schedule of accreditation united kingdom … · schedule of accreditation ... maintenance of...

Assessment Manager: AB2 of 18

Schedule of Accreditation issued by

United Kingdom Accreditation Service

2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

9845

Accredited to

ISO 15189:2012

Betsi Cadwaladr University Health Board

Issue No: 001 Issue date: 27 April 2018

Ysbyty Gwynedd

Penrhosgarnedd

Bangor

LL57 29W

Contact: Bernadette Astbury

Tel: +44 (0) 1978 291 100

E-Mail: [email protected]

Website: http://www.bcu.wales.nhs.uk/

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 Blood Sciences Laboratory Pathology Maelor Hospital Croesnewydd Road Wrexham LL13 7TD United Kingdom

Local contact Tony Coates 01978 725254

Phlebotomy service Management of five blood fridges:

• Laboratory blood fridge

• Theatre blood fridge

• Haemosafe remote issue fridge in theatres

• A & E blood fridge

• Office blood fridge in Pathology laboratory

WMH

Shooting Star Unit Maelor Hospital Croesnewydd Road Wrexham LL13 7TD United Kingdom

Tony Coates 01978 725254

Full blood count SSU

Renal and Diabetic Unit Gladstone Centre Maelor Hospital Croesnewydd Road Wrexham LL13 7TD United Kingdom

Tony Coates 01978 725254

HbA1c analysis RDU

9845

Accredited to

ISO 15189:2012


United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK



Testing performed by the Organisation at the locations specified


Site activities performed away from the locations listed above:

Location details Activity

Mold Community Hospital Ash Grove Mold CH7 1XG


Provision and management of phlebotomy service

Deeside Community Hospita Plough Lane Deeside CH5 1XS



Royal Alexander Hospital Marine Drive Rhyl LL18 3AS



Colwyn Bay Hospital Bryn Avenue Colwyn Bay LL12 8AY



Holywell Community Hospital Halkyn Road Holywell CH8 7TZ



Buckley Health Centre Alltami Road Buckley CH7 3PG



Hope Health Centre Hawarden Road Hope LL12 9NL



Grove Road Health Centre Grove Road Wrexham LL11 1DY



Connah’s Quay Health Centre Fron Road Connah’s Quay CH5 4PJ



9845

Accredited to

ISO 15189:2012





Testing performed by the Organisation at the locations specified


Location details Activity

Marches Medical Practice Main Road Broughton CH4 0NR



Saltney Surgery High Street Saltney CH4 8SF



Caergwrle Medical Centre High Street Caergwrle LL12 9LG



Flint Health Centre Borough Grove Flint CH6 5DR



Clwyd house Argoed Road Buckley CH7 3HZ



9845

Accredited to ISO 15189:2012





Testing performed at main address only


DETAIL OF ACCREDITATION

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

Location

Code

HUMAN BODY FLUIDS Haematology examination

activities for the purpose of clinical diagnosis

In-house documented procedures based on equipment manuals as relevant

Whole blood EDTA Full Blood Counts:

- Haemoglobin - White Blood Cell

count - Red blood cell count - Platelet count - Haematocrit - Mean Cell Volume - Mean Cell

Haemoglobin - Mean Cell

Haemoglobin concentration

- Neutrophil count - Lymphocyte count - Monocyte count - Eosinophil count - Basophil count - Reticulocyte count - Nucleated Red Cell

count

Sysmex XE5000 using flow cytometry, impedance and spectrophotometry SOP PTH/HAEE/2 FBC Processing with Sysmex XE-5000 and HST Sysmex XS1000i using flow cytometry, impedance and spectrophotometry PTH/HAEE/4 Use and Maintenance of XS-1000i (SSU clinic)

WMH SSU

Whole blood EDTA Plasma viscosity Benson viscometer

SOP PTH/HAEE/11 Plasma Viscosity

WMH

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Location

Code

HUMAN BODY FLUIDS (cont’d)

Haematology examination activities for the purpose of clinical diagnosis (cont’d)


Whole blood EDTA Detection of normal and

abnormal morphologies

Sysmex SP1000 automated staining system using May Grunwald – Giemsa method SOP: PTH/HAEE/3 Use and Maintenance of Sysmex SP1000i slide maker/stainer for Routine Blood Films, Malaria Parasites and Bone Marrow films. Manual staining by Clin-tech Speedy Diff kit SOP: PTH/HAEE/56 Speedy Diff – Rapid Blood Film Staining Examination by light microscopy SOP: PTH/HAEE/53 Blood / Malaria Film Examination Authorisation

WMH

Bone Marrow aspirates Detection of normal and

abnormal morphologies

Sysmex SP1000 automated staining system using May Grunwald – Giemsa SOP: PTH/HAEE/3 Use and Maintenance of Sysmex SP1000i slide maker/stainer for Routine Blood Films, Malaria Parasites and Bone Marrow films. Manual staining by Clin-tech Speedy Diff kit SOP: PTH/HAEE/56 Speedy Diff – Rapid Blood Film Staining Manual Perls stain SOP :BLUP3/HAE/0110 Perl's Prussian Blue Reaction for Free Iron

WMH

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Location

Code




Bone Marrow aspirate and stained trephine slides

Detection of normal and abnormal morphologies

Examination by light microscopy SOP PTH/HAEE/0110

WMH

Whole blood Screening for the detection of

Plasmodium falciparum and Plasmodium spp (Including Plasmodium ovale Plasmodium falciparum, Plasmodium malariae Plasmodium vivax)

Humasis rapid malaria test kit SOP: BLUP3/HAE/0125 Malaria Humasis Antigen Test

WMH

Detection and Identification of

Plasmodium species:

• P.falciparum

• P.vivax

• P.ovale

• P.malariae

• P knowlesi

Sysmex SP1000 automated staining system for thick and thin films. Methanol fixed and stained by May Grunwald – Giemsa SOP: PTH/HAEE/3 Use and Maintenance of Sysmex SP1000i slide maker/stainer for Routine Blood Films, Malaria Parasites and Bone Marrow films. SOP: PTH/HAEE/53 Blood / Malaria Film Examination Authorisation

WMH

Whole blood Detection of the presence of

sickling haemoglobins SICKLEDEX solubility test kit SOP PTH/HAEE/10 Sickle Cell Screening

WMH

Whole blood Detection of infectious

mononucleosis heterophile antibodies

Accusay Mono kit rapid immunoassay SOP BLUP3/HAE/0210 Infectious Mononucleosis Screen with Accusay Mono

WMH

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Location

Code




Plasma citrated Coagulation studies:

• Prothrombin time

• APTT

• Fibrinogen

• INR

• D-Dimer

• Thrombin time

Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays SOP: PTH/COAE/6 Prothrombin Time (PT/INR) SOP: PTH/COAE/11 D-dimer on the Sysmex analysers

WMH

Factor Assays:

• Factor II

• Factor V

• Factor VII

• Factor VIII

• Factor IX

• Factor X

• Factor XI

• Factor XII

Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays SOP PTH/COAE/2

WMH

Thrombophilia screening:

• Antithrombin III

• Protein C activity

• Free protein S

• Von Willebrand Factor Assay

• Ristocetin cofactor activity

• Lupus Anticoagulant Screening Low molecular weight Heparin/ Factor Xa

Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays SOP: PTH/COAE/53 Berichrom Antithrombin III SOP: PTH/COAE/3 Berichrom Protein C SOP: PTH/COAE/52 Innovance Free PS Ag SOP: BLUP3/COA/0520 Von Willebrand Antigen SOP: PTH/COAE/4 Ristocetin cofactor activity SOP: BLUP3/COA/0460 Lupus screening reagent and confirmation reagent SOP: PTH/COAE/8 Heparin Assay

WMH

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Location

Code




Whole blood Haemoglobinopathy

screening: Detection of Haemoglobin variants Hb A Hb A2 Hb F Hb S Hb C Hb D Punjab Hb E

SEBIA Minicap Flex Piercing using capillary electrophoresis SEBIA Hydrasys Alkaline and Acid electrophoresis SOP PTH/HAEE/38 Sebia Minicap Flexpiercing

WMH

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Location

Code


Blood transfusion examination activities for the purpose of clinical diagnosis


Blood Blood Grouping by antigen

detection

• A, B and O groups

• Rhesus C, c, D, E,e

• Kell antigen status

Automated testing using Ortho innova, MicroColumns. PTH/TRE/007 Blood Grouping, Biovue method (Manual & Automated)

WMH

Red cell antibody screens

(detection and identification) of the following

• Rhesus

• Kell

• Duffy

• Kid

• Lewis

• P

• MNS

• Lutheran

Automated testing using Ortho innova, MicroColumns. Manual testing using Biovue cassettes SOP PTH/TRE/009 Antibody Screen procedure, Using Biovue anti -human globulin cassettes Manual & Automated SOP PTH/TRE/021 Procedure for Antibody Identification Using BioVue Neutral Cassettes SOP PTH/TRE/022 Procedure for Antibody Investigation Using BioVue IgG Anti-human globulin Cassettes. SOP: PTH/TRE/127 Autovue, Anti-D Screening Test

WMH

Blood Compatibility testing of

patient’s plasma with donor cells

Automated testing using Ortho innova SOP PTH/TR/126 Cross matching on AutoVue Innova Manual using Biovue system SOP PTH/TRE/018 Compatibility testing, Biovue system, Patients over 4 months of age

WMH

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Location

Code


Blood transfusion examination activities for the purpose of clinical diagnosis (cont’d)


Blood Direct antiglobulin test Automated testing using Ortho

innova PTH/TRE/010 Direct Antiglobulin/Coombs Test Profile (IgG & C3), Automated & Manual procedure

WMH

Blood Foetal/maternal haemorrhage

screen (Kleihauer) Source BioScience Foetal red cell detection kit SOP: PTH/TRE/13 Kleihauer Technique for estimation of Fetal-Maternal Haemorrhage

WMH

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Location

Code


Biochemistry examination activities for the purpose of clinical diagnosis


Urine Detection of human chorionic

gonadotropin (hCG) Alere hCG cassette 25 mIU/mL rapid immunoassay pregnancy test SOP: BLUP3/IMM/0020 Pregnancy testing with ALERE NB test is carried out in Haematology department

WMH

Serum, urine, plasma, CSF Detection and quantification of

the following: Beckman Coulter AU5800 and AU680 SOP: PTH/BIOE/13 Routine running of Beckman AU5800 SOP: PTH/BIOE/17 The routine running of the Beckman Coulter AU680

WMH

Albumin Spectrophotometric - BCG Bilirubin total Diazo Calcium Spectrophotometric Arseazo III Bicarbonate Enzymatic PECP Creatinine Jaffé Photometrical

Buffered kinetic Jaffé reaction without deproteinization

Glucose Enzymatic - hexokinase HDL-Cholesterol Immuno-inhibition CHE/CHO Iron TPTZ Lactate Lactate oxidase/peroxidase Total Cholesterol Enzymatic - Cholesterol Esterase Magnesium Spectrophotometric - Xylidyl Blue

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Location

Code


Biochemistry examination activities for the purpose of clinical diagnosis (cont’d)


Serum, urine, plasma, CSF (cont’d)

Detection and quantification of the following: (cont’d)

Beckman Coulter AU5800 and AU680

WMH

Ammonia Enzymatic - GLDH Phosphate Molybdate Total Protein Biuret Triglycerides Enzymatic - lipase Uric Acid Enzymatic - Uricase Urea Enzymatic Urease Alkaline Phosphatase Enzyme activity method based on

the recommendation of the IFCC

Alanine Aminotransferase Enzyme activity method based on


α-Amylase Enzyme activity method based on


Aspartate Aminotransferase Enzyme activity method based on


Creatine Kinase Enzyme activity method based on


γ-Glutamyltransferase Enzyme activity method based on


Lactate Dehydrogenase SCE Pyruvate to Lactate C-Reactive Protein Latex-enhanced

Immunoturbidimetry

Immunoglobulin A Immunoturbidimetric Immunoglobulin G Immunoturbidimetric Immunoglobulin M Immunoturbidimetric

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Location

Code







WMH

Rheumatoid Factors Immunoturbidimetric Transferrin Immunoturbidimetric Chloride Ion-selective electrodes Potassium Ion-selective electrodes Sodium Ion-selective electrodes Ethanol Enzymatic method with alcohol

dehydrogenase

Carbamazepine Homogeneous Enzyme

Immunoassay

Digoxin Immuno-inhibition Lithium Spectrophotometric using 3rd party

reagents from Thermo Electron

Phenytoin Homogeneous Enzyme

Immunoassay

Salicylate Enzymatic - Salicylate hydroxylase

using 3rd party reagents from Siemens

Theophylline Homogeneous Enzyme

Immunoassay

Vancomycin Homogeneous PET Immunoassay Gentamicin Homogenous enzyme

immunoassay

Haptoglobin Immunoturbidimetry Oxalate Enzymatic, using 3rd party reagents

from Trinity Biotech

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Location

Code







WMH

Paracetamol Phenobarbital Homogeneous Enzyme

Immunoassay

Tobramicin Homogeneous PET Immunoassay

using 3rd party reagents from Thermo Scientific

Valproic acid Homogeneous Enzyme

Immunoassay

Direct Bilirubin Spectrophotometric - Diazo CSF Total Protein Pyrogallol Red Urine Albumin Immunoturbidimetry Oxalate Enzymatic using 3rd party reagents

from Trinity Biotech

CSF/Urine Protein Pyrogallol Red Serum, plasma Adjusted Calcium Calculation Serum, plasma eGFR Calculation Serum, plasma Serum Index Calculation Urine 24hr urine output Calculation Serum, plasma Calculated globulin function Calculation Urine Protein creatinine ratio Calculation Urine Albumin creatinine ratio Calculation Serum, plasma Transferrin saturation Calculation

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Location

Code







WMH

Serum, plasma Cholesterol HDL cholesterol

ratio Calculation

Serum, plasma Non-HDL cholesterol Calculation Serum, plasma Detection and quantification of

the following: Beckman Coulter Unicel Dxl 800 SOP: PTH/BIOE/30 Routine running of the Beckman Coulter DxI

WMH

Cardiac Troponin I Two site immuno-enzymatic Assay CEA Two site immuno-enzymatic Assay Cortisol Competitive binding

immunoenzymatic

Ferritin Two site immuno-enzymatic Assay Folic Acid Competitive Binding Receptor

Assay

Free T3 Competitive binding

immunoenzymatic

Free T4 Two-step enzyme immunoassay FSH Sequential two-step

immuno-enzymatic Assay

HCG Two site immuno-enzymatic Assay IFAB Competitive binding

immunoenzymatic

LH Sequential two-step


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Location

Code




Serum, plasma (cont’d) Detection and quantification of

the following: (cont’d) Beckman Coulter Unicel Dxl 800

Oestradiol Competitive binding

immunoenzymatic

Progesterone Competitive binding

immunoenzymatic

Prolactin Simultaneous one-step


PSA Two site immuno-enzymatic Assay PTH Two site immuno-enzymatic Assay Testosterone Competitive binding

immunoenzymatic

TPO Two site immuno-enzymatic Assay TSH(3rd IS) Thyrotropin Two site immuno-enzymatic Assay Vitamin B12 Competitive binding

immunoenzymatic

Vitamin D Two site immuno-enzymatic Assay Serum Paraprotein bands

identification and clarification Protein abnormalities screening

Sebia Capillarys 2 PTH/BIOE/48 Capillarys2 Examination Procedure

WMH

Urine Urine Bence Jones

confirmation and typing

Sebia Hydrasys 2 PTH/BIOE/69 Examination SOP - Bence Jones Protein

WMH

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Location

Code




Serum, Urine Immunofixation Sebia Hydrasys 2

PTH/BIOE/60 Examination SOP for Sebia Immunofixation

WMH

Blood Glycated Haemoglobin

(HbA1c) Tosoh G8 SOP: PTH/BIOE/44 Examination SOP for the TOSOH GX & G8

WMH

Glycated Haemoglobin (HbA1c)

Tosoh GX SOP: PTH/BIOE/44 Examination SOP for the TOSOH GX & G8

RDU

CSF Xanthochromia Jasco V-730 spectrophotometer

SOP: PTH/BIOE/56 The Spectrophotometric examination of cerebrospinal fluid for Haem pigments

WMH

Faeces Faecal Occult Blood testing Hema screen immobilise guaic and

peroxidase reaction SOP: PTH/BIOE/6 Faecal Occult Blood using hemascreen

WMH

Serum, urine Osmolality Advanced instruments 3320

Osmometer Freezing point depression osmometry SOP: PTH/BIOE/55 Examination SOP for serum and urine Osmolality

WMH

Blood Arterial Blood gas Roche Cobas b221

BLUP3/BIO/P020 Processing a sample on the Roche Cobas b221 Blood Gas Analyser

WMH

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Location

Code




Renal calculi Determination of the

composition of renal calculi JASCO FT/IR 4100 spectrometer Spectra Manager Software, including Spectra measurement and Spectra Analysis programmes SOP: PTH/BIOE/40 Preparation and Analysis of Renal Calculi by Infrared Spectroscopy

WMH

END

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