BookSusan Mahler Zneimer.
Contents:
Guidelines for good clinical laboratory practice
Quality management
Design control of tests and FDA guidelines for laboratory developed tests (LDTs)
Pre-clinical validation studies
Reagents, instruments and equipment
Cost of testing and staffing requirements
Process improvement : six sigma approach to laboratory improvement
Staff training and competency for a cytogenetics laboratory
Training program for cytogenetic and FISH technologists
Training program for molecular genetic technologists
General SOP information by test and pre-analytic procedures
Analytic procedures : chromosome analysis
Analytic procedures : FISH analysis
Analytic procedures : microarrays
Post-analytic procedures.