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

Transcription

1 Laboratory locations: Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Haematology Department Box 234 Addenbrooke s Hospital Hills Road CB2 0QQ Contact: Marion Enkel Tel: +44 (0) m.enkel@nhs.net Website: below s covered by the organisation and their relevant activities details Activity code Address Haematology Department Box 234 Addenbrooke s Hospital Hills Road CB2 0QQ Marion Enkel Haematology Coagulation Haemostasis Blood Transfusion Address Blood Sciences Royal Papworth NHS Foundation Trust Papworth Everard CB23 3RE Martin Muir Tel: Haematology Coagulation Blood Transfusion PAP Site activities performed away from the locations listed above: Assessment Manager: PW 1 of 24

2 details Activity code Theatre 2 Royal Papworth NHS Foundation Trust Papworth Everard CB23 3RE Martin Muir Blood Issue Fridge No testing occurs, blood storage only ICU Box 17 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Main Theatres 1,2 Box 206 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Neuro Theatres Box 164 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only ATC Box 283 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott / Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Oncology Box 193 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Assessment Manager: PW Page 2 of 24

3 details Activity code Neonatal unit Box 226 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Delivery Unit Rosie Maternity Box 222 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott / Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Ward C10/E10 Box 14 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Haematology Day unit Box 259 Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only A&E - Resuscitation Addenbrooke s Hospital Hills Road CB2 0QQ Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Ely Day Surgery Unit Princess of Wales Hospital Lynn Road, Ely CB6 1DN Kath Philpott/ Tracy Moore Blood Issue Fridge No testing occurs, blood storage only Assessment Manager: PW Page 3 of 24

4 DETAIL OF ACCREDITATION Haematology examination activities for the purposes of clinical diagnosis: incorporating manufacturers instructions where relevant EDTA Whole Blood Haematology Full blood count- automated differential: Total White Cell Count (WBC) Red Cell Count (RBC) Haemoglobin (Hb) Platelet Count MCV MCH MCHC NRBC Neutrophils Lymphocytes Monocytes Eosinophils Basophils Automated Siemens Advia 2120i analyser SOP.HAE 5345 SOP.HAE 5348 SOP.HAE 5346 EDTA Whole Blood Reticulocyte count Automated Advia 2120i.HAE Manual Manual method using GCC diagnostics reticulocyte stain Supra vital stain SOP.HAE Assessment Manager: PW Page 4 of 24

5 Haematology examination activities Whole Blood Blood film examination: Detection of normal and abnormal morphologies and white blood cell differential Automated Staining Giemsa staining using Siemens Autoslidemaker/ stainer SOP.HAE 8368 Manual Staining Giemsa staining using Haematek semi-automated stainer SOP.HAE 8719 Blood film examination by light microscopy SOP.HAE SOP.HAE Whole Blood Erythrocyte Sedimentation Rate (ESR) Desega S2000-Sedivette ESR System SOP.HAE Whole Blood Plasma Viscosity (PV) Benson Viscometer SOP.HAE Haemoglobinopathy Whole Blood Quantification of: Primary Screening HbA Capillary electrophoresis using HbA2 Sebia CAPILLARYS 2 FLEX- HbF PIERCING instrument HbS SOP.HAE 1099 Identification/ Quantitation of other Variant Hb: HbC, HbD, HbE Assessment Manager: PW Page 5 of 24

6 Haematology examination activities Whole Blood Quantification of: HbA HbA2 HbF HbS Cellulose acetate and acid gel electrophoresis SOP.HAE SOP.HAE Identification/ Quantitation of other Variant Hb: HbC, HbD, HbE Whole Blood Blood Film examination for Malarial Parasites (Thick and Thin film examination) Detection of Malarial parasites of: P. falciparum, P. malariae, P. ovale & P. vivax Film examination, staining of malarial parasites Giemsa stain and reversed field stain (ph7.2). Staining of malarial thick films. SOP.HAE16173 SOP.HAE SOP.HAE SOP.HAE SOP.HAE Whole Blood Detection of Malarial antigens of: P. falciparum Pan-detection for P. malariae, P. ovale & P. vivax Carestart Malaria Rapydtest HRPII Card SOP.HAE 6403 Plasma/ Serum Glandular Fever (Infectious Mononucleosis) - heterophile antibodies to Epstein Barr Virus Oxoid Infectious Mononucleosis Kit SOP.HAE Blood Glucose 6 Phosphate Dehydrogenase (G6PD) Trinity Biotech Flourescent Spot Test SOP.HAE6395 SOP.HAE Whole Blood Sickle Cell Solubility Test: Detection of HbS Microgen Bioproducts S-Test kit SOP.HAE Assessment Manager: PW Page 6 of 24

7 Haematology examination activities Plasma Plasma Coagulation Prothrombin Time (PT) semi automated Activated Partial Thromboplastin Time (APTT) semi automated AS Diagnostics KC-10 mechanical clot detection SOP.HAE SOP.HAE Plasma Automated ACL-TOP 750 Analyser SOP.HAE Prothrombin Time (PT) SOP.HAE Activated Partial SOP.HAE Thromboplastin Time (APTT) Thrombin time (TT) SOP.HAE INR determination SOP.HAE D-dimer SOP.HAE Fibrinogen assay SOP.HAE Anti-Xa assay SOP.HAE Specialized haemostasis examination activities for clinical diagnosis incorporating manufacturers instructions where relevant Plasma Clotting Factor Assays ACL-TOP 750 Analyser using CE marked/ Werfen Locked one stage clot based assays unless otherwise indicated Factor VIII One stage clot based SOP.HAE Chromogenic FVIII SOP.HAE Refacto Factor VIII SOP.HAE Factor IX SOP.HAE Factor XI SOP.HAE Factor XII SOP.HAE Factor II SOP.HAE Assessment Manager: PW Page 7 of 24

8 Specialized haemostasis examination activities Clotting Factor Assays Factor X ACL-TOP 750 Analyser One stage clot based OP.HAE Chromogenic Factor X (Biophen) - SOP.HAE Factor X Antigen ELISA (Zymutest ELISA) SOP. HAE Factor V SOP.HAE Factor VII SOP.HAE Factor XIII SOP.HAE Plasma unless specified Factor Inhibitor screens and quantification assays: Immediate acting intrinsic factor inhibitor screen Time dependent intrinsic factor inhibitor screen Immediate acting extrinsic Factor inhibitor screen Time dependent extrinsic Factor inhibitor screen Intrinsic factor Bethesda Inhibitor assay Extrinsic factor Bethesda Inhibitor assay Nijmegan modification Intrinsic factor Bethesda Inhibitor assay Nijmegan modification Extrinsic factor Bethesda Inhibitor assay Semi-automated techniques performed with manual initial set up and automated clot based s on the ACL-TOP 750 Analyser SOP.HAE SOP.HAE SOP.HAE SOP.HAE SOP.HAE SOP.HAE32298 SOP.HAE 827 SOP.HAE Assessment Manager: PW Page 8 of 24

9 Specialized haemostasis examination activities Plasma Investigation of Willebrand s Disease ACL-TOP750 analyser or Acustar automated analyser (Werfen - SOP.HAE 5240) using CE marked/werfen locked assays von Willebrand Factor Antigen SOP.HAE von Willebrand Factor Activity vwf:ab monoclonal antibody to VWF A1 domain epitope - ACL- TOP750 SOP.HAE Ristocetin-induced binding of VWF to a recombinant WT GPIb fragment using chemiluminescence SOP.HAE 2572 VWF Collagen Binding Activity using chemiluminescence (Acustar (Werfen) SOP.HAE 5683 VWF Collagen Binding Activity Zymutest Collagen Binding Assay ELISA SOP.HAE Platelet Ristocetin CoFactor Activity PAP8E SOP.HAE Plasma Thrombophilia ACL-TOP 750 Analyser using CE marked/ Werfen Locked assays unless otherwise indicated Protein C SOP.HAE Free Protein S SOP.HAE Antithrombin (Human Factor X SOP.HAE 4970 based Antithrombin Activity) Human Factor II Based Using STAGO STAchrom kit Antithrombin Activity SOP.HAE DRVVT SOP.HAE APTT Lupus Ratio SOP.HAE 2356 Assessment Manager: PW Page 9 of 24

10 Specialized haemostasis examination activities Thrombophilia ACL-TOP 750 HemosIL DTI - Dilute SOP.HAE 7674: Thrombin Time Activated Protein C Sensitivity SOP.HAE Heparin Induced Thrombocytopaenia (H.I.T.) Plasma AcuStar HIT-IgG Screen Acustar automated analyser (Werfen) SOP.HAE 1821 ACL-TOP HIT Ab (PF4-H) Screen ACL-TOP 750 Analyser SOP.HAE 398 Plasma Thrombin Generation Thrombinoscope Calibrated Automated Thrombography using in house reagent formulations SOP.HAE Lag Time Citrate Platelet Poor Plasma SOP.HAE Endogenous Thrombin Potential Peak Thrombin Corn Trypsin Inhibitor Platelet Poor Plasma SOP.HAE Citrate Platelet Poor Plasma SOP.HAE Corn Trypsin Inhibitor Platelet Poor Plasma SOP.HAE Citrate Platelet Poor Plasma SOP.HAE Corn Trypsin Inhibitor Platelet Poor Plasma SOP.HAE Assessment Manager: PW Page 10 of 24

11 Specialized haemostasis examination activities Thrombin Generation Time to Peak Thrombinoscope Citrate Platelet Poor Plasma SOP.HAE Velocity Index Corn Trypsin Inhibitor Platelet Poor Plasma SOP.HAE Citrate Platelet Poor Plasma SOP.HAE Corn Trypsin Inhibitor Platelet Poor Plasma SOP.HAE Plasma ADAMTS13 activity and ADAMTS13 inhibitor ADAMTS-13 Activity ADAMTS-13 Inhibitor quantification Commercial ELISA sourced from Pathways Diagnostics (Technozym) Technozym ELISA SOP.HAE 3215 Technozym ELISA SOP.HAE 1543 Platelet Function Analysis Collagen/ ADP agglutination Collagen/ Epinephrine Agglutination PFA-100 analyser SOP HAE PFA-100 analyser SOP HAE Platelet Rich Plasma Light Transmission Platelet Aggregometry PAP-8E semi-automated platelet aggregometer using Borne Aggregation ADP 2.5µM SOP.HAE ADP 5µM SOP.HAE ADP 10µM SOP.HAE ADP 20µM SOP.HAE Arachidonic Acid 1.5mM SOP.HAE Collagen 1.0µg/mL SOP.HAE Collagen 2.0µg/mL SOP.HAE Ristocetin 1.5mg/mL Agglutination SOP.HAE Assessment Manager: PW Page 11 of 24

12 Specialized haemostasis examination activities Platelet Function Analysis PAP-8E Ristocetin 0.5mg/mL Agglutination SOP.HAE TRAP6 12.5µM SOP.HAE U µM SOP.HAE Whole Blood Whole Blood Impedance aggregometry for investigation of bleeding disorders Multiplate analyser impedance aggregometry ADP 3.3µM SOP.HAE ADP 6.6µM SOP.HAE Arachidonic Acid 0.5mM SOP.HAE Collagen 0.65µg/mL SOP.HAE Ristocetin 0.77mg/mL SOP.HAE Ristocetin 0.20mg/mL SOP.HAE TRAP6 4µM SOP.HAE U µM SOP.HAE Spontaneous Aggregation SOP.HAE Impedance aggregometry for investigation of antiplatelet therapy Multiplate analyser impedance aggregometry ADPTest SOP.HAE TRAPTest SOP.HAE ASPITest SOP.HAE Platelet Rich Plasma Platelet Nucleotide Analysis Biorad Biologic Duoflow HPLC in house method ADP Nucleotides SOP.HAE ATP Nucleotides SOP.HAE Total Nucleotides SOP.HAE ATP/ADP Ratio SOP HAE Assessment Manager: PW Page 12 of 24

13 Specialized haemostasis examination activities Whole Blood Rotational Thromboelastometry Clot Time Performed on the ROTEM Delta (Werfen) with reagents sourced from Werfen Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Extrinsic Thromboelastometry (EXTEM) SOP.HAE Clot Formation Time Functional Fibrinogen Rotational thromboelastometry (FIBTEM) SOP.HAE Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Angle Extrinsic Thromboelastometry (EXTEM) SOP.HAE Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Area under curve Extrinsic Thromboelastometry (EXTEM) SOP.HAE Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Extrinsic Thromboelastometry (EXTEM) SOP.HAE Functional Fibrinogen Rotational Thromboelastometry (FIBTEM) SOP.HAE Assessment Manager: PW Page 13 of 24

14 Specialized haemostasis examination activities Rotational Thromboelastometry Maximum Clot Firmness ROTEM Delta (Werfen) Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Extrinsic Thromboelastometry (EXTEM) SOP.HAE Time to maximum velocity Functional Fibrinogen Rotational Thromboelastometry (FIBTEM) SOP.HAE Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Extrinsic Thromboelastometry (EXTEM) SOP.HAE Maximum Lysis Functional Fibrinogen Rotational Thromboelastometry (FIBTEM) SOP.HAE Non-Activated Rotational Thromboelastometry (NATEM) SOP.HAE Extrinsic Thromboelastometry (EXTEM) SOP.HAE Plasma A20 Functional Fibrinogen Rotational Thromboelastometry (FIBTEM) - SOP.HAE SOP.HAE Assessment Manager: PW Page 14 of 24

15 Specialized haemostasis examination activities Direct Oral Anticoagulants ACL-TOP 750 Analyser using CE marked/werfen Locked assays with backup assays using biophen reagent Plasma unless specified Dabigatran Quantification ACL-TOP750 (Werfen Assay) SOP HAE 988 Rivaroxaban Quantification Apixaban Quantification Edoxaban Quantification ACL-TOP 750 (Biophen Assay) SOP. HAE 6025 ACL-TOP750 (Werfen Assay) SOP.HAE. 843 ACL-TOP 750 (Biophen Assay) SOP.HAE 6249 ACL-TOP750 (Werfen Assay) SOP.HAE ACL-TOP 750 (Biophen Assay) SOP.HAE ACL-TOP750 (Werfen Assay) SOP. HAE Investigation of Fibrinolysis ACL-TOP 750 Analyser using CE marked/werfen Locked assays. Plasma unless specified Plasmin Inhibitor SOP.HAE Plasminogen SOP.HAE Thrombin Induced Lysis Time SOP.HAE 8411 PAI-I antigen SOP.HAE (ELISA) TAFI:Ag SOP.HAE (ELISA) Thrombin-Antithrombin SOP.HAE (ELISA) Complex Prothrombin Fragment F1+2 SOP.HAE 8428 (ELISA) tpa Tissue Plasminogen Activator SOP.HAE (ELISA) Plasma Miscellaneous ELISA Tissue Factor Pathway Inhibitor (TFPI) SOP.HAE Assessment Manager: PW Page 15 of 24

16 Specialized haemostasis examination activities Routine Assays of Haemostasis ACL-TOP 750 Analyser SOP.HAE Plasma unless specified Prothrombin Time PT based INR for Warfarin Control SOP.HAE INR PT based INR for Warfarin Control SOP.HAE APTT SOP.HAE Thrombin Time SOP.HAE Liquid Heparin Anti Xa SOP.HAE D-dimer SOP.HAE Fibrinogen Quantified Fibrinogen Assay (QFA) SOP.HAE Fibrinogen Antigen ACLTOP Liaphen Fibrinogen Assay SOP.HAE 1164 Semi-automated assays - KC10 Prothrombin Time SOP.HAE APTT SOP.HAE Reptilase Time SOP.HAE Assessment Manager: PW Page 16 of 24

17 Blood Transfusion examination activities for the purpose of clinical diagnosis: Documented procedures based on manufacturer s instructions Blood grouping by antigen detection: ABO blood group RhD type Automated Grifols Erytra analyser SOP.HAE 5551 SOP.HAE 2425 SOP.HAE 2426 SOP.HAE 2606 Manual - Grifols SOP.HAE SOP.HAE Manual - BioRad BioRad card column agglutination SOP.HAE SOP.HAE Manual Tube SOP.HAE SOP.HAE Assessment Manager: PW Page 17 of 24

18 Blood Transfusion examination activities for the purpose of clinical diagnosis: Documented procedures based on manufacturer s instructions Antibody screening for the identification of the following antibodies: D,C,E,c,e,Cw,K,k,Kpa,Kpb,Fy a,fyb,jka,jkb,lea,leb,p1,m,n,s,s,lua,lub, Xga Automated Grifols Erytra analyser 3 cell screen using Grifols card column agglutination SOP.HAE 5551 SOP.HAE 2425 SOP.HAE 2426 SOP.HAE 2606 Manual - Grifols 3 cell screen using Grifols card column agglutination SOP.HAE SOP.HAE Manual - BioRad 3 cell screen using BioRad card column agglutination SOP.HAE SOP.HAE Manual Tube 3 cell screen SOP.HAE SOP.HAE Assessment Manager: PW Page 18 of 24

19 Blood Transfusion examination activities for the purpose of clinical diagnosis: Documented procedures based on manufacturer s instructions Direct Antiglobulin Test (DAT) for identification of IgG and C3d red cell coating Automated Grifols Erytra analyser SOP.HAE SOP.HAE 2425 Manual - Grifols SOP.HAE Manual - BioRad BioRad card column agglutination SOP.HAE Manual Tube SOP.HAE Red cell phenotyping: Rh & K blood group antigens: C, c, E, e, K Automated Grifols Erytra analyser SOP.HAE SOP.HAE 2425 Manual - Grifols SOP.HAE Manual - BioRad BioRad card column agglutination SOP.HAE Red cell phenotyping: Jka, Jkb, Fya, Fyb, M, N, S, s Manual BioRad BioRad card column agglutination SOP.HAE Assessment Manager: PW Page 19 of 24

20 Blood Transfusion examination activities for the purpose of clinical diagnosis: Documented procedures based on manufacturer s instructions Red cell phenotyping: A1 Manual Tube SOP.HAE Antibody investigation for the identification of the following antibodies: D,C,E,c,e,Cw,K,k,Kpa,Kpb,Fy a,fyb,jka,jkb,lea,leb,p1,m,n,s,s,lua,lub, Xga Manual - Grifols 10 cell panel using Grifols card column agglutination SOP.HAE SOP.HAE 3384 Manual - BioRad 10 cell panel using BioRad card column agglutination SOP.HAE SOP.HAE 3384 SOP.HAE SOP.HAE 1313 SOP.HAE 789 SOP.HAE Manual Tube 10 cell panel SOP.HAE SOP.HAE 3384 Antibody titration: Titration of anti-a and Anti-B against A1, A2 and B cells Manual - BioRad BioRad card column agglutination SOP.HAE Titration of the following antibodies against a heterozygous expression of the corresponding antigen for determination of the risk of Haemolytic Disease of the Newborn and Fetus: C,E,e,Cw,K,Kpa,Kpb,Fya,Fyb, Jka,Jkb M,S,s Manual - BioRad BioRad card column agglutination SOP.HAE Assessment Manager: PW Page 20 of 24

21 Blood Transfusion examination activities Compatibility testing: Serological crossmatch serological compatibility testing between donor red cell antigens and patient plasma Automated Grifols Erytra analyser SOP.HAE SOP.HAE 2425 Manual - Grifols SOP.HAE Manual - BioRad BioRad card column agglutination SOP.HAE Manual Tube SOP.HAE Detection and estimation of Feto-Maternal Haemorrhage Flow cytometry FACS Canto SOP.HAE Manual Acid Elution technique Source BioScience Kleihauer method SOP.HAE Assessment Manager: PW Page 21 of 24

22 Haematology examination activities for the purposes of clinical diagnosis: incorporating manufacturers instructions where relevant Haematology Full blood count Total White Cell Count (WCC) Red Cell Count Haemoglobin (Hb) Platelet Count MCV MCH MCHC NRBC Neutrophils Lymphocytes Monocytes Eosinophils Basophils Advia 2120i analyser SOP.HAE 4348 SOP.BSL 4311 SOP.BSL 4304 SOP.BSL PAP Blood film examination Detection of normal and abnormal morphologies and white blood cell differential SOP.BSL 1514 PAP Erythrocyte Sedimentation Rate (ESR) Manual Method SOP.BSL PAP Coagulation ACL 300 & 500 Coagulometer PAP Prothrombin Time SOP.BSL Activate Partial SOP.BSL Thromboplastin Time INR SOP.BSL Anti-Xa assay SOP.BSL 3362 D-dimer SOP.BSL Fibrinogen assay SOP.BSL.3469 Thrombin Time SOP.BSL Assessment Manager: PW Page 22 of 24

23 Blood Transfusion examination activities incorporating manufacturers instructions where relevant Blood Transfusion Blood grouping by antigen detection: ABO blood group RhD type Automated Grifols Erytra analyser SOP.BSL 5704 SOP.BSL 2431 SOP.BSL 2437 PAP Manual - Grifols SOP.BSL 2501 SOP.BSL Antibody screening for the identification of the following antibodies: D,C,E,c,e,Cw,K,k,Kpa,Kpb,Fy a,fyb,jka,jkb,lea,leb,p1,m,n,s,s,lua,lub, Xga Automated Grifols Erytra analyser 3 cell screen using Grifols card column agglutination SOP.BSL 5704 SOP.BSL 2431 SOP.BSL 2437 PAP Manual - Grifols 3 cell screen using Grifols card column agglutination SOP.BSL 2501 SOP.BSL Antibody investigation for the identification of the following antibodies: D,C,E,c,e,Cw,K,k,Kpa,Kpb,Fy a,fyb,jka,jkb,lea,leb,p1,m,n,s,s,lua,lub, Xga Manual - Grifols 10 cell panel using Grifols card column agglutination SOP.BSL PAP Assessment Manager: PW Page 23 of 24

24 Blood Transfusion examination activities Direct Antiglobulin Test (DAT) for identification of IgG and C3d red cell coating Automated Grifols Erytra analyser SOP.BSL 611 PAP Manual - Grifols SOP.BSL 611 Compatibility testing: Serological crossmatch serological compatibility testing between donor red cell antigens and patient plasma Manual - Grifols SOP.BSL PAP Red cell phenotyping (D, C, c, E, e, K, Jka, Jkb, Fya, Fyb, M, N, S, s, A1) Manual Grifols SOP.BSL 4421 PAP END Assessment Manager: PW Page 24 of 24