101 Topics for Clinical Microbiology Laboratory Leaders (eBook)
256 Seiten
ASM Press (Verlag)
978-1-68367-446-7 (ISBN)
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.
Rebekah M. Martin is currently a Medical Affairs Manager for Molecular Solutions at Becton, Dickinson and Company (BD). 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.
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.
| Erscheint lt. Verlag | 24.2.2025 |
|---|---|
| Reihe/Serie | ASM Books |
| Sprache | englisch |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete |
| Technik | |
| Schlagworte | accreditation regulation • CLIA oversight waived testing • clinical microbiology laboratory • lab-developed test • Laboratory Accreditation • laboratory test validation • Process Improvement • Quality assurance • Quality management system • Regulatory oversight |
| ISBN-10 | 1-68367-446-4 / 1683674464 |
| ISBN-13 | 978-1-68367-446-7 / 9781683674467 |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
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