Advancing Diagnostic Accuracy and Quality of Patient Care Through the Implementation of a Flow Cytometry Quality Assurance Program

Abstract Introduction/Objective Flow cytometry immunophenotypic analysis plays an important role in the diagnosis, classification and disease monitoring of hematological neoplasms. However, interpretation of flow cytometry testing can be challenging, especially when using highly complex antibody panels. Thus exploring ways to improve diagnostic accuracy and in turn improving quality of patient care is needed. Methods/Case Report A flow cytometry quality assurance (QA) program was developed. Cases from various complex flow cytometry panels were randomly selected and cross-reviewed by a second pathologist on a daily basis. The outcomes of the QA review were categorized into three groups: complete agreement, minor discrepancy and major discrepancy. Each discrepancy, once identified, underwent a process of documentation, discussion and resolution. The reports were then modified in a timely manner and the clinical teams were notified of the changes. Recurrent issues and common pitfalls were reviewed and discussed at a weekly QA meeting. Here we summarize our 3-years’ experience with this program. Results (if a Case Study enter NA) In total, 6,166 cases were evaluated by the QA program; 6,028 (97.7%) cases showed complete concordance, 120 (2.0%) cases showed minor discrepancies and 18 (0.3%) cases showed major discrepancies. Antibody panels designed to evaluate mature and immature T-cell abnormalities showed the highest rate of discrepancy, 2.8%, whereas panels designed for evaluation of myelodysplastic syndromes showed the lowest discrepancy rate, 1.7%. When analyzing the trends of concordance and discrepancy over time, we found a statistically significant decrease in discrepancies over time, from 4% at the beginning of the QA program to 1.5% in the most recent time interval. Conclusion The overall concordance rate was 97.7%. The remaining 2.3% cases showed discrepancies that required a correction, underscoring the value and necessity of having a QA program. The overall discrepancy rates exhibited a gradual decline over time, indicative of the positive impact of the QA program on enhancing diagnostic competency and accuracy over time.