International Clinical Cytometry Society 2023 workload survey of clinical flow cytometry laboratories.

Clinical flow cytometry laboratories are facing rising test volumes, greater assay complexity, and increasing requirements for quality control and assay validation. In response, the International Clinical Cytometry Society (ICCS) conducted a workload survey in early 2023 to gather updated information on assay volumes, complexity, staffing, and technology. Data analysis focused on identifying correlations between length of time to introduce new assays and other factors as a means to gain insight about laboratories that seem to be either adapting or struggling. Flow cytometry assays were categorized into 3 levels of technical/interpretative complexity: high (e.g., measurable/minimal residual disease (MRD assays)), moderate (e.g., leukemia/lymphoma assays (AssaysL&L), excluding MRD assays), and low (e.g., CD4 count). Annual assays per staff member were calculated according to staff involved in case sign-out (StaffSignout) or other laboratory operations (StaffLabOps). Respondents were from 101 laboratories in the United States (69.3%), Canada (4.0%), and other countries (26.7%). Low, moderate, and high technical/interpretative complexity assays were performed in 85.1%, 97.0%, and 47.5% of all laboratories, respectively. Median annual total assays (AssaysTotal) per laboratory were 3515 and, based on complexity, were 1518.5 (low), 1808.8 (moderate), and 350 (high). Among all laboratories, the median time (interquartile range) to introduce new AssaysL&L was 6 mos. (4-12 mos.), to introduce MRD assays was 11 mos. (5-12 mos.), and to validate/go-live with new cytometers was 8 mos. (4-12 mos.); these times positively correlated with each other. This study confirmed significantly increased workload since the prior ICCS 2013 workload survey with a concurrent decrease in StaffLabOps. Faster introduction of new assays correlated with other successes, including quicker validation of and going live with new cytometers. Among all laboratories, those that performed myeloid MRD assays versus those that did not were also found to be faster to introduce new assays. The need for sufficient staffing has been emphasized because laboratories with both higher annual volumes of myeloma MRD assays and higher ratios of AssaysTotal per StaffLabOps were slower to introduce new assays. "Lack of staff and/or time dedicated or protected for assay development" and, more generally, "staff number" were the most commonly identified major barriers for new assay development, with the former specifically linked to slower introduction of new assays among all laboratories.

Duke Scholars

Author Thomas Norton Denny Medicine, Duke Human Vaccine Institute