CERTIFICATE OF ACCREDITATION

Transcription

1 CERTIFICATE OF ACCREDITATION LANCET LABORATORIES TANZANIA CONSERVATION HOUSE Registration No: PHL-B2/DSM-KIN/AUT/09 Facility Accreditation Number: MED 016 is a SADCAS accredited Medical Laboratory provided that all SADCAS conditions are complied with This certificate is valid as per the scope stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, SEROLOGY, IMMUNOLOGY, HAEMATOLOGY AND MICROBIOLOGY The facility is accredited in accordance with the recognized International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a laboratory quality management system SADCAS is a subsidiarity organization of SADC. A memorandum of understanding between SADC and SADCAS serves as the basis for the recognition of SADCAS by SADC Member States as a multi-economy accreditation body This certificate has been issued under the SADCAS/SANAS Twinning Partnership Arrangement Mrs Maureen P Mutasa SADCAS Chief Executive Officer Effective Date (Issue No: 1): 13 June 2017 Certificate Expires: 12 June 2022

2 S C H E D U L E OF A C C R E D I T A T I O N Laboratory Accreditation Number: MED 016 (ISO 15189:2012) Permanent Address of Laboratory: Lancet Laboratories Tanzania Conservation House Second Floor Ali Hassan Mwinyi Road Dar es Salaam Tanzania Technical Signatories : as authorized by the Head of the Laboratory Postal Address: P.O Box Dar es Salaam Tanzania Tel : Cell : mohamed.jaldesa@lancet.co.tz Nominated Representative : Mr. Mohamed Jaldesa Issue No : 02 Date of issue : 11 October 2018 Expiry Date : 12 June 2022 CHEMISTRY Serum Albumin COBAS Integra Serum Alkaline Phosphatase (ALP) COBAS Integra Serum Alanine Aminotransferase (ALT) COBAS Integra Serum Aspartate Aminotransferase (AST) COBAS Integra Serum Amylase COBAS Integra Serum Bilirubin, Total COBAS Integra Serum Bilirubin, Neonatal COBAS Integra Serum Bilirubin, Direct COBAS Integra Serum Calcium COBAS Integra Serum Cholesterol (HDL) COBAS Integra Serum Chloride COBAS Integra Serum Creatine Kinase (CK) COBAS Integra Serum Creatinine COBAS Integra Serum CRP COBAS Integra Serum Gamma Glutamyl Transferase COBAS Integra Original date of accreditation: 13 June 2017 Page 1 of 4

3 CHEMISTRY (continued) Plasma Glucose COBAS Integra Whole Blood HBA1C COBAS Integra Serum HDL3 COBAS Integra Serum Lipase COBAS Integra Serum Magnesium COBAS Integra Serum Inorganic Phosphate (PO4) COBAS Integra Serum Iron COBAS Integra Serum LDH COBAS Integra Serum Potassium COBAS Integra Serum Sodium COBAS Integra Serum Total Protein COBAS Integra Serum Triglycerides COBAS Integra Serum Urea COBAS Integra Serum Uric Acid COBAS Integra SEROLOGY Serum HBsAg Cobas e411 Serum HIV ELISA Cobas e411 Serum Widal Manual Serum H. Pylori Abs Manual Serum RPR Manual Serum HCV Manual Serum RF Manual Serum Rapid HIV Manual Serum TPHA Manual IMMUNOLOGY Serum AFP Cobas e411 Serum Ferritin Cobas e411 Serum Cortisol Cobas e411 Serum FT3 Cobas e411 Serum FT4 Cobas e411 Original date of accreditation: 13 June 2017 Page 2 of 4

4 IMMUNOLOGY (continued) Serum TSH Cobas e411 Serum HCG Cobas e411 Serum FSH Cobas e411 Serum LH Cobas e411 Serum Testosterone Cobas e411 Serum PSA Cobas e411 Serum Progesterone Cobas e411 Serum Estradiol Cobas e411 Serum CA125 Cobas e411 Serum CA-19-9 Cobas e411 Serum Prolactin Cobas e411 Serum CEA Cobas e411 HAEMATOLOGY Whole Blood WBC Mindray BC 5380 Whole Blood RBC Mindray BC 5380 Whole Blood HCT Mindray BC 5380 Whole Blood HB Mindray BC 5380 Whole Blood MCV Mindray BC 5380 Whole Blood Platelets Mindray BC 5380 Whole Blood Lymphocytes Mindray BC 5380 Whole Blood Neutrophils Mindray BC 5380 Whole Blood Eosinophils Mindray BC 5380 Whole Blood Monocyte Mindray BC 5380 Whole Blood Basophils Mindray BC 5380 Whole Blood ESR VESMATIC EASY Whole Blood Malaria Antigen Manual Whole Blood Malaria Smear Manual Whole Blood Blood Group Manual MICROBIOLOGY Stool, Urine Wet preparation: Cells Manual Method Crystals Manual Method Parasites Manual Method Iodine Wet Preparation Parasites Manual Method Original date of accreditation: 13 June 2017 Page 3 of 4

5 MICROBIOLOGY (continued) Urine Chemistry analysis: Dipstick Manual Method Kit BHCG(U) Manual Method Stool Helicobacter Pylori Ag Manual Method-Kit Occult Blood Manual Method Sputum Ziehl Nielsen: TB Identification Manual Method CSF Microscopy/Culture/sensitivity/Cell Count Manual Method Urine Culture/Sensitivity Manual Method ENT Swab Microscopy/Culture/Sensitivity Manual Method Sputum Culture/Sensitivity Manual Method Pus/Swab Microscopy/Culture/Sensitivity Manual Method Fluid Microscopy/Culture/Sensitivity Manual Method Stool Culture/sensitivity Manual Method CSF/SERUM Cryptococcal Ag Manual Method Original date of accreditation: 13 June 2017 Page 4 of 4 Jeanne Françoise Ranorovelo SADCAS Technical Manager