CERTIFICATE OF ACCREDITATION LANCET LABORATORIES Registration No: 4120108883 Facility Accreditation Number: MED 006 is a SADCAS accredited Medical Laboratory provided that all SADCAS conditions are complied with This certificate is valid as per the scope stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, HAEMATOLOGY AND MICROBIOLOGY The facility is accredited in accordance with the recognized International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a laboratory quality management system SADCAS is a subsidiarity organization of SADC. A memorandum of understanding between SADC and SADCAS serves as the basis for the recognition of SADCAS by SADC Member States as a multi-economy accreditation body This certificate has been issued under the SADCAS/SANAS Twinning Partnership Arrangement Mrs Maureen P Mutasa SADCAS Chief Executive Officer Original Date of Accreditation: 22 August 2014 Effective Date (Issue No: 2): 27 April 2016 Certificate Expires: 21 August 2019
S C H E D U L E OF A C C R E D I T A T I O N Laboratory Accreditation Number: MED 006 (ISO 15189:2012) Permanent Address of Laboratory: Lancet Laboratories C/o Mbabane Clinic Private Hospital Mkhonubovu Road Mbabane Swaziland Technical Signatories : as authorized by the Head of the Laboratory Postal Address: P.O Box 8475 Johannesburg South Africa Tel : +268 24042368 Cell : +268 76410655 Fax : +268 2404 5347 Email : Helen.Wyatt@lancet.co.sz Nominated Representative : Ms Helen Wyatt Issue No : 04 Date of issue : 11 August 2017 Expiry Date : 21 August 2019 CHEMISTRY Serum Albumin COBAS Integra 400 Serum Alkaline Phosphatase (ALP) COBAS Integra 400 Serum Alanine Aminotransferase (ALT) COBAS Integra 400 Serum Amylase COBAS Integra 400 Serum Aspartate Aminotransferase (AST) COBAS Integra 400 Serum Bilirubin, Conjugated COBAS Integra 400 Serum Bilirubin, Total COBAS Integra 400 Serum Calcium (Corrected COBAS Integra 400 Serum Calcium (Total) COBAS Integra 400 Serum Chloride COBAS Integra 400 Serum Cholesterol (HDL) COBAS Integra 400 Serum Creatine phosphokinase (CPK) COBAS Integra 400 Serum Creatinine COBAS Integra 400 Serum Gamma Glutamyl Transferase COBAS Integra 400 Serum Glucose COBAS Integra 400 Serum Lactate COBAS Integra 400 Serum Magnesium COBAS Integra 400 Serum Phosphate (PO4) COBAS Integra 400 Original date of accreditation: 22 August 2014 Page 1 of 4
CHEMISTRY (continued) Serum Potassium COBAS Integra 400 Serum Sodium COBAS Integra 400 Serum Total Protein COBAS Integra 400 Serum Triglycerides COBAS Integra 400 Serum Urate COBAS Integra 400 Serum Urea COBAS Integra 400 HAEMATOLOGY Plasma Activated Partial Thromboplastin Time (APTT) Erythrocyte Sedimentation Rate (ESR) Full Blood Count (FBC) Mindray BC 5380 International Normalized Ratio (INR) Malaria Films thick/thin Prothrombin Index (PI) MICROBIOLOGY Blood Cultures, CSF, ENT, Gram Stain: Bacterial/Fungal Elements Method Sputum Ziehl Nielsen: TB Identification Method Fluids (Ascetic, Gastric Aspirate, Joint, Peritoneal, Pleural) India Ink: Cryptococcus Method Rectal Swabs, Semen, Sputum Modified ZN: Cryptosporidium Method Stool, Tissue, Urine Wet preparation: Cells Method Crystals Method Parasites Method Iodine Wet Preparation Parasites Method Urine Chemistry analysis: Dipstick Method Kit Detection of antimicrobial substances Method Microscopic examination (Cell count) Method Original date of accreditation: 22 August 2014 Page 2 of 4
MICROBIOLOGY (continued) Stool Campylobacter Method Enterohaemorrhagic E. coli Method Enteropathogenic E. coli Method Kit Iodine wet preparations Method Vibrio Cholera Method Kit CSF, ENT, Fluids (Ascetic, Gastric Aspirate, Joint, Peritoneal, Pleural), Genital, Pus, Rectal Swabs, Semen, Sputum, Stool, Tissue, Urine Blood Cultures Blood Cultures, CSF, ENT, Fluids 3 (Ascetic, Gastric Aspirate, Joint, Peritoneal, Pleural) Genital, Pus, Rectal Swabs, Semen, Sputum, Stool, Tissue, Urine Aerobic, Anaerobic and Micro-aerophilic Culture and isolation of pathogenic organisms Aerobic, anaerobic and micro aerophilic Culture and isolation of pathogenic organisms Identification tests:- Aesculin Bile API Identification Beta Lactamase Coagulase DNAse Catalase Oxidase Pyruvate Rapid Indole Satellitism CAMP Plate Optochin & Bacitracin Discs Haemaphilus X, V & XV Identification Germ-Tube Test Latex agglutination of bacteria: S.Pneumoniae N,Meningitidis ABCY W135 H.Influenza B Strep Group B Method - Culture On Media Method BACTEC 9050 Method Method Kit Method Method Method Method Method Method Method Method Method Method Method Method Method Kit Original date of accreditation: 22 August 2014 Page 3 of 4
MICROBIOLOGY (continued) Sputum, Stool, Tissue, Urine Cryptococcal Antigen Method Kit Latex Streptococcal grouping: A,B,C,D,F,G method Kit Staphylococcal Agglutination Method Kit Serological Identification of Bacteria: Salmonella species Method Kit Shigella species Method Kit Antibiotic Sensitivity test Kirby Bauer E Test Original date of accreditation: 22 August 2014 Page 4 of 4 Jeanne Françoise Ranorovelo SADCAS Technical Manager