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9092 Medical Single Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Viapath Analytics LLP Issue No: 007 Issue date: 11 May 2021 Department of Haematological Contact: Nura Ibrahim Medicine Tel: +44 (0) 203 299 7685 Ground Floor Bessemer Wing E-Mail: [email protected] King's College Hospital 9092 Website: www.viapath.co.uk Denmark Hill Accredited to London ISO 15189:2012 SE5 9RS United Kingdom Testing performed at the above address only Site activities performed away from the locations listed above: Location details Activity King’s College Hospital (Denmark Hill): Storage & issue of blood & blood products only • Emergency Department • Liver Theatre • Neuro Theatre • Main Theatres • Nightingale Birth Centre (NBC) • Liver Unit ITU (LITU) • Centenary Wing • Harris Birthright (Windsor Walk) King’s College Hospital (Orpington Site): • Orthopaedic Theatres Assessment Manager: MS2 Page 1 of 22 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012 Testing performed at main address only DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN TISSUES AND FLUIDS Cytogenetic analysis for the In house documented methods purpose of clinical diagnosis incorporating manufacturers’ instructions as required Bone Marrow Detection of diagnostically and Culturing of human tissues/cells Peripheral Blood prognostically relevant cytogenetic using: Smears abnormalities defined in the WHO LP-HAE-CYT-Booking In CSF Classification of Tumours of LP-HAE-CYT-SYSMEXAUTO Ascitic fluid Haematopoietic and Lymphoid LP-HAE-CYT-Set Up Pleural Effusion Tissues (2008 & 2016 revisions) Preparation of cultured cells by Karyotyping manual harvest and G-banding for chromosome analysis using: LP-HAE-CYT-HRVST LP-HAE-CYT-Slide Prep LP-HAE-CYT-GBAND LP-HAE-CYT-MSLOAD Cell separation of CD138+ cells from Multiple Myeloma referrals using: LP-HAE-CYT-PCD Fluorescence In-situ Hybridisation (FISH) using commercial probes and: LP-HAE-CYT-FISH G-banded metaphase analysis using: LP-HAE-CYT-ANALYSIS Fluorescent In-Situ Hybridisation (FISH) analysis using: LP-HAE-CYT-ANALYSIS LP-HAE-CYT-FISHCAP Peripheral Blood Constitutional analysis to confirm G-banded metaphase analysis & karyotyping findings FISH analysis using: LP-HAE-CYT-ANALYSIS Assessment Manager: MS2 Page 2 of 22 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis instructions as required Amniotic Fluid DNA Extraction, manual methods Chorionic Villus Sample and automated using: Cultured Amniocytes Dried Blood Spot QIAsymphony (blood) Foetal Blood LP-HAE-PND105 Formalin-Fixed Paraffin-Embedded (FFPE) samples Qiagen EZ1 Plasma LP-HAE-PND076 (foetal samples) Saliva LP-HAE-PND116 (saliva) Serum Whole blood Genomic DNA extracted in house PCR amplification using any of from whole blood (unless stated (unless stated otherwise for otherwise for specified tests) or specified tests): received as primary sample type Applied Biosystems Veriti™ Thermal Cycler and: Veriti™ Thermal Cycler User Guide (PN 4375799) Rotor-Gene 600 and: Rotor-Gene 600 Operator manual 1.7.87 Eppendorf Mastercycler Nexus and: Eppendorf Mastercycler Nexus operating manual (2012) and DNA extracted from Saliva Thrombophilia genetic analysis: Detection of three genetic variants RT PCR Allelic discrimination affecting thrombophilia: TaqMan assay Factor V Leiden LP-HAE-PND110 Prothrombin C Methylene Tetrahydrofolate Reductase Hereditary Haemochromatosis genetic analysis: Detection of the two common RT PCR Allelic discrimination genetic variants in the HFE gene TaqMan assay associated with hereditary LP-HAE-PND104 haemochromatosis: HFE p.C282Y HFE p.H63D Assessment Manager: MS2 Page 3 of 22 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type Detection of large deletions and Multiplex ligation-dependent probe duplications in the HFE gene amplification (MLPA) by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND117 Alpha-1-antitrypsin deficiency genotyping: Detection of two genetic variants in RT PCR machine allelic the SERPINA1 gene which are discrimination TaqMan assay known to cause Alpha-1-antitrypsin LP-HAE-PND111 deficiency: Z and S mutations Gilbert’s syndrome genetic analysis: Homozygosity for the 7 repeat Applied Biosystems 3130xl allele of the dinucleotide repeat Genetic Analyser region in the promoter of the LP-HAE-PND071 UGT1A gene and DNA extracted from Saliva Variegate and Acute Intermittent Porphyria genetic analysis: Detection of the most common RT PCR allelic discrimination PPOX gene mutation known to TaqMan assay using: cause Variegate Porphyria: Rotor-Gene 600 R59W LP-HAE-PND122 Detection of other single base Sanger Sequencing using: changes and microlesions in the Applied Biosystems 3130xl PPOX gene that cause Variegate Genetic Analyser Porphyria LP-HAE-PND125 Detection of single base changes Sanger Sequencing using: and microlesions in the HMBS Applied Biosystems 3130xl gene that cause Acute Intermittent Genetic Analyser Porphyria LP-HAE-PND121 Assessment Manager: MS2 Page 4 of 22 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type and DNA extracted from CVS Pyruvate Kinase deficiency genetic analysis: Detection of single base changes Sanger Sequencing using: and microlesions in the PKLR Applied Biosystems 3130xl gene Genetic Analyser LP-HAE-PND126 Detection of large deletions and MLPA by PCR using: duplications in the PKLR gene Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Thermal Cycler- Veriti™ Applied Biosystems 3130xl Genetic Analyser LP-HAE-PND117 Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Detection of the most common RT PCR Allelic discrimination African G6PD mutations: TaqMan assay using: V68M Rotor-Gene 600 N126D LP-HAE-PND046 Detection of the common Restriction fragment length Mediterranean G6PD mutation: polymorphism (RFLP) assay by S188F PCR and agarose gel electrophoresis LP-HAE-PND013 and DNA extracted from: Saliva Haemoglobin variant genetic Dried Blood Spot analysis: Amniotic Fluid Detect of the most common HBB RT PCR Allelic discrimination CVS gene mutation known to cause TaqMan assay using: Cultured Amniocytes Sickle cell disease: HbS Rotor-Gene 600 Foetal Blood and the haemoglobin variant: HbC LP-HAE-PND039 Assessment Manager: MS2 Page 5 of 22 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Viapath Analytics LLP 9092 Issue No: 007 Issue date: 11 May 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used HUMAN TISSUES AND FLUIDS Molecular haematology In house documented methods (cont’d) examinations for the purpose of incorporating manufacturers’ clinical diagnosis (cont’d) instructions as required Genomic DNA extracted in house from whole blood (unless stated otherwise for specified tests) or received as primary sample type Confirmation of HbS and HbC Restriction fragment length variants polymorphism (RFLP) assay by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ and Agarose gel electrophoresis LP-HAE-PND013 Confirmation of HbC variants Amplification refractory mutation system (ARMS) assay by PCR using: Eppendorf Mastercycler Nexus or Applied Biosystems Veriti™ Thermal Cycler and
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