Author: James O. Westgard
Publisher: Elsevier Health Sciences
ISBN: 032347764X
Category : Medical
Languages : en
Pages : 265
Book Description
This issue of Clinics in Laboratory Medicine entitled “Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology will be guest edited by Sten Westgard, James Westgard, and David Armbruster. The issue will cover a broad range of topics related to management in the laboratory including but not limited to: Metrology Perspectives; Biologic Variation Approach to Daily Laboratory; Clinical Outcome Approach to Goal Setting; Six Sigma Quality Management System; Traceability and Comparability; MU, Risk, and Sigma-metrics at Sunway; and Quality Indicators for the Total Testing Process, among others.
Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology, An Issue of the Clinics in Laboratory Medicine
Author: James O. Westgard
Publisher: Elsevier Health Sciences
ISBN: 032347764X
Category : Medical
Languages : en
Pages : 265
Book Description
This issue of Clinics in Laboratory Medicine entitled “Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology will be guest edited by Sten Westgard, James Westgard, and David Armbruster. The issue will cover a broad range of topics related to management in the laboratory including but not limited to: Metrology Perspectives; Biologic Variation Approach to Daily Laboratory; Clinical Outcome Approach to Goal Setting; Six Sigma Quality Management System; Traceability and Comparability; MU, Risk, and Sigma-metrics at Sunway; and Quality Indicators for the Total Testing Process, among others.
Publisher: Elsevier Health Sciences
ISBN: 032347764X
Category : Medical
Languages : en
Pages : 265
Book Description
This issue of Clinics in Laboratory Medicine entitled “Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology will be guest edited by Sten Westgard, James Westgard, and David Armbruster. The issue will cover a broad range of topics related to management in the laboratory including but not limited to: Metrology Perspectives; Biologic Variation Approach to Daily Laboratory; Clinical Outcome Approach to Goal Setting; Six Sigma Quality Management System; Traceability and Comparability; MU, Risk, and Sigma-metrics at Sunway; and Quality Indicators for the Total Testing Process, among others.
Dermatopathology, An Issue of Clinics in Laboratory Medicine
Author: Steven D. Billings
Publisher: Elsevier Health Sciences
ISBN: 0323395708
Category : Medical
Languages : en
Pages : 313
Book Description
This issue of Clinics in Laboratory Medicine, edited by Dr. Steven Billings, will cover Dermatopathology. Topics covered in this issue include Blue nevi and related lesions, sentinel lymph node biopsies in melanoma, Spitzoid melanocytic neoplasms, Tumor immunology related to melanoma, Molecular aspects of melanoma, Merkel cell carcinoma, Cutaneous Squamous Cell Carcinoma, Cutaneous T-cell lymphomas, Cutaneous B-cell lymphomas, Myeloid neoplasms, among others.
Publisher: Elsevier Health Sciences
ISBN: 0323395708
Category : Medical
Languages : en
Pages : 313
Book Description
This issue of Clinics in Laboratory Medicine, edited by Dr. Steven Billings, will cover Dermatopathology. Topics covered in this issue include Blue nevi and related lesions, sentinel lymph node biopsies in melanoma, Spitzoid melanocytic neoplasms, Tumor immunology related to melanoma, Molecular aspects of melanoma, Merkel cell carcinoma, Cutaneous Squamous Cell Carcinoma, Cutaneous T-cell lymphomas, Cutaneous B-cell lymphomas, Myeloid neoplasms, among others.
Emerging Pathogens, An Issue of Clinics in Laboratory Medicine
Author: Nahed Ismail
Publisher: Elsevier Health Sciences
ISBN: 0323530168
Category : Medical
Languages : en
Pages : 169
Book Description
This issue of Clinics in Laboratory Medicine, edited by Drs. Nahed Ismail, A. William Pasculle, and James Snyder, will cover a wide variety of Emerging Pathogens. Topics covered in this issue include, but are not limited to West Nile Virus; Zika Virus; Ebola and Marburg Heamorrhagic Fever; Rift Valley Fever; Carbapenem Resistant Enterobacteriacae; Closteridium Difficuile; and Chikungunya, among others.
Publisher: Elsevier Health Sciences
ISBN: 0323530168
Category : Medical
Languages : en
Pages : 169
Book Description
This issue of Clinics in Laboratory Medicine, edited by Drs. Nahed Ismail, A. William Pasculle, and James Snyder, will cover a wide variety of Emerging Pathogens. Topics covered in this issue include, but are not limited to West Nile Virus; Zika Virus; Ebola and Marburg Heamorrhagic Fever; Rift Valley Fever; Carbapenem Resistant Enterobacteriacae; Closteridium Difficuile; and Chikungunya, among others.
Quality Control in the age of Risk Management, An Issue of Clinics in Laboratory Medicine
Author: James O. Westgard
Publisher: Elsevier Health Sciences
ISBN: 1455772313
Category : Medical
Languages : en
Pages : 220
Book Description
In October of 2011, CLSI published a new guideline EP23A on “Laboratory Quality Control Based on Risk Management. In March, 2012, CMS announced its intention to incorporate key concepts from EP23A into its Interpretative Guidelines and QC policy for “Individualized Quality Control Plans. Thus begins a new era of Quality Control in the Age of Risk Management. This issue is intended to help laboratories with the transition between traditional QC practices and the new risk management approach. Laboratories face a steep learning curve to apply risk analysis for identifying and prioritizing failure-modes, developing and implementing control mechanisms to detect those failure-modes, and assessing the acceptability of the residual risks that exist after implementation of a QC Plan. One of the main benefits of the new risk analysis based QC Plans should be an integration of all the control mechanisms that are needed to monitor the total testing process, including pre-analytic, analytic, and post-analytic controls. One of the main risks of the new approach is an expectation that Statistical QC is no longer important, even though SQC still remains the most useful and flexible approach for monitoring the quality of the analytic process. The key to the future is the successful integration of all these control mechanisms to provide a cost-effective quality system that monitors all phases of the total testing process. This issue should help laboratories understand the evolution of QC practices to include risk management, but also to recognize the need to maintain traditional techniques such as Statistical QC, especially during the transition to well-designed and carefully-validated QC Plans. Risk analysis may be risky business unless laboratories proceed carefully and cautiously.
Publisher: Elsevier Health Sciences
ISBN: 1455772313
Category : Medical
Languages : en
Pages : 220
Book Description
In October of 2011, CLSI published a new guideline EP23A on “Laboratory Quality Control Based on Risk Management. In March, 2012, CMS announced its intention to incorporate key concepts from EP23A into its Interpretative Guidelines and QC policy for “Individualized Quality Control Plans. Thus begins a new era of Quality Control in the Age of Risk Management. This issue is intended to help laboratories with the transition between traditional QC practices and the new risk management approach. Laboratories face a steep learning curve to apply risk analysis for identifying and prioritizing failure-modes, developing and implementing control mechanisms to detect those failure-modes, and assessing the acceptability of the residual risks that exist after implementation of a QC Plan. One of the main benefits of the new risk analysis based QC Plans should be an integration of all the control mechanisms that are needed to monitor the total testing process, including pre-analytic, analytic, and post-analytic controls. One of the main risks of the new approach is an expectation that Statistical QC is no longer important, even though SQC still remains the most useful and flexible approach for monitoring the quality of the analytic process. The key to the future is the successful integration of all these control mechanisms to provide a cost-effective quality system that monitors all phases of the total testing process. This issue should help laboratories understand the evolution of QC practices to include risk management, but also to recognize the need to maintain traditional techniques such as Statistical QC, especially during the transition to well-designed and carefully-validated QC Plans. Risk analysis may be risky business unless laboratories proceed carefully and cautiously.
Quality Assurance in the Pathology Laboratory
Author: Maciej J. Bogusz
Publisher: CRC Press
ISBN: 1439802351
Category : Law
Languages : en
Pages : 376
Book Description
Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute.Leffler, 1982Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is.Pirsig, 2000The continuous formulation of good practices and procedures across fields reflects t
Publisher: CRC Press
ISBN: 1439802351
Category : Law
Languages : en
Pages : 376
Book Description
Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute.Leffler, 1982Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is.Pirsig, 2000The continuous formulation of good practices and procedures across fields reflects t
Laboratory Quality Management System
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Preparing for Future Products of Biotechnology
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231
Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231
Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Modern Approaches To Quality Control
Author: Ahmed Badr Eldin
Publisher: BoD – Books on Demand
ISBN: 9533079711
Category : Technology & Engineering
Languages : en
Pages : 554
Book Description
Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate quality control processes in a variety of areas, ranging from pharmaceutical and medical fields to construction engineering and data quality. A wide range of techniques and procedures have been covered.
Publisher: BoD – Books on Demand
ISBN: 9533079711
Category : Technology & Engineering
Languages : en
Pages : 554
Book Description
Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate quality control processes in a variety of areas, ranging from pharmaceutical and medical fields to construction engineering and data quality. A wide range of techniques and procedures have been covered.
Accuracy Requirements and Uncertainties in Radiotherapy
Author: International Atomic Energy Agency
Publisher:
ISBN: 9789201008152
Category : Technology & Engineering
Languages : en
Pages : 297
Book Description
Accuracy requirements in radiation oncology have been defined in multiple publications; however, these have been based on differing radiation technologies. In the meantime, the uncertainties in radiation dosimetry reference standards have been reduced and more detailed patient outcome data are available. No comprehensive literature on accuracy and uncertainties in radiotherapy has been published so far. The IAEA has therefore developed a new international consensus document on accuracy requirements and uncertainties in radiation therapy, to promote safer and more effective patient treatments. This publication addresses accuracy and uncertainty issues related to the vast majority of radiotherapy departments including both external beam radiotherapy and brachytherapy. It covers clinical, radiobiological, dosimetric, technical and physical aspects.
Publisher:
ISBN: 9789201008152
Category : Technology & Engineering
Languages : en
Pages : 297
Book Description
Accuracy requirements in radiation oncology have been defined in multiple publications; however, these have been based on differing radiation technologies. In the meantime, the uncertainties in radiation dosimetry reference standards have been reduced and more detailed patient outcome data are available. No comprehensive literature on accuracy and uncertainties in radiotherapy has been published so far. The IAEA has therefore developed a new international consensus document on accuracy requirements and uncertainties in radiation therapy, to promote safer and more effective patient treatments. This publication addresses accuracy and uncertainty issues related to the vast majority of radiotherapy departments including both external beam radiotherapy and brachytherapy. It covers clinical, radiobiological, dosimetric, technical and physical aspects.
Countering the Problem of Falsified and Substandard Drugs
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Publisher: National Academies Press
ISBN: 0309269393
Category : Medical
Languages : en
Pages : 377
Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.