schedule of accreditation united kingdom accreditation service€¦ · st james' university...

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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

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Page 1: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 2: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 3: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 4: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 5: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 6: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 7: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 8: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 9: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 10: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 11: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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)

Page 12: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 13: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 14: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 15: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 16: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 17: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 18: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 19: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Page 20: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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)

Page 21: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

Location

Code

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

Page 22: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

Location

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

Page 23: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

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:

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)

Page 24: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

Location

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

Page 25: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

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

Page 26: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

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

Page 27: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

Location

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

Page 28: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

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

Page 29: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

Location

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

Page 30: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Standard specifications/

Equipment/Techniques used

Location

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

Page 31: Schedule of Accreditation United Kingdom Accreditation Service€¦ · St James' University Hospital Beckett Street Leeds LS9 7TF Local contact As above Routine diagnostic service

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

Type of test/Properties

measured/Range of measurement

Standard specifications/

Equipment/Techniques used

Location

Code

END