Following Guidelines During a Crisis

The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).

Trends in infection-related patient safety incident reporting before and during the COVID-19 pandemic in Korea.

Purpose: The purpose of this study was to analyze the trends and characteristics of infection-related patient safety incident reporting before and during the coronavirus disease 2019 (COVID-19) pandemic in Korea, and to provide basic data for preventing infection-related patient safety incidents and improving their management. Methods: A cross-sectional analysis of secondary national data (Patient Safety Reporting Data) was conducted. In total, 517 infection-related patient safety incidents reported from 2018 to 2021 were analyzed. Changes in the number of reports before and during the COVID-19 pandemic and differences in variables related to infection-related patient safety incidents were analyzed using the chi-square test and independent t-test in SPSS 29.0. Results: This study found that infection-related patient safety incidents decreased during the COVID-19 pandemic compared to before the pandemic. Furthermore, incident-related characteristics, such as the type of healthcare organization, severity of harm, and post-incident actions, changed during the COVID-19 pandemic. Conclusion: The many changes in the infection control system and practices during the COVID-19 pandemic may have contributed to a decrease in the reporting of infection-related patient safety incidents. It is hoped that longitudinal studies on patient safety incidents related to the pandemic and analytical studies on factors influencing patient safety incidents will continue to be conducted to prevent and improve patient safety incidents. [ FROM AUTHOR] Copyright of Journal of Korean Biological Nursing Science is the property of Korean Society of Biological Nursing Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

A Qualitative Analysis of Physician, Staff, and Patient Perspectives During the Discharge Process for Vascular Patients

Objectives: Evidence demonstrates that when hospitals focus on the discharge process patient safety improves and overall costs decline. Hospital discharge requires care coordination of multiple disciplines, often leading to fragmented care, and adverse outcomes after discharge include emergency department visits and hospital readmissions. The Re-Engineered Discharge (RED) process was developed as an evidence-based strategy to improve the hospital discharge. We evaluated perspectives and priorities of physicians, health care workers, and patients involved in the vascular discharge process using RED as a framework. Method(s): A single-center qualitative analysis using a semi-structured focus groups and an interview guide based on the RED process. Focus groups were Zoom platform recorded, transcribed into text files, independently coded, and analyzed with Dedoose qualitative software using a directed content analysis approach. Thematic concepts were created, and comparisons between groups were analyzed by coding frequency. Researchers independently thematically coded each transcript;prior to analysis, all redundancy of codes was resolved;and all team members agreed on text categorization and coding frequency. Result(s): Eight focus groups with 38 participants were performed. Participants included: physicians (n = 13), nursing and ancillary staff (n = 19), and patients/caregivers (n = 6). Transcript analyses revealed facilitators and barriers to discharge. Overarching themes identified from the qualitative analysis frequencies are displayed by stakeholder role (Fig 1). Themes identified with the greatest coding frequencies included helpfulness of discharge instructions, patient health literacy, patient medical complexity, poor interdisciplinary team communication, time constraints during discharge, technology literacy of patients, barriers to obtaining medications for patients, barriers to organizing outpatient services for health care workers, barriers for patients to obtain help after discharge, and the impact of COVID-19. Conclusion(s): These findings identify the need to strengthen efforts to overcome stakeholder barriers to improve patient safety at the interface of the hospital to create a well-organized discharge. Physicians were most concerned with low patient health literacy, patient understanding of discharge instructions, organizing outpatient services, and overall patient medical complexity hindering a smooth discharge. Health care staff identified time constraints, obtaining medications and, and inter-team communication as their greatest obstacles to an organized discharge. Patients found the complexity and amount of discharge instructions, the impact of COVID-19 on support systems, and technology utilization after discharge most challenging. Modifications to address individual stakeholder barriers within the discharge process are needed to develop a national standardized discharge specific for vascular surgery patients to improve patient safety and satisfaction. [Formula presented]Copyright © 2023

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

[...]many sponsors have implemented alternative ways to conduct trials or components of them, incorporating remote and virtual activities, which aim to bring studies directly to patients via a range of technologies. Every clinical investigation begins with the development of a protocol that describes h.ow a clinical trial will be conducted-encompassing the objective(s), design, methodology, statistical considerations, and organization of the study-and ensures the safety of the trial subjects and integrity of the data collected. [...]of the pandemic, we will see more hybrid trials that combine site and remote patient visits. In forcing the research community to be more open to using different tools to ensure vital research continues, the pandemic is driving the beginning of a new era of patient and site engagement-one in which a more proactive and efficient approach ensures the lines of communication remain open and data is collected appropriately and with greater speed.

Overcoming Vaccine Development Challenges

According to recent market research, the vaccines market is expected to grow at a compound annual rate of 14.7% for the forecast period of 2020-2026 (1), the growth of which has been accelerated by the recent COVID-19 pandemic. Durability of glass vials at very low temperatures and permeability of plastic vials has complicated the packaging decisions as well." Since the beginning of the pandemic, the bio/pharma industry has been under pressure to produce stable formulations for effective vaccines in accelerated timescales, Blouet asserts. [...]the drive for a COVID-19 vaccine has occurred during a period of increased basic scientific understanding, such as in genomics and structural biology, supporting a new wave of vaccine development and production, she says. According to Phadnis, in addition to single-use technologies, automation for high throughput and robust analytical assays are necessary for rapid turnover during development and manufacturing of vaccines.

Can We Teach an Old Drug New Tricks?

The French study that piqued interest in using hydroxychloroquine to treat COVID-19, by way of example, was not designed to the expected industry standard and, so despite being published (2), is now undergoing an additional independent peer review (3). Furthermore, studies demonstrating a contrary opinion-that chloroquine and hydroxychloroquine do not have a suitable risk-to-benefit ratio in terms of COVID-19 treatment-also have limitations. Bill & Melinda Gates Foundation, "COVID-19 Therapeutics Accelerator Awards $20 Million in Initial Grants to Fund Clinical Trials," gatesfoundation.org, Press Release, 30 March 2020.

Risk of 12-month mortality following a severe inpatient hypoglycaemic event: A single centre retrospective study from the North-West of England

Aims: At our Trust, all severe inpatient hypoglycaemic episodes in individuals with diabetes (defined as a hypoglycaemic episode requiring injectable treatment) are reported to NaDIA-Harms (National Diabetes Inpatient Audit). We conducted a detailed review of the care of all these events to improve patient safety. In this study, we assessed the risk of 12-month mortality following an episode of severe inpatient hypoglycaemia. Method(s): Reportable NaDIA harms of patients admitted during the period 2018-2022 were recorded into a dataset. Applicable patient records were reviewed at 12 months following the event to see how many patients were deceased and details of comorbidities at the time of the severe hypoglycaemic episode were collected. Result(s): To date, of 107 inpatients who experienced a severe hypoglycaemic episode 55% were deceased within 12 months. In patients admitted during the peak of the Covid-19 pandemic recorded as year April 2020/March 2021, 80% of patients who had a NaDIA hypoglycaemic event died within 12 months. Conclusion(s): Mortality rate following an episode of inpatient hypoglycaemia appears to be several-fold higher than previous reported rates of 4.45%-22.1% for community-dwelling individuals who experience a severe hypoglycaemic event. This maybe partially explained by the increased frailty, polypharmacy and multimorbidity among this cohort, but there is evidence linking hypoglycaemia with cardiovascular mortality. Although no causality between severe inpatient hypoglycaemia and death can be inferred from this study because of the observational nature, it does highlight the importance preventing inpatient episodes of hypoglycaemia through effective monitoring and proactive treatment modification.

Moving Clinical Operations Forward During Pandemic

In the short and long term, sponsors should think through: * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Getting the Most From FSP Model

Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions:

Sharpening the Focus on Patient-Centricity as Pandemic Continues

The foundation is rooted in strategic partnerships with contract research organizations (CROs), vendors, and associations who share collective wisdom to develop best practices or apply knowledge acquired from clinical care to the clinical trial realm. A recent analysis suggests that the global market for DCTs is expected to reach $10 billion by 2026, rising at a 6.5% compound annual growth rate between 2020-2026.2 As evidence of this growth, the SCRS/Medidata survey found that televisits, already used in the past two years by 45.1% of the 204 respondents, are likely to be adopted by an additional 39.2% of respondents in the next two years.1 The survey also reported that only 15.5% of respondents participated in decentralized or completely virtual trials in the past two years. Melissa Nezos, Vice President of Clinical Operations at Firma Clinical Research, a provider of in-home health services, comments on the ongoing shift toward DCTs. Regarding the use of more home-based visits, Rasmus Hogreffe, Vice President of Decentralized Clinical Trial Innovation at Medable, a provider of a DCT platform, says, "We are seeing rising decentralized trial adoption in the industry on a daily basis, including home visits.

COVID-Sparked Practices Driving New Patient-Centric Behaviors

To explore these major shifts, several clinical trial stakeholders were interviewed to gain an understanding of remote processes unfolding in the era of COVID-19, and how smart technologies and mobile health staff are key to sites making this transformation. Upheaval now Starting in March, stories began appearing about sponsors slashing clinical trial activity as the coronavirus was actively spreading across the globe.2,3 This slow-down reflects an all-out effort to protect the trial participants and site staff, meaning that study visits are being reduced, shifted to tele-visits, or cut entirely. [...]the traditional study model, whereby all visits take place at the site, is giving way to a more virtual approach, with technologies and platforms enabling this transition. Cioffi adds that sites also have issues with remote monitoring, as source documents cannot leave the site, and any efforts to monitor them remotely must be in accordance with HIPAA guidelines.

Embedding wellbeing support in foundation induction

ContextWork with a diverse environment in a district general Teaching Hospital in the UK. The organisation is known for being an excellent environment for learning, well-being and teaching of junior doctors. It has two sites, one in Sandwell (Sandwell General Hospital) and the other in West Birmingham (City Hospital).I have worked as the Foundation Program Director for Foundation Year 1 doctors for the past 4 years and also have a keen interest in well-being. I have taken an active role more since the COVID pandemic to focus on well-being of junior doctors and been part of a well-being team involved in making the working environment more amenable and healthy. The well-being team is led by the Junior Doctors well-being lead and we in turn have developed a strong working relationship to endeavour that the support foundation Doctors have is robust and consistent.Issue/ChallengeThe specific challenge was around addressing the needs of the Foundation Year 1 doctors and to develop a process to ensure they could have a means/approach to have time to address well-being in a focused manner. This led to development of 1:1 well-being meetings with each trainee with the Foundation program Director and the well-being lead. This involved arranging 10-15 mins appointments in an environment away from the working areas and ensuring It was a confidential and safe space. The whole purpose is to see how the trainee was doing in their day to day work and ensuring they were able to approach with any queries and concerns if they wished to. Meetings were arranged mid Sept to early October and across sites to ensure easy accessibility. Trainees were met face to face to ensure that the contact was felt to be more human and personable.Assessment of issue and analysis of its causesThe size of the challenge was dominated by the number of trainees. It’s on average we have around 65-70 trainees to meet. However with identifying time aside in the allocated times, this was an achievable task to allocate all trainees a slot or work around the time to allocate alternative time slots. This meant dedicating afternoons over a 2-3 week period.Educational supervisors were informed of the meetings in advance to ensure trainees were released for their time slot and again confidentiality was prioritised to ensure the trainees didn’t feel intimidated and forced into meeting.Feedback was then sought from the trainee group to assess if the meetings were helpful and how to improve upon the format.ImpactA feedback survey was sent out following on the meetings and a good response rate (50%) from trainees identifying their views about the well-being meetings.Majority of trainees identified the meetings as very useful and found the environment to be very supportive Witt regards to their well-being. Feedback comments on the meeting format;‘a lovely idea, felt very comfortable'‘A month in was a good time to check in' ‘nice to meet up and chat'Overall the meetings were received very well. It was suggested by trainees to arrange one per rotation, this was going to be challenged mainly by time and availability.For ongoing meetings, it has been consistently well received for the past two years and will continue in this format. We will be guided by survey/feedback responses to ensure the process works consistently well.InterventionThe main outcomes from this work has been to assess wellbeing but also key in identifying any trainees who are struggling and particularly those who have struggled to engage with other senior colleagues to share any concerns. This in turn has resulted in further 1:1 meetings with these trainees (this has been 3 in the past training year 2021-2022) and appropriate signposting and guidance to helpful resources (including occupational health and the Professional Support and Wellbeng Unit) has further supported trainees to guide them through the year. Overall the positive outcomes have been all three trainees achieving the needed competencies to complete their FY1 year successfully. This work has shown focused meetings wit the right stakeholders achieves satisfying outcomes for those in training and those particularly struggling in training.The format of meetings can be easily reproducible at differing training levels or across trusts.Involvement of stakeholders, such as patients, carers or family members:Overall no direct involvement with patients but indirectly if there are concerns which in turn would affect patient safety, appropriate measures have been taken as and when needed. No patient safety concerns came about as a result of these meetings.Key MessagesThe main message is about investing time and focus in trainees at the infancy of their career matters and this time can be invested well to ensure that their well-being is addressed at an earlier stage to ensure that should any concerns are highlighted, they can be addressed.This in turn as improved outcomes in relation to unplanned sickness or time out of training. Ensuring that appropriate platforms of support are highlighted have helped in this respect.It also helps your trainees in identifying those who are going to help when needed and having appropriate signposting at this stage has helped them considerably in processing well.Lessons learntLessons include that you need to be accessible but ensuring that trainees also understand there are other means of support outside this remit. This means ensuring that all knowledge is shared and this would be helpful in identifying resources prior to meetings so they're aware of support mechanisms at hand.It's important to also understand that not all trainees will be open to sharing concerns so early on in a meeting so identifying we can be approached at a later stage is also important.Constraints is time and this isn't always easily accessible to trainees who struggle out of hours. Ensuring appropriate mentorship through peers is an important consideration at this point.Measurement of improvementSurvey feedback via the trainee group is important to ensure the meetings are delivering what the trainee needs. Through feedback and changes, ensuring that follow on meetings have been adjusted as per suggested changes and this will be assessed through the process of QI and establishing a PDSA cycle. Work is ongoing through to ensure the next feedback meetings are planned in a similar format as last year, as the overall feedback has been hugely positive on a wholeStrategy for improvementNext meetings/check in planned Late Sept/early Oct. Feedback to be sought from meetings.Planned further 1:1 meetings with well-being leads for those trainees identified as in need for further support. Follow up meetings will be done as per their choice/consent and involvement of educational supervisors if indicated.

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.

The Evolution of the Normative Regulation in Hospital Safety and Security

The aim of the law is to ensure personal, material and organisational conditions for safe work without endangering human health, to prevent work accidents and occupational diseases by defining the rights and obligations of the state, employers and employees. Since 2003, the concept of occupational safety and health commissioning has been included in the law, which plays a prominent role in the commissioning of dangerous technology or work equipment in health care. [...]of the epidemic, not only the so-called back office area, but also in patient care, the concept of remote work appeared in the field of telemedicine, and some other areas, such as in the case of finding analysis. According to the legislation, the employer must register and Investigate all accidents at work. [...]of this, a wave of insourcing started and in several health institutions they started to employ their own doormen again, wh ich raises further problems.

DMCs: Maintaining Data Integrity in COVID-19 Climate

Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic. Since the outbreak of COVID-19, there has been disruption to clinical trial management including missed patient visits and assessments, laboratory tests not being performed and submitted, and lapses in study drug administration. There are electronic adjudication systems on the market that have real-time status reporting, and this enables the delivery of a streamlined, efficient, and transparent process for accurate event collection, with high quality results In a timely fashion. Craig McLendon is Senior Director, Adjudication & Data Monitoring Management, ICON Clinical Research Services The DMC has the ability to look across various subsets of the trial and different countries and regions to evaluate any differences in the treatment groups based on exposure and infection rates.

Cost and Quality: How Do Surgical Site Infection Bundles Measure Up?

Introduction: Enhanced recovery after operation and surgical site infection (SSI) bundles have been implemented in hospital systems nationwide to mitigate complications after colorectal operation. These quality improvement bundles (QIB) aim to improve patient safety and should decrease healthcare costs. This study identifies the impact of QIB on SSI rate and hospital costs. Method(s): Vizient and SSI reporting data was queried from 2016- 2021, for all colorectal resections tracked by the National Healthcare Safety Network across the enterprise. The operations were linked to a financial database. Data was analyzed quarterly to identify a relationship between SSI rate, hospital cost, and implementation of SSI mitigation elements. Result(s): 4,163 patients were identified during the study period. SSIs peaked in quarter 2 of 2018 at 5.3%, after which SSI mitigation efforts were announced. A steady decrease is seen in SSI rates, until quarter 3 of 2020, when our hospital system experienced its first COVID wave. With adjustment for procedure type, hospital costs increased by 15.8% per case from 2018-Q3 forward on average with the sharpest elevation observed in quarter 3 of 2019, due to medication startup costs for our SSI bundle. Conclusion(s): We successfully reduced colon SSIs with implementation of an ERAS bundle but incurred 16% greater costs compared with pre implementation, especially during the early implementation period.

Expert advice on vaccination against COVID-19 for patients with mental disorders.

The COVID-19 epidemic has caused serious and long-lasting health and social harm. Vaccination is considered as the most effective way to prevent the COVID-19 epidemic. Patients with mental disorders are at high risk of COVID-19 infection who are in urgent need to get protection. However, due to the particularity of their conditions, whether these patients should be vaccinated has become a tough issue that obsesses doctors, patients with mental disorders, and their families. In light of this issue, this article provides expert advice on the safety, legal and ethical issues of vaccination for patients with mental disorders to regulate the vaccination of these vulnerable populations against COVID-19.Copyright © 2022 Chinese Journal of Psychiatry. All rights reserved.

Empowering cultural change at North Manchester general hospital

ContextNorth Manchester General Hospital is a large District General Hospital in Greater Manchester, serving a relatively disadvantaged population. The overall culture change project involved practically all facets of a functioning medical organisation, including the Senior Medical Leadership Team (SMLT), Transformation team, Human Resources, Finance, and many more. However, one of the key aims of the change was to improve the experience of Junior Doctors working at NMGH. Therefore, postgraduate doctors in training have been key to all of the development, including the Medical Director's Leadership Fellow (MDLF), Junior Doctors' Leadership Group (JDLG), and every staff member that they represent.Issue/ChallengeHistorically, North Manchester General Hospital (NMGH) has had a reputation as a poor place to work;staff aimed to avoid the site. The hospital was unable to retain highly-skilled employees, and trainee experience was extremely low, impacting on patient safety metrics. The site was stuck in a continuous cycle of having this reputation, leading to an inability to attract permanent staff, causing a deficit in teaching and training opportunities, further diminishing the reputation.Rotational junior doctors are the most transient group of NHS healthcare workers (HCWs). Their experience is reflective of organisational culture and that of other, less vocal groups of HCWs. Prior to 2020, many junior doctors considered NMGH to be a ‘rite of passage' ‘ one to be avoided if possible, but if unavoidable, just get through it. On-call teams were chronically short-staffed, 3 services were in enhanced General Medical Council (GMC) monitoring, and GMC survey results were unsatisfactory. Teams were forced to be tenacious, lateral thinking, and resilient to cope with the stresses of work.2019 saw NMGH receive significant criticism from GMC and Health Education North West (HENW) monitoring visits. The General Surgery (GS) Department remained in ‘enhanced monitoring', and patient safety concerns were raised. These included inadequate ‘prescribing of admission medication', poor use of incident reporting systems, and challenges escalating sick patients. Trainees described ‘fire-fighting, not learning'. Improvement recommendations included addressing departmental culture, reinforcing the importance of incident reporting, and ensuring trainees had easy access to appropriate senior support at all times. Early in 2020, trainee experience further deteriorated in GS, due to a negative culture and deficiencies in support, education and training. This resulted in Foundation Year 1 doctors being removed from GS.The Senior Medical Leadership Team (SMLT) decided that enough was enough;the hospital culture needed a fundamental overhaul. There was a clear and urgent need to address staff experience.Assessment of issue and analysis of its causesThe Senior Medical Leadership Team (SMLT) set themselves an audacious goal: to support NMGH to transform into the best training and working experience for junior doctors in Greater Manchester. This goal was split into primary drivers, with each driver linked to specific future projects, and projects assigned to each leadership team member. These projects, identified through co-production with junior doctors, were aimed to improve employee experience, including facilitating access to breaks, improving supervision and support, and enhancing development opportunities â€' aiming to raise staff wellbeing and patient safety standards. Changes were made to General Surgery, resulting in huge investments in expanding the permanent junior doctor and consultant workforces.Several initiatives were implemented to help assess the scope of work required, including setting up a Junior Doctors' Leadership Group (JDLG), or ‘Shadow Board'. All hospital specialties are represented;some representatives sit on the SMLT, on Educational Board meetings, and the Clinical Leaders Forum. The SMLT join every JDLG meeting. Whilst acting as a conduit for rapid two-way communication between clinician and leadership teams (e.g. reliably informing doctors about last-minute changes to visiting policy during Covid surges, or effectively communicating crucial information to crash-call teams when building work closed part of the hospital), the group debates issues raised by junior doctor colleagues they represent, and feeds that back to the SMLT. Recent examples include raising patient safety concerns related to misinterpretation of the Emergency Department Referrals policy, and working collaboratively with junior doctors to address urgent staffing and patient safety risks related to the last wave of the pandemic.In addition to this, a Medical Director's Leadership Fellow (MDLF) role was established. This was fundamental in progressing projects related to the SMLT goal and ensuring appropriate input from junior doctors, Human Resources, the Communications and Transformation teams, and more. As a key member of the JDLG, the MDLF is a role designed in part to enhance junior doctor experience, foster better relationships between staff groups, and encourage feedback provision. The role has been vital in bridging the gap between doctors and hospital leaders, managers and executives – often a source of discontent amongst clinicians. Bridging this gap is important in developing the hospital's culture. Even though many projects are still ongoing, improvements are already being experienced.Impact2021 GMC Survey results showed improvement in 15/18 metrics compared to 2019. These included improvements in ‘Reporting Systems', ‘Workload', and ‘Clinical Supervision Out Of Hours'. 2020 Care Quality Commission inspection reports showed improvement in 11 individual aspects, including improvement to ‘outstanding' in 3 elements.HENW/GMC monitoring visits in 2021 reported ‘they have more robust teams to support the ward and on call workload', resulting from investment in clinicians. It also notes, ‘prescribing audits have shown improvements in prescribing of time critical medication', and demonstrable improvements in ‘use of incident reporting systems and sharing of lessons learnt'. Further comments note that there have been ‘significant improvements in culture in the [General Surgery] department over the past year';one doctor described the department as ‘the most supportive place he had worked'. The report summary noted, ‘through strong clinical leadership and oversight, and a concerted effort to improve departmental culture there have been significant improvements in General Surgical trainee experience with good support, supervision and education reported'. The department was subsequently removed from enhanced GMC monitoring.Although this rapid and impressive turnaround occurred within one department, benefits were seen elsewhere in the organisation.The efforts of the SMLT and JDLG have resulted in positive cultural changes. Surveys reflected: ‘friendly colleagues, less work-related stress, helpful management', and ‘thank you for your work to improve NMGH. I was worried about working at NMGH having heard ‘horror stories' about working there. However, these have not been reflected in reality at all, and NMGH has offered excellent training opportunities.InterventionThe JDLG helps ensure that important information is shared with the wider junior doctor group. Colleagues now feel that their voices are heard. The positives from the previous culture are still evident – leadership teams across the Trust have repeatedly recognised the ‘can-do attitudes' of NMGH staff, with the negative culture firmly in the past. Staff testimonials include: ‘there has definitely been an improvement over the years I have worked here;‘my supervisor was supportive and encouraged reflection through discussions about experiences;and ‘the senior staff are INCREDIBLE. They offer support, they teach, and they encourage us to learn new skills. I cannot be more thankful'. This is in contrast to historical Freedom To Speak Up (FTSU) submissions, which pointed to a culture of disregarding the opinions of NMGH staff.The ‘can-do' approach has been evident during the waves of Covid-19;members of the JDLG fed into management and governance structures to highlight problems in real time, increasing the organisation's responsiveness to challenges faced, working as a two-way conduit of information.During the 2021 HENW/GMC visit, the team reported that junior doctors knew the Medical Director and Director of Medical Education by first name, and felt able to raise concerns directly to them, evidencing a more flattened hierarchy. The visiting team reported being impressed by this positive change and were not aware of other organisations where this had been achieved to this extent.Having Postgraduate Doctors in Training play such a significant role within the Senior Leadership Team setup is relatively unique. As explained, empowering staff to feel they can raise any issues directly to the Medical Director or SMLT, or via the JDLG, has played a huge role in facilitating palpable cultural change through leadership structure additions. As a point of contact, the MDLF has acted as an extension of the JDLG, but works directly alongside the Medical Director and Associate Director of Medical Education, essentially enabling the SMLT to keep their ear to the ground, their fingers on the pulse of staff atmosphere and wellbeing.Examples of achievements of the MDLF include projects to introduce personalised theatre caps (benefits include enhanced communication, especially in emergencies, improving patient outcomes), formation of a Wellbeing group (representatives from all cohorts of staff across the site discuss wellbeing initiatives and colleagues' wellbeing concerns), and an impressive and rapid response to staffing crises and patient safety risks during the most recent Covid-19 wave. As a result of these outcomes, other Trusts haveapproached the SMLT, requesting further information regarding the JDLG and MDLF model;another MDLF has since been appointed at a different trust site.Involvement of stakeholders, such as patients, carers or family members:The SMLT itself is made up of clinicians from a variety of backgrounds, across medicine and surgery. SMLT members sit in morning medical handovers to actively gather clinician experience feedback. They also work closely alongside colleagues from Nursing, Finance, HR, Transformation teams, and more, which enables the SMLT to work collaboratively with the multidisciplinary team to improve culture at NMGH.The MDLF is in the perfect position to take advantage of this MDT approach. As a result, the MDLF sits on Group-level Patient Safety Panels (acting to highlight patient safety incidents, initiatives, and achievements across the entire Trust). This panel consists of representatives from hospital, community, and medical education staffing groups. The lessons learnt are then communicated to individual hospitals, no matter where the incident or initiative originated. A big part of the meeting is the FTSU aspect, and local FTSU Guardians are active within the panel.Given that the MDLF role is so closely linked to improving communication and feedback, a Freedom To Speak Up Champion role fitted well within the responsibilities of the post. Therefore, over the past year, the MDLF has worked alongside the FTSU team and has completed training as a FTSU Champion. As a consequence of working closely with shop-floor colleagues, the MDLF has received communications from a wide variety of staff roles and levels of seniority throughout the year, asking questions, or raising awareness about issues. The MDLF can then seek appropriate advice, signpost the colleague, and keep them updated on a potential resolution, further propagating the positive feedback loop and support of the wider MDT. As previously mentioned, the JDLG consists of representatives from all medical specialties, and each member is encouraged to raise concerns, suggest improvements, and lead on projects;these include an overhaul of the medical handover process, enabling a safer and more efficient handover, and escalating concerns of a coll ague speaking up about potential patient safety concerns within a department. Furthermore, speakers at JDLG meetings have included the Head of Nursing: Quality & Patient Experience, local FTSU Guardians, the Director of Human Resources, and the local Guardian of Safe Working Hours, enabling group members to share information from a wide range of disciplines with shop-floor colleagues. As a result of the efforts and MDT approach of the above groups, a placement feedback survey performed early in 2022 demonstrated that 93% of respondents felt their working environment supports a multidisciplinary approach.Key MessagesOne of the hallmarks of good medical leadership is putting all staff members, regardless of their role, seniority, or experience, in the best position for them to succeed. Giving Postgraduate doctors early opportunities to play a significant part in, and learn about, an organisation's leadership structure, is not only beneficial to the doctor, but helps the organisation capitalise on a previously relatively untapped market of ideas and solutions. Crucially, this is not limited to postgraduate doctors in training, but also locally-employed doctors, which make up a significant proportion of the workforce in any hospital yet typically remain underrepresented and under-utilised.NMGH has realised the potential that can be unlocked in Junior Doctors, through leadership placements and roles, and the positive benefit this can have on the individual, team and organisation.Lessons learntNorth Manchester General Hospital was fortunate in that the entire SMLT bought into everything: the overall project for culture change, the introduction of the MDLF into the SMLT, and empowering members of the JDLG to contribute to change at the highest level. Having spoken to other organisations looking to replicate our success, they have found that this buy-in is absolutely crucial. Recruiting effectively, to both the MDLF position and JDLG representative roles, is vital, as a huge amount of motivation to fight for change and the betterment of the system is required when overcoming barriers and challenges. Many of the barriers we faced are well-documented in literature, and to a point we expected them;these included resistance from non-medical stakeholders, which was somewhat abetted by further conversations, explanation of goals and objectives, and outlining the overall vision of the SMLT. Of course, resistance to change is important in any project, as it can highlight potential issues not yet visualised.Measurement of improvementFrom the start, we set out our intention to use openly-available, independent metrics of improvement, such as the GMC Nation Training Survey. To compliment this, the MDLF utilised a variety of temperature-check methods, including surveys (dissemination supported by the increasingly-established network of the Postgraduate doctors in training of the JDLG) and departmental visits. Importantly, having a fellow junior doctor asking for feedback, rather than a traditional member of the SMLT, enabled us to garner potentially more honest opinions, criticisms and ideas. As explained elsewhere, GMC survey results have shown improvement, and local surveys have displayed some very positive results. That said, it is recognised that the vision is a long-term project, and continuous improvement will be sought, rather than settling on the progress made thus far.Strategy for improvementThe SMLT sat down and brainstormed an overall vision alongside the individual large-scale projects that would contribute to achieving change. Within this, individual members of the SMLT were assigned roles leading one or more projects, and the MDLF role was created in part to support with the running of these projects where required. This enabled utilisation of the minds of the JDLG and other Postgraduate doctors in training. The MDLF role was instrumental in not only involving this cohort, but also reaching out to other organisations to share learned experiences when they had gone through implementation of similar projects. The team was kep accountable not by having a set timeline for implementation but by having regular away days, reporting back to their colleagues and the transformation team regarding progress.The JLDG, established in 2020, and reappointed every year, have been key to the success of the culture change, through engagement, sense-checking and feedback regarding strategy and relevant projects. Over time the organisation has increasingly engaged this Shadow Board in the development and role out of projects as well as problem solving of significant challenges. Through this team the SMLT has fedback key messages and challenges to the Junior Doctor workforce, which has resulted in increased engagement across the organisation.