MOLECULAR DIAGNOSTICS
QUESTIONS AND ANSWERS (GRADED
A+)
Quality control - ANSWER-process for detecting and correcting defects by establishing
limits of acceptable performance
Quality assurance (improvement) - ANSWER-a system for continuously monitoring and
improving the reliability, efficiency, and clinical value of laboratory tests
CLIA 88 - ANSWER-Personnel
Specimen ID and integrity
Written QC procedures
Comprehensive QA program
Proficiency testing for each analyte
No specific standards for molecular testing
Molecular Diagnostic Methods for Genetic Diseases: Approved Guidelines
All phases of operation of medical genetics lab - ANSWER-Clinical Laboratory
Standards Institute (CLSI)
Onsite laboratory inspection and certification program
Offers proficiency testing programs
Molecular testing labs can obtain certification through CAP
Has "deemed status" from CMS and JCAHO - ANSWER-College of American
Pathologists (CAP)
Regulates and provides guidance for marketing in vitro diagnostic devices (IVD) -
ANSWER-FDA
Pre-analytic Phase include - ANSWER-Test requests
Collection and labeling
Preservation
Transportation
Storage
Blood and bone marrow must be collected in - ANSWER-nuclease-free EDTA or ACD
tubes for molecular testing
inhibits amplification assays - ANSWER-Heparin
Infectious disease assays need - ANSWER-body fluids
QUESTIONS AND ANSWERS (GRADED
A+)
Quality control - ANSWER-process for detecting and correcting defects by establishing
limits of acceptable performance
Quality assurance (improvement) - ANSWER-a system for continuously monitoring and
improving the reliability, efficiency, and clinical value of laboratory tests
CLIA 88 - ANSWER-Personnel
Specimen ID and integrity
Written QC procedures
Comprehensive QA program
Proficiency testing for each analyte
No specific standards for molecular testing
Molecular Diagnostic Methods for Genetic Diseases: Approved Guidelines
All phases of operation of medical genetics lab - ANSWER-Clinical Laboratory
Standards Institute (CLSI)
Onsite laboratory inspection and certification program
Offers proficiency testing programs
Molecular testing labs can obtain certification through CAP
Has "deemed status" from CMS and JCAHO - ANSWER-College of American
Pathologists (CAP)
Regulates and provides guidance for marketing in vitro diagnostic devices (IVD) -
ANSWER-FDA
Pre-analytic Phase include - ANSWER-Test requests
Collection and labeling
Preservation
Transportation
Storage
Blood and bone marrow must be collected in - ANSWER-nuclease-free EDTA or ACD
tubes for molecular testing
inhibits amplification assays - ANSWER-Heparin
Infectious disease assays need - ANSWER-body fluids
