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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.
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