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Norwegian accreditation

Accreditation scope for

TEST 183

Helse Møre og Romsdal HF

Klinikk for diagnostikk, Avdeling for Medisinsk biokjemi og blodbank Ålesund, MBBÅ

6026 Ålesund

Telephone: 70 10 56 00 / 70 10 56 01
E-mail: Nina.Beate.Solnordal@helse-mr.no
Internet: http://www.helse-mr.no/
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
The administrative / geographical unit:
Medisinsk biokjemi Ålesund



Permanent facility
M0110 Immunology and transfusion medicine; Blood grouping and antibody detection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Direct antiglobulin test
Reference standard
Internal method
Internal method identity
900
Comment
Method based on immunology Ortho Vision/manual method
Object
Blood
Parameter
Rh-Feno-K
Reference standard
Internal method
Internal method identity
15656
Comment
Method based on immunology Ortho Vision/manual method
Object
Blood
Parameter
ABO/Rh(D)
Reference standard
Internal method
Internal method identity
925, 926, 15674
Comment
Method based on immunology Ortho Vision/manual method
Object
Blood
Parameter
Dʷ(Svak) Fyᵃ and Fyᵇ Jkᵃ and Jkᵇ S and s M and N Leᵃ and Leᵇ Pı Cw Kpa A1
Reference standard
Internal method
Internal method identity
349
Comment
Method based on immunology Ortho Vision/manual method
Object
Blood, plasma
Parameter
Conciliation
Reference standard
Internal method
Internal method identity
15720
Comment
Method based on immunology Ortho Vision/manual method
Object
Plasma, serum
Parameter
Antibody titration
Reference standard
Internal method
Internal method identity
344
Comment
Method based on immunology Ortho Vision/manual method
Object
Plasma, serum
Parameter
Blood type antibody (identification)
Reference standard
Internal method
Internal method identity
343
Comment
Method based on immunology Ortho Vision/manual method
Object
Plasma, serum
Parameter
Blood type antibody (Screening)
Reference standard
Internal method
Internal method identity
15721
Comment
Method based on immunology Ortho Vision/manual method
M0120 Immunology and transf. med.; Interview and collection of blood from donors
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood from blood donors
Parameter
Collection of whole blood for preparation and testing of blood components
Reference standard
Internal method
Internal method identity
25746, 316
Comment
Method based on recognized procedures for venous blood collection including donor management and preparation, testing, storage and distribution of blood components.
Object
Blood donors
Parameter
Registration, notification and approval of blood donors
Reference standard
Internal method
Internal method identity
297, 298, 299
Comment
M0130 Immunology and transfusion medicine; Production of blood and blood components
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood from blood donors
Parameter
Preparation of plasma- and trombocyte concentrates by apheresis
Reference standard
Internal method
Internal method identity
4286 25132
Comment
Object
Blood from blood donors
Parameter
Preparation of plasma and erythrocytes from SAG whole blood collection
Reference standard
Internal method
Internal method identity
313, 314
Comment
Object
Blood from blood donors
Parameter
Preparation of trombocyte concentrate from buffy coat
Reference standard
Internal method
Internal method identity
327
Comment
Object
Blood from blood donors
Parameter
Radiation of blood
Reference standard
Internal method
Internal method identity
357
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 from blood donors
Parameter
Storage and delivery of blood and blood products
Reference standard
Internal method
Internal method identity
313, 314, 327, 334, 32260, 30550
Comment
M04 Clinical pharmacology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
Cyklosporin
Reference standard
Internal method
Internal method identity
11136
Comment
ECLIA, Cobas 8000
Object
Blood
Parameter
Takrolimus
Reference standard
Internal method
Internal method identity
11114
Comment
ECLIA, Cobas 8000
Object
Serum
Parameter
Tobramycin
Reference standard
Internal method
Internal method identity
5002
Comment
Photometry, Cobas 8000
Object
Serum
Parameter
Valproat
Reference standard
Internal method
Internal method identity
4894
Comment
Photometry, Cobas 8000
Object
Serum
Parameter
Vancomycin
Reference standard
Internal method
Internal method identity
7508
Comment
Photometry, Cobas 8000
Object
Serum
Parameter
Ethanol
Reference standard
Internal method
Internal method identity
449
Comment
Photometry Cobas 8000
Object
Serum
Parameter
Lithium
Reference standard
Internal method
Internal method identity
435
Comment
Photometry Cobas 8000
Object
Serum
Parameter
Paracetamol
Reference standard
Internal method
Internal method identity
450
Comment
Photometry Cobas 8000
Object
Serum
Parameter
Digoxin
Reference standard
Internal method
Internal method identity
17587
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Karbamazepin
Reference standard
Internal method
Internal method identity
4790
Comment
Photometry, Cobas 8000
Object
Serum
Parameter
Fenobarbital
Reference standard
Internal method
Internal method identity
11086
Comment
Phptpmetry, Cobas 8000
Object
Serum
Parameter
Teofyllin
Reference standard
Internal method
Internal method identity
427
Comment
Photometry, Cobas 8000
Object
Serum/plasma
Parameter
Fenytoin
Reference standard
Internal method
Internal method identity
6739
Comment
Photometry, Cobas 8000
M12 Medical biochemistry
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood
Parameter
HbA1c
Reference standard
Internal method
Internal method identity
519
Comment
HPLC BioRad D-100
Object
Whole blood
Parameter
Leukocytes
Reference standard
Internal method
Internal method identity
9988
Comment
Optic measurement Sysmex XN
Object
Whole blood
Parameter
Erytrocytes
Reference standard
Internal method
Internal method identity
9816
Comment
Impedance and Optic measurement Sysmex XN
Object
Whole blood
Parameter
Hemoglobin
Reference standard
Internal method
Internal method identity
9800
Comment
Photometry Sysmex XN
Object
Whole blood
Parameter
EVF
Reference standard
Internal method
Internal method identity
10338
Comment
Calculated parameter Sysmex XN
Object
Whole blood
Parameter
MCV
Reference standard
Internal method
Internal method identity
10339
Comment
Calculated parameter Sysmex XN
Object
Whole blood
Parameter
MCH
Reference standard
Internal method
Internal method identity
10249
Comment
Calculated parameter Sysmex XN
Object
Whole blood
Parameter
MCHC
Reference standard
Internal method
Internal method identity
10337
Comment
Calculated parameter Sysmex XN
Object
Whole blood
Parameter
Trombocytes
Reference standard
Internal method
Internal method identity
9852
Comment
Impedans/optisc and fluorescens measurement Sysmex
Object
Whole blood
Parameter
Neutrophils
Reference standard
Internal method
Internal method identity
21901, 4013
Comment
Optic measurement Sysmex XN
Object
Whole blood
Parameter
Reticulocytes
Reference standard
Internal method
Internal method identity
10340
Comment
Optic measurement Sysmex XN
Object
Feces
Parameter
F-blood (iFOB)
Reference standard
Internal method
Internal method identity
37687
Comment
Photometry Cobas 8000
Object
Plasma
Parameter
Anti-Xa
Reference standard
Internal method
Internal method identity
530
Comment
Colorimetric method Sysmex CS 5100
Object
Plasma
Parameter
Antithrombin III
Reference standard
Internal method
Internal method identity
1510
Comment
Colorimetric method Sysmex CS 5100
Object
Plasma
Parameter
Protein C
Reference standard
Internal method
Internal method identity
5003
Comment
Colorimetric method Sysmex CS 5100
Object
Plasma
Parameter
Activated partial thromboplastin
Reference standard
Internal method
Internal method identity
11240
Comment
Optical Clot Method Sysmex CS 5100
Object
Plasma
Parameter
Homocysteine
Reference standard
Internal method
Internal method identity
1254
Comment
Photometry Cobas 8000
Object
Plasma
Parameter
Nonbonded Protein S
Reference standard
Internal method
Internal method identity
25063
Comment
Immunurburbimetry Sysmex CS 5100
Object
Plasma
Parameter
PT-INR
Reference standard
Internal method
Internal method identity
681
Comment
Optical Clot Method Sysmex CS 5100
Object
Plasma
Parameter
Fibrinogen
Reference standard
Internal method
Internal method identity
527
Comment
Optical Clot Method Sysmex CS 5100
Object
Plasma
Parameter
D-Dimer
Reference standard
Internal method
Internal method identity
528
Comment
Immunurburbimetry Sysmex CS 5100
Object
Plasma
Parameter
ACTH
Reference standard
Internal method
Internal method identity
2323
Comment
ECLIA Cobas 8000
Object
Plasma
Parameter
Ammoniakk
Reference standard
Internal method
Internal method identity
411
Comment
Photometri, Cobas 8000
Object
Plasma
Parameter
Laktat
Reference standard
Internal method
Internal method identity
426
Comment
Photometri, Cobas 8000
Object
Plasma, serum
Parameter
PTH
Reference standard
Internal method
Internal method identity
679
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Cortisol
Reference standard
Internal method
Internal method identity
822
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
IgE total
Reference standard
Internal method
Internal method identity
851
Comment
ILMA Immulite 2000 XPI
Object
Serum
Parameter
Prolactin
Reference standard
Internal method
Internal method identity
823
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
FSH
Reference standard
Internal method
Internal method identity
820
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
LH
Reference standard
Internal method
Internal method identity
821
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Progesterone
Reference standard
Internal method
Internal method identity
677
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Estradiol
Reference standard
Internal method
Internal method identity
725
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
AFP
Reference standard
Internal method
Internal method identity
1285
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
CEA
Reference standard
Internal method
Internal method identity
1041
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
CA 125
Reference standard
Internal method
Internal method identity
1040
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
CA 15-3
Reference standard
Internal method
Internal method identity
12127
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
CA 19-9
Reference standard
Internal method
Internal method identity
12125
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
PSA
Reference standard
Internal method
Internal method identity
995
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Bicarbonate CO2-total
Reference standard
Internal method
Internal method identity
38377
Comment
Photometry Cobas 8000
Object
Serum
Parameter
HE4
Reference standard
Internal method
Internal method identity
42786
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Cystatin C
Reference standard
Internal method
Internal method identity
42776
Comment
Turbidimetry Cobas 8000
Object
Serum
Parameter
SHBG
Reference standard
Internal method
Internal method identity
723
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
IgG
Reference standard
Internal method
Internal method identity
3498
Comment
Turbidimetri, Cobas 8000
Object
Serum
Parameter
IgA
Reference standard
Internal method
Internal method identity
3497
Comment
Turbidimetri, Cobas 8000
Object
Serum
Parameter
IgM
Reference standard
Internal method
Internal method identity
3499
Comment
Turbidimetri, Cobas 8000
Object
Serum
Parameter
Serumelektroforese
Reference standard
Internal method
Internal method identity
18738
Comment
Capillary electrophoresis Capillarys 2
Object
Serum
Parameter
Immuntyping
Reference standard
Internal method
Internal method identity
18740
Comment
Capilary elektroforese Capillarys 2
Object
Serum
Parameter
Immune Fixation
Reference standard
Internal method
Internal method identity
18795
Comment
Gel elektroforese Hydrasys 2
Object
Serum
Parameter
Alfa1-antitrypsin
Reference standard
Internal method
Internal method identity
3508
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Alfa1-acid glykoprotein
Reference standard
Internal method
Internal method identity
3507
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Ceruloplasmin
Reference standard
Internal method
Internal method identity
3494
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Haptoglobin
Reference standard
Internal method
Internal method identity
3496
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Complement factor C3
Reference standard
Internal method
Internal method identity
3492
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Complement factor C4
Reference standard
Internal method
Internal method identity
3493
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Prealbumin
Reference standard
Internal method
Internal method identity
3503
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Soluble transferrin receptor
Reference standard
Internal method
Internal method identity
20715
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
NSE
Reference standard
Internal method
Internal method identity
38108
Comment
ECLIA Cobas 8000
Object
Serum
Parameter
Free light chains kappa
Reference standard
Internal method
Internal method identity
17990
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
Free light chains lambda
Reference standard
Internal method
Internal method identity
17995
Comment
Nefelometri Atellica NEPH 630
Object
Serum
Parameter
CDT
Reference standard
Internal method
Internal method identity
610
Comment
Capillary elektroforese Capillarys 2
Object
Serum, plasma
Parameter
Growth hormone
Reference standard
Internal method
Internal method identity
24586
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Testosterone
Reference standard
Internal method
Internal method identity
724
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
C-peptide
Reference standard
Internal method
Internal method identity
722
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
LDL-cholesterol
Reference standard
Internal method
Internal method identity
7274
Comment
Photomerty Cobas 8000
Object
Serum, plasma
Parameter
Vitamine B12
Reference standard
Internal method
Internal method identity
936
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Direct and indirect bilirubin
Reference standard
Internal method
Internal method identity
12887
Comment
Photomerty Cobas 8000
Object
Serum, plasma
Parameter
Ferritin
Reference standard
Internal method
Internal method identity
3495
Comment
Turbidity Cobas 8000
Object
Serum, plasma
Parameter
Folate
Reference standard
Internal method
Internal method identity
1030
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Nonbonded T3
Reference standard
Internal method
Internal method identity
1029
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
Nonbonded T4
Reference standard
Internal method
Internal method identity
934
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
TSH
Reference standard
Internal method
Internal method identity
933
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
IGF-1
Reference standard
Internal method
Internal method identity
24592
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
IGFBP-3
Reference standard
Internal method
Internal method identity
24610
Comment
ECLIA Cobas 8000
Object
Serum, plasma
Parameter
ALAT
Reference standard
Internal method
Internal method identity
408
Comment
Photometry Vitros
Object
Serum, plasma
Parameter
Albumin
Reference standard
Internal method
Internal method identity
407
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Alkaline phosphatase
Reference standard
Internal method
Internal method identity
409
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Amylase
Reference standard
Internal method
Internal method identity
410
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
ASAT
Reference standard
Internal method
Internal method identity
412
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Total Bilirubin
Reference standard
Internal method
Internal method identity
413
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
GGT
Reference standard
Internal method
Internal method identity
423
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Glucose
Reference standard
Internal method
Internal method identity
420
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
HDL-Cholesterol
Reference standard
Internal method
Internal method identity
7454
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Iron
Reference standard
Internal method
Internal method identity
425
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
CK
Reference standard
Internal method
Internal method identity
424
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
CRP
Reference standard
Internal method
Internal method identity
6002
Comment
Turbidity Cobas 8000
Object
Serum, plasma
Parameter
Cholesterol
Reference standard
Internal method
Internal method identity
419
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
LD
Reference standard
Internal method
Internal method identity
434
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Lipase
Reference standard
Internal method
Internal method identity
433
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Total protein
Reference standard
Internal method
Internal method identity
430
Comment
Photometry Cobas 8000
Object
Serum, plasma
Parameter
Triglyceride
Reference standard
Internal method
Internal method identity
431
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Carbamide
Reference standard
Internal method
Internal method identity
502
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Uric acid
Reference standard
Internal method
Internal method identity
428
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Magnesium
Reference standard
Internal method
Internal method identity
421
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Sodium
Reference standard
Internal method
Internal method identity
437
Comment
Potentiometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Creatinine
Reference standard
Internal method
Internal method identity
418
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Phosphate
Reference standard
Internal method
Internal method identity
429
Comment
Photometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Potassium
Reference standard
Internal method
Internal method identity
445
Comment
Potentiometry Cobas 8000
Object
Serum, plasma, urine
Parameter
Cloride
Reference standard
Internal method
Internal method identity
446
Comment
Potentiometry Cobas 8000
Object
Serum, plasma, urine
Parameter
calcium
Reference standard
Internal method
Internal method identity
417
Comment
Photometry Cobas 8000
Object
Serum/plasma
Parameter
25-OH Vitamin D
Reference standard
Internal method
Internal method identity
19787
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
Prokalsitonin
Reference standard
Internal method
Internal method identity
30275
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
Anti-CCP
Reference standard
Internal method
Internal method identity
10496
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
Troponin T hs
Reference standard
Internal method
Internal method identity
30363
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
NT-proBNP
Reference standard
Internal method
Internal method identity
30285
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
HCG+ß
Reference standard
Internal method
Internal method identity
4034
Comment
ECLIA, Cobas 8000
Object
Serum/plasma
Parameter
Anti-TPO
Reference standard
Internal method
Internal method identity
678
Comment
ECLIA Cobas 8000
Object
Spinale/urine
Parameter
Proteine in spinale and urine
Reference standard
Internal method
Internal method identity
4279
Comment
Photometri, Cobas 8000
Object
Urin
Parameter
Albumin inn urin
Reference standard
Internal method
Internal method identity
47681
Comment
Turbidimetry, Cobas 8000
M30 Sample collection
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Patient, blood donors
Parameter
Blood for medical-biochemical and microbiological analyzes
Reference standard
Internal method
Internal method identity
648
Comment
Method based on recognized procedures for venous or capillary puncture and blood collection from artery tap
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Blood and blood components
Parameter
Blood type, blood type antibody and blood type antigen Antibody
Reference standard
Internal method
Internal method identity
Principle / analysis platforms which is accredited under immunology (M01) as well blood typing and antibody provision (M0110) Procedure for FA: 18525
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Body fluids
Parameter
Hematological analytes Clinical-chemical analytes Pharmacological analytes
Reference standard
Internal method
Internal method identity
Principle / analysis platforms which is accredited under medical biochemistry (M12), clinical pharmacology (M04) and sampling (M30) Procedure for FA: 18525
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.