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clinical manual of anxiety disorders
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clinical manual of anxiety disorders
Social phobia (or social anxiety disorder)—In the past few years, the first FDA-approved medications for this disorder have been made available. Cognitive-behavioral therapy is also effective for the treatment of this underdiagnosed and undertreated condition. Obsessive-compulsive disorder (OCD) —OCD was the first disorder where it was shown that both specific medications and cognitive-behavioral techniques resulted in normalization of activity in particular brain structures. It is now possible to provide patients with integrated treatment approaches. Posttraumatic stress disorder (PTSD) —Once viewed as a normal reaction to trauma, PTSD is increasingly understood as a pathological response, characterized by specific psychobiological dysfunctions. Again, there have been exciting advances in the treatment of this disorder, with the release of the first FDA-approved agents for PTSD. Generalized anxiety disorder (GAD) —For a number of years GAD was thought of as a residual disorder occasionally seen in combination with more primary conditions. Nowadays, we know that GAD is an independent condition that is prevalent, persistent, and disabling. Busy residents and psychiatrists in active clinical practice, psychologists, primary care practitioners, and other mental health professionals will find this clinical manual—with its integrated approach of both pharmacotherapy and psychotherapy—a valuable tool in their everyday practices. The chapters are well-organized and present state-of-the-art information for busy clinicians including tips for assessment, discussion of risk factors and etiology, and treatment algorithms. I recommend this manual highly.— Donald W. Black, M.D., Professor of Psychiatry, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa Clinical Manual of Anxiety Disorders is relatively short and it is good—quite good, in fact. It is small enough to digest in easy bites yet large enough to be thoroughly nourishing.
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As described in the Privacy Policy, this website utilizes cookies, including for the purpose of offering an optimal online experience and services tailored to your preferences. By closing this message, browsing this website, continuing the navigation, or otherwise continuing to use the APA's websites, you confirm that you understand and accept the terms of the Privacy Policy, including the utilization of cookies. Fortunately, there have been major advances in understanding and treating these conditions in recent years; this is one of the most exciting areas in modern medicine. This clinical manual has earned its place in the literature as one of just a few volumes that covers all of the major anxiety disorders and presents integrated contributions from both psychopharmacologists and psychotherapists—all in one compact work written for busy clinicians. Though concepts of anxiety have long enjoyed a central position in philosophical and psychoanalytic theories, empirical research on anxiety disorders has a relatively short history. Here, 16 experts discuss advances in diagnosis, assessment (including relevant rating scales), pharmacotherapy, and psychotherapy. This volume begins by reviewing recent important diagnostic, epidemiological, neurobiological, and treatment findings—all of which have significant implications for clinicians. Subsequent chapters cover Panic disorder and agoraphobia —Laboratory studies of fear have significantly advanced our understanding of the neurocircuitry and neurochemistry of panic. Furthermore, panic disorder is now readily treated with both medications and psychotherapy. Specific phobia —Viewed for many years as mild and even trivial, this common disorder is now recognized for its very real associated distress and impairment. Exposure therapy is the treatment mainstay, though pharmacotherapy should be considered particularly when there is comorbidity.
- Social phobia (or social anxiety disorder) -- In the past few years, the first FDA-approved medications for this disorder have been made available. Cognitive-behavioral therapy is also effective for the treatment of this underdiagnosed and undertreated condition. - Obsessive-compulsive disorder (OCD) -- OCD was the first disorder where it was shown that both specific medications and cognitive-behavioral techniques resulted in normalization of activity in particular brain structures. It is now possible to provide patients with integrated treatment approaches. - Posttraumatic stress disorder (PTSD) -- Once viewed as a normal reaction to trauma, PTSD is increasingly understood as a pathological response, characterized by specific psychobiological dysfunctions. Again, there have been exciting advances in the treatment of this disorder, with the release of the first FDA-approved agents for PTSD. - Generalized anxiety disorder (GAD) -- For a number of years GAD was thought of as a residual disorder occasionally seen in combination with more primary conditions. Busy residents and psychiatrists in active clinical practice, psychologists, primary care practitioners, and other mental health professionals will find this clinical manual -- with its integrated approach of both pharmacotherapy and psychotherapy -- a valuable tool in their everyday practices. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. Overall, the book gets my seal of approval. Its readership should extend from the greenest of residents to the most seasoned old-timers and include all clinicians (including primary care physicians) who deal with anxiety disorders.Anxiety disorders are the most prevalent of psychiatric disorders and account for a significant proportion of the costs of mental illness.
Its readership should extend from the greenest of residents to the most seasoned old-timers and include all clinicians (including primary care physicians) who deal with anxiety disorders. The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again. Used: GoodAll pages are intact, and the cover is intact. The spine may show signs of wear. Pages can include limited notes and highlighting, and the copy can include previous owner inscriptions. At ThriftBooks, our motto is: Read More, Spend Less.We'll e-mail you with an estimated delivery date as soon as we have more information. Your account will only be charged when we ship the item. Fortunately, there have been major advances in understanding and treating these conditions in recent years; this is one of the most exciting areas in modern medicine. This clinical manual has earned its place in the literature as one of just a few volumes that covers all of the major anxiety disorders and presents integrated contributions from both psychopharmacologists and psychotherapists -- all in one compact work written for busy clinicians. This volume begins by reviewing recent important diagnostic, epidemiological, neurobiological, and treatment findings -- all of which have significant implications for clinicians. Subsequent chapters cover - Panic disorder and agoraphobia -- Laboratory studies of fear have significantly advanced our understanding of the neurocircuitry and neurochemistry of panic. Furthermore, panic disorder is now readily treated with both medications and psychotherapy. - Specific phobia -- Viewed for many years as mild and even trivial, this common disorder is now recognized for its very real associated distress and impairment. Exposure therapy is the treatment mainstay, though pharmacotherapy should be considered particularly when there is comorbidity.
The authors have eloquently simplified and described the core cognitions, which are fundamental to understanding what is required to promote change and cognitive restructuring for each of the disorders mentioned. The latest edition of this book retains a similar layout to the original, with additional information based on new research findings and fine-tuning of treatment techniques based on the personal experiences of the authors. The authors provide information on various assessment tools for each anxiety disorder including: its practicality; ease of administration; sensitivity and specificity. Clinicians will find this information invaluable when developing a disorder specific CBT program. Four chapters are devoted to six different anxiety disorders which include: Panic disorder; Social phobia; Specific phobias; Obsessive Compulsive disorder; Generalized Anxiety disorder and finally Post-traumatic disorder. The authors provide an overview of each disorder with a particular emphasis on classification, differential diagnosis, assessment tools, aetiology, clinical features and the latest research findings. The reader will appreciate that the authors have included a clinician guide for assessing patients for CBT, as well as monitoring treatment progress. They examine the reasons to support non-drug treatment for the aforementioned conditions but are not opposed to combining these methods with pharmacotherapy. Emphasis is placed on the additional bonus in cognitive behaviour therapy (CBT) that modifies the vulnerability factors that give rise to anxiety disorders. In addition to the clinician guide, a patient manual is included for each disorder. Each manual has a psycho-educational component that is essential for the patient to develop insights into their problem.
Fortunately, there have been major advances in understanding and treating these conditions. Here, 16 experts summarize and synthesize recent work on the diagnosis, assessment (including relevant rating scales), pharmacotherapy, and psychotherapy of anxiety disorders. Subsequent chapters cover panic disorder and agoraphobia specific phobia social phobia obsessive-compulsive disorder posttraumatic stress disorder generalized anxiety disorder Busy residents and psychiatrists in active clinical practice, psychologists, primary care practitioners, and other mental health professionals will find this clinical manual -- with its integrated approach of pharmacotherapy and psychotherapy -- a valuable tool in their everyday practices. Anxiety disorders are the most prevalent of psychiatric disorders and account for a significant proportion of the costs of mental illness. Subsequent chapters cover - panic disorder and agoraphobia- specific phobia- social phobia- obsessive-compulsive disorder- posttraumatic stress disorder- generalized anxiety disorder Busy residents and psychiatrists in active clinical practice, psychologists, primary care practitioners, and other mental health professionals will find this clinical manual -- with its integrated approach of pharmacotherapy and psychotherapy -- a valuable tool in their everyday practices. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. The general layout is systematically organized with smooth transitions into subsequent sections of the chapters. The theme is on theory and practical application of Cognitive Behaviour Therapy. (CBT).
During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician. After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well. It combines clinical and research expertise in the recognition and treatment of the anxiety and depressive disorders. Vincent’s Hospital 394-404 Victoria Street Darlinghurst NSW 2010 (02) 8382 1400. It contains the relevant treatment chapters and CBT manuals from the book The Management of Mental Disorders. During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician. After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well. During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician. After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well. During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician.
After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well. It combines clinical and research expertise in the recognition and treatment of the anxiety and depressive disorders. Vincent’s Hospital 394-404 Victoria Street Darlinghurst NSW 2010 (02) 8382 1400. Over half the material in the second edition is new, and there is an entirely new section covering post-traumatic stress disorder. This is a unique and authoritative overview of the recognition and treatment of anxiety disorders, giving Clinician Guides and Patient Treatment Manuals for each. The Clinician Guides describe how to create a treatment program, and by working through the Patient Treatment Manual together with the clinician enables each patient to understand and put into effect the strategies of cognitive behaviour therapy. The Treatment of Anxiety Disorders offers both a theoretical overview and a framework to help psychiatrists and clinical psychologists build successful treatment programs. Thoroughly revised and updated second edition of a highly successful bookJournal of the Royal Society of Medicine 'The Treatment of Anxiety Disorders is a well-referenced resource book and treatment guide.'. ADAA Reporter 'This is a terrific contribution to the field. Its unique structure, designed for both clinician and patient, is a real asset.'. Doody's 'This book goes a long way towards increasing awareness of both the art and science of conducting cognitive-behavioural therapy in clinical settings. SAMJ Forum See more reviews Social phobia: clinician guide 11. Social phobia: patient treatment manual 12. Specific phobias: syndrome 13. Specific phobias: treatment 14. Specific phobias: clinician guide 15. Specific phobias: patient treatment manual 16. Obsessive compulsive disorder: syndrome 17.
The authors have also included various worksheets for task completion, scales to measure severity of symptoms, tools to monitor progress and step-by-step instruction for patients to carry out task assignments. The content in the patient manual is user friendly and is written in simple language for easy comprehension. Obsessive Compulsive Disorder (OCD) is a complex and chronic condition. In this book, the intricate detail in making a proper assessment required to implement an effective behavioural intervention of OCD is very informative and enlightening. The book highlights difficulties with the assessment and monitoring progress since the clinician has to rely on patient self-report, more specifically, ruminative thoughts without rituals. The chapter on Post-traumatic stress disorder is revised in this edition. It was only briefly discussed in the original edition. The authors are very resourceful in developing the graded exposure technique for traumatic memories. The book contains a list of recommended resources, which can be found in the final section of the patient manual for each disorder. This is valuable information for the patient since it enables them to maintain their treatment gains once therapy with a clinician is no longer required. Some techniques are not disorder specific and may seem repetitive. However, this format allows the reader to focus their reading on a specific disorder without having to refer to other chapters. The final chapter provides a general discussion on CBT. It highlights the funding problem in designing a randomized placebo control trial similar to industry funded drug trials for valid comparison between drug and non-drug treatment outcome. The authors provide a balanced view regarding this issue. The Treatment of Anxiety Disorders: Clinician Guides and Patient Manuals is an informative book covering CBT, however it does not comprehensively cover areas on pharmacotherapy and augmentation strategies.
Addition of chapters covering these areas would have made this book more comprehensive for the treatment of anxiety disorders. I enjoyed reading this book. It provided clinically relevant information along with an in-depth guide to developing a structured treatment plan. This book will appeal to those with an educational background and training in treating mental health disorders in the outpatient setting. The content in the treatment manual is designed for adult patients. However, Anxiety disorders have an early onset and are known to be a common clinical condition in the child and adolescent out-patient population. The treatment manual in this book can be easily modified and adapted to reflect the specific developmental needs of our young patients. Articles from Journal of the Canadian Academy of Child and Adolescent Psychiatry are provided here courtesy of Canadian Academy of Child and Adolescent Psychiatry. During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician. After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well. During treatment, it is a workbook in which individuals can record their own experience of their disorder, together with the additional advice for their particular case given by their clinician. After treatment has concluded, this manual will serve as a self-help resource enabling those who have recovered, but who encounter further stressors or difficulties, to read the appropriate section and, by putting the content into action, stay well.
Obsessive compulsive disorder: treatment 18. Obsessive compulsive disorder: clinician guide 19. Obsessive compulsive disorder: patient treatment manual 20. Generalized anxiety disorder: syndrome 21. Generalized anxiety disorder: treatment 22. Generalized anxiety disorder: clinician guide 23. Generalized anxiety disorder: patient treatment manual 24. Post-traumatic stress disorder: syndrome 25. Post-traumatic stress disorder: treatment 26: Post-traumatic stress disorder: clinician guide 27. Post-traumatic stress disorder: patient treatment manual 28. Conclusions References Index. Look Inside Marketing Excerpt (170 KB) Marketing Sample (130 KB) Index (144 KB) Front Matter (204 KB) Copyright Information Page (144 KB) Table of Contents (72 KB) Authors Gavin Andrews, University of New South Wales, Sydney Gavin Andrews is a psychiatrist who is Professor of Psychiatry in the School of Psychiatry at the University of New South Wales, and Director of the Clinical Research Unit for Anxiety and Depression at St. Vincent's Hospital, Sydney, a joint university and hospital facility. Mark Creamer, University of Melbourne Mark Creamer is Director of the Australian Centre for Posttraumatic Mental Health and a Professor in the Department of Psychiatry at the University of Melbourne. He is a clinical psychologist with many years of experience in the field of traumatic stress from both research and clinical perspectives. Rocco Crino, University of New South Wales, Sydney Rocco Crino is a clinical psychologist at St. Vincent's Hospital. He is Director of the Anxiety Disorders Clinic and Manager of Psychology at St Vincent's Hospital, Sydney. Caroline Hunt, University of New South Wales, Sydney Caroline Hunt is a clinical psychologist and Senior Lecturer in the School of Psychology, University of Sydney. She is a clinician with the Clinical Research Unit for Anxiety and Depression, Sydney.
Lisa Lampe, University of Sydney Lisa Lampe is a psychiatrist and Lecturer, School of Psychiatry, University of New South Wales. Andrew Page, University of Western Australia, Perth Andrew Page was a clinical psychologist at St. Vincent's Hospital and a clinician with the Clinical Research Unit for Anxiety and Depression. He is currently Senior Lecturer, Department of Psychology, University of Western Australia, Perth. Create an account now. If you are having problems accessing these resources please emailYour eBook purchase and download will be. Generalized Anxiety Disorder (GAD) GAD is a condition characterized by persistent, excessive, uncontrollable and unrealistic worry about everyday things. Individuals meeting criteria for GAD mostly worry about the same material that the average person worries about, such as finances, their health and the health of their loved ones, and safety concerns, but people diagnosed with GAD spend much more time worrying. Whereas a healthy person may worry up to an hour a day, it is usually 3 to 10 hours per day for a person with GAD. Diagnostic Criteria People meeting criteria for GAD experience exaggerated worry and tension, often expecting the worst, even when there is no apparent reason for concern. Whereas patients with panic disorder show the very intense and short-lived fight-flight reaction experienced in case of immediate danger, patients with GAD experience the constant anxious reaction that would be normal entering unfamiliar terrain (e.g. being in an unfamiliar town at night alone), not knowing what dangers await them, they are hypervigilant. A common report is that they feel a moderate level of anxiety (such as a 60 on a 0 to 100-point anxiety scale) at all times, regardless of the situation. Although people with GAD often report social anxiety, the focus is not only on negative evaluation (as in social anxiety disorder).
GAD patients dislike uncertainty and unpredictability, and what is less predictable than another person. They anticipate disaster and are overly concerned about money, health, family, work, or daily hassles — the small things that complicate life (e.g., traffic, parking). They don’t know how to stop the worry cycle and feel it is beyond their control, even though they usually realize that their anxiety is more intense than the situation warrants. Therefore, they do their best to control the worry by distraction, by using safety behaviors (e.g., drinking alcohol; phoning loved ones for reassurance; asking many questions about events such as who will be there, how long, who is driving), and avoidance behaviors (e.g., not opening mail, not answering their phone, not answering texts). Individuals can continue to function with mild GAD and assume they are just worriers and this is how they will always be. It is often not until symptoms increase and they are having a more difficult time meeting the requirements of daily life or serious sleeping problems that they seek help. It is common for those experiencing GAD symptoms to see several medical providers to obtain assistance with the physical symptoms of anxiety such as an upset stomach, headaches, sleep disturbances, and muscle tension. Once physical causes for these symptoms have been ruled out, it may be time to consult a mental health specialist to discuss cognitive-behavioral therapy, or CBT. Individuals often begin CBT for GAD believing the following: Their worrying is out of their control. Worrying offers some protective value. Through worrying, they will be better able to manage future negative scenarios. As people move through treatment, they come to understand: They cannot control their fears, but they can control how they respond to their fears by engaging in the behavior of worrying.
Worrying offers no protective value, and in fact it reinforces negative thinking and increases the likelihood that they will experience more anxiety in the future. Worrying does not assist in managing negative future scenarios, but instead they are equipped to handle whatever future challenges come their way. Effective treatment for GAD entails assisting clients in developing new strategies to manage their worries and cope with life stressors, and how to reduce the physical symptoms of anxiety. Treatment Options Adults Children First-Line Treatments: Psychotherapy Cognitive-behavioral therapy (CBT) usually combines several different interventions: psychoeducation, worry exposure, relaxation, applied relaxation, problem-solving, cognitive re-structuring, and interpersonal psychotherapy. The most important ingredient is thought to be the exposure procedures. Variants include pure cognitive therapy, cognitive restructuring, meta-cognitive therapy, and intolerance of uncertainty therapy. This therapy is different from relaxation alone, which is not helpful. Applied relaxation entails having people relax in actual anxiety-provoking situations. Format: individual Sessions: usually 15 Cognitive-behavioral therapy for children (CBT) is aimed at the child and the parents.Most of them failed to show any advantage of combined therapy over monotherapy. One study involving older adults did show that augmentation of escitalopram with CBT was superior to continued escitalopram alone. Combination therapy can be more effective than mono therapy. A large study showed that both sertraline and CBT were more effective than placebo in treating childhood anxiety (including GAD). In addition, the combination of CBT and sertraline was more effective than either treatment alone. Second-Line Treatments: Psychotherapy Acceptance and commitment therapy (ACT) and mindfulness are newer types of cognitive-behavioral therapy, and initial studies are promising.
They teach patients to focus on the present moment and follow actions guided by their values rather than by emotions and anxiety. They should be considered third-line treatment. Adjunctive Treatments Augmentation Agents (pharmacological; not FDA approved) Olanzapine 5-10 mg qd Risperidone 0.5-1.5 mg qd Quetiapine see above Pregabalin see above Interpersonal psychotherapy (IPT) and motivational interviewing (MI) Both IPT and MI have been evaluated for augmentation of CBT, albeit in a limited number of studies, and no evidence of positive results. Exercise: A large body of work supports the beneficial effects of exercise on mood and anxiety disorders. However, currently only small pilot trials are specific to GAD. Passionflower: Generally considered safe when taken as directed, but some studies have found it can cause drowsiness, dizziness, and confusion. A few small clinical trials suggest that passionflower might help with anxiety. In many commercial products, passionflower is combined with other herbs, making it difficult to distinguish the unique qualities of each herb. Kava: Avoid using until more rigorous safety studies are done, especially if you have liver problems or take medications that affect your liver. Some studies showed kava was helpful for anxiety reduction, and others did not. More importantly, reports of serious liver damage even with short-term use caused European countries and Canada to pull it off the market. The Food and Drug Administration has issued warnings, but not banned sales in the United States. Valerian: Generally well-tolerated, with a few case reports of people developing liver problems when taking preparations containing valerian. In some studies, people reported less anxiety and stress, but in other studies, people reported no benefit. Discuss valerian with your doctor before trying it. If you've been using valerian for a long time and want to stop, many authorities recommend tapering down to prevent withdrawal symptoms.
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clinical manual for assessment and treatment of suicidal patients pdf
Download Link: ➡ clinical manual for assessment and treatment of suicidal patients pdf
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clinical manual for assessment and treatment of suicidal patients pdf
The chapter on assessment has been revised to put the fundamental components of effective treatment in a clinical, case-oriented context and includes an easy-to-use assessment protocol that allows clinicians to determine where individual patients stand on seven dimensions (cognitive rigidity, problem-solving deficits, heightened mental pain, emotionally avoidant coping style, interpersonal deficits, self-control deficits, and environmental stress and social support deficits). The many issues involved in the use of psychotropic medications in suicidal patients are addressed in a new chapter, which includes information on the relevant classes of drugs (such as antidepressants and antianxiety agents) and the issues that may arise with their use, including side effects, degree of lethality, and tendency to aggravate suicidality on introduction and withdrawal of the medication. The chapter on special populations has been expanded to include adolescents, elders, and patients with co-occurring substance abuse or psychosis. Because of additional vulnerabilities, treating these groups may call for the use of added or special techniques to ensure the best therapeutic outcomes. Primary care physicians are the first point of contact for many patients, and they may require additional preparation in order to assess and respond to those experiencing suicidal thoughts. The chapter Suicidal Patients in Primary Care explores strategies for screening, recognizing, and assessing risk; treating the initial crisis; and developing a crisis management plan. Tips for Success appear at intervals, and The Essentials are included at the end of each chapter, highlighting the most important concepts. In addition, there are scores of helpful charts and exercises. Practical, accessible, and reader-friendly, the Clinical Manual for Assessment and Treatment of Suicidal Patients is not an academic book but rather is one designed to become an indispensable part of clinicians' working libraries.
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As described in the Privacy Policy, this website utilizes cookies, including for the purpose of offering an optimal online experience and services tailored to your preferences. By closing this message, browsing this website, continuing the navigation, or otherwise continuing to use the APA's websites, you confirm that you understand and accept the terms of the Privacy Policy, including the utilization of cookies. Although clinicians cannot unerringly predict which patients will die by suicide, they can focus more successfully on early identification of suicidal behavior and effective intervention, and this new edition of the clinical manual thoroughly explores not only assessment of suicidality but what comes after an at-risk patient has been identified. The authors argue that treating specific psychiatric disorders is not enough to prevent suicide, and they offer clinicians the necessary information and strategies to bridge that gap. The authors’ main premise is that suicide is a dangerous and short-term problem-solving behavior designed to regulate or eliminate intense emotional pain—a quick fix where a long-term effective solution is needed—and this understanding is the underpinning of the assessment and treatment strategies the authors recommend. The content of this new edition has been thoroughly reviewed and revised, and substantive changes have been made to specific chapters to ensure that the book represents the most current thinking and research, while retaining the strengths of the previous edition.
Used: Like NewFor many patients, however, treating the mental illness is not enough -- that is, suicidal behavior is not necessarily reduced by treatments that target those illnesses. Something more is needed. In this provocative and insightful work, Drs. Chiles and Strosahl offer a concrete, practical framework to fill this gap. In doing so, they challenge one of the chief underlying assumptions of traditional approaches to suicide assessment and treatment -- that suicidal behavior can be predicted and controlled. In its place, they propose a new conceptualization of suicidality -- as learned, reinforced problem-solving behaviors that an individual uses when all other options seem to have failed. Rather than focusing on risk prediction and management, interventions in this learning model target the problems that the suicidal behavior is being used to solve. The assumption is that a patient's suicidal behavior represents his or her best attempt at that moment in time to deal with life's difficulties. The clinician's initial task is therefore not to judge or criticize but rather to acknowledge the struggle and pain the patient is experiencing and to help the patient begin to explore other ways of dealing with the overwhelming troubles. Efforts to reduce suicidal risk are accomplished by techniques that maximize individual autonomy and encourage positive behaviors -- the person's unique resources for addressing and modifying the suicidal behavior. Designed to be used both for personal instruction and as a training manual, this comprehensive guide. In Clinical Manual for the Assessment and Treatment of Suicidal Patients, the authors -- a psychiatrist and clinical psychologist -- have combined their diverse training and disciplinary backgrounds to create a workable approach to dealing with suicidal patients.
Suicidality and Special Populations Chapter 11. Suicidal Patients in Primary Care: Responding to the Challenge Appendix A: Philosophies About Suicide Appendix B: Consequences of Suicidal Behavior Questionnaire Appendix C: Reasons for Living Inventory Appendix D: Malpractice Management Assessment Appendix E: Suicidal Thinking and Behaviors Questionnaire Index Laura Weiss Roberts, M.D., M.A., is Chair and Katharine Dexter McCormick and Stanley McCormick Memorial Professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California. Multidisciplinary in approach, it regards suicidal behavior as not only a symptom of psychiatric illness but as a behavior that can be reinforced and also extinguished. From the moment the evaluation of a suicidal person begins, the behavior is being reframed as a response to problems that require a response. Evidence-based measures are highlighted, and the use of vignettes and examples of interviewing styles ground this volume in clinical practice. It should be essential reading for everybody working in this most challenging area.— Patricia R. Casey, M.D., FRCPsych, is Professor of Psychiatry at University College Dublin in Dublin, Ireland Their wise approach puts needless fears and anxieties about legal and ethical matters to rest and instead empowers practitioners to assess suicidal behavior with confidence and to effectively intervene with it. This book should be on the shelf of every psychiatrist, psychologist, primary care provider, social worker or counselor who wants to be effective in the moment of a suicidal crisis. It is useful to the intended audience as well as those in other specialties and students.— Valerie E Mathis-Allen, M.D., Doody's Book Reviews. The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again.
It also has been my experience that the intervention has been more helpful in the long run for clients than just predicting risk and hospitalizing as needed. This book offered a lot of revelatory ideas that I still use. Introduction: the dimensions of suicidal behavior. The clinician's emotions, values, legal exposure, and ethics: global issues in the treatment of suicidal patients. A basic model of suicidal behavior. Assessment of suicidal behavior and predisposing factors: blending your assessment with treatment. Outpatient interventions with suicidal patients. The repetitiously suicidal patient: evaluation, psychotherapy, and basic case management. Discover everything Scribd has to offer, including books and audiobooks from major publishers.Browse Books Site Directory Site Language: English Change Language English Change Language. Du kan ocksa ha rakat pa en felaktig lank. Anvand garna var sokruta overst pa sidan for att hitta fler alternativ.Jag forstar. You must be logged in and have 100 points to unlock it. Although clinicians cannot unerringly predict which patients will die by suicide, they can focus more successfully on early identification of suicidal behavior and effective intervention, and this new edition of the clinical manual thoroughly explores not only assessment of suicidality but what comes after an at-risk patient has been identified. The authors argue that treating specific psychiatric disorders is not enough to prevent suicide, and they offer clinicians the necessary information and strategies to bridge that gap. Because of additional vulnerabilities, treating these groups may call for the use of added or special techniques to ensure the best therapeutic outcomes.- Primary care physicians are the first point of contact for many patients, and they may require additional preparation in order to assess and respond to those experiencing suicidal thoughts.
Much more than merely an academic text on suicide, this thought-provoking handbook provides detailed guidance and a true sense of what to do to help suicidal patients. Practitioners in all domains of health care -- clinicians, residents, therapists, and graduate students in psychiatry, psychology, social work, and nursing -- will benefit from this valuable and accessible work. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. It is highly recommended as an excellent, readable resource for clinicians and administrators in the mental health and medical fields. It deserves a place on the bookshelves of any educational or professional library serving students or practitioners in the fields of medicine, psychiatry, social work, psychology, or counseling. --E-StreamsMuch more than merely an academic text on suicide, this thought-provoking handbook provides detailed guidance and a true sense of what to do to help suicidal patients. Practitioners in all domains of health care -- clinicians, residents, therapists, and graduate students in psychiatry, psychology, social work, and nursing -- will benefit from this valuable and accessible work. Kirk Strosahl, Ph.D., is a Clinical Psychologist at Mountainview Consulting Group Inc., in Moxee, Washington. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Please try again later. Swoods459 5.0 out of 5 stars Thre are clear practice examles and a lot of studies noted a well balanced and useful work.I have used Chiles' and Strosahl's approach for several years now and find that it really de-escalates crisis situations.
Consistently, patients with borderline personality disorder (BPD) that are among the individuals with the highest rates of chronic suicidal ideations (SI), NSSI and repeated suicide attempts, experience both, highly frequent hospitalizations and termination of treatment as a result of their high suicidality ( 13, 14 ). Hence, what is behind chronic suicidality. What are the psychological mechanisms that maintain its chronicity. Can we apply concepts that helped us understanding and treating NSSI also for suicidal behavior. Can or should we do therapy in suicidal patients at all. And if yes, what are useful interventions. Suicidality and Non-Suicidal Self-Injury in Borderline Personality Disorder NSSI (e.g., cutting, scratching, head banging, skin burning) is a world-wide phenomenon that occurs not only in BPD ( 15 ). As highlighted in the recent meta-analysis of Taylor et al. ( 19 ), we learned that NSSI can have a wide range of underlying functions within an individual ( Table 1 ). Table 1 Function of non-suicidal self-injury and suicide attempts. For this reason, items that are likely to be related appear in one line. These observations correlate nicely with recent neurobiological findings of NSSI, so that we can now retrace why patients repeatedly harm themselves - accepting necessity of surgical intervention, subsequent conflicts with their relatives, and even stigmatizing scars on their skin. In particular, NSSI reduces the activity of the amygdala while functional connectivity to the superior frontal gyrus is normalized in resting-state functional magnetic resonance imaging ( 23 ). Clinically, aversive tension decreases immediately after NSSI, and patients can think clearer again. It is further assumed that NSSI activates the reward system including the endogenous opioid system, presumably also the endocannabinoid system ( 24 ).
In a prospective clinical study of frequently self-injuring BPD patients using continuous palmtop assessment of emotional states, Houben et al. ( 25 ) have impressively demonstrated the strong contingency between the occurrence of an aversive emotional state and subsequent NSSI. Clinically, we can use this background knowledge in therapy. For example, behavioral analysis like the stimulus-organismic-response-contingencies (SORKC or SORC) model of reinforcement-consequence ( 26 ) can illustrate to the patient in terms of psychoeducation that NSSI is a negative reinforcer (reduction of aversive tension) increasing the probability of NSSI in the next stressful situation. Most simply like in Dialectic Behavioral Therapy (DBT), the therapist can explain why it is necessary to stop NSSI and develop alternative means (“skills”) to reduce aversive tension in order interrupt the reward contingency received by NSSI ( 14 ). Can Suicidality in Borderline Be Conceptualized Similar to Non-Suicidal Self-Injury. Brown, Comtois, and Linehan ( 20 ) were among the first investigating the background of NSSI in comparison to suicide attempts (SA). They found that in both cases, emotional regulation was a predominant function. In a between-person analysis, NSSI was more intended to generate feeling, self-punish, express anger and even distract, while SA was significantly more often intended to make others better off. Interestingly, self-punishment significantly differed between suicide attempters and non-suicidal self-injurers in the between-persons comparison, but not in the within-person comparison. The authors hypothesize that people who engage in non-suicidal acts intend to self-punish with both suicidal and non-suicidal parasuicide. Similarities and differences between NSSI and SA are depicted in Table 1.
The chapter “Suicidal Patients in Primary Care” explores strategies for screening, recognizing, and assessing risk; treating the initial crisis; and developing a crisis management plan.- “Tips for Success” appear at intervals, and “The Essentials” are included at the end of each chapter, highlighting the most important concepts. In addition, there are scores of helpful charts and exercises. Practical, accessible, and reader-friendly, the Clinical Manual for Assessment and Treatment of Suicidal Patients is not an academic book but rather is one designed to become an indispensable part of clinicians’ working libraries. Recent Posts. While BPD patients continue suffering from distress and aversive emotions, therapists and relatives feel often stunned and helpless when confronted with suicidality resulting in interruption of therapies, repeated presentations to emergency rooms and referrals to hospitals. Reviewing the current knowledge of the functions and background of non-suicidal self-injury, we learned that reinforcement mechanisms play an important role to understand why individuals act in deliberate self-mutilation. While individual motives for non-suicidal self-injury and suicidal behavior including suicidal ideations can differ, the principle mechanisms appear to be transferrable. Elucidating the individual motives and function of suicidal behavior is an important therapeutic step, giving us access to very central maladaptive schemes and false believes that we need to address in order to reduce chronic suicidality in BPD patients. This Perspective article aims to give a better idea of what is behind and what are the differences between non-suicidal self-injury, suicidal ideations and suicide attempts. It further integrates recent developments of behavioral science in a reinforcement model of suicidality that can provide therapists a practical armamentarium in their work with chronic suicidal clients.
Keywords: suicidality, borderline personality disorder, psychotherapy, reinforcement, behavioral analysis, suicide attempt, non-suicidal self-injury, DBT Introduction Suicidality is one of the most alerting and urgent symptomatology in mental health. It summarizes a subset of psychopathological phenomena ranging from suicidal ideations (including thinking about, considering and planning suicide) to ambivalent suicide attempt, suicide attempt and suicide ( 1, 2 ). Across psychiatric disorders, risk factors for suicidal behavior such as childhood maltreatment, non-suicidal self-injury (NSSI), and previous suicide attempts have been identified ( 3, 4 ). Further, suicide rates even increased in some populations such as adolescent girls during last years ( 5, 8 ). On the other hand, mental health care providers often refuse treating suicidal individuals or refer clients that become suicidal, with few evidence that treatment termination, referrals, or even involuntary hospitalization are effective in reducing suicide risk ( 6 ). Although we know, that the majority of suicide ideators will never act on their thoughts ( 9 ), in clinical practice, we do not have useful indicators (like fearlessness about death, subjective pain tolerance, and objective pain persistence) that help us to differentiate between suicide ideators and attempters ( 10 ). Further, NSSI often co-occurs in individuals with suicidal behavior, and although it is by definition not intended to be suicidal, clinical differentiation and appropriate managing can be demanding ( 3, 11 ). We further do not have good evidence for any pharmacological approach that addresses suicidality in these individuals ( 12 ).
Nevertheless, suicide attempts are just one symptom of suicidality and patients not conducting SA may still have frequent suicidal ideations or occupy with death and suicide in the internet and exchange suicide methods in social media ( 27 ). Indeed, SA typically occur in a circumscribed (early) phase during the course of BPD ( 28 ), whereas suicide ideations tend to persist over years ( 29 ). Fatally, it also turned out that highest suicide rates occur later in the course of the illness and follow long courses of unsuccessful treatment ( 30 ), meaning that patients are not at their highest risk of suicide when they are young and frequent visitors to the emergency room ( 29 ). Thus, working in therapy with chronic suicidality (beyond management of NSSI and SA) appears to be mandatory in order to prevent later suicides. At this point, the question rises whether we can simply adapt the reinforcement model described for NSSI to chronic suicidality. Can we assume similar contingency consequences for the appearance of suicide ideations in aversive emotional states. In other words: Can Thoughts Be Modeled Like Behavior in Psychotherapy. When we work with behavioral analysis in psychotherapy, we usually focus on (mostly) dysfunctional behavior, i.e., things that we have done, that have some kind of positive or negative consequences. As seen above, these consequences can reinforce me to act similarly the next time: Cutting in a stressful situation, e.g., will immediately reduce aversive tension (negative reinforcement) and may even give me the feeling of control over my emotions (positive reinforcement). But, is being absorbed to suicidal ideations really that different if these suicidal thoughts give me a kind of perspective, relief or just the idea that the current aversive situation will end.
Similar to various behavioral patterns assigned to Hayes's so-called Experiential Avoidance ( 32 ), like NSSI, eating disorder or substance abuse that function to escape, avoid or modify an experience, suicidality can be regarded as a way to suppress emotions with suicide being the ultimate attempt at controlling psychological pain ( 33, 34 ). It was further Hayes ( 35 ), who integrated the obvious conceptual gap of internal processes (cognition) and behavior in his Relational Frame Theory ( 35 ) and, therapeutically, in the Acceptance and Commitment Therapy (ACT) ( 32 ). Assuming, according to the ACT theory, that human behaviors are functional, suicidality including thinking of suicide can be regarded as “a learned method of problem solving that involves escaping from or avoiding intense negative emotions” ( 31 ). Hayes states, that compared to classical reinforcement models (e.g., avoidance of closed rooms in agoraphobia, or relief from obsessional thoughts (e.g., contamination) by acting out compulsions (e.g., excessive hand washing), the relief in these situations is not directly conditioned (i.e., persons have not experienced that death releases emotional pain). Thus, applying this model to chronic suicidality in BPD, suicidal ideations (the verbal behavior) can reduce hopelessness, helplessness or unbearable anger and act as a negative reinforcer that will increase the probability of similar suicidal associations in an upcoming situation that produce similar aversive tension ( Figure 1 ). The individual that experience a relief from suicidal ideations may feel an even bigger reinforcement value when he considers how, when, and where suicide would occur ( 31 ), letting him researching suicide methods in the internet, discuss suicide in online platforms, or even, when he prepares a suicide by collecting pills, looking for an appropriate place for hanging or a bridge to jump.
The individual who ideates suicide, “from this perspective, experiences the ultimate reinforcement—a way to permanently and completely control difficult emotional experiences” ( 31 ). Open in a separate window Figure 1 Chain analysis and stimulus-organismic-response-contingencies (SORKC) model of suicidal symptoms: A behavioral (chain) analysis of suicidal symptoms (e.g., suicidal ideation, internet research, preparation of suicide) that occur after the boyfriend of Jess questioned their relationship (cue, S). Jess instantly is surprised and fears losing Pete (primary emotions directly related to the situation; grief would be likely also). The first emotions disappear rapidly while Jess's maladaptive cognitive schemes (O) get activated (her interpretation of the situation against the background of her childhood experiences). These judgements in turn activate secondary emotions (like helplessness, hopelessness, panic) causing significant distress. Of note, these transitions from primary emotions to secondary emotions can be very fast letting patients even not notice their primary emotion at all ( 14 ). Thinking of suicide, the visit of suicide chats in the internet and suicidal communication with peers (R) calms Jess down and gives her a kind of feeling of control and hope (“I could escape,” “There is a way out,” “I must not suffer”). Contagious Suicidality. It is frequently observed (for example in acute psychiatric settings) that BPD patients adopt dysfunctional behavior from other BPD patients (e.g., cutting although not having cutting before) indicating that the behavior must have a quite strong (at least short-term) positive consequence (they find out what helps best or they feel connected to peers that understand their need) ( 37, 38 ). One can speculate that exchange of suicide topics in online platforms is a similar phenomenon where patients try out different suicidal associations while discussing among each other.
Not only can a suicidal association in Hayes's sense act as a negative reinforcer as described above (e.g., relief of pain), the exchange itself may become a kind of addictive behavior. In his theory of suicide addiction, Tullis ( 21 ) nicely describes these observations in his patients: Contemplating suicide can be pleasurable in some people, or, at least can be a break from psychological pain. Suicidal thoughts or behavior can be a form of self-medication in these individuals and reliving previous suicide attempts in thought or imaging death can become a ritual (or even trance-like) behavior providing a sense of control and an optional way out of pain. In his patients, Tullis further observed a calming sensation during suicidal thinking (up to a “rush,” “high,” “thrill,” “exhilaration”), they developed a tolerance to the effects of suicidal thoughts over time and engaged in compulsive rituals and behaviors, including secretly collecting and hoarding paraphernalia for suicide, characteristics we observe similarly in addictive disorders. Hence, these behavioral observations support the hypothesis that in some individuals, occupation with suicide is pleasurable, reduces pain and becomes “a way of life” ( 39 ) - psychologically spoken, are object to reinforcement and contingency loops. Judgments and Beliefs Are the Toxic Ingredients of the Reinforcement Model of Suicidality When we look out for a new approach addressing suicidality in BPD, then working with the background and motives becomes vital in the proper sense. In the language of behavioral analysis, it is the organism variable that determines how we rate and react upon upcoming stimuli ( 40, 41 ). Besides biological factors, the organism variable is largely influenced by experiences we made, messages we became when we were a child or parent models we had ( 42 ).
Similar to our clinical example in Figure 1, suicidal adolescents and BPD frequently share believes of being worthless, inadequate, rejected or blameworthy resulting from invalidation or traumatization ( 33, 42 ). As shown recently, dependent of the severity of BPD, aversive emotional states can then highly contingently linked to a specific dysfunctional behavior (e.g., intense anger after being offended, or NSSI after being disappointed) ( 44 ). Using behavioral analysis, the therapist may elucidate reinforcing contingencies within the vicious chain of cues, activated faulty believes and subsequent suicidal ideations. He further can look for more adaptive behavioral alternatives or identify possible obstacles that inhibit the application of functional behavior. Typical obstacles can be, e.g., intensive emotions of fear, shame or guilt, or faulty believes and assumptions (e.g., “I am a looser,” “I have no right”) ( 14 ). The latter is probably the most important aspect that helps understanding the background and function of suicidality in these patients. Similar to the reinforcer model of NSSI described above, we can speculate that the confirmation of central schemes together with the reinforcement of suicidal ideations stabilizes the dysfunctional system of chronic suicidality. Conversely, in NSSI on the other hand, the rapid dynamic of the next aversive emotional states directly after NSSI exemplified in the Houben study ( 25 ) acts as a punishment in the behavioral sense, resulting presumably in an earlier fade out of self-injuring behavior after some time (as frequently observed in the courses of BPD), while chronic suicidality persists. Interventions Deduced From the Reinforcement Model of Suicidality Addressing the motives and psychic function behind suicidal behavior depending on specific situations (or triggers) may be a first, but potentially very powerful step in the therapeutic work with suicidal BPD patients.
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clinical laboratory sample collection manual
Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC. Please follow this link for the addresses and hours of operation of these facilites. Urine containers requiring special preservatives are not stocked on the floors, but can be obtained from the specimen processing desk at each hospital laboratory. This information is also available via the individual test entries in our test menu. Other collection tubes may be rejected. While the minimum volume necessary for testing is stated in the test menu, when clinically possible it is advisable to collect the preferred volume, as this will allow for repeat testing when necessary. We recognize that this is not always possible, and will make every effort to provide a result on the sample submitted If it is necessary to draw proximal to an IV it is important that the IV be stopped and the vein allowed to clear (minimum 1 minute) before the sample is drawn. Laboratory phlebotomists have been instructed not to collect samples proximal to an IV, and will ask nursing personnel to stop the IV prior to phlebotomy and restart it after the samples have been collected. Short filling a citrate tube (Blue top) will alter the required 9:1 plasma:citrate ratio and may result in erroneously prolonged coagulation test results. This will ensure that an adequate blood volume is collected. If a patient's hematocrit is above 55%, contact the Hematology laboratory and request a tube adjusted to contain the appropriately decreased amount of citrate anticoagulant. There is no standard at present for adjusting the amount of anticoagulant for specimens with low hematocrits. Check the expiration date of all tubes prior to collecting samples and discard any expired tubes. DO NOT use expired tubes for sample collection.
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Click to login or enroll. Visit our Help Center Click to login or enroll. Visit our Help Center This Specimen Collection Manual is a professional service that gives our teams the information they need to ensure your tests are collected correctly. This reduces the chance of an incorrect test result. It serves communities in 28 states. The organization offers acute and ambulatory care, an insurance company with a dental plan, and post-acute and academic business lines. Driven by its Mission to improve your health and well-being, ProMedica has been nationally recognized for its advocacy programs and efforts to address social determinants of health. For more information about ProMedica, please visit About Us. Quality specimens must be collected in order to provide the most clinically relevant microbiology results for our patients ( The instructional information should be made available to your clinicians, clinical laboratory scientists, nursing staff, patients, or other clients. Specimens are to be labeled with the patient name and medical records number. The last preanalytical consideration before processing the specimen is to ensure that the specimen is processed in accordance with the test ordered and the organism suspected. The tables in this section are meant to be used as a guide for these important preanalytical steps. Leber A (ed),ASM Press, Washington, DC.ASM Press, Washington, DC. ASM Press, Washington, DC. ASM Press, Washington, DC. American Public Health Association, Washington, DC. Star Publishing Co., Belmont, CA. Elsevier Inc., Philadelphia, PA. ASM Press, Washington, DC. J Infect Dis 141: 531. Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.Leber A (ed),ASM Press, Washington, DC.
If one is not available, a screw-top container or extra padding is acceptable. Be aware that dry ice is a dangerous good and must always be declared by marking, labeling and documentation. If there are no other dangerous goods in a shipment with dry ice, a formal Shipper’s Declaration is not required. Refer to IATA packing instruction 904. If this is not possible, specify antibiotic in the request. Contamination can usually be evaluated by the number of epithelial cells seen on gram stain examination. It is preferable to obtain specimens bypassing normal flora whenever possible. For urines, single catheterized specimens are cleaner than midstream clean catch specimens. Deep wounds collected by aspiration are preferable to superficial swab collection. For sputum specimens, having the patient rinse their mouth before expectorating may reduce oral-pharyngeal contamination. Follow instructions for proper use of specimen collection devices provided with each unit. Use no fixatives or bacteriostatic agents for cultures. View guidelines for choosing the correct swab or container for the test. Deliver immediately if results are needed STAT. Urine can be refrigerated if delivery is delayed.Please contact the laboratory for provision of required transport tubes or, if necessary, STAT pickup. Note: Due to the instability of Neisseria gonorrheae, specimens for GC culture from off-site clinics should be collected in transport media. Anaerobic transport media is usually not necessary if the specimen is delivered to the laboratory immediately. Do not inoculate blood culture media except for peritoneal fluid and also send uninoculated fluid in a sterile container. This occurs periodically for routine preventive maintenance, reprogramming procedures and back-up of the system.This may be temporary, lasting as little as a few minutes or more severe, lasting hours.
If, by contrast, the venipuncture is difficult with much searching for the vein, the blood flow is slow, or the collection is made into a large syringe, the coagulation cascade may become activated; in that case, an initial blue top tube should be filled, discarded and a second filled tube should be collected for testing. The anticoagulants and clotting activators in each tube are specific for the type of sample necessary for testing. Transferring sample between tubes results in adulteration of the sample and will produce spurious test results. If blood is to be obtained from a catheter, it must be collected by nursing staff. If unavailable, a plastic vial with a black screw top cap is acceptable. Each vial should be labeled with patient information (full name and medical record number are minimum requirements) and also list the name of the person who collected the specimen and the date it was collected.In this circumstance cell counts should be interpreted with caution. Go to the UCD Pathology page. This will provide enough sample to perform multiple tests with adequate volume for repeat analysis and add-on tests. To ensure the best patient care, if at all possible, CSF samples should be submitted in this manner. This often provides sufficient sample to perform chemical tests, cell counts and culture though, depending on the exact volume submitted, the laboratory cannot guarantee the ability to perform every ordered test. Tests ordered for which there is not enough CSF to perform the test will be resulted as “quantity not sufficient for analysis” (QNS). In addition, submitting fewer than four tubes will necessitate that a single sample be shared among multiple laboratory departments which may increase the result turnaround time. Note: specimens known to originate from patients with a Risk Group II or II pathogen should be shipped as Biological Substances. A 95 kPa bag or container is recommended.
Use at least two patient identifiers when collecting blood samples and other specimens for clinical testing. See Specimen Labeling section of this web page. Using the wrong container often leads to erroneous results. See the test catalog for exact requirements. Specimens must be submitted to the laboratory in the container used originally for collection. See Test Catalog for storage and transport requirements. When red cells are hemolyzed, there is a release of these analytes and dilution of plasma, resulting in erroneous laboratory values. Then draw the syringe for the desired tests. The “flush” may be given back to the patient if needed. Time is measured from receipt of the specimen in the laboratory to release of results. The following policy for unacceptably labeled specimens will be enforced: If a specimen is placed in a plastic bag, it is not adequate to place a label on the bag rather than on the tube. Whenever the specimen itself is not labeled, the label will be considered unacceptable. There are no exceptions. Click here to view UCHealth “Blood Administration” policy. Labels must be straight, wrinkle-free, and oriented as follows: Refer to “Specimen Labeling” section of this document. Prompt transport of fresh specimens is expected. If unable to transport within this guideline, the specimen must be refrigerated until delivery. 24-hour specimens are unacceptable for urinalysis testing. Catch midstream specimen in a sterile urine container. Collection containers must not have been cleaned using detergents or have contained any liquid other than distilled water previous to the collection. The laboratory does not supply collection containers. Please refer to the individual test listings for details of preservative requirements. Dietary restrictions are required for some procedures and are specified in the individual test listings. Add this specimen to the collection container. Write this time and date on the bottle.
Depending on the length of the downtime and the anticipated time to start up, critical values will be called and STAT results will be faxed, tubed, or hand-delivered to the ordering unit until computer operations are restored. The distance from the nose to the ear gives an estimate of the distance the swab should be inserted.Immediately place swab into the M4 Transport media. Leave swab in transport media. Swab should be entirely enclosed in tube, no wire should extend past lip of tube. Replace lid to transport media, tighten to prevent leakage during transport. Transport same day, refrigerated or on ice. If delivery is not expected within 24 hours, freeze at -70 degrees C and ship on dry ice. Base syringe size and tubing length on age and size of patient. Amount depends on size and age of patient. Attach tubing to syringe tip. NOTE: Recovery must occur rapidly or instilled fluid will rapidly drain down the throat. Repeat with other nostril and inject specimen into same container. Discard syringes and tubing or bulb in biohazard waste. Mark with thumb and forefinger. Adjust suction to appropriate pressure. NOTE: Don’t use lubricants other than saline to aid tube insertion. Hold trap upright to prevent loss of secretions from trap. NOTE: Catheter should remain in nasopharynx no longer than 10 seconds Label trap and place in biohazard bag. Ensure that lids of containers are secure. The secondary container is a securely sealed zip lock plastic bag labeled with the biohazard symbol pictured below. Exception: Blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from this requirement. Specimens must be obtained in the proper tubes or containers, correctly labeled, and then promptly transported to the laboratory. Obtaining reliable and accurate laboratory test results The following are essential safeguards for your patients.
Refer to the Online Testing Guide For timed collections, patients should be given two containers and Patients should receive Specimen containers should be labeled with the type of preservative added. DISCARD THIS VOIDING since the urine was formed prior to the collection COLLECT ALL SUBSEQUENT VOIDINGS UNTIL THE SAME TIME ON THE SECOND DAY, emptying Preservative may have been added to the container; this may As a guideline, START THE COLLECTION Submit only the required aliquot of a Refer to the Online Testing Guide to determine the appropriate pH adjustment. Carefully following instructions The specimen should be labeled and refrigerated until pick up. A clean catch or The patient should void a small amount of urine before collecting in a clean container. Make sure the swab is fully immersed in the UTM, and that Send to the laboratory as soon as possible. This specimen is appropriate for PCR or culture for many In cases of mumps, swab the inflamed orifices of Stenson's ducts. Swabs should Break or cut swab making sure that the swab shaft doesn't extend beyond the top of the vial, secure Break swab off immediately into universal transport media.Swabbing pus collection in corner of eyes is not adequate. First morning voids usually contain the highest titers of virus.PCR is a much more sensitive method for diagnosing viral infections from CSF. 0.2 mL per PCR test ordered is Do not dilute in universal transport media (UTM).Macular lesions do not yield high titers of viruses. Vesicular lesions should be opened with a The swab should be placed in a vial of universal transport. Lesion specimens collected in this manner provide material both for PCR or viral Do NOT add the flocked swab to the transport media. Large pieces may be Tissues for PCR testing do not need to be placed in transport media. Heparin is inhibitory to PCR reactions and should be avoided.
Specimens should Laboratory procedures are performed ONLY upon a physician's written CLIA-88, the Joint Commission, and Fold completed request form and place in the outside If submitting multiple specimens with different storage temperature requirements, use separate bags and requisitions for each sample. Be sure label or tag is secure. For these rare Any questions should be directed to Client Support All specimens must be bagged for handling. The request forms must be in a Please follow the appropriate directions whether you intend to use our All specimens should be Containers for shipping Shipping containers should be filled with dry ice to prevent samples Specimens should be shipped in containers Do not ship frozen specimens in glass containers Mark the outside of the container with label: FROZEN MATERIAL - DO NOT THAW. Place on a coolant pack and fill the vacant space with any type of Mark the outside of the container: REFRIGERATED However, safe specimen Such options will be The courier route includes bus and air freight depots. Stops are made at Sea-Tac Stops are made at the Greyhound Bus Terminal in the morning and afternoon, See Transport and Packaging of Specimens. Routine specimens At times outside of these hours, please call the For information, assistance, or for pre-addressed labels, call (206) 520-4600 or. All internal and frequently ordered send out tests can be found in this section. A test can be selected from the list, or the list can be searched by test name. The Quest test code can also be included, if known. Lab staff will research the requested test and contact the ordering provider if there are any issues. Following are general guidelines for blood and urine (urinalysis) specimen processing and handling at this facility. Use good laboratory working practices when handling specimens. Follow all bio-safety practices established by OSHA. All tests requested by the physician should be properly identified with a written or electronic order.
Indicate collection start date and time and stop date and time in the request. The laboratory will measure and report the total volume on all timed urines. Alternatively, it is acceptable to submit an aliquot of a well-mixed, accurately measured urine specimen. The total volume must then be included in the request. By continuing to use this site you are giving us your consent. Learn how cookies are used on our site. Accept terms. Separate plasma as soon as possible, Transfer plasma to a plastic vial and indicate the anticoagulant used on the label. Avoid hemolysis, as Let specimens clot at room temperature unless otherwise specified, and Transfer serum to a plastic vial unless otherwise specified. Avoid hemolysis, Indicate the anticoagulant used on the label. Do not allow to freeze. Do not substitute the yellow top (SPS) Do not allow to freeze. This tube must be accompanied by Please see test guide or contact Transfusion Support Lab (TSL). After drawing specimen, invert the tube to If frozen plasma is required, pour off plasma into plastic vial and freeze. This is used for Immediately after filling the tubes, shake them ten (10) times just firmly enough to make sure the entire This will dissolve antigens on the tube walls. They are used for serum The tube is used for the collection of serum for selected chemistry tests and special An SST tube should never be substituted as the gel barrier can interfere with analysis. Please contact Client Support Services before collection. This tube is a serum separator tube with clot activator and barrier gel to separate This tube is used for common chemistry panels such as the Basic and Comprehensive Metabolic Panels, This tube should not be used for drug Cell-Free DNA BCT stabilizes cell-free Tube must be accompanied with requisition specific to this test.
While not always feasible, specimens should be Specimens should be collected in a manner which minimizes contamination When multiple tests are ordered, sufficient samples or volume should be submitted in order to provide for the Do not add fluid to the container. Larger pieces of tissue are ideal and Remove the needle and replace it with a stopper. Alternately, collect the fluid in an empty Do not remove the liquid transport media in the ESwab as this is Alternatively, samples may be collected using Amies gel transport swabs for culture, however they may Dry swabs are not acceptable for bacterial culture testing. On request form, clearly indicate site of the body Note: See below for more information on Virology swab collection. Obtain specimen from the most active site of the wound. Take care not to swab Each set contains one aerobic (Redox1) and one anaerobic (Redox2) bottles. Ideally add 10 mL of Note the original volume of media in the bottle before inoculating and add to a 10 mL mark above. Do not overfill For infants the minimum volume is 0.5 mL in one aerobic bottle. For UW Medicine only: If unable to draw directly into a blood culture bottle, draw into a SPS tube (not ACD) The Isolator tube must be filled to the line on the side. If the tube is not filled completely In cases of Catheter tips specimens should be the segment near the skin and tip end and must not Longer tip segments can be cultured but will not be given a colony count. Note: Foley catheter tips Instruct patient on the need for Collect specimen in a sterile container. A good specimen will show purulent material. If the specimen is watery and almost Transport in Cary-Blair for bacterial culture and Enteric Pathogen For fecal leukocytes or C. difficile testing transport fresh stool in a clean container. Submit in an approved For Viral culture, clean catch Morning voids have highest titers.Urine collection containers are available on request.
These are requirements for acceptable specimens. These requirements may also be found in the Specimen Handling sections of individual assay procedures. The Lab Supervisor will notify the Medical Director, or their designee, who will message all clinicians potentially afffected by the discarded specimen. If the specimen is collected in a plain red top tube, carefully separate the serum from the clot, and transfer it to a specimen container that can be capped and labeled. Label it with complete patient information. Store at conditions recommended by the reference lab. Specimens collected in these tubes may be stored without transfer, as long as the gel creates a complete separation between serum and red cells. Separate plasma from cells. Follow reference lab instructions for storing and sending plasma. If plasma is frozen, it should be frozen rapidly (-20 degrees C or lower). The ICSH (International Committee for Standardization in Hematology) defines fresh blood specimens as processed within four hours after collection. Whole blood collected in EDTA provides accurate results for all parameters within eight hours of collection. Gently invert the collection tube several times just prior to sample transfer. Do not shake the collection tube; shaking may cause hemolysis. Glucose concentrations are affected by the length of time since the patient has eaten and by the type of sample collected from the patient. To accurately determine glucose results, samples should be obtained from a patient who has been fasting for at least 12 hours.If analysis of the specimen is to be delayed, carefully separate the plasma from the red blood cells, and transfer it to a specimen container that can be capped and labeled. Store at conditions recommended by the method manufacturer. Bring the sample to room temperature before testing. If urine is not tested immediately, mix the specimen before testing. Do not centrifuge before performing the chemical portion of the analysis.
Take care not to touch the inside lip of the container or the underside of lid. At the end of this time, void one last time and add this sample to the container. Separate two aliquots of urine and label both adequately. Include the 24 urine volume on the labels. Send one to the reference laboratory and keep one in the facility laboratory refrigerator until completed results from the reference laboratory are received. There are also very specific instructions in the restrooms. Remove the cap. Gently rotate for 10 seconds. Screw the cap tightly on the tube. There are also very specific instructions in the restrooms. Remove the cap. Gently rotate for 10 seconds. Screw the cap tightly on the tube. For patients checking in after 4:30, the Lab staff reviews the orders and consults with the ordering clinician or charge nurse, as necessary, to determine testing urgency. This is necessary to allow for adequate clotting and spinning time prior to the daily reference lab pick up at 5pm. However, if the in-house labs are ordered STAT, the Lab staff will draw the in-house labs that day. A late blood draw will be done, the blood processed, and the Lab will request a STAT pick up from our reference lab. In these cases, the outdoor lock box is used to secure the specimen until the reference lab courier arrives. Because the lock box is located outside, temperatures are variable and specimen quality may be compromised. The UF College of Nursing continually attracts and retains the highest caliber of nursing students and faculty with a passion for science and caring. Ranked among the top schools of pharmacy nationally, the college supports research, service and educational programs enhanced with online technologies. We offer a a four-year Doctor of Veterinary Medicine programs as well as M.S. and Ph.D. degrees in Veterinary Medical Sciences. Our state-of-the-art medical center serves an urban population of 1 million from north Florida to south Georgia.
Students rotate through the various clinical settings on the campus, and primary care centers and specialty care centers located throughout Jacksonville. Also offered on campus is an American Society of Health-System Pharmacists-accredited pharmacy residency program at Shands Jacksonville. That is why we provide online Continuing Medical Education (CME) courses for you to complete for CME credits. These courses share the latest in medical knowledge, teach new patient-relationship skills and help providers deal with relevant current issues. You may find the information you were looking for by browsing through the navigation menus above and below or via the search box in the upper right corner of this page. If you believe that you have reached this destination due to an error on our part, please let us know. Together we teach. Together we care for our patients and our communities. Together we create unstoppable momentum. All over the world the laboratories use GCLP to improve the quality of their work, to improve patient care given by clinicians and also to improve safety of staff who work in the laboratories. Implementation of GCLP is a step wise process of meticulous planning, perfect execution with involvement by the whole team of laboratory personnel. Even though many laboratories in India do follow some measures of good laboratory practices, I feel there is a big need to repeatedly remind about GCLP in as many fora as possible. Therefore first of all I would like to thank and acknowledge the ICMR team which brought out the GCLP booklet. The laboratories in our country can be brought under three categories: primary care, secondary and tertiary level laboratories. In addition there are also reference laboratories and research laboratories. Therefore each laboratory should align themselves with the category they belong to. Depending upon the scope of work the laboratories should have the following facilities according to their needs.
Infrastructure Infrastructure of laboratories should be planned according to the services provided by the laboratory. Personnel, Training and Development Every laboratory should have properly qualified staff at various levels depending upon the nature of the work. Every staff member should be given a job description and should be trained to do the job that they are assigned to perform. There are well accepted promotional avenues and polices and these should be made available to all the staff of the laboratory. Equipment The laboratories should be appropriately equipped for the task that they are going to perform. Unnecessary fancy equipments should be avoided and only appropriate technology and instruments should be installed. Care should be taken to install the instruments in suitable locations to facilitate smooth flow of samples. Regular maintenance and cleaning should be performed. The operating manual should be available for all the staff members. Maintenance contract, contact telephone number of service engineers and good log book should be provided for the trouble shooting and maintenance of the equipment. Equipment should be properly calibrated and the performance should be verified by running internal and external quality control samples. All calibrations of equipments including pipettes and thermometers should be performed only by authorized personnel and documented. Accreditation agencies, such as NABL, require that calibration certificates are issued at prescribed intervals (to see NABL 112 (2007)). Reagents, Chemicals and Consumables All reagents used in the laboratory should be of certain certified standards. The reagents, chemicals and consumables should be stored under appropriate environmental conditions. The water used by the laboratory should be of prescribed quality. Specimen Collection The patient should be properly counselled before the specimen collection and consent should be taken whenever needed.
A lot of pre analytical errors can happen if care is not taken during the specimen collection. The phlebotomist, nurses and doctors who collect samples should be trained periodically in sample collection. The lab should prepare a “Primary specimen collection manual” containing information on patient preparation, methodology for specimen collection, labeling and transporting the samples. Necessary instructions on the preservative to be used, storage and transportation conditions should be provided. Requisition Form The requisition form for testing should be written only by the doctor and sent along with the sample. This should contain patient identity, age, sex, date and time of sample collection and investigation requested. A brief clinical history of the patient would be helpful to the laboratory. Registration of Samples When samples for analysis are received by the laboratory, the laboratory should note down the time of specimen receipt and all details like name, age, sex, location in the hospital or medical unit the patient is attached to, name of physicians, investigation requested and date. There should be a column for remarks where the condition of specimen can be recorded. The laboratory should assign a unique registration number and then the process of analysis can start. Work Sheet Nowadays many analysers can read barcode labels and the ID number, tests requested etc could be printed and stuck on the tube. Every laboratory should also provide a work sheet to the analyst wherein the test requested, with a column for signature of the person analyzing the sample and other relevant data can be entered. The request form and the work sheet can also be combined and made into a single form. The laboratory should not deviate from the standard operating procedure (SOP) which is already prepared by the laboratory for the parameter. There is no room for any errors or corrections, in the reporting. On line transfer of results will avoid the transcriptional errors.
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clinical laboratory quality manual
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clinical laboratory quality manual
HelpWriting.net ? and found a writer within a few minutes. Because I had to move house and I literally didn’t have any time to sit on a computer for many hours every evening. Thankfully, the writer I chose followed my instructions to the letter. I know we can all write essays ourselves. For those in the same situation I was in, I recommend ? www.HelpWriting.net ?.HelpWriting.net ? ? I did and I am more than satisfied.He now uses the Demolisher system to generate income.Research and development services are not applicableas supposed to the nature of services provided. This document applies to all COMPANY XYZsites including Quality System, Medical Laboratories (Central United Medical Laboratory (CUML)and International Clinic Laboratory (ICL)), Al Seef Hospital, Dental Laboratory (Central UnitedDental Laboratory (CUDL)) and any projected premises for COMPANY XYZ in the future.Our goal is to achieve thehighest level of client satisfaction.Aid in the diagnosis, treatment, and monitoring of the health status of our patients. ? Developing, sharing, and implementing disease management strategies to reduce overall costs and improve patient care. ? Lowering unit costs by sharing, standardizing and integrating laboratory services. ? Increasing revenues through enhanced outreach services. ? Successfully competing for managed care contracts for laboratory services.2.2 VISION:To serve as a wide-reference company for Kuwait and Gulf region that provides laboratory testingand consultation in the health care sector. ? Diagnostic services leadership in the Private health care of Kuwait. ? A single, influential, educational laboratory with an entrepreneurial approach. High quality patient care through effective and efficient use of laboratory resources. Maximal provision of specialized and reference clinical laboratory services for the country. ? Responsive to changing clinical, service, education, technological and fiscal needs.
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It comprises a main document providing information and examples to assist with writing a laboratory quality manual, and 24 appendices (examples of standard operating procedures, forms, and processes). All documents are in Word format because they are meant to serve as templates and are thus modifiable. The individual laboratories are required to customize the text of the template to the local situation. To browse Academia.edu and the wider internet faster and more securely, please take a few seconds to upgrade your browser. You can download the paper by clicking the button above. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to presentate such a system in the form of a quality manual. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned. Key Words: accreditation, audit, certification of quality system, good laboratory practice, quality improvement, quality management, quality manual, quality system To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By closing this message, you are consenting to our use of cookies. If you continue browsing the site, you agree to the use of cookies on this website. See our User Agreement and Privacy Policy.If you continue browsing the site, you agree to the use of cookies on this website. See our Privacy Policy and User Agreement for details.If you wish to opt out, please close your SlideShare account. Learn more. You can change your ad preferences anytime. I can promise you 100% un-plagiarized text and good experts there. Use with pleasure! ? www.WritePaper.info ?I sent a request to ? www.
Ensure that all spillages and breakages are dealt with correctlyThese procedures for specimen collection are available for the phlebotomist and all otherstaff in the hematology departments.In addition COMPANY XYZ All test report results shall be reviewed andvalidated by Medical director at COMPANY XYZ. Laboratory staff shall first review theresults and ensure no discrepancies or deficiencies are observed. QC can beconsidered part of the operational control of processes, being extremely useful fordetecting and correcting real and potential deviations. COMPANY XYZ currentlyparticipates in inter-laboratory comparison ?proficiency testing program.The report is electronic and could be written.COMPANY XYZ have developed a typical report format which comply with the needs ofusers, clear and unambiguous and enables the user to interpret the results. The reportshall be as follows:.Clear identification of the examination. ? time and date of report.Once a problem occurs, labmanagement takes into consideration first to document the problem, and assign adesignate for problem solving.QAManager develops the audit plan annually, taking into consideration the status andimportance of the activities and areas to be audited as well as the results of previousaudits. The audit plan is revised after each audit and updated if needed. The audit criteria,scope, frequency and methods are defined.Audits are conducted by personnel other than those who perform the activity beingaudited. LIMS is very crucial to the lab where it serves as a tool fortracking all tasks related to primary samples from receiving, collecting, testing, retesting,and reporting test results. Medical Lab and dental staff at COMPANYXYZ shall. Maintain strict confidentiality of patient information and test results. ? Be accountable for the quality and integrity of the services and tests they provide. ? Exercise sound judgment in conducting, and evaluating laboratory testing. ?
Commercialized applied research and internationally recognized expertise. Balance between generalists and specialists. Serve as a Kuwait -wide reference company for laboratory testing and consultation UNCONTROLLED DOCUMENT IF PRINTED It also provides comprehensive and cost effective diagnostic services whichbalance the needs of clinical programs with the resources of laboratory medicine.As a result, COMPANY XYZ provides optimal patient care in the clinical and dental fields.COMPANY XYZ became accredited by the College American of Pathologists (CAP) in 2007 (Firstin Kuwait).COMPANY XYZ became accredited under ISO 15189:2007 in 2009.Moreover department managers should:.QA is defined as a program that guarantees quality patientcare by tracking outcomes through scheduled reviews.Management iscommitted to solving health and safety problems in a co-operative approach withemployees, to performing workplace inspections, monitoring on the-job safetyperformance, auditing for health and safety program success, and is committed to theprocess of continuous improvement in health and safety performance.COMPANY XYZ is committed to training and motivating employees for safety performanceand to sustaining and updating their safety knowledge.Proper preparation of the patient,specimen collection and handling are essential for the production of valid results by alaboratory.Prior to, during and after executing the medical testing of the specimen collected the labstaff shall: a. Check the completion of the request form and confirming the identity of the patient b. Verify that the specimen container is labeled correctly c. Ensure that the patient is appropriately prepared d. Ensure that the specimen is collected correctly e. Exercise precautions and awareness of risk of interchange of samples f. Ensure that environmental and storage conditions are fulfilled g. Ensure the safe disposal of all materials used in specimen collection h.
For any potentially infectious or toxic sample, triple packaging rules outlined by the International Air Transport Association (IATA) regulations should be followed and proper warning labels attached. Samples that might undergo degradation could lead to false results. Storing aliquots of test material provides back-up in cases of errors in downstream processes. This could be due to the use of the wrong test reagents, the use of defective and non-calibrated equipment, the use of the wrong proportions of reagents, and general non-adherence to standard operating procedures (SOPs). It encompasses both the managerial and technical aspects of the lab procedures. The goal of a laboratory QMS is to ensure that results are accurate, reliable, and obtained under a traceable process that can easily detect errors. In addition, there should be documentation showing the functions and duties of every lab member, their competencies, experience, training attended and training required. Capacity building by ensuring they undergo regular training and motivation, as well as proper handling of staff concern ensures optimal performance. There should be regular meetings between the management and all staff to disseminate information and discuss issues of concern. After its installation, members should be properly trained on the use of the new equipment. Equipment manuals should be easily accessible in the laboratory area for easy reference. The procedures should be written and implemented to ensure that all supplies are correctly selected. This involves all the pre-analytical, analytical, and post-analytical stages. Documentation should be availed for all parties and a coordination person or team in place to ensure a smooth workflow. The documents provide information about the laboratory’s policies, processes, and testing procedures and should be stored in the laboratory quality manual for each laboratory.
Maintain a reputation of honesty, integrity and reliability with respect to profession.Medical laboratories — Particular requirements for quality and competence ISO 15189:2007(E). NCCLS A Quality System Model for Health Care; Approved Guideline Vol. 19 No. 20 ? Quality Management Systems -- Requirements ISO 9001 Fourth edition. COMPANY XYZ Business Process Interaction, refer to C. Confidentiality Agreement.Now customize the name of a clipboard to store your clips. Environmental Conditions 5.3 Laboratory Equipment, Reagents, and Consumables 5.4 Pre-examination Processes 5.5 Examination Processes TheSenior Management and Staff of. XYZ Laboratory also undertake to ensure that all activities areThe quality document structure containsRecords. XYZ Company. All agreements are reviewed and accepted only ifThis includes informing the client of anyAgreements Review Procedure. This procedureThe record states whetherLaboratory takes into account these factors in developing test andProcedure is applied for estimating uncertainty ofReasonable estimation is based on knowledge ofRequirements of the test method. Requirements of the client The. Our news promotes the best new methodologies in science. Our news promotes the best new methodologies in science. It involves systems that safeguard the accuracy, reliability, and timeliness of lab results by ensuring the early detection of results or measurement errors and the procedures to rectify them. It should be performed regularly and quality control materials should be treated the same as samples, from the beginning to the end of the run. In addition, the QC measures developed in a lab are the building blocks for the process of certification and accreditation. This may include errors like sample mix-up, mislabeling, improper storage or transportation and unsuitable sample collection methods.
Many of the twelve quality system essentials overlap each other (i.e., there is a close relationship between documents and records, and information management). However, some specific meningitis laboratory quality assurance measures can be highlighted. Many of them are detailed again in the respective chapters of this manual. The laboratory should prepare an organizational chart that reflects the hierarchy and lines of authority with functions and responsibilities of each post. The current duties and responsibilities of staff should be specified in written job descriptions including training required and necessary experience. The director’s commitment is crucial. A quality manager should be designated to ensure the implementation and monitoring of the quality policies. Continuous education opportunities should be offered to the staff and recorded, especially if new tests or methods are introduced. Regular competency assessment and proficiency testing should be conducted and documented.Equipment manuals should be available in the laboratory area for easy reference. An inventory of equipment including records of maintenance and repair should be maintained. The procedures should be written and implemented to assure that all reagents and supplies are correctly selected, purchased, used, and stored in a manner that preserves integrity and reliability. The inventory should be kept up to date including information on reception, storage, and issuance. Package inserts and Material Safety Data Sheets (MSDS) should be archived as part of records keeping. This manual should serve as a basis for writing the laboratory Standard Operating Procedures (SOPs) which need to be adapted to the laboratory’s role and capacity.See Chapter 3: Results Management and Reporting of Data for items that should be included in the request and report forms.
Internal QC of specimen identification and characterization should include: QC should be performed quarterly as well as when a new lot is received in the laboratory. If access to QC strains is difficult, well-characterized clinical isolates confirmed and characterized in a reference laboratory (such as a WHO Collaborating Center) are available. Isolates received from another laboratory as part of a proficiency testing program received in the scope of External Quality Assessment Schemes can also be used. See Chapter 3: Results Management and Reporting of Data. A system is needed for detecting and documenting these occurrences, for handling them properly, and for taking corrective action to reduce the chance of recurrence. Common errors include: Ultimately, corrective actions should be implemented to prevent similar errors from recurring. Assessment may be internal, performed by the laboratory’s own staff, or may be external, conducted by an external group or agency outside the laboratory. There are three commonly used EQA methods or processes:The laboratory reports the results back to the organizer who will compare the test results with known results and record a pass (all results concordant) or fail (any discrepant results) for the PT. While internal QC primarily assesses the examination steps, other quality indicators can be designed to monitor the pre- and post-examination steps:This indicator provides information on the pre-examination performance. Customers’ satisfaction can be assessed by means of questionnaire, interviews, or meetings. A number of tools have been described above to identify errors, such as customer service surveys, internal QC, EQA, auditing, and quality indicators. A rigorous analysis of all of these indicators should lead to improvements in procedures and practices. These changes should be recorded and reflected in the SOPs and implemented in the laboratory.
An SOP should be written for all procedures in the laboratory, including specimen collection, transport, storage, and waste disposal. The laboratory must have provision for documentation of such errors and occurrences that may interfere with proper laboratory operations. It can be either internal or external assessment and audit. The internal assessment is done by members of the lab and makes use of test controls like standards to validate the testing process and equipment. This is done through lab visits by the assessors to observe processes, validating tests by sending aliquots of test materials to the external assessment agency or having the assessing agency send in unknown material for testing in the lab. It involves all the corrective efforts made after the identification of points of errors and non-compliance. All actions should be documented, SOPs and QMS should be updated, and the changes in process and procedures should be communicated to the lab members. Ensure that the customer is able to freely give feedback through interviews, questionnaires or meetings and have access to a complaints medium. All customer feedback should be documented, analyzed, and used for process improvement. The laboratory management should ensure that all lab members are well-trained in safety requirements, SOPs, emergency response, and waste management. Different guidelines exist depending on the risk level of the lab. Detailed information on laboratory safety can be found here. The standards developing body may recognize an institution through three different processes. Various standards are provided under different categories, i.e. general quality management systems like the ISO 9001 certification that a lab can use to prove its proficiency. Third-party audits are done to evaluate the laboratory with the goal of attaining accreditation.
When developing quality practices, ensure that all the lab’s processes and procedures are outlined so as to create a proper workflow with clear responsibilities. The lab management should make certain that the staff is actively involved in the development and implementation of the quality system to enhance compliance. The many benefits of a proper laboratory quality management system far outweigh the laborious design, set-up, and monitoring process and it is important for any analytical, diagnostic, or research lab to have one in place. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007 Please inquire about bulk order discounts. To view our SAM, or FBO credentials please contact us for our CAGE code and DUNS number. Conduct Science products and its suppliers are NOT designed for human consumption, testing, or clinical utilization. They are designed for pre-clinical utilization only. CDC twenty four seven. Saving Lives, Protecting People In a medical laboratory, the quality can be defined as accuracy, reliability, and timeliness of the reported test results ( 1 ). QC refers to those measures that must be included in each assay to verify that the test is working properly. QA is defined as the overall program that ensures that the final results reported by the laboratory are as correct and accurate as possible. Inaccurate meningitis diagnostic results can have significant consequences at the patient care or public health level. At the patient care level, errors can lead to: A quality management system, which oversees the entire system, is very important for achieving optimal laboratory performance. Laboratory processes can be grouped into pre-examination, examination, and post-examination categories. Quality management measures should be applied during the entire path of workflow that begins with the patient and ends in interpreting and reporting results.
Open communication among staff members is also important to encourage suggestions that may improve the quality and efficiency of the laboratory. See Chapter 4: Biosafety. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007. The current documents and links were last reviewed in May 2020. Users are directed to countercheck facts when considering their use in other applications. With a firm understanding of the 12 essentials of quality management in laboratory environments, you'll be able to confidently lead your medical services team to new levels of excellence and avoid potentially life-threatening mistakes. The concepts first used in medieval European guilds have been solidified and refined over the centuries into what is now known as quality management systems. The quality management system (QMS) model has been adapted to the medical laboratory environment resulting in a dozen essentials that form the framework for quality. The model for the following 12 essentials is from the Clinical and Laboratory Standards Institute (CLSI) and ISO 15189. The management team and quality unit play an integral role in a quality-driven culture, along with structures for monitoring ongoing quality. Training, motivation, and engagement are key parts of the quality management system. Inventory activities should verify that materials and supplies are stored in a way that protects integrity. This data needs to be managed in a way that ensures all information is accurate, secure, confidential, and accessible to individuals with the right privileges, such as lab managers and leadership. One of the most essential lab documents is standard operating procedures (SOPs) to create a standard for each process. Documents need to be available at the point of work, maintained, accurate, and secure.
A QMS software can help you detect these issues and facilitate investigations to discover the root cause and prevent reoccurrence. Assessments include the activities of lab or QC managers, internal auditors, or external inspectors. Components of the QMS which support improvement can include QC and CAPA (occurrence management). A laboratory’s QMS should support operations that consistently provide a positive customer experience through the production of consistently high-quality products or other missions. The laboratory needs to understand the customers and their needs and use customer feedback for improvement. This includes physically securing the lab, containment procedures for hazards, worker safety, and ergonomics. If your QMS is missing several elements, such as document control or physical security, the entire system can easily crumble. Similarly, if your QMS hits all the basics but you can’t coordinate between the essentials by understanding the bigger picture of quality trends or root causes, you’re at risk of error. The right software can help you avoid having to reinvent the wheel by building a QMS from the ground up. Maintaining coordinated quality processes with paper systems can lead to poor visibility and human error. It includes all the essentials to help fast-growing lab startups and scale-ups create a solid quality baseline. Learn more about our solution here. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to: It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program. Include a general policies section addressing lab-specific issues, such as: The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual.
The following information is required to be included (CLIA regulations, Subpart K, 493.1211): All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization. Some tips include: This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual. Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer. AMENDMENT DATE: DESCRIPTION OF AMENDMENT Document was reviewed on the Amendment 1: Page 2 of 70 Appendix 4: Objektif Kualiti Makmal- Makmal Perubatan HUSM was deleted. Added record of review. Amendment 3: Page 8 of 70 and 16 of 70 The word cytopathology was deleted. Amendment 4: Page 17 of 70 The word genetic testing was replaced by Cytogenetic. Amendment 5: Page 30 of 70 Level 4 documents were redefined as Level 3 documents. 5 Page 4 of 70 Title:RECORD OF AMENDMENT Version 2 RECORD OF AMENDMENT VERSION NO. DISTRIBUTION LIST Controlled Copy Holder 1. DIRECTOR OF HOSPITAL USM 2. MANAGEMENT REPRESENTATIVE MS 1SO CHIEF DOCUMENT CONTROLLER 4. DIRECTOR OF PATHOLOGY LABORATORY 5. DOCUMENT CONTROLLER OF PATHOLOGY LABORATORY 6. DIRECTOR OF HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY 7. DOCUMENT CONTROLLER OF HAEMATOLOGY AND TRANSFUSION MEDICINE LABORATORY 8. DIRECTOR OF MEDICAL MICROBIOOGY AND PARASITOLOGY LABORATORY 9.
DOCUMENT CONTROLLER OF MEDICAL MICROBIOOGY AND PARASITOLOGY LABORATORY 10.A laboratory director whom may or may not be the head of the department heads the medical laboratory is in-charge of the medical laboratory. A quality manager, assisting the laboratory director, is in-charge of the daily running of the Quality Management System in the laboratory. The following is the list of all the medical laboratories and their respective departments: i) Pathology Laboratory under the Department of Pathology ii) Haematology Laboratory and Transfusion Medicine Laboratory under the Department of Haematology iii) Medical Microbiology Laboratory and Parasitology Laboratory under the Department of Microbiology and Parasitology iv) Chemical Pathology Laboratory under the Department of Chemical Pathology v) Immunology Laboratory under the Department of Immunology vi) vii) viii) Pharmacology Laboratory under the Department of Pharmacology Genetic Laboratory under the Human Genome Center Therapeutic Drug Monitoring Laboratory under the Department of Pharmacy 9 Title: FUNCTION OF MEDICAL LABORATORIES, HUSM Page 8 of 70 Version Function of Medical Laboratories HUSM: a) To provide diagnostic testing in the following disciplines: Histopathology, Medical Microbiology, Virology, Serology, Chemical Pathology, Haematology, Transfusion Medicine, Toxicology, Genetic and Drug Monitoring. These testing activities are done on patients samples in the HUSM as well as referred samples from outside HUSM.This policy is to be displayed at strategic locations so that it will be guidance to the staff to always maintain a high quality of laboratory services. Universti Sains Malaysia Hospital is an excellent teaching and referral hospital with quality and advanced technology services. We promise to give the best services to all patients and practice the quality values in realizing the Hospital Client Charter.
We are determined to prioritize customer well-being and satisfaction by implementing continuous improvement programs to fulfill the government aspiration. We are committed to provide adequate facilities in order to ensure excellent graduate produced by USM 11 Page 10 of 70 Title: QUALITY OBJECTIVES Version Quality Objectives All medical laboratories, Hospital USM are determined and committed to carry out the following objectives: a) To establish the implementation and maintenance of a Quality Management System.The staff of all laboratories are also determined and committed to fully adhere to the Specific Quality Objectives designed for their laboratories as stated in the document below. The laboratories of other disciplines operate only during working hours.This will demonstrate that the Medical Laboratories, HUSM are competent to operate as an accredited medical testing laboratory in accordance to the requirements of MS ISO 15189:2007 and MS ISO 9001:2008.Obsolete documents are recognized by a specific identification method. They may be retained for knowledge and teaching proposes. The test results provide information for the diagnosis, prevention, treatment of disease or assessment of the health of human beings and the presence or absence of various substances.Personnel providing such clinical interpretation or professional judgment shall possess such qualification, training and experience, relevant to the specialty of pathology in which they practice (e.g. Histocytopathology, Hematology, Chemical Pathology and Medical Microbiology).They shall have suitable qualifications or training and have sufficient experience and ability to perform the scientific and technical work required in the laboratory.Authority, interrelation and responsibilities of all laboratory personnel are on file in the form of job descriptions (JD) and organizational charts (please refer to Appendix 1 and 2: Organization Chart for the Medical Laboratories, Hospital USM).
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clinical laboratory quality assurance manual
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clinical laboratory quality assurance manual
Design and Development (Excluded). Customer Property (Excluded). Control of Measuring and Test Equipment. Preventive Maintenance. Estimate of Uncertainty of Measurement. Reference Standards and Standard Reference Materials. Data Validation. Measurement, Analysis, and Improvement of the Quality System. Statistical Methods. Subcontracting Services and Supplies. Quality Audits. Nonconformity. Customer Satisfaction and Complaints. Corrective and Preventive Action. Method Validation. Reliability. Quality Cost Reporting.Establishing Objectives and Priorities. Collection and Review of Existing Procedures. Preparation of a Flowchart. Identification of Program Requirements. Identification of Shortfalls and the Assignment of Priorities. Writing the Manual. PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL. PART 4: SAMPLE QUALITY ASSURANCE FORMS. Index. It is an ongoing, comprehensive program which analyzes every aspect of an entire operation; it involves determining a quality goal, deciding whether or not the goal has been achieved, and implementing corrective action if the goal has not been reached. The Code of Federal Regulations (42 CFR 493) states laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” As the saying goes, if it is not written down, it did not happen. The lab is to have systems in place to evaluate the effectiveness of corrective actions in regard to the QC program, including: The lab is to assess the effectiveness of corrective action taken to address any unacceptable, unsatisfactory, or unsuccessful PT results. If a laboratory has more than one method of performing the same test, the lab must (twice a year) evaluate and define the relationship between the two methods (i.e., run the same specimen by each method and check for comparable results).
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To browse Academia.edu and the wider internet faster and more securely, please take a few seconds to upgrade your browser. You can download the paper by clicking the button above. The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again. Used: GoodVery minimal damage to the cover including scuff marks, but no holes or tears. The dust jacket for hard covers may not be included. Binding has minimal wear. The majority of pages are undamaged with minimal creasing or tearing, minimal pencil underlining of text, no highlighting of text, no writing in margins. No missing pages.Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Please try again later. Murph's 4.0 out of 5 stars. Would you like to change to the United States site? To download and read them, users must install the VitalSource Bookshelf Software. E-books have DRM protection on them, which means only the person who purchases and downloads the e-book can access it. E-books are non-returnable and non-refundable.This is a dummy description.This is a dummy description.This is a dummy description.This is a dummy description.Introduction. Title Page. Letter of Promulgation. Quality Policies. Quality Objectives. Management of the Quality Manual. Control of Quality Documentation and Records. Customer Focus. Quality System Planning. Organization for Quality. Communications. Management Review. Human Resources. Laboratory Infrastructure. Work Environment. Quality in Procurement. Sample Handling, Identification, Storage, and Shipping. Chain-of-Custody Procedures. Laboratory Testing and Control: Intra-and Interlaboratory Proficiency Testing.
QC refers to those measures that must be included in each assay to verify that the test is working properly. QA is defined as the overall program that ensures that the final results reported by the laboratory are as correct and accurate as possible. Inaccurate meningitis diagnostic results can have significant consequences at the patient care or public health level. At the patient care level, errors can lead to: A quality management system, which oversees the entire system, is very important for achieving optimal laboratory performance. Laboratory processes can be grouped into pre-examination, examination, and post-examination categories. Quality management measures should be applied during the entire path of workflow that begins with the patient and ends in interpreting and reporting results.Many of the twelve quality system essentials overlap each other (i.e., there is a close relationship between documents and records, and information management). However, some specific meningitis laboratory quality assurance measures can be highlighted. Many of them are detailed again in the respective chapters of this manual. The laboratory should prepare an organizational chart that reflects the hierarchy and lines of authority with functions and responsibilities of each post. The current duties and responsibilities of staff should be specified in written job descriptions including training required and necessary experience. The director’s commitment is crucial. A quality manager should be designated to ensure the implementation and monitoring of the quality policies. Continuous education opportunities should be offered to the staff and recorded, especially if new tests or methods are introduced. Regular competency assessment and proficiency testing should be conducted and documented.Equipment manuals should be available in the laboratory area for easy reference. An inventory of equipment including records of maintenance and repair should be maintained.
If the lab performs testing on non-regulated analytes, the lab must have a method for verifying the accuracy of its test results. Proficiency testing or split sampling may be used. The fifth standard involves the relationship of patient information to patient test results. This is an internal quality assurance function. The lab must have a system in place to identify and evaluate patient test results when they appear inconsistent such criteria as the patient’s age, sex, diagnosis, and the relationship with other test results. The sixth standard involves personnel assessment. The laboratory must have a system in place to evaluate the effectiveness of its policies and procedures for assuring employee competence. The seventh standard involves communications. The lab must have a mechanism for documenting problems arising as a result of a breakdown in communication. Corrective actions must be taken to both resolve the problem and minimize future communication breakdowns. The eighth standard addresses complaint investigations. The lab must have a system to assure that all complaints and problems are documented. Investigations must be made and corrective action taken. The ninth standard is quality assurance review with staff. In addition to documenting and assessing problems identified in QA reviews, the lab personnel must discuss the issues and take corrective action to prevent recurrences. The tenth standard addresses QA records. Documentation of all QA activities must be made available to the Department of Health and Human Services. In the latter case, pleaseHow are we doing. Europe PMC is part of the ELIXIR infrastructureEurope PMC is a service of theIt includes content provided to the. CDC twenty four seven. Saving Lives, Protecting People In a medical laboratory, the quality can be defined as accuracy, reliability, and timeliness of the reported test results ( 1 ).
While internal QC primarily assesses the examination steps, other quality indicators can be designed to monitor the pre- and post-examination steps:This indicator provides information on the pre-examination performance. Customers’ satisfaction can be assessed by means of questionnaire, interviews, or meetings. A number of tools have been described above to identify errors, such as customer service surveys, internal QC, EQA, auditing, and quality indicators. A rigorous analysis of all of these indicators should lead to improvements in procedures and practices. These changes should be recorded and reflected in the SOPs and implemented in the laboratory. Open communication among staff members is also important to encourage suggestions that may improve the quality and efficiency of the laboratory. See Chapter 4: Biosafety. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007. Our news promotes the best new methodologies in science. Our news promotes the best new methodologies in science. It involves systems that safeguard the accuracy, reliability, and timeliness of lab results by ensuring the early detection of results or measurement errors and the procedures to rectify them. It should be performed regularly and quality control materials should be treated the same as samples, from the beginning to the end of the run. In addition, the QC measures developed in a lab are the building blocks for the process of certification and accreditation. This may include errors like sample mix-up, mislabeling, improper storage or transportation and unsuitable sample collection methods. For any potentially infectious or toxic sample, triple packaging rules outlined by the International Air Transport Association (IATA) regulations should be followed and proper warning labels attached. Samples that might undergo degradation could lead to false results.
The procedures should be written and implemented to assure that all reagents and supplies are correctly selected, purchased, used, and stored in a manner that preserves integrity and reliability. The inventory should be kept up to date including information on reception, storage, and issuance. Package inserts and Material Safety Data Sheets (MSDS) should be archived as part of records keeping. This manual should serve as a basis for writing the laboratory Standard Operating Procedures (SOPs) which need to be adapted to the laboratory’s role and capacity.See Chapter 3: Results Management and Reporting of Data for items that should be included in the request and report forms. Internal QC of specimen identification and characterization should include: QC should be performed quarterly as well as when a new lot is received in the laboratory. If access to QC strains is difficult, well-characterized clinical isolates confirmed and characterized in a reference laboratory (such as a WHO Collaborating Center) are available. Isolates received from another laboratory as part of a proficiency testing program received in the scope of External Quality Assessment Schemes can also be used. See Chapter 3: Results Management and Reporting of Data. A system is needed for detecting and documenting these occurrences, for handling them properly, and for taking corrective action to reduce the chance of recurrence. Common errors include: Ultimately, corrective actions should be implemented to prevent similar errors from recurring. Assessment may be internal, performed by the laboratory’s own staff, or may be external, conducted by an external group or agency outside the laboratory. There are three commonly used EQA methods or processes:The laboratory reports the results back to the organizer who will compare the test results with known results and record a pass (all results concordant) or fail (any discrepant results) for the PT.
The many benefits of a proper laboratory quality management system far outweigh the laborious design, set-up, and monitoring process and it is important for any analytical, diagnostic, or research lab to have one in place. NCCLS document GP26-A3. NCCLS. Wayne, Pennsylvania. 2004. Geneva, Switzerland: International Organization for Standardization; 2007 Please inquire about bulk order discounts. To view our SAM, or FBO credentials please contact us for our CAGE code and DUNS number. Conduct Science products and its suppliers are NOT designed for human consumption, testing, or clinical utilization. They are designed for pre-clinical utilization only. Track air quality and smoke forecasts at wasmoke.blogspot.com. This checklist can help you write or review a quality assurance manual for your lab. Before you submit your manual, use the following guide to review it. Keep in mind that not all points may apply to every lab. Use this checklist to guide your review of your own manual. Some points may not apply to smaller non-commercial labs. What was challenging.Your name: Phone number. Policies and procedures insure accurate reliable and prompt reporting of test results, as well as help to meet standards from regulating agencies. Ongoing quality assurance activities can detect errors, procedural lapses or divergences from goals, while also suggesting changes need in procedures or training. See the QUALITY CONTROL policy located in Section VI of the LAB MANUAL for specific descriptions of quality control materials and activities. Proficiency samples are handled in the same manner as patient samples. All testing personnel participate in analyzing proficiency samples. The medical director reviews all results and corrective actions (if needed). See the PROFICIENCY TESTING policy located in Section VI of the LAB MANUAL for more details of proficiency testing activities and monitoring. Training checklists and performance reviews are reviewed by the lab supervisor.
Performance reviews and competency checks are performed at 6 months for new staff, and annually thereafter. Moderate to highly complex testing is only performed by licensed clinical lab scientists, while waived testing is only performed by personnel that have successfully completed training. Phlebotomy is only performed by licensed phlebotomists or clinical lab scientists. See the LABORATORY STAFF ORIENTATION, TRAINING AND ASSESSMENT policy located in Section VI of the LAB MANUAL for more details. Abnormal or unexpected results are verified as needed. Any results questioned by the clinician are repeated and verified if possible. Critical results are called to clinicians within 30 minutes of final result. Critical result phone calls follow the format of using two forms of patient identification and having the recipient read-back the result. Documentation of the call is included in the medical record with the result. Corrected test results are called to the clinician as soon as possible. Documentation of corrected result calls is included in the medical record with the results. See the REVIEW OF TEST RESULTS policy located in Section VI of the LAB MANUAL for more details. Hand labeled specimens may be acceptable but must have at least two forms of identification. In this case, the Lab Supervisor notifies the Medical Director, or their designee, who messages all clinicians potentially affected by the discarded specimen. The validation consists of precision testing, correlation with a previously verified method and verification of linearity (if quantitative results are involved). Established instruments and methods are verified to be accurate through the use of Interlaboratory Quality Assurance Programs (IQAP) when available, quarterly proficiency testing and biannual calibration verification (where applicable).
Storing aliquots of test material provides back-up in cases of errors in downstream processes. This could be due to the use of the wrong test reagents, the use of defective and non-calibrated equipment, the use of the wrong proportions of reagents, and general non-adherence to standard operating procedures (SOPs). It encompasses both the managerial and technical aspects of the lab procedures. The goal of a laboratory QMS is to ensure that results are accurate, reliable, and obtained under a traceable process that can easily detect errors. In addition, there should be documentation showing the functions and duties of every lab member, their competencies, experience, training attended and training required. Capacity building by ensuring they undergo regular training and motivation, as well as proper handling of staff concern ensures optimal performance. There should be regular meetings between the management and all staff to disseminate information and discuss issues of concern. After its installation, members should be properly trained on the use of the new equipment. Equipment manuals should be easily accessible in the laboratory area for easy reference. The procedures should be written and implemented to ensure that all supplies are correctly selected. This involves all the pre-analytical, analytical, and post-analytical stages. Documentation should be availed for all parties and a coordination person or team in place to ensure a smooth workflow. The documents provide information about the laboratory’s policies, processes, and testing procedures and should be stored in the laboratory quality manual for each laboratory. An SOP should be written for all procedures in the laboratory, including specimen collection, transport, storage, and waste disposal. The laboratory must have provision for documentation of such errors and occurrences that may interfere with proper laboratory operations. It can be either internal or external assessment and audit.
The internal assessment is done by members of the lab and makes use of test controls like standards to validate the testing process and equipment. This is done through lab visits by the assessors to observe processes, validating tests by sending aliquots of test materials to the external assessment agency or having the assessing agency send in unknown material for testing in the lab. It involves all the corrective efforts made after the identification of points of errors and non-compliance. All actions should be documented, SOPs and QMS should be updated, and the changes in process and procedures should be communicated to the lab members. Ensure that the customer is able to freely give feedback through interviews, questionnaires or meetings and have access to a complaints medium. All customer feedback should be documented, analyzed, and used for process improvement. The laboratory management should ensure that all lab members are well-trained in safety requirements, SOPs, emergency response, and waste management. Different guidelines exist depending on the risk level of the lab. Detailed information on laboratory safety can be found here. The standards developing body may recognize an institution through three different processes. Various standards are provided under different categories, i.e. general quality management systems like the ISO 9001 certification that a lab can use to prove its proficiency. Third-party audits are done to evaluate the laboratory with the goal of attaining accreditation. When developing quality practices, ensure that all the lab’s processes and procedures are outlined so as to create a proper workflow with clear responsibilities. The lab management should make certain that the staff is actively involved in the development and implementation of the quality system to enhance compliance.
See procedures, EVALUATION OF AUTOMATED TEST METHODS, LINEARITY TESTING (REPORTABLE RANGE) CALIBRATION VERIFICATION, PROFICIENCY TESTING and QUALITY CONTROL AND ASSESSMENT in section VI of the Laboratory Manual for further information. These activities may be ongoing or may change periodically to meet the needs and the goals of lab management. It is desirable to decrease the TAT for testing that is needed urgently (STAT) so as to expedite patient care. Monitoring TAT can help facilitate corrective actions where the TAT does not meet goals and can lead to overall changes in procedures and personnel in order to maximize efficiencies. The lab will monitor STAT in-house CBCs and STAT urine dipsticks for TAT during the current year. The Lab Supervisor will notify the Medical Director, or their designee, who will message all clinicians potentially afffected by the discarded specimen. All erroneous lab results must be corrected and the clinician notified promptly. Such errors are documented in the problem log. The projects will ascertain to measure the quality of the process in terms of sensitivity, specificity or timeliness. It will also be assessed as to whether the process can be improved by implementing various changes or having staff focus on the issue. Examples of such past QI projects are the Wet Mount vs Trichomonas Culture project (improve sensitivity) or the Urine Leukocyte Esterase vs Manual WBC Count project (improve accuracy, sensitivity and utilization). Faster Solution Delivery. Compliance with FDA regulations and the CLIA amendments can be easily ensured with the implementation and use of MasterControl's clinical laboratory quality control software.The basic aim of this software is to integrate quality process management and to enable online cross communication between company departments.
MasterControl is the leading pioneer in providing web-based solutions to companies that need to streamline their business processes and operations with a single web-based platform. In order to help companies attain FDA compliance, MasterControl’s clinical laboratory quality assurance software provides validation tools and services. The entire validation solution is comprised of a combination of products and services that address different levels of validation needs. Organizations can either automate or manually validate their software solutions based on their risk assessment model. MasterControl's validation tools and services dramatically reduce the time involved in validating a system, reducing the risk of project implementation and making it easier to validate software upgrades, all of which help contribute to a lower cost of validation. The MasterControl suite consists of the following integrated applications: Clinical Laboratory Quality Control System for Document Control The biggest challenge faced by life science organizations including clinical and medical laboratories is inefficiency in their business operation units. Inefficiencies invariably hamper the effectiveness of a business's processes (and subsequently its products) and are not properly aligned and managed. Clinical Laboratory Quality Assurance Software and CAPA System Quality assurance is a major part of testing, analyzing and observing processes in the system. This ensures that any deviation or nonconformity from the standard is immediately reported. The MasterControl clinical laboratory quality assurance and CAPA system interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. Since the software ensures integration between quality processes, a CAPA form can be launched directly from another form within the clinical laboratory quality assurance system (e.g, nonconformance or deviation report).
Relevant data is automatically entered into the CAPA form that reduces data entry and eliminates errors from the manual transfer of information. Clinical Laboratory Quality Control System for Change Control Success of any company lies in how quickly it adapts to change. Change control features streamline the entire change control procedure for faster turnaround. MasterControl’s clinical laboratory quality control system offers best-practice forms that incorporate priority levels and prompt risk assessments and classifications of the change as low, medium, or high. Any high-level change implies a great impact on the product and is likely to require regulatory filing. This is where MasterControl Documents helps in documenting the change that eliminates the risk of practicing business by following outdated procedures in the system. Customizable reports in our clinical laboratory quality control software provide real-time quality system data. Training Management in Clinical Laboratory Quality Assurance Systems The majority of life science companies spend valuable capital on hiring specialized teams of trainers to train employees about various aspects of the business. MasterControl's clinical laboratory quality assurance training system automates the assignment and monitoring of training tasks and the grading of online exams. It allows for the sequencing of training courses so that after a prerequisite course is complete the next one can be automatically launched. This helps in training large numbers of employees in training programs verified by the group sign-off feature. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change. Companies can allocate internal resources and save capital that can be used in other areas of the business.
Clinical Laboratory Quality Assurance System and Nonconformance Automation Software Emphasis on compliance has enabled life science companies from across the globe to build their business so that it adheres to FDA regulations. Adherence to FDA regulations can lead to nonconformance events and severe consequences for companies. A critical eye for catching any anomalies is the basic requirement of any business. Because of this reason, MasterControl has devised a robust clinical laboratory quality assurance and nonconformance automation software solution that will automate, manage, and streamline a process for identifying, evaluating, reviewing, and handling nonconformance materials, components, parts and finished products. The solution's best-practice form and five-step process connects all responsible personnel for the effective and timely disposition of a nonconformance. Depending on the size of a business, the company can choose to maintain a standalone nonconformance process for small-scale, localized incidents, or may choose to connect it to the CAPA process, which will trigger automated escalations when the situation is warranted. The training solutions will automatically invoke training tasks upon approval of a document change (e.g, an SOP) or when specified by a training manager. Clinical Laboratory Quality Control Software and Audit Management System Companies that handle multiple and intricate kinds of procedures often require large amounts of documentation. Over time, it becomes increasingly difficult to maintain all of the documentation especially as a good portion of that documentation is updated and results in new document versions. This poses problems as multiple version of the same document are often left circulating among employees. The company may run the risk of a serious nonconformance event and may even have to temporarily shut down a specific manufacturing unit from production.
MasterControl clinical laboratory quality control software solutions and audit management systems automate, streamline and effectively manage the audit process. It provides advanced tracking capabilities, from scheduling and planning to execution, completion and reporting. Apart from this, the advanced reporting feature helps in analyzing different dimensions of the business so managers can get a real-time view of the audit process. Clinical Laboratory Quality Control Systems and Customer Complaints Software Companies want to be able to process customer complaints in an effective manner so that a resolution of these complaints can occur without excessive delay. MasterControl's clinical laboratory quality control and customer complaints software streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. The solution provides a three-step process that starts with the processing of a customer complaint through the web-based portal, automatically moving to internal investigation and culminating with a resolution of the issue. In order to resolve issues, top-level management can generate reports and analyze the root cause of the problem with increased oversight. Form-Based Clinical Laboratory Quality Control Software MasterControl's clinical laboratory quality control software is a forms-based quality system which automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. One big advantage of the forms-based clinical laboratory quality control system is that it offers best practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to HTML, so users will see the same form and won't need new training. It is based on the discretion of the company to either improve existing forms or design new ones to suit specified company needs.
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