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 pre–clinical validation study designs.  The second focus of the book describes 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 step–wise standard operating procedures for chromosomal, FISH and microarray–based tests, including pre–analytic, analytic and post–analytic steps in testing, and 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 both a wealth of information on laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians world–wide in the field of laboratory testing and genetics testing in particular.
This book gives the essentials of:
 Developing and implementing good quality management programs in laboratories
 Understanding design control of tests and pre–clinical validations 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.

Susan Mahler Zneimer, Ph.D., FACMGG is a clinical cytogeneticist and is the Scientific Director and CEO of MOSYS Consulting, and Adjunct Professor at Moorpark College in Moorpark, California.

Dedication

Preface

Acknowledgments

Part I: Best Practices for Laboratory Operations

Chapter 1: Guidelines for Good Clinical Laboratory Practice

1.1. Physical facilities

1.2. Specimen transport and management

1.3. Personnel safety

1.4. Laboratory information system

1.5. Quality management

1.6. Organization and personnel

1.7. Laboratory equipment

1.8. Testing operating procedures

1.9. Safety Plan

1.10. Biosafety Plan

1.11. Chemical Hygiene Plan

1.12. HIPAA Incident Plan

References

Chapter 2: Quality Management

2.1. Quality control program

2.2. Individualized quality control plan (IQCP)

2.3. Standards for test records and reporting

2.4. Overview of general culturing issues

2.5. Quality improvement program

2.6. Proficiency testing

2.7. Inspection preparation

2.8. Calibration verification

References

Chapter 3: Design Control of Tests and FDA Guidelines for Laboratory Developed Tests (LDTs)

3.1. Design control of tests

3.2. FDA guideline summary for laboratory developed tests (LDTs)

References

Chapter 4: Pre–Clinical Validation Studies

4.1. Validation plans and protocols

4.2. Validation reports

4.3. Example validation plan and report – FISH probes for chromosome 5 deletion and monosomy

4.4. Example validation plan and report FDA approved Vysis ALK FISH probe

References

Chapter 5: Reagents, Instruments and Equipment

5.1. IQ, OQ, PQ procedures

5.2. Reagents, verification for clinical use and media preparation

5.3. Equipment and instruments

References

PART II – Best Practices for Staffing and Training

Chapter 6: Cost of Testing and Staffing Requirements

6.1. Labor costs

6.2. Time and cost assessment

6.3. Staffing hiring needs

6.4. Staff task requirements

References

Chapter 7: Process Improvement – Six Sigma Approach to Laboratory Improvement

7.1. Introduction

7.2. DMAIIC Tools

7.3. Defining the project

7.4. Measuring variables

7.5. Analyze data for the project

7.6. Innovate and improve the project

7.7. Controlling the results of the project

References

Chapter 8: Staff Training and Competency for a Cytogenetics laboratory

8.1. Technician (non–licensed/certified lab personnel) training and competency

8.2. Technologist (licensed/ASCP certified) training and competency

8.3. General supervisor/manager training and competency

8.4. Cytogenetic technical supervisor/director training and competency

References

Chapter 9: Training Program for Cytogenetic and FISH Technologists

9.1. Training program overview and objectives

9.2. Program content

9.3. Practical component of the training program

9.4. Lectures, quizzes and assignments

9.5. Trainee competency and completion of the program

9.6. Trainee handbook

9.7. Logs, competency forms and evaluations forms

References

Chapter 10: Training Program for Molecular Genetic Technologists

10.1. Training overview

10.2. Training objectives

10.3. Complete program content

10.4. Validation of trainee competency

10.5. Trainee handbook

10.6. Logs, competency forms and evaluations forms

References

PART III – Standard Operating Procedures

Chapter 11: General SOP Information by test and Pre–analytic procedures

11.1. Definition of an SOP

11.2. Template for an SOP

11.3. CAP and ACMG guidelines for writing SOPs

11.4. Accessioning specimens

References

Chapter 12: Analytic Procedures – Chromosome Analysis

12.1. Peripheral blood and PUBS for constitutional disorders

12.2. Amniotic fluid specimens

12.3. Chorionic villus sampling

12.4. Solid tissue samples: tissue biopsies and products of conception

12.5. Bone marrow and blood for hematologic diseases

12.6. Lymph nodes and solid tumors

12.7. Breakage syndromes

References

Chapter 13: Analytic Procedures – FISH Analysis

13.1. General information

13.2. Metaphase versus interphase FISH analyses

13.3. Cell sorting for plasma cell dysplasia s for FISH analysis

13.4. General procedure for direct labeling of FISH probes

13.5. Prenatal multicolor probes

13.6. ToTelVysion Multi–color DNA Probe Mixtures

13.7. Multicolor–telomere, centromeres and paint probes

13.8. Microscope analysis for metaphase scoring

13.9. Microscope analysis for interphase scoring

13.10. Formalin fixed paraffin embedded procedure for FISH analysis

13.11. Her2 testing

13.12. UroVysion bladder cancer FISH Analysis

References

Chapter 14: Analytic Procedures Microarrays

14.1. Test Principle

14.2. Comparing conventional chromosome analysis, FISH analysis with chromosomal microarray analysis

14.3. Interpretation

14.4. Procedure Overview

References

Chapter 15: Post–analytic procedures

15.1. Reviewing and reporting cases for chromosome analysis

15.2. Reviewing and reporting cases for FISH analysis

15.3. Reviewing and reporting cases for microarrays

15.4. Procedure for avoidance and detection of clerical errors post reporting

15.5. Specimen, Material and Record Retention and Specimen Disposal

References

Glossary

Index