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Assessment Manager: PW Page 1 of 19
Schedule of Accreditation issued by
United Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR UK
8178
Accredited to
ISO 15189:2012
University Hospital Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Department of Cellular Pathology
MP002 Level E
Pathology Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
Contact: Dr Victoria Elliot
Tel: +44 (0) 238120 8655/5720
Mob: +44 (0) 7812 610 686
E-Mail: [email protected]
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
Department of Cellular Pathology Levels E & B Pathology Block Southampton General Hospital Tremona Road Southampton SO16 6YD
Local Contact
Neil Woodward Cellular Pathology Operations Manager Tel : +44 (0) 238120 8954 / 6393 Email :[email protected]
Histopathology Neuropathology Immunocytochemistry Non-Gynae Cytopathology Electron Microscopy
A
Site activities performed away from the locations listed above:
Location details Activity Location code
EUS & EBUS Clinics Endoscopy Department Level E Southampton General Hospital SO16 6YD
Local Contact
Sharon Kooner-Evans Tel: +44 (0) 2381204879 [email protected]
Assessment of adequacy of cellular material for diagnostic purposes.
B
FNA Clinic Outpatients Department Royal South Hampshire Hospital, Brintons Terrace Southampton SO14 0YG
Local Contact
Sharon Kooner-Evans Tel: +44 (0) 2381204879 [email protected]
Assessment of adequacy of cellular material for diagnostic purposes.
C
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 2 of 19
DETAIL OF ACCREDITATION
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES
Examination activities for the purpose of clinical diagnosis
In-house documented methods incorporating manufacturers’ instructions where relevant
Fresh frozen human tissue samples
Frozen section technique by Cryotomy
In house documented methods incorporating manufacturers’ instructions where relevant LP 103 002 & LP 120 006 Bright Cryostat Thermo-Fisher Cryostat Hand staining
A
T helper cell marker CD4 T cytotoxic cell marker CD8 B cell marker CD20 Neurodegenerative marker TDP43 Neurodegenerative marker P62 Fresh frozen human skin tissue samples
Microscopic interpretation of manual Immunofluorescence staining for identification of sites of immunoglobulin deposition :
Documented in-house procedure LP 103 009 for manual hand staining using Bright Cryostat & Thermo-Fisher Cryostat using:
A
Complement C3 Immunoglobulin label IgA Immunoglobulin label IgG
Specimen dissection Formalin fixed tissue samples
Manual methods using documented in-house procedures LP 102 014 & LP 102 011
A
Tissue Processing Formalin fixed tissue samples
Documented in-house procedure LP 104 002, LP 104 004, LP 104 009, LP 104 011, LP 120 013 & LP 120 050 in conjunction with manufacturers instructions using Excelsior tissue processor, Peloris tissue processor & Vacuum Infiltration Processors
A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 3 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Processed tissue samples
Tissue embedding Documented in-house procedure LP 104 004, LP 120 013 & LP 120 050 in conjunction with manufacturers instructions using embedding centres
A
Paraffin waxed tissue samples
Tissue sectioning (microtomy) Documented in-house procedure LP 105 001, LP 105 002 & using microtomes
A
Routine staining Paraffin waxed tissue samples
Documented in-house procedures LP 105 023 & LP 105 008 for hand staining or in conjunction with manufacturers instructions for and using Dako Coverstainer & LEICA XL Autostainer
A
Paraffin waxed tissue samples
Identification of basophilic and eosinophilic structures
Haemotoxylin & Eosin A
Special staining Formalin fixed paraffin embedded tissue samples
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis
Documented in-house procedures LP 106 048 for manual hand staining (M) or in conjunction with manufacturers instructions using Dako Artisan Link Pro (A) using:
A
Acid Mucopolysaccharides
Alcian blue (M) LP106 012
A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 4 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Special staining Formalin fixed paraffin embedded routine histopathology, and Neuropathology, tissues samples
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis
Documented in-house procedures LP 106 048 for manual hand staining (M) or in conjunction with manufacturers instructions using Dako Artisan Link Pro (A) using:
A
Acid & neutral mucins Alcian Blue/ PAS Stain (A)
LP 106 047
Calcium deposits
Alizarin Red Stain (M) LP106 032
Amyloid
Congo Red (A) LP 106 047
Elastic tissue fibres, Muscle, collagen EVG - Miller's Elastic Tissue
Stain (M) LP106 006
Mast cells & H. pylori Giemsa Ph5.0 (M)
LP106 040
Gram +/- organisms Gram (M)
LP106 019
Fungi Grocott- Gomori Methenamine
Silver (A) LP 106 047
Basophilic and eosinophilic structures
H & E Rapid (M) LP106 001
Elastic fibres and connective tissue
Haematoxylin Van Gieson (M) LP106 003
Basement membranes Jones H&E Stain (M)
LP106 009
Myelin & Nissl substance Kluver Barrera Stain (M)
LP 120 018
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 5 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Special staining (cont’d) Formalin fixed paraffin embedded routine histopathology, and Neuropathology, tissues samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 106 048 for manual hand staining (M) or in conjunction with manufacturers instructions using Dako Artisan Link Pro (A) using:
A
Melanin pigment
Masson Fontana (M) LP106 025
Connective tissue
Masson Trichrome (A) LP 106 047
Fibrin MSB (M)
LP106 018
Hepatitis B surface antigen Orcein (M)
LP106 039
Elastic fibres Orcein Elastic Stain (M)
LP106 007
PAS +ve substances eg: glycogen (and
cells of pituitary)
Periodic Acid Schiff with and without diastase (A) LP 106 047
Removal of Glycogen
Periodic Acid Schiff Diastase (A) LP 106 047
Haemosiderin and ferric iron
Perls Prussian Blue (A) LP 106 047
Removal of formalin pigment
Melanin Bleach (M) LP106 026
Reticulin Untoned Reticulin method -
Gordon & Sweets (A) LP 106 047
Reticulin Toned Reticulin Method (A)
LP 106 047
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 6 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Special staining (cont’d) Formalin fixed paraffin embedded routine histopathology, and Neuropathology, tissues samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 106 048 for manual hand staining (M) or in conjunction with manufacturers instructions using Dako Artisan Link Pro (A) using:
A
Copper Rhodanine Stain (M)
LP106 030
Mycobacterium Leprae Wade-Fite (Modified ZN) (M)
LP106 022
Helicobacter pylori
Warthin-Starry Stain (A) LP 106 047
Tubercle bacilli (TB)
Ziehl-Neelsen (A) LP 106 047
Immunocytochemistry Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
Histocytes A-1-antichymotrypsin Hepatic Tumours, histocytes A-1-antitrypsin Alzheimer proteins A-synuclein Acetyl cholinesterase ACTH Epithelial cells AE1/AE3 Lymphomas ALK 1 Hepatocytes & germ cell tumour Alpha foetal protein Secondary Amyloid AMYLOID A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 7 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
Amyloid AMYLOID P Smooth Muscle, myofibroblasts,
myoepithelial cells ASMA
Prostate 34 BE12 Amyloid purified protein Beta APP Placenta and in certain trophoblastic
tumors Beta HCG
Cytoplasmic Protein Beta Catenin Scattered T cells in germinal centres and
mantle zone B cells-follicular lymphoma BCL2
lymphoma BCL 6 mesothelioma panel marker- epithelial BEREP4 Hydrocortisone BHCG renal compliment C1Q renal compliment C3c GI tumours / Pancreas Ca19-9 Ovarian tumours CA125 Thyroid C cells and carcinoma CALCITONIN Smooth muscle and sarcoma CALDESMON Mesothelial and lung tumours CALRETININ
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 8 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
T cells in mantle zone CD3 T cells CD4 T and B cells-leukaemia CD5 T cells CD8 T cell malignancy CD7 Childhood ALL, follicular lymphoma CD10 Reed Sternberg cells, hodgkins and meso
panel CD15 Leu M1
B cells-lymphoma CD20 B cells- dendritic cells CD21 Lymphocytes in germinal centres CD23 B Cells CD19 Reed Sternberg cells, hodgkins CD30 (Ki1) Endothelial cells- malignancy CD31 Vascular epithelium CD34 (Q bend/10) T cell lymphoma CD43 Neuroectodermal cells, neurones,
astrocytes CD56
Neuroectodermal cells & tumour CD57 (NK-1)
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 9 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
T & B Cells CD45 (LCA, PD7-2B11) Megakaryocyes in trephines CD61 Macrophages CD68 B cells CD79a Ewings sarcoma CD99 (MIC2) Endothelial cells CD105 GIST tumours CD117 (c-kit) B lymphocyte differentiation CD138 Differentiation of carcinoids and metastatic
adenoCa CDX-2
Epithelial malignancy CEA (monoclonal only) Neuroendocrine cells CHROMOGRANIN prostate CK5/6 ovarian CK7 Cytoskeleton, epithelial cells CK8 Cytoskeleton, epithelial cells CK14 Cytoskeleton, epithelial cells CK17 stratified epithelium CK18 ductal and glandular epithelium CK19
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 10 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
ovarian CK20 Inflammatory marker CR3/43 mantle cell lymphoma CYCLIN D1 Cytomegalovirus CMV B cells but not plasma cells, lymphatic
endothelium D2-40
Hairy cell leukaemia DBA44 Smooth and striated muscle DESMIN Epithelial cell Ca E-CADHERIN Epithelial cells EMA Breast epithelial cell nuclei ER Endothelial cells and megakaryocytes FACTOR 8 (Von Willebrand
Factor)
Blood proenzyme- platelets, histocytes,
megakaryocytes FACTOR 13a
Follicular Stimulating Hormone FSH Breast ca GCDFP-15 Gross cystic
disease fluid protein
Glial fibrillary acide protein GFAP Pituitary hormone marker Growth Hormone
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 11 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
Red blood cells & their precursors Glycophorin Protease in cytotoxic T cells & NK cells Granzyme B Cell cytoplasm with Hepatitis (B) HBsAG Hepatocytes Hepatocyte Melanocytes HMB 45 Herpes simplex virus HSV Renal immunoglobulin IgA Renal immunoglobulin IgD Renal immunoglobulin IgG Renal immunoglobulin IgM Sex cord stromal tumours INHIBIN Glial tumours INI-1 Glial tumours IDH-1 Proliferating cells Ki67 (MIB1) Langerhans cells & dendritic cells Langerin Pituitary hormone marker Luteinising Hormone Mast Cells Mast Cell Trypase (MCT) Melanocytes MELAN A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 12 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
b cell lymphoma MUM-1 Skeletal muscle MYOGENIN DNA mismatch repair enzyme MLH1 DNA mismatch repair enzyme MSH2 DNA mismatch repair enzyme MSH6 Mucin 4 colonic cells MUC4 Cytokeratin cocktail MNF116 Granulocytes & monocytes Myeloperoxidase Nuclei of myoblasts, fetal muscle MYO D1 Nuclei of myoblasts, fetal muscle Myogenin Proto-oncogene marker MDM2 Neuroendocrine tissues Neurofilament protein Neurofilament marker N52 Neuroblastoma NB84 Neutophils NP57 Germ cell tumour OCT3/4 Cervical Ca P16 Prostatic adenocarcinoma P504S
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 13 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
Nuclear component over-expressed in
some tumours P53
Myoepithelial cells P63 Glandular epithelium in prostate PAP Parvovirus Parovirus B-cell neoplasms PAX-5 Cytoplasm of activated T & B cells PD1 Inflammatory proitein marker Perforin Protein in neuroendocrine cell+s PGP9.5 Germ cell tumours PLAP DNA mismatch repair enzyme PMS2 Prostate tissue PMSA Pneumocystis fungi Pneumocystis Breast epithelium Progesterone Receptor (PR) Pituitary hormone marker Prolactin Prostate neoplasm PSA Renal cell ca RCC Melanoma, glial cells S100 Smooth muscle myosin SMMS-1
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 14 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry (cont’d) Paraffin tissue sections of routine histopathology, and Neuropathology, tissue samples (cont’d)
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont’d)
Documented in-house procedures LP 130 007 & LP 130 027 in conjunction with manufacturers instructions using antibodies and Dako Autostainer Link 48
A
Yolk sac tumour SALL 4 Pancreatic hormone Somatostatin Protein in neuroendocrine cells Synaptophysin Cytolitic lymphocytes TIA-1 T and B cells in leukaemia TDT Thyroid THYROGLOBULIN Toxoplasma Toxoplasma Lung and thyroid TTF-1 Mesenchymal cells VIMENTIN Renal tumours, mesothelioma WT1 Immunocytochemistry Paraffin tissue section
Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis
Documented in-house procedures LP 130 007 & LP 130 022 in conjunction with manufacturers instructions using antibodies and BenchMark Ventana
A
HER2 receptors/gene HER2 Gastrointestinal stromal tumour DOG1
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 15 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Immunocytochemistry Paraffin sections of routine histopathology, and Neuropathology, tissue samples
Microscopic interpretation of thin tissue sections stained by manual immunohistochemical (IHC) techniques to demonstrate specific tissue components to aid diagnosis for the purposes of disease identification:
Documented manual in-house procedures LP 120 026 in conjunction with manufacturers instructions using antibodies.
A
Prion protein KG9 Alzheimers amyloid Beta-Amyloid Amyloid Tangles Tau APP protein Beta-APP Amyloid proteins A-synuclein Neuronal marker Anti-NeuN Slides prepared in house from samples listed above
Morphological assessment and interpretation/diagnosis
Qualitative Microscopy using Nikon bright field microscopes per in-house procedure TP 000 005 in conjunction with manufacturer’s instructions.
A
Diagnostic Cytopathology Air-dried aspirated and voided human body fluids, fine needle aspirates (FNA’s) and brushings.
Examination of cell preparations to identify or exclude cytological abnormalities for the purposes of diagnosis.
Preparation of slides Using documented in-house procedure LP 220 012 & LP 220 013 in conjunction with manufacturer’s instructions by cytospin.
A
Manual staining:
Using documented in house procedure LP 220 006
Cytological smear preparations
Romanowsky stain A
Cytological Brushing slide preparations
Romanowsky stain A, B & C
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 16 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Diagnostic Cytopathology (cont’d) Examination of cell preparations to identify
or exclude cytological abnormalities for the purposes of diagnosis. (cont’d)
Manual staining: Using documented in house procedure LP 220 006
Fine needle aspirate slide preparations
Romanowsky stain A, B & C
Wet-fixed aspirated and voided human body fluids, fine needle aspirates (FNA’s) and brushings.
Preparation of slides Using documented in-house procedure LP 220 012 & LP 220 013 by cytospin.
A
Automated staining Staining of slides for analysis, using documented in-house procedure LP220 003 conjunction with manufacturer’s instructions for staining using Leica Autostainer XL (A)
A
Cytological smear preparations
Papanicolaou (A)
Sputum slide preparations
Papanicolaou (A)
Body fluid slide preparations
Papanicolaou (A)
Brushing slide preparations
Papanicolaou (A)
Fine needle aspirate slide preparations
Papanicolaou (A)
Bronchial Lavage slide preparations
Papanicolaou (A)
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 17 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Diagnostic Cytopathology (cont’d) Unstained wet-preparations of synovial fluid samples
Examination of Crystals in Synovial Fluid (M)
Qualitative Microscopy using Nikon bright field microscopes per in-house procedure TP 000 005 in conjunction with manufacturer’s instructions.
A
Wet preparations of urine samples
Identification for fat-laden macrophages Oil Red O (M) A
Wet-fixed aspirated and voided human body fluids, fine needle aspirates (FNA’s) & brushings.
Examination of cell preparations to identify or exclude cytological abnormalities for the purposes of diagnosis.
Production of cell block Preparation of cell blocks (Manual) using documented in-house procedure LP 220 018 using “Cytoblock Kit”
A
Slides prepared in house from samples listed above
Morphological assessment and interpretation/diagnosis
Qualitative Microscopy using Nikon bright field microscopes per in-house procedure TP 000 005 in conjunction with manufacturer’s instructions.
A
Electron Microscopy for PCD diagnosis Glutaraldehyde fixed nasal and bronchial brushing samples
Demonstration of ultrastructural components of ciliated epithelial cells
Preparation of samples for Electron Microscopy for PCD diagnosis, including fixation, dehydration, infiltration with resin of tissue samples. Cutting thick survey sections, staining and assessment of thick sections. Cutting and staining thin sections using Documented in-house procedures LP 400 026, LP 400 050, LP 400 020, LP 400 033, LP 400 032, LP 400 013, LP 400 027, LP 400036 using Reichert and Ultracut Ultramicrotomes
A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 18 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Electron Microscopy for PCD diagnosis (cont’d)
Glutareldehyde Fixed Resin Embedded Tissue sections prepared as above
Morphological assessment and interpretation including quantification of defects in ciliary structure contributing to diagnosis of PCD. Production of micrographs suitable for diagnostic use.
Counting and analysing cilia in nasal and bronchial brushings for PCD (Primary Ciliary Dyskinesia) diagnosis, using Documented in-house procedures LP 400 057, LP400 031, LP 400 010 & LP 400 055 in conjunction with manufacturers instructions for staining using FEI Tecnai TEM and Hitachi H7000 TEM
A
Routine Diagnostic Electron Microscopy Formalin and glutaraldehyde fixed tissue samples
Demonstration of ultrastructural components of renal, muscle, nerve and other tissues. Production of micrographs suitable for diagnostic use by Biomedical Imaging staff and their interpretation by consultant pathologists.
Receiving and Preparing diagnostic Specimens for EM Processing including fixation, dehydration, infiltration with resin of tissue samples. Cutting thick survey sections, staining and assessment of thick sections. Cutting and staining thin sections, using Documented in-house procedures LP 400 050, LP 400 020, LP 400 033, LP 400 032, LP 400 013, LP 400 027 & LP 400 036 in conjunction with manufacturers instructions for staining using Reichert and Ultracut Ultramicrotomes
A
8178
Accredited to
ISO 15189:2012
Schedule of Accreditation issued by
United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR UK
University Hospitals Southampton NHS Foundation Trust
Issue No: 001 Issue date: 18 January 2017
Testing performed by the Organisation at the locations specified
Assessment Manager: PW Page 19 of 19
Materials/Products
tested
Type of test/Properties measured/Range
of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY FLUIDS AND TISSUES (cont’d)
Examination activities for the purpose of clinical diagnosis (cont’d)
Documented in-house methods.
Routine Diagnostic Electron Microscopy (cont’d)
Glutareldehyde Fixed Resin Embedded Tissue sections prepared as above
Morphological assessment and interpretation. Production of micrographs suitable for diagnostic use by Biomedical Imaging staff and their interpretation by consultant pathologists.
Taking Diagnostic TEM photographs, using Documented in-house procedures LP400 031, LP 400 010 & LP 400 055 in conjunction with manufacturer’s instructions using FEI Tecnai 12 TEM and Hitachi H7000 TEM
A
END
