HAA je potpisnica multilateralnog sporazuma s Europskom organizacijom za akreditaciju (EA) HAA is a signatory of the European co-operation for
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1 HAA je potpisnica multilateralnog sporazuma s Europskom organizacijom za akreditaciju (EA) HAA is a signatory of the European co-operation for Accreditation (EA) Multilateral Agreement
2 PRILOG POTVRDI O AKREDITACIJI br: 7473 Annex to Accreditation Certificate Number: Klasa/Ref. : /14-35/002 Urbroj/Id. : / Datum izdanja priloga /Annex Issued on: Zamjenjuje prilog/replaces Annex: Klasa/Ref. : /14-35/002 Urbroj/Id. : / Datum/Date: Norma: HRN EN ISO 15189:2012 Standard: (ISO 15189:2012; EN ISO 15189:2012) Akreditacija istječe: Accreditation expiry: Prva akreditacija: Initial accreditation: Akreditirani medicinski laboratorij Accredited medical laboratory KLINIČKA BOLNICA DUBRAVA Klinički zavod za laboratorijsku dijagnostiku, kliničku mikrobiologiju i bolničke infekcije Klinička jedinica - Klinički zavod za laboratorijsku dijagnostiku Avenija Gojka Šuška 6, HR Zagreb Područje akreditacije: Scope of Accreditation: Medicinska biokemija - ispitivanja u području kliničke kemije, laboratorijske hematologije i koagulacije, laboratorijske imunologije i molekularne dijagnostike Medical Biochemistry Testing in the field of Clinical Chemistry, Laboratory Hematology and Coagulation, Laboratory Immunology and Molecular Diagnostics Važeće izdanje Priloga dostupno je na web adresi: / Valid issue of the Annex is available at the web address: Ravnatelj: Director General: Tihomir Babić, dipl. ing. HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 1 od/of 7
3 PODRUČJE AKREDITACIJE / SCOPE OF ACCREDITATION Klinička kemija/clinical Chemistry 1. α Amilaza α Amylase Aspartat-aminotransferaza (AST) Aspartate-aminotransferase Alanin-aminotransferaza (ALT) Alanine-aminotransferase SMP SMP SMP Alkalna fosfataza (ALP) Alkaline phosphatase SMP Kreatin-kinaza (CK) Creatine-kinase SMP Gama-glutamiltransferaza (GGT) Gamma glutamyltransferase SMP Fotometrija Photometry 7. Laktat-dehidrogenaza (LD) Lactate-dehidrogenase SMP Lipaza Lipase SMP Albumin Albumin SMP Bilirubin, ukupni Bilirubin, total SMP Kalcij, ukupni Calcium, total SMP Kolesterol Cholesterol SMP Kolesterol, HDL Cholesterol, HDL SMP Enzimska fotometrijska metoda Enzymatic photometric method Fotometrija Photometry HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 2 od/of 7
4 14. Kreatinin Creatinine SMP 067-2, Mokra ć a,u rin e 15. Glukoza Glucose SMP Laktat Lactate SMP Magnezij Magnesium SMP Proteini, ukupni Total protein Trigliceridi Triglyceride SMP SMP Fotometrija Photometry Ureja Urea Mokraćna kiselina Uric acid SMP SMP 076-2, Mokra ć a,u rin e 22. Anorganski fosfati Inorganic phosphorus SMP Proteini, ukupni Total protein SMP Mokra ć a, Likvo r Urine, CSF 24. C-reaktivni protein (CRP) C-reactive protein SMP Imunoturbidimetrija Immunoturbidimetry 25. Kalij Potassium SMP Natrij Sodium SMP Indirektna potenciometrija Indirect potentiometry, Mokra ć a,u rin e 27. Kloridi Chloride SMP Etanol Ethanol SMP Fotometrija Photometry 29. Acidobazni status ABS Acid-base balance SMP Elektrokemijska metoda Electrochemical method Arter ijsk a krv, Vensk a krv Artery blood, Venous blood HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 3 od/of 7
5 Karboksihemoglobin Carboxyhemoglobin Methemoglobin Methemoglobin SMP SMP Spektrofotometrijska Spectrophotometry Arter ijsk a krv, Vensk a krv Artery blood, Venous blood 32. Kalcij, ionizirani Calcium, ionized SMP Potenciometrija Potentiometry, Puna krv, Whole blood 33. Amonijak Ammonia SMP Fotometrija UV Photometry UV Plazma Plasma 34. Troponin I Troponin I SMP Elektrokemiluminiscentna imunoanaliza Electrochemiluminescece immunoassay 35. Pregled mokraće kemijski Urine analysis - chemical SMP Refraktometrija Refractometry Mokra ć a Urine Tireoidni stimulirajući hormon (TSH) Thyrotropin Slobodni tiroksin (FT4) Free Thyroxine SMP SMP Imunokemijska metoda s obilježenim reagensima kemiluminiscencija Immunoassays with labeling substances - Chemiluminescence 38. Slobodni trijoditironin (FT3) Free Triiodthyronine SMP Ukupni prostata-specifičan antigen (PSA) Total-prostate-specific antigen Slobodni prostata-specifičan antigen (fpsa) Free prostate-specific antigen SMP SMP Hybritech PSA - Imunokemijska metoda s obilježenim reagensima kemiluminiscencija Immunoassays with labeling substances - Chemiluminescence HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 4 od/of 7
6 Laboratorijska hematologija/laboratory Haematology Prilog potvrdi o akreditaciji Optika i impedancija Optical count & impedantion 1. Krvna slika na brojaču Haematology parameters on automated analyzer SMP Impedancija Impedantion Spektrofotometrijska Spectrophotometry Računski parametri Calculated parameters Puna krv Whole blood Optičko brojanje stanica Optical count cells 2. Diferencijalna krvna slika Differential blood count SMP Protočna citometrija Flow citometry VCS (volumetrija, provodljivost, raspršenje) VCS (volumetry, conductivity & scattering) Laboratorijska koagulacija/laboratory Coagulation 1. Protrombinsko vrijeme (PV) Prothrombin time (PT) SMP Aktivirano parcijalno tromboplastinsko vrijeme (APTV) Activated partial thromboplastin time (APTT) SMP Koagulometrija Coagulometry Plazm a Plasm a 3. Fibrinogen Fibrinogen SMP Koagulometrija Coagulometry 4. Antitrombin (AT) - % aktivnosti Antithrombin (AT) - % activity SMP Kromogena metoda Chromogenic assay HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 5 od/of 7
7 5. D-dimeri D-dimers SMP Imunoturbidimetrija Immunoturbidimetry Laboratorijska imunologija / Laboratory Imunology 1. Antinuklearna antitijela (ANA) Antinuclear antibodies (ANA) SMP Antitijela na dvostruku uzvojnicu DNA (dsdna) Autoantibodies to doublestranded DNA (dsdna) SMP Enzimimuno analiza (ELISA) Enzyme-linked immunosorbent assay 3. Antitijela na mijeloperoksidazu (MPO) Anti-myeloperoxidase (Anti-MPO) antibodies SMP Antitijela na proteinazu 3 (Pr- 3) Anti-proteinase 3 (Anti-PR3) antibodies SMP Antikardiolipinska antitijela IgG/IgM Anti-cardiolipin IgG/ IgM antibodies SMP HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 6 od/of 7
8 Molekularna dijagnostika/molecular Diagnostics 1. JAK2 (V617F), stečena mutacija tirozin kinaze JAK2 (Val617Phe) JAK2 (V617F), acquired mutation of the tyrosine kinase JAK2 (Val617Phe) SMP Lančana reakcija polimeraze (PCR) Polimerase chain reaction (PCR) DNA DNA HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 7 od/of 7
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