J Korean Med Assoc.  2006 Jul;49(7):583-588. 10.5124/jkma.2006.49.7.583.

Quality Assurance of Genetic Testing

• Shin BM

• KMID: 1958256
• DOI: http://doi.org/10.5124/jkma.2006.49.7.583

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.

Keyword

Genetic test; Quality assurance; Proficiency test; Laboratory accreditation

MeSH Terms

Accreditation
Checklist
Chemistry
Compliance
Cytogenetics
Diagnosis
Genetic Testing*
Indicators and Reagents
Infant, Newborn
Leukemia
Metabolic Diseases
Molecular Biology
Muscular Dystrophies
Neonatal Screening
Quality Control
Quality Improvement
Tuberculosis
Indicators and Reagents

Reference

1. Unger ER, Piper MA. Henry JB, editor. Molecular diagnosis: basic principles and techniques. Clinical diagnosis and management by laboratory methods. 2001. 20th ed. Philadelphia: WB Saunders;1275–1280.

2. Travers EM, McClatchey KD. McClatchey KD, editor. Basic laboratory management. Clinical laboratory medicine. 2002. 2nd ed. Philadelphia: Lippincott;3–48.

6. Watson M, Gersen SL. Gersen SL, Keagle MB, editors. Quality control and quality assurance. The principles of clinical cytogene-tics. 2005. 2nd ed. Totowa: Human Press;93–112.

7. Ferreira-Gonzalez A, Wilkinson DS. Henry JB, editor. Establishing a molecular diagnosis laboratory. Clinical diagnosis and management by laboratory methods. 2001. 20th ed. Philadelphia: WB Saunders;1333–1343.