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

Transcription

1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Haematology Department Manchester University NHS Foundation Trust Oxford Road Manchester M13 9WL United Kingdom Contact: Claire Whitehead Tel: +44 (0) Website: below Laboratory locations: s covered by the organisation and their activities details ctivity code ddress Haematology Department Local contact Claire Whitehead Diagnostic Testing Manchester University NHS Foundation Trust Manchester M13 9WL United Kingdom ddress Haematology Department Local contact Claire Whitehead Diagnostic Testing Trafford General Hospital Moorside Road M14 5SL Site activities performed away from the locations listed above: details ctivity code lood issue fridges at: dult &E Paediatric &E Central Delivery Suite Paediatric Theatre dult Theatre Haematology Ward Storage and issue of blood and blood products Trafford General Hospital, Pathology Storage and issue of blood and blood products ssessment Manager: MH 1 of 10

2 DETIL OF CCREDITTION Human body fluids Haematology examinations for the purposes of clinical diagnosis lood Full lood Count White lood Cell Count Neutrophils Lymphocytes Monocytes Eosinophils asophils Red lood Cell Count Haemoglobin Haematocrit Mean Cell Volume Red Cell Distribution width. Mean Cell Haemoglobin Mean Cell Haemoglobin concentration. Platelets Mean Platelet volume Nucleated Red lood cells (not XN450) Reticulocyte count Sysmex XN 9000, 1000 and 450 nalyser modules by flow cytometry, impedance and Spectrophotometry SOPs LP-HEM-C19 LP-HEM-C20 LP-HEM-C31 Sysmex XN2000 analyser by flow cytometry, impedance and spectrophotometry LP-HEM-C19 LI_TGH_H19 lood lood film assessment for detection of abnormal cell types, morphology and numbers SP10 automated slide maker stainer and May Grunwald and Giemsa stain examined by light microscopy, LP-LP- HEM-C34 Manual blood film preparation and automated staining using RL stainer and May Grunwald and Giemsa stain examined by light microscopy using LP-LP-HEM-C33, ssessment Manager: MH Page 2 of 10

3 HUMN ODY FLUIDS Haematology examinations for the purposes of clinical diagnosis lood Malaria screen for P. falciparum P. vivax P. ovale P. malariae P. knowlesi Using Giemsa/Fields Staining for thin smears and manual microscopy SOPs LP_TGH_H6 Using Giemsa/Fields Staining for thin smears and manual microscopy LP HEM CM 202 (in combination with INX NOW) lood Malaria screen for P. falciparum P. vivax P. ovale P. malariae INX NOW Malarial screen kit and SOP LP-HEM CM 202, lood Qualitative detection of infectious mononucleosis heterophile antibody Clearview kit using HEM CM PRO 203, lood Estimation of Erythrocyte Sedimentation Rate utomated method using Sysmex Interliner and Westergren method, LP- HEM-C29, Manual CQUISEL Westergren Micro System, LP-HEM-C18 one marrow one marrow assessment for detection of abnormal cell types, morphology and numbers Sysmex SP10 slide stainer and Romanowski stain, HEM CM PRO 401 RL staining machine and Romanowski stain, LI-HEM-C33 ssessment Manager: MH Page 3 of 10

4 HUMN ODY FLUIDS Haematology examinations for the purposes of clinical diagnosis Serum Ferritin Vitamin 12 Intrinsic Factor ntibody Red cell folate Roche Cobas c8000 analyser using photometry and electrochemiluminescence and SOP C-uto-PRO-019 Serum Vitamin 12 Folate Ferritin Roche Cobas 6000 analyser, C_TRF_PROC-27 Coagulation- Prothrombin time Prothrombin time correction with normal plasma PTT PTT correction with normal plasma Clauss fibrinogen D Dimer Low molecular weight heparin Sysmex CS5100i coagulation analyser using immuno-turibidimetry, LP_HEM_COG38 and LP_HEM_COG40 Thrombophilia screening: nti-thrombin 3 activity Protein C activity Free Protein S level Thrombin time Reptilase time Sysmex CS5100i coagulation analyser using immuno-turibidimetry, LP_HEM_COG45, LP_HEM_ COG30 Lupus anticoagulant testing: PTT Dilute Russell Viper venom time Dilute Russell Viper venom confirmation Sysmex CS5100i coagulation analyser using immuno-turibidimetry, LP_HEM_COG43 ssessment Manager: MH Page 4 of 10

5 HUMN ODY FLUIDS Haematology examinations for the purposes of clinical diagnosis Novel nticoagulant levels: Dabigatran Rivoroxaban pixaban Sysmex CS5100i coagulation analyser using immuno-turibidimetry, LP_HEM_COG40 Coagulation: Prothrombin time PTT D-Dimer Thrombin time Fibrinogen Sysmex CS2500i coagulation analyser using immuno-turibidimetry, and chromogenic methods, LP_TGH_H5 Coagulation Factor ssays: Factor II, V, VII, VIII, IX, X, XI, XII Factor VIII Refacto Chromogenic Factor VIII and XIII Sysmex CS5100i coagulation analyser using immune-turbidometry, LP_HEM_COG46 LP_HEM_COG35 LP_HEM_COG36 and COG37 Von Willebrand antigen level LP_HEM-COG47 Ristocetin Cofactor level LP_HEM_COG47 lood Platelet function analysis Siemens Innovance PF-200 system using high-shear force dynamic flow, LP_HEM_COG17 lood Platelet aggregation and nucleotide release Lab Medics Chronolog 700 platelet aggregometer, LP_HEM_COG50 ssessment Manager: MH Page 5 of 10

6 HUMN ODY FLUIDS Haematology examinations for the purposes of clinical diagnosis lood Quantification of Zinc Protoporphyrin Helena Protofluor Z Spectrophotometer and LP_HEM_RC14 ZPP Estimation of plasma viscosity enson V1 Viscometer and LP_HEM_RC21 lood Sickle solubility test for presence of sickle haemoglobin (HbS) Clinitech Sickle Test kit and HEM RC PRO 006. Serum Detection of: Intrinsic factor antibody Erythropoietin ackman ccess 2 analyser and LI_HEM_RC22, RC21, RC18 lood Detection of abnormal haemoglobin including HS, C, D, E, Orab, Lepore, and Dpunjab mersham iosciences Mutiphor II iso-electric focussing, Perkin Elmer staining kit and Neonatal staining kit, HEM RC PRO 005 IEF lood G6PD screen and assay Trinity iotech G6PD screening test kit, LP-HEM RC 50 G-6-PDH Screen Trinity iotech G6PD assay kit, HEM RC PRO 007 G-6-PDH Enzyme ssay lood Sickle cell and Thalassemia screen for beta trait and evidence of alpha trait. iorad Variant II HPLC analyser, LP_HEM_RC19 Variant II Operation. Urine Detection of haemosiderin Manual staining using Clinitech Perl s staining kit, HEM RC PRO 010 Haemosiderin, ssessment Manager: MH Page 6 of 10

7 HUMN ODY FLUIDS lood Transfusion examinations for the purposes of clinical diagnosis lood Serological Cross match utomated cross match using Grifols Erytra analyser and LP_HEM_T75, Manual cross match using Grifols cards and LP_HEM_T78 lood Determination of blood group (O, RhD) and ntibody screening using the following panel: NS cellstab 2 cell panel (CE) covering D, C, E, c, e, C w, K, k, Kp a, Js a, Fy a, Fy b, Jk b, Le a, Le b, P1, M, N, S, s, Kp b, Lu b utomated using Grifols Erytra analyser, LP_HEM_T09 Manual using Grifols cards and LP_HEM_T77, lood ntibody identification and phenotyping Using Griffols IT and ENZ panels panel to ID: D, C, E, c, e, C w, K, k, Kp a, Js a, Fy a, Fy b, Jk a Jk b, Le a, Le b, P1, M, N, S, s, Lu a, Co b, Xg a utomated using Grifols Erytra analyser and manual method using Grifols cards and LP_HEM_T14, lood Direct antiglobulin test for detection of antibody bound red cells utomated method using Grifols Erytra analyser and manual method using Grifols cards and LP_HEM_T21, lood Determination of Rhesus and Kell Phenotyping (D, C, E, c, e, C w, K) utomated using Grifols Erytra analyser and manual using Grifols Cards and LP_HEM_T14, ssessment Manager: MH Page 7 of 10

8 HUMN ODY FLUIDS lood Transfusion examinations for the purposes of clinical diagnosis lood Measurement of foetal Hb in maternal blood for FMH determination Using the Kleihauer technique with acid elution and the Clin-Tech Shepard s stain kit, LP_HEM_T61 Molecular Haematology examinations for the purposes of clinical diagnosis lood Detection of Factor 8 intron 22 gene inversion mutation lood Detection of Factor 8 intron 1 gene inversion mutation DN extraction using Maxwell 16 or manual ammonium acetate followed by long PCR on pplied iosystems 9700, 2720 or Veriti thermal cyclers, followed by gel electrophoresis SOP LP_HEM_MD1 DN extraction using Maxwell 16 or manual ammonium acetate extraction followed by PCR on Peqlab/MWG thermal cyclers, followed by gel electrophoresis SOP LP_HEM_MD4 lood Detection of haemoglobin mutations DN extraction using Maxwell 16 extractor followed by RMS PCR on Peqlab/MWG thermal cyclers, followed by gel electrophoresis SOP LP_HEM_MD67 lood Detection of single nucleotide polymorphism of: Prothrombin G20210 FV Leiden HFE C282Y/H63D TPMT DN extraction using Maxwell 16 followed by PCR using pplied iosystems 9700/2720/Veriti thermal cyclers followed by gena tandem MS analysis, LP_HEM_MD72 ssessment Manager: MH Page 8 of 10

9 HUMN ODY FLUIDS Molecular examinations for the purposes of clinical diagnosis lood Detection of gene deletions of the following: GP PCR analysis using Progene and Peqlab/MWG thermal cyclers followed by gel electrophoresis, SOP LP_HEM_MD44 MLP analysis using pplied iosystems/ 2720 thermal cyclers followed by use of pplied iosystems 3130XL Genetic nalyser and Coffalyser software LP_HEM_MD21 lpha globin gene cluster deletion/duplication LP_HEM_MD22 and MD44 eta globin gene cluster deletion/duplication LP_HEM_MD56 F11 whole gene deletion LP_HEM_MD45 lood and bone marrow Quantitative monitoring of gene expression for: CR-L (t(9;22)) ML-ETO (t(8;21)) PML-RR (t(15;17)) CF-MYH11 (inv(16) /t(16;16)) NPM1 Qiagen Qiacube based RN extraction followed by Real Time PCR using and pplied iosystems 7900HT/QuantStudio6 amplification, SOPs LP_HEM_MD36, MD75 lood Detection of JK2 V617F mutation Qiagen DN extraction followed by PCR on PeqLab/MWG thermal cyclers, SOP LP_HEM_MD24, MD34 ssessment Manager: MH Page 9 of 10

10 HUMN ODY FLUIDS Molecular examinations for the purposes of clinical diagnosis lood Detection of gene mutations of the following: Factor 7 Factor 8 Factor 9 Factor 11 VWF TPMT H and HG2 promoter region H1 and H2 Manual or semi-automated DN extraction (ammonium acetate or Maxwell 16) followed by PCR on PeqLab/MWG or Progene thermal cyclers and Sanger sequencing using pplied iosystems 3130XL analyser and Mutation Surveyor and lamut software. LP_HEM_MD57 LP_HEM_MD57 LP_HEM_MD13 LP_HEM_MD40 LP_HEM_MD18 LP_HEM_MD61 LP_HEM_MD23 LP_HEM_M39 dditional deletion/duplication detection in the following: Factor 7 Factor 8 Factor 9 Factor 11 VWF MLP analysis using pplied iosystems 2720/Peqlab thermal cyclers followed by use of pplied iosystems genetic analyser 3130XL and Coffalyser software. SOP/instruction LP_HEM_MD21, LI_HEM_MD81, LI_HEM_MD82 END ssessment Manager: MH Page 10 of 10