TY - JOUR
T1 - An Extensive Quality Control and Quality Assurance (QC/QA) Program Significantly Improves Inter-Laboratory Concordance Rates of Flow-Cytometric Minimal Residual Disease Assessment in Acute Lymphoblastic Leukemia
T2 - An I-BFM-FLOW-Network Report
AU - Maurer-Granofszky, Margarita
AU - Schumich, Angela
AU - Buldini, Barbara
AU - Gaipa, Giuseppe
AU - Kappelmayer, Janos
AU - Mejstrikova, Ester
AU - Karawajew, Leonid
AU - Rossi, Jorge
AU - Suzan, Adın Çınar
AU - Agriello, Evangelina
AU - Anastasiou-Grenzelia, Theodora
AU - Barcala, Virna
AU - Barna, Gábor
AU - Batinić, Drago
AU - Bourquin, Jean-Pierre
AU - Brüggemann, Monika
AU - Bukowska-Strakova, Karolina
AU - Burnusuzov, Hasan
AU - Carelli, Daniela
AU - Deniz, Günnur
AU - Dubravčić, Klara
AU - Feuerstein, Tamar
AU - Gaillard, Marie Isabel
AU - Galeano, Adriana
AU - Giordano, Hugo
AU - Gonzalez, Alejandro
AU - Groeneveld-Krentz, Stefanie
AU - Hevessy, Zsuzsanna
AU - Hrusak, Ondrej
AU - Iarossi, Maria Belen
AU - Jáksó, Pál
AU - Kloboves Prevodnik, Veronika
AU - Kohlscheen, Saskia
AU - Kreminska, Elena
AU - Malusardi, Cecilia
AU - Marinov, Neda
AU - Martin, Bibiana Maria
AU - Möller, Claudia
AU - Nikulshin, Sergey
AU - Palazzi, Jorge
AU - Paterakis, Georgios
AU - Popov, Alexander
AU - Ratei, Richard
AU - Rodríguez, Cecilia
AU - Sajaroff, Elisa Olga
AU - Sala, Simona
AU - Samardzija, Gordana
AU - Sartor, Mary
AU - Scarparo, Pamela
AU - I-BFM-FLOW
PY - 2021/12/6
Y1 - 2021/12/6
N2 - Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Münster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts.
AB - Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Münster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts.
KW - acute lymphoblastic leukemia
KW - minimal residual disease
KW - flow cytometry
KW - quality control program
U2 - 10.3390/cancers13236148
DO - 10.3390/cancers13236148
M3 - Article
C2 - 34885257
SN - 2072-6694
VL - 13
JO - Cancers
JF - Cancers
IS - 23
M1 - 6148
ER -