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Norwegian accreditation

Accreditation scope for

TEST 277

Universitetssykehuset Nord-Norge HF

Klinisk patologi

Postboks 46
9038 Tromsø

Telephone: 77627202/77627204
E-mail: post@unn.no
Internet: http://www.unn.no
The laboratory meets the requirements in

NS-EN ISO 15189:2012




Accreditation includes:
The administrative / geographical unit:
Klinisk patologi
Sykehusveien 38
9038 TROMSØ



Permanent facility
M02 Anatomical pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Tissue material from cervix biopsies
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
PR57314
Comment
Macroscopic cut-up, visual assessment (microscopy) and interpretation of accredited analysis results (M0210)
Object
Liquid based cervical cytological material
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
PR57318
Comment
Visual assessment (microscopy) and interpretation of accredited analysis results (M0230)
M0210 Anatomical pathology, histopathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Fixated tissue material
Parameter
Prossessing and staining of tissue sections (rutine staining)
Reference standard
Internal method
Internal method identity
PR42846 PR30235 PR30271
Comment
Tissue prossessing, embedding and cutting. HE-staining (Tissue-Tek Prisma & Film)
Object
Paraffin-embedded tissue material
Parameter
Special-staining
Reference standard
Internal method
Internal method identity
PR30196
Comment
Manual staining and automatic on BenchMark Special Stains
Object
Paraffin embedded tissue
Parameter
Immunohistochemical analysis. See details at the organisation.
Reference standard
Internal method
Internal method identity
PR18471, PR41341, PR28400, PR41341, PR26606, PR41341
Comment
Immunhistokjemi, Benchmark ULTRA
Object
Paraffin-embedded tissue material: Ovarium, uterus, cervix and mola
Parameter
DNA ploidy gyn tumor
Reference standard
Internal method
Internal method identity
PR20239
Comment
Flow cytometry, Beckman Coulter CytoFLEX
Object
Unfixed tissue material (frozen section)
Parameter
Exclude / detect discontinuation of immunglobulins and complementary factors
Reference standard
Internal method
Internal method identity
PR46256
Comment
Immunfluorescens Benchmark ULTRA
M0230 Anatomical pathology, cytopathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Liquid based cervical cytological material
Parameter
Processing and staining of Liquid based cytology
Reference standard
Internal methods
Internal method identity
PR30002 PR4528
Comment
ThinPrep and Papanicolaous staining method
M0250 Anatomical pathology, molecular pathology
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Cervical cytological material
Parameter
HPV status
Reference standard
Internal method
Internal method identity
PR27898
Comment
Real-Time PCR, Cobas 4800
Object
Paraffin-embedded tissue material
Parameter
MSI (Microsatellite instability)
Reference standard
Internal method
Internal method identity
PR5437
Comment
PCR and fragment analysis
Object
Paraffin-embedded tissue material and cytological material
Parameter
Mutation analysis of genes with clinical importance for patients with solid tumors
Reference standard
Internal method
Internal method identity
PR43545
Comment
Deep sequencing Illumina TrueSight Tumor 15 Genepanel, MiSeq
Object
Paraffin-embedded tissue material and cytological material
Parameter
Determination of clonality status in suspected lymphoproliferative conditions
Reference standard
Internal method
Internal method identity
PR37272
Comment
PCR and fragment analysis
M31 Flexible accreditation
Object
Parameter
Reference standard
Internal method identity
Comment
Object
Material from the cervix
Parameter
Diagnosis
Reference standard
Internal method
Internal method identity
Assessment of diagnoses accredited under pathology (M02)
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.
Object
Gynecological cell material, Tissues and biopsies, Paraffin embedded tissue material, Frozen section
Parameter
Prosessing and coloring, Immunohistochemical analyze, Mutation analyses, Microsatellite instability, Clonality survey, Chromosomal rearrangements, DNA ploidy HPV-screening
Reference standard
Internal method
Internal method identity
Measurement principle/analysis platforms which is accredited under histopathology (M0210), cytopathology (M0230), Molecular Pathology (M0250)
Comment
An updated list of methods included in the flexible scope of accreditation, is available with the organization.