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Hellenic Accreditation System Annex G1/4 to the Certificate No.766-2 SCOPE of ACCREDITATION of the Hematology Department of Laboratories Division of General Hospital of Athens «G. GENNIMATAS» Tested materials / products Types of tests/ Properties to be measured Applied Methods / Techniques to be used Hematological tests Determination of 13 parameters Automated Hematological Analyzers COULTER LH780* (A), COULTER LH780* (Β) 1. Hemoglobin (HGB) Photometric 2. Red Blood Cells (RBC) Volume analysis (Coulter principle) 3. Hematocrit (HCT%) calculated as: RBC x MCV / 10 4. Mean Corpuscular Volume (MCV) Derived from RBC histogram 5. Mean Corpuscular Ηb (MCH) calculated as: Hb / RBC 6. Mean Corpuscular Ηb Concentration (MCHC) calculated as: Hb / RBC x MCV 7. White Blood Cells (WBC) Volume analysis (Coulter principle) Whole Blood 8. Neutrophils (absolute number and Technology VCS (Volume, Conductivity, %) Scatter) Page 1 of 3 9. Lymphocytes (absolute number and %) Technology VCS (Volume, Conductivity, Scatter) 10. Monocytes (absolute number and %) Technology VCS (Volume, Conductivity, Scatter) 11. Eosinophils (absolute number and %) Technology VCS (Volume, Conductivity, Scatter) 12. Basophils (absolute number and %) Τechnology VCS (Volume, Conductivity, Scatter) 13. Platelets (PLTs) Derived from PLT histogram Annex G1/4 to the Certificate No. 766-2 08.12.2015 Tested materials / products Whole Blood (continued) Types of tests/ Properties to be measured Applied Methods / Techniques to be used Determination of 13 parameters Automated Hematological Analyzer ADVIA 2120 SIEMENS* 1. Hemoglobin (HGB) Photometric 2. Red Blood Cells (RBC) Flow Cytometry 3. Hematocrit (HCT%) calculated as: RBC x MCV /10 4. Mean Corpuscular Volume (MCV) Derived from RBC histogram 5. Mean Corpuscular Ηb (MCH) calculated as: Hb / RBC 6. Mean Corpuscular Ηb Concentration (MCHC) calculated as: Hb / RBC x MCV 7. White Blood Cells (WBC) Flow Cytometry 8. Neutrophils (absolute number and Flow Cytometry and Cytochemistry – %) (peroxidase activity) 9. Lymphocytes (absolute number and %) Flow Cytometry and Cytochemistry 10. Monocytes (absolute number and %) Flow Cytometry and Cytochemistry 11.Eosinophils (absolute number and %) Flow Cytometry and Cytochemistry 12. Basophils (absolute number and %) Flow Cytometry and Cytochemistry 13. Platelets (PLTs) Flow Cytometry Determination of 13 parameters Automated Hematological Analyzers CELLTAC F* (A), CELLTAC F* (B) 1. Hemoglobin (HGB) Photometric 2. Red Blood Cells (RBC) Volume analysis 3. Hematocrit (HCT%) calculated as: RBC x MCV /10 4. Mean Corpuscular Volume (MCV) Derived from RBC histogram 5. Mean Corpuscular Ηb (MCH) calculated as: Hb / RBC 6. Mean Corpuscular Ηb Concentration (MCHC) calculated as: Hb / RBC x MCV 7. White Blood Cells (WBC) Volume analysis 8. Neutrophils (absolute number and Flow Cytometry %) Page 2 of 3 9. Lymphocytes(absolute number and %) Flow Cytometry 10. Monocytes (absolute number and %) Flow Cytometry 11.Eosinophils (absolute number and %) Flow Cytometry 12. Basophils (absolute number and %) Flow Cytometry 13. Platelets (PLTs) Volume analysis Annex G1/4 to the Certificate No. 766-2 08.12.2015 Tested materials / products Blood plasma (sodium citrate) Blood films Types of tests/ Properties to be measured Applied Methods / Techniques to be used Determination of 4 parameters Automated Coagulation Analyzers BCS XP (1), BCS XP (2) SIEMENS* 1. Prothrombin time (PT) Coagulometric 2. Activated Partial Thromboplastin time (APTT) Coagulometric 3. Fibrinogen (FIB) Modified Clauss method 4. DDimers (DD) Immunoturbidimetric Determination of 4 parameters Automated Coagulation Analyzer BCS XP (2) SIEMENS* 1. Antithrombin III (AT III) Chromogenic 2. Protein C (Prot – C) Chromogenic 3. Activated Protein C Resistance (APCR) Coagulometric 4. Lupus Anticoagulant (LA) Coagulometric Red Blood Cells’ Morphology / Platelets’ Count and Morphology/ White Blood Cell Differential Count (absolute number and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Abnormal Cells Microscopic examination *Reference to the commercial name of a specific analyzer, refers to a specific analytical method and protocol Site of assessment: Department laboratory facilities, General Hospital of Athens «G. Gennimatas» 154 Mesogeion Av. 11527 Athens, Greece. Approved signatories: Μ. Georgiakaki, E. Voucouti, Ε. Griva – Kritikou, , Α. Τsakri, Ε. Gkoumakou, S. I. Papadimitriou, S. Chaniotaki. This scope of Accreditation replaces the previous one dated 03.09.2015. The Accreditation Certificate No. 766-2, to ELOT EN ISO 15189:2012, is valid until 07.09.2019. Athens, December 08, 2015 Ioannis Sitaras Director of the Laboratories Accreditation Division Page 3 of 3 Annex G1/4 to the Certificate No. 766-2 08.12.2015