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How to be the Lab Director of a general hospital lab. Includes tutorials on: how to make a corrective action, how to remediate proficiency testing failures, how to make a Plan of Correction (PoC), how to respond to CMS form 2567, how to put a new analyzer into service, how to do validation and verification, how to do quality assurance and root cause analysis, how to write a policy and/or procedure and how to respond to complaints and incident reports involving lab. Includes easy to understand explanations of accuracy, precision, sensitivity, specificity, proficiency testing, correlation, reference range (also called normal values), critical values (also called panic values), Limit of Detection (LoD), Limit of Quantitation (LoQ), ruggedness, robustness, linearity, Analytic Measurement Range (AMR), controls, calibration, false positive, and false negative as applied to the clinical lab and diagnostic lab testing. The 2016 edition has newly added sections on Laboratory Developed Test (LDT) or "off label" test verification, qualitative analyzer verification, how to make an Individualized Quality Control Plan (IQCP) and how to perform voluntary closure of a laboratory.
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25 years experience in Pathology and Lab Medicine. Board Certified in Anatomic Pathology and Clinical Pathology.
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Book Description CreateSpace Independent Publis, 2014. Paperback. Condition: New. Never used!. Seller Inventory # P111505602661