M0143A.12.15 - South African National Accreditation System
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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:- AMPATH NATIONAL LABORATORIES DRS DU BUISSON, KRAMER, SWART, BOUWER INC Co. Reg. No.: 2007/018337/21 Practice No.: 052 000 5200431 PORT ELIZABETH LABORATORY Facility Accreditation Number: M0143A 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, ENDOCRINOLOGY 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: 01 December 2015 Certificate Expires: 30 November 2019 Facility Number: M0143A ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0143A Permanent Address of Laboratory: Signatories: Signatories as authorised by the Head of Laboratory Ampath National Laboratories Port Elizabeth Laboratory 2nd Floor, Suite 200, Rochelle Road Port Elizabeth Port Elizabeth 6070 Postal Address: Contact Person: PO Box 27482 Mr R Gilmore Greenacres 6057 Tel: (041) 399-9000 Issue No.: 11 Fax: E-mail: (041) 363-0615 Date of Issue: Expiry Date: 22 September 2015 gilmorer@ampath.co.za Discipline / Sample Type Type of Tests 30 November 2019 Equipment / Method Chemistry Serum, Body Fluid, CSF Adenosine Deaminase (ADA) DXC Serum Alanine Aminotransferase (ALT) DXC Serum Albumin DXC Urine Albumin (Micro) DXC Serum Alkaline Phosphatase (ALP) DXC Plasma Ammonia DXC Serum Amikacin DXC Urine Amphetamine Manual Method Serum, Urine Amylase DXC Serum Aspartate Aminotransferase (AST) DXC Urine Barbiturates Manual Method Urine Benzodiazepines Manual Method Serum Bicarbonate (CO2) DXC Serum Bilirubin, Direct DXC Serum Bilirubin, Total DXC Serum, Urine Calcium DXC Urine Cannabis DXC Serum Carbamazepine DXC Serum, Urine, CSF Chloride DXC Serum Cholesterol (HDL) DXC Page 1 of 4 Facility Number: M0143A Serum Cholesterol (LDL) DXC Serum Cholesterol (Total) DXC Urine Cocaine Manual Method Serum C­Reactive Protein (CRP) DXC Serum Creatine Kinase (CK) DXC Serum, Urine Creatinine DXC Serum Creatine Kinase MB Mass (CKMB Mass) DXl / Access Serum Ferritin DXl Serum Gamma Glutamyl Transferase (GGT) DXC Plasma, Urine, CSF Glucose DXC Serum Glucose Tolerance Test (GTT) DXC Whole Blood HbA1c Biorad D10 Serum Iron DXC Plasma Lactate DXC Serum Lactate Dehydrogenase (LDH) DXC Serum Lithium DXC Serum, Urine Magnesium DXC Urine Methamphetamines Manual Method Serum, Urine Osmolality Osmometer Serum Paracetamol DXC Serum, Urine Phosphate DXC Serum, Urine Potassium DXC Urine Protein (Micro) DXC Serum Protein (Total) DXC Serum, Urine Sodium DXC Sweat Sweat Test Wescor Sweat Check 3120 Serum Triglycerides DXC Serum, Urine Urate DXC Serum, Urine Urea DXC Serum Alpha Feto­protein (AFP) DXl Serum Beta Human Chorionic Gonadotrophin (βHCG) DXl Serum CA 125 DXl Serum CA 15.3 DXl Serum CA 19.9 DXl Serum Carcinoembryonic Antigen (CEA) DXl Serum Cortisol DXl Serum Digoxin DXl Plasma Ethanol (Alcohol) DXC Serum Follicle Stimulating Hormone (FSH) DXl Endocrinology Page 2 of 4 Facility Number: M0143A Serum Free Thyroxine (F­T4) DXl Serum Free Triiodothyronine (F­T3) DXl Serum Insulin DXl Serum Luteinising Hormone (LH) DXl Serum Myoglobin Access Urine Opiates Manual Method Serum Oestradiol (E2) DXl Serum Phenobarbitone DXC Serum Phenytoin DXC Serum Pro Brain Natriuretic Peptide (proBNP) Biomerieux­Mini Vidas Serum Procalcitonin (PCT) Biomerieux­Mini Vidas Serum Progesterone DXl Serum Prolactin DXl Serum Prostate Specific Antigen (PSA) Complex DXl Serum Prostate Specific Antigen (PSA) Total DXl Serum Salicylic Acid DXC Serum Theophylline DXC Serum Transferrin DXC Urine Tricyclic Antidepressants (TAD) Manual Method Serum Troponin I DXl/Access Serum Thyroid Stimulating Hormone (TSH) Free DXl Serum Vancomycin DXC Serum Valproic Acid DXC Serum Anti­Cyclic Citrullinated Peptide (Anti­CCP) Architect i1000SR Serum Hepatitis A IgM Architect i1000SR Serum Hepatitis B Core IgM Architect i1000SR Serum Hepatitis B Surface Antibody Architect i1000SR Serum Hepatitis B Surface Antigen Architect i1000SR Serum Hepatitis C IgG Architect i1000SR Serum HIV Architect i1000SR Serum Immunoglobulins: IgG, IgA, IgM DXC Serum Rapid Plasma Reagin (RPR) Manual Method­ Agglutination Serum Rubella IgG Architect i1000SR Serum Rubella IgM Architect i1000SR Serology Original Date of Accreditation: 01 November 2001 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM __________________________________ Page 3 of 4 Facility Number: M0143A Field Manager Page 4 of 4