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101 Topics for Clinical Microbiology Laboratory Leaders : Accreditation, Verification, Quality Systems, and More
| 101 Topics for Clinical Microbiology Laboratory Leaders : Accreditation, Verification, Quality Systems, and More |
| Autore | Martin Rebekah M |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Newark : , : ASM Press, , 2025 |
| Descrizione fisica | 1 online resource (256 pages) |
| Disciplina | 579.076 |
| Collana | ASM Bks. |
| Soggetto topico |
Laboratories, Clinical - standards
Microbiological Techniques - standards Accreditation - standards |
| ISBN |
9781683674481
1683674480 9781683674474 1683674472 9781683674467 1683674464 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Cover -- Title Page -- Copyright Page -- Dedication Page -- Contents -- Foreword -- Preface -- Acknowledgments -- About the Author -- List of Abbreviations -- Part I Getting Started: Regulatory Oversight and Laboratory Accreditation -- Chapter 1 Clinical Laboratory Improvement Amendments (CLIA) and Regulatory Oversight -- How is "clinical laboratory" defined? -- What is CLIA? -- What is the Code of Federal Regulations (CFR)? -- What roles do the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA) play in regulating clinical laboratories? -- What is an FDA-cleared or FDA-approved test? -- What is a laboratory developed test (LDT)? -- What does the FDA final rule mean for my laboratory? -- FDA Requirements -- Implementation Stages and Compliance Start Dates -- LDT Categories -- Targeted Enforcement Discretion -- Legal Challenges to the FDA Final Rule -- What is Emergency Use Authorization (EUA)? -- What is test complexity? -- Is there a list of tests categorized by complexity? -- References -- Chapter 2 Clinical Laboratory Improvement Amendments (CLIA) Certificates -- Which laboratories need a CLIA certificate? -- Which laboratories are NOT required to obtain a CLIA certificate? -- What are the types of CLIA certificates? -- What procedures are categorized as provider-performed microscopy (PPM) procedures? -- How does a laboratory obtain a CLIA certificate? -- How many laboratories can be on one CLIA certificate? -- Can one location have multiple CLIA certificates? -- How many CLIA certificates can one laboratory director have? -- How long is a CLIA certificate effective, and how does a laboratory renew a CLIA certificate? -- What are the laboratory specialties and subspecialties? -- Which states have CLIA-exempt laboratory programs?.
When can a laboratory begin testing? -- Who should be notified if there are changes in the laboratory, and when? -- What happens if a laboratory is out of compliance with CLIA requirements? -- References -- Chapter 3 Waived Testing -- What are waived tests? -- Is there a list of tests that are waived? -- Is my laboratory subject to inspection if we perform waived testing? -- What are the personnel qualifications for performing waived testing in clinical laboratories? -- Are there compliance exemptions for laboratories performing waived testing? -- References -- Chapter 4 Laboratory Accreditation -- What is laboratory accreditation? -- What are the current CMS-approved accrediting agencies? -- How can my laboratory become accredited? -- How does my laboratory maintain accreditation? -- What happens during a laboratory inspection? -- How does a laboratory respond when cited for deficiencies? -- How is laboratory noncompliance addressed by CMS? -- Can I become a laboratory inspector? -- What is "ISO certification/accreditation" and does my laboratory need it? -- I need some help with terms! -- References -- Part II Going Live: Verification and Validation of Test Systems -- Chapter 5 Verification and Validation -- What are verification and validation? -- When should a laboratory perform a verification or validation study? -- What is a test system? -- What counts as a modification to a test system? -- Who is responsible for designing and implementing a verification or validation study? -- Can the company who made the instrument perform the verification study? -- What performance characteristics should be assessed for a verification study? -- What performance characteristics should be assessed for a validation study? -- Is verification/validation necessary for point of care and other CLIA-waived assays?. My laboratory is moving an instrument. Is a verification/validation necessary? -- My laboratory has five of the same instruments running the same assay. Do we have to run a verification/validation on each instrument? -- My laboratory has multiple high-complexity laboratories across the health system that run the same assays on the same platform. Does a verification/validation need to be performed at each location? -- My laboratory stopped running a particular assay. Is verification/validation necessary to resume testing with this assay? -- My laboratory is running a test under Emergency Use Authorization (EUA). Is verification/validation required? -- Which laboratory personnel are involved in a verification/validation study? -- References -- Chapter 6 Performance Characteristic: Precision -- What is precision? -- How many and what types of samples should be used to assess precision? -- How does a laboratory assess precision for qualitative assays? -- How does a laboratory assess precision for quantitative assays? -- What calculations should be used for precision? -- How can precision be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? -- How can precision be assessed for antimicrobial susceptibility test (AST) systems? -- How can precision be assessed for multiplex molecular systems? -- References -- Chapter 7 Performance Characteristic: Accuracy/Agreement -- What is accuracy? -- How many and what types of samples should be used to assess accuracy? -- What calculations should be used for accuracy? -- What calculations should be used for agreement? -- How does disease prevalence affect test performance? -- How can accuracy be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems?. How can accuracy be assessed for antimicrobial susceptibility test (AST) systems? -- How can accuracy be assessed for multiplex molecular systems? -- References -- Chapter 8 Performance Characteristic: Reportable Range -- What is reportable range? -- How many and what types of samples should be used to assess reportable range? -- How does a laboratory assess reportable range for quantitative assays? -- How does a laboratory assess reportable range for qualitative assays? -- How can reportable range be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? -- How can reportable range be assessed for antimicrobial susceptibility test (AST) systems? -- How can reportable range be assessed for multiplex molecular systems? -- References -- Chapter 9 Performance Characteristic: Reference Interval -- What is a reference interval? -- How many and what types of samples should be used to assess the reference interval? -- How does a laboratory assess the reference interval? -- What calculations should be used for reference interval? -- How can the reference interval be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? -- How can the reference interval be assessed for antimicrobial susceptibility test (AST) systems? -- How can the reference interval be assessed for multiplex molecular systems? -- References -- Chapter 10 Performance Characteristic: Analytical Sensitivity -- What is analytical sensitivity? -- How many and what types of samples should be used to assess analytical sensitivity? -- How does a laboratory assess analytical sensitivity? -- What calculations should be used for analytical sensitivity? -- How can analytical sensitivity be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems?. How can analytical sensitivity be assessed for antimicrobial susceptibility test (AST) systems? -- How can analytical sensitivity be assessed for multiplex molecular systems? -- References -- Chapter 11 Performance Characteristic: Analytical Specificity -- What is analytical specificity? -- How many and what types of samples should be used to assess analytical specificity? -- How does a laboratory assess analytical specificity? -- What should we do if cross-reactivity or interfering substances are identified? -- How can analytical specificity be assessed for matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) identification systems? -- How can analytical specificity be assessed for antimicrobial susceptibility test (AST) systems? -- How can analytical specificity be assessed for multiplex molecular systems? -- References -- Chapter 12 Additional Performance Characteristics -- What additional performance characteristics could be considered, and how are they assessed? -- References -- Chapter 13 Unacceptable Results and Resolution -- What should we do if there are significant discrepancies between our new assay and the comparator assay? (Accuracy) -- We are using a less sensitive method as our comparator method, and our new test is showing poor agreement and increased "false positives." What should we do? (Accuracy) -- Our assay shows significant cross-reactivity with a particular organism. What should we do? (Analytical specificity) -- References -- Chapter 14 Documentation for Verification and Validation Studies -- What documentation is necessary for a verification or validation study? -- What should be included in a verification/validation plan? -- What should be included in a verification/validation summary? -- How long is the laboratory required to keep verification/validation documentation?. What do I do if my laboratory's legacy assays do not have verification/validation documentation?. |
| Record Nr. | UNINA-9911020467303321 |
Martin Rebekah M
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| Newark : , : ASM Press, , 2025 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910555136903321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910830890003321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
