Improving the laboratory result release process in the light of ISO 15189:2012 standard
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2021
Authors
Çubukçu, Hikmet Can
Vanstapel, Florent
Thelen, Marc
Bernabeu-Andreu, Francisco A.
Van Schrojenstein Lantman, Marith

Brugnoni, Duilio

Mesko Brguljan, Pika
Milinković, Neda

Linko, Solveig
Vaubourdolle, Michel
O'Kelly, Ruth
Kroupis, Christos
Lohmander, Maria
Šprongl, Luděk
Panteghini, Mauro
Boursier, Guilaine
Article (Published version)

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The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning me...ssages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release.
Keywords:
Result release / Quality control / Laboratory errors / Accreditation / ISO 15,189Source:
Clinica Chimica Acta, 2021, 522, 167-173Publisher:
- Elsevier
DOI: 10.1016/j.cca.2021.08.013
ISSN: 0009-8981
WoS: 000704865700022
Scopus: 2-s2.0-85113808744
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PharmacyTY - JOUR AU - Çubukçu, Hikmet Can AU - Vanstapel, Florent AU - Thelen, Marc AU - Bernabeu-Andreu, Francisco A. AU - Van Schrojenstein Lantman, Marith AU - Brugnoni, Duilio AU - Mesko Brguljan, Pika AU - Milinković, Neda AU - Linko, Solveig AU - Vaubourdolle, Michel AU - O'Kelly, Ruth AU - Kroupis, Christos AU - Lohmander, Maria AU - Šprongl, Luděk AU - Panteghini, Mauro AU - Boursier, Guilaine PY - 2021 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4077 AB - The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning messages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release. PB - Elsevier T2 - Clinica Chimica Acta T1 - Improving the laboratory result release process in the light of ISO 15189:2012 standard VL - 522 SP - 167 EP - 173 DO - 10.1016/j.cca.2021.08.013 ER -
@article{ author = "Çubukçu, Hikmet Can and Vanstapel, Florent and Thelen, Marc and Bernabeu-Andreu, Francisco A. and Van Schrojenstein Lantman, Marith and Brugnoni, Duilio and Mesko Brguljan, Pika and Milinković, Neda and Linko, Solveig and Vaubourdolle, Michel and O'Kelly, Ruth and Kroupis, Christos and Lohmander, Maria and Šprongl, Luděk and Panteghini, Mauro and Boursier, Guilaine", year = "2021", abstract = "The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning messages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release.", publisher = "Elsevier", journal = "Clinica Chimica Acta", title = "Improving the laboratory result release process in the light of ISO 15189:2012 standard", volume = "522", pages = "167-173", doi = "10.1016/j.cca.2021.08.013" }
Çubukçu, H. C., Vanstapel, F., Thelen, M., Bernabeu-Andreu, F. A., Van Schrojenstein Lantman, M., Brugnoni, D., Mesko Brguljan, P., Milinković, N., Linko, S., Vaubourdolle, M., O'Kelly, R., Kroupis, C., Lohmander, M., Šprongl, L., Panteghini, M.,& Boursier, G.. (2021). Improving the laboratory result release process in the light of ISO 15189:2012 standard. in Clinica Chimica Acta Elsevier., 522, 167-173. https://doi.org/10.1016/j.cca.2021.08.013
Çubukçu HC, Vanstapel F, Thelen M, Bernabeu-Andreu FA, Van Schrojenstein Lantman M, Brugnoni D, Mesko Brguljan P, Milinković N, Linko S, Vaubourdolle M, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Panteghini M, Boursier G. Improving the laboratory result release process in the light of ISO 15189:2012 standard. in Clinica Chimica Acta. 2021;522:167-173. doi:10.1016/j.cca.2021.08.013 .
Çubukçu, Hikmet Can, Vanstapel, Florent, Thelen, Marc, Bernabeu-Andreu, Francisco A., Van Schrojenstein Lantman, Marith, Brugnoni, Duilio, Mesko Brguljan, Pika, Milinković, Neda, Linko, Solveig, Vaubourdolle, Michel, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Panteghini, Mauro, Boursier, Guilaine, "Improving the laboratory result release process in the light of ISO 15189:2012 standard" in Clinica Chimica Acta, 522 (2021):167-173, https://doi.org/10.1016/j.cca.2021.08.013 . .