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:- LANCET LABORATORIES (PTY) LTD HEAD OFFICE CHEMISTRY LABORATORY Co. Reg. No.: 1996/006950/07 Practice No.: Facility Accreditation Number: 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, ENDOCRINOLOGY 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: Permanent Address of Laboratory: Lancet Laboratories (Pty) Ltd Chemistry Laboratory Cnr Stanley & Menton Road Richmond Johannesburg 2092 Postal Address: P O Box 8475 Johannesburg 2000 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Mrs M de Wet Tel: (011) Issue No.: 10 Fax: (011) Date of Issue: 15 August monica.dwet@lancet.co.za CHEMISTRY Serum Alanine Aminotransferase (ALT) Architect C8000 Serum Albumin Architect C8000 Urine Micro Albumin Architect C8000 Serum Alkaline Phosphate (ALP) Architect C8000 Serum Amikacin Integra Whole Blood Ammonia Integra Urine Amphetamines Integra Serum, Urine Amylase Architect C8000 Serum Aspartate Aminotransferase (AST) Architect C8000 Serum, Urine Barbiturates Integra Serum Bicarbonate (CO2) (Total) Architect C8000 Serum Bilirubin, Direct Architect C8000 Serum Bilirubin, Total Architect C8000 Serum Bone Alkaline Phosphatase (BAP) Liaison Serum Caeruloplasmin BN Prospec Serum, Urine Calcium (Total) Architect C8000 Urine Cannabinoids Integra Serum Carbamazepine Integra Serum, Urine Chloride Architect C8000 Serum Cholesterol (Total) Architect C8000 Urine Cocaine Integra Serum Complement C3 Architect C8000 Serum Complement C4 Architect C8000 Serum C-Reactive Protein (CRP) Architect C8000 Serum Creatine Kinase (CK) Architect C8000 Serum Creatine Kinase MB Mass (CKMB Mass) Mini Vidas Original Date of Accreditation: 01 February 2000 Page 1 of 4
3 Date of Issue: 15 August 2014 CHEMISTRY (Continued) Serum, Urine Creatinine Architect C8000 Serum Ferritin Architect C8000 Serum Gamma Glutamyl Transferase (GGT) Architect C8000 Plasma Glucose Architect C8000 Serum Haptoglobin BN Prospec Whole Blood HbA1c Bio-Rad Variant Serum IgG Subclasses BN Prospec Serum Iron Architect C8000 Serum Kappa BN Prospec Plasma Lactate Integra Serum Lactate Dehydrogenase (LDH) Architect C8000 Serum Lambda BN Prospec Serum Lithium Integra Serum, Urine Magnesium Architect C8000 Urine Methadone Integra Urine Methaqualone Integra Serum, Urine, Stool Osmolality Osmometer Serum Paracetamol Integra Serum Phenobarbital Integra Serum, Urine Phosphate Architect C8000 Serum Potassium Architect C8000 Urine Propoxyphene Integra Urine Protein Architect C8000 Serum Protein (Total) Architect C8000 Serum Protein Electrophoresis Minicap Serum Rheumatoid Factor (RF) Architect C8000 Serum, Stool Sodium Architect C8000 Serum Triglycerides Architect C8000 Serum, Urine Urate Architect C8000 Serum, Urine Urea Architect C8000 ENDOCRINOLOGY Plasma Adrenocorticotrophic Hormone (ACTH) Immulite 2000xpi Serum Alpha-1-Antitrypsin BN Prospec Amniotic Fluid Alpha Feto-Protein (AFP) Kryptor Serum Alpha Feto-Protein (AFP) Immulite 2000xpi / Architect Serum Anti Thyroglobulin-Antibodies (ATG) Architect i2000 Serum Anti-TPO Antibodies Architect i2000 Body Fluid, CSF Beta Trace Protein (βtp) BN Prospec Serum C-Peptide Immulite 2000xpi Serum CA 125 Architect i2000 Serum CA 15.3 Architect i2000 Serum CA 19.9 Architect i2000 Original Date of Accreditation: 01 February 2000 Page 2 of 4
4 Date of Issue: 15 August 2014 ENDOCRINOLOGY (Continued) Serum CPSA Centaur Serum Carcinoembryonic Antigen (CEA) Architect i2000 Serum Cortisol Architect i2000 Serum Dehydroepiandrosterone Sulphate (DHEAS) Immulite 2000xpi Serum Digoxin Integra Serum EPO Immulite 2000xpi Serum Estradiol (E2) Architect i2000 Serum Ethanol Integra Serum Folate Architect i2000 Serum Follicle Stimulating Hormone (FSH) Architect i2000 Serum Free Thyroxine (F-T4) Architect i2000 Serum Free Triiodothyronine (F-T3) Architect i2000 Serum Gentamycin Integra Serum Growth Hormone Immulite 2000xpi Serum HCG-Free Kryptor Serum HCG-Total Architect i2000 Serum Human Chorionic Gonadotropin (hcg) Immulite 2000xpi Serum H Pylori Immulite 2000xpi Serum IgF1 Immulite 2000xpi Serum Insulin Architect i2000 Serum Luteinising Hormone (LH) Architect i2000 Serum Myoglobin Mini Vidas Serum Oestriol (E3) Immulite 2000xpi Urine Opiates Integra Plasma Parathyroid Hormone (PTH) Modular Urine Phenycyclidine Integra Serum Phenytoin Integra Serum Plasma Protein A (PAPP-A) Kryptor Serum Pre-Albumin BN Prospec Serum Procalcitonin (PCT) Mini Vidas Serum Progesterone Architect i2000 Serum Prolactin Architect i2000 Serum Prostate Specific Antigen (PSA) Architect i2000 Serum Prostate Specific Antigen (PSA-Free) Architect i2000 Serum RAST Allergy Test Phadia 2500E Whole Blood Red Cell Folate Architect i2000 Serum Salicylate Integra Serum Sex Hormone Binding Globulin (SHBG) Immulite 2000xpi Serum Testosterone (Total) Immulite 2000xpi Serum Theophylline Integra Serum Thyroid Stimulating Hormone (TSH) Architect i2000 Original Date of Accreditation: 01 February 2000 Page 3 of 4
5 Date of Issue: 19 August 2013 ENDOCRINOLOGY (continued) Serum Tobramycin Integra Serum Transferrin Architect C8000 Serum TSH Receptor Ab Kryptor Serum Valproic Acid Integra Serum Vancomycin Integra Serum Vitamin B12 Architect i2000 Serum Vitamin D025 Architect i2000 SEROLOGY Serum Antistreptolysin O titre (ASOT) BN Prospec Serum Chromogranin A Kryptor Serum, Urine Immunofixation Electrophoresis (IFE) Hydrases Isofocusing Serum Immunoglobulin A (IgA) Architect C8000 Serum Immunoglobulin M (IgM) Architect C8000 Serum Immunoglobulin G (IgG) Architect C8000 Original Date of Accreditation: 01 February 2000 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
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