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101 Topics for Clinical Microbiology Laboratory Leaders: Accreditation, Verification, Quality Systems, and More

SKU: 9781683674450
ISBN: 9781683674450
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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.

Περιεχόμενα

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