Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
Issue No: 004 Issue date: 04 January 2021
Department of Biochemistry Contact: John Hepburn McEwan Building Tel: +44 (0) 141 211 5534 Glasgow Royal Infirmary E-Mail: [email protected] 9572 Castle Street Website: http://www.nhsggc.org.uk/
Accredited to Glasgow ISO 15189:2012 G4 0SF
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 Core Chemistry A Department of Biochemistry As above Immunoassay McEwan Building Endocrinology Glasgow royal Infirmary Electrophoresis Castle Street Gastroenterology Glasgow Vitamins G4 0SF Trace Elements
Biochemistry As above Core Chemistry B Gartnavel general Hospital Immunoassay 1053 Great Western Road Glasgow G12 0YN
Biochemistry As above Core Chemistry C Stobhill ACH 133 Balornock Road Glasgow G21 3UW
Assessment Manager: CM Page 1 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Site activities performed away from the locations listed above:
Location details Activity Location code
Diabetic Clinic As above HbA1C D Gartnavel general Hospital 1053 Great Western Road Glasgow G12 0YN
Clinic D As above HbA1C E Stobhill ACH 133 Balornock Road Glasgow G21 3UW
Assessment Manager: CM Page 2 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS activities for the purposes of and manufacturer’s instructions clinical diagnosis
Core Chemistry Abbott Architect Chemistry SOP CP 129 c16000 A c8000 B c8000 C
Serum Alanine transaminase (ALT) Photometric end/detection point A, B, C Alkaline phosphatase (ALP) Amylase Aspartate transaminase (AST) Bicarbonate Bilirubin (Total) Calcium C-reactive Protein Creatine Kinase A, B Electrolytes A, B, C • Sodium • Potassium • Chloride Gamma-Glutamyl Transferase Magnesium Cholesterol A, B Immunoglobulins (IgA, IgG,IgM) Bilirubin Conjugated A Digoxin Haptoglobin Lactate Paracetamol Phenobarbitone Phenytoin Phosphate A,B,C Salicylate Theophylline Urate A Angiotensin-converting B enzyme Transferrin A, B Triglycerides Iron
Assessment Manager: CM Page 3 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Core Chemistry (cont’d) Abbott Architect Chemistry SOP CP 129
Plasma Lipoprotein (a) Photometric end/detection point A
Serum/plasma Ethanol A HDL A, B HIL Index A, B, C Lipase B
Serum/plasma/CSF Glucose A, B, C
Serum/urine Enzymatic creatinine A, B, C
Serum Urea A, B, C
Serum Lactate DeHydrogenase A, B Urea A, B, C
Serum Protein A, B, C
CSF Protein A, B
Urine Oxalate A
Serum Albumin A, B, C
Serum Alpha 1-antitrypsin A Caeruloplasmin
Plasma Apolipoprotein A1 Apolipoprotein B
Serum Carbamazepine A
Serum Lithium A
Serum Gentamicin A Tobramycin A
Assessment Manager: CM Page 4 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d )
Core Chemistry (cont’d) Abbott Architect Chemistry SOP CP 129 Serum Valproate A Vancomycin A, C
Abbott Alinity ci A SOP INST 0570 Serum/Plasma • Albumin Spectrophotometry-Absorbance • ALP • ALT • Amylase • AST • Total Bilirubin • Calcium
• Creatinine Enzymatic
• Ethanol
• Glucose • Gamma-Glutamyl Transferase • Lactate • Paracetamol • Phosphate • Salicylate • Urate • Urea
• Chloride Ion selective electrode (ISE) • Potassium • Sodium
• CRP Turbidimetric
• Cholesterol Spectrophotometry-Enzymatic • Creatinine Kinase • Direct Bilirubin • LDH • Magnesium • Triglyceride
Assessment Manager: CM Page 5 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d ) Abbott Alinity ci A SOP INST 0570
Serum/Plasma • BHCG Chemiluminescent microparticulate • HSTNI immunoassay (CMIA) • Gentamycin • Vancomicin
Abbott Architect Immunoanalyser A, B ISR 2000 SOP CP 129 Serum Alpha Fetoprotein A, B
Cancer Antigen 125 (Abbott) CarcinoEmbryonic Antigen Human Chorionic Gonadotropin Prostate Specific Antigen Thyroid Stimulating Hormone (TSH) FreeT4
Cortisol A Dehydroepiandrosterone sulfate (DHAS) Ferritin Folates FSH Methotrexate Progesterone Prolactin Sex Hormone Binding Globulin Testosterone Triiodothyronine (total) (T3) TPO AB
Vitamin B12 Vitamin D
Plasma Brain natriuretic Peptide A Insulin Parathyroid Hormone Troponin I hs
Assessment Manager: CM Page 6 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Core Chemistry (cont’d) ISR 2000 Abbott Architect Immunoanalyser SOP CP 129 Serum/plasma Luteinising Hormone A Oestradiol
Serum Macroprolactin PEG precipitation A SOP ENDO045 Special Chemistry
Blood HbA1C Menarini HA 8180 D, E Reverse Phase Cation exchange SOP CP 201
Serum/urine Osmolality Vitech advanced micro-osmometer A, B, C Freezing point Depression SOP CP 091
Beckman Access- CMIA A
Serum Anti-Mullerian hormone SOP ENDO 101
Plasma Erythropoietin SOP ENDO 120
Grifols’s Triturus Analyser -ELISA A
Faeces Calprotectin SOP GP 015
Serum Thyroid receptor AB (Trab) SOP ENDO 016
Assessment Manager: CM Page 7 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Special Chemistry (cont’d) Berthold Gamma Counter-RIA A Plasma/serum 1,25-dihydroxyvitamin D SOP ENDO 017 (calcitriol)
Plasma Calcitonin SOP ENDO 012
Siemens Immulite 2000XPi-CMIA A Plasma Adrenocorticotropic hormone SOP ENDO 046 C-peptide SOP ENDO 023 Gastrin SOP ENDO 086
Serum Growth hormone SOP ENDO 021
Thyroglobulin SOP ENDO 031
Thyroglobulin Antibody SOP ENDO 030
Serum Insulin like growth factor 1 IDS iSYS Automated Analyser A CMIA SOP ENDO 093
XEVO TQ-S liquid chromatography A tandem mass spectrometer
Blood spot 17-Hydroxyprogesterone SOP ENDO 098
serum Androgen Profile SOP ENDO 089 • Testosterone • Androstenedione • 17α-hydroxyprogesterone
Urine Cortisol SOP ENDO 094
Serum Vitamin D (D2 D3 Total) SOP ENDO 070
Plasma/serum/urine Calculated tests • AKI By Calculation A, B, C • eGFR By MDRD Calculation A, B, C • LDL Cholesterol By Friedwald Calculation A • Adjusted calcium By Calculation A, B, C
Assessment Manager: CM Page 8 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Special Chemistry (cont’d) Thermo TSQ 8000 Analyser GC A Mass Spectrometry
Urine Steroid profile: SOP STER 001 • Androsterone • Aetiocholanolone • dehydroepiandrosterone (DHA),11- oxaetiocholanolone, • 17-hydroxypregnanolone, • 11β-hydroxyandrosterone, • 11β- hydroxyaetiocholanolone, • 16α-hydroxy-DHA, Pregnanediol, • Pregnanetriol, Androstenetriol, Tetrahydrodeoxycortisol, • tetrahydro- 11deoxycorticosterone, • 11-oxopregnanetriol, Pregnenetriol, tetrahydrocortisone, tetrahydro-11- • dehydrocorticosterone, tetrahydrocorticosterone(T HB) • allo-THB, • tetrahydrocortisol (THF), • allo-THF, • α-cortolone, • β-cortol, • β-cortolone
Assessment Manager: CM Page 9 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Proteins Sebia Hydrasys 2-electrophoresis A
Serum ALP Isoenzymes SOP ENDO 018
Cryoglobulin SOP MS 005
Plasma Cryofibrinogen SOP MS 005
Serum/urine Monoclonal bands Immunofixation SOP MS 004
Urine Protein bands Sebia Hydrasys 2 EP Electrophoresis SOP MS 029
Serum Protein Bands SEBIA Capillarys 2-Electrphoresis SOP MS 027
Vitamins Waters HPLC System HPLC; A photometric detection
Plasma/serum A SOP VIT 001 E K1/ PhylQ SOP VIT 020
Plasma Beta-Carotene SOP VIT 001
Whole blood B1 Thiamine SOP VIT 002
Packed red cells B2 SOP VIT 004 B6
Assessment Manager: CM Page 10 of 11
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Greater Glasgow and Clyde
9572 Issue No: 004 Issue date: 04 January 2021 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 TISSUES AND Biochemistry Examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of and manufacturer’s instructions clinical diagnosis (cont’d)
Trace Elements Agilent 7700 ICP-MS A
Urine Cadmium SOP TE 154 Arsenic Chromium Cobalt Copper SOP TE164 Iron Magnesium Nickel SOP TE 154 Zinc SOP TE 164
Blood Chromium SOP TE 153 Cobalt Lead SOP TE 163 Manganese Mercury
Agilent 7900 ICP-MS A
Hair Arsenic SOP TE 165 Mercury Urine Mercury
Liver Iron Copper
Red cells Selenium SOP TE 174
Plasma Aluminium SOP TE 035 Copper SOP TE 145 Selenium SOP TE 145 Zinc SOP TE 145
END
Assessment Manager: CM Page 11 of 11