Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK NHS Ayrshire and Arran Issue No: 002 Issue date: 10 May 2019 Department of Biochemistry Contact: Gordon Taylor NHS Ayrshire and Arran Tel: +44 (0)1563 827449 9786 University Hospital Crosshouse E-Mail: [email protected] Kilmarnock Accredited to KA2 0BE ISO 15189:2012 Testing performed by the Organisation at the locations specified below Locations covered by the organisation and their relevant activities Laboratory locations: Location details Activity Location code Address Local contact A Department of Biochemistry Gordon Taylor Clinical Biochemistry University Hospital Crosshouse Kilmarnock KA2 0BE Address Local Contact Department of Biochemistry Gordon Taylor Clinical Biochemistry B University Hospital Ayr Dalmellington Road Ayr Ayrshire KA6 6DX Assessment Manager: KS Page 1 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and activities for the purposes of manufacturers instructions for : clinical diagnosis: Roche Cobas 8000 system (A+B) C702/e602 x2 (A) c702/e602 x1 (B) Using Photometric methods: Serum/plasma Albumin LPB COB017 A B Serum/plasma Alkaline phosphatase LPB COB009 A B Serum/plasma Digoxin LPB COB033 A Serum/plasma Direct Bilirubin LPB COB008 A Serum/plasma Iron LPB COB027 A Serum/plasma/ CSF Lactate LPB COB032 A B Serum/plasma Lithium LPB COB046 A Serum/plasma/urine Magnesium LPB COB025 A B Serum/plasma/urine Phosphate LPB COB019 A B Serum/plasma Bilirubin LPB COB007 A B Serum/plasma/ CSF/Urine Total Protein LPB COB016 A B Serum/plasma GGT LPB COB014 A Serum/plasma HDL cholesterol LPB COB022 A B Serum/plasma Triglyceride LPB COB023 A B Assessment Manager: KS Page 2 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for: clinical diagnosis: (cont’d) Roche Cobas 8000 system (A+B) c702/e602 x2 (A) c702/e602 x1 (B) Using enzymatic/colorimetric methods: Serum/plasma Urate LPB COB026 A B Using Immunoassay methods Serum/plasma Beta HCG LPB COB056 A CA-125 LPB COB044 A CA-19-9 LPB COB053 A Cortisol LPB COB058 A FSH LPB COB064 A LH LPB COB063 A Macroprolactin A Oestradiol LPB COB047 A Progesterone LPB COB057 A Prolactin LPB COB065 A EDTA plasma PTH LPB COB070 A Serum/Plasma Testosterone LPB COB059 A Troponin-T LPB COB042 A B Siemens Centaur Using Immunoassay methods: Serum/Plasma AFP LPB CEN012 A CEA LPB CEN013 A Free T3 LPB CEN004 A Free T4 LPB CEN003 A PSA LPB CEN015 A TSH LPB CEN002 A Roche Cobas 8000 system (A+B) c702/e602 x2 (A) c702/e602 x1 (B) Serum/plasma Alpha-1-antitrypsin LPB COB054 A CRP LPB COB024 A B IgA LPB COB060 A IgG LPB COB060 A IgM LPB COB060 A Assessment Manager: KS Page 3 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for : clinical diagnosis: (cont’d) Roche Cobas 8000 system (A+B) c702/e602 x2 (A) c702/e602 x1 (B) Using immunoturbidometric assay methods: Urine Microalbumin LPB COB040 A Using enzymatic assay methods: Serum/plasma Ammonia LPB COB049 A Serum/plasma Alanine aminotransferase LPB COB011 A B Aspartate aminotransferase LPB COB010 A B Serum/plasma/urine Amylase LPB COB015 A B Serum/plasma Bicarbonate LPB COB006 A B Serum/plasma Cholesterol LPB COB021 A B Serum/plasma Alcohol LPB COB031 A B Serum/plasma/CSF Glucose LPB COB020 A B Serum/plasma Lactate Dehydrogenase LPB COB013 A B Serum/Plasma Salicylate LPB COB029 A B Serum/plasma/urine Paracetamol LPB COB030 A B Serum/plasma/urine Calcium LPB COB018 A B Assessment Manager: KS Page 4 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for : clinical diagnosis: (cont’d) Roche Cobas 8000 system (A+B) c702/e602 x2 (A) c702/e602 x1 (B) Using photometric assay method Serum/plasma Creatinine kinase LPB COB012 A B Serum/plasma Unsaturated Iron binding LPB COB028 A concentration Using enzymatic immunoassay methods: Serum/plasma Tobramycin LPB COB052 A Serum/plasma Valproate LPB COB038 A Serum/plasma Digoxin LPB COB033 A Using Jaffe kinetic colorimetric methods: Serum/plasma/urine Creatinine LPB COB004 A B Using kinetic photometric methods: Serum/plasma/urine Urea LPB COB003 A B Using KIMS methods: Serum/plasma Carbamazepine LPB COB034 A Serum/plasma Phenytoin LPB COB036 A Serum/plasma Phenobarbitone LPB COB035 A Serum/plasma Theophylline LPB COB048 A Serum/plasma Gentamicin LPB COB055 A Serum/plasma Vancomycin LPB COB050 A Assessment Manager: KS Page 5 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for : clinical diagnosis: (cont’d) Roche Cobas 8000 system (A+B) c702/e602 x2 (A) c702/e602 x1 (B) Using ISE methods: Serum/Plasma/urine Chloride LPB COB005 A B Potassium LPB COB005 A B Sodium LPB COB005 A B Ivicon XS Spectrophotometer using spectrophotometry methods: CSF Xanthochromia LPB MIS022 A Alere Easy HCG kit using immunochromatographic methods: Urine HCG LPB MIS021 A Advanced Instruments Micro osmometer 3300 using freezer point depression: Serum/plasma/urine Osmolality LPB MIS010 A Corning 925 Chloride analyser measuring conductivity: Sweat Chloride/conductivity LPB MIS014 A Menarini/Arkray Adams HA-8160: HPLC Whole Blood HbA1c LPB HPL003 A Assessment Manager: KS Page 6 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemistry examination Documented in house methods and (cont’d) activities for the purposes of manufacturer’s instructions for: clinical diagnosis: (cont’d) Gilson HPLC with Chromsystems specific kit: Urine VMA LPB HPL001 A 5HIAA LPB HPL001 HVA LPB HPL001 Adrenaline LPB HPL002 Noradrenaline LPB HPL002 Dopamine LPB HPL002 Normetadrenaline LPB HPL004 Metadrenaline LPB HPL004 Sebia Hydrasis using Hydragel- Electrophoresis and immunofixation Protein electrophoresis Serum/Plasma/urine monoclonal bands LPB PRO003 A Immunofixation Serum/plasma/urine Characterising abnormal LPB PRO004 A protein bands identified during routine protein electrophoresis Calculated tests for the Documented in house methods and A purposes of clinical diagnosis manufacturer’s instructions using B LFB LAB004 and the following analysers Serum/Plasma Globulin Roche C8000 Serum/Plasma Adjusted calcium Roche C8000 Serum/Plasma EGFR Roche C8000 Serum/Plasma Cholesterol/HDL ratio Roche C8000 Serum/Plasma LDL cholesterol Roche C8000 Urine 24 hr Sodium Roche C8000 Urine 24 hr Potassium Roche C8000 Urine 24 hr Urea Roche C8000 Assessment Manager: KS Page 7 of 8 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK NHS Ayrshire and Arran 9786 Issue No: 002 Issue date: 10 May 2019 Accredited to ISO 15189:2012