Rebekah M. Martin

101 Topics for Clinical Microbiology Laboratory Leaders

Accreditation, Verification, Quality Systems, and More

• Gebundenes Buch

Produktbeschreibung

Successfully manage your laboratory accreditation and compliance audits with this easily accessible how-to resource for clinical laboratories Laboratory accreditation is an essential process for all clinical laboratories. Requirements are freely available from various clinical oversight bodies, but they are not always stated clearly, and significant complications sometimes arise from efforts to implement them in the lab. Working to keep a microbiology laboratory in compliance while dealing with microbe outbreaks and other contingencies is a considerable challenge for laboratory managers and supervisors. 101 Topics for Clinical Microbiology Laboratory Leaders simplifies this process with an engaging, accessible introduction to regulatory oversight and accreditation. Incorporating information from all major regulatory bodies and offering key insights for interpreting and applying complex regulations, it is a vital tool for the successful maintenance of any microbiology lab. 101 Topics for Clinical Microbiology Laboratory Leaders readers will also find: * A detailed FAQ for lab compliance and quality assurance systems * Discussion of topics including validation of test systems, CLIA oversight waived testing, and many more * A thorough how-to guide for completing required compliance activities 101 Topics for Clinical Microbiology Laboratory Leaders is ideal for clinical laboratory directors, supervisors, and managers, as well as public health laboratory directors.

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Produktdetails

• Verlag: American Society for Microbiology
• Seitenzahl: 224
• Erscheinungstermin: 11. Juni 2025
• Englisch
• ISBN-13: 9781683674450
• ISBN-10: 1683674456
• Artikelnr.: 72653584

Autorenporträt

Rebekah M. Martin is currently Manager, Clinical Projects, at Becton, Dickinson and Company-Integrated Diagnostic Solutions. She completed a CPEP-accredited medical microbiology fellowship, is a Diplomate of the American Board of Medical Microbiology (ABMM), a former Associate Technical Director of Microbiology for a national reference laboratory and has been working in clinical microbiology for more than a decade.

Inhaltsangabe

Part I: Regulatory Oversight and Laboratory Accreditation 1) Clinical
Laboratory Improvement Amendments (CLIA) and Regulatory Oversight 2) CLIA
Certificates 3) Waived Testing 4) Laboratory Accreditation
Part II: Verification and Validation of Test Systems 1) Verification and
Validation 2) Performance characteristic: Precision 3) Performance
characteristic: Accuracy 4) Performance characteristic: Reportable Range 5)
Performance characteristic: Reference Interval 6) Performance
characteristic: Analytic Sensitivity 7) Performance characteristic:
Analytic Specificity 8) Additional Performance Characteristics 9)
Unacceptable Results and Resolution 10) Documentation for Verification and
Validation Studies
Part III: Quality Management Systems 1) Quality Management Systems (QMS) 2)
Essential 1: Organizational Structure 3) Essential 2: Personnel 4)
Essential 3: Customer Service 5) Essential 4: Facilities 6) Essential 5:
Purchasing and Inventory 7) Essential 6: Equipment 8) Essential 7: Process
Control 9) Essential 8: Document Control 10) Essential 9: Information
Management 11) Essential 10: Occurrence Management 12) Essential 11:
Assessment 13) Essential 12: Process Improvement