Download Annex G1/4 to the Certificate No.766-2

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)
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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
%)
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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
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Annex G1/4 to the Certificate No. 766-2
08.12.2015