Hellenic Accreditation System

Annex G1/1 to the Certificate No 1044
SCOPE of ACCREDITATION
of the
Department of Microbiology
of
General Hospital of Nea Ionia «Konstantopouleio-Patission»
Tested materials/ products / Types of tests/ Properties to be measured / Applied Standards/ Techniques to be used
Microbiology testing
1.  BLOOD / BLOOD CULTURE / BACTEC 9240
Becton-Dickinson
2.  URINE / QUANTITATIVE URINE CULTURE / Laboratory Instruction Ο.Μ.530.04
3.  MICROBIAL ISOLATE FROM CULTURES OF HUMAN BIOLOGICAL SAMPLES / IDENTIFICATION / WalkAway Instrument, Beckman Coulter
(PANELS)
Fluorometric identification
4.  MICROBIAL ISOLATE FROM CULTURES OF HUMAN BIOLOGICAL SAMPLES / SUSCEPTIBILITY TESTING (DETERMINATION OF MINIMUM INHIBITORY CONCENTRATION (MIC) / WalkAway Instrument, Beckman Coulter
(PANELS)
Colorimetric test
Urine tests
1.  Urine / Determination of 10 parameters / Automated analyzers AUTION MAX AX-4280
(MENARINI)
1. Specific Gravity / Refractometry
2. pH / Reflectometry
3. Leukocytes
4. Nitrates
5. Protein
6. Glucose
7. Ketones
8. Urobilinogen
9. Bilirubin
10. Erythrocytes (blood)
2. Urine Sediment
/ Determination of 8 parameters
1.  Leucocytes ( number and type ) / Microscopic examination
(x10,x40 )
2.  Red blood cells ( number and type )
3.  Epithelial cells of urine system (number and type )
4.  Bacteria
5.  Fungi
6.  Casts ( number and type )
7.  Crystal ( number and type )
8.  Amorphous salts (type )
Immunoassays
1.  Blood serum / Determination of 5 parameters / Automated immunoassay analyzer
Cobas e411, Roche.
1.  Alpha-fetoprotein (α-FP) / Electrochemiluminescence/
Magnetic particle (ECL technology)
2.  Carcinoembryonic antigen(CEA)
3.  Cancer Antigen 15-3(CA 15-3)
4.  Cancer Antigen 19-9 (CA 19-9)
5.  Cancer Antigen 125 (CA 125)
2.  Blood serum / Determination of 8 parameters / Automated analyzer Cobas Integra 800, Roche
1.  C-Reactive Protein (CRP) / Immunoturbidimetric assay
2.Antistreptolysin O (ASTO)
3.Immunoglobulin A (IgA)
4.Immunoglobulin G (IgG)
5.Immunoglobulin M (IgM)
6.Complement C3 (C3)
7.Complement C4 (C4)
8.Rheumatoid factor (RF)

Site of assessment: Laboratory permanent premises: 3-5 Agias Olgas, 14233, N. Ionia, Athens Greece.

Approved signatories:E. Platsouka, Z. Roussou, E. Merkouri, E. Palla, D. Manthou, K. Fragiadaki, S. Likousi

The Accreditation Certificate No. 1044, to ELOT EN ISO 15189:2012, is valid until 28..6.2020

Athens, 29.6. 2016

Ioannis Sitaras

Director of the Laboratories Accreditation Division

Page 1 of 4 Annex G1/1 to the Certificate ESYD No.1044 29.6.2016