Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal, FISH and microarray-based tests, including preanalytic, analytic, and postanalytic steps in testing, which are divided into categories by specimen type and test type.

All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory.

Providing a wealth of information on both laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians worldwide in the field of laboratory testing and genetic testing in particular.

This book gives the essentials of:

Developing and implementing good quality management programs in laboratories
Understanding design control of tests and preclinical validation studies and reports
FDA guidelines for laboratory-developed tests
Use of reagents, instruments, and equipment
Cost of testing assessment and process improvement using Six Sigma methodology
Staffing training and competency objectives
Complete training programs for molecular and cytogenetic technologists
Standard operating procedures for all components of chromosomal analysis, FISH, and microarray testing of different specimen types

This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting, and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements.

Autorentext

SUSAN MAHLER ZNEIMER, Ph.D., FACMGG, is a clinical cytogeneticist, is the scientific director and CEO of MOSYS Consulting, and an adjunct professor at Moorpark College in Moorpark, California, USA.

Zusammenfassung
Cytogenetic Laboratory Management Cytogenetic Laboratory Management Chromosomal, FISH and Microarray-Based Best Practices and Procedures Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal, FISH and microarray-based tests, including preanalytic, analytic, and postanalytic steps in testing, which are divided into categories by specimen type and test type. All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory. Providing a wealth of information on both laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians worldwide in the field of laboratory testing and genetic testing in particular. This book gives the essentials of:

Developing and implementing good quality management programs in laboratories
Understanding design control of tests and preclinical validation studies and reports
FDA guidelines for laboratory-developed tests
Use of reagents, instruments, and equipment
Cost of testing assessment and process improvement using Six Sigma methodology
Staffing training and competency objectives
Complete training programs for molecular and cytogenetic technologists
Standard operating procedures for all components of chromosomal analysis, FISH, and microarray testing of different specimen types This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting, and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements.

Inhalt
Dedication xiii

Preface xvii

Acknowledgments xix

About the Companion Website v

Section I: Best Practices for Laboratory Operations 1

1 Guidelines for Good Clinical Laboratory Practice 3

1.1 Physical Facilities 4

1.2 Specimen Transport and Management 5

1.3 Personnel Safety 6

1.4 Laboratory Information System (LIS) 7

1.5 Quality Management 7

1.6 Organization and Personnel 10