Because of this fluid regulatory environment, the Flow Cytometry CLIA Compliance Manual has been written to help make sense of the CLIA requirements and give laboratories a clear format by which to monitor Quality Assurance and Quality Control. This manual outlines compliance requirements for clinical laboratories engaged in the practice of flow cytometry, which is considered "high complexity." Since the legislative requirements are based on the complexity of the laboratory testing, recommendations in this manual apply to high-complexity testing; instructions and forms are provided for complying with the personnel, quality control, proficiency testing, and quality assurance requirements.

        We hope the explanations put forth here will help cytometry laboratories meet these regulatory requirements with greater ease, so that they may focus with more clarity on the quality of patients' results.