MOLECULAR DIAGNOSTICS QUESTIONS AND ANSWERS (GRADED A+)

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