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Quality Assurance Management
A Comprehensive Overview of Real-World Applications for High Risk Specialties
- 1st Edition - July 20, 2024
- Authors: Gayathri De Lanerolle, Evette Sebastien Roberts, Athar Haroon, Ashish Shetty
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 2 7 3 2 - 9
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 2 7 3 3 - 6
Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating proced… Read more
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Request a sales quoteQuality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.
- Uses practice-based evidence for developing and delivering quality assurance and management systems
- Includes case studies associated with ‘failures’ and ‘lessons learned’
- Discusses clinical trials in academic, clinical and industry settings
- Demonstrates how to build resilience into systems that could evolve to promote best practices, even with limited resources
- Compares and contrasts different QA/QC practices
Research and clinical staff working in clinical research with a focus on QA manager, Trial managers and Research Operational staff working within healthcare, academia and industry
- Cover image
- Title page
- Table of Contents
- Copyright
- List of contributors
- Author biographies
- Chapter 1. Introduction
- 1.1. Introduction
- 1.2. Quality assurance
- 1.3. Behavioral quality assurance
- 1.4. Quality control
- 1.5. Quality management
- 1.6. System thinking
- 1.7. Conclusion
- Chapter 2. Building a quality management system
- 2.1. Introduction
- 2.2. Quality improvement methodologies
- 2.3. Developing a quality management system
- Chapter 3. Audits and monitoring
- 3.1. Introduction
- 3.2. How to prevent failures with audits/monitoring visits?
- Chapter 4. Inspections
- 4.1. Introduction
- 4.2. Key areas for regulatory inspections
- 4.3. Introduction to developing a specialist specific inspection plan and policy
- Chapter 5. Quality assurance management in pain medicine
- 5.1. Introduction
- 5.2. Rationale for quality assurance in pain medicine
- 5.3. Patient-centered outcomes
- 5.4. Interventional pain management
- 5.5. Quality assurance in pain management—challenges and confounders
- Chapter 6. Quality assurance management in maternity care
- 6.1. Introduction
- 6.2. Association of quality management and clinical epidemiology
- 6.3. Governance implications on issues with maternity care
- 6.4. Advice for improvement
- 6.5. Digital technology for quality management
- Chapter 7. Neuropsychiatry and mental health
- 7.1. Background
- 7.2. Introduction
- 7.3. Neuropsychiatric disorders
- 7.4. Mood disorders: Depressive disorder
- 7.5. Symptom profile: Clinical manifestation of secondary comorbid disorders that reinforce primary disorder
- 7.6. Brain circuit activity in depressive disorder
- 7.7. Anxiety or fear-related disorders: Generalized anxiety disorder
- 7.8. Categorical diagnosis and disease severity
- 7.9. Symptom profile: Clinical manifestation of secondary comorbid disorders that reinforce primary disorders
- 7.10. Neurocognitive disorders: Alzheimer's disease and dementia
- 7.11. Symptom profile with details of psychopathology: Clinical manifestation of secondary comorbid disorders that reinforce primary disorder
- 7.12. Quality assurance and quality control in neuropsychiatry
- 7.13. Importance of quality for neurology/neurosurgery in clinical research
- 7.14. Conceptual frameworks and practice-based applications used to optimize quality assurance in neuropsychiatric clinical care and optimizing mental healthcare
- 7.15. Conceptual frameworks and practice-based applications used to optimizes quality assurance in neuropsychiatric and mental health research
- 7.16. Translation of improved quality in real-world contexts
- 7.17. Managing quality optimization methods for neuropsychiatric populations
- 7.18. Quality optimization in investigational medical product development and deployment
- 7.19. Quality methods in medical device development and deployment
- 7.20. Quality control and assurance in digital technology development and deployment
- 7.21. Managing quality protocols for mental healthcare populations
- 7.22. Quality optimization in complex intervention development and deployment
- 7.23. Quality control and assurance procedures in the development and deployment of novel therapeutics
- 7.24. Future directions
- Chapter 8. Clinical and translational radiology
- 8.1. Background
- 8.2. Clinical radiology applications
- 8.3. Clinical utility and quality standards of imaging
- 8.4. Clinical radiology for clinical research
- 8.5. Quality assurance and organizational framework
- 8.6. Artificial intelligence and quality assurance
- Chapter 9. Case studies
- 9.1. Resource influenced near misses-maternity
- 9.2. Inspection preparedness
- 9.3. Risk mitigation
- Index
- No. of pages: 334
- Language: English
- Edition: 1
- Published: July 20, 2024
- Imprint: Academic Press
- Paperback ISBN: 9780128227329
- eBook ISBN: 9780128227336
GD
Gayathri De Lanerolle
Gayathri Delanerolle is a Researcher. Her interests include women's health, artificial intelligence and chronic conditions with a special focus on disease sequalae. She has experience in evidence synthesis, epidemiology and mixed-methods research. Gayathri's experience in quality assurance inspired her to develop the content for this book and co-author with others with a special focus on complex healthcare areas that are rapidly evolving.
Affiliations and expertise
Digital Evidence Based Medicine LabER
Evette Sebastien Roberts
Evette Sebastien Roberts is a practising nurse and midwife in London, England. Evette has been pivotal in assisting healthcare organisations to better understand the principles of governance and quality assurance, leading them in achieving compliance during accreditation and audit programmes. Her passion for risk management in healthcare has propelled her into seeking a number of roles; some of which include; Risk Midwife, Clinical Governance Manager and Regulatory and Compliance Lead. Having undertaken several inspections for the Care Quality Commission, Evette has knowledge and experience in what ‘good’ looks like and the factors which often impinge on the ability to match required standards. In addition to her clinical roles, Evette has embarked on a research journey, seeking to contribute new knowledge on the subject matter of midwives’ experiences working with risk management frameworks. It is her enthusiasm for quality assurance which drives her appetite for research into this area which encompasses the patient safety agenda.
Affiliations and expertise
Clinical Governance Manager at Spire London East Hospital and Midwife at Homerton University Hospital NHS Foundation Trust, London, UKAH
Athar Haroon
Dr. Athar Haroon is a Consultant Radionuclide Radiologist and has worked in an array of NHS organisations and academia, including United Lincolnshire Hospitals NHS Trust, University of Leicester, University Hospitals of Leicester NHS Trust, Nottingham University Hospitals NHS Trust, University College London Hospitals NHS Foundation Trust and University College London respectively. He has a special interest in hybrid imaging and utility of biomarkers for diagnosis, disease management and treatment of a variety of clinical areas including Neurology, Oncology, Endocrinology and Emergency Medicine. He has experience working with several biomarkers such as 18F FDG, 18F Choline, Ga 68 PSMA, Ga68 DOTATATE, and 18F Amyloid.
Affiliations and expertise
Consultant Radionuclide Radiologist, St Bartholomew’s Hospital, London, United KingdomAS
Ashish Shetty
Dr Shetty trained at Cambridge University Hospitals and underwent a clinical fellowship in pain management at Guys & St Thomas Hospital in London. He is a consultant in pain medicine at University College London Hospitals and Associate Professor at UCL. His private practice is located at Harley Street Clinic and London Bridge Hospital. His special interests relating to chronic pain include neuromodulation, spinal cord stimulators, sports medicine, pelvic pain, and CRPS.
Affiliations and expertise
Consultant in Pain Medicine, University College London Hospitals and Associate Professor, University College London, UKRead Quality Assurance Management on ScienceDirect