Management of Preanalytical Noncompliances in the Biochemistry Laboratory

Authors : Hicham Chemsi; Samira Nani; Samira Hassoune; Nabiha Kamal

Volume/Issue : Volume 6 - 2021, Issue 7 - July

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Introduction The preanalytical phase is a crucial step in the analytical process at the Laboratory of Biochemistry. The control of nonconformities during this phase is a requirement of the Standard EN ISO 15189 Version 2012. This control is considered one of the most reliable performance indicators. The objective of our study was to detect the percentage of annuals differents nonconformities in order to improve the quality of reception and results of biochemical examinations. Materials and Methods This is a cross-sectional, prospective study of the preanalytical phase in biochemical analyzes carried out in the Biochemistry Laboratory during a period from 01/01/2020 to 31/12/2020. The study included all types of samples requested by clinical services and excluded samples and prescriptions that did not meet the criteria for good prescription and for which they were the subject of nonconformities. Analysis requests are processed at the reception level, nonconformities will be noted in a register and entered into the computer system for analysis. Results A total of 1,533 nonconformities were identified. 728 (47%) related to the prescription sheet, 796 (52%) related to the sample and 9 (1%) related to a delivery error or delay. Regarding the prescription sheet, the identity mismatch between the collection tube and the prescription represented the highest proportion with 313 (20%), followed by the absence of the doctor's stamp on the prescription with 235 (15 %), the absence of the patient's entry number with 110 (7%), a nonconformity of the same entry number in two patients with the same name 44 (3%) and finally the absence of the sheet prescription with 26 (2%). Regarding the nonconformities relating to the sample, the highest proportion was that of the absence of the identity on the collection tube with 457 (29%), followed by the nonconformity of the collection tube with 216 (14%), the absence of the sample to be treated recorded 55 (4%), the insufficient quantity with 42 (3%) and finally the broken tube which was of the order of 26 (2%). Regarding routing issues, it was rated 9 (1%). Conclusion In view of the results of our study, proposals can be made, namely the provision of a manual of parameters and sampling, the continuous training of medical personnel and the improvement of communication between the laboratory and the clinical services

Keywords : Nonconformity, Preanalysis, Prescription, Samples


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31 - October - 2023

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