Applications of immunophenotyping using flow cytometry offer precise and accurate means for providing information used to both diagnose and monitor disease; they serve as a standard platform for many research endeavors that study discrete populations of biological entities. The proper use of this highly sophisticated technology requires daily and ongoing monitoring of both the instrument and the methodology. Best practices for this begin with quality control (QC) procedures designed to set up and monitor the instrument performance, the reagents, and the results to ensure that they are working properly both on the day of use and over time. If the results of those QC procedures are outside of acceptable then recording the corrective action taken must also be included in the quality control records. Quality assurance (QA) is a way to know that the three phases of testing, namely, preanalytic, analytic, and postanalytic procedures, are being followed. This chapter describes the procedures used to assess quality control as it pertains to flow cytometry and immunophenotyping in all three phases of testing.
Keywords: Accuracy; Color compensation; FMO controls; Flow cytometry; Immunofluorescence; Immunophenotyping; Levey–Jennings; Method validation; Monoclonal antibodies; Precision; Proficiency testing; Quality assurance; Quality control.