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

NHS 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 E-Mail: [email protected] 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 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

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 Calculated tests for the Documented in house methods and A (cont’d) purposes of clinical diagnosis manufacturer’s instructions using B (cont’d) LFB LAB004

Urine 24 hr Creatinine Roche C8000

Urine 24 hr Calcium Roche C8000

Urine 24 hr Phosphate Roche C8000

Urine 24 hr Amylase Roche C8000

Urine 24 hr Total Protein Roche C8000

Urine Protein/Creatinine ratio Roche C8000

Urine Creatinine Clearance Roche C8000

Urine Microalbumin Roche C8000

Urine 24 hr glucose Roche C8000

Urine Calcium/Creatinine ratio Roche C8000

Serum/Plasma Saturation Roche C8000

Urine/Serum/Plasma Amylase/creatinine clearance Roche C8000

Urine Phosphate/creatinine ratio Roche C8000

Urine/Serum/Plasma Urine/Plasma Osmolality LIMS

Whole blood HbA1c LIMS

Serum/Plasma Alcohol Roche C8000

Serum/Plasma TIBC Roche C8000

END

Assessment Manager: KS Page 8 of 8