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 HSL (nalytics) LLP ccredited to The Halo Building 1 Mabledon Place WC1H 9X United Kingdom Contact: Jacqueline Sutherland Tel: +44 (0) Jacqueline.sutherland@hslpathology.com Website: Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress Rapid Response Laboratory (UCLH) 60 Whitfield Street W1T 4EU Local contact Biochemistry Haematology Haemostasis Blood Transfusion Diabetic Clinic Satellite Laboratory First Floor Podium Diabetic Clinic K University College Hospital Biochemistry B Intra-operative PTH Satellite Laboratory Biochemistry C Operating Theatres University College Hospital OSCR Clinic Satellite Laboratory Foetal and Maternal ssessment Unit Elizabeth Garrett nderson Unit University College Hospital Biochemistry D Satellite Laboratory ccident & Emergency Department University College Hospital Haematology E ssessment Manager: MP Page 1 of 9

2 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to details ctivity code Near Patient Testing Laboratory Macmillan Cancer Centre University College Hospital Huntley Street WC1E 6G Haematology F Site activities performed away from the locations listed above: details ctivity ccident & Emergency Department University College Hospital Tower Floor, Level 16 University College Hospital Podium Level 3 University College Hospital Operating Theatres University College Hospital ssessment Manager: MP Page 2 of 9

3 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to details ctivity Elizabeth Garrett nderson Unit University College Hospital Macmillan Cancer Centre University College Hospital Huntley Street WC1E 6G National Hospital for Neurology & Neurosurgery Queen Square WC1N 3BG University College Hospital at Westmoreland Street Westmoreland Street W1G 8PH ssessment Manager: MP Page 3 of 9

4 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to DETIL OF CCREDITTION HUMN BODY FLUIDS General Biochemistry Biochemical examination clinical diagnosis. Quantitation of: standard methods as specified: Serum & urine Osmolality Freezing point depression using Micro-Osmometer 3320 SOP TDL-NWLH-CB-013 Blood Hb1c Ion-exchange high performance liquid chromatography using TOSOH G8 SOP HE-009 B Serum / Plasma Intra-operative of Parathyroid Hormone Immunoassay using Future Digistat SOP POCT-60RR-002 C Serum Beta- Human chorionic gonadotrophin (hcg) Protein ssociated Plasma Protein- (PPP-) Chemiluminescent immunoassay using Perkin Elmer Delfia Xpress SOP POCT-60RR-001 D Haematology Haematological examination clinical diagnosis. standard methods as specified: EDT Blood Full Blood Count: Measurement principles as described using Sysmex XE SOP WSL-H-001 Measurement principles as described using Sysmex XS-1000 SOP HEM-CC-LP-&E Measurement principles as described using Sysmex XN-1000 SOP HEM-PC-LP-XN-1000 E F ssessment Manager: MP Page 4 of 9

5 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to HUMN BODY FLUIDS Haematology Haematological examination clinical diagnosis standard methods as specified: White blood cells, neutrophils, lymphocytes, eosinophils, monocytes, basophils, nucleated red blood cells, reticulocytes by fluorescence flow cytometry Red blood cells, platelets by impedance Haemoglobin by SLS photometry Haematocrit by cumulative pulse Peripheral Blood Blood film assessment & cell differential Staining with May Grunwald & Giemsa stain manually or using SP1000 Staining Machine followed by microscopy SOPs WSL-H-028, 031 & 052 Whole Blood Reticulocyte Counting Manual method using Supravital stain SOP WSL-H-027 EDT Blood Erythrocyte sedimentation rate utomated using Starrsed Interrliner (automated) SOP WSL-H-006 Manual using Sarstedt CB 200 SOP TDWSL-H-021 Plasma Coagulation: Prothrombin Time International Normalised ratio ctivated Partial Thromboplastin Time (PTT) PTT ratio Fibrinogen-Clauss D-Dimer Light absorption using Sysmex CS5100 SOP WSL-H-065, WSL-H-066, WSL-H-035, WSL-H-044, WSL- H-045, WSL-H-047, WSL-H- 050, WSL-H-041 ssessment Manager: MP Page 5 of 9

6 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to HUMN BODY FLUIDS Haematology Haematological examination clinical diagnosis standard methods as specified: Whole Blood Detection of Sickle Cell bnormal Haemoglobin Helena Sickle Solubility Screen kit SOP WSL-H-018 Serum / plasma Detection of Infectious Mononucleosis Heterophile ntibody Immunoassay using Biokit Monogen kit SOP WSL-H-019 Special Coagulation Plasma ntithrombin III ctivity Chromogenic assay using Sysmex SOP WSL-H-064 Plasma nti-xa Chromogenic assay using Sysmex SOP COG-001 Plasma Dilute Russell Viper Venom Time (DRVVT) Clotting assay using Sysmex SOP WSL-H-064 Plasma Intrinsic and Extrinsic Factor ssays: Detection of: Factor II Factor V Factor VII Factor VIII Factor IX Factor X Factor XI Factor XII Clotting assay using Sysmex SOP COG-UCLH-014 Plasma Factor 13 Chromogenic assay using Sysmex SOP WSL-H-069 ssessment Manager: MP Page 6 of 9

7 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP ccredited to HUMN BODY FLUIDS Special Coagulation Haematological examination clinical diagnosis. standard methods as specified Plasma / Serum Heparin / Platelet Factor 4 Induced ntibodies Manual ELIS using sserachrom kit (Diagnostica Stago) SOP COG-UCLH-016 Plasma Detection of: Sysmex and the following principles: SOP WSL-H-063 Protein C ctivity Protein S ntigen Protein S ctivity by chromogenic assay by immunoturbidimetric assay by clotting based assay Plasma Taipan Venom Time Clotting assay using Sysmex SOP COG-002 Plasma Von Willibrand Factor ntigen and ctivity Immunoturbidimetric assay using Sysmex SOP WSL-H-072 Plasma DMTS-13 ctivity Immunoassay and FRET method using Flurostar Omega SOP COG-003 Plasma DMTS-13 ntibody Manual ELIS using FRET method SOP COG-020 Plasma Viscosity Capillary oscillation using Benson Viscometer SOP HEM-HH-LPVIS ssessment Manager: MP Page 7 of 9

8 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP 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 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 utomated using Ortho Vision Max nalyser SOP BT-101 Manual using Ortho Cassettes SOP BT-60RR-027 EDT Blood ntigen phenotyping: Rh: C, E, c, e, C W Kell: K utomated using Ortho Vision Max nalyser SOP BT-101 Manual using Ortho Cassettes SOP BT-60RR-027 EDT Blood Serological crossmatch Manual Tube IT, Immediate Spin and Cassette method SOP BT-119 Electronic issue of blood by calculation SOP BT-119 EDT Detection of Foetal Haemoglobin and cells Manual method using Source Bioscience Kleihauer test SOP BT-60RR-028 ssessment Manager: MP Page 8 of 9

9 Schedule of ccreditation United Kingdom ccreditation Service HSL (nalytics) LLP 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: 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 utomated using Ortho Vision Max nalyser SOP BT-101 Manual method using cassettes, enzyme panels and tube method BT-60RR-027 EDT Blood Direct ntiglobulin test (including newborn) utomated using Ortho Vision Max nalyser SOP BT-60RR-026 Manual method using Ortho cassettes and tube method SOP BT-60RR-026 END ssessment Manager: MP Page 9 of 9