Prilog Potvrdi o akreditaciji broj: 7132/07 Annex to Accreditation Certificate Number: Norma: Standard: HRN EN ISO 15189:2006 (ISO 15189:2003; EN ISO 15189:2003) Klasa: 383-02/07-35/01 Urbroj: 569-02/5-07-69 Zagreb, 2007-12-28 Akreditacija vrijedi do: 2012-12-31 Accreditation is valid to: Akreditirani laboratorij Accredited laboratory KLINIČKA BOLNICA SESTRE MILOSRDNICE KLINIČKI ZAVOD ZA KEMIJU Vinogradska 29, HR-10000 Zagreb Područje akreditacije: Scope of accreditation: Ispitivanje odabranih značajki u području medicinske biokemije Opća i specijalna klinička kemija, laboratorijska imunologija, uzorkovanje krvi i mokraće Testing of selected field in medical biochemistry General and special clinical chemistry, immunology, blood and urine sampling HAA-Ob-7/7-2/1 /Izdanje 1 stranica/page 1 od/of 9
PODRUČJE AKREDITACIJE / SCOPE OF ACCREDITATION 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Imunoglobulin G (IgG) Immunoglobulin G (IgG) Imunoglobulin G (IgG) Immunoglobulin G (IgG) Imunoglobulin A (IgA) Immunoglobulin A (IgA) Imunoglobulin M (IgM) Immunoglobulin M (IgM) Komplement - komponenta C3 (C3) Complement - component C3 (C3) Komplement - komponenta C4 (C4) Complement - component C4 (C4) Lagani lanci imunoglobulina kapa tipa (Ig/L-kapa) Light immunoglobulin chains kappa type (Ig/L-kappa) Lagani lanci imunoglobulina lambda tipa (Ig/L-lambda) Light immunoglobulin chains lambda type (Ig/L-lambda) Ceruloplazmin (Cp) Ceruloplasmin (Cp) Haptoglobin (Hp) Haptoglobin (Hp) Transferin (Tf) Transferrin (Tf) MP-5.5-73-1/1 MP-5.5-73-2/1 MP-5.5-73-3/1 MP-5.5-73-4/1 MP-5.5-73-5/1 MP-5.5-73-6/1 MP-5.5-73-7/1 MP-5.5-73-8/1 MP-5.5-73-9/1 MP-5.5-73-10/1 MP-5.5-73-11/1 MP-5.5-73-12/1 MP-5.5-73-13/1 MP-5.5-73-14/1 Imunonefelometrija Immunonephelometry na na HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 2 od/of 9
15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. α-1-antitripsin (AAT) α-1-antitrypsin (AAT) Apolipoprotein A I (Apo A I) Apolipoprotein A I (Apo A I) Apolipoprotein B (Apo B) Apolipoprotein B (Apo B) Troponin T (Tn T) Troponin T (Tn T) Vitamin B12 Vitamin B12 Folna kiselina Folic acid Mioglobin (Mb) Myoglobin (Mb) Mioglobin (Mb) Myoglobin (Mb) Osteokalcin Osteocalcin C-terminalni crosslinking telopeptid kolagena tip I (CTX) C-terminal crosslinking collagen telopeptide type I (CTX) Kalij Potassium Kalij Potassium Kalij Potassium Kalij Potassium Natrij Sodium Natrij Sodium Natrij Sodium Kloridi Chloride Kloridi Chloride MP-5.5-73-15/1 MP-5.5-72-3/1 MP-5.5-72-4/1 MP-5.5-5-1/1 MP-5.5-72-1/1 MP-5.5-72-2/1 MP-5.5-72-9/1 MP-5.5-72-10/1 MP-5.5-72-12/1 MP-5.5-72-13/1 MP-5.5-4-16/1 MP-5.5-4-15/1 MP-5.5-4-22/1 MP-5.5-4-80/1 MP-5.5-4-17/1 MP-5.5-4-23/1 MP-5.5-4-81/1 MP-5.5-4-18/1 MP-5.5-4-24/1 Imunonefelometrija Immunonephelometry Elektrokemiluminiscencija Electrochemiluminescence Potenciometrija Potentiometry, plazma, plasma, plazma, plasma Plazma Plasma na na HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 3 od/of 9
34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. Kloridi Chloride Kisela fosfataza Acid phosphatase Prostatična kisela fosfataza Acid phosphatase, prostatic Alanin-aminotransferaza (ALT) Alanine-aminotransferase (ALT) Alkalna fosfataza (ALP) Alkaline phosphatase (ALP) α-amilaza (AMS) α-amylase (AMS) α-amilaza (AMS) α-amylase (AMS) α-amilaza (AMS) α-amylase (AMS) Angiotenzin-konvertaza (ACE) Angiotensin-converting enzyme (ACE) Aspartat-aminotransferaza (AST) Aspartateaminotransferase (AST) Bilirubin - konjugirani Bilirubin - conjugated Bilirubin - ukupni Bilirubin - total Kalcij - ukupni Calcium - total Kalcij - ukupni Calcium - total Karboksihemoglobin (COHb) Carboxyhemoglobin (COHb) MP-5.5-4-82/1 MP-5.5-4-11/1 MP-5.5-4-12/1 MP-5.5-4-2/1 MP-5.5-4-54/1 MP-5.5-4-10/1 MP-5.5-4-73/1 MP-5.5-4-6/1 MP-5.5-4-7/1 MP-5.5-4-13/1 MP-5.5-4-1/1 MP-5.5-4-31/1 MP-5.5-4-30/1 MP-5.5-4-19/1 MP-5.5-4-25/1 MP-5.5-5-4/1 Potenciometrija Potentiometry Spektrofotometrija Spectrophotometry na, plazma,, plasma, Punktati Puncture, plazma, plasma, plazma,, plasma,, plazma, plasma Puna krv, plazma Whole blood, plasma HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 4 od/of 9
50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. Kolesterol - ukupni Cholesterol - total Kolesterol - HDL Cholesterol - HDL Kolesterol - LDL Cholesterol - LDL Kreatin-kinaza (CK) Creatine-kinase (CK) Izoenzim kreatin-kinaze MB (CK-MB) Creatin- kinase MB izoenzyme (CK-MB) Kreatinin Creatinine Kreatinin Creatinine γ-glutamiltransferaza (GGT) γ-glutamyltransferase (GGT) Glukoza Glucose Glukoza Glucose Glukoza Glucose Glukoza Glucose Fosfati - anorganski Phosphates - inorganic Fosfati - anorganski Phosphates - inorganic Željezo Iron Laktat-dehidrogenaza (LD) Lactate-dehydrogenase (LD) MP-5.5-4-44/1 MP-5.5-4-45/1 MP-5.5-4-46/1 MP-5.5-4-3/1 MP-5.5-4-4/1 MP-5.5-4-35/1 MP-5.5-4-40/1 MP-5.5-4-9/1 MP-5.5-4-36/1 MP-5.5-4-78/1 MP-5.5-4-79/1 MP-5.5-4-32/1 MP-5.5-4-20/1 MP-5.5-4-27/1 MP-5.5-4-49/1 MP-5.5-4-74/1 Spektrofotometrija Spectrophotometry, plazma,, plasma,, plazma, plasma, amnijska, amniotic, plazma,, plasma,, plazma, plasma urine na Punktati Puncture, plazma, plasma, plazma,, plasma, Punktati Puncture HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 5 od/of 9
66. 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. Laktat-dehidrogenaza (LD) Lactate-dehydrogenase (LD) Lipaza (LPS) Lipase (LPS) Magnezij - ukupni Magnesium - total Magnezij - ukupni Magnesium - total Methemoglobin (MetHb) Methemoglobin (MetHb) Porfirini - ukupni Porphyrins - total Ukupni proteini Total proteins Ukupni proteini Total proteins Ukupni proteini Total proteins Ukupni proteini Total proteins Trigliceridi Triglycerides Željezo - nezasićeni kapacitet vezanja željeza (UIBC) Iron - unsaturated iron binding capacity (UIBC) Urea Urea Urea Urea Urati Uric acid Urati Uric acid 5'-nukleotidaza 5 -nucleotidase Ukupne žučne kiseline Total bile acids, MP-5.5-4-5/1 MP-5.5-4-8/1 MP-5.5-4-21/1 MP-5.5-4-28/1 MP-5.5-5-5/1 MP-5.5-4-59/1 MP-5.5-4-53/1 MP-5.5-4-58/1 MP-5.5-4-72 MP-5.5-5-34/1 MP-5.5-4-48/1 MP-5.5-4-50/1 MP-5.5-4-33/1 MP-5.5-4-37/1 MP-5.5-4-34/1 MP-5.5-4-39/1 MP-5.5-72-8/1 MP-5.5-72-7/1 Spektrofotometrija Spectrophotometry, plazma, plasma, plazma,, plasma,, plazma, plasma Puna krv, plazma Whole blood, plasma, plazma, plasma Punktati Puncture na, plazma,, plasma,, plazma, plasma, plazma, plasma HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 6 od/of 9
84. 85. 86. 87. 88. 89. 90. 91. 92. 93. Kolesterol - HDL2 Cholesterol - HDL2 Kolesterol - HDL3 Cholesterol - HDL3 Slobodne masne kiseline (FFA) Free fatty acids (FFA) Hemoglobin - slobodni Hemoglobin - free Hemoglobin - fetalni (HbF) Hemoglobin fetal (HbF) Bilirubin - ukupni - spektralna fotometrija Bilirubin - total - spectal photometry Kolesterol - LDL Cholesterol - LDL Bilirubin - nekonjugirani Bilirubin - unconjugated Saturacija željeza Fe saturation Željezo - ukupni kapacitet vezanja željeza (TIBC) Iron - total iron binding capacity (TIBC) MP-5.5-72-5/1 MP-5.5-72-6/1 MP-5.5-73-10/1 MP-5.5-73-9/1 MP-5.5-73-8/1 MP-5.5-74-22/1 MP-5.5-4-47/1 MP-5.5-4-32/1 MP-5.5-4-52/1 MP-5.5-4-51/1 Spektrofotometrija Spectrophotometry Računski Calculating Majčino mlijeko Breast milk Plazma Plasma Hemolizat Hemolysate Amnijska Amniotic, plazma,, plasma, Osobe s pravom potpisa svih izvještaja o ispitivanju iz područja akreditacije: Authorized persons to sign all test reports in the scope of accreditation: prof. dr. sc. Topić Elizabeta, dr. sc. Šimundić Ana-Maria, dr. sc.štefanović Mario, dr. sc.vrkić Nada, dr. sc. Vukasović Ines, mr. sc Ferenec Ružić Dragica, predstojnica KZZK Head of the Clinical Institute of Chemistry Voditelj Odsjeka za kliničko-molekularnu dijagnostiku Division of Clinical Molecular Diagnostics, Head Voditelj Odsjeka za farmakogenetiku Division of Pharmacogenetics, Head Voditelj Odjela za specijalnu medicinsku biokemiju Department of Special Medical Biochemistry, Head Voditelj Odsjeka za neurobiokemiju Division of Neurobiochemistry, Head Voditelj Odsjeka za opću medicinsku biokemiju Division of General Medical Biochemistry, Head HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 7 od/of 9
mr. sc.tešija-kuna Andrea, mr.sc Vukelić Nada, mr. sc. Zubčić Anka, Prilog potvrdi o akreditaciji broj Voditelj Odsjeka za laboratorijsku imunologiju i metaboličke pogreške Division of Immunology and Metabolic Disorders, Head Voditelj Odsjeka za hitnu laboratorijsku dijagnostiku Division of Emergency Laboratory Diagnostic Voditelj Odsjeka za specifične proteine i izoenzime Division of Specific Proteins and Isoenzymes, Head Osobe s pravom potpisa navedenog dijela izvještaja o ispitivanju iz područja akreditacije: Authorized persons to sign listed test reports in the scope of accreditation: MP-5.5-4-51/1, MP-5.5-73-10/1, MP-5.5-73-11/1, MP-5.5-4-16/1, MP-5.5-4-15/1, MP-5.5-4- 22/1, MP-5.5-4-17/1, MP-5.5-4-23/1, MP-5.5-4-18/1, MP-5.5-4-24/1, MP-5.5-4-2/1, MP-5.5-4-54/1, MP-5.5-4-10/1, MP-5.5-4-73/1, MP-5.5-4-6/1, MP-5.5-4-7/1, MP-5.5-4-1/1, MP-5.5-4-31/1, MP-5.5-4-30/1, MP-5.5-4-19/1, MP-5.5-4-25/1, MP-5.5-4-44/1, MP-5.5-4-45/1, MP- 5.5-4-46/1, MP-5.5-4-3/1, MP-5.5-4-35/1, MP-5.5-4-40/1, MP-5.5-4-9/1, MP-5.5-4-36/1, MP-5.5-4-78/1, MP-5.5-4-32/1, MP-5.5-4-20/1, MP-5.5-4-49/1, MP-5.5-4-74/1, MP-5.5-4- 5/1, MP-5.5-4-21/1, MP-5.5-4-53/1, MP-5.5-4-58/1, MP-5.5-4-72/1, MP-5.5-4-48/1, MP-5.5-4-50/1, MP-5.5-4-33/1, MP-5.5-4-37/1, MP-5.5-4-34/1, MP-5.5-4-39/1, MP-5.5-4-47/1, MP- 5.5-4-32/1, MP-5.5-4-52/1, MP-5.5-73-9/1 Kvaternik Marina, dipl. ing. Milanović Stipković Branka, dipl. ing. Nikolac Nora, dipl. ing. Papić Futač Dalja, dipl. ing. Samošćanec Ksenija, dipl. ing., spec. analitičke toksikologije Medicinski biokemičar u Odsjeku za opću medicinsku biokemiju Division of General Medical Biochemistry, medical biochemist Medicinski biokemičar u Odsjeku za specifične proteine i izoenzime Division of Specific Proteins and Isoenzymes, medical biochemist Medicinski biokemičar u Odsjeku za farmakogenetiku Division of Farmacogenetics, medical biochemist Medicinski biokemičar u Odsjeku za farmakološko toksikološku dijagnostiku i elemente u tragu Division of Pharmacology and Toxicology Diagnostics and Trace Elements, medical biochemist Voditelj Odsjeka za farmakološko toksikološku dijagnostiku i elemente u tragu Division of Pharmacology and Toxicology Diagnostics and Trace Elements, Head HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 8 od/of 9
Svržan Primožić Jasminka, dipl. ing. Žirović Marijana, dipl. ing. Prilog potvrdi o akreditaciji broj Medicinski biokemičar u Odsjeku za opću medicinsku biokemiju Division of General Medical Biochemistry, medical biochemist Medicinski biokemičar u Odsjeku za laboratorijsku imunologiju i metaboličke pogreške Division of Immunology and Metabolic Disorders, medical biochemist HAA-Ob-7/7-2/1 / Izdanje 1 stranica/page 9 od/of 9