Extra-analytical Point of Care Testing errors in the pandemic era

AUTORI

ABSTRACT

Introduction: during the current SARS-CoV-2 pandemic phase, the use of rapid diagnostic devices outside the laboratory has expanded enormously, creating great opportunities but also new risks. Methods: the present observational study evaluated the type and frequency of errors of the extra-analytical phases through an active search on all unclear or ambiguous cases. 252 241 rapid antigenic tests performed outside the laboratory in different health facilities over a 132-day period were considered. The requests, the patient demographics and the results were later entered manually onto the Laboratory Information System (LIS). Results: through a number of data checks and internal reports, 2 556 cases of errors in the pre-examination phase were recorded, with a relative frequency of 12,274 parts per million (ppm). The vast majority of errors were observed in this phase; these were due mainly to computer communication problems induced by human errors that made the loading of results or the issuing of the reports difficult. The remaining cases involving erroneous personal data or patient identification amounted to 16 (64 ppm), confirming the relative safety of this phase in decentralized analysis. The errors identified in the post-examination phase were 540, with a relative frequency of 2140 ppm. The assessment of the severity of the errors with Failure Mode and Effect Analysis (FMEA) allowed us to identify in particular, the attribution of the report to the wrong person (20 ppm) and the manual transcription of an incorrect result (20 ppm). Discussion: this study contributes to the comprehension of the critical issues connected to the Point of Care Testing and made it possible to establish corrective actions: improving staff training, choice of instruments with reading devices and establishing direct computer connection for the entering of the requests and results to the LIS.

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