Interdisciplinary Quality Improvement Led by the Molecular Pathology Laboratory Expedites Diagnosis of Acute Promyelocytic Leukemia.

Abstract

Acute promyelocytic leukemia (APL) requires emergent treatment while definitive laboratory results are pending. Following the death of a patient whose diagnosis was delayed, we sought to improve our institution's workflow by using the EPIDEM (Exploration, Promotion, Implementation, Documentation, Evaluation, Modification) quality improvement model. APL is confirmed by identifying translocation t(15;17)(q24;q21) PML-RARA by using either molecular or cytogenetic methods on peripheral blood or bone marrow specimens. We used the EPIDEM model to decrease the turnaround time (TAT) of molecular diagnosis by improving communication and developing reflex testing. We additionally compared 32 APL cases against a control group of 18 suspected APL cases. Our review of 687 multiplex polymerase chain reaction orders and 33 PML-RARA orders (January 2012 to April 2021) showed an initial TAT decrease from 4.48 days to 2.71 days (P < .0001), which further decreased to 0.64 days (P < .0001) after implementation of the PML-RARA qualitative assay. Compared with patients suspected of having APL, patients with confirmed APL had higher dimerized plasmin fragment D (P = .0145), lower fibrinogen (P ≤ .0001), and lower WBC (P ≤ .0001). By using the EPIDEM model, with its emphasis on local context, culture, and resources, improved communication and workflow changes enabled us to reduce the time needed to diagnose APL to 0.64 days and identify potential locally derived screening cutoffs.