Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
Barts Health NHS Trust as the host of NHS East and South East London Pathology Partnership
Issue No: 005 Issue date: 23 August 2021
Queen Elizabeth Hospital Contact: Melanie Williams-Dogbe
8440 Stadium Road Tel: +44 (0) 208 836 6000 ext. 5672 Woolwich E-Mail: [email protected] Accredited to SE18 4QH Website: www.lewishamandgreenwich.nhs.uk ISO 15189:2012
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 Local contact
Queen Elizabeth Hospital Kathleen kidd Routine Histopathology QEH Stadium Road Special Stains Woolwich Tel: +44 (0) 208 333 3000 ext. 8478 Immunohistochemistry SE18 4QH E mail: [email protected] Immunology Clinical Biochemistry Haematology Blood transfusion
University Hospital Kathleen Kidd Clinical Biochemistry UHL Lewisham Haematology High Street Tel: +44 (0) 208 333 3000 ext. 8478 Blood transfusion Lewisham E mail:[email protected] London SE13 6LH
Assessment Manager: SW3 Page 1 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Site activities performed away from the locations listed above:
Location details Activity Location code
Blood Sciences Laboratory Blood storage (stock/issue) QEH Queen Elizabeth Hospital Fridge managed by laboratory Stadium Road Woolwich SE18 4QH
Ward 21 Haematology/Oncology Blood storage only QEH Queen Elizabeth Hospital Fridge managed by laboratory Stadium Road Woolwich SE18 4QH
Theatres Blood storage only QEH Queen Elizabeth Hospital Fridge managed by laboratory Stadium Road Woolwich SE18 4QH
Blood issue room Blood product storage (Stock/issue) UHL Rapid response laboratory Fridge managed by laboratory University Hospital Lewisham High Street Lewisham London SE13 6LH
Main TheatrePaediatric Blood storage UHL University Hospital Lewisham Fridge managed by laboratory High Street Lewisham London SE13 6LH
Assessment Manager: SW3 Page 2 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
DETAIL OF ACCREDITATION
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH activities for the purposes of using manual methods or clinical diagnosis analysers in conjunction with manufacturers’ instructions as specified:
Tissue samples (including Examination of tissues in order Supported by: breast; gastrointestinal; skin; to identify or exclude urological; morphological and cytological Specimen dissection: bronchial/lung/thoracic; abnormalities for the purpose Cut-up Manual - Routine endocrine including thyroid, of diagnosis Specimens categorised parathyroid, adrenal; according to the RCPath as, lymphoreticular including SOP CHQ-DP-008 & SOP CHQ- lymph nodes, spleen, and DP-009, CHQ-RP-00013 & CHQ bone marrow trephines DP 0010 [processing only for bone ‘A’ specimens marrow trephines]; liver; ‘B’ specimens bone and soft tissues; , ‘C’ specimens gynaecological; and head ‘D’ specimens and neck)
Formalin Fixed Tissue Decalcification using acid decalcifiers (Decalcifier 1 and 2) SOP CHQ-DP-0010
Processing using Sakura TissueTek VIPs ; VIP5 : SOP CHQ-MP-0026 VIP6 : SOP CHQ-MP-0065
Embedding using : Tissue tek Embedding Centre SOP CHQ- MP-005
Formalin Fixed Paraffin Microtomy: Using rotary Embedded Tissue (FFPE) Microtomes, Shandon Finesse, Leica (SOP CHQ-MP-006, CHQ- MF-0024)
Macroscopic and Microscopic examination: Documented in- house procedures for staining for staining and reading
Assessment Manager: SW3 Page 3 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Demonstration Of:
Formalin Fixed Paraffin Basophilic and eosinophilic Haematoxylin and Eosin staining Embedded Tissue (FFPE) structures SOP CHQ-SP-001 in conjunction sections on glass slides with manufacturer’s instructions for Leica Autostainer
Special Tinctorial Histochemical Staining:
Acid Mucopolysaccharides Alcian Blue (SOP CHQ-SP-003)
Acid and Neutral Alcian Blue/Periodic Acid Schiff Mucopolysaccharides (SOP CHQ-SP-002)
Amyloid Congo Red (SOP CHQ-SP-005)
Elastic fibres and connective Elastic/Haematoxylin Van Gieson tissue (EVG/HVG) (SOP CHQ-SP-007, CHQ-SP-014)
Bile pigments Fouchet van Gieson (SOP CHQ- SP-008)
Fungi including Pneumocystis Grocott Hexamine Silver (SOP- jiroveci (carinii) CHQ-SP-013)
Mucin; Cryptococcus Mucicarmine (SOP CHQ-SP- 0020)
Helicobacter/Microorganisms Giemsa (SOP CHQ-SP-009)
Gram +ve & -ve Gram (SOP CHQ-SP-0011) microogranisms
Connective tissue and fibrin Martius Yellow, Brilliant Crystal Scarlet, Soluble Blue (MSB) (SOP CHQ-SP-0019)
Assessment Manager: SW3 Page 4 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Demonstration Of: (cont’d)
Formalin Fixed Paraffin Special Tinctorial Histochemical Embedded Tissue (FFPE) StainingCont’d.: sections on glass slides
Melanin, Argentaffin cells and Masson Fontana (SOP CHQ-SP- Lipofuchsin 0016)
Connective tissue Masson’s Trichrome (SOP CHQ- SP-0017)
Neutral Mucopolysaccharides, Periodic Acid Schiff (PAS) & glycogen and fungus Diastase PAS (D/PAS) (SOP CHQ-SP-0023)
Haemosiderin and ferric iron Perl’s Prussian Blue (SOP CHQ- SP-0024)
Reticulin fibres Reticulin- Gordon & Sweets (SOP CHQ-SP-0010)
Copper-associated protein and Shikata’s Orcein (SOP CHQ-SP- Hepatitis B-affected cells 0022)
Mast cells Toluidine Blue (SOP CHQ-SP- 0028)
Tubercle bacilli Ziehl Neelsen (ZN) (SOP CHQ- SP-0021)
Melanin bleach Mallory Melanin Bleach (SOP CHQ-SP-0015)
Leprosy bacilli Wade-Fite (SOP CHQ-SP-0029)
Assessment Manager: SW3 Page 5 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
Embryonic cell in normal Alpha Fetoprotein tissues and germ cell tumours
Cytokeratins (acidic, basic) AE1/AE3
HGPIN, prostate AMACR (Racemase) adenocarcinoma
T lymphocytes, follicular Bcl2 oncoprotein lymphoma, basal cell carcinoma
Epithelial cell types Ber Ep4
Pancreaticobiliary CA 19.9 adenocarcinomas
Ovarian tumours CA 125
Smooth muscle Caldesmon
Myoepithelial cells, smooth Calponin muscle cells
Mesothelial cells Calretinin
Glandular cells CAM 5.2
T cells CD3
Mature T cells, T cell CD5 lymphomas
Assessment Manager: SW3 Page 6 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
Mature B cells, CALLA CD10
Granulocytes, Reed-Sternberg CD15 cells
B cells CD20
Reed-Sternberg cells, plasma CD30 cells, ALCL
Endothelial cells CD31
Haematopoetic cells, vascular CD34 endothelium
Natural killer cells, CD56 neuroendocrine tissues
Macrophages, monocytes, CD68 myeloid cells
B cells CD79alpha
Ewing Sarcoma, atypical CD99 fibroxanthoma
Mast cells, GIST CD117/CKIT
Plasma cells CD138
Intestinal epithelial cells, CDX2 colorectal + other adenocarcinomas
Assessment Manager: SW3 Page 7 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
CEA glycoproteins CEA
Tissues of neuroendocrine Chromogranin origin
CytoMeglo Virus CMV
Mantle cell lymphoma Cyclin D1
Basal cells, filamentous Cytokeratin (HMWCK/34βE12) keratins from glandular to stratified squamous
Epithelial tissue from glandular Cytokeratin (MNF116) to stratified squamous
Stratified squamous Cytokeratin 5/6 epithelium, basal cells, mesotheliomas
Normal and neoplastic Cytokeratin 7 epithelia
Carcinomas of simple Cytokeratin 8/18 epithelium
Epithelial and carcinoma cells Cytokeratin 19
Adenocarcinomas, columnar Cytokeratin 20 epithelial cells
Striated and smooth muscle Desmin cells
Assessment Manager: SW3 Page 8 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
Lymphatic vessels D2-40
Gastrointestinal stromal DOG-1 tumour
Normal ductal epithelial cells, E-Cadherin ductal carcinoma
Normal and neoplastic EMA epithelium
Endothelial cell Factor XIIIa
Thyroid tumours Galectin 3
Mammary gland carcinomas GATA-3
Mammary gland carcinomas GCDFP-15
Mammary gland carcinomas Mammaglobin
Placental trophoblasts HCG
Hep B virus Hep B surface antigen
Kaposi’s sarcoma HHV-8
Melanoma, melanocyte HMB45 differentiation
Sex cord stromal tumours Inhibin
Proliferating Cells Ki 67
Assessment Manager: SW3 Page 9 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
B cells, T cells, monocytes, LCA macrophages
Melanoma marker Melan-A
Adenocarcinoma MOC-31
Rhabdomyosarcoma MyoD1
Alveolar cells, lung Napsin A adenocarcinoma
Nuclei of cells expressing Oestrogen Receptors oestrogen
High grade dysplasia of cervix p16
Dysplasia in Barrett’s p53 oesophagus
Gestational trophoblastic p57 disease
Prostate basal cells, p63 myoepithelial cells
Prostatic glandular epithelium PAP
Ovarian tumour, renal cell PAX-8 carcinoma
Neurones, melanocytes, PGP 9.5 neuroendocrine cells
Assessment Manager: SW3 Page 10 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
Germ cell tumours PLAP
Pneumocystis jiroveci (carinii) Pneumocystis jiroveci (carinii)
Nuclei of cells expressing Progesterone Receptors Progesterone
Prostate secretory and ductal PSA epithelium
Renal cell carcinoma RCC
Schwann cells, nerve S100 processes, neural and melanocytic neoplasms
Smooth muscle cells, Smooth Muscle Actin (SMA) myoepithelial cells
Smooth muscle cells, Smooth Muscle Myosin (SMMS- myoepithelial cells 1)
Melanocytes SOX-10
Neuroendocrine cells Synaptophysin
Thyroid epithelial cells Thyroglobulin
Thyroid and lung epithelial TTF1 cells
Gastrointestinal epithelium Villin
Assessment Manager: SW3 Page 11 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY TISSUE Histopathological examination In-house documented procedures QEH (cont’d) activities for the purposes of using manual methods or clinical diagnosis (cont’d) analysers in conjunction with manufacturers’ instructions as specified:
Formalin Fixed Paraffin Immunohistochemistry to Ventana Benchmark stainer Embedded Tissue (FFPE) detect the following: (cont’d) SOP (CHQ-IP-0015) in sections on glass slides conjunction with manufacturers (cont’d) instructions Incorporating the following antibodies:
Mesothelial cells, serous WT-1 carcinoma
Mismatch Repair Genes in MMR Panel (MSH2, MSH6, Hereditary Nonpolyposis MLH1, PMS2) Colonic Cancer (HNPCC)
lung squamous cell P40 carcinomas
skin basal cell carcinomas CK14
breast and prostate carcinoma Androgen receptor
Assessment Manager: SW3 Page 12 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ clinical diagnosis instructions as required
Serum unless otherwise Roche Cobas c8000 -with Roche QEH stated ISE, c702 for spectrophotometric UHL and e801 for immunoassays in (Unless conjunction with manufacturer’s otherwise instructions and SOP BB-AP-042 stated) (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 (UHL) and the following principles:
ACE Kinetic method using third party QEH reagents Buhlmann as an open channel using SOP BB-AP-065
Albumin Colorimetric detection methods
Ammonia Enzymatic detection, BB-AP-078
Fluid Fluid amylase Enzymatic detection QEH
Serum Bicarbonate Colorimetric detection methods
Bile Acid Colorimetric method BB-AP-006 QEH Bile acid as an open channel
Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 and the following principles:
Assessment Manager: SW3 Page 13 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated) Serum/blood CSF glucose Enzymatic detection
CK Enzymatic detection Fructosamine Colorimetric detection CSF protein Turbidmetric detectoion Bilirubin Total Colorimetric detection
Serum/urine Calcium Colorimetric detection
Serum Adjusted Calcium Calculation
Iron Colorimetric detection methods
Magnesium Colorimetric detection methods
Total Protein Colorimetric detection methods
Globulin Calculation
Alkaline Phosphatase enzymatic detection methods
Serum/urine Amylase Enzymatic detection methods
Serum Cholesterol Enzymatic detection methods
Blood, Urine Creatine Kinase Colorimetric detection methods
CSF Lactate Enzymatic detection methods QEH
Serum Glucose (Fasting, random) Enzymatic detection methods
Assessment Manager: SW3 Page 14 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 and the following principles:
Ethanol Enzymatic detection methods
Gamma GT Enzymatic colorimetric
Urine Protein:creatinine ratio Calculation
Urine Albumin:creatinine ratio Calculation QEH
Urine Microalbumin Immuno-turbidimetric detection QEH methods
Rheumatoid Factor Immuno-turbidimetric detection QEH methods
Direct Bilirubin Wako Vandate oxidation method colorimetric SOP BB-AP-074 Direct Bilirubin on Cobas 8000 as an open channel
Ferritin sandwich immunoassay detection
Troponin T sandwich immunoassay detection
Vitamin D competitive immunoassay detection
HDL Cholesterol Enzymatic colorimetric detection methods
Assessment Manager: SW3 Page 15 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated) Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 (UHL) and the following principles:
Non HDL Cholesterol Calculation
LDL Cholesterol Calculation
CSF Lactate Enzymatic detection methods QEH
Serum Lactate Enzymatic colorimetric detection methods
Triglycerides Enzymatic colorimetric detection methods
Serum/Urine Uric acid Enzymatic colorimetric detection methods
Blood Lactate Dehydrogenase rate enzymatic detection
Fluid Lactate Dehydrogenase rate enzymatic detection QEH
Blood/urine Potassium ion selective electrode (indirect) detection
Sodium ion selective electrode (indirect) detection
Urine Protein Turbidimetry detection
Blood/Urine Urea Kinetic enzymatic
Phosphate UV Photometric
Alpha Fetoprotein Sandwich immunoassay QEH detection
Assessment Manager: SW3 Page 16 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 and the following principles:
NT-Pro-BNP (natriuretic Sandwich immunoassay QEH peptide) detection
CA125 Sandwich immunoassay QEH detection
CA 15-3 Sandwich immunoassay QEH detection
CA 19-9 Sandwich immunoassay QEH detection
Follicle Stimulating Hormone Sandwich immunoassay QEH detection
BhCG Sandwich immunoassay detection
Leutinising Hormone Sandwich immunoassay QEH detection
Prolactin Sandwich immunoassay QEH detection
Total Prostate Specific Antigen Sandwich immunoassay QEH detection
Parathyroid Hormone Sandwich immunoassay QEH detection
Assessment Manager: SW3 Page 17 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 and the following principles:
Sex Hormone Binding Globulin Sandwich immunoassay QEH detection
Thyroid Stimulating Hormone Sandwich immunoassay detection
Carcinoembryonic Antigen Sandwich immunoassay QEH detection
Cortisol Competitive Immunoassay detection
Free T3 Competitive Immunoassay detection
Free T4 Competitive Immunoassay detection
Progesterone Competitive Immunoassay detection
Testosterone Competitive Immunoassay QEH detection
Oestradiol Competitive Immunoassay QEH detection
Anti-TPO (Thyroid Peroxidase) Competitive Immunoassay QEH detection
Assessment Manager: SW3 Page 18 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Serum unless otherwise Roche Cobas c8000 -with Roche stated ISE, c702 for spectrophotometric and e801 for immunoassays in conjunction with manufacturer’s instructions and SOP BB-AP-042 (QEH) & SOP BB-AP-052 BB-AP-046 & BB-AP-073 BB-AP-079 and the following principles:
Digoxin competitive Immunoassay detection
Lithium colorimetric detection
Paracetamol enzymatic detection
Salicylate enzymatic detection
Phenytoin KIMS detection QEH
Theophylline KIMS detection
Carbamazepine KIMS detection QEH
Valproate enzymatic immunoassay QEH detection
Gentamicin enzymatic immunoassay detection
Vancomycin enzymatic immunoassay detection
Amikacin KIMS detection, BB-AP-077 UHL Amikacin run on Roche Cobas 8000
Blood, arterial and Venous Actual Base Excess (blood Radiometer ABL90 Plus, gas) calculated with manufacturer’s instructions using SOP PC-P-051
Assessment Manager: SW3 Page 19 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Blood, arterial and Venous Standard Bicarbonate (blood Radiometer ABL90 Plus, gas) calculated with manufacturer’s instructions using SOP PC-P-051
Calcium (Blood gas) Potentiometry Radiometer ABL90 Plus, calculated with manufacturer’s instructions using SOP PC-P-051
Oxygen saturation (blood gas) Radiometer ABL90 Plus calculated with manufacturer’s instructions using SOP PC-P- 051and Using Ion selective electrode
Glucose (Blood gas) Amperometry
Haematocrit (Blood gas) Calculated method
Lactate (Blood gas) Amperometry
Methaemoglobin spectrophotometry
Oxyhaemoglobin (Blood gas) spectrophotometry
Oxygen saturation (Blood gas) spectrophotometry
Chloride (Blood gas) Potentiometry
Potassium (blood gas) Using Ion selective electrode, Potentiometry
Sodium (blood gas) Using Ion selective electrode, potentiometry
pH (blood gas) Using Ion selective electrode, potentiometry
pCO2 (blood gas) potentiometry
Assessment Manager: SW3 Page 20 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Blood, arterial and Venous pO2 Radiometer ABL90 Plus, with manufacturer’s instructions using SOP PC-P-051 spectrophotometry
Total Haemoglobin (blood gas) Spectrophotometry, Radiometer ABL90 Plus, with manufacturer’s instructions using SOP PC-P-051
Blood Carboxyhaemoglobin (blood Spectrophotometric Radiometer gas) ABL90 Plus with manufacturer’s instructions and SOP PC-P-051
Faeces Calprotectin Immunoassay, using QEH chemiluminescent technology – Werfen instrument – AcuStar Manual extraction – pre-analytical
Blood HbA1c Biorad D100 HPLC with QEH manufacturer’s instructions using SOP BB-MP-049
Ketones Electrode strips, Abbott Freestyle QEH Optimum H ketone meter with manufacturer’s instructions using SOP PC-P-009
Blood/Urine Osmolality Advanced micro osmometer 3300 freezing point depression using BB-AP-002
Blood Macroprolactin PEG precipitation and Cobas QEH 8000 with manufacturer’s instructions using SOP BB-MP- 014
Urine Myoglobin Multi-sticks dipstick. Seimens QEH Clinitek Urinalysis with manufacturer’s instructions using SOP BB-MP-010 and PC-P-028
Assessment Manager: SW3 Page 21 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Biochemistry examination In house documented methods QEH/UHL BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (Unless (cont’d) clinical diagnosis (cont’d) instructions as required otherwise stated)
Faeces Faecal Immunichemical Latex Immune-agglutiination testing method using nephlaometry- Instrumenr OCsensor iO MAST CSF Xanthochromia Scanning spectrophotometric QEH Perkin Elmer Spectrophotometer with manufacturer’s instructions using SOP BB-MP-017
Urine Catecholamines Thermo Fisher U3000, HPLC, QEH BB-MP-038 HPLC Method for Urine Catecholamines
Urine 5 Hrydroxy indole acetic acid Thermo Fisher U3000, HPLC, QEH (5HIAA) BB-MP-038 HPLC. BB-MP-041 Urine 5-hydroxy-indole acetic acid (5HIAA) by HPLC
Sweat Sweat Chloride Wescor Macroduct Collection UHL system Wescor 3100 Sweat Check Sweat conductivity analyser, Corning 925 Chloride analyser
Faeces Haemoglobin concentration Faecal Immunochemical Test QEH based on Latex immune- agglutination method, using 22ephelometry– Instrument OC sensor iO MAST- BB-MP-059
Assessment Manager: SW3 Page 22 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS Haematological examination In house documented methods QEH/UHL activities for the purpose of incorporating manufacturers’ (Unless clinical diagnosis instructions where relevant otherwise stated)
Whole Blood (EDTA) Full blood count (FBC): Sysmex XN 2000 (XN10) SOP BH-AP-045 Sysmex XN 9000 (XN10/20) SOP BH-AP-007 Sheath flow detection Sysmex XN 2000/9000 (XN10/20) Platelets Red blood cells Haematocrit MCV MCH MCHC RDW White cell count neutrophils Lymphocytes Monocytes Eosinophils Basophils Reticulocytes Nucleated Red Cells Haemoglobin Hb Sysmex XN 2000/ 9000 (XN10 & XN20) using SLS haemoglobin method-photometric method with manufacturer’s instructions using SOP BH-AP-007/045
Blood Blood Film examination- Romanowski staining Haematek Detection of normal and 2000 and Light microscopy using abnormal morphologies and SOP BH-AP-014 white blood cell differential
Bone marrow Examination of bone marrow: Light microscopy using SOP BH- in order to identify or exclude SP-013 Morphological and Cytological MGG and Iron stain using SOP abnormalities for the purpose BH-SP-024 of diagnosis
Assessment Manager: SW3 Page 23 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS Haematological examination In house documented methods QEH/UHL (cont’d) activities for the purpose of incorporating manufacturers’ (Unless clinical diagnosis (cont’d) instructions where relevant otherwise stated)
Erythrocyte Sedimentation Westergren reference method UHL Rate (automated) using StaRRsed ST Analyser SOP BH-AP-042
Plasma- citrate Coagulation screen Werfen ACL350/550/750 with manufacturers instructions using SOP BH-CP-003,007,012, ,022, ,025, photo optical method Prothrombin time (PT)
INR
Activated Partial Thromboplastin Time (APTT)
Thrombin time
Fibrinogen Anti Xa Assay D-Dimer l latex immunoassay using SOP BH-CP-011
Glandular fever/infectious Clearview IM ELISA test kit using mononucleosis (IM) SOP BH-AP-018 Heterophile antibodies
Malarial Parasite identification ICT method pLDH/HRP-2 Detection of Malarial antigens combination antibody test SOP of: BH-AP- 016 P. falciparum Pan-detection for P. malariae P. ovale P. vivax
Assessment Manager: SW3 Page 24 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS Haematological examination In house documented methods QEH/UHL (cont’d) activities for the purpose of incorporating manufacturers’ (Unless clinical diagnosis (cont’d) instructions where relevant otherwise stated)
Blood films Malarial Parasite identification Manual interpretation of blood Detection of: films Using microscope and SOP BH- AP- 016 P. falciparum P. malariae P. ovale P. vivax P.Knowlesi
Blood (EDTA) Detection of HbS solubility Sickle cell screen using Itano’s solution an Microgen S-Test kit using SOP BH-SP-011 with manufacturer’s instructions
Abnormal Haemoglobin HPLC using SOP BH-SP-018 studies detection of presence and separation of Hb, Hb C Hb D Hb E HbF Hb Lepore Hb O
Abnormal Haemoglobin Sebia Hydrasys 2 scan using gel QEH studies detection of presence electrophoresis with and separation of Hb, manufacturers instructions using Hb C SOP BH-SP-016,017 Hb D Hb E HbF Hb Lepore Hb O
Assessment Manager: SW3 Page 25 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS Haematological examination In house documented methods QEH/UHL (cont’d) activities for the purpose of incorporating manufacturers’ (unless clinical diagnosis (cont’d) instructions where relevant otherwise stated)
Blood Werfen ACL 750 with QEH Plasma:citrate manufacturer’s instructions using SOP BH-CP-003, 007, 012,014,015,022,024,025,026,02 7,031
Lupus screening Factor assays:
Factor II Factor V Factor VII Factor VIII Factor IX Factor X Factor XI Factor XII Protein C Chromogenic method Protein S Anti-thrombin iii Chromogenic method
Mutation Detection for Factor PCR technique using GeneXpert QEH V Leiden/ Prothrombin gene and SOP BH-CP-033 (G20210A)
CD4/CD8 Immunophenotyping Beckman Coulter Aquios by flow QEH cytometry BH-AP-033
Assessment Manager: SW3 Page 26 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Blood Transfusion In house documented methods QEH/UHL BIOLOGICAL FLUIDS examination activities for the incorporating manufacturers’ (unless (cont’d) purpose of clinical diagnosis: instructions as required stated otherwise)
Blood: EDTA Blood Group A,B,O and AB Gel techniques using Grifols: DG detected, Antibody detection Gel Coombs card, DG Gel • A B O Neutral card, Serascan Diana • Rhesus: 3/3P, DG Gel Sol. anti-Cw, anti-C, anti-c, SOPs required: QE-BTAUT008, anti-D, anti-E, anti-e, QE-BT-AUT009, QE-BT- • Kell system: MAN002, QE-BT-MAN003 anti-K, anti-k, anti-Kpa, • Kidd: anti-Jka, anti-Jkb, • Duffy: anti-Fya, anti-Fyb, • Lutheran: anti-Lua, • MNS: anti-M, anti-N, anti-S, anti- s, • Lewis: anti-Lea, anti-Leb, P1: anti-P:-
Antibody identification of the Gel techniques using Grifols: DG following: Gel Coombs card, DG Gel • Rhesus: Neutral card, DG Gel Sol, anti-Cw, anti-C, anti-c, Identisera Diana, NHSBT ID anti-D, anti-E, anti-e, Panel Cells in CellMedia. • Kell system: SOPs required: QE-BTAUT008, anti-K, anti-k, anti-Kpa, QE-BT-AUT009, QE-BT- • Kidd: MAN002, QE-BT-MAN003. anti-Jka, anti-Jkb, • Duffy: anti-Fya, anti-Fyb, • Lutheran: anti-Lua, • MNS: anti-M, anti-N, anti-S, anti- s, • Lewis: anti-Lea, anti-Leb, P1: anti-P:-
Assessment Manager: SW3 Page 27 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Blood Transfusion In house documented methods QEH/UHL BIOLOGICAL FLUIDS examination activities for the incorporating manufacturers’ (unless (cont’d) purpose of clinical diagnosis: instructions as required stated (cont’d) otherwise)
Red blood cells in EDTA Direct Anti-globulin Test Gel techniques using Grifols: DG Automated / Manual: Gel Coombs card, DG Gel DC Monospecific and Polyspecific) Scan card, DG Gel Sol. SOPs required: QE-BTAUT008, QE-BT-MAN004, QE-BT- MAN005.
Transfusion reaction Grifols Manual Gel Card investigation technololgy SOP QE-BT-ISS011
Electronic Issue Crossmatch WinPath. SOPs required: QE-BT-ISS007, QE-BT-ISS008, QE-BT-ISS009, QE-BT-ISS010, QE-BT-ISS012, QE-BT-ISS 0202, QE-BT-ISS021, QE-BT-ISS029, QE-BT-ISS030, QE-BT-ISS031, QE-BT-ISS032, QE-BT-ISS035, QE-BT-ANT002, QE-BT-ANT005.
Donor red blood cells, IAT manual Crossmatch Manual gel technique using patient red blood cells Grifols: DG Gel Coombs card, GD and/or plasma in EDTA Gel Sol, NHSBT OR1r, NHSBT Weak Anti-D SOP required:QE-MAN005
Whole blood in EDTA Foetal Maternal Haemorrhage Manual techniques using QEH/UHL Estimation (Kleihauer Test) BioScience: PBSS Ph 7.0, Fixol unless fixative, fetal red cell detection otherwise Kit. stated SOP required: QE-BT-ANT004
Assessment Manager: SW3 Page 28 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Immunology examination In house documented methods QEH BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (cont’d) clinical diagnosis instructions as required
Serum RAST (specific IgE) Phadia Immunocap 250 with manufacturer’s instructions using SOP BB-IP-009 Immunocap 250 Avocado Almond Alternaria alternate Apple Aspergillus fumigatus Banana Blue Mussel Brazil nut Cacao Cashew Cat dander Cheese Coconut Cod Dog dander Egg white Egg yolk Gluten Hazel nut House dust mite Kiwi Latex Milk Mixed fish (cod, shrimp, blue mussel, salmon, tuna) Mixed food (egg white, milk, cod, wheat, peanut, soya) Mixed grass Mixed nuts (peanut, hazelnut, brazil nut, almon, coconut) Mixed trees Orange Peanut Pistachio Salmon Sesame seed Shrimp Silver birch Soya
Assessment Manager: SW3 Page 29 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Immunology examination In house documented methods QEH BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (cont’d) clinical diagnosis (cont’d) instructions as required
Serum (cont’d) RAST (specific IgE) (cont’d) Phadia Immunocap 250 with manufacturer’s instructions using SOP BB-IP-009 Immunocap 250 Strawberry Timothy grass Tomato Tuna Walnut Wheat
Serum Total IgE EIA Phadia Immunocap 250 with manufacturer’s instructions using SOP BB-IP-009 Immunocap 250
Cyclic citrullinated protein (CCP)
Tissue transglutaminase antibody (Ttg)
Cardiolipin Abs
Double stranded DNA
Extractable Nuclear Antigen (ENA)
Anti Neutrophil Cytoplasmic Antibody (ANCA), includes: • MPO antibody • PR3 antibody
GBM Antibodies- Glomerular Basement membrane antibodies
CTD Connective Tissue Disease
Aspergillius Antibody
Assessment Manager: SW3 Page 30 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Immunology examination In house documented methods QEH BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (cont’d) clinical diagnosis (cont’d) instructions as required
Serum Autoantibody screen: Helmed automated indirect Immunofluorescence with manufacturer’s instructions using SOP BB-IP-020 automated IFA Anti-nuclear antibodies (ANA) Anti-mitochondrial antibodies (AMA) Anti-smooth muscle antibodies (ASMA) Anti-liver kidney microsomal antibodies (ALKM) Anti-gastric parietal cell antibodies (AGPCA)
Anti-Neutrophil cytoplasmic Antibody (ANCA) screen (includes P-ANCA & C-ANCA)
Antinuclear antibody (Hep2 screen)
Serum/Urine Abnormal/normal serum/urine Gel electrophoresis proteins quantitation of Sepia Hydrasys with paraprotein bands. manufacturer’s instructions using SOP BB-PP-3 using gel Electrophoresis and immunofixation BB-PP-4
Serum/Urine Identification of abnormal SOP BB-PP-4 using protein bands Immunofixation
Serum Abnormal/normal serum/urine Capillary zone electrophoresis proteins, quantitation of Sebia CZE BB-PP-8 paraprotein bands
Serum IgA Beckman Immage Nephelometry with manufacturer’s instructions using SOP BB-PP-6
IgG
IgM
Assessment Manager: SW3 Page 31 of 32
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Barts Health NHS Trust as the host of NHS East and South East London
8440 Pathology Partnership
Accredited to Issue No: 005 Issue date: 23 August 2021 ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN TISSUES AND Immunology examination In house documented methods QEH BIOLOGICAL FLUIDS activities for the purpose of incorporating manufacturers’ (cont’d) clinical diagnosis (cont’d) instructions as required
Serum C3 Beckman Immage Nephelometry with manufacturer’s instructions using SOP BB-PP-6
C4
A1 Antitrypsin
Haptoglobin
Ceruloplasmin
Transferrin
Serum B2 Microglobulin Beckman Immage Nephelometry with manufacturer’s instructions using SOP BB-PP-6
Serum/Urine Free light Chains Binding site Spa Plus nephelometry BB-PP-7
Blood Cryoglobulins visual technique using SOP BB- PP-5
END
Assessment Manager: SW3 Page 32 of 32