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, TW18 3HR, UK Department of Blood Sciences and Transfusion Dorset County Hospital Williams Avenue Dorchester DT1 2JY Contact: Sharon Wood Tel: +44 (0) Testing performed at the above address only Site activities performed away from the laboratory Location details Activity Blood issue room Theatres Maternity Assessment Manager: VB Page 1 of 10

2 Site activities performed away from the location above Location details Activity Blamdford Community Hospital Milldown Road Blandford DT11 7DD Bridport Community Hospital Hospital Lane N Allington Bridport DT6 5DR Yeatman Community Hospital Hospital Road Sherborne DT9 3JU Westhaven Community Hospital Radipole Lane Weymouth DT4 0QE Winterbourne Hospital Herringston Road Dorchester Road Dorchester Dorset DT2 2DR Assessment Manager: VB Page 2 of 10

3 HUMAN BODY FLUIDS DETAIL OF ACCREDITATION Biochemistry examination activities for the purposes of clinical diagnosis: Documented in-house methods and manufacturer s operating instructions for as specified to support clinical diagnosis: Abbott Architect Spectrophotometry With specific reference to the following SOP s: Serum, Urine AKI Alert Calculated Serum Albumin 0149 Urine Albumin/creatinine ratio 0149 Calculated Serum Alcohol 0660 Serum Alkaline Phosphatase 0150 Alanine Aminotransferase (ALT) 0151 Ammonia 0162 Serum, Urine Amylase 0152 Anion gap Calculated Serum Direct Bilirubin (Conjugated) 0143 Bile Acid 6531 Total Bilirubin 0158 Compliment C Compliment C Carbamazepine 0129 Serum, Urine Calcium 0135 Urine excretion Calcium 0135 Calculated Serum, Urine Corrected Calcium 0135 Calculated Serum Cholestrol/HDL Ratio 0136 Calculated Cholestrol 0136 Creatinine Phospho Kinase (CPK) 0137 Total Bicarbonate 0124 Creatinine 0138 C-Reactive Protein 0140 Digoxin 0101 Estimated GFR Calculated Iron 0146 Iron saturation 0146 Calculated Gentamicin Levels 0107 Gamma GT 0144 Serum, Urine Glucose Random/Fasting 0154 CSF Glucose 0400 HDL 0145 Immunoglobulin IgA 5904 Immunoglobulin IgG 5901 Immunoglobulin IgM 5905 Serum Lactate 0132 Assessment Manager: VB Page 3 of 10

4 Biochemistry examination activities for the purposes of clinical diagnosis (cont d) Documented in-house methods and manufacturer s operating instructions for as specified to support clinical diagnosis: Abbott Architect Spectrophotometry With specific reference to the following SOP s: Serum Lactate dehydrogenase LDH 0147 Low density lipoprotein Non-HDL Calculated Cholesterol Lithium 0289 Urine Micro Albumin 7068 Serum Magnesium 0148 Serum, urine Paracetamol 8997 Serum Phenytoin 7091 Serum, urine Phosphate 0167 Urine Phosphate excretion 0167 Calculated Serum Rheumatoid Factor 1753 Salicylate 0170 Theophylline 0157 Serum, Urine, CFS Total Protein 0142,0155, 0156 Serum Triglyceride 0159 Unbound iron binding capacity UIBC 0160 Urine Urinary protein UPR 0156 Urinary protein/creatinine ratio 0156 Calculated Serum, Urine Urate 0165 Urea 0161 Urine Urea excretion 0161 Calculated Uric acid excretion Calculated Serum Valproate 0131 Vancomycin 2296 Urine 24hr Potassium Excretion hr Urinary Calcium hr Urinary Creatinine hr Urinary Phosphate hr Urinary Protein hr Urinary Sodium hr Urinary Urate hr Urinary Urea 0131 Creatinine clearance & protein 0138 Calculated Creatinine clearance Calculated Creatininine Excretion Calculated Serum Alpha Feto Protein 0095 Vitamin B12 II 0096 Beta Human Chorionic Gonadotropin 0108 Cancer antigen (Ca 125 II) 0097 Assessment Manager: VB Page 4 of 10

5 Biochemistry examination activities for the purposes of clinical diagnosis (cont d) Documented in-house methods and manufacturer s operating instructions for as specified to support clinical diagnosis: Abbott Architect Spectrophotometry With specific reference to the following SOP s: Serum Carcinoembryonic antigen (CEA) 0098 Cortisol 0100 Oestradiol 0123 Ferritin 0102 Folate II 0103 Free thiiodothronine (FT3) 0105 Free Thyroxine 0106 Follicle stimulating hormone (FSH) 0104 Lutinising hormone (LH) 0109 Serum Progesterone 0111 Prolactin 0119 Prostate Specific Antigen 0120 Sex hormone binding globulin)shbg 0381 Testosterone 0121 Troponin I 1423 Thyroid stimulating hormone TSH 7123 Tacrolimus 0382 Vitamin D 3 Vit D (25 OH VitD) 0110 Abbott Architect ISE With specific reference to the following SOP s: Serum, Urine Chloride 7339 Potassium 7339 Urine Potassium excretion 7339 Calculated Sodium 7339 Sodium excretion 7339 Calculated Serum Roche Cobas E411electrochemiluminescence Using SOP 0801 and 0804 With specific reference to the following SOP s: N terminal prohormone brain 0806 natriuretic peptide (NT pro BNP) Parathyroid hormone (PTH) 0804 Cancer antigen CA Assessment Manager: VB Page 5 of 10

6 Biochemistry examination activities for the purposes of clinical diagnosis (cont d) Documented in-house methods and manufacturer s operating instructions for as specified to support clinical diagnosis: Serum, Urine Osmolality Osmometer-freezing point depression (Vapour pressure) using SOP 0133 Whole Blood Haemoglobin A1c (HbA1c) TOSOH 8160 high pressure liquid chromatography SOP 0302, 3094 CSF Xanthochromia screen Analytikajena: Specord 200 PLUS=Spectrophotometry SOP 0310 Whole Blood Sickle Screen using sickle cell solubility Bioproducts S Test kit turbidity SOP 0297 Serum Detection of paraproteins: SEBIA Electrophoresis SOP 0306 Alpha Kappa Mu Lambda Gamma Urine Urine Dipstick tests: Cobas Combur Test-test strip colour change SOP 0304 ph Glucose Ketones Leukocytes Nitrite Protein Urobillnogen Billirubin Erythrocytes and haemoglobin Urine Suspected transfusion reactions detecting the presence of: Protein Urobillinogen/Urobilin Billirubin Blood/Haemoglobin Cobas Combur Test-test strip colour change SOP 8767 Assessment Manager: VB Page 6 of 10

7 Biochemistry examination activities for the purposes of clinical diagnosis (cont d) Documented in-house methods and manufacturer s operating instructions for as specified to support clinical diagnosis: Urine Bile Pigments Cobas Combur Test-test strip colour change /chemical colour change SOP 0304 Faecal Faecal Occult Blood Beckman Coulter: Haemoccult filter paper colour change SOP 0284 Bone Marrow Haematological examinations for the purpose of clinical diagnosis Cell morphology (detection of abnormalities) Procedures documented in manufacturer s equipment manuals in conjunction with documented inhouse procedures by the following methods: May-Grunwald & Giemsa stain. Manual film reading SOP 0295 Whole Blood Erythrocyte sediment rate (ESR) Manual in-house method: Westergreen tube gravitational pull/time SOP 0443 Citrated whole blood Erythrocyte sediment rate (ESR) Automated method using Vitech Starrsed Compact Westergren method. SOP 8704 Full Blood Count Reticulocyte count Haemoglobin White blood cells Haematocrit Red blood cells Mean cell volume Platelets Nucleated red blood cells Neutrophils Lymphocytes Monocytes Eosinophils Abbott Cell-Dyn Sapphire analyser New methylene Blue stain and flow cytometry SOP 2244 Assessment Manager: VB Page 7 of 10

8 Whole Blood (EDTA) Whole Blood Haematological examinations for the purpose of clinical diagnosis (cont d) Malarial Screening Plasmodium falciparum and pan-detection for: Plasmodium malariae, Plasmodium ovale & Plasmodium vivax Differential cell count and cell morphology (detection of abnormalities) Procedures documented in manufacturer s equipment manuals in conjunction with documented inhouse procedures by the following methods: Ph 7.2 Giemsa satin. Hematek stain. BinaxNOW malaria immunochromatographic assay (Monoclonal) SOP 0316, 0319, 0290 In-house method blood film staining and microscopy: Bayer:Hematek-Genna/Giemsa stain. Manual film reading Whole Blood (EDTA) Reticulocyte Count (Manual) Manual in-house method:new Methylene Blue stain. Manual film reading using SOP 8842 Bone Marrow Haemosiderin Manual in-house staining/microscopy: Potassium Ferrocyanide and HCL. Manual film reading SOP 0288 Sysmex CA1500 Photometric End Point. With specific reference to the following SOP s: Citrated Plasma Activated Partial Thromboplastin time 0210 Activated Protein C Resistance 7109 D-Dimer 0214 Factor II Assay 0220 Factor V Assay 0221 Factor V11 Assay 0222 Factor V111 Assay 0223 Factor IX Assay 0224 Factor X Assay 0217 Factor XI Assay 0210 Factor XII Assay 0219 Fibrinogen Assay 0226 Lupus Anticoagulant 0230 Free Protein S Antigen Assay 7821 Prothrombin Time 0237 International normalised ratio (INR) 0237 Thrombin Time 0248 Assessment Manager: VB Page 8 of 10

9 Haematological examinations for the purpose of clinical diagnosis (cont d) Procedures documented in manufacturer s equipment manuals in conjunction with documented inhouse procedures by the following methods: Sysmex CA1500 Chromogenic method using With specific reference to the following SOP s: Anti-thrombin III 0211 Protein C Assay 0235 Venous Blood Venous Blood; plasma Factor VIII Assay Inhibitor Assay (BETHSEDA Method) Blood Transfusion examinations to assist in clinical investigations Blood Grouping & Antigen typing A B O Rhesus: C, c, D, E, e, Kell system: K Blood Grouping A B O Rhesus: D Antibody Detection Rh: D, C, E, c, e, Cw Kell: K, k, Kpb Fya, Fyb Jka, Jkb Lea, Leb P1 M, N, S, s Lua, Lub Xga Sysmex CA1500 Photometric End Point and manual calculation using SOP 0225 Procedures documented in manufacturer s equipment manuals in conjunction with documented inhouse procedures by the following methods: Biorad IH-500 automation platform utilising the Biorad (Diamed) Column agglutination technology HTL-SOP0207 IH500 Sample processing and maintenance Manual procedures by Tube agglutination and Biorad (Diamed) Column agglutination Key SOP s HTL-SOP 0088 Manual Tube grouping HTL-SOP 0057 Neonatal grouping Biorad IH-500 automation platform utilising the Biorad (Diamed) Column agglutination Key SOP s HTL-SOP0207 IH500 Sample processing and maintenance Assessment Manager: VB Page 9 of 10

10 Venous blood; red cells Venous blood; plasma Venous blood; Blood Transfusion examinations to assist in clinical investigations (cont d) Antibody Identification D, C, E, c, e, Cw, K, Fya, Fyb, Jka, Jkb, Lea, Leb, P1, M, N, S, s, Lua, Antigen Testing A1, C, E, c, e, K, Fya, Fyb, Jka, Jkb, M, N, S, s Compatibility testing of patients plasma with donor cells Quantification of fetal-maternal haemorrhage Procedures documented in manufacturer s equipment manuals in conjunction with documented inhouse procedures by the following methods: Manual procedures by Tube agglutination and Biorad (Diamed) Column agglutination technology Key SOPs: HTL-SOP 0003 Allo-antibody Investigations (HBB) Manual procedures by Tube agglutination and Biorad (Diamed) Column agglutination Key SOP s HTLSOP 0045 Genotyping & antigen testing Manual procedures by Biorad (Diamed) Column agglutination technology Key SOPs: HTL-SOP 0040 Red cell crossmatch In-house method using Kleihauer testing by Sure Tech stain kit, manual reading SOP 4486 Venous Blood Direct antiglobulin testing Automated IH500 and manual procedures using by Biorad (Diamed) Column agglutination technology Key SOP s HTL-SOP0207 IH500 Sample processing and maintenance HTL-SOP 0042 Direct Antiglobulin Test (DAT) END Assessment Manager: VB Page 10 of 10

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