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:- FARMOVS PAREXEL (PTY) LTD Co reg no: 2000/003545/07 Facility Accreditation Number: M0170 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 LABORATORY TESTING, HAEMATOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO/IEC 17025:2005 This 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 April 2010 Certificate Expires: 31 March 2014
2 S C H E D U L E O F A C C R E D I T A T I O N Testing Laboratory Number: M0170 Permanent Address of Laboratory: FARMOVS-PAREXEL (Pty) Ltd Bioanalytical Services Division Kampuslaan Suid University of the Free State Bloemfontein 9300 Postal Address: FARMOVS-PAREXEL (Pty) Ltd Bioanalytical Services Division PO Box X09 Brandhof Bloemfontein 9301 Tel : (051) / 3165 Fax : (051) Jianine.jonker@paraxel.com Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms J Jonker Issue No. Date of issue Expiry date : 09 : 17 January 2011 : 31 March 2014 Serum Acid Phosphate Modular Analytics SWA (P800) Serum, Plasma Albumin Modular Analytics SWA (P800) Urine Albumin (Micro) Modular Analytics SWA (P800) Serum, Plasma Alanine Aminotransferase (ALT) Modular Analytics SWA (P800) Serum, Plasma Alkaline Phosphatase (ALP) Modular Analytics SWA (P800) Serum Alpha 1 Globulin Modular Analytics SWA (P800) Urine Alpha 1 Microglobulin Modular Analytics SWA (P800) Serum Alpha 2 Globulin Modular Analytics SWA (P800) Plasma Ammonia Modular Analytics SWA (P800) Serum, Plasma, Urine Amylase Modular Analytics SWA (P800) Serum, Plasma Aspartate Aminotransferase (AST) Modular Analytics SWA (P800) Serum, Plasma β - 2 Microglobulin Modular Analytics SWA (P800) Serum β - Globulin Modular Analytics SWA (P800) Serum, Plasma Beta Human Chorionic Gonadotrophin (βhcg) Modular Analytics SWA (E170) Serum, Plasma Bicarbonate Modular Analytics SWA (P800) Serum, Plasma Bilirubin, Conjugated Modular Analytics SWA (P800) Serum, Plasma Bilirubin, Total Modular Analytics SWA (P800) Serum, Plasma, Urine Calcium Modular Analytics SWA (P800) Serum, Plasma, Urine Chloride Modular Analytics SWA (ISE) Serum, Plasma Cholesterol Modular Analytics SWA (P800) Serum, Plasma Cholesterol (HDL) Modular Analytics SWA (P800) Serum, Plasma Cholesterol (LDL) Modular Analytics SWA (P800) Serum, Plasma Cholinesterase Modular Analytics SWA (P800) Serum, Plasma C-Reactive Protein (CRP) Modular Analytics SWA (P800) Serum, Plasma C-Reactive Protein (CRP) High Sensitive Modular Analytics SWA (P800) Serum, Plasma Creatinine Kinase (CK) Modular Analytics SWA (P800) Serum, Plasma Creatine Kinase MB (CKMB) Modular Analytics SWA (E170) Serum, Plasma, Urine Creatinine Modular Analytics SWA (P800) Serum, Urine Creatinine Clearance Calculation Urine Dipstick Test Clinitek 500 Serum, Plasma Ferritin Modular Analytics SWA (E170) Serum, Whole Blood Folate Modular Analytics SWA (E170) Serum Free Fatty Acids Modular Analytics SWA (P800) Original date of accreditation: 01 April 2002 Page 1 of 4
3 Serum, Plasma Fructosamine Modular Analytics SWA (P800) Serum, Plasma Free T3 Modular Analytics SWA (E170) Serum, Plasma Free T4 Modular Analytics SWA (E170) Serum Gamma Globulin Modular Analytics SWA (E170) Serum, Plasma Gamma Glutamyl Transferase (GGT) Modular Analytics SWA (P800) Serum, Plasma, CSF GLDH Modular Analytics SWA (P800) Serum Glucose Modular Analytics SWA (P800) Serum HbA1c Modular Analytics SWA (P800) Serum, Plasma HBDH Modular Analytics SWA (ISE) Serum, Plasma, Urine Inorganic Phosphorus Modular Analytics SWA (P800) Serum, Plasma Insulin Modular Analytics SWA (E170) Serum, Plasma Iron Modular Analytics SWA (P800) Serum, Plasma Iron Binding Capacity Modular Analytics SWA (P800) Plasma, CSF, Whole Blood Lactate Modular Analytics SWA (P800) Serum, Plasma Lipase Modular Analytics SWA (P800) Serum, Plasma, Urine Magnesium Modular Analytics SWA (P800) Urine Microscopy for Crystals, WBC, RBC, Casts Manual Serum, Plasma Myoglobin Modular Analytics SWA (P800) Urine NAG Modular Analytics SWA (P800) Stool Occult Blood Manual Serum, Plasma, Urine Potassium Modular Analytics SWA (ISE) Urine, CSF Protein Modular Analytics SWA (P800) Serum, Plasma Protein Total Modular Analytics SWA (P800) Serum, Plasma, Urine Sodium Modular Analytics SWA (ISE) Serum, Plasma Transferrin Modular Analytics SWA (P800) Serum, Plasma Triglycerides Modular Analytics SWA (P800) Serum, Plasma Troponin I Modular Analytics SWA (E170) Serum, Plasma Thyroid Stimulating Hormone (TSH) Modular Analytics SWA (E170) Serum, Plasma Total Thyroxine (TT4) Modular Analytics SWA (E170) Serum, Plasma Total Triiodothyronine (TT3) Modular Analytics SWA (E170) Serum, Plasma, Urine Urate Modular Analytics SWA (P800) Serum, Plasma, Urine Urea Modular Analytics SWA (P800) Serum, Plasma Vitamin B12 Modular Analytics SWA (E170) Drugs of Abuse Screening Urine Amphetamines Modular Analytics SWA (P800) Urine Barbiturates Modular Analytics SWA (P800) Urine Benzodiazepines Modular Analytics SWA (P800) Urine Cannabinoids Modular Analytics SWA (P800) Urine Cocaine Modular Analytics SWA (P800) Urine, Serum, Plasma, Whole Blood Ethanol Modular Analytics SWA (P800) Urine LSD Dipstick Urine Methadone Modular Analytics SWA (P800) Urine Methaqualone Modular Analytics SWA (P800) Urine Nicotine / Cotinine Dipstick Urine Opiates Modular Analytics SWA (P800) Urine Phencyclidine Modular Analytics SWA (P800) Urine Propoxyphene Modular Analytics SWA (P800) Urine Tricyclic Antidepressants Modular Analytics SWA (P800) Original date of accreditation: 01 April 2002 Page 2 of 4
4 Specific Protein Section Serum, Plasma Alpha 1 Acid Glycoprotein Modular Analytics SWA (P800) Serum, Plasma Alpha 1 Antitrypsin Modular Analytics SWA (P800) Serum, Plasma Apolipoprotein A-1 Modular Analytics SWA (P800) Serum, Plasma Apolipoprotein B Modular Analytics SWA (P800) Serum, Plasma Complement C3 Modular Analytics SWA (P800) Serum, Plasma Complement C4 Modular Analytics SWA (P800) Serum, Plasma Ceruloplasmin Modular Analytics SWA (P800) Serum, Plasma Ferritin Modular Analytics SWA (P800) Serum, Plasma Haptoglobin Modular Analytics SWA (P800) Serum, Plasma Immunoglobulin A Modular Analytics SWA (P800) Serum, Plasma, CSF Immunoglobulin G Modular Analytics SWA (P800) Serum, Plasma Immunoglobulin M Modular Analytics SWA (P800) Serum, Plasma Immunoglobulin E (IgE) Modular Analytics SWA (P800 Serum, Plasma Lipoprotein (a) Modular Analytics SWA (P800) Serum, Plasma Myoglobin Modular Analytics SWA (P800) Serum Pre-albumin Modular Analytics SWA (P800) CHEMICAL CHEMISTRY Therapeutic Drug Monitoring Serum, Plasma Acetaminophen Modular Analytics SWA (P800) Serum, Plasma Amikacin Modular Analytics SWA (P800) Plasma Carbamazepine Modular Analytics SWA (P800) Serum, Plasma Digitoxin Modular Analytics SWA (P800) Serum, Plasma Gentamicin Modular Analytics SWA (P800) Serum, Plasma Lidocaine Modular Analytics SWA (P800) Serum, Plasma N-Acetyl-procainamide Modular Analytics SWA (P800) Serum, Plasma Phenobarbital Modular Analytics SWA (P800) Serum, Plasma Phenytoin Modular Analytics SWA (P800) Serum, Plasma Primidone Modular Analytics SWA (P800) Serum, Plasma Procainamide Modular Analytics SWA (P800) Serum, Plasma Quinidine Modular Analytics SWA (P800) Serum Salicylate Modular Analytics SWA (P800) Serum, Plasma Theophylline Modular Analytics SWA (P800) Serum, Plasma Tobramycin Modular Analytics SWA (P800) Serum, Plasma Valproic Acid Modular Analytics SWA (P800) Serum, Plasma Vancomycin Modular Analytics SWA (P800) HAEMATOLOGY Plasma Antithrombin III BCT / Sysmex CA-560 Plasma Coagulation factors BCT / Sysmex CA-560 Plasma D-Dimer Sysmex XT-1800i Whole Blood Erythrocyte Sedimentation Rate (ESR) Sysmex XT-1800i Plasma Factor VII Assays Antigen Manual Plasma Fibrinogen BCT / Sysmex CA-560 Plasma Fibrin Monomer BCT / Sysmex CA-560 Plasma Fibrin Peptide A BCT / Sysmex CA-560 Whole Blood Full Blood Count BCT / Sysmex CA-560 Plasma Heptest BCT / Sysmex CA-560 Plasma International Normalised Ratio (INR) BCT / Sysmex CA-560 Plasma Pathway Inhibitor - Free BCT / Sysmex CA-560 Plasma Pathway Inhibitor - Total BCT / Sysmex CA-560 Plasma Plasminogen Activator Inhibitor (PAI) BCT / Sysmex CA-560 Whole Blood Platelets BCT / Sysmex CA-560 Plasma Platelet Aggregation - Collagen BCT / Sysmex CA-560 Plasma Platelet Aggregation- DP BCT / Sysmex CA-560 Original date of accreditation: 01 April 2002 Page 3 of 4
5 HAEMATOLOGY Plasma Prothrombin 1 & 2 BCT / Sysmex CA-560 Plasma Prothrombin Time (PT) BCT / Sysmex CA-560 Plasma Part Thromboplastin Time (aptt) BCT / Sysmex CA-560 Plasma Skin Bleeding Time Simplate Device Plasma Thrombin Antithrombin Complex BCT / Sysmex CA-560 Plasma Thrombin Time (TT) BCT / Sysmex CA-560 Plasma Tissue Factor BCT / Sysmex CA-560 Plasma Von Willebrand Factor BCT / Sysmex CA-560 SEROLOGY Serum, Plasma Hepatitis A IgM Antibodies Modular Analytics SWA (E170) Serum, Plasma Hepatitis B Antibody Modular Analytics SWA (E170) Serum, Plasma Hepatitis B Core Antibody Modular Analytics SWA (E170) Serum, Plasma Hepatitis B Early Antigen (HbE) Modular Analytics SWA (E170) Serum, Plasma Hepatitis B Surface Antigen (HBsAg) Modular Analytics SWA (E170) Serum, Plasma Hepatitis C Virus Antibody (HCV) Modular Analytics SWA (E170) Serum, Plasma Human Immunodeficiency Viruses (HIV 1/ HIV 2) Modular Analytics SWA (E170) Serum, Plasma Human Immunodeficiency Viruses (Ab / Ag) Modular Analytics SWA (E170) Original date of accreditation: 01 April 2002 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
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