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Norwegian accreditation

Accreditation scope for

TEST 314

Helse Bergen HF, Haukeland universitetssjukehus

Laboratorieklinikken, Avdeling for immunologi og transfusjonsmedisin

Postboks 1400
5021 Bergen

Telephone: 55974683
E-mail: eikr@helse-bergen.no
Internet: http://www.helse-bergen.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
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The administrative / geographical unit:
Avdeling for immunologi og transfusjonsmedisin
Postboks 1400
5021 Bergen


Permanent facility
M01 Immunology and transfusion medicine
Object
Parameter
Reference standard
Internal method identity
Comment
Object
EDTA blood
Parameter
PNH Immunophenotyping
Reference standard
Internal method
Internal method identity
18312
Comment
Flowcytometri
Object
EDTA blood
Parameter
HLA-B27
Reference standard
Internal method
Internal method identity
21985, 43405
Comment
Flow cytometry
Object
EDTA blood
Parameter
Lymfocyte quantification
Reference standard
Internal method
Internal method identity
08143
Comment
Flow cytometry
Object
EDTA blood
Parameter
CD4/CD8
Reference standard
Internal method
Internal method identity
08143
Comment
Flow cytometry
Object
EDTA blood
Parameter
HbF-test
Reference standard
Internal method
Internal method identity
06846
Comment
Flow cytometry
Object
EDTA blood and apheresis product
Parameter
stem cell quantification
Reference standard
Internal method
Internal method identity
19714
Comment
Flow cytometry
Object
EDTA blood and bone marrow
Parameter
Immune phenotyping
Reference standard
Internal method
Internal method identity
57604
Comment
Flow cytometry
Object
Leucocyte filtrated blood components
Parameter
Leuccocount
Reference standard
Internal method
Internal method identity
05973, 06542
Comment
Flow cytometry
Object
Exudate
Parameter
Beta Trace protein
Reference standard
Internal method
Internal method identity
02501
Comment
Nephelometry Athellica Neph.
Object
Serum
Parameter
Rheumatoid factor antibody
Reference standard
Internal method
Internal method identity
02504
Comment
Nephelometry Athellica Neph.
Object
Serum
Parameter
Quantification of immunoglobulins: IgG, IgG subclasses, IgA, IgA ped, IgM, IgM ped,
Reference standard
Internal method
Internal method identity
02503
Comment
Nephelometry Athellica Neph.
Object
Serum
Parameter
Complementary function (Classic, lectin and alternative activation pathway)
Reference standard
Internal method
Internal method identity
08088
Comment
ELISA
Object
Serum
Parameter
Liver / kidney microsome 1 (LKM1) antibody
Reference standard
Internal method
Internal method identity
49533
Comment
ELISA LKM-1 QUANTA Lite
Object
Serum
Parameter
Intrinsic Factor antibody
Reference standard
Internal method
Internal method identity
10762
Comment
ELISA QUANTA Lite
Object
Serum
Parameter
Anti-M2
Reference standard
Internal method
Internal method identity
01833
Comment
ELISA
Object
Serum
Parameter
F-actin IgG
Reference standard
Internal method
Internal method identity
52821
Comment
ELISA Quanta Lite
Object
Serum
Parameter
Anti-PLA2-R
Reference standard
Internal method
Internal method identity
55790
Comment
ELISA
Object
Serum
Parameter
CCP antibody
Reference standard
Internal method
Internal method identity
45044
Comment
Multiplex Immunoassay
Object
Serum
Parameter
ANCA og GBM antibody
Reference standard
Internal method
Internal method identity
36363
Comment
Multiplex Immunoassay
Object
Serum
Parameter
Anti-cardiolipin og Beta2-Glycoprotein IgG/IgM
Reference standard
Internal method
Internal method identity
34132
Comment
Multiplex Immunoassay
Object
Serum
Parameter
Transglutaminase 2 (IgA) antibody and deamidated gliadin (IgG) antibody
Reference standard
Internal method
Internal method identity
36361
Comment
Multiplex Immunoassay
Object
Serum
Parameter
ANA-Bioplex 2200
Reference standard
Internal method
Internal method identity
44116
Comment
Multiplex Immunoassay
Object
Serum
Parameter
Infliximab concentration and antibody
Reference standard
Internal method
Internal method identity
61975, 61976
Comment
ELISA
Object
Serum
Parameter
Immunofixation
Reference standard
Internal method
Internal method identity
07122
Comment
Gel Electrophoresis
Object
Serum
Parameter
Adalimumab concentration and antibody
Reference standard
Internal method
Internal method identity
72252 72472
Comment
ELISA instrument DS2
Object
Serum
Parameter
Complement: C3, C4 og C1-1NH
Reference standard
Internal method
Internal method identity
02503
Comment
Nephelometry Athellica Neph.
Object
Serum
Parameter
Quantification free light chains kappa and lambda
Reference standard
Internal method
Internal method identity
22829
Comment
Nephelometry Athellica Neph.
Object
Serum and EDTA plasma
Parameter
Cryoglobulins and cryofibrinogen
Reference standard
Internal method
Internal method identity
01844
Comment
Precipitation
Object
Serum and urine
Parameter
Monoclonal component
Reference standard
Internal method
Internal method identity
58670, 58416, 61234
Comment
Capillarys
Object
Spinal fluid
Parameter
Quantification of immunoglobulins and albumin
Reference standard
Internal method
Internal method identity
02503
Comment
Nephelometry Athellica Neph.
Object
Spinal fluid
Parameter
Immune phenotyping
Reference standard
Internal method
Internal method identity
64797
Comment
Flowcytometry
M0110 Immunology and transfusion medicine; Blood grouping and antibody detection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Citrate blood
Parameter
TEG
Reference standard
Internal method
Internal method identity
60543, 60573
Comment
TEG 6s Viscoelastography
Object
EDTA blood
Parameter
HIT Stic Expert
Reference standard
Internal method
Internal method identity
51154
Comment
Agglutinasjon, manuell
Object
EDTA blood
Parameter
Celiac tissue typing
Reference standard
Internal method
Internal method identity
66725
Comment
LAMP / Nucleic acid amplification test
Object
EDTA-blood
Parameter
Bloodtyping AB0/RhD
Reference standard
Internal method
Internal method identity
54554, 05908, 06003, 26616, 05920
Comment
Manually and with IH-1000
Object
EDTA blood
Parameter
Blood type antigen screen
Reference standard
Internal method
Internal method identity
07491, 05991, 51020, 07491, 06968
Comment
Manually and with IH-1000
Object
EDTA blood
Parameter
Cold antibody typing
Reference standard
Internal method
Internal method identity
07161
Comment
Manually
Object
EDTA blood
Parameter
Antibody identification
Reference standard
Internal method
Internal method identity
06066, 07491, 05991, 06967, 07203, 06004
Comment
Manually and with IH-1000
Object
EDTA blood
Parameter
Feetal RHD screening
Reference standard
Internal method
Internal method identity
39161, 41910, 41105
Comment
PCR
Object
EDTA blood
Parameter
Direct antiglobulin test and assessment
Reference standard
Internal method
Internal method identity
05919, 05932
Comment
Agglutination, manual method
Object
EDTA blood
Parameter
Phenotyping
Reference standard
Internal method
Internal method identity
31090, 26616
Comment
Agglutination, manually and with IH-1000
Object
EDTA blood
Parameter
Titration
Reference standard
Internal method
Internal method identity
05910
Comment
Agglutination, manual method
Object
EDTA blood
Parameter
Titration of anti-A and anti-B at donors
Reference standard
Internal method
Internal method identity
54460
Comment
Agglutination, manual method
Object
EDTA blood
Parameter
Compatibility test
Reference standard
Internal method
Internal method identity
54553, 55230
Comment
Agglutination, manual method
Object
EDTA blood
Parameter
Extended compatibility testing
Reference standard
Internal method
Internal method identity
54553
Comment
Agglutination, manually and with IH-1000
Object
Umbilical cord blood
Parameter
Blood typing RhD
Reference standard
Internal method
Internal method identity
06086, 05992
Comment
Agglutination, manually glass teqhnique
Object
Serum
Parameter
Streptolysin antibody, DNAseB antibody.
Reference standard
Internal method
Internal method identity
02504
Comment
Nefelometri. Athellica Neph.
Object
Serum
Parameter
CH50
Reference standard
Internal method
Internal method identity
01710
Comment
Hemolysis
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
Registration and approval of donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Interview of new and approved donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Collection of whole blood
Reference standard
Internal method
Internal method identity
05902
Comment
Object
Blood donors
Parameter
Collection of platelets in Trima Accel apheresis machine
Reference standard
Internal method
Internal method identity
18497
Comment
Apheresis
Object
Blood donors
Parameter
Notice
Reference standard
Internal method
Internal method identity
06104
Comment
M0130 Immunology and transfusion medicine; Production of blood and blood components
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood products
Parameter
Exchangeblood for newborn
Reference standard
Internal method
Internal method identity
05950
Comment
Manual method
Object
Blood products
Parameter
Irradiation
Reference standard
Internal method
Internal method identity
06344
Comment
Instrumental method
Object
Erythrocytes and platelets
Parameter
Washing of cells
Reference standard
Internal method
Internal method identity
05949, 05962
Comment
Manual method
Object
Whole blood
Parameter
Leucocytefiltration from whole blood with platelet sparing filters
Reference standard
Internal method
Internal method identity
30776
Comment
Manual method
Object
Whole blood
Parameter
Production of full-blood with Terumo singelbag CPDA-1
Reference standard
Internal method
Internal method identity
50211
Comment
Manual method
Object
Whole blood
Parameter
Production of blood components from full-blood (erythrocyte concentrate, IPU and plasma)
Reference standard
Internal method
Internal method identity
35544
Comment
Reveos
Object
Whole blood, erythrocyte concentrate, platelet concentrate and plasma
Parameter
Issue of blood components
Reference standard
Internal method
Internal method identity
05939,29437,07254
Comment
Manual and electronic method
Object
IPU
Parameter
Production of platelet concentrate from IPU
Reference standard
Internal method
Internal method identity
35545
Comment
Manual method
Object
Plasma from donor
Parameter
Freezing of plasma
Reference standard
Internal method
Internal method identity
14307,05956
Comment
Lundair
Object
Platelet concentrate from donor
Parameter
Preparation of platelet concentrate collected with apheresis
Reference standard
Internal method
Internal method identity
05961
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 and blood products
Parameter
Issue and shipment of blood and blood products
Reference standard
Internal method
Internal method identity
58260, 06201, 28748, 06298, 05955, 05976, 06669, 58309, 58329, 06853, 58371, 06516, 41784
Comment
Manual method
Object
Erythrocyte concentrate and full-blood
Parameter
Storage of erythrocyte concentrate and whole blood
Reference standard
Internal method
Internal method identity
61228
Comment
Manual method
Object
Octaplasma
Parameter
Storage of Octaplasma
Reference standard
Internal method
Internal method identity
61228, 59754, 06892, 25508, 33982, 06893
Comment
Manual method
Object
Plasma-derived products
Parameter
Storage of plasma-derived products
Reference standard
Internal method
Internal method identity
61228
Comment
Manual method
Object
Platelet concentrate
Parameter
Storage of platelet concentrate
Reference standard
Internal method
Internal method identity
05983
Comment
Manual method
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood and blood components
Parameter
Blood typing, blood type antibody and blood type antigen. Production of blood and blood components. Allergens Complement factors Immunoglobulins
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms accredited under immunology and transfusion medicine M01 (M0110, M0120, M0130, M0140) Procedure for FA: AIT-76179 Log for FA: AIT-71823
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Blodbanken Voss
Sjukehusvegen 16
5704 Voss


Permanent facility
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
Registration and approval of donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Interview of new and approved donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Collection of full-blood
Reference standard
Internal method
Internal method identity
05902
Comment
Object
Blood donors
Parameter
Notice
Reference standard
Internal method
Internal method identity
31536
Comment
Object
Blood products
Parameter
Shipment of blood products
Reference standard
Internal method
Internal method identity
58371,06200
Comment
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood and blood components
Parameter
Registration, interview, blood sampling, summoning and dispatch
Reference standard
Internal method
Internal method identity
Changes in methods accredited under immunology and transfusion medicine M0120. Procedure for FA: AIT-76179 Log for FA: AIT-71823
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Blodbussen
Postboks 1400
5021 Bergen


Field testing laboratory
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood donors
Parameter
Registration and approval of donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Interview of new and approved donors
Reference standard
Internal method
Internal method identity
06215
Comment
Object
Blood donors
Parameter
Collection of whole blood
Reference standard
Internal method
Internal method identity
05902
Comment
Permanent facility
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood and blood components
Parameter
Registration, interview, whole blood collection, summoning and dispatch
Reference standard
Internal method
Internal method identity
Changes in methods accredited under immunology and transfusion medicine M0120. Procedure for FA: AIT-76179 Log for FA: AIT-71823
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
The administrative / geographical unit:
Kysthospitalet Hagavik
Hagavikbakken 25
5217 Hagavik


Permanent facility
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
Shipment of blood products
Reference standard
Internal method
Internal method identity
30458
Comment
Object
Erythrocyte concentrate
Parameter
Storage of erythrocyte concentrate
Reference standard
Internal method
Internal method identity
31021
Comment
Manual method
Object
Erythrocyte concentrate
Parameter
Issue of blood products
Reference standard
Internal method
Internal method identity
42583, 42305, 42334, 30860, 30458, 42825, 30469, 42923
Comment
Manual method
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood and blood components
Parameter
Shipping, storage and delivery
Reference standard
Internal method
Internal method identity
Changes in methods accredited under immunology and transfusion medicine M0140. Procedure for FA: AIT-76179 Log for FA: AIT-71823
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.