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:- NATIONAL HEALTH LABORATORY SERVICE (NHLS) INKOSI ALBERT LUTHULI CENTRAL HOSPITAL Practice No.: PR 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
2 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) /10 Issue No.: 01 Fax: (031) Date of Issue: 11 March elizabeth.samuel@nhls.ac.za Expiry Date: 01 March 2020 Discipline / Sample Type Type of s Equipment / Method Chemistry Serum Acetaminophen Advia Urine Adrenaline HPLC 225-Perkin Elmer Serum Adrenocorticotrophic Hormone (ACTH) Immulite Serum Alanine Aminotransferase (ALT) Advia / Advia Serum Albumin Advia / Advia Urine Albumin (Micro) Advia Serum Alkaline Phosphatase (ALP) Advia / Advia Serum Amikacin Advia Plasma Ammonia Advia / Advia Serum Amylase Advia / Advia Urine Amylase Advia Serum Aspartate Aminotransferase (AST) Advia / Advia Serum Beta-2-microglobulin Immulite Serum Bicarbonate (CO2) Advia / Advia Serum Bilirubin, Direct Advia / Advia Page 1 of 5
3 Serum Bilirubin, Total Advia / Advia Serum Caeruloplasmin Immage Serum Calcium Advia / Advia Urine Calcium Advia Serum Carbamazepine Advia Serum Chloride Advia / Advia Urine, CSF Chloride Advia Sweat Chloride Sherwood Chloride Analyser Serum Cholesterol Advia Serum Complement 3 Advia / Advia Serum Complement 4 Advia / Advia Serum, Urine Copper ICPMS-Perkin Elmer Nexion 300 Serum C-Reactive Protein (CRP) Advia / Advia Serum Creatinine Advia / Advia Urine Creatinine Advia Serum Creatine Kinase (CK) Advia / Advia Serum Creatine Kinase MB (CKMB) Centaur 4706 Urine Dopamine HPLC 225-Perkin Elmer Serum Ferritin Centaur 4708 Serum Gamma Glutamyl Transferase (GGT) Advia / Advia Plasma, Urine, CSF Glucose Advia / Advia Whole Blood HbA1c HPLC Tosoh G8 (90 / 290) Serum Immunofixation Sebia Hydrasys 2 Serum Iron Advia / Advia Plasma Lactate Advia / Advia Serum Lactate Dehydrogenase L-P Advia / Advia Serum Lipase Advia / Advia Serum Magnesium Advia / Advia Urine Magnesium Advia Urine Noradrenaline HPLC 225 Page 2 of 5
4 Stool Occult Blood Rapid One Step Screening Serum, Urine Osmolality OsmometerGonotec / OsmometerGonotec Serum Phosphate Advia / Advia Urine Phosphate Advia Serum Potassium Advia / Advia Urine Potassium Advia Serum, Urine Protein Electrophoresis Sebia Hydrasys 2 Serum Protein (Total) Advia / Advia Urine, CSF Protein (Total) Advia Serum Sodium Advia / Advia Urine Sodium Advia Serum Triglycerides Advia Serum Urate Advia / Advia Urine Urate Advia Serum Urea Advia / Advia Urine Urea Advia 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
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 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 Serum Growth Hormone (GH) Immulite Page 4 of 5
6 Serum High Density Lipoprotein Advia 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 Serum Phenytoin Advia 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 Serum Sex Hormone Binding Globulin (SHBG) Centaur 4708 Serum osterone Centaur 4708 Serum Theophylline Advia Serum Thyroid Stimulating Hormone (TSH) Centaur 4708 / Centaur 4706 Serum Troponin I Centaur 4706 Serum Transferrin Advia / Advia Serum Valproate (Valproic Acid) Advia Serum Vancomycin Advia Serology Serum Anti Thyroid Peroxidase (atpo) Centaur 4706 Serum Immunoglobulin A (IgA) Advia / Advia Serum Immunoglobulin G (IgG) Advia / Advia Serum Immunoglobulin M (IgM) Advia Original Date of Accreditation: 02 March 2016 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 5 of 5
CERTIFICATE OF ACCREDITATION
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),
CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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