Automated validation of clinical laboratory test results: do we get what we expect?

Abstract

Validation of clinical laboratory reports is the final step before transmission to the clinician, whereby test results are checked for intrinsic consistency and compatibility with the information available on the patient. Validation can be carried out manually by laboratory professionals or assisted by an automated system, which is currently the case in many laboratories (1, 2). The primary aim of validation is to prevent reporting of analytically erroneous test results. Furthermore, it can deliver a valuable contribution to the medical interpretation of deviant results, thereby reinforcing the advising role towards clinicians, and conceding to recent proposals of medical consultancy as a key competency of laboratory medicine (3, 4). We evaluated the performance of the automated validation system VALAB (Validation Assistee pour LABoratoire, Instrumentation Laboratory, Barcelona, Spain) and of our laboratory professionals in validating routine haematological test results. All laboratory reports (ns591) of 1 day containing haematological test results and other patient information (such as, age, sex, urgency of request, ambulatory or hospitalised, medical specialty of the prescribing physician, previous results) were submitted for validation to VALAB and to a group of laboratory professionals (ns7). VALAB and the laboratory professionals had to decide independently which reports needed a more detailed revision and/or some type of action (such as retesting or a call to the clinician) and should, for that reason, not be validated immediately. All decisions were registered. After individual decisions, the laboratory professionals obtained a consensus on which reports should be retained (inconsistent reports) and which reports