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Norwegian accreditation

Accreditation scope for

TEST 295

St. Olavs hospital HF

Laboratoriemedisinsk klinikk, Avd.for immunologi og transfusjonsmedisin

Postboks 3250 Sluppen
7006 Trondheim

Telephone: 72573200
E-mail: immunoblodbank@stolav.no
Internet: http://www.stolav.no
The laboratory meets the requirements in

NS-EN ISO 15189:2022




Accreditation includes:
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The administrative / geographical unit:
Avd. for immunologi og transfusjonsmedisin, Orkdal
Sjukehusvegen 3
7300 Orkanger


Permanent facility
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donor
Parameter
Collection of whole blood
Reference standard
Internal method
Internal method identity
6095 22956
Comment
Object
Blood donors
Parameter
Interview and approval of blood donation
Reference standard
Internal method
Internal method identity
6394
Comment
Object
Blood donors
Parameter
New registration and approval for blood donation
Reference standard
Internal method
Internal method identity
6441 26529
Comment
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
Vein- and capillary samples
Reference standard
Internal method
Internal method identity
1756 6095
Comment
Recognized procedures for venous or capillary puncture
The administrative / geographical unit:
Avd.for immunologi og transfusjonsmedisin, Trondheim
Postboks 3250 Sluppen
7006 Trondheim


Permanent facility
M01 Immunology and transfusion medicine
Object
Parameter
Reference standard
Internal method identity
Comment
Object
EDTA blood
Parameter
HLA-B27 typing
Reference standard
Internal method
Internal method identity
7433
Comment
Flow cytometry, FACSLyric
Object
EDTA blood
Parameter
Absolute number of lymphocytes with immunodeficiency
Reference standard
Internal method
Internal method identity
12618
Comment
Flow cytometry, FACS Lyrics
Object
EDTA blod Stem cell product
Parameter
Quantitation of CD34 positive cells and viability test in stem cell treatment
Reference standard
Internal method
Internal method identity
8223
Comment
Flow cytometry, FACSLyric
Object
Serum
Parameter
Mitochondrial antibody M2
Reference standard
Internal method
Internal method identity
31685
Comment
ELISA, Dynex DS2
Object
Serum
Parameter
Smooth muscle (F-actin) antibody
Reference standard
Internal method
Internal method identity
31685
Comment
ELISA, Dynex DS2
Object
Serum
Parameter
LKM-1 antibody
Reference standard
Internal method
Internal method identity
31685
Comment
ELISA, Dynex DS2
Object
Serum
Parameter
Intrinsic factor antibody
Reference standard
Internal method
Internal method identity
31701
Comment
ELISA, Phadia 250
Object
Serum
Parameter
Parietalceller antbody
Reference standard
Internal method
Internal method identity
31701
Comment
ELISA, Phadia 250
Object
Serum
Parameter
GMB anti body
Reference standard
Internal method
Internal method identity
5034
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
PR3 anti body
Reference standard
Internal method
Internal method identity
5034
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
MPO antibody
Reference standard
Internal method
Internal method identity
5034
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Deamidated gliadin peptide IgG
Reference standard
Internal method
Internal method identity
15360
Comment
EliA, Phadia 250
Object
Serum
Parameter
Tissue transglutaminase (tTG) IgA
Reference standard
Internal method
Internal method identity
12465
Comment
EliA, Phadia 250
Object
Serum
Parameter
Tryptase
Reference standard
Internal method
Internal method identity
8301
Comment
ImmunoCap, Phadia 1000
Object
Serum
Parameter
Beta 2 glykoprotein IgG
Reference standard
Internal method
Internal method identity
5031
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Beta 2 glykoprotein IgM
Reference standard
Internal method
Internal method identity
5031
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Cardiolipin IgG
Reference standard
Internal method
Internal method identity
5031
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Cardiolipin IgM
Reference standard
Internal method
Internal method identity
5031
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
ANA-screening
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
dsDNA anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
SSA 52kD anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
SSA 60kD anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
SSB anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Sm anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Sm+RNP anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
RNP 68kD anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Scl 70kD anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Jo1 anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Centromer B anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Ribosom P anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
Chromatin anti body
Reference standard
Internal method
Internal method identity
10051
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
CCP anti body
Reference standard
Internal method
Internal method identity
8068
Comment
Multiplex, Bioplex 2200
Object
Serum
Parameter
D1 House dust mite (Derm. pteronyssinus)
Reference standard
Internal method
Internal method identity
7347
Comment
ImmunoCAP, Phadia 1000
Object
Serum
Parameter
E1 Cat epithelium
Reference standard
Internal method
Internal method identity
7347
Comment
ImmunoCAP, Phadia 1000
Object
Serum
Parameter
G6 Timothy
Reference standard
Internal method
Internal method identity
7347
Comment
ImmunoCAP, Phadia 1000
Object
Serum
Parameter
T3 Birch
Reference standard
Internal method
Internal method identity
7347
Comment
ImmunoCAP, Phadia 1000
Object
Serum
Parameter
F1 Egg white
Reference standard
Internal method
Internal method identity
7347
Comment
ImmunoCAP, Phadia 1000
Object
Serum
Parameter
Rheumatoid factor IgM
Reference standard
Internal method
Internal method identity
9717
Comment
ELISA, Dynex DS2
Object
Serum
Parameter
Total IgE
Reference standard
Internal method
Internal method identity
7349
Comment
ImmunoCAP, Phadia 1000
Object
Thrombocyte concentrate Erythrocyte concentrate
Parameter
Leukocyte control of blood component
Reference standard
Internal method
Internal method identity
7585
Comment
Flow cytometry, FACSLyric
M0110 Immunology and transfusion medicine; Blood grouping and antibody detection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Blood type antigens Cw and Jk
Reference standard
Internal method
Internal method identity
48246
Comment
Hemagglutination, manual and automatic technique
Object
Blood
Parameter
Blood type antigens, Fy and Ss
Reference standard
Internal method
Internal method identity
48025
Comment
Hemagglutination, manual and automatic technique
Object
Blood
Parameter
Cross-match; Simple
Reference standard
Internal method
Internal method identity
7022
Comment
Indirect anti-globuline technique, manual and automatic
Object
Blood
Parameter
Blodtyping; ABO typing and Rh D typing
Reference standard
Internal method
Internal method identity
6221
Comment
Hemagglutination, manual and automatic technique.
Object
Blood
Parameter
Bloodtyping; D weak
Reference standard
Internal method
Internal method identity
6228
Comment
Indirect anti-globuline technique, manual and automatic.
Object
Blood
Parameter
Blood group antigens; Rh phenotyping and K
Reference standard
Internal method
Internal method identity
8174
Comment
Hemagglutination, manual and automatic technique.
Object
Blood
Parameter
Blood type antibody; screening
Reference standard
Internal method
Internal method identity
7477
Comment
Indirect anti-globuline technique, manual and automatic
Object
Blood
Parameter
Identification of irregular blood type antibodies
Reference standard
Internal method
Internal method identity
8044
Comment
Indirect anti-globuline technique/enzyme, manual and automatic
Object
Blood
Parameter
Titration of irregular blood type antibodies
Reference standard
Internal method
Internal method identity
7265
Comment
Indirect anti-globuline technique, manual and automatic
Object
Blood
Parameter
Cross-match; Simple
Reference standard
Internal method
Internal method identity
7022
Comment
Hemagglutination, manual and automatic technique
Object
Blood
Parameter
Direct antiglobulin test (DAT)
Reference standard
Internal method
Internal method identity
7024
Comment
Direct anti-globuline technique, manual and automatic
Object
Blood
Parameter
Bloodtyping; A1
Reference standard
Internal method
Internal method identity
6913
Comment
Hemagglutination, manual and automatic technique.
Object
Blood
Parameter
Blood type antigens; Fy,, Kp, k, Lu, and Ss
Reference standard
Internal method
Internal method identity
29634
Comment
Indirect anti-globuline technique, manual and automatic
Object
Blood
Parameter
Blood type antigens; M, N
Reference standard
Internal method
Internal method identity
8342
Comment
Hemagglutination, manual and automatic technique.
Object
Blood
Parameter
Blood type antigens; P1, Le
Reference standard
Internal method
Internal method identity
7157
Comment
Hemagglutination, manual and automatic technique.
Object
Blood
Parameter
ABO titration
Reference standard
Internal method
Internal method identity
5956
Comment
Hemagglutinasjon and Indirect anti-globuline technique, manual and automatic
Object
Blood
Parameter
Thromboelastography (TEG) 6S
Reference standard
Internal method
Internal method identity
46853
Comment
Viscoelastic method for coagulation monitoring.
Object
Blood from infants <3 months old, blood from umbilical cord
Parameter
Direct antiglobulin test (DAT)
Reference standard
Internal method
Internal method identity
9079
Comment
Direct anti-globuline technique, manual and automatic
Object
Blood from infants <3 months old, blood from umbilical cord
Parameter
Blodtyping; ABO typing and Rh D typing
Reference standard
Internal method
Internal method identity
9079
Comment
Hemagglutination, manual and automatic technique.
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
New registration and approval for blood donation
Reference standard
Internal method
Internal method identity
6441 26529
Comment
Object
Blood donors
Parameter
Summons of blood donation
Reference standard
Internal method
Internal method identity
6630
Comment
Object
Blood donors
Parameter
Interview and approval of blood donation
Reference standard
Internal method
Internal method identity
6394
Comment
Object
Blood donor
Parameter
Collection of whole blood
Reference standard
Internal method
Internal method identity
6095
Comment
Object
Blood donor
Parameter
Harvesting of blood components by apheresis
Reference standard
Internal method
Internal method identity
46849 6500 24720
Comment
AmiCORE Trima Accel Automated Blood Collection System PCS2 plasmapheresis machine
Object
Pasient
Parameter
Harvesting of stem cells by apheresis technique
Reference standard
Internal method
Internal method identity
43934
Comment
Spectra Optia
M0130 Immunology and transfusion medicine; Production of blood and blood components
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood components from blood donors
Parameter
Storage and release (erythrocyte concentrate, thrombocyte concentrate, filtrated whole bllod, )plasma)
Reference standard
Internal method
Internal method identity
7377 7842 8838 16622
Comment
Object
Erythrocyte concentrate
Parameter
Preparation for intrauterine transfusion
Reference standard
Internal method
Internal method identity
7040
Comment
Object
Whole blood
Parameter
Production of blood components (erythrocyte concentrate, thrombocytes concentrate, plasma, filtated whole blood)
Reference standard
Internal method
Internal method identity
7412 7842
Comment
Object
Plasm
Parameter
Freezing
Reference standard
Internal method
Internal method identity
7412
Comment
Object
Stem cell product
Parameter
Stem cells - freezing, storage, preparation for reinfusion
Reference standard
Internal method
Internal method identity
9214 9215
Comment
Object
Thrombocyte concentrate
Parameter
Pathogen inactivation
Reference standard
Internal method
Internal method identity
7842
Comment
M0140 Immunology and transfusion med.; Storage, distribution and transport of blood and blood components
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood products
Parameter
Storage (erythrocyte concentrate, thrombocyte concentrate, Octaplasma, filtraed whole blood)
Reference standard
Internal method
Internal method identity
8838 7842 9225
Comment
Object
Blood products
Parameter
Selection and distribution (erythrocyte concentrate, thrombocyte concentrate, Octaplasma, filtrated full blod)
Reference standard
Internal method
Internal method identity
14747 9371 7038 7465 32952 41809 41077
Comment
Object
Erythrocyte concentrate
Parameter
Selection and distribution for intrauterine transfusion
Reference standard
Internal method
Internal method identity
7040
Comment
Object
Erythrocyte concentrate
Parameter
Emergency blood
Reference standard
Internal method
Internal method identity
5995
Comment
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
Vein- and capillary samples
Reference standard
Internal method
Internal method identity
1756
Comment
Recognized procedures for venous or capillary puncture
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Parameter, object, reference standard
Parameter
All analytical principles/techniques listed under Immunology and Transfusion medicine
Reference standard
Internal method
Internal method identity
34701
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.