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 15,189
TY - 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 . .
