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:- PATHCARE GROUP INC PORT ELIZABETH LABORATORY Co. Reg. No.: 1971/013873/21 Practice No.: Facility Accreditation Number: M0022 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, CYTOGENETICS, CYTOLOGY, ENDOCRINOLOGY, HAEMATOLOGY, HISTOLOGY, MICROBIOLOGY 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 February 2012 Certificate Expires: 31 January 2016
2 SCHEDULE OF ACCREDITATION Facility Number: M0022 Permanent Address: PathCare Group Inc Drs Hofmeyr, Kasango & Partners Port Elizabeth Laboratory Life Health Training Centre St George s Hospital 40 Park Drive Central Port Elizabeth 6001 Postal Address: Drs Hofmeyr, Kasango & Partners P O Box Port Elizabeth 6000 Signatories Signatories as authorised by the Head of Laboratory Contact Person: Ms J Wassüng Issue No.: 13 Tel: (041) Date of Issue: 14 August 2014 Fax: (041) Expiry Date: 31 January 2016 CHEMISTRY Serum Acetaminophen AU 680 Serum Alanine Aminotransferase (ALT) AU 680 Serum Albumin AU 680 Serum Alkaline Phosphatase (ALP) AU 680 Serum Amikacin AU 680 Plasma Ammonium AU 680 Serum, Urine Amylase AU 680 Serum Aspartate Aminotransferase (AST) AU 680 Urine Benzodiazepine Serum Bicarbonate (CO2) AU 680 Serum Bilirubin, Direct AU 680 Serum Bilirubin, Total AU 680 Serum Calcium (Total) AU 680 Urine Cannabis Serum Carbamazepine AU 680 Serum, Urine, CSF Chloride AU 680 Serum Cholesterol (HDL) AU 680 Serum Cholesterol (LDL) Measured AU 680 Serum Cholesterol (Total) AU 680 Serum Cholinesterase AU 680 Serum C-Reactive Protein (CRP) AU 680 Serum Creatine Kinase (CK) AU 680 Serum Creatine Kinase MB Mass (CKMB Mass) DXI Serum, Urine Creatinine AU 680 Serum Gamma Glutamyl Transferase (GGT) AU 680 Plasma, CSF, Fluid Glucose AU 680 Whole Blood HbA1c Biorad D10 Serum Iron AU 680 Original Date of Accreditation: 01 February 2000 Page 1 of 4
3 Facility No.: M0022 Date of Issue: 14 August 2014 Expiry Date: 31 January 2016 CHEMISTRY (Continued) Plasma Lactate AU 680 Serum Lactate Dehydrogenase (LDH) AU 680 Serum Magnesium AU 680 Serum, Urine Osmolality Advanced Instruments Osmo Model 3320 Serum Phenobarbital AU 680 Serum Phosphate AU 680 Serum, Urine Potassium AU 680 Urine, CSF Protein (Micro) AU 680 Serum Protein (Total) AU 680 Serum, Urine Sodium AU 680 Serum Triglycerides AU 680 Serum Urate AU 680 Serum Urea AU 680 ENDOCRINOLOGY Urine Amphetamines -Accusign Kits Urine Barbiturates -Accusign Kits Serum Beta Human Chorionic Gonadotrophin (βhcg) DXI Serum CA 125 DXI Serum CA 15.3 DXI Serum CA 19.9 DXI Serum Carcinoembryonic Antigen (CEA) DXI Urine Cocaine -Accusign Kits Serum Cortisol DXI Serum Digoxin DXI Serum Estradiol (E2) DXI Serum Ethanol AU 680 Serum Ferritin DXI Serum Follicle Stimulating Hormone (FSH) DXI Serum Free Thyroxine (F-T4) DXI Serum Free Triiodothyronine (F-T3) DXI Serum Luteinising Hormone (LH) DXI Urine Metamphetamines -Accusign Kits Serum Myoglobin DXI Urine Opiates -Accusign Kits Serum Phenytoin AU 680 Serum Procalcitonin (PCT) (Quantitative) Mini Vidas Serum Pro-Brain Natriuretic Peptide (probnp) Vidas Serum Progesterone DXI Serum Prolactin DXI Serum Prostate Specific Antigen (PSA) Free DXI Serum Prostate Specific Antigen (PSA) Total DXI Serum Salicylate AU 680 Serum Theophylline AU 680 Serum Thyroid Stimulating Hormone (TSH) DXI Serum Transferrin AU 680 Whole Blood, Serum Troponin I Stratus CS / DXI Serum Valproic Acid AU 680 SEROLOGY Serum Hepatitis A IgM DXI Serum Hepatitis B Surface Antibody (AUSAB) DXI Serum Hepatitis B Surface Antigen (HBsAg) DXI Serum HIV DXI Original Date of Accreditation: 01 February 2000 Page 2 of 4
4 Facility No.: M0022 Date of Issue: 14 August 2014 Expiry Date: 31 January 2016 SEROLOGY (Continued) Serum Immunoglobulin E (IgE) DXI Serum RPR Serum Rubella IgG DXI Serum Rubella IgM DXI Serum Tricyclic Antidepressants (TAD) AU 680 HAEMATOLOGY Whole Blood ABO Blood Grouping Whole Blood Ab Screening Plasma Activated Partial Thromboplastin Time (APTT) CL Analyser Whole Blood D-Dimer ACL Elite Whole Blood Differential Cell Count Whole Blood Direct Coombs Plasma Fibrinogen CL Analyser Whole Blood Full Blood Count and Differential Count HMAX Plasma International Normalised Ratio (INR) CL Analyser / ACL Lite Whole Blood Malaria Smears Whole Blood Reticulocyte Count Whole Blood White Cell Differential Count MICROBIOLOGY Pus Swabs, Urine, Stool, CSF, Aspirates, Tissue, Sputums, Bronchial Washings, Nasal Washings, Antrum Wash Outs, Tracheal Asp Aerobic, Anaerobic and Micro-Aerophilic Identification Culture and Sensitivity for Pathogenic Organisms Kirby Bauer / Vitek Mic Stool Campylobacter Culture for Stools Blood Blood Culture BacT/Alert Stool Microscopy Wet preparation - Saline, Iodine All Micro Specimens Staining Techniques: / Previcolor Gram stain Sputum, Tracheal Asp, Bronchial Lavage, Urine, Tissue, Pus, CSF Kinyouns Stain Stool Cryptosporidium Stain Stool Concentration Method for Parasites Pus Swabs, Urine, Stool, CSF, Anaerobic Organism Identification Vitek Aspirates, Tissue, Sputums, Bronchial Washings, Nasal Washings, Antrum Wash Outs, Tracheal Asp D-Nase Catalase Test Beta Lactamase Bacterial Culture Identification of Gram Negative Bacteria using API 20E and API 10S Identification of Gram Negative Diplococci Phadebact GC Test Original Date of Accreditation: 01 February 2000 Page 3 of 4
5 Facility No.: M0022 Date of Issue: 14 August 2014 Expiry Date: 31 January 2016 MICROBIOLOGY (Continued) Bacterial Culture Serology Identification of Bacteria: Shigella Species Salmonella Species Bacterial Culture Oxidase Test Streptex Test Staph Plus Satellitism Test, X, XV, V Factors Optochin Test Bacitracin Test Novobiocin Singer s Test Sensitivity Testing -Kirby Bauer E Test MICs CSF, Blood Culture, Urine Wellcogen Bacterial Antigens Micro Culture Streptococcus Pneumoniae Agglutination CYTOGENETICS Blood Specimen Lymphocyte Cultures and Cord Blood Leukemic Bloods and Bone Marrow Samples Amniotic Fluid Products of Conception, Skin CYTOLOGY All Body Fluids, Bronchial Smears, Brushings, Bronchial Washings, Cervical, Vaginal, Vulval Smears, Endometrial Smear, Fine Needle Aspiration, Gastric Washing, Brushing, Impression Smear, Kidney Washing, Oesophageal Brushing, Penile Secretions, Scraping, Sputum, Urine, CSF HISTOLOGY All General Histology, Decalcification Bone Marrow Trephine, Aspirate Chromosomal Analysis Staining: Routine Giemsa G Banding Q Banding Karyotyping Cytovision Staining, Mounting and Screening H & E Routine Staining Microtomy Prepmate Liquid Based Cytology DRS Stainer Cover Slipper Stains Special Staining DRS 2000 Original Date of Accreditation: 01 February 2000 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
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CERTIFICATE OF ACCREDITATION
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