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Report on External Quality Assessment Schem me Survey no. 231/232 Immunohematology April 2015 INSTAND e.v. Priv. Doz. Dr. Franz Wagner Dr. Christof Geisen provided by: Instand e.v. Gesellschaft zur Förderung der Qualitätssic cherung in medizinisch hen Laboratorien e.v. Düsseldorf, 10.08.2015

EQA scheme consultant Priv. Doz. Dr. Franz Wagner Blutspendedienst NSTOB Eldagsener Str. 38 D 31832 Springe Tel. +49 (0)5041 772 172 Fax +49 (0)5041 772 421 Email: fwagner@bsd nstob.de Assistant EQA scheme consultant Dr. Christof Geisen DRK Blutspendedienst Baden Württemberg/Hessen Sandhofstr. 1 D 60528 Frankfurt/M. Tel. +49 (0)69 6782 296 Email: c.geisen@blutspende.de Reference and Targetvalue Laboratories: Dr. Ulla Bauerfeind Institut für Transfusionsmedizin Kliniken der Stadt Köln Krankenhaus Merheim Ostmerheimer Str. 200 51109 Köln Merheim Prof. Dr. med. Walter Hitzler Transfusionszentrale Johannes Gutenberg Universität Mainz Hochhaus Augustusplatz 55101 Mainz Dr. Albrecht Leo Institut für Klinische Transfusionsmedizin und Zelltherapie Heidelberg ggmbh Im Neuenheimer Feld 305 69120 Heidelberg Herr Hein Hustinx BSD SRK BERN AG Labordiagnostik Murtenstrasse 133 CH 3008 Bern Dr. Christof Geisen DRK Blutspendedienst Baden Württemberg Hessen ggmbh Institut für Transfusionsmedizin und Immunhämatologie Sandhofstr. 1 60528 Frankfurt Organisation and Logistics: INSTAND e.v. Ubierstr. 20 40223 Düsseldorf Tel. +49 (0)211 1592 13 0 Fax +49 (0)211 1592 1330 Email instand@instand ev.de www.instand ev.de Report on Instand e.v. EQAS 231 / 232 April 2015 2 of 5

Further Information In the following sections you can obtain more information about the EQA scheme, in addition to the documents sent by post. Certificate The certificate lists those analyses for which the requirements of the collaborative study are met. A confirmation of participation will be issued for each analyte with which you have participated in the EQAS. Validity of the certificates Certificates are valid for 6 months starting at the closing date of the EQA. This date is printed on top of the certificates. The printing or delivery date has no effect on the period of validity. Parameters listed in the policy B2 of the German Medical Association are indicated by a (R*). Individual results Here we specify your reported value for each analysis, as well as the applicable target value. This information is given line by line for each sample analyzed. Additionally displays a "+" that the correct results for all samples were reported, a " " indicates that at least one sample has been submitted with an incorrect result. In the lower section you can find the information about the results of the antibody differentiation and titer determination. Report on Instand e.v. EQAS 231 / 232 April 2015 3 of 5

Dispatched samples This EQA scheme included two samples of 2% red blood cells in stabilizing solution and two corresponding serum samples for antibody determination. Two additional serum samples were used for the calculation of quotients of antibody titers. Target values The target values are determined by the findings of the setpoint laboratories listed above. These laboratories represent a mix of university, state, municipal and regional blood transfusion services and cover the full spectrum of imunohematological oriented laboratories. The depreciation areas have been defined as follows: Sample 31 Code Sample 32 Code AB0 grouping 0 (3) A (1) Rh factor D negative (2) positive (1) A subgroup A 1 (1) Rh typing cc..ee (2255) ccd.ee (2244) antibody screening detectable (1) detectable (1) Coombs testing (direct) negative (2) negative (2) Kell antigen detectable (1) not detectable (2) Antibody screening and identification Antibody titer quotient Antibody screening and identification Antibody titer quotient 1. Antib. Sample 31 Code Sample 33/31 Sample 32 Code Sample 34/32 Anti D (51) 0.25 (0.125 0.5) Anti C (52) 2 (1 4) 2. Antib. Report on Instand e.v. EQAS 231 / 232 April 2015 4 of 5

Annotation of the EQA scheme adviser There was no relationship of delayed delivery and erroneous results. The results of the EQA were excellent. A relevant error rate war only detectable related to the Rh phenotype and antibody screen of sample 32. The Rh phenotype of sample 32 (ccd.ee) was missed by about 3% of participants of EQA 231 (In contrast, there were almost no errors among the participants of 232 or the participants of the EQA schemes for automated blood group determination). The most frequent erroneous result war ccd.ee. Probably, nonspecific reactivity with some anti e was misinterpreted as positive antigen determination. The anti C in sample 32 was missed by almost 2% of participants of EQA 231. Again, there were no problems among the participants of EQA scheme 232 and in the EQA schemes for automated blood group determination. The false negative results were distributed among diverse test systems; there was no obvious relationship to one of these systems. Report on Instand e.v. EQAS 231 / 232 April 2015 5 of 5