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:- NATIONAL HEALTH LABORATORY SERVICE (NHLS) GROOTE SCHUUR HOSPITAL HAEMATOLOGY & ANTENATAL Practice no: PR 5200296 Facility Accreditation Number: M0252 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 CYTOGENETICS, HAEMATOLOGY, 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: 01 July 2010 Certificate Expires: 30 June 2014
S C H E D U L E O F A C C R E D I T A T I O N Testing Laboratory Number: M0252 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Groote Schuur Hospital Haematology & Antenatal Laboratory C17 Groote Schuur Hospital Observatory Postal Address: Haematology & Antenatal C17 Groote Schuur Hospital Observatory 7935 Signatories: Signatories as authorised by the Head of Laboratory Contact person: Dr D Roditi Tel : (021) 404-5280 Fax : (021) 404-5281 Issue No. Date of issue Expiry date : 10 : 13 July 2010 : 30 June 2014 HAEMATOLOGY Whole Blood Differential Cell Count Conductivity and Flow Whole Blood Erythrocyte Sedimentation Rate (ESR) Westergren Whole Blood Full Blood Count (FBC) Conductivity and Flow Bone Marrow Histological-microscopy Manual -Microscopy CSF, WBC, Fluids, Peripheral Blood Morphology Review (Buffy Slide, Cytospin) Conductivity and Flow / Manual -Microscopy Bone Marrow Perl's Prussian Blue Iron Stain Manual -Microscopy Whole Blood Platelet Count Conductivity and Flow Whole Blood Reticulocyte Count Conductivity and Flow / Manual -Microscopy COAGULATION Plasma Activated Partial Thromboplastin Time (APTT) Turbidimetric Plasma Activated Protein C Turbidimetric Plasma Antithrombin III Chromogenic Skin Bleeding time Manual Butcher Plasma D-Dimer (Fibrin Degradation Product) Latex Agglutination Plasma Factor II, V, VII, VIII, IX, X, XI, XII, XIII Turbidimetric Plasma Factor VIII and IX Inhibitors Turbidimetric Plasma Fibrinogen Turbidimetric / Clauss Plasma International Normalised Ratio (INR) Turbidimetric Plasma Kaolin Clotting Time Turbidimetric / Manual Plasma Lupus Anticoagulant Turbidimetric Plasma Platelet Neutralisation Turbidimetric / Clauss Plasma Protein C Chromogenic Plasma Protein S Turbidimetric Plasma Thrombin Time Turbidimetric / Clauss HAEMOLYTIC STUDIES Whole Blood Acid Electrophoresis Manual Whole Blood Alkaline Electrophoresis Manual Whole Blood, Serum Cold Agglutinins Manual Antibody Titration Whole Blood Direct Coombs Test Diacent and Manual Anti-Human Globulin (AHG) Original date of accreditation: 01 August 2003 Page 1 of 5
HAEMOLYTIC STUDIES (CONTINUED) Serum Donath Landsteiner Antibody Screen Manual / Haemolysis Whole Blood Haemoglobin A2 (HbA2) High Pressure Liquid Chromatography (HPLC) Whole Blood Haemoglobin F (HBF) Singer / High Pressure Liquid Chromatography (HPLC) Whole Blood Haemoglobin F (HBF) - Kleihauer test Kleihauer-Betke / Manual - Microscopy Whole Blood, Serum Hams Acid Test Acidified Serum Lysis Whole Blood Heinz Body Preparation Manual -Microscopy Serum, Urine Muramidase Turbidimetric Spectrophotometry Heparinised Whole Blood Osmotic fragility Haemolysis / Spectrophotometry Whole Blood Sickle Cell Wet Preparation Reducing Agent / Manual -Microscopy Whole Blood, Serum Sucrose Lysis Test Haemolysis / Spectrophotometry PARASITE IDENTIFICATION Whole Blood Concentration Technique for Microfilaria Manual -Microscopy Whole Blood Malaria Antigen Manual Whole Blood Malaria Smear Manual Whole Blood Wet Preparation for Trypanosomes Manual- Microscopy CYTOCHEMISTRY Peripheral Blood, Bone Acid Phosphates with Tartrate Manual -Microscopy Peripheral Blood, Bone Alkaline Phosphatase Manual -Microscopy Peripheral Blood, Bone Esterase Activity: Alpha Naphthyl Acetate Manual -Microscopy Peripheral Blood, Bone Esterase Activity: Alpha Naphthyl Butyrate Manual -Microscopy Peripheral Blood, Bone Esterase Activity: Chloroacetate Manual -Microscopy Peripheral Blood, Bone Esterase Activity: Combined / Dual Esterase Manual -Microscopy Urine, Blood Haemosiderin Manual -Microscopy Peripheral Blood, Bone Lipid Activity: Sudan Black Manual -Microscopy Peripheral Blood, Bone Myeloperoxidase Manual -Microscopy IMMUNOPHENOTYPING, Fluid, CSF, Fluid, CSF Acute Leukaemia work up: Primary Panel (Myeloid and Lymphoid Markers) Acute Leukaemia work up: Secondary Panel (Myeloid, Lymphoid, Platelet or Erythroid Markers) CD34 Enumeration CD4 Enumeration Chronic Leukaemia work up: Primary Panel (Myeloid and Lymphoid Markers) FACS Calibur Dual / Single Platform 4 Colour Flow Epics XL MCL Flow / PLG Original date of accreditation: 01 August 2003 Page 2 of 5
IMMUNOPHENOTYPING (CONTINUED) Chronic Leukaemia work up: Primary Panel (Myeloid, Lymphoid, Platelet or Erythroid Markers ) PNH Screen (CDPNH) CD 64 Screen (Marker for Sepsis) Peripheral Blood CD Subsets (CD3, 4, 8 and 45); (CD16, 56 Additional Markers) ANTENATAL Whole Blood ABO Discrepancies Test Tube Blood Grouping / ABO Antigens and Antibodies Whole Blood Antibody Identification Commercial Antibody Identification Panel Whole Blood Antibody Titre Doubling Dilution Titrations Whole Blood Blood Grouping (ABO And Rh(D)) Manual Microtitre Tray / Test Tube Blood Grouping Whole Blood Phenotyping - Blood Group System Test Tube Phenotyping / Specified Blood Group System Whole Blood Phenotyping - Rhesus Test Tube Phenotyping / Rhesus Antigens Whole Blood Rhesus Discrepancies Test Tube Blood Grouping / Rhesus Antigens HAEMATOLOGY MOLECULAR BIOLOGY Whole Blood Thrombophilia Screen Factor V Leiden Prothrombin MTHFR Amplification Restriction Enzyme Digestion Whole Blood BCR / ABL RNA Extraction RT / Amplification Whole Blood Whole Blood Jak2V617F Flt3 ITD Detection Amplification Melt Curve Analysis Electrophoresis Original date of accreditation: 01 August 2003 Page 3 of 5
HLA SEROLOGY Peripheral Blood Blood Grouping (ABO & Rh) Red Blood Cell Grouping Reagents (Anti-sera) Group Identified Red Blood Cells (for Reverse Grouping) Peripheral Blood HLA Class I & II Antibody Screening Lifecode Screening Kit Test Evaluation and Luminex Fluoro Analyser Peripheral Blood HLA Class I & II -SSOP Typing DNA Quantitation / SSP / SSOP Luminex Fluoro Analyser Peripheral Blood HLA Class I & II -SSP Typing DNA Quantitation PC / SSP Software Based Interpretation Peripheral Blood HLA Class I Antibody Identification Lifecode HLA-Class Antibody Identification Kit Luminex Fluoro Analyser Peripheral Blood HLA Class I Lymphocytotoxic Cross - Match Lymphocyte Isolation Lymphocyte Cell Count Complement Dependant Lymphocytotoxic Test Microscopic Evaluation Peripheral Blood HLA Class I Typing Lymphocyte Isolation Lymphocyte Cell Count Complement Dependant Lymphocytotoxic Test Microscopic Evaluation MOLECULAR HUMAN GENETICS Blood, Amniotic Fluid Aristaless-related Homeobox Gene (X-linked Mental Retardation) DNA Sequencing Blood, Amniotic Fluid Bardet-Biedl Syndrome (BBS10) DNA Sequencing Blood, Amniotic Fluid Dentatorubral Palidolyusian Atrophy (DRPLA) Genotyping () Original date of accreditation: 01 August 2003 Page 4 of 5
MOLECULAR HUMAN GENETICS (CONTINUED) Blood, Amniotic Fluid Duchenne s Muscular Dystrophy (DMD) Multiplex Ligation - Dependant Probe Amplification (MLPA) Analysis for Exon Deletions Blood, Amniotic Fluid Fragile X Syndrome Restriction Enzyme Analysis Blood, Amniotic Fluid Friedreich s Ataxia Blood, Amniotic Fluid Huntington s Disease (HD1/3, H344/482 and HDL2) Genotyping () Blood, Amniotic Fluid Microsatellite Linkage Analysis for DMD Blood, Amniotic Fluid CYTOGENETICS Amniotic Fluid, Peripheral Blood Chorionic Villus Biopsy Products of Conception Skin Bone Marrow Amniotic Fluid, Peripheral Blood, Bone Marrow Spinocerebellar Ataxias 1, 2, 3, 6, 7, 12 & 17 Chromosomal Analysis Chromosome Analysis (Acquired Haematological Cancers) Fluorescent in Situ Hybridisation (FISH) for Aneuploidy Analysis, and for Microdeletion Analysis FISH for Haematological Cancers Tissue Culture, Harvesting, Slide Preparation, Banding and Microscopic Analysis. Preparation, Analysis and Interpretation of Karyotypes. (Cytovision Karyotyping System) Tissue Culture, Harvesting, Slide Preparation, Banding and Microscopic Analysis. Preparation, Analysis and Interpretation of Karyotypes. (Cytovision Karyotyping System) Preparation of Slides from Cultured and Uncultured Cells. Denaturation, Hybridisation and Analysis of Fluorescent Signals. Original date of accreditation: 01 August 2003 Page 5 of 5 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM