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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.
Auteur
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.
Résumé
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:
Contenu
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
1.7 Laboratory Equipment 10
1.8 Testing Operating Procedures 11
1.9 Safety Plan 12
1.10 Biosafety Plan 22
1.11 Chemical Hygiene Plan 31
1.12 Health Insurance Portability and Accountability Act (HIPAA) Incident Plan 55
Appendix 1.A: OSHA's Form 300 60
Appendix 1.B: OSHA's Form 300A 61
Appendix 1.C: Information on HMIS and NFPA Labeling Systems used in Laboratories 62
Further Reading 66
More Resources 69
HIPAA Reference 70
2 Quality Management 71
2.1 QC Program 74
2.2 Individualized QC Plan (IQCP) 80
2.3 Standards for Test Records and Reporting 81
2.4 Overview of General Culturing Issues 83
2.5 QI Program 95
2.6 Proficiency Testing 101
2.7 Inspection Preparation 110
2.8 Calibration Verification 112
Further Reading 121
3 Design Control of Tests and FDA Guidelines for Laboratory Developed Tests (LDTs) 125
3.1 Design Control of Tests 125
3.2 FDA Guideline Summary for LDTs 139
Further Reading 157
4 Preclinical Validation Studies 159
4.1 Validation Plans and Protocols 159
4.2 Validation Reports 179
4.3 Example Validation Plan and ReportAnalysis of FISH Probes for Chromosome 5 Deletion and Monosomy 181
4.4 Example Validation Plan and Report for the FDAApproved Vysis ALK FISH Probe 192
Further Reading 206
5 Reagents, Instruments, and Equipment 209
5.1 Reagents 209
5.2 Instruments and Equipment 227
5.3 IQ, OQ, and PQ Procedures 237
5.4 Example Equipment Process Validation Protocol 245
Further Reading 250
Section II: Best Practices for Staffing and Training 253
6 Cost of Testing and Staffing Requirements 255
6.1 Labor Costs 256
6.2 Time and Cost Assessment 260
6.3 Staffing Hiring Needs 260
6.4 Staff Task Requirements 262
Further Reading 267
7 Process Improvement: Six Sigma Approach to Laboratory Improvement 269
7.1 Introduction 269
7.2 DMAIIC Tools 273
7.3 Defining the Project 274
7.4 Measuring Variables 279
7.5 Analyze Data for the Project 282
7.6 Innovate and Impro…