Molecular genetic testing laboratory management: emerging challenges for quality assurance

For decades, laboratory managers in the area of molecular genetic testing have struggled to adapt to rapid technological change, growing demand, evolving regulatory frameworks, and frequently changing best practice guidelines. While impressive progress has been made, the scale and scope of these challenges is unlikely to decline in the near future. Instead the challenges are likely to become even more imposing as a result of the emerging new clinical applications, the need for increasingly comprehensive international regulatory and quality assurance frameworks, and the rapidly growing demand for molecular genetic testing in the developing world. All of these challenges can be expected to create new pressures in the areas of cost and efficiency. Efforts to increase the effectiveness and adaptability of quality assurance frameworks should be prioritized with increased attention by scholars, policymakers, and laboratory managers. This review will introduce and familiarize the reader with the basic historical trajectory for the development of quality management frameworks and standardization practices involved in the management of molecular genetic testing laboratories. This review will also identify recurrent dynamics that have posed challenges for quality assurance in the field.