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Cytogenetic Laboratory Management : Chromosomal, Fish and Microarray-based Best Practices and Procedures
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A technical resource, Cytogenetic Laboratory Management focuses on how to manage a clinical cytogenetic and molecular cytogenetic laboratory. This book would include best practices for the clinical laboratory managment of constitutional genetic disorders and cancer diseases .A companion to Zneimer's recently-published, Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting, this title will provide cytogenetic, FISH and microarray laboratory standard operating procedures (SOP's) and information on how to effectively write SOP's; validation plans and summaries; chemical, safety, quality control and quality assurance programs; and plans for effective use of reagents, instruments and equipment. As a result, this second book is a good companion to the first book, which, when combined, will give all the necessary information for laboratories and providers of cytogenetics testing.
The book will also provide information on developing and implementing a Genetic Technology Training Program, staffing requirements, workload benchmarks, calibration verification and training and competency programs for genetic laboratories, as well as a summary of the American College of Medical Genetics and Genomic guidelines, and College of American Pathologist inspection guidelines for proper governance of a genetics laboratory. Budgeting for hiring and capital expenses and process improvement models will also be included.
A unique text in the field, this book would be divided into chapters that first describe how to write an SOP and give example templates, then followed by chapters for each type of SOP performed in Cytogenetic Laboratories, including pre-analytic, analytic and post-analytic analyses of chromosome analysis, fluorescence in situ hybridization and microarray analyses. Chapters that follow will include chemical and saftey requirements, reagents, instruments and equipment needed for testing, quality control and quality assurance plans for labs to meet and exceed regulatory requirements. Further chapters will include examples of cytognetic and molecular genetic technology training programs, staffing requirements with calculations on staffing needs basedon volume and types of testing performed, workload benchmarks for cytogenetics testing, calibration verification of FISH probes, example validation plans needed before new tests can be implemented in a clinical laboratory, training and competency programs, process improvement examples and budgeting prototypes.