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 lood Sciences Department Royal lackburn Hospital Haslingden Road lackburn 2 3HH United Kingdom Contact: Dayle Squires Tel: +44 (0) Fax: +44 (0) dayle.squires@elht.nhs.uk Website: Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress Local contact lood Sciences Department Royal lackburn Hospital Haslingden Road lackburn 2 3HH United Kingdom Dayle Squires Tel: +44 (0) Fax: +44 (0) dayle.squires@elht.nhs.uk Clinical iochemistry Haematology Coagulation lood Transfusion lood Sciences Department urnley General Hospital Casterton venue urnley 10 2PQ United Kingdom Clinical iochemistry Haematology Coagulation lood Transfusion Site activities performed away from the locations listed above: details ctivity code Gisburn Park Hospital Park Rd Gisburn, Clitheroe 7 4HT lood issue fridge for storage of blood products only; no testing occurs at this site C ssessment Manager: WH 1 of 14

2 DETIL OF CCREDITTION General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: stated Ortho Vitros 4600 with reference to the following documented procedures: lbumin Colorimetric (S/N SOP10) Urine only lbumin Turbidimetric (S/N SOP124) lkaline Phosphatase lanine Transaminase (LT) Multiple-point Enzymatic Rate (S/NSOP12) Multiple-point enzymatic rate (S/N SOP13) mikacin Turbidimetric (S/N SOP200) mmonia Colorimetric (S/N SOP35) Urine also mylase Enzymatic Rate (S/N SOP14) spartate Transaminase (ST) icarbonate Multiple-point Enzymatic rate (S/N SOP15) Enzymatic end point (S/N SOP25) ilirubin (Total) Colorimetric (S/N SOP41) ilirubin (Conjugated) Colorimetric (S/N SOP16) Urine also Calcium Colorimetric (S/N SOP18) ssessment Manager: WH Page 2 of 14

3 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: stated Ortho Vitros 4600 with reference to the following documented procedures Chloride Potentiometric (S/N SOP20) Cholesterol Colorimetric (S/N SOP19) Complement C3 Complement C4 C-Reactive Protein lanked Endpoint (S/N SOP122) lanked Endpoint (S/N SOP133) Fixed point immuno-rate (S/N SOP22) Urine also Creatinine 2 point enzymatic rate (S/N SOP21) Creatine Kinase (CK) Digoxin Multiple-point enzymatic rate (S/ SOP5) Multiple-point immuno-rate (S/N SOP23) Ethanol Colorimetric (S/N SOP11) Gamma Glutamyl Transferase Multipoint enzymatic rate (S/N SOP27) Gentamicin Two point rate (S/N SOP134) CSF also Glucose Colorimetric (S/N SOP28) HDL-cholesterol Colorimetric (S/N SOP24) ssessment Manager: WH Page 3 of 14

4 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: stated Ortho Vitros 4600 with reference to the following documented procedures Immunoglobulins (Ig, IgM, IgG) lanked Endpoint (S/N SOP126, 127 & 128) Iron inding Capacity (TIC) Colorimetric (S/N SOP123) Iron Colorimetric (S/N SOP140) Lactate Colorimetric (S/N SOP30) Lactate Dehydrogenase (LDH) Multipoint enzymatic rate (S/N SOP31) Lithium Colorimetric (S/N SOP32) Magnesium Colorimetric (S/N SOP33) Paracetamol Colorimetric (S/ SOP8) Phenytoin Multiple-point immuno-rate (S/N SOP38) Phosphate Colorimetric (S/N SOP37) Urine also Potassium Potentiometric (S/N SOP29) Total Protein Colorimetric (S/N SOP43) Urine only Total Protein Colorimetric (S/N SOP 39 and S/N SOP 181)) Rheumatoid Factor Turbidimetric (S/N SOP125) ssessment Manager: WH Page 4 of 14

5 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Urine only Salicyclate Colorimetric (S/N SOP40) Sodium Potentiometric (S/N SOP34) stated Ortho Vitros 4600 with reference to the following documented procedures Theophylline 2 point enzymatic rate (S/N SOP42) Triglyceride Colorimetric (S/N SOP44) Tobramycin Two-point rate (S/N SOP105) Urine also Urea Colorimetric (S/N SOP17) Urine also Uric cid Colorimetric (S/N SOP46) Vancomycin Two-point rate (S/N SOP135) stated Vitros Fusion 5.1 with reference to the following documented procedures: lbumin Colorimetric (S/N SOP10) lkaline Phosphatase lanine Transaminase (LT) mikacin Multiple-point Enzymatic Rate (S/NSOP12) Multiple-point enzymatic rate (S/N SOP13) Turbidimetric (S/N SOP200) mmonia Colorimetric (S/N SOP35) ssessment Manager: WH Page 5 of 14

6 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Urine also mylase Enzymatic Rate (S/N SOP14) icarbonate Enzymatic end point (S/N SOP25) ilirubin (Total) Colorimetric (S/N SOP41) ilirubin (Conjugated) Colorimetric (S/N SOP16) Urine also Calcium Colorimetric (S/N SOP18) stated Vitros Fusion 5.1 with reference to the following documented procedures Cholesterol Colorimetric (S/N SOP19) C-Reactive Protein Fixed point immuno-rate (S/N SOP22) Urine also Creatinine 2 point enzymatic rate (S/N SOP21) Ethanol Colorimetric (S/N SOP11) Gamma Glutamyl Transferase Multipoint enzymatic rate (S/N SOP27) Gentamicin Two point rate (S/N SOP134) CSF also Glucose Colorimetric (S/N SOP28) HDL-cholesterol Colorimetric (S/N SOP24) ssessment Manager: WH Page 6 of 14

7 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: stated Vitros Fusion 5.1 with reference to the following documented procedures Lactate Colorimetric (S/N SOP30) Magnesium Colorimetric (S/N SOP33) Paracetamol Colorimetric (S/ SOP8) Phosphate Colorimetric (S/N SOP37) Urine also Potassium Potentiometric (S/N SOP29) Total Protein Colorimetric (S/N SOP43) Salicyclate Colorimetric (S/N SOP40) Urine also Sodium Potentiometric (S/N SOP34) stated Vitros Fusion 5.1 with reference to the following documented procedures Triglyceride Colorimetric (S/N SOP44) Urine also Urea Colorimetric (S/N SOP17) Urine also Uric cid Colorimetric (S/N SOP46) ssessment Manager: WH Page 7 of 14

8 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Serum / Plasma unless otherwise stated Siemens dvia Centaur XPT and the following immunoassay principles and inhouse documented procedures: lpha-fetoprotein (FP) 2 site non-competitive (S/N SOP169) 12 Competitive (S/N SOP188) Ca125 2 site non-competitive (S/N SOP172) Ca site non-competitive (S/N SOP170) Carbamazepine Competitive (S/N SOP178) CE 2 site non-competitive (S/N SOP173) Cortisol Competitive (S/N SOP176) Ferritin 2 site non-competitive (S/N SOP177) Folate Competitive (S/N SOP189) Follicle Stimulating Hormone (FSH) 2 site non-competitive (S/N SOP179) Human Chorionic Gonadotrophin (HCG) 2 site non-competitive (S/N SOP174) Luteinising Hormone (LH) 2 site non-competitive (S/N SOP180) ssessment Manager: WH Page 8 of 14

9 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Serum / Plasma unless otherwise stated Siemens dvia Centaur XPT and the following immunoassay principles and inhouse documented procedures: Macroprolactin PEG precipitation followed by 2 site non-competitive (S/N SOP183) Oestradiol Competitive (S/N SOP191) Progesterone Competitive (S/N SOP192) Prolactin 2 site non-competitive (S/N SOP182) Prostate Specific ntigen 2 site non-competitive (S/N SOP175) Parathyroid Hormone 2 site non-competitive (S/N SOP187) SHG 2 site non-competitive (S/N SOP219) Testosterone Competitive (S/N SOP218) Triiodothyronine (T3) Free Competitive (S/N SOP181) Thyroxine (T4) Free Competitive (S/N SOP171) Troponin I (TnI) 3 site non-competitive (S/N SOP186) ssessment Manager: WH Page 9 of 14

10 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Serum / Plasma unless otherwise stated Siemens dvia Centaur XPT and the following immunoassay principles and inhouse documented procedures: Thyroid Stimulating Hormone 2 site non-competitive (S/N SOP185) Valproate Competitive (S/N SOP184) Total 25-hydroxy Vitamin D Competitive (S/N SOP201) llergy Testing (Specific IgE) 2 site non-competitive (S/N SOP160) nti-thyroid Peroxidase (TPO) 2 site non-competitive (S/N SOP150) NTproNP 2 site non-competitive (S/N SOP161) Growth Hormone 2 site non-competitive (S/N SOP155) IgE (Total) 2 site non-competitive (S/N SOP156) Phenobarbitone Competitive (S/N SOP202) ssessment Manager: WH Page 10 of 14

11 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: Urine Using Thermo Indiko by colourimetry with reference to the following in-house documented procedures: Creatinine S/ SOP83 ngiotensin Converting Enzyme S/N SOP4 ile cids S/N SOP180 lood Zinc S/N SOP111 Serum & urine Detection of normal and abnormal protein electrophoretic patterns SOPs S/N SOP by electrophoresis and immunofixation using Sebia Hydrasys Detection of Cryoglobulins S/N SOP20 using Sebia Hydrasys lood Glycated Haemoglobin S/N SOP38 using Tosoh G8 (ion exchange chromatography) Serum & urine Osmolality S/N SOP67 using dvanced Micro-Osmometer (freezing point depression) & Urine Urine 5-HI Normetadrenaline & metadrenaline SOP S/N SOP64 & SOP63 by HPLC with electrochemical detection using Chromsystems HPLC analyser Sweat Chloride N/S SOP119 by coulometry using Chloro-chek Chloride nalyser ssessment Manager: WH Page 11 of 14

12 General iochemistry HUMN ODY FLUIDS iochemical examination clinical diagnosis: CSF ilirubin S/ SOP55 using UVICON XS Scanning Spectrophotometer Urine HCG S/ SOP109 using Surestep Pregnancy Testing Kit lood lood Gases: (pco2, p02, ph Carboxyhaemoglobin Methaemoglobin) S/ SOP109 using Roche Cobas b221 Gas nalyser (potentiometry) & HUMN ODY FLUIDS lood (unless otherwise stated) Haematology Haematological examination clinical diagnosis: Full lood Count nalysis: Haemoglobin White lood cells Platelets Red blood cells PCV MCV MCH MCH MCHC RDW Reticulocytes S/Y SOP41 using dvia 2120i & Coagulation: In-house documented procedures using CL TOPS 550 with specific reference to: Coagulation Screen (INR, PTT) Functional assay (S/ SOP29) & ntithrombin level Chromogenic assay (S/ SOP14) D-Dimer Immunoassay (S/ SOP35) & ssessment Manager: WH Page 12 of 14

13 Haematology HUMN ODY FLUIDS lood (unless otherwise stated) Haematological examination clinical diagnosis: Factor ssays Functional / chromogenic assays (S/Y SOP41 & 188) Fibrinogen Functional assay (S/ SOP78) & Lupus nticoagulant Functional assay (S/Y SOP17) Protein S/C Functional / chromogenic assays (S/ SOP15 & S/Y SOP13) VWF activity & VWF Ristocetin Functional assay (S/Y SOP188) Erythrocyte Sedimentation Rate Differential White lood Cell count G6PD Haemoglobinopathy Screening Hb2 / HbF) H S Screening Infectious Mononucleosis Screening Malaria Parasites Rapid Screening: P Falciparum, P Vivax, P Ovale, P Malariae S/Y SOP60 using Sedivette Gravity Manual method using S/ SOP17 Manual flourescence method using S/ SOP13 S/ SOP90 using TOSOH G8 Manual solubility method using SOP S/ SOP99 S/ SOP12 using Clearview IM S/ SOP107 using Care Start malaria g kit & & & & & ssessment Manager: WH Page 13 of 14

14 lood Transfusion HUMN ODY FLUIDS lood (unless otherwise stated) Examination activities for the purposes of clinical diagnosis: utomated lood Grouping and Screening Positive Negative Positive Negative O Positive O Negative Positive Negative S/T SOP11,31,20,69 using Ortho Vision & ntibody identification: Rh: D, C, E, c, e, f, V, C W Kell: K, k, kp a, kp b, Js a, Js b Duffy: Fy a, Fy b Kidd: Jk a, Jk b Lewis: Le a, Le b P: P1 MNS: M, N, S, s Luth: Lu a, Lu b Xy: Xy a S/T SOP11,31,20,69 using Ortho Vision & Manual lood Grouping, & ntibody identification(panels) S/T SOP 11,51,30, using Ortho system & Crossmatch (Manual) S/T SOP11, 31, 35, 38, 47 & 61 using Ortho system & Detection of foetal maternal hemoglobin Manual cytochemical method using S/T SOP3 & END ssessment Manager: WH Page 14 of 14