TY - JOUR
T1 - Guideline on the requirements of external quality assessment programs in molecular pathology
AU - Van Krieken, J. Han
AU - Normanno, Nicola
AU - Blackhall, Fiona
AU - Boone, Elke
AU - Botti, Gerardo
AU - Carneiro, Fatima
AU - Celik, Ilhan
AU - Ciardiello, Fortunato
AU - Cree, Ian A.
AU - Deans, Zandra C.
AU - Edsjö, Anders
AU - Groenen, Patricia J T A
AU - Kamarainen, Outi
AU - Kreipe, Hans H.
AU - Ligtenberg, Marjolijn J L
AU - Marchetti, Antonio
AU - Murray, Samuel
AU - Opdam, Frank J M
AU - Patterson, Scott D.
AU - Patton, Simon
AU - Pinto, Carmine
AU - Rouleau, Etienne
AU - Schuuring, Ed
AU - Sterck, Silke
AU - Taron, Miquel
AU - Tejpar, Sabine
AU - Timens, Wim
AU - Thunnissen, Erik
AU - Van De Ven, Peter M.
AU - Siebers, Albert G.
AU - Dequeker, Elisabeth
PY - 2013/1
Y1 - 2013/1
N2 - Molecular pathology is an integral part of daily diagnostic pathology and used for classification of tumors, for prediction of prognosis and response to therapy, and to support treatment decisions. For these reasons, analyses in molecular pathology must be highly reliable and hence external quality assessment (EQA) programs are called for. Several EQA programs exist to which laboratories can subscribe, but they vary in scope, number of subscribers, and execution. The guideline presented in this paper has been developed with the purpose to harmonize EQA in molecular pathology. It presents recommendations on how an EQA program should be organized, provides criteria for a reference laboratory, proposes requirements for EQA test samples, and defines the number of samples needed for an EQA program. Furthermore, a system for scoring of the results is proposed as well as measures to be taken for poorly performing laboratories. Proposals are made regarding the content requirements of an EQA report and how its results should be communicated. Finally, the need for an EQA database and a participant manual are elaborated. It is the intention of this guideline to improve EQA for molecular pathology in order to provide more reliable molecular analyses as well as optimal information regarding patient selection for treatment.
AB - Molecular pathology is an integral part of daily diagnostic pathology and used for classification of tumors, for prediction of prognosis and response to therapy, and to support treatment decisions. For these reasons, analyses in molecular pathology must be highly reliable and hence external quality assessment (EQA) programs are called for. Several EQA programs exist to which laboratories can subscribe, but they vary in scope, number of subscribers, and execution. The guideline presented in this paper has been developed with the purpose to harmonize EQA in molecular pathology. It presents recommendations on how an EQA program should be organized, provides criteria for a reference laboratory, proposes requirements for EQA test samples, and defines the number of samples needed for an EQA program. Furthermore, a system for scoring of the results is proposed as well as measures to be taken for poorly performing laboratories. Proposals are made regarding the content requirements of an EQA report and how its results should be communicated. Finally, the need for an EQA database and a participant manual are elaborated. It is the intention of this guideline to improve EQA for molecular pathology in order to provide more reliable molecular analyses as well as optimal information regarding patient selection for treatment.
KW - External quality assessment
KW - Guideline
KW - Molecular pathology
KW - Oncology
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U2 - 10.1007/s00428-012-1354-4
DO - 10.1007/s00428-012-1354-4
M3 - Article
C2 - 23250354
AN - SCOPUS:84872316245
VL - 462
SP - 27
EP - 37
JO - Virchows Archiv - A Pathological Anatomy and Histopathology
JF - Virchows Archiv - A Pathological Anatomy and Histopathology
SN - 0945-6317
IS - 1
ER -