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 Issue No:002 Issue date: 12 February 2019 Pennine cute Hospitals NHS Trust Trust Headquarters North Manchester General Hospital Delaunays Road Manchester M8 5RB Contact: Michelle Hurst Tel: +44 (0) Website: Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress: Biochemistry Department Royal Oldham Hospital Rochdale Road Oldham OL1 2JH United Kingdom Local contact: Michelle Hurst General Biochemistry (rchitect ci16000& ci8000) Endocrinology Toxicology Site activities performed away from the locations listed above: details ctivity code Essential Services Laboratory Fairfield General Hospital Rochdale Old Road Bury BL9 7TD United Kingdom General Biochemistry (rchitect ci8000) Endocrinology Toxicology B Essential Services Laboratory North Manchester General Hospital Delaunays Road Manchester M8 5RB United Kingdom General Biochemistry (rchitect ci8000) Endocrinology Toxicology C ssessment Manager: CK1 1 of 9

2 DETIL OF CCREDITTION clinical diagnosis General chemistry bbott rchitect by the following principles using, Plasma lbumin using Bromocresol purple, B, C lkaline phosphatase using Paranitrophenyl phosphate, B, C lpha 1 ntitrypsin lpha feto protein, Plasma lanine amino transferase using NDH without P-5-P, B, C Plasma mmonia using Glutamate dehydrogenase, B, C Plasma, mylase using 2-Chloro-p-nitrophenyl-GD maltrioside, B, C only, plasma spartamine amino transferase using NDH without P-5-P, B, C, plasma Bicarbonate using PEP carboxylase, B, C Bile cids using TB enzyme cycling Bilirubin Conjugated using Diazo colourimetry, B, C Bilirubin Total using Diazo colourimetry, B, C, Plasma Calcium using enzymatic arsenazo III, B, C only, Chloride using ICT chip method indirect, B, C only ssessment Manager: RC4 Page 2 of 9

3 General chemistry bbott rchitect by the following principles using, plasma Cholesterol using enzymatic GOD PP, B, C Creatine Kinase using NC, B, C Creatinine using kinetic alkaline picrate, B, C only, plasma C-Reactive Protein (CRP), B, C, plasma Ethanol using enzymatic methods, B, C only, plasma Gamma GT using IFCC standardised GGCN, B, C Plasma CSF Glucose using hexokinase, B, C only, plasma Haptoglobin HDL Cholesterol using accelerator selective DHE, B, C, plasma IG IGG IGM ssessment Manager: RC4 Page 3 of 9

4 General chemistry bbott rchitect by the following principles using, plasma Iron using colourimetric ferene Plasma, Lactate using lactic acid-pyruvate enzymatic PP, B, C Plasma Lactate Dehydrogenase using IFCC 2002 lactic acidpyruvate, B, C,, plasma Magnesium using enzymatic arsenazo III, B, C, plasma Phosphate using phosphomolybdate, B, C only, plasma Paracetamol using colourimetry, B, C, plasma Potassium using ICT chip indirect method, B, C only, plasma Total Protein using Biuret, B, C, CSF Protein using Benzemethonium chloride Rheumatoid Factor, plasma Salicyclate using colourimetry, B, C, Plasma, Sodium using ICT chip indirect method, B, C only ssessment Manager: RC4 Page 4 of 9

5 General chemistry bbott rchitect by the following principles using, plasma Transferrin, plasma Triglycerides using GPO, B, C, plasma Troponin I, B, C, plasma, Urate using Uricase, B, C Urea using Urease, B, C only, plasma Vitamin D Therapeutic Drug Monitoring bbott rchitect by the following principles using & plasma Carbamazepine using enzyme immunoassay Digoxin Gentamicin using turbidimetry, B, C Lithium using colurimetry Phenytoin Sodium Valproate using turbidimetry ssessment Manager: RC4 Page 5 of 9

6 Therapeutic Drug Monitoring (cont d) bbott rchitect by the following principles using & plasma Theophyilline using enzyme immunoassay Vancomycin using turbidimetry, C Tumour Markers bbott rchitect by the following principles using & plasma C-125 by chemiluminescence CE PS, B, C & plasma C-153 C-199 Roche Cobas e411 by chemiluminescence using SOP BC-SOP-53 HCG Total ssessment Manager: RC4 Page 6 of 9

7 Blood Gases Whole blood Quantitation of: Bicarbonate ctual Bicarbonate Std - calculated Base Excess - calculated Carboxyhaemoglobin Haemoglobin Methaemoglobin Oxygen Saturation - calculated Oxyhaemoglobin PCO2, PH, PO2 BC-SOP-98 based on equipment manuals and standard methods using Instrumentation Laboratories GEM 4000, C Endocrinology BC-SOP-7, BC-SOP-74, BC-SOP- 75 based on equipment manuals by chemiluminescence using bbott rchitect & plasma FSH FT3 FT4 HCG Pregnancy LH Progesterone Prolactin (macroprolactin) Testosterone TSH Oestradiol Parathyroid, B, C, B, C, B, C Sex hormone binding globulin, plasma, urine Cortisol ssessment Manager: RC4 Page 7 of 9

8 Electrophoresis Detection of normal & abnormal protein electrophoretic patterns SOP by capillary electrophoresis using BC-SOP- 46 Sebia Capillarys 2, urine Detection of monoclonal components SOP BC-SOP-45 BC-SOP-46 by gel electrophoresis using Sebia Hydrasys 2 Quantification of Bence Jones Protein SOP BC-SOP-45, BC-SOP-46 by gel electrophoresis using Sebia Capillarys 2 /Hydrasys 2 Paraprotein quantitation SOP BC-SOP-45, BC-SOP-46 by capillary and gel electrophoresis using Sebia Capillarys 2 /Hydrasys 2, urine Osmolality SOP BC-SOP-38 by freezing point depression using Vitech Osmometer NT Pro BNP SOP BC-SOP-89 by ELF using Vidas 3 Whole blood Hb1c SOP BC-SOP-9 by HPLC using TOSOH G8 (x5) CSF Xanthochromia screening SOP BC-SOP-4 by spectrophotometry using Northstar Scientific, B, C ssessment Manager: RC4 Page 8 of 9

9 Human body fluids as stated Sweat Conductivity SOP BC-SOP-18 using WESCOR system and conductance meter Sweat Measurement of Sweat chloride WESCOR Chlorochek Chloride meter using SOP: BC-SOP-18 volume Weighing on calibrated balance using SOP: BC-SOP-37, B, C Calculated values Using SOP: BC-REC-4 Plasma, Plasma,, Plasma, cute Kidney Injury (KI) Corrected Calcium Cholesterol/HDL ratio LDL Cholesterol EGFR Creatinine Clearance Calcium/creatinine ratio Hammersmith Free ndrogen Index Prolactin Recovery Transferrin Saturation 24 hour urines Protein /Creatinine ratio lbumin/creatinine ratio Calcium/Creatinine ratio, B, C END ssessment Manager: RC4 Page 9 of 9