title: Laboratory reporting of hemostasis assays: the final post-analytical opportunity to reduce errors of clinical diagnosis in hemostasis?
abstract: The advent of modern instrumentation, with associated improvements in test performance and reliability, together with appropriate internal quality control (IQC) and external quality assurance (EQA) measures, has led to substantial reductions in analytical errors within hemostasis laboratories. Unfortunately, the reporting of incorrect or inappropriate test results still occurs, perhaps even as frequently as in the past. Many of these cases arise due to a variety of events largely outside the control of the laboratories performing the tests. These events are primarily preanalytical, related to sample collection and processing, but can also include post-analytical events related to the reporting and interpretation of test results. The current report provides an overview of these events, as well as guidance for prevention or minimization. In particular, we propose several strategies for the post-analytical reporting of hemostasis assays, and how this may provide the final opportunity to prevent serious clinical errors in diagnosis. This report should be of interest to both the laboratory scientists working in hemostasis and clinicians that request and attempt to interpret the test results. Laboratory scientists are ultimately responsible for these test results, and there is a duty to provide both accurate and precise results to enable clinicians to manage patients appropriately and to avoid the need to recollect and retest. Also, clinicians will not be in a position to best diagnose and manage their patient unless they gain an appreciation of these issues.
authors.affiliation: Department of Hematology, Institute of Clinical Pathology and Medical Research ICPMR, Westmead Hospital, SWAHS, Westmead, NSW, Australia. emmanuel.favaloro@swahs.health.nsw.gov.au
authors.forename: Emmanuel J
authors.initials: EJ
authors.lastname: Favaloro
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
mesh_terms: D001779:Blood Coagulation Factors / Q000032:analysis; D001798:Blood Proteins / Q000032:analysis; D001800:Blood Specimen Collection; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003951:Diagnostic Errors; D006487:Hemostasis; D006801:Humans; D011786:Quality Control; D012015:Reference Standards; D012016:Reference Values; D012107:Research Design
chemical_list: D001779:Blood Coagulation Factors; D001798:Blood Proteins