CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION LANCET KENYA LIMITED UPPERHILL NAIROBI LABORATORY Co. Reg. No.: C Facility Accreditation Number: is a South African National Accreditation System accredited laboratory provided that all SANAS 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, CYTOLOGY, ENDOCRINOLOGY, HAEMATOLOGY, HISTOLOGY, MICROBIOLOGY, MOLECULAR BIOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2007 The accreditation demonstrates technical competency for a defined scope and the operation of a laboratory quality management system While this certificate remains valid, the Accredited Facility named above is authorised to use the relevant SANAS accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 23 December 2010 Certificate Expires: 22 December 2014
2 SCHEDULE OF ACCREDITATION Facility Number: Permanent Address of Laboratory: Lancet Kenya Limited Upperhill Nairobi Laboratory 5 th Ave Ngong Road Nairobi Hill Nairobi Kenya Signatories: Signatories as authorised by the Head of Laboratory Postal Address: P O Box 8474 Johannesburg 2000 Contact Person: Mrs M de Wet Tel: Issue No.: 03 Fax: Monica.dwet@lancet.co.za CHEMISTRY Serum Alanine Aminotransferase (ALT) Integra 400 Serum Albumin Integra 400 Serum Alkaline Phosphatase (ALP) Integra 400 Serum Amylase Integra 400 Serum Aspartate Aminotransferase (AST) Integra 400 Urine Beta Human Chorionic Gonadotrophin (βhcg) Screen -Kit Serum Bilirubin, Direct Integra 400 Serum Bilirubin, Total Integra 400 Serum Calcium (Total) Integra 400 Serum, CSF Chloride Integra 400 Serum Cholesterol (HDL) Integra 400 Serum Cholesterol (Total) Integra 400 Serum C-Reactive Protein (CRP) Integra 400 Serum Creatine Kinase (CK) Integra 400 Whole Blood Creatine Kinase MB Mass (CKMB Mass) Cobas H232 Serum Creatinine Integra 400 Serum Ferritin Elecsys e411 Serum Gamma Glutamyl Transferase (GGT) Integra 400 Serum, CSF Glucose Integra 400 Serum Iron Integra 400 Serum Lactose Dehydrogenate (LDH) Integra 400 Serum Magnesium Integra 400 Serum Phosphate Integra 400 Serum Potassium Integra 400 Original Date of Accreditation: 23 December 2010 Page 1 of 4
3 CHEMISTRY (Continued) Serum, CSF Protein (Total) Integra 400 Serum Sodium Integra 400 Serum Triglycerides Integra 400 Serum Urate Integra 400 Serum Urea Integra 400 ENDOCRINOLOGY Serum Alpha Feto-protein (AFP) Elecsys e411 Serum Beta Human Chorionic Gonadotrophin (βhcg) Quantitative Elecsys e411 Serum CA 19.9 Elecsys e411 Serum CA 125 Elecsys e411 Serum Carcinoembryonic Antigen (CEA) Elecsys e411 Serum Cortisol Elecsys e411 Serum Estradiol (E2) Elecsys e411 Serum Folate Elecsys e411 Serum Follicle Stimulating Hormone (FSH) Elecsys e411 Serum Free Thyroxine (F-T4) Elecsys e411 Serum Free Triiodothyronine (F-T3) Elecsys e411 Serum Luteinising Hormone (LH) Elecsys e411 Whole Blood Pro Brain Natriuretic Peptide (probnp) Cobas H232 Serum Progesterone Elecsys e411 Serum Prostate Specific Antigen (PSA) (Total) Elecsys e411 Serum RPR -Kit Serum Testosterone Elecsys e411 Serum Thyroid Stimulating Hormone (TSH) Elecsys e411 Serum Transferrin Integra 400 Whole Blood Troponin T (Quantitative) Cobas H232 Serum Vitamin B12 Elecsys e411 HAEMATOLOGY Plasma Activated Partial Thromboplastin Time (APTT) Fibrintimer / Whole Blood Blood Grouping (ABO and Rh (D)) Whole Blood CD4 BD Facscount Whole Blood CD8 BD Facscount Whole Blood D-Dimer Cobas H232 Whole Blood Erythrocyte Sedimentation Rate (ESR) Humased / - Westergren Whole Blood Full Blood Count and Differential Count Sysmex XT-2001 Plasma International Normalised Ratio (INR) Fibrintimer / Whole Blood Malaria Antigens -Kit Whole Blood Malaria QBC Whole Blood Malaria Smears Plasma Prothrombin Index (PI) Fibrintimer / MOLECULAR BIOLOGY Whole Blood HIV PCR Quantitative Taqman / Ampliprep Original Date of Accreditation: 23 December 2010 Page 2 of 4
4 Discipline / Sample Type Types of Tests Equipment / Method MICROBIOLOGY Pus, Tissue Culture & Identification Genital Swabs Stool Culture & Identification Occult Blood -Kit Rota and Adeno Virus (Children under 5) Sputum Adequacy Culture & Identification Gram Stain Ziel Nielsen Ear, Nose, Throat Swab Culture and Identification Blood Culture Culture and Identification VersaTREK VersaTREK VersaTREK CSF, Synovial Pleural and Ascetic Cell Count Fluids Culture and Identification CSF CSF Cryptococcal Antigens Indian Ink Urine Chemistry Culture and Identification HISTOLOGY Tissues Routine Histological Techniques / VIP Original Date of Accreditation: 23 December 2010 Page 3 of 4
5 HISTOLOGY (Continued) Immunohistochemistry Slides IHC Stain Bond Max CYTOLOGY Gynae: Cervical Smears Exfoliative Cytology Prep Stain Non Gynae Pleural Fluids, Ascitic Fluids, Exfoliative Cytology Sputum, Urine, Bronchial Washings & Prep Stain Brushings, Oesophageal Brushings Gastric Brushings, CSF, Cystic Fluids SEROLOGY Stool Helicobacter pylori Antibodies -Kit Serum Salmonella typhi O and H -Kit Serum Weil-felix Test -Kit Original Date of Accreditation: 23 December 2010 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
CERTIFICATE OF ACCREDITATION
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