101 topics for clinical microbiology laboratory leaders : accreditation, verification, quality systems, and more / Rebekah M. Martin.

Includes bibliographical references and index.

Clinical Laboratory Improvement Amendments (CLIA) and Regulatory Oversight -- Clinical Laboratory Improvement Amendments (CLIA) Certificates -- Waived Testing -- Laboratory Accreditation -- Verification and Validation -- Performance Characteristic : Precision -- Performance Characteristic : Accuracy/Agreement -- Performance Characteristic : Reportable Range -- Performance Characteristic : Reference Interval -- Performance Characteristic : Analytical Sensitivity -- Performance Characteristic : Analytical Specificity -- Additional Performance Characteristics -- Unacceptable Results and Resolution -- Documentation for Verification and Validation Studies -- Quality Management Systems -- Essential : Organization -- Essential : Laboratory Personnel -- Essential : Customer Service -- Essential : Facilities and Safety -- Essential : Purchasing and Inventory -- Essential : Equipment -- Essential : Process Control -- Essential : Document and Records Management -- Essential : Information Management -- Essential : Occurrence Management -- Essential : Assessment -- Essential : Process Improvement.

"Laboratory accreditation is a vital and necessary process for clinical laboratories, and the requirements coming from the oversight bodies, CAP, CLIA, and FDA. And although information are freely accessible, they are often confusing and difficult to execute in the lab. Every clinical microbiology laboratory director, manager, and supervisor must interpret the requirements and work to keep the laboratory in compliance while responding to novel microbe outbreaks in addition to the regular workflow of testing. This resource gathers information from many different sources into one place and addresses the "how-tos" of implementing regulations around laboratory activities"--cProvided by publisher.