Measuring the impact: Severity of harm from laboratory errors in 195 tests.

Objectives: This study aimed to objectively assess the potential severity of harm associated with erroneous results in 195 laboratory tests by surveying 514 specialist physicians and medical biochemistry experts.

Methods: The survey obtained participants' (75 medical biochemists, 439 clinicians) opinions on severity of harm for the erroneous results of 195 tests. The comprehensive list of errors and their effects on test results were obtained from the literature, and then matched with severity of harm scores, from 1 (negligible effect) to 5 (life-threatening injury/death), obtained from the survey responses.

Results: Participants perceived tests such as cardiac biomarkers, blood gases, coagulation parameters (activated partial thromboplastin time, prothrombin time, international normalized ratio, and dimerized plasmin fragment D), critical ions (potassium, sodium), toxic trace elements (lead, mercury), and specific serum drug levels (lithium, digoxin) to have a greater potential for patient harm in case of errors. Medical biochemistry specialists assigned higher severity scores to some laboratory tests, including total bilirubin, pseudocholinesterase, platelet indices, and some drug levels (cyclosporine, methotrexate, vancomycin).

Conclusions: A substantial agreement (91%) was observed between medical biochemists and clinicians in terms of the most frequently chosen severity of harm score. The study provided objective severity scores and identified high-risk tests for targeted quality improvement.