativa e recomendações apesar da influência institucional de entes reguladores e firmas de auditoria. Mesmo que algumas empresas revelam informação sobre efeitos financeiros, um grande grupo não tem sido capaz de quantificá-los e tem acabado afetando o cumprimento do objetivo da informação financeira segundo NIIF de utilidade para a toma de decisões. Isto tem levado a encontrar uma influência institucional mimética ou normativa do efetivo cumprimento das NIIF ou recomendações de firmas de auditoria.Alternate abstract:Cette recherche qualitative nous a permis d∂analyser et de décrire la nature des divulgations dans les annotations des états financiers annuels 2019 et intermédiaires 2020 des sociétés cotées chiliennes et péruviennes, dans le contexte de la pandémie de COVID-19, encadrées dans la théorie institutionnelle. Les résultats de l∂étude confirment que le niveau de divulgation de l∂impact de COVID-19 ne répond pas à tous les critères des réglementations et recommandations, malgré l∂influence institutionnelle des régulateurs et des cabinets d∂audit. Si certaines entreprises publient des informations sur les effets financiers, un grand nombre d∂entre elles n∂ont pas été en mesure de les quantifier et ont fini par nuire à la concrétisation de l∂objectif d∂une information financière IFRS utile à la prise de décision. Cela a conduit à trouver une influence institutionnelle ou réglementaire mimétique de la conformité effective aux IFRS ou aux recommandations des cabinets d∂audit.Alternate abstract:Esta investigación cualitativa permitió analizar y describir la naturaleza de las revelaciones en notas a los estados financieros anuales del 2019 e intermedios del 2020, en empresas chilenas y peruanas cotizadas en el contexto de pandemia por COVID-19, bajo el marco de la teoría institucional. Los resultados del estudio confirman que el nivel de revelación sobre el impacto de la COVID-19 no cumple con todos los criterios de la normativa y recomendaciones a pesar de la influencia institucional de entes reguladores y firmas de auditoría. Si bien, algunas empresas revelan información sobre efectos financieros, un gran grupo no ha sido capaz de cuantificarlos y ha terminado afectando el cumplimiento del objetivo de la información financiera según NIIF de utilidad para la toma de decisiones. Esto ha llevado a encontrar una influencia institucional mimética o normativa de efectivo cumplimiento de las NIIF o recomendaciones de firmas de auditoría.Alternate abstract:Under the framework of institutional theory, this qualitative research analyzes and describes the disclosure nature in the notes to the 2019 annual and 2020 interim financial statements of Chilean and Peruvian listed companies in the context of the COVID-19 pandemic. Despite the institutional influence of regulators and audit firms, the findings confirm that the level of disclosure on the impact of COVID-19 does not meet all the regulation and recommendation criteria. Although some companies disclose information on financial effects, a large number of them have been unable to quantify them, affecting compliance with the objective of IFRS financial information, useful for decision making. This has allowed to identify a mimetic or normative institutional influence of effective compliance with IFRS or audit firms' recommendations.

Fraud concerns and support for economic relief programs

Using a probability-based sample of the Norwegian population, we test whether an informational treatment about fewer audits by the Norwegian Tax Administration during the peak of the COVID-19 crisis affects support for an economic relief program designed to save jobs and prevent bankruptcies. The information treatment significantly reduces support for the economic relief program. The underlying mechanisms are lower trust in the tax administration's handling of the program and more pessimism about its ability to detect fraud. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

SG-APSIC1062: The role of active surveillance in the primary-care setting during a pandemic in Singapore

Objectives: In response to the COVID-19 pandemic, primary care swiftly transformed and re-established patient flow in clinics to red, orange, and green zones based on a set of screening criteria. To further manage the influx of suspected COVID-19 patients and their needs safely, a list of surveillance audit criteria was developed to ensure good infection control standards. Methods: The infection control team prepared the surveillance audit criteria based on recommended CDC/WHO guidelines for pandemic preparedness. These criteria were contextualized to the primary-care polyclinic setting. The surveillance audit criteria were grouped according to their category: screening, triage, early recognition and source control, inventory management of personal protective equipment (PPE), infection control measures in the red zone, precautionary measures during collection of nasopharyngeal swabs and environmental cleaning and disinfection for premises in the red, orange, and green zones, respectively. The infection control liaison nurses in each polyclinic were trained to use the checklist to ensure consistency in interpretation of the criteria. Results: Surveillance audits were conducted biweekly in the first 3 months then monthly once the compliance rate was steady at 90%–100% for all categories. The overall average compliance rate since commencing in March 2020 for all polyclinics was sustained at 90%–100%. Common findings included inappropriate use of PPE (eg, self-contamination during removal of gown or wrong sequence of doffing), inadequate ventilation, and inadequate cleaning processes. All findings were corrected immediately, and staff education was provided. Conclusions: Primary care plays an important role during a pandemic. It is essential that both patients and healthcare workers in the primary care setting are protected from infection risk during a pandemic. Having a good surveillance audit process helps ensure that primary care services can continue for the general population. Surveillance is an essential component of the health system's response to a pandemic.

Artificial Intelligence Applications in Quality Management Systems of Philippine Higher Education Institutions

To ensure quality assurance, Higher Education Institutions (HEIs) implement a Quality Management System (QMS) anchored on international benchmarks like ISO 9001:2015 Standards. With the COVID-19 pandemic, quality audits have become more challenging. Also, to address the lapses due to human error and lack of technical knowledge in clause identification during audit processes, an artificial intelligence (AI)-enabled QMS is presented. This study successfully demonstrated how AI-enabled QMS can match audit findings in accreditation compliance reports and internal quality audit reports with the clauses of ISO 9001:2015. Audit findings corpus data gathered are within the span of the last five years, which serve as the dataset to be employed. After data pre-processing, a long short-term memory (LSTM) deep neural network was created and trained using MATLAB. The AI model achieved a combined classification accuracy (CA) of 82.15% and predicted 70% of the examined audit findings in actual implementation. Further analyses illustrate how AI can be maximized in generating useful and precise and useful audit reports for HEIs to develop and implement globally competitive educational policies, programs, and standards. © 2023, The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.

Transferring the care of patients who are approaching the end of their lives – a re-audit of hospital discharge summaries

IntroductionDischarge summaries are fundamental in transferring care from hospital to community. However, our GP colleagues tell us these vital letters require improvement.1 Since 2014, junior doctors from Royal Derby Hospital have examined the quality of discharge summaries written about patients who are reaching their last weeks of life. These patients are eligible for immediate access to NHS continuing healthcare funding, the Fast Track pathway, to facilitate discharge.2 This audit has led to a sticker which is added to the notes when Fast Track is invoked, as a reminder of the important aspects of discharge summaries for these patients. It has also led us to deliver education to foundation doctors about discharging patients at the end of their lives. Here, we present a re-audit evaluating the impact of these interventions.MethodThe content of 181 discharge summaries written about patients receiving Fast Track funding produced at Royal Derby Hospital between 31/05/21 and 03/09/21 were reviewed against set criteria. Findings were compared to previous audits to identify trends and areas for improvement.ResultsThis re-audit had positive and negative findings. We found an increase in documented instructions to GP (62% from 46%), and in anticipatory medications prescribed on discharge (94% from 80%). However, we also found ongoing poor documentation of preferred place of care/death (36% from 38%) and fewer discharge summaries detailing a clear follow-up plan (47% from 61%). This may account for the increase in readmissions in this patient group (9% from 16%).ConclusionThe quality of discharge summaries written about patients who are approaching the end of their life remains variable. Disruptions to service provision and education due to COVID have led to a lack of guidance provided for writing discharge summaries. We recommend reinstating early teaching for junior doctors on this important topic. Re-audit following this is advised.ReferencesKripalani S, LeFevre F, Phillips C, Williams M, Basaviah P, Baker D. Deficits in Communication and Information Transfer Between Hospital-Based and Primary Care Physicians. JAMA [Internet]. 2007 [cited 14 September 2022];297(8):831. Available from: https://jamanetwork.com/journals/jama/article-/205790Fast-track pathway tool for NHS continuing healthcare guidance [Internet]. GOV.UK. 2022 [cited 14 September 2022]. Available from: https://www.gov.uk/government/publications/nhs-continuing-healthcare-fast-track-pathway-tool/fast-track-pathway-tool-for-nhs-continuing-healthcare-guidance#what-the-fast-track-pathway-tool-is

Impact of remote audit on audit quality, audit efficiency, and auditors' job satisfaction

The audit profession has experienced a digital transformation over the last decade with a rapid shift towards remote auditing forced by the recent COVID pandemic. This shift has led to changes related to the way auditors work and perceive. Through a survey of external auditors, this study addresses how the changes from on-site audits to remote audits affect audit success (i.e., audit quality, audit efficiency, and auditors' job satisfaction);we also explore dispositional and situational factors that contribute to remote audit success. Our results show that working remotely leads to high audit efficiency. Auditors' flexibility management competency leads to high remote audit quality and efficiency;and a physical working environment conducive for concentrating on audit tasks is positively associated with audit efficiency and auditors' job satisfaction for remote audits. We also found that working remotely could enhance audit quality and efficiency when the audit firm provides sufficient support to auditors. Our study provides insights for audit firms, regulators, and other stakeholders as they evaluate the many challenges the audit profession faces in achieving remote audit success. © 2023 John Wiley & Sons Ltd.

Auditors' response to regulators during COVID-19: disclosures of key audit matters

PurposeNew Zealand regulatory bodies guided preparers and auditors of financial statements to deal with potential COVID-19 impacts on the financial statements and audit procedures. This study provides evidence of auditors' response to the impact of COVID-19 on the reporting of key audit matters (KAMs) in audit reports of listed companies in New Zealand. The purpose of this paper is to address this issue.Design/methodology/approachA sample of 50 New Zealand listed companies was selected to compare the KAMs in 2019 (pre-COVID-19) and 2020 (during COVID-19). The study uses content analysis to evaluate the KAMs' disclosures and descriptive analysis to examine the differences between 2019 and 2020 in terms of the auditor type, industry sector and accounting standards.FindingsAuditors responded positively to the request from regulators to communicate the impacts of COVID-19. The findings show an increase in the amount and length of KAMs in 2020 compared to 2019, with 82% of companies and 61% of KAMs reporting the impact of COVID-19. The real estate and information technology sectors disclosed more on the impact than other sectors. In analysing the KAMs, accounting standards for inventories, property plant and equipment, impairment of assets, investment property, revenue from contracts with customers and leases were highly affected by COVID-19.Practical implicationsThe findings support regulators to evaluate how well auditors communicated matters relating to COVID-19 in the audit report. Also, the findings will help standard setters to identify key accounting standards affected by COVID-19 of KAMs and provide insights to users on how the KAM reporting enhances communicative value during the pandemic.Originality/valueThe current study captures the impact of COVID-19 on the reporting of KAMs by comparing changes before and during the pandemic.

Post-Pandemic Follow-Up Audit of Security Checkpoints

This paper provides a follow-up audit of security checkpoints (or simply checkpoints) for mass transportation hubs such as airports and seaports aiming at the post-pandemic R&D adjustments. The goal of our study is to determine biometric-enabled resources of checkpoints for a counter-epidemic response. To achieve the follow-up audit goals, we embedded the checkpoint into the Emergency Management Cycle (EMC) –the core of any doctrine that challenges disaster. This embedding helps to identify the technology-societal gaps between contemporary and post-pandemic checkpoints. Our study advocates a conceptual exploration of the problem using EMC profiling and formulates new tasks for checkpoints based on the COVID-19 pandemic lessons learned. In order to increase practical value, we chose a case study of face biometrics for an experimental post-pandemic follow-up audit. Author

Evidence on Internal Audit Quality from Transitioning to Remote Audits because of COVID-19

As in-person audits were banned by governments and by company policies due to the COVID-19 pandemic, internal auditors had to transition to remote audits to perform their work. Based on survey responses of internal auditors who have conducted both remote and in-person audits, we find that internal auditors perceive no difference in the efficiency and effectiveness of and stakeholders' reliance on results from remote and in-person audits when considering all responses. However, we also find that perceived efficiency and effectiveness increase the more experience internal auditors have with remote audits. Supplemental analyses show that support from the auditee, but not management or the audit committee, is a central determinant of perceived remote audit success. It is important for internal auditors to consider this later finding in the design of remote audits as it indicates the importance of building support with the auditee to have a successful remote auditing experience.