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

NHS

Issue No: 008 Issue date: 10 September 2021

Blood Sciences Department Contact: Zeshan Mahmood Zone 3 Laboratories (1st Floor) Tel: +44 (0)1463 704113

9610 Hospital E-Mail: [email protected] Old Perth Road Accredited to ISO 15189:2012 IV2 3UJ 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

Raigmore Hospital Zeshan Mahmood Routine Clinical Chemistry and A Zone 3 Laboratories (1st Floor) Tel: 01463 704113 Immunochemistry Email: Miscellaneous Chemistry Old Perth Road [email protected] Routine haematology and Coagulation, Inverness Haematinics IV2 3UJ Haemoglobinopathy screening

Laboratory Tina Webster Routine Clinical Chemistry and B Tel: 01397 707423 Immunochemistry Belford Road Email: [email protected] Routine haematology and Coagulation Fort William Manual Blood group serology PH33 6BS

Laboratory Johan Campbell Routine Clinical Chemistry Routine C General Hospital Tel: 01955880266 or 267 haematology and Coagulation Bankhead Manual Blood group serology Wick Email: KW1 5NS [email protected]

Site activities performed away from the locations listed above:

Location details Activity Location code

Blood Fridge Belford Pre-assessment Unit Blood Storage only D

Assessment Manager: CM Page 1 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Blood Transfusion In house documented procedures AND TISSUE examination activities for the based on manual gel methods purpose of clinical diagnosis using-

Blood Blood Group Diamed ABO and rhesus blood B and C • A group BSBT 005, • B • O • Rh

Antibody detection Diamed antibody screen BSBT 06, 3 cell panel

Crossmatch-Compatibility Diamed crossmatch procedure testing of patients’ plasma with BSBT 07 donor cells

Direct Antiglobulin (DAGT) Diamed direct antiglobulin test BSBT 008

Biochemistry examination In house documented procedures activities for the purpose of based on equipment manuals and clinical diagnosis standard methods using- Advia 2400(SOP-BSL 117)

Serum Albumin Detected by Photometry. A, Alkaline Phosphatase ALT Amylase AST Bicarbonate Bilirubin, total Calcium Cholesterol Creatinine (Jaffe) Creatine Kinase (CK) Gentamicin Gamma Glutamyl Transferase Glucose HDL-Cholesterol

Assessment Manager: CM Page 2 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Biochemistry examination In house documented procedures AND TISSUE (cont’d) activities for the purpose of based on equipment manuals and clinical diagnosis (cont’d) standard methods using- Advia 2400(SOP-BSL 117) A

Serum Magnesium Detected by photometry cont. A, Urea Phosphate Triglycerides

Toxicology • Ethanol • Paracetamol • Salicylate

Urate

Lactate Dehydrogenase (LDH) A

Plasma Glucose A,

Lactate A

Serum Bilirubin, direct A Carbamazepine Creatinine (Enzymatic) Digoxin Lithium Phenobarbitone Phenytoin Serum Iron Theophyline Tobramycin Valproate Vancomycin

Plasma Ammonia

CSF Glucose BSL 117

Total protein

Serum Sodium Detected by ISE A, Potassium Chloride

Assessment Manager: CM Page 3 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Biochemistry examination In house documented procedures AND TISSUE (cont’d) activities for the purpose of based on equipment manuals and clinical diagnosis (cont’d) standard methods using- Urine Siemens Advia 2400 (BSL 117) A Creatinine (Jaffe) by ion selective electrodes Potassium Sodium Microalbumin By Photometry Protein Urea

Siemens Advia 1800 B and C SOP BSL 022 by Photometry Serum Sodium Potassium Chloride Albumin Ethanol_ Alkaline Phosphatase_ Alanine Aminotransferase Amylase AST (GOT) Total Bilirubin Calcium Cholesterol Direct HDL Cholesterol Creatine Kinase CRP_ Gamma-Glutamyl Transferase Gentamicin_ Glucose Magnesium Acetaminophen Phosphate Salicylate Total Protein Triglycerides_ Urea Uric Acid

Serum LDH B Plasma Lactate

Serum Creatinine (Enzymatic) B and C

Assessment Manager: CM Page 4 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Biochemistry examination In house documented procedures AND TISSUE (cont’d) activities for the purpose of based on equipment manuals and clinical diagnosis (cont’d) standard methods using-

Serum By Friedwald Calculation BSL 117 A, LDL Cholesterol By CKD-EPI Calculation eGFR By calculation BSL 116 Adjusted/corrected Calcium By calculation Free androgen index (FAI)(male only)

Urine Albumin/Creatinine Ratio By calculation A Protein/Creatinine Ratio SOP BSL 117 Creatinine clearance

Serum Chemistry-Immunoassay using Chemiluminescent Immunoassay (CMIA) Siemens Centaur XP (BSM 116) A Siemens Centaur CP (BSL 010) B Ferritin A, B Folic acid Free thyroxine

PSA TSH Vitamin B12

HCG

Plasma High Sensitive Troponin-I Architect i2000 A (hsTrop-I) Immunoassay BSL 124

Serum Troponin I Siemens Centaur CP (BSL 010) B

Whole Blood Troponin I iSTAT Cardiac Troponin I test C cartridge- ELISA BSL327

Assessment Manager: CM Page 5 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Biochemistry examination In house documented procedures AND TISSUE (cont’d) activities for the purpose of based on equipment manuals and clinical diagnosis (cont’d) standard methods using-

Siemens Centaur XP (BSL 116) A using suppliers’ methods and measurement by immunoassay. Serum AFP

CEA Cortisol FSH LH Oestradiol Progesterone Prolactin PTH CA125 Testosterone (male only)

Whole blood Tacrolimus Abbott Architect supplier method A and measurement by immunoassay BSL 121

Miscellaneous Biochemistry

CSF Xanthochromia Suppliers (Perkin Elmer and A WinLab) method and measurement by spectrophotometry BSL 102 using North Star BIO- UV Spectrophotometre

Urine Drugs of Abuse screen Nal Von Minden drug-screen dip A test BSL 112

Serum/Urine Osmolality Vitech MicroOsmometer 3320 A supplier’s method and measurement by freezing point depression BSL 110

Assessment Manager: CM Page 6 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Biochemistry examination In house documented procedures AND TISSUE (cont’d) activities for the purpose of based on equipment manuals and clinical diagnosis (cont’d) standard methods using-

Urine hCG Alere Testpack Plus hCG COMBO B, C using manufacturers’ instructions BSL 107

Whole blood HbA1C TOSOH G8 supplier method A measurement by HPLC BSL 114

Haematology examination Documented In-house methods activities for the purpose of using: ACL TOPS 500 clinical diagnosis

Venous Blood: Citrated Blood Coagulation

• Prothrombin time Turbidimetric method A, B, C o INR Clot detection by optical rate of • Activated Partial change of absorbance end point Thromboplastin Time being the maximum rate of change SOP BSL 252 • Thrombin Time • Fibrinogen estimation o Clauss

• DDimers Latex method: - SOP: BSL 252

Factors assays (Intrinsic) BSL 254 A • VIII • IX • XI • XII

Factors assays (Extrinsic) BSL 253 A • II • V • VII • X

Factor Inhibitor Screen Factor BSL 259 Inhibitor Assay BSL 263

Assessment Manager: CM Page 7 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Haematology examination Documented In-house methods AND TISSUE (cont’d) activities for the purpose of using: ACL TOPS 500 clinical diagnosis (cont’d)

Anti-Xa Assay Chromogenic A SOP: BSL 255

Von Willebrand Factor Latex method o Antigen SOP: BSL 256 o Activity

Thrombophilia screen; - BSL 257 • Anti-Thrombin clot detection • protein C Chromogenic • protein S Chromogenic 257 Lupus Screen latex BSL 258-clot detection

Siemens Advia 2120i, supplier A, B, C methods and measurement by; SOP BSL 201

FBC; - • Haemoglobin colorimetry • Red Cell Count Light scatter • Platelet Count • Mean Cell Volume by calculation • HCT • MCH • MCHC flow cytometry • Nucleated Red Cell

Count

• White Blood Cell light scatter, and impedance Count (total) • Neutrophil Count • Lymphocyte Count • Monocyte Count • Eosinophil Count • Basophil Count • Reticulocyte Count

Assessment Manager: CM Page 8 of 9

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

NHS Highland 9610 Issue No: 008 Issue date: 10 September 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 BODY FLUIDS Haematology examination Documented In-house methods AND TISSUE (cont’d) activities for the purpose of using: clinical diagnosis (cont’d)

Whole Blood Blood Films: Modified Wrights stain and Light A, B, C Morphology microscopy BSL 202(manual preparation), BSL 205 (reporting) BSL 204 Advia 2120i Autoslide A

Haemoglobinopathy Screening TOSOH G8 supplier method A • HbA2 measurement by HPLC BSL 221 • HbF • HbA • HbS

Glucose 6-phosphate Trinity Biotech enzyme method A dehydrogenase using spectrophotometry BSL 217

Plasma viscosity Benson viscometer suppliers’ A method and measurement by plasma viscosity BSL 209

Infectious Mononucleosis Rapid Clearview IM II lateral flow A, B, C antibody immunoassay BSL 015

END

Assessment Manager: CM Page 9 of 9