Clinical laboratory directorship in Asia-Pacific and North America: Current practices and pathways to global framework development

Abstract

Clinical laboratories are essential to modern healthcare, playing a critical role in diagnosing, monitoring, and managing diseases. Laboratory directors, as the highest authority in the laboratory, are responsible for overseeing operations, ensuring test accuracy, maintaining quality control, and safeguarding patient safety. These directors are highly qualified professionals, but the qualifications required for the role vary significantly across countries. In some countries, medical doctors (MDs) are the standard, while in others, non-MD clinical scientists are eligible for the position. This variation presents challenges, leading to ongoing discussions in scientific societies about the best pathways to prepare individuals for this critical role. This debate underscores the need to balance clinical expertise with specialized scientific knowledge to meet the evolving demands of laboratory medicine. To address these challenges, establishing a global common pathway for laboratory directorship qualifications is essential. Recognizing the diversity of qualification systems across countries is crucial for developing a pathway that can be globally adaptable and applicable to various healthcare contexts. Drawing inspiration from successful models around the world will be key in shaping such a framework. Europe, with its well-documented qualification frameworks, has made significant efforts toward harmonizing standards for laboratory directorship. However, data on qualification systems in regions like Asia-Pacific and North America remain limited. This review aims to evaluate the current qualification requirements in these regions, compare them to established models, and discuss the feasibility of creating a globally standardized pathway for laboratory director qualifications. The findings could serve as the foundation for developing a more detailed, common curriculum by international scientific societies such as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), addressing the demands of various countries.