The growing demand for molecular testing poses some distinct challenges for laboratories: molecular labs using paper-based workflows may find it challenging to meet the expected volume of genetic or esoteric tests, and paper-based systems make it difficult to manage quality control and inventory.
Adding molecular testing features to an existing laboratory information system (LIS) can help laboratories bring molecular testing into the clinical lab environment. Molecular-specific features within the LIS include managing complex molecular protocols, electronic activity logs, instrument interfacing, and automated quality control. Workflow that is automated is faster and reduces the risk for error, creating a more efficient laboratory that can accept a higher volume of molecular testing. It is critical to manage inventory, master mix generation, preventive maintenance, and instrument activities, allowing staff to focus on the assays instead of paperwork and instrument template preparation.
A robust laboratory information system can be used to enforce protocols and review daily activities, integrating required tasks into daily workflow and eliminating the possibility of missing documentation. An LIS with specialized reporting must allow molecular results to be reported in both clinical and anatomic pathology laboratory information systems, integrating anatomic, clinical, and molecular pathology laboratories. In addition to a more efficient laboratory, addressing molecular testing through the laboratory information system provides enhanced quality control. Regulatory bodies for molecular diagnostics, such as the College of American Pathologists, perform complicated inspections of molecular laboratories, often involving multiple checklists. Typically, time-consuming preparation for inspections includes preparing and reviewing hundreds of documents, and tagging multiple binders and files for each inspection question. An automated, paperless system with integrated CAP checklists and reporting tools enables laboratories always to be prepared for inspection.
Integration of molecular testing in the LIS addresses many challenges that are faced by today’s molecular labs. Successful molecular labs of the future will be paperless, efficient, and always ready.
