CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION NAMIBIA INSTITUTE OF PATHOLOGY (NIP) LTD Co. Reg. No.: 2000/41 WINDHOEK CENTRAL REFERENCE LABORATORY Facility Accreditation Number: M0459 is a South African National Accreditation System accredited facility provided that all conditions and requirements are complied with This certificate is valid as per the scope as stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, ENDOCRINOLOGY, HAEMATOLOGY, MOLECULAR DIAGNOSTICS AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a quality management system While this certificate remains valid, the accredited facility named above is authorised to use the relevant accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 01 June 2014 Certificate Expires: 31 May 2018
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0459 Permanent Address of Laboratory: Namibia Institute of Pathology (NIP) Ltd Signatories: Signatories as authorised by the Head of Laboratory Windhoek Central Reference Laboratory Windhoek Central Hospital Complex, Ground Floor, Cnr Harvey and Ooievaar Street Windhoek West Namibia Postal Address: P O Box 277 Contact Person: Mr D Chiwara Windhoek Namibia Tel: Issue No.: 07 Fax: Date of Issue: 14 September douglas.chiwara@nip.com.na Expiry Date: 31 May 2018 Discipline / Sample Type Type of Tests Equipment / Method Chemistry Acetaminophen Cobas 6000 Alanine Aminotransferase (ALT) Cobas 6000 / Architect Albumin Cobas 6000 / Architect Alkaline Phosphatase (ALP) Cobas 6000 / Architect Amikacin Cobas 6000 Amylase Architect Aspartate Aminotransferase (AST) Cobas 6000 / Architect Bicarbonate (CO2) Cobas 6000 / Architect Bilirubin, Direct Cobas 6000 / Architect Bilirubin, Total Cobas 6000 / Architect Blood Urea Nitrogen (BUN) Cobas 6000 / Architect Calcium Architect Carbamazepine Cobas 6000 Chloride Cobas 6000 / Architect Page 1 of 4
3 Cholesterol Architect Cholesterol (HDL) Cobas 6000 / Architect C-Reactive Protein (CRP) Cobas 6000 / Architect Complement C3 Cobas 6000 Complement C4 Cobas 6000 Creatine Kinase (CK) Total Cobas 6000 / Architect Creatine Kinase MB (CKMB) Architect Creatinine Cobas 6000 / Architect Ferritin Cobas 6000 / Architect Gamma Glutamyl Transferase (GGT) Cobas 6000 / Architect CSF Glucose Cobas 6000 Plasma Glucose (Fasting) Cobas 6000 / Architect Plasma Glucose (Random) Cobas 6000 / Architect Inorganic Phosphorus Architect Iron Architect Lactate Dehydrogenase (LDH) Cobas 6000 / Architect Magnesium Cobas 6000 / Architect Potassium Cobas 6000 / Architect CSF Protein (Micro) Cobas 6000 Protein (Total) Cobas 6000 / Architect Sodium Cobas 6000 / Architect Triglycerides Cobas 6000 / Architect Urate Architect Blood Gas: Whole Blood ph Rapidlab 348 Whole Blood PCO2 Rapidlab 348 Whole Blood PO2 Rapidlab 348 Endocrinology Alpha Feto-protein (AFP) Architect Beta Human Chorionic Gonadotrophin (βhcg) Qualitative Manual Method Page 2 of 4
4 Beta Human Chorionic Gonadotrophin (βhcg) Quantitative Architect CA 125 Architect CA 15.3 Cobas 6000 / Architect CA 19.9 Cobas 6000 / Architect Carcinoembryonic Antigen (CEA) Architect Digoxin Cobas 6000 Estradiol (E2) Architect Follicle Stimulating Hormone (FSH) Architect Free Thyroxine (F-T4) Architect Free Triiodothyronine (F-T3) Architect Gentamycin Cobas 6000 Luteinising Hormone (LH) Architect Phenobarbitone Cobas 6000 Phenytoin Cobas 6000 Progesterone Architect Prolactin Architect Prostate Specific Antigen (PSA) Free Cobas 6000 / Architect Prostate Specific Antigen (PSA) Total Architect Salicylate Cobas 6000 Theophylline Cobas 6000 Thyroid Stimulating Hormone (TSH) Cobas 6000 / Architect Transferrin Architect Troponin I Architect i2000sr Whole Blood Troponin T Manual Method Valproic Acid Cobas 6000 Vitamin B12 Cobas 6000 / Architect Haematology Whole Blood CD4 FC500 / Cellmek Plasma D-Dimer ACL Elite Plasma Fibrinogen ACL Elite Whole Blood Full Blood Count (FBC) Sysmex xt4000i / Sysmex xs1000i Whole Blood Malaria Smears Manual Method Plasma Prothrombin Index (PI) ACL Elite Plasma Partial Prothmbin Time (PTT) ACL Elite Whole Blood Reticulocyte Count Manual Method Page 3 of 4
5 Molecular Diagnostics Plasma HIV-1 Viral Load Ampliprep / Taqman 96 / Abbott m2000rt / Cobas 4800 DBS, Whole Blood Early Infant Diagnosis Ampliprep / Taqman 96 Serology Antistreptolysin O Titre (ASOT) Cobas 6000 Epstein-Barr Virus (EBV) Manual Method-Elisa Helicobacter Pylorii Manual Method Hepatitis A Antibodies Architect Hepatitis B Core Antibodies Architect Hepatitis B Core IgM Architect Hepatitis B Surface Antibody (AUSAB) Architect Hepatitis B Surface Antigen (HBsAg) Architect Hepatitis C Antibodies Architect Herpes Simplex Virus (HSV) Manual Method-Elisa HIV 1 and 2 Antibodies Cobas 6000 / Architect Immunoglobulin A (IgA) Cobas 6000 Immunoglobulin G (IgG) Cobas 6000 Immunoglobulin M (IgM) Cobas 6000 Rapid Plasma Reagin (RPR) Manual Method Treponema Pallidum Heamagglutination (TPHA) Original Date of Accreditation: 28 September 2010 Manual Method ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 4 of 4
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