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

1. Auflage März 2025
256 Seiten, Hardcover
Wiley & Sons Ltd
Successfully manage your laboratory accreditation and compliance audits with this easily accessible how-to resource for clinical laboratories
101 Topics for Clinical Microbiology Laboratory Leaders: Accreditation, Verification, Quality Systems, and More by Rebekah M. Martin is your roadmap to achieving and maintaining excellence in clinical microbiology laboratory administration. This quick reference guide is designed to help laboratory professionals efficiently navigate the key aspects of accreditation, regulatory compliance, and quality management. This practical resource is perfect for both new and experienced laboratory leaders who need accessible, actionable information.
Inside, you'll find:
* Regulatory Overview: Information on the Clinical Laboratory Improvement Amendments, test complexity categories, and the roles of key agencies like the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Food & Drug Administration in overseeing clinical laboratories.
* Accreditation Basics: Guidance on how to obtain and maintain laboratory accreditation, including what to expect during inspections and how to respond to deficiencies.
* Test Verification & Validation: Essential tips on conducting verification and validation studies to ensure your laboratory's test systems are accurate, reliable, and compliant with regulatory standards.
* Quality Management Essentials: Practical strategies for implementing and maintaining a quality management system, including process control, document management, and continuous improvement techniques that keep your lab running smoothly.
Presented in a user-friendly question-and-answer format, 101 Topics for Clinical Microbiology Laboratory Leaders is your go-to resource for quick, reliable guidance on leading a compliant and high-performing clinical microbiology laboratory.
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