CERTIFICATE OF ACCREDITATION

Transcription

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) Practice No.: PR MAHATMA GANDHI LABORATORY Facility Accreditation Number: M0547 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, HAEMATOLOGY, MICROBIOLOGY 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: 20 January 2015 Certificate Expires: 19 January 2019

2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0547 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Signatories: Signatories as authorised by the Head of Laboratory Mahatma Gandhi Laboratory 100 Phoenix Highway Phoenix Durban 4068 Postal Address: 149 Prince Street Contact Person: Mr S Marrimuthu Durban 4000 Tel: (031) Issue No.: 04 Fax: (031) Date of Issue: 13 November sugan.marrimuthu@nhls.ac.za Expiry Date: 19 January 2019 Discipline / Sample Type Type of Tests Equipment / Method Chemistry Serum Acetaminophen (Paracetamol) DX800 Serum Alanine Aminotransferase (ALT) DX800 Serum Albumin DX800 Urine Albumin (Micro) DX800 Serum Alkaline Phosphatase (ALP) DX800 Serum, Urine Amylase DX800 Urine Beta Human Chorionic Gonadotrophin (βhcg) Beta Clear HCG (Kit) Serum Bicarbonate (CO2) Total DX800 Serum Bilirubin, Direct DX800 Serum Bilirubin, Total DX800 Serum Calcium (Total) DX800 Serum, CSF Chloride DX800 Serum Cholesterol (Total) DX800 Serum C-Reactive Protein (CRP) DX800 Serum Creatine Kinase (CK) DX800 Serum, Urine Creatinine DX800 Serum, CSF Glucose DX800 Serum Gamma Glutamyl Transferase (GGT) DX800 Whole Blood HbA1c Tosoh G8 Plasma Lactate DX800 Page 1 of 4

3 Serum Lactate Dehydrogenase (LDH) DX800 Serum Magnesium DX800 Stool Occult Blood Serum Phosphate DX800 Serum, Urine Potassium DX800 Serum, Urine, CSF Protein (Total) DX800 Serum, urine Sodium DX800 Serum Triglycerides DX800 Serum Urate DX800 Serum, Urine Urea DX800 Blood Gas: Whole Blood Arterial Gem Prem 3000 Endocrinology Serum High Density Lipoprotein (HDL) DX800 Serum Salicylate DX800 Whole Blood Troponin T Cobas h232 Haematology Plasma Activated Partial Thromboplastin Time (APTT) Sysmex CS 2100i Whole Blood CD4 Count Cytomix FC500 MPL Whole Blood Differential Count Whole Blood Erythrocyte Sedimentation Rate (ESR) Westergren Method Whole Blood Full Blood Count and 5 Part Differential Count Advia 2120i Whole Blood Malaria Whole Blood Malaria Rapid Antigen / Binax Rapid Antigen Test Plasma Prothrombin Index (PI) Sysmex CS 2100i Microbiology Tracheal Aspirates, Sputum, Nasopharyngeal, Aspirates, Frank Pus Aspirates Microscopy: Gram Stain - Body Fluids including CSF Microscopy: Gram Stain - Cryptococcal Antigen Latex Agglutination Lateral Flow Assay Page 2 of 4

4 Sputum Auramine O Stain Wescor Stainer TB PCR GeneXpert CV Tips Pus Swabs (Wound, Burns, Bedsores, Leg, Ulcers, Ear, Nose and Throat, Eye, Genital) Gram Stain - Blood Gram Stain - Identification Sensitivity Vitek 2 / Vitek 2 / Stool and Rectal Swabs Microscopy - Wet Preparation Modified Ziehl Nielsen Urine including Mid-Stream and SPU (Suprapubic Urine) Vitek 2 Catheter and Tissue Specimens Non Sputum Samples Ziehl Nielsen Stain Serology Serum HIV 1/2 Alere Determine Original Date of Accreditation: 20 January 2015 Page 3 of 4

5 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 4 of 4