Documenting Clinical Microbiology Impact: Performing Clinical Research to Document the Value of the Microbiology Laboratory

For those intending to achieve the maximum validity and usefulness of microbiology results, the interface between clinical medicine and diagnostic methods in laboratory medicine is a critical focus. As such, method verification studies and quality improvement projects in clinical microbiology should optimally be performed with the rigor of scientific research, even if the project intent is not clinical research. This review aims to translate the concepts of clinical research into laboratory strategies that are relevant to clinical microbiologists who are attempting to document the value of their laboratory programs. This review focuses on the overall sequence of events that help to ensure a successful project that generates clinical impact that is data driven by laboratory results. We describe the steps needed to fully document laboratory impact after what we call a “diagnostic intervention.”