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) INKOSI ALBERT LUTHULI CENTRAL HOSPITAL Practice No.: PR 5200296 CHEMICAL PATHOLOGY LABORATORY Facility Accreditation Number: M0571 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 AND ENDOCRINOLOGY 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: 02 March 2016 Certificate Expires: 01 March 2020
ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0571 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Signatories: Signatories as authorised by the Head of Laboratory IALCH, 2nd Floor Chemical Pathology Laboratory Level 5, 800 Vusi Mzimela (Bellair) Road Cato Manor, Mayville Durban 4091 Postal Address: Private Bag X03 Contact Person: Dr EY Samuel Mayville 4058 Tel: (031) 240-2809/10 Issue No.: 01 Fax: (031) 240-2812 Date of Issue: 11 March 2016 E-mail: elizabeth.samuel@nhls.ac.za Expiry Date: 01 March 2020 Discipline / Sample Type Type of s Equipment / Method Chemistry Serum Acetaminophen Advia 1800 74 Urine Adrenaline HPLC 225-Perkin Elmer Serum Adrenocorticotrophic Hormone (ACTH) Immulite Serum Alanine Aminotransferase (ALT) Advia 180065 / Advia Serum Albumin Advia 180065 / Advia Urine Albumin (Micro) Advia 1800 65 Serum Alkaline Phosphatase (ALP) Advia 180065 / Advia Serum Amikacin Advia 1800 74 Plasma Ammonia Advia 180065 / Advia Serum Amylase Advia 180065 / Advia Urine Amylase Advia 1800 65 Serum Aspartate Aminotransferase (AST) Advia 180065 / Advia Serum Beta-2-microglobulin Immulite Serum Bicarbonate (CO2) Advia 180065 / Advia Serum Bilirubin, Direct Advia 180065 / Advia Page 1 of 5
Serum Bilirubin, Total Advia 180065 / Advia Serum Caeruloplasmin Immage Serum Calcium Advia 180065 / Advia Urine Calcium Advia 1800 65 Serum Carbamazepine Advia 1800 74 Serum Chloride Advia 180065 / Advia Urine, CSF Chloride Advia 1800 65 Sweat Chloride Sherwood Chloride Analyser Serum Cholesterol Advia 1800 65 Serum Complement 3 Advia 180065 / Advia Serum Complement 4 Advia 180065 / Advia Serum, Urine Copper ICPMS-Perkin Elmer Nexion 300 Serum C-Reactive Protein (CRP) Advia 180065 / Advia Serum Creatinine Advia 180065 / Advia Urine Creatinine Advia 1800 65 Serum Creatine Kinase (CK) Advia 180065 / Advia Serum Creatine Kinase MB (CKMB) Centaur 4706 Urine Dopamine HPLC 225-Perkin Elmer Serum Ferritin Centaur 4708 Serum Gamma Glutamyl Transferase (GGT) Advia 180065 / Advia Plasma, Urine, CSF Glucose Advia 180065 / Advia Whole Blood HbA1c HPLC Tosoh G8 (90 / 290) Serum Immunofixation Sebia Hydrasys 2 Serum Iron Advia 180065 / Advia Plasma Lactate Advia 180065 / Advia Serum Lactate Dehydrogenase L-P Advia 180065 / Advia Serum Lipase Advia 180065 / Advia Serum Magnesium Advia 180065 / Advia Urine Magnesium Advia 1800 65 Urine Noradrenaline HPLC 225 Page 2 of 5
Stool Occult Blood Rapid One Step Screening Serum, Urine Osmolality OsmometerGonotec- 81205 / OsmometerGonotec- 110601 Serum Phosphate Advia 180065 / Advia Urine Phosphate Advia 1800 65 Serum Potassium Advia 180065 / Advia Urine Potassium Advia 1800 65 Serum, Urine Protein Electrophoresis Sebia Hydrasys 2 Serum Protein (Total) Advia 180065 / Advia Urine, CSF Protein (Total) Advia 1800 65 Serum Sodium Advia 180065 / Advia Urine Sodium Advia 1800 65 Serum Triglycerides Advia 1800 65 Serum Urate Advia 180065 / Advia Urine Urate Advia 1800 65 Serum Urea Advia 180065 / Advia Urine Urea Advia 1800 65 Drugs of Abuse: Urine Amphetamine Rapid One Step Screening Urine Barbiturates (BAR) Rapid One Step Screening Urine Benzodiazepine (BZO) Rapid One Step Screening Urine Cocaine Rapid One Step Screening Urine Marijuana Rapid One Step Screening Urine Methadone Rapid One Step Screening Urine Methamphetamine (MET) Rapid One Step Screening Urine Methylenedioxymethamphetamine Rapid One Step Screening Urine Opiates Rapid One Step Screening Page 3 of 5
Urine Tricyclic Antidepressants (TCA) Rapid One Step Screening Urine Beta Human Chorionic Gonadotrophin (βhcg) Manual Method/ Rapid One Step Screening Urine Bilirubin Manual Method / Clinitek Urine Blood Manual Method / Clinitek Urine Glucose Manual Method / Clinitek Urine Ketones Manual Method / Clinitek Urine Leucocytes Esterase Manual Method / Clinitek Urine Nitrite Manual Method / Clinitek Urine ph Manual Method / Clinitek Urine Protein Manual Method / Clinitek Urine Specific Gravity (SG) Manual Method / Clinitek Urine Urobilinogen Manual Method / Clinitek Endocrinology Serum Alpha-fetoprotein (AFP) Centaur 4708 Serum Alpha-1-Antitrypsin Immage Serum Androstenedione Immulite Serum CA 125 Centaur 4706 Serum CA 15.3 Centaur 4706 Serum CA 19.9 Centaur 4706 Serum Carcinoembryonic Antigen (CEA) Centaur 4706 Serum, Urine Cortisol Centaur 4706 Serum C Peptide (CPEP) Centaur 4706 Serum Cyclosporine (CsA) Centaur 4708 Serum Digoxin Advia 1800 74 Serum Dehydroepiandrosterone Sulphate (DHEAS) Immulite Serum Follicle Stimulating Hormone (FSH) Centaur 4708 Serum Free Thyroxine (F-T4) Centaur 4708 / Centaur 4706 Serum Free Triiodothyronine (F-T3) Centaur 4708 / Centaur 4706 Serum Gentamycin Advia 1800 74 Serum Growth Hormone (GH) Immulite Page 4 of 5
Serum High Density Lipoprotein Advia 1800 65 Serum Human Chorionic Gonadotropin (hcg) Total Centaur 4708 Serum IgF1 Immulite Serum Insulin Centaur 4706 Serum Luteinising Hormone (LH) Centaur 4708 Serum Oestradiol (E2) Centaur 4708 Plasma Parathyroid Hormone (PTH) Centaur 4708 Serum Phenobarbital Advia 1800 74 Serum Phenytoin Advia 1800 74 Serum Pro Brain Natriuretic Peptide (probnp) Centaur 4706 Serum Procalcitonin (PCT) Centaur 4708 Serum Progesterone Centaur 4708 Serum Prolactin Centaur 4708 Serum Prostate Specific Antigen (PSA) Centaur 4706 Serum Salicylate Advia 1800 74 Serum Sex Hormone Binding Globulin (SHBG) Centaur 4708 Serum osterone Centaur 4708 Serum Theophylline Advia 1800 74 Serum Thyroid Stimulating Hormone (TSH) Centaur 4708 / Centaur 4706 Serum Troponin I Centaur 4706 Serum Transferrin Advia 180065 / Advia Serum Valproate (Valproic Acid) Advia 1800 74 Serum Vancomycin Advia 1800 74 Serology Serum Anti Thyroid Peroxidase (atpo) Centaur 4706 Serum Immunoglobulin A (IgA) Advia 180065 / Advia Serum Immunoglobulin G (IgG) Advia 180065 / Advia Serum Immunoglobulin M (IgM) Advia 1800 65 Original Date of Accreditation: 02 March 2016 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 5 of 5