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 Quality in Laboratory Hemostasis and Thrombosis eBook

Quality in Laboratory Hemostasis and Thrombosis


eBook Publisher: John Wiley & Sons
Imprint: Wiley-Blackwell

Format: ePub Encrypted (DRM)


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"Over the last decades, major progress has been made in quality assurance of hemostatic laboratory assays. This book will be an indispensable part of every hemostasis laboratory, where, given its hands-on nature, it will rarely sit to get dusty on the shelves." - Frits R. Rosendaal, Leiden University Medical Center

The hemostasis laboratory has a vital role in the diagnosis and management of patients with familial and acquired hemorrhagic and thrombotic disorders. Its role in the monitoring traditional anticoagulant therapy as well as therapy using new anticoagulants presents new challenges to the laboratory. Quality in Laboratory Hemostasis and Thrombosis not only addresses these important issues, but also covers international guidelines for testing, the development of international standard materials, management of hemostasis testing from the laboratory to the point of care as well as molecular genetic testing.

Designed as a guide for all those working in hemostasis laboratories, this book details a quality program that, when put into place, will help to improve standards in testing. All of the authors are internationally recognised for their work in hemostasis and thrombosis. Using their experience, they provide information on standards, equipment and methods that will guide the development of a quality program to support all activities in the hemostasis laboratory.

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Title of eBook: Quality in Laboratory Hemostasis and Thrombosis
Release Date: 08-24-2011
Publisher: Wiley-Blackwell

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Quality in Laboratory Hemostasis and Thrombosis


Chapter One

General quality planning in the hemostasis laboratory

J.D. Olson

"So", you might ask, "What is quality, anyway?" The word quality repeatedly infiltrates our discussions and interactions as we work to produce or choose a product. The Oxford English Dictionary devotes more that 3000 words in its effort to define the many variations on the use of this word. We may all have difficulty with a definition, but we do know what we mean. The customer of the product or service defines many aspects of its quality while those who are producing define many others. Stated in its simplest terms, quality is the condition or state of a person, thing or process.

Elements of quality management systems began with a publication by Shewhart in 1931 providing a footing for quality processes based on a scientific and/or statistical footing. He stated: "A phenomenon will be said to be controlled when, through the use of past experience, we can predict, at least within limits, how the phenomenon may be expected to vary in the future. Here it is understood that prediction means that we can state, at least approximately, the probability that the observed phenomenon will fall within given limits."

The evolution of quality management systems were influenced by experiences in World War II. During the war, individuals involved in the production of reliable devices (weapons and other implements to support a war effort) for the consumer (soldier) to do their job effectively tied the entire system from raw material to the use of the finished product in a unique "team" from start to finish. Few circumstances can link the p

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