Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Transcription

1 Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK ccredited to Laboratory locations: The Doctors Laboratory Ltd 1 Mabledon Place London WC1H 9X NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Contact: Sally Curtis Tel: +44 (0) sally.curtis@tdlpathology.com Website: below s covered by the organisation and their relevant activities details ctivity code ddress Local contact Department of lood Sciences / Microbiology London North West Healthcare NHS Trust Northwick Park Hospital Watford Road Harrow H1 3UJ Sally Curtis General Microbiology Virology iochemistry Haematology lood Transfusion Department of Cellular Pathology London North West Healthcare NHS Trust St Marks Hospital (Northwick Park Campus) Watford Road Harrow H1 3UJ Sally Curtis Histology Cytology (gynae & non-gynae) Department of lood Sciences Central Middlesex Hospital cton Lane Park Royal NW10 7NS Sally Curtis Virology iochemistry Haematology lood Transfusion C ssessment Manager: E of 30

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Site activities performed away from the locations listed above: details ctivity code lood Fridge Main Theatre lock Northwick Park Hospital Watford Road Harrow H1 3UJ lood issue fridge for storage of blood products only; no testing occurs at this site D lood Fridge Maternity lock Level 4 Room 4N144 Northwick Park Hospital Watford Road Harrow H1 3UJ lood issue fridge for storage of blood products only; no testing occurs at this site E ssessment Manager: MP Page 2 of 30

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 DETIL OF CCREDITTION Microbiology General acteriology HUMN ODY SMPLES Examination activities for the purposes of clinical diagnosis In-house documented procedures as referenced and based on PHE SMIs Specimens from wounds, eyes, ears, nose, throat, mouth, pus, tissue, joint fluids, CSF, valves, sputum, bronchial washings, bronchial lavage, genitalia, cannulae, shunts, CSF General isolation of microorganisms of clinical significance Culture onto selected media with reference to SOP TDL-GM-046-ET- 001 for manual and automated inoculation of samples onto culture media using D Kiestra acterial cultures isolated inhouse General identification of microorganisms of clinical significance SOP TDL-GM-046-ET-001 using general biochemical methods acterial cultures isolated inhouse ntimicrobial susceptibility testing determination of minimum inhibitory concentration (MIC) TDL-M-6-34 by manual disc diffusion using SC guidelines, TDL-M using EUCST guidelines and TDL-M-6-35 using E-Tests and MIC Evaluators lood Detection of microbial growth and general isolation of microorganisms of clinical significance TDL-M-6-21 in conjunction with manufacturers instructions for act/ert 3D analyser lood, fluids and respiratory samples Detection and isolation of Mycobacterium sp. TDL-M-6-79 in conjunction with manufacturers instructions for act/ert 3D analyser (automated) and culture on Lowenstein-Jensen slopes manual) lood, fluids and respiratory samples Detection of acid fast bacilli TDL-M-6-79 by manual staining using uramine Phenol and Ziehl Neelsen stains and microscopy CSF and joint fluids Quantification of white and red blood cells and qualitative demonstration of bacteria TDL-M-6-20 using manual microscopy ssessment Manager: MP Page 3 of 30

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 General acteriology HUMN ODY SMPLES Examination activities for the purposes of clinical diagnosis (cont d) In-house documented procedures as referenced and based on PHE SMIs Faeces General isolation and characterisation of Salmonella, Shigella, Campylobacter & E. coli 0157, Vibrio sp., Listeria sp. and Yersinia sp. TDL-M-6-38 by manual and automated culture using D Kiestra and selective culture media Faeces Detection of Clostridium difficile GDH antigen and toxins & TDL-M-6-80 in conjunction with manufacturers instructions using Quik Chek Complete General isolation and characterisation of Clostridium difficile TDL-M-6-37 by manual culture using selective media Faeces Detection of Helicobacter pylori antigen TDL-M-6-14 by ELIS using Premier Platinum Plus HpS and DS2 analyser Faeces Detection of Rotavirus antigen TDL-M-6-43 using Immunocard Stat Rotavirus Urine Quantification of white and red blood cells, and qualitative demonstration of bacteria, epithelial cells, yeast cells and casts TDL-M-6-63 using manual microscopy and Sedimax automated analyser General isolation, characterisation and sensitivity testing of micro-organisms of clinical significance WSL-MIC-001 using Mast Uri microtitre culture system General isolation and characterisation of microorganisms of clinical significance TDL-M-6-63 by manual and automated culture using D Kiestra ssessment Manager: MP Page 4 of 30

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 General acteriology HUMN ODY SMPLES Examination activities for the purposes of clinical diagnosis (cont d) In-house documented procedures as referenced and based on PHE SMIs Urine Detection of Legionella pneumophila serotype 1 antigen S TDL-M-6-65 using inax NOW rapid card Detection of Streptococcus pneumoniae TDL-M-6-66 using inax NOW rapid card Parasitology Examination activities for the purposes of clinical diagnosis In-house documented procedures based on PHE SMIs Faeces, rectal swabs, sputum, urine & aspirates Examination for the presence of parasites (ova, cysts, trophozoites and worms) of clinical significance TDL-M-6-39 using MIDI Parasep SF and manual microscopy or by direct microscopy Clear adhesive tape slides Enterobius sp TDL-M-6-39 by direct microscopy Faeces Cryptosporidium sp TDL-M-6-39 using modified Ziehl- Neelsen and microscopy Mycology Skin, hair and nail Examination activities for the purposes of clinical diagnosis General isolation and characterisation of fungi of human clinical significance TDL-M-6-53 by manual culture onto selective culture media and microscopic / macroscopic identification Yeast cultures isolated inhouse Susceptibility testing TDL-M-6-56 using Sensititre Yeastone CSF, blood Detection of Cryptococcal antigen TDL-M-6-22 using IMMY latex agglutination kit ssessment Manager: MP Page 5 of 30

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Molecular iology HUMN ODY SMPLES Examination activities for the purposes of clinical diagnosis based on and in conjunction with manufacturers instructions Sputum, bronchial washings / lavage, pus, aspirates, CSF, tissue and biopsies Detection of Mycobacterium tuberculosis complex and genes encoding for rifampicin resistance TDL-M-6-60 using Cepheid GeneXpert Throat, nasal and nasopharyngeal swabs, nasopharyngeal aspirate (NP) and NP in universal transport medium Detection of Influenza, Influenza & 2009 H1N1 virus TDL-M-6-61 using Cepheid GeneXpert Viral Serology Serum / Plasma unless otherwise stated Examination activities for the purposes of clinical diagnosis. Detection of: based on and in conjunction with manufacturers instructions Hepatitis IgM & IgG total Hepatitis core IgM, core total antibody, e antigen, e antibody TDL-NWLH-C-037 by immunoassay using Roche Cobas 8000 ( ) & 6000 ( C) Hepatitis surface antigen and surface antibody & C Hepatitis C anti HCV antibody & C Detection of HIV 1 & 2 antibody and p24 antigen & C Rubella IgG antibody Varicella-Zoster IgG antibody HIV 1 & 2 antibody and p24 antigen TDL-NWLH-C-010 by immunoassay using iomerieux mini-vids HIV 1 & 2 antibodies TDL-I using io-rad Geenius ssessment Manager: MP Page 6 of 30

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Cytopathology Cervical Cytopathology Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis based on and in conjunction with manufacturers instructions Thin Prep material from cervical smears Detection of Human Papilloma Virus: HPV-16, HPV18 and non-hpv 16/18 genotypes collectively TDL-NWLH-C-046 using bbott m2000 Cervical smears Cervical smear abnormalities TDL-NWLH-C-039 Microscopy TDL-NWLH-C-044 Hologic T2000 & T5000 processors and papanicolaou staining Cytopathology (Non-Gynae) FNs, needle washings, fluids, urine, sputum, L Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Processing, Staining and reporting of Diagnostic Specimens using documented in-house procedures with reference to the following procedures and equipment TDL-NWLH-C-011 Sputum TDL-NWLH-C-012 ronchial rushings TDL-NWLH-C-013 ronchial Washings TDL-NWLH-C-014 L TDL-NWLH-C-015 Serous & Cyst fluids TDL-NWLH-C-016 Urine TDL-NWLH-C-009 Centrifuge TDL-NWLH-C-010 Cytocentrifuge TDL-NWLH-C-030 ThinPrep 2000 processor TDL-NWLH-C-044 ThinPrep 5000 processor ssessment Manager: MP Page 7 of 30

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 ndrology ndrological examination activities for the purposes of clinical diagnosis based on and in conjunction with the following guidelines Post-Vasectomy: Ejaculate Detection of Spermatazoa TDL-NWLH-C-026 by manual microscopy based on WHO Laboratory Manual for Examination and Processing of Human Semen 5 th Edition 2010 Ejaculate Fertility Testing: Manual methods based on WHO Laboratory Manual for Examination and Processing of Human Semen 5 th Edition 2010 Volume Sperm motility Detection of Ig Sperm concentration Sperm morphology TDL-NWLH-C-021 Volume/weight TDL-NWLH-C-022 Manual microscopy TDL-NWLH-C-023 MR Test TDL-NWLH-C-024 Manual microscopy TDL-NWLH-C-025 Manual microscopy ssessment Manager: MP Page 8 of 30

9 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Routine Histopathology Fixed, fresh and frozen tissue; excisional and incisional biopsies and surgical resection specimens Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis Macroscopic and Microscopic examination. In house documented procedures in conjunction with equipment as specified below: Formalin fixed tissues samples (as above) Specimen dissection Using manual methods TDL-NWLH-HP-006 ssisting in Consultant Led Specimen Dissection TDL-NWLH-HP-080 Procedure for MS Specimen Transfer TDL-NWLH-HP-081 Procedure and assisting MS specimen dissection Ext-1044 Pathologist s cut-up SOPs Formalin fixed tissues samples (as above) Tissue Processing TDL-NWLH-HP-011 using Thermo Scientific Excelsior, Leica Peloris II, and Sakura Tissue Tek VIP tissue processors tissue processor Formalin fixed and processed tissues samples (as above) Tissue embedding TDL-NWLH-HP-012 using Thermo and Leica EG1150 H embedding stations Formalin fixed and embedded tissues samples (as above) Tissue sectioning (microtomy) TDL-NWLH-HP-013 using Thermo Finesse E, E+, & ME microtomes and nglia Scientific 325 & 300 microtomes Frozen Sections SOP TDL-NWLH-HP-008 using Thermo Shandon S620 Cryostat ssessment Manager: MP Page 9 of 30

10 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Routine Histopathology Fixed, fresh and frozen tissue; excisional and incisional biopsies and surgical resection specimens Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis in conjunction with equipment as specified below: Staining Formalin fixed slides Detection of: Documented in-house procedures for staining using manual methods Identification of basophilic and eosinophilic structures Haemotoxylin & Eosin (TDL- NWLH-HP-046) Mast cells and mucopolysaccharides zure (TDL-NWLH-HP-038) myloid Congo Red (TDL-NWLH-HP-039) Haemopoetic cells Giemsa (TDL-NWLH-HP-040) Helicobacter pylori Giemsa (TDL-NWLH-HP-041) Reticulin Gordons & Sweets Reticulin (TDL- NWLH-HP-042) Fungi Grocott (TDL-NWLH-HP-045 ) ssessment Manager: MP Page 10 of 30

11 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Special staining Formalin fixed slides Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis: (cont d) in conjunction with equipment as specified below: Melanin pigment Masson Fontana (TDL-NWLH-HP- 049) Connective tissue Masson Trichrome (TDL-NWLH- HP-50) Connective tissue Melanin leach (TDL-NWLH-HP- 051) Elastic fibres Millers Elastic (TDL-NWLH-HP- 052) Lipofuchsin Schmori Reaction (TDL-NWLH-HP- 055) Copper associated protein Calcium Victoria lue (TDL-NWLH-HP-057 ) Von Kossa (TDL-NWLH-HP-058) Tubercle bacilli Ziehl Neelsen (TDL-NWLH-HP- 061) ssessment Manager: MP Page 11 of 30

12 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Immunocytochemistry Paraffin tissue section Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis SOPs TDL-NWLH-HP-079, TDL- NWLH-HP-066 (with pre-fixed Q Cards as stated) in conjunction with manufacturers instructions using Leica ond III and the following antibodies: Cytokeratin cocktail for CK1-8, 10, and 19 E1/E3 (Q-01) Diffuse lymph-proliferative disease and neoplastic cells of follicular lymphomas. Cl-2 (Q-02) Prognostic marker in some - cell Non-Hodgkins lymphomas. CL-6 (Q-03) Epithelial cell types er-ep4 (Q-04) Normal cortical thymocytes, Langerhan cells, dendritic reticulum cells CD1 (Q-07) T cells CD3 (Q-08) T cells (helper+mature) CD4 (Q-09) Mature T cells, T cell lymphomas CD5 (Q-10) T cells CD8 (Q-12) Mature cells, follicular dentritic cells, CLL CD10 (Q-13) Granulocytes, Reed-Sternberg cells CD15 (Q-14) cells CD20 (Q-15) ssessment Manager: MP Page 12 of 30

13 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Immunocytochemistry Paraffin tissue section Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont d) SOPs TDL-NWLH-HP-079, TDL- NWLH-HP-066 (with pre-fixed Q Cards as stated) in conjunction with manufacturers instructions using Leica ond III and the following antibodies: Mature cells, Follicular dentritic cells CD21 (Q-16) cells, some T cells CD23 (Q-17) Reed-Sternberg cells, plasma cells CD-30 (Q-18) Endothelial cells CD31 (Q-19) Haematopoetic cells, vascular endothelium CD34 (Q-20) Leukocyte common antigen (LC) CD45 (Q-21) Natural killer cells, neuroendocrine tissues CD56 (Q-22) Macrophages, monocytes, myeloid cells CD68 (Q-23) cells CD79a (Q-24) Mast cells CD117 (Q-25) Differentiating cells CD138 (Q-26) Tissues of neuroendocrine origin Chromogranin (Q-28) Cytokeratin 5 CK5 (Q-29) Stratified squamous epithelium, basal cells, mesotheliomas CK5/6 (Q-30) ssessment Manager: MP Page 13 of 30

14 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Immunocytochemistry Paraffin tissue section Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont d) SOPs TDL-NWLH-HP-079, TDL- NWLH-HP-066 (with pre-fixed Q Cards as stated) in conjunction with manufacturers instructions using Leica ond III and the following antibodies: Normal and neoplastic epithelia CK7 (Q-31) Epithelial cells CK14 (Q-31) Cytokeratin 5 CK19 (Q-33) denocarcinomas, columnar epithelial cells CK20 (Q-34) CMV CMV (Q-35) Tumours CYC-D1 (Q-36) Normal duct epithelial cells, ductal carcinoma E-cad (Q-39) Normal and neoplastic epithelium EM (Q-40) Oestrogen receptors ER (Q-41) V.W factor in endothelial cells FCTOR VIII (Q-42) Placental trophoblasts HCG (Q-44) Melanoma, melanocyte differentiation Hmb45 (Q-45) cells and plasma cells Kappa (Q-46) cell follicles Lambda (Q-50) Melanoma marker Melan (Q-51) ssessment Manager: MP Page 14 of 30

15 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Immunocytochemistry Paraffin tissue section Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont d) SOPs TDL-NWLH-HP-079, TDL- NWLH-HP-066 (with pre-fixed Q Cards as stated) in conjunction with manufacturers instructions using Leica ond III and the following antibodies: Differential identification of colorectal carcinoma MLH1 (Q-52) MNF116 MNF116 (Q-53) Myeloperoxidase MPO (Q-54) Mismatch repair protein MSH2 (Q-55) Mismatch repair protein MSH6 (Q-56) Multiple myeloma oncogene MUM1 (Q-57) Myosin Myosin (Q-58) Peripheral nerves, neuroendocrine tumours NSE (Q-59) Postmeitotic segregation increased 2 pms2 (Q-60) Progesterone receptors pgr (Q-61) Prostate basal cells, profliferative cells P63 (Q-62) Prostate secretory and ductal epithelium PS (Q-63) Schwann cells, nerve processes, S100 +ve neoplasms S100 (Q-64) Smooth muscle cells, myoepithelial cells SM (Q-65) ssessment Manager: MP Page 15 of 30

16 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Immunocytochemistry Paraffin tissue section Examination of tissues to identify or exclude morphological and cytological abnormalities for the purposes of diagnosis (cont d) SOPs TDL-NWLH-HP-079, TDL- NWLH-HP-066 (with pre-fixed Q Cards as stated) in conjunction with manufacturers instructions using Leica ond III and the following antibodies: Neuroendocrine cells Synaptophysin (Q-66) Lining blood vessels, lymphatic vessels, mesothelial cells Thromobomodulin (Q-67) Thyroglobulin containing cells Thyroglobulin (Q-68) Lung and thyroid (thyroid follicular cells) TTF1 (Q-69) Cells of mesenchymal origin Vim (Q-70) reast carcinoma Her 2 (TDL-NWLH-HP-025 ) Kras mutation & Epidermal Growth Factor Receptors KRS & EGFR (TDL-NWLH-HP- 027) ssessment Manager: MP Page 16 of 30

17 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Haematology HUMN ODY FLUIDS Haematology examination activities for the purposes of clinical diagnosis: based on equipment manuals and standard methods as specified below: EDT lood Full lood Count: White lood Cells (WC) Red lood Cells (RC) Haemoglobin (HG) Haematocrit (HCT) Mean Cell Volume (MCV) Mean Cell Haemoglobin (MCH) Mean Cell Haemoglobin Concentration (MCHC) Platelets (PLT) Red Cell Distribution (RDW) Neutrophils (NEUT) Lymphocytes (LYMP) Monocytes (MONO) Eosinophils (EO) asophils (SO) Nucleated Red lood Cells (NRC) Reticulocytes (RET) WSL-H-001 using Sysmex XE WSL-H-001 using Sysmex XE C EDT lood lood film assessment & cell differential TDL-E-H-053, TDL-NWLH-H-037 & WSL-H-052 with May-Grunwald & Giemsa stains using: Sysmex Sp-1000i & Hematak staining machines or manual hand staining and microscopy Hematek staining machine and microscopy C EDT lood Erythrocyte Sedimentation Rate TDL-NWLH-H-002 using Sysmex Interrliner TDL-NWLH-H-044 using StaRRsed utocompact C ssessment Manager: MP Page 17 of 30

18 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Haematology HUMN ODY FLUIDS Haematology examination activities for the purposes of clinical diagnosis: based on equipment manuals and standard methods as specified below: EDT lood Erythrocyte Sedimentation Rate WSL-H-021 using guest Scientific Micro Dispettes (Westergen method) & C EDT lood Detection of Infectious Mononucleosis heterophile antibodies TDL-NWLH-H-006 using iokit Monogen rapid antigen detection cards & C EDT lood Detection of Malarial antigens (HRPII antigen, Pan malarial antigen, P. falciparum, P. vivax, P. malariae, P. ovale) TDL-NWLH-H-003 using inax NOW rapid antigen test & C Urine Haemosiderin TDL-NWLH-H-035 by manual staining and microscopy using Perls stain one marrow aspirate one marrow for detection of microscopic cell contents and structure TDL-NWLH-H-008 by manual staining and microscopy using May-Grunwald and Giemsa stains Iron deposits TDL-NWLH-H-035 by manual staining and microscopy using GCC Iron stain kit EDT lood Sickle Cell Haemoglobin Screening Test TDL-NWLH-H-007 using Streck Sickledex Solubility test & C EDT lood Quantitation of HbF, HbS & Hb2 TDL-NWLH-H-025 using iorad high performance liquid chromatography C ssessment Manager: MP Page 18 of 30

19 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 Haematology HUMN ODY FLUIDS Haematology examination activities for the purposes of clinical diagnosis: based on equipment manuals and standard methods as specified below: EDT lood Identification of Haemoglobin variants TDL-NWLH-H-023 by Iso-electric focusing using Perkin Elmer C TDL-NWLH-H-029 by acid gel electrophoresis using Helena kit C TDL-NWLH-H-034 by capillary electrophoresis using Sebia Capillarys C TDL-NWLH-H-028 by mass spectrometry using Quattro Premier XE Tandem Quadropole Mass Spectrometer EDT lood G6PD quantitation TDL-NWLH-H-031 using Jenway Spectrophotometer C Citrated blood Coagulation International Normalised ratio (INR) Prothrombin time Fibrinogen-Clauss ctiviated Partial Thromboplastin time WSL-H-035, WSL-H-044 & WSL-H-047 using Sysmex CS5100 WSL-H-018, WSL-H-017 & WSL-H- 019 using Sysmex CS2100 C Citrated blood D-Dimer WSL-H-050 using Sysmex CS5100 TDL-NWLH-H-020 using Sysmex CS2100 C ssessment Manager: MP Page 19 of 30

20 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 lood Transfusion HUMN ODY FLUIDS General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT lood lood group: RhD Positive RhD Negative RhD Positive RhD Negative RhD Positive RhD Negative O RhD Positive O RhD Negative TDL-T-083 using Diamed IH-1000 analyser TDL-T-021 using Diamed GelStation C EDT lood lood group (groups as above) TDL-T-025 using Diamed Gelcards and tube technique using Lorna-anti-sera cells and NHST panel cells TDL--025 using Diamed Gelcards and tube technique using ioscot monoclonal anti-sera and NHST panel cells C EDT lood ntibody panels to antigens of the following systems: Rh: D,C,E,c,e,Cw Kell: K,k,Kpa,Jsa,Jsb Duffy: Fya,Fyb Kidd: Jka,Jkb Lewis: Lea,Leb P: P1 MNS: M,N,S,s Lutheran: Lua,Lub Xg: Xga TDL-T-083 & TDXL-T-023 using Diamed IH-1000 analyser (automated) ssessment Manager: MP Page 20 of 30

21 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 lood Transfusion HUMN ODY FLUIDS General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT lood ntibody panels to antigens of the following systems: TDL-T-023 using Diamed Gel cards with NHST panel cells & C Rh: C,D,E,c,e,Cw MNS: M,N,S,s P: P1 LutheranLLua Kell: K,k,Kpa Lewis: Lea,Leb Duffy: Fya,Fyb Kidd: Jka,Jkb EDT lood Serological crossmatch TDL-T-087 using Diamed Gel cards and indirect antiglobulin test & C EDT lood ntibody screen using antigens of the following systems: TDL-T-025 & TDL-T-083 using Diamed IH-1000 with 3-cell Diamed screening cells Rh: D,C,E,c,e,Cw Kell: K,k,Kpa,Kpb,Jsa,Jsb Duffy: Fya,Fyb Kidd: Jka,Jkb Lewis: Lea,Leb P: P1 MNS: M,N,S,s Luth: Lua,Lub Xg: Xga TDL-T-021 & TDL-T-025 using Diamed Gel Stationwith 3-cell Diamed screening cells C EDT lood Direct ntiglobulin test (automated) TDL-T-083 using Diamed IH-1000 Direct ntiglobulin test (manual) TDL-T-024 using Diamed Gel cards C ssessment Manager: MP Page 21 of 30

22 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 lood Transfusion HUMN ODY FLUIDS General examination activities for the purposes of clinical diagnosis: in conjunction with equipment manuals and standard methods as specified below: EDT lood ntigen Phenotyping: Rh: C,E,c,e, Kell: K Duffy:Fya, Fyb Kidd: Jka,Jkb MNS: M,S,s 1 TDL-T-026 using Diamed IH-1000 and Diamed Rh Gel cards (automated) TDL--026 using Diamed Gel cards or tube technology with liquid anti-sera & C EDT lood Measurement of Foetal Rbc in maternal blood for FMH determination TDL-T-077 by modified Kleihauer- etke test using Source ioscience Fetal Red Cell Detection kit and Fixol ssessment Manager: MP Page 22 of 30

23 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles:, urine lbumin & C lanine transaminase & C, urine lkaline phosphatase & C lpha fetoprotein mikacin mmonia, urine mylase & C spartate aminotransferase, urine icarbonate & C ilirubin (total) & C ssessment Manager: MP Page 23 of 30

24 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Ca125 lood, urine Calcium & C Carbamazepine Carcinoembryonic antigen, urine Chloride by ion sensitive electrode Cholesterol & C Complement C3 by turbidimetry Complement C4 by turbidimetry lood, urine Creatinine (jaffe method) & C ssessment Manager: MP Page 24 of 30

25 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Conjugated ilirubin Cortisol C-reactive protein by turbidimetry & C Creatinine (enzymatic method) & C Creatinine Kinase & C Digoxin Ethanol by spectrophotometry Ferritin & C Free Triiodothyronine & C Free Thyroxine & C Folate Follicle stimulating hormone ssessment Manager: MP Page 25 of 30

26 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Fructosamine Gamma glutamyl transferase Gentamicin, CSF Glucose & C HDL-Cholesterol & C Human chorionic gonadotrophin Iron by spectrophotometry Immunoglobulins, G, M by turbidimetry, CSF Lactate & C Lactate dehydrogenase & C Lithium & C ssessment Manager: MP Page 26 of 30

27 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Luteinizing hormone Magnesium & C, urine Microalbumin & C NT Pro-rain natriuretic peptide Oestradiol Parathyroid hormone Paracetamol Phenytoin, urine Phosphate & C, urine Potassium by ion sensitive electrode & C Progesterone Prolactin & C ssessment Manager: MP Page 27 of 30

28 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Prostate specific antigen, urine, CSF Protein (total) & C Rheumatoid factor Salicyclate, urine Sodium by ion sensitive electrode & C Sex hormone binding globulin Theophylline Triglycerides Thyroid stimulating hormone & C Transferrin Troponin T & C, urine Urate & C, urine Urea & C ssessment Manager: MP Page 28 of 30

29 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: TDL-NWLH-C-037 & TDL-NWLH- C-043 by ion sensitive electrode using Roche Cobas 8000 ( ) and 6000 ( C) with reference to the following principles: Vancomycin Valproate Vitamin 12 & C Corrected Calcium by calculation EGFR by calculation KI by calculation Macroprolactin TDL-NWLH-C-046 by PEG precipitation followed by Roche Cobas immunoassay Whole blood Hb1c TDL-NWLH-C-006 by high performance liquid chromatography using TOSOH G8 Serum / Plasma, urine Osmolality TDL-NWLH-C-013 by freezing point depression using Vitech Osmometer & C ssessment Manager: MP Page 29 of 30

30 Schedule of ccreditation United Kingdom ccreditation Service ccredited to NWLHT nalytical LLP Issue No: 002 Issue date: 10 ugust 2018 iochemistry General iochemistry HUMN ODY FLUIDS iochemical examination activities for the purposes of clinical diagnosis. Quantification of: based on equipment manuals and standard methods as specified below: Urine Porphobilinogen TDL-NWLH-C-024 by ion exchange column extraction and spectrophotometry using Thermo Scientific Evo 201 Urine Porphyrins TDL-NWLH-C-027 by scanning spectrophotometry using Thermo Scientific Evo 201 CSF Xanthochromia TDL-NWLH-C-030 using which Thermo Scientific Evo 201 Faeces Occult blood TDL-NWLH-C-019 using Hema Check kit, urine, urine Detection of kappa & lambda light chains Detection of normal and abnormal protein electrophoretic patterns - Monoclonal antibodies TDL-NWLH-C-018, TDL-NWLH- C-033 & TDL-NWLH-C-017 by electrophoresis using Sebia Hydrasys END ssessment Manager: MP Page 30 of 30