Overview

How to be the Lab Director of a general hospital lab. Includes tutorials on: how to make a corrective action, requirements for proficiency testing, 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. This book includes information on how to start a new lab, how to verify a Laboratory Developed Test (LDT) or off label test, qualitative analyzer verification, how to make an Individualized Quality Control Plan (IQCP), how to perform voluntary closure of a laboratory. information on how to helm a hospital lab through a major disaster, and information on Lab Director liability (malpractice) insurance, recommendations on how to validate microbiology organism identification and antibiotic sensitivity testing. The section on Individualized Quality Control Plan (IQCP) has an example IQCP. The 2022 edition includes information on lab testing in the COVID pandemic including SARS-CoV-2 test verification, SARS-CoV-2 specimen handling and pooling, laboratory expansion to accommodate SARS-CoV-2 testing,

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