"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"--
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, youll 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 laboratorys 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.
