From test selection to mitigation strategies, the expert panel outlines practical steps to protect result integrity and streamline decision-making.
The Association for Diagnostics & Laboratory Medicine (ADLM) has released new expert guidance aimed at helping laboratory leaders navigate one of the most challenging gray zones in coagulation testing: how to accurately assess clotting status in patients taking direct oral anticoagulants (DOACs).
As DOAC use continues to grow across healthcare systems, the recommendations give labs a clearer framework for selecting appropriate assays, managing interferences, and strengthening communication with clinical teams.
According to a press release, DOACs are now among the most commonly prescribed anticoagulants, used to prevent strokes, pulmonary embolisms, deep vein thrombosis, and other clotting-related conditions. While these medications reduce the need for routine monitoring—one of their key advantages over traditional agents like warfarin—they still intersect with the laboratory in critical, high-stakes scenarios. Patients on DOAC therapy often require coagulation testing during emergencies involving heavy bleeding, when clinicians are investigating potential clotting disorders, or before surgeries where bleeding risk must be carefully controlled.
Challenges for Lab Professionals
For lab professionals, these situations pose significant operational and interpretive challenges. Because DOACs act directly on the same clotting factors measured in many standard assays, they can distort results or create the appearance of coagulopathies that are not truly present. ADLM’s new guidance condenses a complex body of research into a clear set of recommendations designed to help labs safeguard accuracy while supporting fast clinical decision-making.
A major takeaway for lab leaders is the recommendation to avoid clot-based assays whenever possible for DOAC-treated patients. The document details which tests are susceptible to interference and which remain reliable, providing a decision-making framework that labs can incorporate into protocols, test menus, and clinician education efforts. This clarity is especially valuable in high-volume settings where turnaround expectations and operational pressures are significant.
“Clinicians ordering coagulation testing for patients taking DOACs should approach these scenarios thoughtfully, as this requires discretion to determine appropriate and optimal timing for testing,” wrote the document authors Lindsay A.L. Bazydlo, Maximo J. Marin, Anna E. Merrill, Louise M. Man, Olajumoke O. Oladipo, and Neil S. Harris.
Lindsay A.L. Bazydlo and the other authors also noted, “Communication and collaboration with the laboratory leadership and staff is strongly suggested prior to testing. The laboratory medical director can provide guidance to the clinical team on current methodologies and how to interpret results for patients on DOACs.” (Photo credit: University of Virginia)
When Clot-Based Testing Is Unavoidable
Still, the guidance recognizes that avoiding clot-based assays is not always feasible.
For such cases, the expert panel outlines practical mitigation steps that labs can adopt. These include using agents that neutralize DOAC effects in vitro, coordinating temporary discontinuation of DOAC therapy prior to testing when medically appropriate, or facilitating a short-term switch to low-molecular-weight heparin. Each option requires careful planning, but they give laboratories concrete tools to reduce result distortion.
Perhaps most importantly for lab leadership, the guidance underscores the need to strengthen communication pathways with clinicians. Coagulation testing in DOAC patients is inherently multidisciplinary: labs need timely information on medication type and timing, while clinicians rely on labs to explain assay limitations and interpretive considerations. The document calls for labs to proactively engage with providers through education, consultative services, and updated testing algorithms to ensure both sides are aligned.
For laboratory leaders managing quality, workflows, staffing, and clinician expectations, ADLM’s guidance arrives at a crucial time. As DOAC use rises and clinical teams increasingly depend on laboratories to provide rapid, accurate data in emergent situations, the recommendations offer a roadmap for reducing diagnostic risk, standardizing best practices, and elevating the lab’s role as a strategic partner in patient care.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
—Janette Wider
