Region Västernorrland

Accreditation no: 1361

Org no:: 232100-0206
Phone:: 0611-80000
Postal address:: Regionens Hus, 871 85 Härnösand
Visiting address:: Storgatan 1, 871 85 Härnösand · Show on map

Business unit

Örnsköldsviks Sjukhus (ID 005) Sollefteå Sjukhus (ID 006) Sundsvall, Avdelningen för Patologi och Cytologi (ID 002) Sundsvall, Länssjukhuset Sundsvall-Härnösand (ID 001)

Medical testing, SS-EN ISO 15189:2022

Latest decision date: 2025-11-07

Clinical chemistry
Teknikområde	Metod/utrustning	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Coagulation	Roche cobas pro c 503	Human kroppsvätskor	Biochemical markers	Photometers
Coagulation	Roche cobas pure c 303	Human kroppsvätskor	Biochemical markers	Fotometer
Coagulation	Roche cobas pure c 303	Human kroppsvätskor	Biochemical markers	Photometers
Coagulation	Sysmex CS-2500	Human kroppsvätskor	Biochemical markers	Photometers
Endocrinology	Abbott Architect i2000	Human kroppsvätskor	Biochemical markers	CLIA
Endocrinology	Roche cobas pro c 503	Human kroppsvätskor	Biochemical markers	Photometers
Endocrinology	Roche cobas pro e 801	Human kroppsvätskor	Biochemical markers	CLIA
Endocrinology	Roche cobas pure e 402	Human kroppsvätskor	Biochemical markers	CLIA
Endocrinology	Thermo Fisher Vanquish LC Quantis MS/MS	Human kroppsvätskor	Biochemical markers	LC-MS/MS
Endocrinology	Thermo Scientific Ultimate 3000 LC Endura MS/MS	Human kroppsvätskor	Biochemical markers	LC-MS/MS
Funktionsundersökning	-	Patient	Glukosbelastning	Funktionsundersökning
General chemistry	Atellica NEPH 630	Human kroppsvätskor	Biochemical markers	Nephelometers
General chemistry	Roche cobas pro	Human kroppsvätskor	Biochemical markers	Beräknad
General chemistry	Roche cobas pro c 503	Human kroppsvätskor	Biochemical markers	Photometers
General chemistry	Roche cobas pro e 801	Human kroppsvätskor	Biochemical markers	CLIA
General chemistry	Roche cobas pro ISE	Human kroppsvätskor	Biochemical markers	Potentiometry
General chemistry	Roche cobas pure	Human kroppsvätskor	Biochemical markers	Beräknad
General chemistry	Roche cobas pure c 303	Human kroppsvätskor	Biochemical markers	Fotometer
General chemistry	Roche cobas pure c 303	Human kroppsvätskor	Biochemical markers	Photometers
General chemistry	Roche cobas pure c 303	Human kroppsvätskor	Biochemical markers	Potentiometry
General chemistry	Roche cobas pure e 402	Human kroppsvätskor	Biochemical markers	CLIA
General chemistry	Shimadzu Prominence SPD-20AV	Human kroppsvätskor	Biochemical markers	HPLC
Hematology	Sysmex XN-10	Human kroppsvätskor	Biochemical markers	Beräknad
Hematology	Sysmex XN-10	Human kroppsvätskor	Biochemical markers	Cytometri
Hematology	Sysmex XN-10	Human kroppsvätskor	Biochemical markers	Spektrofotometri
Hematology	Sysmex XN-20	Human kroppsvätskor	Biochemical markers	Beräknad
Hematology	Sysmex XN-20	Human kroppsvätskor	Biochemical markers	Cytometri
Hematology	Sysmex XN-20	Human kroppsvätskor	Biochemical markers	Spektrofotometri
Morphology and cell counting	Sysmex XN-10	Human kroppsvätskor	Biochemical markers	Beräknad
Morphology and cell counting	Sysmex XN-10	Human kroppsvätskor	Biochemical markers	Cytometri
Morphology and cell counting	Sysmex XN-20	Human kroppsvätskor	Biochemical markers	Beräknad
Morphology and cell counting	Sysmex XN-20	Human kroppsvätskor	Biochemical markers	Cytometri
Protein Chemistry	Roche cobas pro c 503	Human kroppsvätskor	Biochemical markers	Photometers
Protein Chemistry	Siemens Atellica NEPH 630	Human kroppsvätskor	Biochemical markers	Photometers

Clinical human genetics
Metod/utrustning	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Biocartis Idylla	DNA	Detection of sequence variants	Real-time PCR
Cepheid GeneXpert GX-XVI	DNA	Detection of sequence variants	Real-time PCR
Roche BenchMark ULTRA	DNA	Detektion av kopietalsvariation	SISH

Clinical immunology and transfusion medicine
Teknikområde	Metod/utrustning	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Clinical immunology	Fluorescensmikroskop Olympus BX60	Human kroppsvätskor	Detektion av antikroppar	IF
Clinical immunology	Roche cobas pro c 503	Human kroppsvätskor	Detektion av antikroppar	Photometers
Clinical immunology	Roche cobas pro e 801	Human kroppsvätskor	Proteins	CLIA
Clinical immunology	Roche cobas pure e 402	Human kroppsvätskor	Proteins	CLIA
Clinical immunology	Siemens Atellica NEPH 630	Human kroppsvätskor	Proteins	Turbidimeters
Clinical immunology	Thermo Fisher Phadia 250	Human kroppsvätskor	Detektion av antikroppar	EIA
Transfusion medicine	-	Human kroppsvätskor	Blood grouping	Direct agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Blood grouping	Indirect agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Compatibility testing	Direct agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Compatibility testing	Indirect agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Determination of erythrocyte antigen	Direct agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Determination of erythrocyte antigen	Indirect agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Direct antiglobulin test (DAT)	Direct agglutination technique
Transfusion medicine	-	Human kroppsvätskor	Erytrocyt-antikroppsundersökning	Indirect agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Blood grouping	Direct agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Blood grouping	Indirect agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Compatibility testing	Direct agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Compatibility testing	Indirect agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Determination of erythrocyte antigen	Direct agglutination technique
Transfusion medicine	QuidelOrtho ORTHO VISION	Human kroppsvätskor	Direct antiglobulin test (DAT)	Direct agglutination technique

Clinical microbiology
Teknikområde	Metod/utrustning	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Clinical bacteriology	Icke-standardiserad metod	Human material	Resistensbestämning	Real-time PCR
Clinical bacteriology	Standard method	Human material	Antigen detection	Immunokromatografiska snabbtest
Clinical bacteriology	Standard method	Human material	Detektion av antikroppar	Agglutinationstester
Clinical bacteriology	Standard method	Human material	Detektion av antikroppar	CLIA
Clinical bacteriology	Standard method	Human material	Detektion av relevanta bakterier	Microscopic diagnostics
Clinical bacteriology	Standard method	Human material	Detektion av relevanta bakterier	Odling
Clinical bacteriology	Standard method	Human material	Detektion av relevanta bakterier	Real-time PCR
Clinical bacteriology	Standard method	Human material	Detektion av specifika gener	LAMP
Clinical bacteriology	Standard method	Human material	Identifikation	Real-time PCR
Clinical bacteriology	Standard method	Human material	Resistensbestämning	Immunokromatografiska snabbtest
Clinical bacteriology	Standard method	Human material	Resistensbestämning	LAMP
Clinical bacteriology	Standard method	Human material	Resistensbestämning	Odling
Clinical bacteriology	Standard method	Human material	Resistensbestämning	Spektrofotometri
Clinical bacteriology	Standard method	Human material	Resistensbestämning	Turbidimeters
Clinical bacteriology	Standard method	Isolate	Identifikation	MALDI-TOF
Clinical bacteriology	Standard method	Isolate	Identifikation	Spektrofotometri
Clinical mycology	Standard method	Human material	Detektion av relevanta jästsvampar	Microscopic diagnostics
Clinical mycology	Standard method	Human material	Detektion av relevanta jästsvampar	Odling
Clinical mycology	Standard method	Human material	Resistensbestämning	Turbidimeters
Clinical mycology	Standard method	Isolate	Identifikation	MALDI-TOF
Clinical mycology	Standard method	Isolate	Identifikation	Microscopic diagnostics
Clinical mycology	Standard method	Isolate	Identifikation	Spektrofotometri
Clinical parasitology	BD MAX	Human material	Realtids-PCR	Tarmparaister
Clinical parasitology	Manual method	Human material	Mikroskopisk diagnostik	Blodparasiter
Clinical parasitology	Manual method	Human material	Mikroskopisk diagnostik	Tarmparaister
Clinical virology	Abbott Alinity m	Human material	Virus DNA and RNA	Real-time PCR
Clinical virology	Abbott Architect i2000	Human material	Antigen detection	CMIA
Clinical virology	Abbott Architect i2000	Human material	Detektion av antikroppar	CMIA
Clinical virology	BD MAX	Human material	Virus DNA and RNA	Real-time PCR
Clinical virology	BIO-RAD Geenius	Human material	Detektion av antikroppar	Immunokromatografi
Clinical virology	Cepheid GeneXpert GX-XVI	Human material	Virus DNA and RNA	Real-time PCR
Clinical virology	Cepheid GeneXpert IV	Human material	Virus DNA and RNA	Real-time PCR
Clinical virology	Manual method	Human material	Detektion av antikroppar	LIA
Clinical virology	Roche cobas pro e 801	Human material	Antigen detection	CLIA
Clinical virology	Roche cobas pro e 801	Human material	Detektion av antikroppar	CLIA
Infection control diagnostics	Standard method	D-Diverse ytor, blodcentral	Detektion av bakterier	Odling
Infection control diagnostics	Standard method	D-Diverse ytor, blodcentral	Detektion av svamp	Odling
Infection control diagnostics	Standard method	Dialysvätska	Endotoxin	Spektrofotometri
Infection control diagnostics	Standard method	Endoskopdiskmaskin	Detektion av bakterier	Odling
Infection control diagnostics	Standard method	Endoskopdiskmaskin	Detektion av svamp	Odling
Infection control diagnostics	Standard method	Vatten	Detektion av bakterier	Odling
Infection control diagnostics	Standard method	Vatten	Detektion av svamp	Odling
Infection control diagnostics	Standard method	Vatten	Sterilkontroll dialys	Odling

Clinical pathology
Teknikområde	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Morphological Diagnostics	Cells	Exfoliativ cytologi cervixcytologi	Microscopic diagnostics
Morphological Diagnostics	Tissue	-	Microscopic diagnostics
Morphological Diagnostics	Tissue	Bröstdiagnostik	Microscopic diagnostics
Morphological Diagnostics	Tissue	Gastrointestinal diagnostik appendix	Microscopic diagnostics
Morphological Diagnostics	Tissue	Urological diagnostics prostate	Microscopic diagnostics
Morphological Diagnostics	Tissue	Urologisk diagnostik urinvägar, endast tumörsjukdomar	Microscopic diagnostics

Pharmaceuticals and Toxicology
Teknikområde	Metod/utrustning	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Mätprincip	Flex	Business unit
Alcohol analyses	Sebia Capillarys 3 Tera	Human kroppsvätskor	Alcohols	-
Alcohol analyses	Thermo Fisher Trace 1300 GC	Human kroppsvätskor	Alcohols	GC-FID
Alcohol analyses	Thermo Fisher Vanquish LC Quantis MS/MS	Human kroppsvätskor	Alcohols	LC-MS/MS
Alcohol analyses	Thermo Scientific Ultimate 3000 LC Endura MS/MS	Human kroppsvätskor	Alcohols	LC-MS/MS
Drug analysis	Roche cobas pro c 503	Human kroppsvätskor	Drugs	Photometers
Läkemedelanalyser	Roche cobas pro c 503	Human kroppsvätskor	Pharmaceuticals	Photometers
Läkemedelanalyser	Roche cobas pro e 801	Human kroppsvätskor	Pharmaceuticals	CLIA
Läkemedelanalyser	Roche cobas pure c 303	Human kroppsvätskor	Pharmaceuticals	Fotometer
Läkemedelanalyser	Roche cobas pure c 303	Human kroppsvätskor	Pharmaceuticals	Photometers

Pre-analysis
Teknikområde	Provtyp/System/Provmaterial	Parameter/Analys/Process/Undersökning	Flex	Business unit
Sampling	Human material	-
Sampling drugs	Human kroppsvätskor	-
Sampling drugs	Human kroppsvätskor	Övervakad provtagning

The accredited body has been granted flexible scope. The body shall be able to provide an updated list of the current scope of accreditation upon request.

Regulations

STAFS 2020:1: Swedacs föreskrifter och allmänna råd om ackreditering