Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

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1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, 18 3HR, UK Sciences Department Maidstone Hospital Hermitage Lane Maidstone ME16 9QQ Contact: Jane Dalton Tel: +44 (0) Laboratory locats: Testing performed at the above address only s covered by the organisat and their relevant activities details Activity code Address Sciences Department Maidstone Hospital Hermitage Lane Maidstone ME16 9QQ Local Contact Jane Dalton Haematology Coagulat Transfus Biochemistry Address Sciences Department Tunbridge Wells Hospital at Pembury, Tonbridge Road Tunbridge Wells TN2 4QJ Local Contact Jane Dalton Haematology Coagulat Transfus Biochemistry Site activities performed away from the locats listed above: details Activity code Address Maidstone Hospital Hermitage Lane Maidstone ME16 9QQ Local Contact Louise Moore Phlebotomy Address Tunbridge Wells Hospital at Pembury Tonbridge Road Tunbridge Wells TN2 4QJ Local Contact Louise Moore Phlebotomy Assessment Manager: PW Page 1 of 14

2 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK details Activity code Address Fridge Maternity Ward Tunbridge Wells Hospital at Pembury Tonbridge Road Tunbridge Wells TN2 4QJ Local Contact Robert Reilly Issue Fridge No testing occurs, blood storage only Address Phlebotomy Out Patients Sevenoaks Hospital Hospital Road Sevenoaks TN13 3PG Local Contact Louise Moore Phlebotomy Assessment Manager: PW Page 2 of 14

3 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK DETAIL OF ACCREDITATION Haematological examinat activities for the purposes of clinical diagnosis instructs where relevant EDTA whole blood Haematology Film Appraisal. Examinat of peripheral blood films, detect of normal and abnormal morphology and white cell differential count Manual peripheral blood film preparat and automated Romanowski staining using Sysmex SP10 stainer and examinat by light microscopy RWF-BS-HAEM-SOP52 Manual peripheral blood film preparat and automated Romanowski staining using Sysmex SP1000 stainer and examinat by light microscopy RWF-BS-HAEM-SOP52 EDTA whole blood film malaria parasite screening and speciat for determinat of malarial parasites: P.falciparum, P.vivax, P.ovale, P.malariae, P. knowlesi and nonmalarial parasites including filarial worms. Manual peripheral blood film preparat of thick and thin films May-Grunwald-Giemsa (MGG) stain and light microscopy SOP RWF-BS-HAEM-SOP50, Bone Marrow Aspirate Examinat of bone marrow films, detect of normal and abnormal morphology Manual bone marrow film preparat May-Grunwald Giemsa staining and examinat by light microscopy RWF-BS-HAEM-SOP51, Bone Marrow Aspirate Iron Manual bone marrow film preparat and Perls staining and examinat by light microscopy RWF-BS-HAEM-SOP51, Assessment Manager: PW Page 3 of 14

4 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Haematological examinat activities for the purposes of clinical diagnosis instructs Full Count (FBC): White Cell count (WBC) Red Cell count (RBC) Haemoglobin (HGB) Haematocrit (HCT) Mean Cell Volume (MCV) Mean Cell Haemoglobin (MCH) Mean Cell Haemoglobin Concentrat (MCHC) Platelet count (PLT) Red Cell Distribut (RDW) Neutrophil count (NEUT) Lymphocyte count (LYMP) Monocyte count count(mono) Eosinophil count (EO) Basophil count (BASO) Nucleated Red Cell count (NRBC) Reticulocyte count (RET) Flow cytometry using semiconductive laser, Direct Current (Impedance), sodium lauryl sulphate (SLS) haemoglobin measurement method and using: Sysmex Instruments XN9000- Track RWF-BS-HAEM-SOP55 Sysmex Instruments XE2100 RWF-BS-HAEM-SOP8 RWF-BS-HAEM-SOP19 Erythrocyte Sedimentat Rate (ESR) Modified Westergren Sedimentat method RWF-BS-HAEM-SOP3 and using: Manual method StaRRsed Microvette ESR Automated methods Vitech V8 Interliner analyser Starsed AutoCompact analyser Starrsed AutoCompact analyser Assessment Manager: PW Page 4 of 14

5 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Haematological examinat activities for the purposes of clinical diagnosis instructs Antenatal Screening for Sickle Cell and Thalassemia: Detect of variants HbS, HbC, HbD, HbE Primus Diagnostics High Performance Liquid Chromatography (HPLC) RWF-BS-HAEM-SOP7 Sickle screen Clinitech sickle screen commercial kit. RWF-BS-HAEM-SOP44, Vitamin B12, Serum folate, red cell folate Beckman Coulter Access II analyser Chemiluminescent RWF-BS-HAEM-SOP6 Malaria Detect of Plasmodium falciparum and the differential diagnosis of falciparum from other pan-specific Pasmodium species (vivax, ovale, malariae) CareStart Kit method (antigen/antibody react) and manual staining method using May Grunwald Giemsa and examinat by light microscopy RWF-BS-HAEM-SOP50, Coagulat (Coagulat screens, Clauss fibrinogen, INR, APTTs, D Dimers. Lupus) ACL TOP550 Coagulometric (turbidimetric), chromogenic (absorbance) and immunological methods RWF-BS-HAEM-SOP54 RWF-BS-HAEM-SOP28 RWF-BS-HAEM-SOP46 RWF-BS-HAEM-SOP33, Thrombophilia screens ( ProS, Pro C, ATIII, APCR, TT,) ACL TOP550 RWF-BS-HAEM-SOP28 RWF-BS-HAEM-SOP53 Anticardiolipin Orgentec commercial kit RWF-BS-HAEM-SOP29 Assessment Manager: PW Page 5 of 14

6 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Transfus examinat activities for the purposes of clinical diagnosis instructs where relevant Transfus Group: ABO RhD IBG Immucor ECHO analyser Automated method using solid phase antibody/antigen react using coated wells, agglutinat visualised by instrument RWF-BS-BT-SOP45 RWF-BS-BT-SOP46, Antibody screen: Rh: D,C,E,c,e,Cw, V Kell: K,k,Kpa,Kpb,Jsa,Jsb Duffy: Fya,Fyb Kidd: Jka,Jkb Lewis: Lea,Leb P: P1 MNS: M,N,S,s Luth: Lua,Lub Xg: Xga IBG Immucor ECHO analyser Automated method using solid phase antibody/antigen react using coated wells, agglutinat visualised by instrument RWF-BS-BT-SOP6, Antibody identificat: Rh: D,C,E,c,e,Cw,V Kell: K,k,Kpa,Kpb,Jsa,Jsb Duffy: Fya,Fyb Kidd: Jka,Jkb Lewis: Lea,Leb P: P1 MNS: M,N,S,s Lutheran: Lua,Lub Xg: Xga IBG Immucor ECHO analyser Automated method using solid phase antibody/antigen react using coated wells, agglutinat visualised by instrument RWF-BS-BT-SOP6, Antibody identificat: Rh: D,C,E,c,e,Cw,V Kell: K,k,Kpa,Kpb,Jsa,Jsb Duffy: Fya,Fyb Kidd: Jka,Jkb Lewis: Lea,Leb P: P1 MNS: M, N,S,s Lutheran: Lua,Lub Xg: Xga Manual method using Biorad Gel cards (antibody/antigen agglutinat) read manually RWF-BS-BT-SOP6, Assessment Manager: PW Page 6 of 14

7 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Transfus examinat activities for the purposes of clinical diagnosis instructs ABO Group Manual method Antibody/antigen agglutinat read macroscopically Tube method RWF-BS-BT-SOP17 RWF-BS-BT-SOP35, Microplate method RWF-BS-BT-SOP3 Antibody screen Manual method using Biorad Gel cards (antibody/antigen agglutinat) read manually RWF-BS-BT-SOP7 Crossmatching Manual method using Biorad Gel cards (antibody/antigen agglutinat) read manually RWF-BS-BT-SOP40 RWF-BS-BT-SOP42 DAT Manual method using Biorad Gel cards (antibody/antigen agglutinat) read manually RWF-BS-BT-SOP11,,, Assessment Manager: PW Page 7 of 14

8 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Biochemistry Quantificat of: Documented procedures and manufacturer s instructs for Roche Cobas 8000 and Roche Cobas 6000 with specific reference to: Renal Serum/Urine Sodium Roche Cobas indirect ISE Serum/Urine Potassium Roche Cobas indirect ISE Serum/ Urine Creatinine (jaffe) Roche Cobas Compensated Kinetic jaffe colorimetric Serum Creatinine (Enzymatic) Roche Cobas Enzymatic colorimetric principle Serum/Urine Urea Roche Cobas Kinetic urease Liver Funct Serum Alanine Aminotransferase (ALT) Roche Cobas UV TRIS buffer without PLP Albumin Roche Cobas bromcresol green Serum (BCG) colorimetric Serum Alkaline Phosphatase (ALP) Roche Cobas colorimetric AMP buffer (IFCC) assay Serum Aspartate Amino Transferase (AST) Roche Cobas UV TRIS buffer without PLP Serum Bilirubin (Total) Roche Cobas diazonium Colorimetric assay Serum Gamma Glutamyl Transferase (γgt) Roche Cobas Enzymatic colorimetric Carboxynitroanilide (IFCC),,,,,,,,,,, Assessment Manager: PW Page 8 of 14

9 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs Lipid Profiles Serum Cholesterol Roche Cobas Cholesterol oxidase Enzymatic, colorimetric method. Serum High density lipoproteins (HDL) Roche Cobas Homogeneous enzymatic colorimetric test Serum Triglycerides Roche Cobas GK/GPO-PAP Enzymatic colorimetric test. Serum Thyroid Funct Thyroid Stimulating Hormone (TSH) Roche Elecsys sandwich Serum Free T3 Roche Elecsys Competit principle Serum Free T4 Roche Elecsys Competit principle Cardiac Serum Creatine Kinase (CK) Roche Cobas UV-test NAC (IFCC) Serum Troponin T (high sensitivity) Roche Elecsys Sandwich principle Plasma Pro BNP (N-terminal pro b-type natriuretic peptide) Roche Elecsys sandwich,,,,,,, Assessment Manager: PW Page 9 of 14

10 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Bone Serum/urine Calcium Roche Cobas photometric NM- BAPTA assay Serum/urine Phosphate Roche Cobas phosphomolybdate uv Serum Magnesium Roche Cobas xylidyl blue Colorimetric endpoint General Biochemistry Urine Albumin Roche Cobas Immunoturbidimetric assay. Plasma Ammonia Roche Cobas Enzymatic (GLDH) Serum Amylase Roche Cobas Enzymatic colorimetric assay G7 substrate (IFCC) Serum C Reactive Protein (CRP) Roche Cobas Particle enhanced immunoturbidimetric assay. Serum Chloride Roche Cobas indirect ISE Serum Conjugated Bilirubin Roche Cobas Diazo colorimetric assay Plasma/ CSF Glucose Roche Cobas UV Hexokinase +G6PD Serum Lactate Dehydrogenase (LDH) Roche Cobas UV method P to L phosphate Serum Protein (Total) Roche Cobas biuret Colorimetric assay CSF/Urine Protein (Total) Roche Cobas - Benzethonium chloride Turbidimetric method.,,,,,,,,,,,, Assessment Manager: PW Page 10 of 14

11 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Serum/Urine Urate (Uric Acid) Roche Cobas End point uricase colorimetric test Proteins & Tumour markers Serum Alpha Fetoprotein (AFP) Roche Elecsys Sandwich Serum Beta 2 Microglobulin Roche Cobas Immunoturbidimetric assay. Serum Carbohydrate Antigen Tumour Markers CEA CA 125 CA 15-3 CA 19-9 Roche Elecsys Sandwich Serum Immunoglobulins IgA, IgG, IgM Roche Cobas immunological agglutinat and Immunoturbidimetric assay Serum Serum Prostate Specific Antigen (PSA) Total Endocrinology Beta Human Chronic Gonadotrophin Roche Elecsys sandwich Roche Elecsys Sandwich Serum Cortisol (Serum) Roche Elecsys Competit principle Serum Follicle Stimulating Hormone (FSH) Roche Elecsys sandwich Serum Luteinising Hormone (LH) Roche Elecsys sandwich,,, Assessment Manager: PW Page 11 of 14

12 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Serum Oestradiol (Oestrogen) Roche Elecsys Competit principle Plasma Parathyroid Hormone (PTH) Roche Elecsys sandwich Serum Progesterone Roche Elecsys Competit principle Serum Prolactin (and Macro Prolactin) Roche Elecsys sandwich +/- PEG precipitat Serum Sex hormone binding globulin Roche Elecsys sandwich Serum Testosterone Roche Elecsys Competit principle Therapeutic drug monitoring & Toxicology Serum Carbamazepine Roche Cobas Competive kinetic interact of microparticles (KIMS) Serum Digoxin Roche Cobas Competit principle. Plasma Ethanol Roche Cobas Enzymatic method with alcohol dehydrogenase. Serum Gentamicin Roche (CEDIA) Cobas homogenous enzyme bacterial β- galactosidase Serum Lithium Roche 9180 ISE RWF-BS-BIO-SOP38,,,, Assessment Manager: PW Page 12 of 14

13 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Serum Paracetamol Roche Cobas arylacylamidase colorimetric Serum Phenytoin Roche Cobas Competive kinetic interact of microparticles (KIMS) Serum Salicylate Roche Cobas enzymatic. Serum Theophylline Roche Cobas Competive kinetic interact of microparticles (KIMS) Serum Vancomycin Roche Cobas homogeneous enzyme Haematinics & Nutrit Serum Ferritin Roche Cobas Sandwich principle. Serum Iron Roche Cobas Colorimetric assay. Serum Transferrin Roche Cobas Immunoturbidimetric assay. Serum Vitamin D (25 Hydroxy) Roche Elecsys Competitiive,,,,,, Serum / Urine Proteins Electrophoresis (Paraprotein Typing and Quantificat Sebia Hydrasys2 Protein zone electrophoresis agarose gel RWF-BS-BIO-SOP77 HbA1c (Glycosylated Haemoglobin) Menarini Hb9210 High-Pressure Liquid Chromatography (HPLC) borate RWF-BS-BIO-SOP43 Urine ph determinat ph combinat polymer electrode RWF-BS-BIO-SOP90, Assessment Manager: PW Page 13 of 14

14 2 Pine Trees, Cher t s ey L an e, Stai nes - u po n - T ham es, 18 3HR, UK Biochemistry examinat activities for the purposes of clinical diagnosis instructs where relevant Miscellaneous Serum/ Urine Osmolality Advanced Micro Osmometer Freezing point depress RWF-BS-BIO-SOP78 CSF Xanthochromia Super Aurius Cecil CE 3041 Spectrophotometry RWF-BS-BIO-SOP79 Faeces Faecal Calprotectin Buhlmann method ELISA Dynex microplate reader RWF-BS-BIO-SOP88, END Assessment Manager: PW Page 14 of 14