CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1), (2) and (3) of the said Act, I hereby certify that:- LANCET LABORATORIES (PTY) LTD Co. Reg. No.: 1996/006950/07 Practice No.: PENCARDIA LABORATORY Facility Accreditation Number: M0235 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, CYTOLOGY, ENDOCRINOLOGY, HAEMATOLOGY, MICROBIOLOGY 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: 26 June 2015 Certificate Expires: 31 May 2019
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0235 Permanent Address of Laboratory: Lancet Laboratories (Pty) Ltd Pencardia Laboratory 509 Pretorius Street, 1st Floor, Pencardia-1 Pretoria 0002 Postal Address: P O Box 8475 Johannesburg 2000 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Mrs M de Wet Tel: Issue No.: 16 Fax: Date of Issue: 06 July monica.dwet@lancet.co.za Expiry Date: 31 May 2019 Chemistry Discipline / Sample Type Type of Tests Serum Alkaline Phosphatase (ALP) Cobas 6000 Equipment / Method Serum, Pleural and Ascitic Fluids, CSF Adenosine Deaminase (ADA) Cobas 6000 Serum Alanine Aminotransferase (ALT) Cobas 6000 Serum Albumin (BCP and BCG) Cobas 6000 CSF Albumin Cobas 6000 Serum Amikacin Cobas 6000 Urine Amphetamine Cobas 6000 Serum, Pleural and Ascitic Fluid, Urine Amylase Cobas 6000 Serum Aspartate Aminotransferase (AST) Cobas 6000 Urine Barbiturates Cobas 6000 Urine Benzodiazepine Cobas 6000 Serum Bicarbonate (CO2) Cobas 6000 Serum Bilirubin, Direct Cobas 6000 Serum Bilirubin, Total Cobas 6000 Urine Cannabis Cobas 6000 Heparin Whole Blood Calcium (Ionised) Gem Premier Serum, Urine Calcium (Total) Cobas 6000 Serum Carbamazepine Cobas 6000 Serum, Plasma, Urine Chloride Cobas 6000 Serum Cholesterol (HDL) Cobas 6000 Serum Cholesterol (LDL) Cobas 6000 Serum Cholesterol (Total) Cobas 6000 Serum Cholinesterase Cobas 6000 Urine Cocaine Cobas 6000 Page 1 of 7
3 Serum C-Reactive Protein (CRP) Cobas 6000 Serum C-Reactive Protein High Sensitivity (HSCRP) Cobas 6000 Serum Creatine Kinase (CK) Cobas 6000 Serum Creatine Kinase MB (CKMB) Cobas 6000 Serum, Plasma, Urine Creatinine Cobas 6000 Serum Ferritin Cobas 6000 Serum Fructosamine Cobas 6000 Serum Gamma Glutamyl Transferase (GGT) Cobas 6000 Plasma, CSF, Pleural and Ascitic Fluid Glucose Cobas 6000 Whole Blood HbA1c Variant II Turbo Serum Human Chorionic Gonadotrophin (HCG) Cobas 6000 Serum Iron Cobas 6000 Serum Interleukin 6 Cobas 6000 Plasma Lactate Cobas 6000 Serum, Pleural and Ascitic Fluid Serum, Pleural and Ascitic Fluid Lactate Dehydrogenase (LDH) Cobas 6000 Lipase Cobas 6000 Serum, Urine Magnesium Cobas 6000 Urine Methamphetamine Cobas 6000 Urine Methadone Cobas 6000 Urine Methaqualone Cobas 6000 Urine Noble Cup Serum, Urine Osmolality (measured) Osmometer 3320 Serum Paracetamol Cobas 6000 Serum ph Urine Phencyclidine Cobas 6000 Serum, Urine Phosphate Cobas 6000 Serum, Plasma, Urine Potassium Cobas 6000 Urine Propoxyphene Cobas 6000 CSF, Urine Protein (Micro) Cobas 6000 Serum Protein (Total) Cobas 6000 Serum, Plasma, Urine Sodium Cobas 6000 Serum Triglycerides Cobas 6000 Serum, Urine, Pleural and Ascitic Fluid Urate Cobas 6000 Serum, Plasma, Urine Urea Cobas 6000 Endocrinology Serum Alpha Feto-protein (AFP) Cobas 6000 Serum CA 15.3 Cobas 6000 Serum CA 19.9 Cobas 6000 Serum CA 125 Cobas 6000 Serum Carcinoembryonic Antigen (CEA) Cobas 6000 Serum C-Peptide Cobas 6000 Serum Cortisol Cobas 6000 Serum Digoxin Cobas 6000 Page 2 of 7
4 Serum Estradiol (E2) Cobas 6000 Serum Ethanol Cobas 6000 Serum Folate Cobas 6000 Serum Follicle Stimulating Hormone (FSH) Cobas 6000 Serum Free Thyroxine (F-T4) Cobas 6000 Serum Free Triiodothyronine (F-T3) Cobas 6000 Serum Gentamycin Cobas 6000 Serum Human Chorionic Gonadotropin (hcg) Cobas 6000 Serum Insulin Cobas 6000 Plasma Homocystine Cobas 6000 Serum Lipoprotein (a) Cobas 6000 Serum Luteinising Hormone (LH) Cobas 6000 Serum Myoglobin Cobas 6000 Urine Opiates Cobas 6000 Serum Phenobarbitone Cobas 6000 Serum Phenytoin Cobas 6000 Serum Pro Brain Natriuretic Peptide (probnp) Cobas 6000 Serum Procalcitonin (PCT) Quantitative Cobas 6000 Serum Progesterone Cobas 6000 Serum Prolactin Cobas 6000 Serum Prostate Specific Antigen (PSA) Free Cobas 6000 Serum Prostate Specific Antigen (PSA) Total Cobas 6000 Serum Prostate Specific Antigen (PSA) Complex Centaur Serum Salicylate Cobas 6000 Serum Testosterone Cobas 6000 Serum Theophylline Cobas 6000 Serum Thyroid Stimulating Hormone (TSH) Cobas 6000 Serum Tobramycin Cobas 6000 Serum Transferrin Cobas 6000 Serum Troponin T (HS) Cobas 6000 Serum Valproic Acid Cobas 6000 Serum Vancomycin Cobas 6000 Serum Vitamin B12 Cobas 6000 Special Chemistry Urine Albumin (Micro) Cobas 6000 Serum Complement C3 Cobas 6000 Serum Complement C4 Cobas 6000 Serum Cotinine Immulite Serum, Plasma Cryogloblin Serum Dehydroepiandrosterone Sulphate (DHEAS04) Cobas 6000 Urine Deoxypyridinoline (DPD) Immulite Serum, Urine Immunofixation Electrophoresis Sebia Hydrasys Serum Immunoglobulin A (IgA) Cobas 6000 Serum Immunoglobulin G (IgG) Cobas 6000 Serum, CSF Immunoglobulin M (IgM) Cobas 6000 Page 3 of 7
5 CSF, Serum CSF Oligoclonal Bands Sebia Hydrasys Plasma Parathyroid Hormone (PTH) Cobas 6000 Serum, Urine Protein Electrophoresis Sebia Hydrasys Serum Sex Hormone Binding Globulin (SHBG) Cobas 6000 Renal Stones Renal Stones Nicolet is 10 Haematology Plasma Activated Partial Thromboplastin Time (APTT) Stago Whole Blood, Serum Antibody Identification Plasma Antithrombin III (AT III) Stago Whole Blood Blood Grouping (ABO and Rh(D)) Bone Marrow Bone Marrow Cytological Examination Bone Marrow Bone Marrow Stain Plasma D-Dimer Stago Whole Blood Direct Coombs Test Whole Blood Erythrocyte Sedimentation Rate (ESR) Alifax / Westergren Plasma Factor VIII and IX Stago Plasma Factor XA Stago Plasma Fibrinogen Stago Whole Blood Full Blood Count & Differential Count Coulter LH750 / Act 5 Whole Blood Haemoglobin F (HBF) - Kleihauer Test Urine Haemosiderin Whole Blood, Serum Indirect Antiglobulin Test (RH Antibodies) Bone Marrow Iron Stain Whole Blood Malaria Antigens Whole Blood Malaria Smears Bone Marrow Non-Specific Estrase Serum, Whole Blood Paul Bunnell Test Whole Blood Periodic Acid Schiff's Reaction (PAS) Whole Blood Peroxidase Plasma Protein C Stago Plasma Protein S Stago Plasma Prothrombin Time (PT) Stago Whole Blood Quick Stain for Blood Smears Whole Blood Reticulocyte Count / Coulter LH750 Plasma Thrombin Time (TT) Stago Whole Blood Thromboelastography-(RN) Thromboelastograph Microbiology Urine, CSF Wet Preparation and Cell Count Page 4 of 7
6 Stool, Rectal Swabs Wet Preparations Cryptosporidium Stain Urine Dipstick (Chemistry) Pus, Fluid (Synovial Peritoneal, Pleural, Pericardial), Respiratory, Genital, CSF, Catheter Tip, Blood Culture Specimens, Skin, Hair, Nails Urine, Pus, Fluid (Synovial Peritoneal, Pleural, Pericardial) Respiratory Genital, Stool, Rectal, CSF, Catheter Tip, Blood Culture Specimens, Skin, Hair, Nails Gram Stain Malachite Green Stain Nigrosin Stain Ziehl Neelsen Stain KOH Stain Lactophenol Cotton Blue Aerobic, Anaerobic and Micro-aerophilic Cultures Blood Cultures Fungal Cultures Antimicrobial Sensitivity Testing: Break Point Method Disc Diffusion Bact/Alert 3D Organism Identification Organism Sensitivities Bacterial Antigen Latex Test Bacterial Identification Techniques: HCI for DNAse Detection Cytochrome Oxidase Test Coagulase Test Cryptococcal Antigen Nitrocefin Test Streptococcal Typing Faecal Blood Germ Tube Test Catalase Test Latex Test for Identification of S Aureus Salmonella Sero-typing Remel Rapid One System Vitek MS Vitek 2 XL Beta- Lactamase Typing Immuno- Assay Id of C.albicans Differentiation between Strep. and Staph Typing Biochemical ID Enterbacteriaceace Page 5 of 7
7 Wellcolex Shigella Latex Mycofast TB LAM Ag Clostridium Difficile GeneXpert Mycobacterium Tuberculosis GeneXpert Typing Biochemical ID Mycoplasma & Ureaplasma PCR Method PCR Method Stool Adenovirus Stool Rotavirus Serology Serum Antistreptolysin O titre (ASOT) Cobas 6000 Serum, BAL Aspergillus Galactomannan Ag -Elisa Swab, Sputum Flu Assay GeneXpert Serum, Plasma Hepatitis A IgM Cobas 6000 Serum, Plasma Hepatitis B Core Antibody Cobas 6000 Serum, Plasma Hepatitis B Surface Antibody Cobas 6000 Serum, Plasma Hepatitis B Surface Antigen Cobas 6000 Serum, Plasma Hepatitis C Cobas 6000 Serum, Plasma HIV Ag/Ab Combo Cobas 6000 Serum, Plasma HIV I/II Rapid -Rapid Serum, Plasma HIV I/II Combo (Confirmation) Centaur Serum, Plasma Immunology E (Specific) ImmunoCAP 250 Serum, Plasma Immunoglobulin E (Total) ImmunoCAP 250 Serum ECP ImmunoCAP 250 Serum, Plasma Tryptase ImmunoCAP 250 Serum, Plasma Intrinsic Factor Antibodies Access Swab, Sputum Respiratory Virus Group Antigen -IFA Serum, Plasma Rapid Plasma Reagin (RPR) Serum Weil-felix Test -Latex Cytology Gynaecological: Conventional Smears: Cervix, Vagina Exfoliate Cytology LBC Smears: Cervix, Vagina Liquid Based Cytology BD Total Ys-Slideprep Cytrocentrifuge PapSpin Method Non-gynaecological: Body Fluids: Pleural, Peritoneal, Sputum, Urine, Bonchial Washing and Bushing, CSF, Cystic Fluids Aspirations, Drained Fluids and Brush Cytology Cytocentrifuge Method Page 6 of 7
8 Non-gynaecological: Fine Needle Aspiration Smears: Breast, Salivary Gland, Thyroid Gland, Lymph Node, Pancreas, Liver Fine Needle Aspirations Direct Imprint Smears: Ulcers, Nipple Discharge Imprint Smear Cytoblock: Body Fluids and Small Biopsies Cell Block for Special Stains Cytospin Method Original Date of Accreditation: 01 June 2003 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Field Manager Page 7 of 7
CERTIFICATE OF ACCREDITATION
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