Committed to Safety: Ten Case Studies on Reducing Harm to Patients

Presents case studies of healthcare organizations, clinical teams, and learning collaborations to illustrate successful innovations for improving patient safety nationwide. Includes actions taken, results achieved, lessons learned, and recommendations

Quality and Safety of Minimally Invasive Surgery: Past, Present, and Future

Adverse events because of medical errors are a leading cause of death in the United States (US) exceeding the mortality rates of motor vehicle accidents, breast cancer, and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors because they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery (MIS) has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. To mitigate errors and protect patients, a multidisciplinary approach is needed to improve MIS. Clinical human factors, and biomedical engineering principles and methodologies can be used to develop and assess laparoscopic surgery instrumentation, practices, and procedures. First, the foundational understanding and the imperative to transform health care into a high-quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. Finally, the future of this field and the research needed to further improve the quality and safety of MIS is discussed

Improving Health Care Quality and Safety: The Development and Assessment of Laparoscopic Surgery Instrumentation, Practices and Procedures

Adverse events due to medical errors are a leading cause of death in the United States exceeding the mortality rates of motor vehicle accidents, breast cancer and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors since they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. In order to mitigate errors and protect patients, a multidisciplinary approach was taken to improve minimally invasive surgery. Clinical, human factors, and biomedical engineering principles and methodologies were used to develop and assess laparoscopic surgery instrumentation, practices and procedures. First, the foundational understanding and the imperative to transform health care into a high quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. The remainder of this dissertation presents the experimental results of four studies used to develop and assess laparoscopic surgery instrumentation, practices and procedures. In the first experiment, a novel hand-controlled electrosurgical laparoscopic grasper was developed and evaluated to eliminate the use of foot pedals, reduce surgery-related discomfort, and minimize the risk of actuation errors. The final three studies compared the emerging technique of single-incision surgery to conventional laparoscopic surgery to determine whether there were any technical, physical or subjective performance differences across the two surgical techniques. In all, these studies contribute towards the improvement of the quality and safety of minimally invasive surgery. Advisor: M. Susan Hallbec

Improving Health Care Quality and Safety: The Development and Assessment of Laparoscopic Surgery Instrumentation, Practices and Procedures

Adverse events due to medical errors are a leading cause of death in the United States exceeding the mortality rates of motor vehicle accidents, breast cancer and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors since they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. In order to mitigate errors and protect patients, a multidisciplinary approach was taken to improve minimally invasive surgery. Clinical, human factors, and biomedical engineering principles and methodologies were used to develop and assess laparoscopic surgery instrumentation, practices and procedures. First, the foundational understanding and the imperative to transform health care into a high quality and safe system is discussed. Next, a generalized perspective is presented on the impact of the design and redesign of surgical technologies and processes on human performance. The remainder of this dissertation presents the experimental results of four studies used to develop and assess laparoscopic surgery instrumentation, practices and procedures. In the first experiment, a novel hand-controlled electrosurgical laparoscopic grasper was developed and evaluated to eliminate the use of foot pedals, reduce surgery-related discomfort, and minimize the risk of actuation errors. The final three studies compared the emerging technique of single-incision surgery to conventional laparoscopic surgery to determine whether there were any technical, physical or subjective performance differences across the two surgical techniques. In all, these studies contribute towards the improvement of the quality and safety of minimally invasive surgery. Advisor: M. Susan Hallbec

A safer place for patients: learning to improve patient safety

1 Every day over one million people are treated successfully by National Health Service (NHS) acute, ambulance and mental health trusts. However, healthcare relies on a range of complex interactions of people, skills, technologies and drugs, and sometimes things do go wrong. For most countries, patient safety is now the key issue in healthcare quality and risk management. The Department of Health (the Department) estimates that one in ten patients admitted to NHS hospitals will be unintentionally harmed, a rate similar to other developed countries. Around 50 per cent of these patient safety incidentsa could have been avoided, if only lessons from previous incidents had been learned. 2 There are numerous stakeholders with a role in keeping patients safe in the NHS, many of whom require trusts to report details of patient safety incidents and near misses to them (Figure 2). However, a number of previous National Audit Office reports have highlighted concerns that the NHS has limited information on the extent and impact of clinical and non-clinical incidents and trusts need to learn from these incidents and share good practice across the NHS more effectively (Appendix 1). 3 In 2000, the Chief Medical Officer’s report An organisation with a memory 1 , identified that the key barriers to reducing the number of patient safety incidents were an organisational culture that inhibited reporting and the lack of a cohesive national system for identifying and sharing lessons learnt. 4 In response, the Department published Building a safer NHS for patients3 detailing plans and a timetable for promoting patient safety. The goal was to encourage improvements in reporting and learning through the development of a new mandatory national reporting scheme for patient safety incidents and near misses. Central to the plan was establishing the National Patient Safety Agency to improve patient safety by reducing the risk of harm through error. The National Patient Safety Agency was expected to: collect and analyse information; assimilate other safety-related information from a variety of existing reporting systems; learn lessons and produce solutions. 5 We therefore examined whether the NHS has been successful in improving the patient safety culture, encouraging reporting and learning from patient safety incidents. Key parts of our approach were a census of 267 NHS acute, ambulance and mental health trusts in Autumn 2004, followed by a re-survey in August 2005 and an omnibus survey of patients (Appendix 2). We also reviewed practices in other industries (Appendix 3) and international healthcare systems (Appendix 4), and the National Patient Safety Agency’s progress in developing its National Reporting and Learning System (Appendix 5) and other related activities (Appendix 6). 6 An organisation with a memory1 was an important milestone in the NHS’s patient safety agenda and marked the drive to improve reporting and learning. At the local level the vast majority of trusts have developed a predominantly open and fair reporting culture but with pockets of blame and scope to improve their strategies for sharing good practice. Indeed in our re-survey we found that local performance had continued to improve with more trusts reporting having an open and fair reporting culture, more trusts with open reporting systems and improvements in perceptions of the levels of under-reporting. At the national level, progress on developing the national reporting system for learning has been slower than set out in the Department’s strategy of 2001 3 and there is a need to improve evaluation and sharing of lessons and solutions by all organisations with a stake in patient safety. There is also no clear system for monitoring that lessons are learned at the local level. Specifically: a The safety culture within trusts is improving, driven largely by the Department’s clinical governance initiative 4 and the development of more effective risk management systems in response to incentives under initiatives such as the NHS Litigation Authority’s Clinical Negligence Scheme for Trusts (Appendix 7). However, trusts are still predominantly reactive in their response to patient safety issues and parts of some organisations still operate a blame culture. b All trusts have established effective reporting systems at the local level, although under-reporting remains a problem within some groups of staff, types of incidents and near misses. The National Patient Safety Agency did not develop and roll out the National Reporting and Learning System by December 2002 as originally envisaged. All trusts were linked to the system by 31 December 2004. By August 2005, at least 35 trusts still had not submitted any data to the National Reporting and Learning System. c Most trusts pointed to specific improvements derived from lessons learnt from their local incident reporting systems, but these are still not widely promulgated, either within or between trusts. The National Patient Safety Agency has provided only limited feedback to trusts of evidence-based solutions or actions derived from the national reporting system. It published its first feedback report from the Patient Safety Observatory in July 2005

The World Health Organization Multi-Professional Patient Safety Curriculum: implementation of key modules and its impact on patient safety knowledge, skills, and attitudes of medical students at the University of Algarve

ABSTRACT - Objectives: We attempted to show how the implementation of the key elements of the World Health Organization Patient Safety Curriculum Guide Multi-professional Edition in an undergraduate curriculum affected the knowledge, skills, and attitudes towards patient safety in a graduate entry Portuguese Medical School. Methods: After receiving formal recognition by the WHO as a Complementary Test Site and approval of the organizational ethics committee , the validated pre-course questionnaires measuring the knowledge, skills, and attitudes to patient safety were administered to the 2nd and3rd year students pursuing a four-year course (N = 46). The key modules of the curriculum were implemented over the academic year by employing a variety of learning strategies including expert lecturers, small group problem-based teaching sessions, and Simulation Laboratory sessions. The identical questionnaires were then administered and the impact was measured. The Curriculum Guide was evaluated as a health education tool in this context. Results: A significant number of the respondents, 47 % (n = 22), reported having received some form of prior patient safety training. The effect on Patient Safety Knowledge was assessed by using the percentage of correct pre- and post-course answers to construct 2 × 2 contingency tables and by applying Fishers’ test (two-tailed). No significant differences were detected (p < 0.05). To assess the effect of the intervention on Patient Safety skills and attitudes, the mean and standard deviation were calculated for the pre and post-course responses, and independent samples were subjected to Mann-Whitney’s test. The attitudinal survey indicated a very high baseline incidence of desirable attitudes and skills toward patient safety. Significant changes were detected (p < 0.05) regarding what should happen if an error is made (p = 0.016), the role of healthcare organizations in error reporting (p = 0.006), and the extent of medical error (p = 0.005). Conclusions: The implementation of selected modules of the WHO Patient Safety Curriculum was associated with a number of positive changes regarding patient safety skills and attitudes, with a baseline incidence of highly desirable patient safety attitudes, but no measureable change on the patient safety knowledge, at the University of Algarve Medical School. The significance of these results is discussed along with implications and suggestions for future research.RESUMO - Objetivos: Tentamos demonstrar como a aplicação de elementos-chave da World Health Organization Patient Safety Curriculum Guide Multi-professional Edition no currículo afeta conhecimentos, competências e atitudes em relação à segurança do paciente no curso de Medicina pós-graduado da Universidade do Algarve,Portugal. Métodos: Após reconhecimento formal pela OMS como um Site Complementar e aprovação da comissão de ética organizacional, os questionários pré-curso validados foram administrados ao 2º e 3º ano de um curso de quatro anos (n = 46). Módulos chave do currículo da OMS foram implementadas ao longo do ano letivo utilizando varias de estratégias pedagógicas, incluindo aulas por peritos, sessões de ensino em pequenos grupos baseada em problemas(PBL),tal como sessões de laboratório de simulação seguido por administração de questionários idênticos.O impacto das atividades de aprendizagem foram availadas,tal como a introdução do currículo como ferramenta de aprendizagem neste contexto. Resultados: Um número significativo de inquiridos 47%, (n = 22) relataram algum tipo de formação prévia na área de segurança do paciente. O efeito sobre os Conhecimentos de Segurança do Paciente foram avaliados utilizando a percentagem de respostas certas pré e pós-curso para construir tabelas de contingência 2x2 e aplicando o Teste de Fischers(2 caudas).Não foram detetadas diferenças significativas (P <0,05). Para avaliar o efeito da intervenção em competências e atitudes de Segurança do Paciente, a média e o desvio-padrão foi calculada para as respostas pré e pós-curso, e foi aplicado o teste de Mann-Whitney para amostras independentes. A avaliação de atitudes indicou uma incidência base muito elevada de atitudes desejáveis para a segurança do paciente. Foram detetadas alterações significativas (P <0,05) em relação ao que deveria acontecer no caso de ocorrer um erro (p = 0,016), o papel das organizações de saúde em reportar o erro (p = 0,006) e na ocorrência elevada do erro médico (p = 0,005). Conclusões: A implementação de módulos chave do Curriculum Multiprofissional Segurança do Paciente da OMS foi associado a algumas alterações de atitude positivas em relação à segurança do paciente num grupo com incidênciad e atitudes positivas, de base,já elevada. Não foi mensurável qualquer alteração no nível de Conhecimentos no âmbito de segurança do paciente, neste grupo de estudantes do curso de medicina da Universidade do Algarve. O significado destes resultados é discutido tal como as sugestões para futuras investigações

The Contributing Factors to Student Nurse Medication Administration Errors and Near Misses in the Clinical Setting as Identified By Clinical Instructors

The report, To Err is Human, by the Institutes of Medicine (IOM, 2000) brought attention to medication safety in the United States healthcare system. While advances have been made in patient safety, including electronic medication dispensing systems, electronic medication administration records, and scanning systems, it is estimated that 7,000 to 9,000 people die each year due to medication errors (Tariq et al., 2019). The medication administration process involves steps from prescribing to administration. However, nurses administering the medications are the final check point. James Reasons’ Swiss Cheese Model of Accident Causation illustrates the role that systems play in medical errors. The purpose of this dissertation is to determine the factors that contribute to undergraduate, prelicensure student nurse medication errors and near misses as identified by clinical instructors and the interventions that may help to mitigate these factors. The top 5 most common contributing factors of medication errors and near misses were ‘students having limited knowledge about medications,’ ‘the names of many medications are similar.’ ‘all medications for one team of patients cannot be passed within an accepted time frame,’ ‘the packaging of many medications is similar,’ and ‘students do not receive enough instruction on medications.’ The results have implications in nursing education and the potential to impact patient safety

Contemporary Topics in Patient Safety

As healthcare systems continue to evolve, it is clear that providing safe, high-quality care to patients is an extremely complex process. Ranging from multi-disciplinary teams to bedside care, virtually every aspect of the patient-care experience provides us with an opportunity for doing things better, from improving efficiency, safety, and overall outcomes to reducing costs and promoting team synergy. This book, the fifth in our patient safety series collection, consists of chapters that help explore key concepts related to both the safety and quality of care. In a departure from the vignette-driven format of our earlier books, this installment gravitates toward discussing frameworks, theoretical considerations, team-centric approaches, and a variety of other concepts that are critical to both our understanding and the implementation of safer and better-performing health systems. We also feel that the knowledge presented herein increasingly applies across the world, especially as global health systems evolve and mature over time. It is our goal to improve the recognition of potential opportunities that will highlight various aspects of the delivery of healthcare and thus contribute to better patient experiences, with safety at the forefront. Topics covered in this volume, as well as the previous volumes, highlight the critical importance of identifying and addressing opportunities for improvement, not as one-time events, but rather as continuous, hardwired institutional processes

Managing chemotherapy risks : Learning from medication errors and developing a national knowledge source for chemotherapy regimens

The basics in cancer treatment are surgery, radiation therapy, and treatment with cancer drugs, often combined. Chemotherapy regimens that define the drugs used, the dosage, the frequency and duration of drug administration, have been developed and used for different cancer diagnoses. Several healthcare professionals are involved in the treatment: the physician prescribing the drugs, the pharmacist preparing or dispensing the drugs, and finally, the nurse or the patient administering the drugs. Chemotherapy errors that can occur during the treatment represent potential risks for severe patient harm. The aims of this PhD thesis were to increase knowledge about serious medication errors (MEs) in chemotherapy and to develop, implement, and evaluate a national knowledge source for chemotherapy regimens (an e-library) that can support healthcare professionals and mitigate patient safety risks.The characteristics of MEs with parenteral cytotoxic drugs were identified in a retrospective qualitative analysis of 60 cases reported to the Swedish national incident reporting systems 1996-2008. The drugs most involved were fluorouracil, carboplatin, and cytarabine. The largest ME categories included too high doses originating from prescribing, and the wrong drug used during preparation or prescription. Twenty-five of the 60 MEs occurred when physicians were prescribing. Another 25 occurred within the pharmacies. The remaining 10 MEs occurred when the nurses prepared or administered the drug. All the drugs with MEs that occurred during prescription were delivered to the patients. The consequences were especially severe in these cases, including death and harm to the patients. The general failure types (GFTs) and active failures were identified in the 60 cases to better understand why these errors happened. The most frequently encountered GFTs were in Defences (e.g., missed double checking of the patient’s or the drug’s identity) and Procedures (e.g., routines that were lacking or insufficient). Working conditions were a common denominator, often underlying the MEs. Examples were high workloads, and low staffing.A national e-library for chemotherapy regimens with standardised nomenclature and content was developed in close co-operation with healthcare professionals in an iterative process within the Swedish Regional Cancer Centres. The national e-library is a knowledge source containing updated regimens and other supportive information based on the latest evidence, available at: https://kunskapsbanken.cancercentrum.se. To ensure that the design and content complied with the users’ needs, the usage and usability of the national e-library were evaluated using mixed methods. Statistics from the website show an average of just over 2,500 visits and 870 unique visitors per month. The web survey, with 292 answers, showed that the visitors were mainly physicians and nurses. Almost 80% searched for regimens, and 90% found what they were looking for and were satisfied with their visit. An expert evaluation showed that the e-library follows many existing design principles. Qualitative interviews with 4 nurses, 3 physicians, and 3 pharmacists revealed various ways to use the information in the regimens. Users have different needs depending on their profession and their workplace, and the e-library can support these different needs. The national e-library was used in the intended way, and the users were able to interact without any problems. The research in this thesis shows that it is of utmost importance to minimise the potential for errors in the prescribing stage and that a common denominator behind the errors often was working conditions. Today’s Swedish national e-library for chemotherapy regimens contains information based on the latest evidence, is embedded in a national quality system, and contributes to organisational and national learning, ultimately supporting healthcare professionals in managing chemotherapy risks

Monitoring Hospital Safety Climate Using Control Charts of Non-harm Events in Reporting Systems

The primary aim of this thesis is to design an approach and demonstrate a methodology to supplement safety culture assessment efforts. The framework affords an enhanced understanding of hospital safety climate, specifically reporting culture, through the use of control charts to monitor non-harm patient safety events documented in reporting systems. Assessing safety culture and climate remains difficult. One of the most common methods to assess safety culture is a self-report survey administered annually. Surveys assess safety climate, because they are a snapshot of the management\u27s and front-line staff\u27s perceptions of safety within their settings. One component of safety culture is reporting culture, which is assessed by survey questions targeting the total number and frequency of events reported by individuals. Surveys use subjective data to measure outcome variables with regard to patient safety event reporting. Relying on subjective data when organizations also collect data on actual reporting rates may not be optimal. Additionally, the time lag limits management\u27s ability to efficiently assess the need for, and the effect of improvements. Strategic interventions may result in effective change, but annual summary data may mask the effects. Additionally, there are advantages to focusing on non-harm events, and capturing non-harm event reporting rates may aid safety climate assessment. Despite the limitations of reporting systems, incorporating actual data may allow organizations to gain a more accurate depiction of the safety climate and reporting culture. With the increased prevalence of reporting systems in healthcare organizations, the data can be used to track and trend reporting rates of the organization. Incorporating control charts can help identify expected non-harm event reporting rates, and can be used to monitor trends in reporting culture. Data in reporting systems are continuously updated allowing quicker assessment and feedback than annual surveys. The methodology is meant to be prescriptive and uses data that hospitals typically collect. Hospitals can easily follow the summarized approach: check for underlying data assumptions, construct control charts, monitor and analyze those charts, and investigate special cause variation as it arises. The methodology is described and demonstrated using simulated data for a hospital and three of its departments