Department: Testing Laboratory-Medical
ISO 15189
Appendix to Certificate No.
Accreditation No.
083-05
Schedule of Accreditation
Name and Address:
Laboratory name
Address
Phone
Fax
E-Mail
Blood Services Center – Tel Hashomer, Magen David Adom in Israel
Tel Hashomer 52621, Israel
+972-3-530-0400
+972-3-530-0500
.
Date of issue
01.01.2014
Version No. 1
Page No.
1
of:
3
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬
083
Department: Testing Laboratory-Medical
ISO 15189
Appendix to Certificate No.
Accreditation No.
083
083-05
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Test principle / Characteristics
Equipment used /
Work station
‫ידניות‬/‫ ללא תרבית באוטואנלייזרים‬,‫ זיהוי ואפיון הדבקה במחוללי מחלות‬,‫בדיקות ביולוגיות‬
Biological Testing, Identification and Characterization of Pathogenic Infections, Nonculture Identification Methods by Autoanalysers/Manual
2
3
4
A
A
A
A
P
P
P
P
Remarks
‫ בנק דם‬- ‫ רפואה‬,‫ בריאות‬:‫משפחת מוצרים‬
Group of products: Health, Medicine - Blood Bank
1
Opinion and
Interpretation
Virus :anti HIV (Human Virus :anti HIV (Human Plasma, Serum
Immunodeficiency Virus) Immunodeficiency
I/II- O plus screening
Virus) I/II- O plus
screening
‫ סרום‬,‫ פלסמה‬Chemiluminescent
immunoassay
PRISM
Virus: : HBsAg
(Hepatitis B surface
Antigen) screening
Virus: : HBsAg
(Hepatitis B surface
Antigen) screening
Plasma, Serum
‫ סרום‬,‫ פלסמה‬Chemiluminescent
immunoassay
PRISM
Virus: anti HCV
(Hepatitis C Virus)
screening
Virus: anti HCV
(Hepatitis C Virus)
screening
Plasma, Serum
‫ סרום‬,‫ פלסמה‬Chemiluminescent
immunoassay
PRISM
Virus: anti HTLV-I/II
(Human T lymphocyte
Virus I/II) confirmatory
Virus: anti HTLV-I/II Plasma, Serum
(Human T lymphocyte
Virus I/II) confirmatory
‫ סרום‬,‫ פלסמה‬Western blot assay
INNO-LIA HTLV I/II
---
---
---
---
5
A
P
Virus: anti HTLV-I/II
screening
Virus: anti HTLV-I/II
screening
Plasma, Serum
‫ סרום‬,‫ פלסמה‬Chemiluminescent
immunoassay
PRISM
6
A
P
Virus: HBsAg (Hepatitis
B surface Antigen )
neutralization confirmatory
Virus: HBsAg (Hepatitis Plasma, Serum
B surface Antigen )
neutralization confirmatory
‫ סרום‬,‫ פלסמה‬Chemiluminescent
immunoassay
PRISM
---
---
Site: P or T or M, P-Permanent, T-Temporary, M-Mobile
Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's
approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.
Date of issue
01.01.2014
Version No. 1
Page No.
2
of:
3
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬
Department: Testing Laboratory-Medical
ISO 15189
Appendix to Certificate No.
Accreditation No.
083
083-05
Schedule of Accreditation
Item Scope
Type
Site
Types of Test / Properties Measured
Materials / Samples Tested
Test principle / Characteristics
Equipment used /
Work station
Opinion and
Interpretation
‫ בנק דם‬- ‫ רפואה‬,‫ בריאות‬:‫משפחת מוצרים‬
Group of products: Health, Medicine - Blood Bank
‫ ספירת דם‬,‫הכנת מרכיבי דם‬
Blood Component Preparation, CBC
7
A
P
Determination of factor
VIII
8
A
P
Hct (Heamatocrit)
9
A
P
Hgb (Heamoglobin)
10
A
P
PLT(Platelets)
11
A
P
RBC (Red Blood Cells)
12
A
P
WBC (White Blood
Cells)
Remarks
VIII ‫ קביעת פקטור‬Plasma,
Cryoprecipitate
Cryoprecipitate ,‫ פלסמה‬Clotting time
ACL300 coagulation
system
‫ דם מלא‬Calculation from RBC count
and mean cell volume
CellDyn RUBY
‫ דם מלא‬Absorption
CellDyn RUBY
Whole blood
‫ דם מלא‬Electrical impedance
CellDyn RUBY
‫ תאי דם אדומים‬Whole blood
‫ דם מלא‬Electrical impedance
CellDyn RUBY
‫ תאי דם לבנים‬Whole blood
‫ דם מלא‬Electrical impedance
CellDyn RUBY
Hct (Heamatocrit)
Whole blood
‫ המוגלובין‬Whole blood
PLT (Platelets)
-------------
Site: P or T or M, P-Permanent, T-Temporary, M-Mobile
Type of Scopes: A- Fixed, C- Flexible scope in analytical tests : Type of matrix, analytes, experimental systems and/or analytical characteristics may be subject to changes, in accordance with the laboratory's
approved and documented procedures. For details, please refer to the list of Accredited Tests, available from the laboratory upon request.
Date of issue
01.01.2014
Version No. 1
Page No.
3
of:
3
The certificate attached is an integral part of the schedule and is numbered identically ‫התעודה המצורפת לנספח זה מהווה חלק בלתי נפרד ממנו ומספרה זהה למספר הנספח‬