Challenges and Opportunities for Medical Directors in Pathology and Laboratory Medicine: Standardization, Integration, and InnovationThe Authors’ Reply

Abstract

Because the practice of pathology and laboratory medicine evolves rapidly, laboratory medical directors must constantly introduce new tests and services and continue to provide consistent, reliable results for existing tests. Innovations in laboratory medicine are frequently introduced, and the number of commercial vendors of test kits and reagents increases yearly. These innovations, however, may pose barriers to standardization and integration of laboratories and to interpretation of results generated by different laboratories. We propose a practical framework for medical directors to address the seemingly contradictory challenges of standardizing and integrating while simultaneously providing the flexibility to introduce innovations. We recommend initiating standardization first, then integration, while maintaining flexibility for innovation. As organizations strive to create effective processes to enhance value, the role of the laboratory medical director will become critical in resolving the natural tension between standardization/integration and innovation in laboratory medicine and pathology. The practice of pathology and laboratory medicine has evolved substantially in the past decade. Laboratory medical directors are faced with the dual challenges of introducing new tests and services while simultaneously providing consistent, reliable results for existing tests. Point-of-care testing, noninvasive testing, automation, genetic testing, and telepathology are just a few of the many innovations that have changed the practice of laboratory medicine and pathology. This burgeoning growth includes a similar increase in the number of commercial vendors of test kits and reagents. Although greater purchasing options may offer financial savings, lack of standardization across vendors and practices impedes integration of laboratories and often presents problems for physicians who