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 Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK ccredited to Laboratory locations: Pathology Laboratory Ealing Hospital Uxbridge Road Southall Middlesex UB1 3HW Contact: Gavyn Barrett Tel: +44 (0) Gavyn.barrett@tdlpathology.com Website: below s covered by the organisation and their relevant activities details ctivity code ddress Pathology Laboratory Ealing Hospital Uxbridge Road Southall Middlesex UB1 3HW Local contact Biochemistry Haematology Blood Transfusion Serology Histology Pathology Laboratory BMI Clementine Churchill Hospital Sudbury Hill Harrow Middlesex H1 3RX Biochemistry Haematology B Pathology Laboratory BMI Mount lvernia 46 Harvey Road Guildford GU1 3LX Biochemistry Haematology C ssessment Manager: MP Page 1 of 17

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Site activities performed away from the locations listed above: details ctivity code BMI Hendon Hospital 46/50 Sunny Gardens Rd London NW4 1RP Blood issue fridge for storage of blood products only; no testing occurs at this site D BMI Cavell Hospital Cavell Drive Upland Park Road Enfield EN2 7PR Blood issue fridge for storage of blood products only; no testing occurs at this site E BMI The Chiltern Hospital London Road Great Missenden Buckinghamshire HP16 0EN Blood issue fridge for storage of blood products only; no testing occurs at this site F BMI Princess Margaret Osborne Road Windsor Berkshire SL4 3SJ Blood issue fridge for storage of blood products only; no testing occurs at this site G BMI Kings Oak Hospital Chase Farm Ridge Way Enfield EN2 8SD Blood issue fridge for storage of blood products only; no testing occurs at this site H BMI The Bishopswood Rickmansworth Road Northwood Middlesex H6 2JW Blood issue fridge for storage of blood products only; no testing occurs at this site I ssessment Manager: MP Page 2 of 17

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to DETIL OF CCREDITTION HUMN BODY FLUIDS General Biochemistry Examination activities for the purposes of clinical diagnosis. Quantitation of: otherwise stated) SOP TDL-E-B using Roche Cobas 6000 by the following principles: lbumin Colorimetric - Bromocresol Green Urine only Tina-quant albumin Immunoturbidimetric Urine only CR(lbumin/Creatinine Ratio By calculation Urine also Creatinine clearance By calculation lkaline Phosphatase (LP) lanine Transaminase (LT) mylase spartate Transaminase mmonia MP Buffer (IFCC) Tris Buffer with PLP Enzymatic colorimetry G7 substrate Tris Buffer without PLP Enzymatic with GDH Urine also Bilirubin Colorimetric diazo D-Bilirubin Diazo method 2 Urine also Calcium NM-BPT djusted Calcium Chloride By calculation Ion selective electrode (I.S.E) Urine also Cholesterol Cholesterol oxidase Creatinine kinase (CK) NC ssessment Manager: MP Page 3 of 17

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS otherwise stated) General Biochemistry Examination activities for the purposes of clinical diagnosis. Quantitation of : SOP TDL-E-B using Roche Cobas 6000 by the following principles: Creatinine Compensated Jaffe Estimated Glomerular Filtration rate (egfr) By calculation Creatinine (Enzymatic) Creatinase CO2 Enzymatic using PEPC C-Reactive Protein Immunoturbidimetric Ethanol lcohol dehydrogenase Gamma Glutamyl Transferase (GGT) Carboxynitroanilide CSF also Glucose Hexokinase + G6PD HDL Cholesterol Iron PEG Enzymes FerroZine method CSF also Lactate Lactate oxidase Lactate dehydrogenase (LDH) Lactate dehydrogenase Urine also Magnesium Xylidyl-blue Urine also Sodium I.S.E Urine also Phosphate Phosphomolydate Potassium Indirect I.S.E Urine & CSF also Total Protein Benzethonium chloride ssessment Manager: MP Page 4 of 17

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS otherwise stated) General Biochemistry Examination activities for the purposes of clinical diagnosis. Quantitation of : SOP TDL-E-B using Rocha Cobas 6000 by the following principles: Protein/Creatinine Ratio By calculation Urine only Triglycerides Trinder endpoint reaction, Lipase Urine also Cholesterol(Total/HDL) By calculation Cholesterol (LDL-non fasting) Tubular Phosphate Reasbsorption Urea Uric acid By calculation By calculation Kinetic Urease End point uricase otherwise stated) SOP TDL-B-EQPT-001 using Roche Cobas c111 by photometry using the following principles: lbumin Bromocresol Green B & C lkaline Phosphatase (LP) IFCC MP Buffer B lanine Transaminase (LT) IFCC Tris Buffer with PLP B & C spartate Transaminase Tris Buffer without PLP B Bilirubin Diazo B Calcium NM-BPT C Chloride Indirect I.S.E B & C Creatinine Compensated Kinetic Jaffe B & C ssessment Manager: MP Page 5 of 17

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS General Biochemistry Examination activities for the purposes of clinical diagnosis. Quantitation of : otherwise stated) SOP TDL-B-EQPT-001 using Roche Cobas c111 by photometry using the following principles: Estimated Glomerular Filtration rate (egfr) By calculation B & C Gamma Glutamyl Transferase IFCC Carboxynitroanilide B & C Glucose Hexokinase + G6PD C Potassium Indirect I.S.E B & C Sodium Indirect I.S.E B & C Total Protein Biuret B & C Urea Kinetic Urease B & C Uric acid End point uricase C otherwise stated) SOP TDL-B-EQPT-015 using Roche Cobas c311 by photometry using the following principles: lbumin Bromocresol Green B & C lkaline Phosphatase (LP) IFCC MP Buffer B & C lanine Transaminase (LT) IFCC Tris Buffer with PL B & C mylase IFCC G7 Substrate B & C spartate Transaminase Tris Buffer without PLP B & C Bilirubin Diazo B & C ssessment Manager: MP Page 6 of 17

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS General Biochemistry Examination activities for the purposes of clinical diagnosis. Quantitation of : otherwise stated) SOP TDL-B-EQPT-015 using Rocha Cobas c311 by photometry using the following principles: Calcium NM-BPT B & C djusted Calcium By calculation B Chloride Indirect I.S.E. B & C Creatinine Kinase IFCC NC B Creatinine Compensated Kinetic Jaffe B & C C Reactive Protein Immunotrubidimetry B & C Estimated Glomerular Filtration rate (egfr) Calculated B & C Gamma Glutamyl Transferase IFCC Carboxy nitroanilide B & C Glucose Hexokinase + G6PD B & C Potassium Indirect I.S.E. B & C Lactate Dehydrogenase IFCC L to P glucamine B & C Magnesium Xylidyl Blue B & C Sodium Indirect I.S.E B & C Phosphate Phosphomolybdate UV B & C Total Protein Biuret B & C Urea Kinetic urease B & C ssessment Manager: MP Page 7 of 17

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Therapeutic Drug Monitoring Biochemical examination clinical diagnosis. Quantitation of: otherwise stated) SOP TDL-E-B using Rocha Cobas 6000 by the following principles: cetaminophen rylacylamidase mikacin KIMS Carbamazepine KIMS Gentamicin Recombinant DN technology- Enzyme-B-Galactosidase Lithium Porphyrin compound Phenytoin KIMS Salicylate Salicylate hydroxylase Theophylline KIMS Valproic cid G6PDH Vancomycin G6PDH HUMN BODY FLUIDS otherwise stated) Drugs of abuse Biochemical examination clinical diagnosis. Quantitation of : mphetamin SOP TDL-E-B using Rocha Cobas 6000 by KIMS Barbiturates ssessment Manager: MP Page 8 of 17

9 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Drugs of abuse Biochemical examination clinical diagnosis. Quantitation of: otherwise stated) Benzodiazepines SOP TDL-E-B using Rocha Cobas 6000 by KIMS Cannabinoids Cocaine Methadone Opiates Immunoassay otherwise stated) Biochemical examination clinical diagnosis. Quantitation of: SOP TDL-E-B using Rocha Cobas e601 immunoassay by chemiluminescence Human Chorionic Gonadotrophin (Beta HCG) Cortisol Digoxin Eastridiol Follicle Stimulating Hormone Free T4 Free T3 Thyroid Stimulating Hormone Troponin T High Sensitivity ssessment Manager: MP Page 9 of 17

10 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Immunoassay Biochemical examination clinical diagnosis. Quantitation of : otherwise stated) Progesterone SOP TDL-E-B using Rocha Cobas e601 immunoassay by chemiluminescence Parathyroid Hormone (PTH) Procalcitonin B12 Ferritin Folate Hepatitis B Surface ntigen ntibodies to HIV 1 & 2 and p24 antigen SOP ESL-E-MOD-E-023 using Rocha Cobas e601 immunoassay by chemiluminescence Syphilis total antibodies Cancer ntigen 125 Cancer ntigen 15-3 SOP TDL-B-EQPT-013 using Rocha Cobas e411 immunoassay by chemiluminescence C Cancer ntigen 19-9 Carcinoembryonic ntigen Prostate specific antigen total and free ssessment Manager: MP Page 10 of 17

11 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS otherwise stated) Other General Biochemistry Biochemical examination clinical diagnosis. Determination of: Blood Glycated haemoglobin SOP TDL-EHT-B-VR-010 using Bio-Rad Variant II turbo using highperformance liquid chromatography Blood, urine Osmolality SOP TDL-EHT-OSMO-001 using Vitech Scientific dvanced Micro- Osmometer using freezing point depression Sweat Chloride SOP TDL-EHT-B-CHL-001 using Sherwood Sweat Chloride meter by colourimetry Sweat Conductivity SOP TDL-EHT-B-SWT-001 using Sweat CHEK conductivity model 3100 flow-through conductivity cell Haematology Haematological examination clinical diagnosis. EDT Blood Full blood count: SOP TDL-E-H-048 using Sysmex XE2100 by the following principles: SOP TDL-H-EQPT-008 using Sysmex XT2000i by the following principles: SOP TDL-H-EQPT-001 using Sysmex XS1000i by the following principles: B C White blood cells, neutrophils, lymphocytes, eosinophils, monocytes, basophils Flow cytometry, B, C ssessment Manager: MP Page 11 of 17

12 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Haematology Haematological examination clinical diagnosis EDT Blood Full blood count: Red blood cells, platelets Hydro-dynamic focusing, B, C Reticulocytes Haemoglobin SLS method, B, C Mean cell volume, mean cell haemoglobin, mean cell haemoglobin concentration, red cell distribution width, nucleated red cell count By calculation, B, C EDT Blood Erythrocyte sedimentation rate (automated) SOP TDL-E-H-057 using Vescube Optical Electronic method Erythrocyte sedimentation rate (manual) SOP TDL-E-H-004 using Dispette 11 Westergren method SOP TDL-H-010 using Dispette 11 Westergren method B & C Whole blood Detection of Glucose-6- Phospate-Dehydrogenase SOP TDL-E-H-044 using Sigma Diagnostics UV Flourescence EDT Blood Detection of Sickle Cell bnormal haemoglobin SOP TDL-E-H-047 using TSC Biosciences Solubility Screen Whole Blood Blood film assessment & cell differential SOPs TDL-E-H-015 & 053 using May Grunwald Giemsa stain and SP1000i Slide Maker Stainer or Wright Giemsa stain and Hematek flat bed stainer followed by light microscopy Whole blood Detection of intra-erythrocyte parasites SOP TDL-E-H-001 using Giemsa ph7 stain and light microscopy ssessment Manager: MP Page 12 of 17

13 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Haematology Haematological examination clinical diagnosis. Bone marrow Detection of normal and abnormal cell lines SOP TDL-E-H-015 using May Grunwald Giemsa stain and SP1000i Slide Maker Stainer TDL-E-H-045 using Perls iron stain and light microscopy Whole blood Detection of Parasite Lactate Dehydrogenase of Plasmodium vivax, P. malariae, P. ovale, P. falciparum SOP TDL-E-H-045 using Bio-Rad Optimal Whole blood Detection of Infectious Mononucleosis Heterophile ntibody SOP TDL-E-H-051 using Clearview IM Screen Coagulation Coagulation examination clinical diagnosis: Citrated blood Prothrombin time INR SOPs TDL-H-EQPT-009 using Sysmex C500 by optical clot detection B PTT SOPs TDL-H-EQPT-010, 011, 012 & 019 using Sysmex C50 by optical clot detection: C ssessment Manager: MP Page 13 of 17

14 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Coagulation Coagulation examination clinical diagnosis: Citrated blood Prothrombin time Thrombin time SOPs TDL-E-H-050 using Sysmex C1500 by optical clot detection unless stated: ctivated partial thromboplastin time (PTT) Fibrinogen By calculation Immunoturbidimetry PTT ratio D-Dimer International Normalised Ratio (INR) Blood Transfusion General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT Blood utomated blood group: Rh D positive Rh D negative O Rh D positive O Rh D negative B Rh D positive B Rh D negative B Rh D positive B Rh D negative SOPs TDL-BT-021 using Diamed GelStation by gel-based microtyping system Manual blood group SOP TDL-BT-025 using Diamed Gelcards and tube technology using Bioscot monoclonal antisera and NHSBT cells ssessment Manager: MP Page 14 of 17

15 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Blood Transfusion General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT Blood ntibody detection and identification (automated) Rh: D, C, E, c, e, C W Kell: K, k, kp a, kp b, Js a, Js b Duffy: Fy a, Fy b Kidd: Jk a, Jk b Lewis: Le a, Le b P: P1 MNS: M, N, S, s Luth: Lu a, Lu b Xg: Xg a SOP TDL-BT-021 using Diamed GelStation by gel-based microtyping system and 11 Diamed panel cells ntibody detection and identification / ntigen profile (manual) SOP TDL-BT-023 using Diamed Gel cards by column agglutination with 10 NHSBT panel cells Rh: D, C, E, c, e, C W Kell: K, k, kp a Duffy: Fy a, Fy b Kidd: Jk a, Jk b Lewis: Le a, Le b P: P1 MNS: M, N, S, s Luth: Lu a EDT Blood ntigen profiling: Rh: D, C, E, c, e, C W Kell: K, k, kp a, Js a, Js b Duffy: Fy a, Fy b Kidd: Jk a, Jk b Lewis: Le a, Le b P: P1 MNS: M, N, S, s Luth: Lu a, Lu b Xg: Xg a SOP TDL-BT-021 using Diamed GelStation with 3 Diamed screening cells (automated) SOP TDL-BT-023 using Diamed Gel cards and 3 cell Diamed screening cells (manual) ssessment Manager: MP Page 15 of 17

16 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY FLUIDS Blood Transfusion General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT Blood Manual Serological crossmatch SOP TDL-BT-087 using Diamed gel cards and indirect antibglobulin test Direct antiglobulin test SOP TDL-BT-024 using Diamed GelStation and gel cards EDT Blood ntigen phenotyping: Rh: C, E, c, e, C W Kell: K Duffy: Fy a, Fy b Kidd: Jk a, Jk b Lewis: Le a, Le b MNS: M, N, S, s 1 SOPs TDL-BT-026 using Diamed GelStation (automated) and Diamed Gel cards with liquid antisera using tube technology (manual) Electronic issue SOP TDL-BT-056 using GelStation HUMN BODY TISSUE ND FLUIDS Cellular Pathology Histopathological examination clinical diagnosis Macroscopic and Microscopic examination: Documented in house procedures in conjunction with manufacturers instructions where relevant: Tissue: biopsy, excision, resection Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Specimen Dissection SOPs: TDL-E-HP-002 TRIMMING ROOM PROCEDURES. TDL-E-HP-001 SPECIMEN RECEPTION PROCEDURES TDL-E-HP-013 TRIMMING EQUIPMENT OPERTIONL PREOCEDURES ssessment Manager: MP Page 16 of 17

17 Schedule of ccreditation United Kingdom ccreditation Service ccredited to HUMN BODY TISSUE ND FLUIDS Cellular Pathology Histopathological examination clinical diagnosis Documented in house procedures in conjunction with manufacturers instructions where relevant: Fixation and Decalcification SOPs: TDL-E-HP-005 DECLCIFICTION PROCEDURES TDL-E-HP-002 TRIMMING ROOM PROCEDURES FFPE slides (Formalin fixed paraffin embedded) tissue on glass slides Interpretive/diagnostic microscopy SOP TDL-E-HP-020 Fresh frozen tissue Cryotomy SOP: TDL-E-HP-006 Using Leica CM180 UV cryostat Fresh frozen tissue Routine morphological staining Documented in house procedures in conjunction with manufacturers instructions where relevant: Detection of Basophilic and eosinophilic structures SOP TDL-E-HP-006 FROZEN SECTION by routine morphological staining with manual method using Haematoxylin and Eosin (H & E) END ssessment Manager: MP Page 17 of 17