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Assessment Manager: LD1 Page 1 of 31
Schedule of Accreditation issued by
United Kingdom Accreditation Service
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
8924
Accredited to
ISO 15189:2012
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Cellular Pathology
St James' University Hospital
Beckett Street
Leeds
LS9 7TF
Contact: Michelle Eager
Tel: +44 (0) 113 206 5265
Fax: +44 (0) 113 206 6526
E-Mail: [email protected]
Website: http://www.pathology.leedsth.nhs.uk/pathology/Departments/CellularPathology.aspx
Testing performed by the Organisation at the locations specified
Laboratory locations:
Location details Activity Location code
Address Bexley Wing St James' University Hospital Beckett Street Leeds LS9 7TF
Local contact As above
Routine diagnostic service for histopathology (including neuropathology and paediatric pathology) Reporting of the above and non gynae cytology Out of hours on call service for urgent frozen sections / diagnosis
A
Address Chancellors Wing St James' University Hospital Beckett Street Leeds LS9 7TF
Local contact As above
Gynaecological and non-gynaecological cytology Reporting of the above Muscle / nerve histopathology, enzyme histochemistry
B
Address Microbiology Department Leeds General Infirmary Great George Street Leeds LS1 3EX
Local contact As above
HPV testing
C
Address Seacroft Hospital York Road Leeds West Yorkshire LS14 6UH
Local contact As above
Andrology (post vasectomy and infertility investigation).
D
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 2 of 31
Additional site activity performed away from the laboratory:
Location details Activities
On-site Mortuary and Body Store, St James' University Hospital Storage of bodies
Viewing facilities Record keeping (body identification and audit trail) On-site Mortuary and Body Store, Leeds General
Infirmary
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 3 of 31
DETAIL OF ACCREDITATION
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Cervical/vaginal cells (Liquid Based Cytology/LBC sample)
Cervical Cytopathology Specimen Processing, slide preparation and stain (Papanicolaou: HPSOP CY0081 SurePath Prepmate HPSOPCY 0202 LBC Sample Preparation using BD Totalys Multiprocessor
B
HPSOPCY0198 Use of SlidePrep
HPSOPCY0085 Leica CV5030 Coverslipper
Slides prepared in house as above
Morphological assessment and interpretation/diagnosis
HPSOPCY0026 Leica DM2000 Microscope
B
HPSOPCY0204 Screening Liquid
Based Cytology slides
HPSOPCY0169 Checking Liquid
Based Cytology Slides
HPSOPCY0144 The Medical
Reporting and management of Gynaecological Cytology Samples
Cervical/vaginal cells (Liquid Based Cytology/LBC sample)
Detection of HR-HPV HPSOPCY0166 HPV testing: Aliquoting of LBC samples
B
MBOPHPV02 HPV PCR/ Genotyping detection using GEN-PROBE Panther
C
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 4 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HPSOPCY0167 Reporting of HPV results
B
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Body fluids / Fine needle aspirations, urines and bronchial/ sputum samples
Diagnostic Non Gynae Cytopathology
Sample preparation (Rotina 380 centrifuge, , Shandon cytospin 4):
B
HPSOP 0199 Preparation of Non Gynae Samples
HPSOPCY0020 Preparation of Cell
blocks B
Visualisation of nuclear detail
in cells present HPSOPCY0024 H&E (automated using Jung Autostainer)
B
HPSOPCY0086 Papanicolaou
(automated using Jung Autostainer)
HPSOPCY0132 Rapid
Romanowsky Stain
Slides prepared in house as above
Morphological assessment and interpretation/diagnosis
HPSOP0143 Medical reporting of Non-Gynae cytology
A
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 5 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue / organs Histopathology Tissue dissection: A
HPSOP 0300 Cut Up of Specimens by Biomedical Scientists
HPSOP 0305 Cut Up of Specimens
by Medical Staff
HPSOP 0317 Guidelines For
Inflating A Lung
HPSOP 0217 Handling of CJD
Specimens
HPSOP 0325 Further Blocks HPSOP 0320 Guidelines for
Opening a Fresh Uterus
HPSOP 0315 Guidelines on
Opening a Kidney
HPSOP 0227 Renal Biopsy
Procedure
HPSOPMDLG2 009 Dissection of
gall bladder resection specimens
HPSOPMDLG2 010 Dissection of
appendiceal resection specimens
HPSOPMDLG3 001 Examination of
high risk infective group 3 specimens
HPSOPMDLGYN 001 Cut up of
gynae specimens
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 6 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue / organs (cont’d) Histopathology (cont’d) Tissue dissection: A HPSOPMDLPd 003 Operations for
Hirschsprung’s Disease and Other Motility Abnormalities
HPSOPMDLPd 004 Handling
paediatric tumours in the laboratory
HPSOPMDLPd 006 Reporting of
placental examination (unaccompanied by a fetus)
X-ray/photography (Breast cases
only) (Faxitron):
HPSOP 0360 Decalcification: A HPSOP 0330 Decalcification of
Specimens
HPSOP 1626 Ex-Decal Specimens
for Processing
HPSOP 1622 X-raying of
Decalcification Samples
HPSOP 1632 Chemical End Point
Testing of Decalcification Samples
HPSOP 1624 Ground Section
Preparation
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 7 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue / organs (cont’d) Histopathology (cont’d) Tissue processing: A HPSOP 441 Processing tissue
using the Leica Peloris tissue processor (routine & big blocks & long process)
HPSOP 410 Processing tissue
using the Citadel 2000 (small urgent biopsies and neuropath specimens)
Embedding:
HP SOP 425 Embedding paraffin wax impregnated tissues
Microtomy: HPSOP 502 Sectioning using
rotary microtome
HPSOP 550 Sectioning using
automated microtome
HPSOP 0504 Sectioning of
Problem Blocks
HPSOP 505 Sections/levels
required for particular tissue types
Frozen Sections: A
HPSOP 1609 Leica 1950 cryostat HPSOP 1614 Specimens Requiring
Frozen Sections
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 8 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HPSOP 1603 Preparation of Split Skin Biopsies for Immunofluorescence
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue / organs (cont’d) Histopathology (cont’d) Frozen Sections A HPSOP 1602 Processing and
Embedding of Alopecia Cases and other Paraffins
HPSOP 1105 Protocol for
Transplant Donor Lesion Biopsies – Frozen Sections
Tissue Identification of basophilic and
eosinophilic structures Routine Haematoxylin and Eosin Staining Automated: HP SOP 739 Use and maintenance of Leica Autostainer/coverslipper
Manual:
HPSOP 743 Mayers haematoxylin and eosin for rapid method for frozen sections
Tissue Histopathology - Identification
of: Automated: HPSOP 657 Use of the Dako Artisan Link Pro for Special stain techniques
A
Acid and neutral mucins ABPAS
Diastase resistance acidic and
neutral mucins ABPAS+D
Mucins, glycogen PAS Diastase resistance mucin DPAS Basement membranes, fungi ExPAS
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 9 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue (cont’d) Histopathology - Identification of: (cont’d)
Automated: HPSOP 657 Use of the Dako Artisan Link Pro for Special stain techniques
A
Basement membranes, fungi ExDPAS
Fungi Grocott
Iron (ferric) Perls
Reticulin fibers Retic
Spirochettes, H.Pylori Warthin & Starry
Amyloid Congo Red Manual staining:
Copper/Hepatitis B Orcein
Sulphated acid mucins HPSOP 607 Alcian blue pH1.0
Acid mucins HPSOP 608 Alcian blue pH2.5 Acid mucins/connective tissue HPSOP 609 Alcian blue van
gieson
Acid mucins/connective
tissue/elastic HPSOP 653 Alcian blue elastic van gieson
AL amyloid HPSOP 611 Congo red
potassium permanganate
Nissl granules and neurones HPSOP 612 Cresyl violet
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 10 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Elastic/connective tissue HPSOP 613 Elastic van gieson
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue (cont’d) Histopathology - Identification of (cont’d):
Manual special staining:
A
DNA HPSOP 614 Feulgen for DNA Bile pigment HPSOP 615 Fouchets
H Pylori HPSOP 616 Giemsa- modified
Bone marrow HPSOP 617 Giemsa- overnight
Gram positive bacteria HPSOP 618 Grams technique
Gram positive and negative bacteria
HPSOP 619 Gram twort
Neuroendocrine granules HPSOP 620 Grimelius General tissue morphology HPSOP 6744 Mayers
Haematoxylin and Eosin
Collagen/muscle HPSOP 659 Haematoxylin picro
sirius red
Collagen/muscle HPSOP 625 Haematoxylin van
gieson
Acid mucin HPSOP 651 Hales colloidal iron
Myelin HPSOP 627 Luxol fast blue
Haematoxylin and Eosin
Melanin HPSOP 628 Masson Fontana
Muscle/collagen HPSOP 629 Masson Trichrome
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 11 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Paired sections identifies melanin pigment
HPSOP 630 Melanin bleach
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue (cont’d) Histopathology - Identification
of (cont’d): Manual special staining:
A
Fibrin/connective tissue HPSOP 631 MSB Copper HPSOP 639 Rhodanine
technique
Melanin HPSOP 640 Schmorls technique
Fat HPSOP 643 Sudan IV
Amyloid HPSOP 644 Thioflavine T Mast cells HPSOP 645 Toluidine blue
Calcium HPSOP 646 Von Kossa
Mycobacterium leprae HPSOP 647 Wade fite
Tubercle bacilli HPSOP 649 Ziehl Neelsen Lipids HPSOP 643 Sudan IV staining
(frozen sections only)
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 12 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks Histopathology – identification
of: Automated Immunohistochemical staining, Dako PTLink/Autostainer HPSOP 712 Preparation of Primary antibodies and associated reagents HPSOP 715 DAKO Autostainer Link 48 HPSOP 716 DAKO PTLinks for antigen retrieval Using the following monoclonal, polyclonal and cocktail antibodies:
A
Amyloid deposits AMYLOID-A Lung cancer PDL-1 Marker of normal throid/lung
tumours TTF-1
Automated Immunohistochemical
staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies: HPSOP 734 Use of Leica Bond III Immunostainer
A1-AT deiciency A1-AT
Pituitary hormone ACTH
Epithelial marker AE1/3
Primary liver tumours/yolk sac
tumours AFP
Prostate cancer AMACR
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 13 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Prostate/breast marker ANDROGEN R
Tissue and cell blocks (cont’d)
Lewy bodies /Parkinsons disease
A-SYN
Melanocytic lesions BAP1
Neuronal damage BAPP Marker for apoptosis BCL-2
Epithelial marker BER-EP4
Senile plaques in Alzheimers disease
B-AMYLOID
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Fibromatous lesions B-CATENIN
Germ cell tumours B-HCG
Marker of breast tumours BRST-2 (GCDFP15)
Marker of ovarian tumours CA125
Tumours of GI tract and pancreas
CA19.9
Marker of thyroid tumours CALCITONIN
Marker of smooth nuscle CALDES
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 14 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Marker for mesothelioma CALRET
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Marker of rejection in renal/liver transplants
C4D
Langerhan cells CD1A
T lymphocytes CD3
T helper lymphocytes CD4
T supressor lymphocytes CD8 Lymphoid/endometrial
malignancies CD10
Hogkins lymphoma CD15
B lymphocytes CD20
Lymphoma marker CD21
Hogkins lymphoma CD30
Endothelial marker CD31
Endothelial marker CD34
Lymphocyte marker CD45
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 15 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Marker of nerve/neuroendocrine tumours
CD56
Tissue and cell blocks (cont’d)
Histiocytes/macrophages CD68
B lymphocytes CD79a
Ewings sarcoma CD99 Mesothelioma marker CD141 Histiocytes/macrophages CD163
GI tract tumours CDX2
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Epithelial marker CEA-M Epithelial marker/liver tumour
marker CEA-P
Neuroendocrine cells CHROMO
Epithelial marker CK5
Epithelial marker CK5/6
Epithelial marker CK7
Epithelial marker/mallory bodies
CK8/18
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 16 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Tissue and cell blocks (cont’d)
Epithelial marker CK14
Epithelial marker CK19 Epithelial marker CK20
Gastrointestinal stromal tumour marker
C-KIT (CD117)
Cytomegalovirus infection CMV
Marker of basement membrane
COLL IV
Marker of lymphatic channels D2-40
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Pan muscle marker DES Gastrointestinal stromal
tumour marker DOG-1
Cell adhesion molecule E-CAD
Epidermal growth factor
receptor EGFR
Epithelial marker EMA
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 17 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Estrogen receptor/ prognostic breast marker
ER
Tissue and cell blocks (cont’d)
Vascular tumours ERG
Pituitary hormone FSH
Marker of gastrin producing
tumours GASTRIN
Glial cells benign and
malignant GFAP
Pituitary hormone GH
Pancreatic tumour typing Glucagon Pancreatic tumour typing Glucagon
Adenoma v HCC Glutamine Synthetase
Liver adenoma/HCC Glypican-3
Hepatitis B infected cells HEP B c Hepatitis B infected cells HEP B s
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Marker of normal/malignant
hepatocytes HEPAR 1
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 18 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
Marker of Her2 amplification in breast tumours.
HER 2
Melanoma marker HMB45
Tissue and cell blocks (cont’d)
Epithelial marker HMC
Marker for H pylori HP Marker for teratoma HPL
Herpes simlex 1 infection HSV 1
Brain tumours IDH1 Lymphoma markers
IgA IgG IgM
IgG4 disease marker IgG4
Granulosa cell tumours Mucinous epithelial ovarian tumours
Inhibin
Paediatric tumours INI-1 Pancreatic tumours Insulin
Lymphoma marker KAPPA
Proliferation marker KI67
Lymphoma marker Lambda
Pituitary hormone LH Head and Neck tumour Mammaglobin
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 19 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Melanoma marker MEL-A Mismatch repair protein MLH 1
MSH 2 MSH6
Epithelial marker MNF
MUC4 in tumours MUC4 Marker for rhabdomyosarcoma MYOD 1
Marker for rhabdomyosarcoma MYOGENIN Neuronal marker N52
Neuronal marker NEU N
Neuronal marker NFP Neuroectodermal marker NSE
Epithelial gynae tumours PAX-8 Marker of CIN P16 Marker of wild type P53 in
malignancy P53
Marker of molar pregnancy p57
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 20 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
Standard specifications/
Equipment/Techniques used
Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Marker in breast/prostate tumours
p63
Infection with parvo virus PARVO Marker of neuroblastoma Phox 2B Marker of germ cell tumours PLAP Mismatch repair protein PMS2
Polyoma virus infection I renal
transplant patients POLYOMA SV40
Pituitary hormone PROLACTIN
Progesterone
receptor/prognostic breast marker
PR
Marker of normal/malignant
prostate PSA
Marker of normal/malignant
prostate PSAP
Marker of parthyroid tumours PTH
Marker of ovarian malignancy R1(inhibin)
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 21 of 31
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Marker of primary renal carcinoma
RCC
Nerve sheath, neural marker S100
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue and cell blocks (cont’d)
Histopathology – identification of (cont’d):
Automated Immunohistochemical staining, Leica Bond III Immunostainer using the following monoclonal, polyclonal and cocktail antibodies (cont’d):
A
Marker of serotonin producing
tumours SEROT
Pancreatic tumours SOMAT Smooth muscle marker SMA
Smooth muscle marker SMM Marker of neural
cells/neuroendocrine tumors SYNAPT
Stat6 Expression STAT6 Tangles in Alzheimers disease TAU Marker of normal/malignant
thyroid THYROG
Pituitary hormone TSH Tangles, plaques and
inclusions in dementia UBIQ brain
Marker of Mallory bodies. UBIQ liver Mesenchymal tumours Vimentin
Wilms tumour/mesothelioma WT-1
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 22 of 31
Materials/Products tested
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Code
Desmoplastic cell tumour WT-1 C19
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Histopathology Tissue (Breast primary) HER2
Automated Immunohistochemical staining, SOP 721: Use of Ventana Benchmark Ultra for HER2 Antibody: anti-HER-2/neu(4B5)
A
Tissue (Renal) Identification of immune
deposits in the glomerular membrane and mesangium
HPSOP 717 Manual Immunocytochemical staining of renal biopsies Using antibodies IgA, IgM, IgG, C1q, C3d
A
Histopathology – Enzyme
histochemistry Immuno fluorescence (IF) for identification/demonstration of:
Tissue (Rectal) Presence/absence of ganglion
cells and acetylcholinesterase when Hirschsprung’s disease is suspected
HPSOP 1605 Acetylcholinesterase A
Tissue (Renal) Immunoglobulins and
complement HPSOP 1606 Immunofluorescence staining of renal biopsies Using antibodies IgA IgG IgM C3C C1q Kappa Lambda
A
Tissue (Skin) Immunoglobulins and
complement HPSOP 1607 Sectioning & Immunofluorescence Staining of Skin/ Oral/Neuro frozen sections Using antibodies in IgA IgG IgM C3C Fibrinogen
A
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 23 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Location
Code
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Histopathology –
Morphological assessment and interpretation/diagnosis:
Using light microscopy and SOPs: A
Slides prepared in house as above (Breast)
HPSOPMDLG1 001 Dissection and Reporting of Breast Specimens
Slides prepared in house as above (Gastrointestinal)
HPSOPMDLG2 001 Reporting of colonic resection specimens with vascular pathology
HPSOPMDLG2 003 Reporting of
ileo-colic resection specimens
HPSOPMDLG2 004 Reporting of
small intestinal resection specimens
HPSOPMDLG2 005 Reporting of
Colorectal Cancer Specimens
HPSOPMDLG2 006 Reporting of
resections for pancreatic, ampullary and bile duct carcinoma
HPSOPMDLG2 007 Reporting of
stomach resection specimens
HPSOPMDLG2 008 Reporting of
oesophageal resection specimens
HPSOPMDLG2 013 Reporting of
endomucosal resection specimens (EMR)
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 24 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Code
HPSOPMDL G4 016 Reporting of liver resections not transplant
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Histopathology –
Morphological assessment and interpretation/diagnosis:
Using light microscopy and SOPs: A
Slides prepared in house as above (Thoracic, skin)
HPSOPMDLG3 003 Reporting of skin specimens, biopsies and resections
HPSOPMDLG3 004 Reporting of
lung resection specimens
HPSOPMDLG3 005 Reporting of
Thoricic lung biopsies and segmental excisions
HPSOPMDLG3 006 Reporting of
Soft Tissue tumours specimens, core biopsies, excisions, amputations
Slides prepared in house as above (Head & neck)
HPSOPMDLG4 001 Reporting of oral mucosal specimens for tumours
HPSOPMDLG4 002 Reporting of
thyroid specimens
HPSOPMDLG4 005 Reporting of
small mucosal specimens
HPSOPMDLG4 006 Reporting of
small bone specimens
HPSOPMDLG4 007 Reporting of
salivary gland specimens for tumours
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 25 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Location
Code
HPSOPMDLG4 008 Reporting of radical neck dissection specimens
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Histopathology –
Morphological assessment and interpretation/diagnosis (cont’d):
Using light microscopy and SOPs: A
Slides prepared in house as above (Head & neck) (cont’d)
HPSOPMDLG4 009 Reporting of maxillectomy specimens for tumours
HPSOPMDLG4 010 Reporting of
laryngectomy specimens for tumours
Slides prepared in house as above (Neuropathology)
HPSOPMDLG6 002 Reporting of Globes
HPSOPMDLG6 003 Reporting the
examination of orbital exenterations
HPSOPMDLG6 004 Reporting of
wedge excisions - eyelid lesions
HPSOPMDLG6 005 Reporting of
Temporal Artery Specimens
HPSOPMDLG6 006 Reporting of
Trabeculectomy Specimens
HPSOPMDLG6 007 Reporting a
penetrating keratoplasty (Cornea)
Slides prepared in house as above (Urology)
HPSOPMDLUr 001 Prostatic biopsies, transurethral or open prosatic resections and radical prostatectomies
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 26 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Equipment/Techniques used
Location
Code
HPSOPMDLUr 002 Adult renal
parenchymal tumours
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Histopathology –
Morphological assessment and interpretation/diagnosis (cont’d):
Using light microscopy and SOPs:
Slides prepared in house as above (Urology)
HPSOPMDLUr 003 Penile biopsies and resections
HPSOPMDLUr 004 Testicular
biopsies and resections, retroperitoneal lymph node dissections
HPSOPMDLUr 005 Urinary
bladder, ureteric, renal pelvic and urethral specimen
Slides prepared in house as above (Skin)
HPSOP 1416 Screening of skin biopsies by Immunofluorescence
Digital images from slides prepared in house as above
Histopathology – Morphological assessment and interpretation/diagnosis (cont’d):
Using digital pathology (slide scanners and viewing software): Slide Scanning SOP 730 Scanning Digital Cases Using Aperio Scanners (AT2 and CS2 ) Slide Reporting SOP 746 Reporting digital slides using eSlide Manager
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 27 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Code
Tissue Muscle / Nerve Histopathology B Frozen section preparation (Microm
Cryostat): HPSOP 1306 Cryostat Section Preparation for Histochemistry
Sample preparation techniques:
HPSOP 1328 Tissue Quenching for Histochemistry HPSOP1323 Specimen Handling for Muscle, Nerve, Rectal, Skin and Conjunctival Biopsies
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue (cont’d) Muscle / Nerve Histopathology
(cont’d) B
Identification of basophilic and
eosinophilic structures HPSOP 1309 Haematoxylin and Eosin Staining Method (cryostat sections)
B
Muscle / Nerve Histopathology
- Identification of: Manual special staining techniques: B
Glycogen HPSOP 1317 Periodic Acid Schiff
(PAS) and Diastase-PAS Staining Method for Cryostat Sections
Mitochondria and their
distribution HPSOP 1308 Gomori Trichrome HPSOP 1324 Succinate Dehydrogenase Demonstration
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 28 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Location
Code
Muscle / Nerve Histopathology - Identification of normal /abnormal muscle fibre elements
HP SOP 1372 Immunocytochemical Sarcolemmal Staining Method (Dako Real) Using the following monoclonal, polyclonal and antibodies:
B
Tissue (Muscle) Dystrophin 1
Dystrophin 2
Dystrophin 3 Alpha Sarcoglycan BetaSarcoglycan Gamma Sarcoglycan Delta Sarcoglycan Emerin
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Muscle / Nerve Histopathology
- Identification of normal /abnormal muscle fibre elements (cont’d)
HP SOP 1372 Immunocytochemical Sarcolemmal Staining Method (Dako Real) Using the following monoclonal, polyclonal and antibodies (cont’d):
B
Tissue (Muscle) Dysferlin Merosin Spectrin Identification of nucleated cells MHC-1 (HLA-ABC) Tissue (Surgical and MH muscle)
Muscle / Nerve Histopathology - identification /demonstration of:
Enzyme histochemical staining HPSOP 1419 Specialist Histopathology Staining Panels
B
Acid Phosphatase HPSOP 1304 Acid Phosphatase –
Naphthol AS-BI Phosphate
Fibres with abnormal COX
activity HPSOP 1383 Combined Demonstration of Cytochrome Oxidase & Succinate Dehydrogenase
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 29 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Code
HPSOP 1307 Cytochrome Oxidase Demonstration
Myoadenylate Deaminase HPSOP 1312 Myoadenylate
Deaminase Demonstration
Tissue (Surgical and MH muscle cont’d)
Adenosine triphosphatase HPSOP 1313 Myosin ATPase Staining Method
NADH HPSOP 1314 NADH - Tetrazolium
Reductase Demonstration
PFK and Aldolase activity HPSOP 1319 Phosphofructokinase
and Aldolase Demonstration
Myophosphorylase in muscle HPSOP 1364 Phosphorylase
Demonstration
HUMAN BODY TISSUE AND FLUIDS (cont’d)
Examination activities in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis (cont’d)
Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers’ instructions where relevant:
Tissue (Muscle) Muscle / Nerve Histopathology
- identification /demonstration of:
Manual tinctorial Stain techniques for:
B
Presence and distribution of
lipid in muscle HPSOP 1321 P-Phenylene diamine Staining Method
HPSOP 1365 Sudan Black B
Staining Method
Myelin in nerves HP SOP 1316 Palade
Fixation/Staining Method
Internode length, fibre
diameter and myelin degeneration
HPSOP 1327 Teased Nerve Procedure
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 30 of 31
Materials/Products tested
Type of test/Properties
measured/Range of measurement
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Code
Slides prepared in house as above
Muscle / Nerve Histopathology - Morphological assessment and interpretation/diagnosis
HPSOPMDL G6 011 Reporting of muscle biopsy specimen examination and handling
A
HPSOPMDL G6 012 Reporting of
peripheral nerve biopsy specimen examination
A
Molecular Pathology FFPE sections prepared in house as above
Detection of BRAF mutation at codon 600
RT-PCR HPSOP 733 IdyllaTM System
A
HUMAN BODY FLUIDS
Andrology examination activities for the purposes of clinical diagnosis:
All techniques carried out manually according to WHO (2010) guidelines using Phase contrast microscopy:
Semen Infertility testing:
Volume Appearance Viscosity pH Motility Agglutination
HPSOP 850 Infertility testing D
Sperm density HPSOP 851 Sperm density Sperm motility HPSOP 852 Motility testing Morphology HPSOP 861 Sperm morphology Post vasectomy testing:
Sperm presence/absence HPSOP 871 Post vasectomy testing
D
Haematoxylin & Eosin staining
for identification of basophilic and eosinophilic structures to demonstrate morphology of cells and spermatozoa
Sample staining: HPSOP 868 H&E staining
D
8924
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
Leeds Teaching Hospitals NHS Trust
Issue No: 004 Issue date: 25 October 2018
Testing performed by the Organisation at the locations specified
Assessment Manager: LD1 Page 31 of 31
Materials/Products tested
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Code
END