Quality Assurance of Genetic Testing

ABSTRACT

The proper quality control and quality assurance of clinical laboratory require not only ceaseless efforts of all lab-related personnel but also systematic programs supported and monitored by institutions or academic societies nationwide. For an external quality control program, 'The Korean Association of Quality Assurance for Clinical Laboratory' is performing proficiency tests and inter-laboratory comparison programs twice a year. This program includes cytogenetics for prenatal tests, constitutional abnormalities and neoplasia, molecular genetics for viruses, tuberculosis, leukemia, genotyping and diagnosis of muscular dystrophy, and neonatal screening of congenital metabolic diseases. For an internal quality control program, each laboratory is mandatory to make the policies for validation of protocols and reagents, training and credentials of individuals performing analysis, sample identification, safety for laboratory staff, and other compliance issues. In addition to those programs, proper testing of quality control materials, periodic monitoring of failure rates, careful review of laboratory errors, statistical analysis of the results, comparison with clinical information, and other programs for quality improvement are also needed. For those purposes, clinical laboratories must be enrolled in an approved external inspection program. 'Laboratory Accreditation Program' of 'Korean Society of Laboratory Medicine' gives an accreditation to each laboratory on a one-or two-year basis. A laboratory's ability to perform proper genetic testing is inspected for hundreds of checklist items encompassing laboratory management, chemistry, cytogenetics and molecular genetics. The programs above have been enhancing the lab quality and welcomed by most institutions and labs that experienced the inspection.