User Guide 2020 - Health Services Laboratories
UserGuide2020
TAP4147D/24-08-20/V31
ContentsAbout Health Services Laboratories (HSL)2HSL Locations3Quality assurance4Data protection8Measurement of uncertainty10Complaints policy10HSL referral laboratories11HSL Genetics referral laboratories13How to order a test14Guidance on specimen collection16Specimen transport18Sample rejection criteria20Sample requirements22Cervical Screening London23HSL Advanced Diagnostics36HSL Biochemistry43HSL Cellular Pathology55HSL Flow Cytometry65HSL Genetics69HSL Haematology101HSL Haemoglobinopathies107HSL Immunology110HSL Microbiology122HSL Parasitology134HSL Rapid Response Laboratories159HSL Virology177Request Forms189HSL USER GUIDE 20201
About Health ServicesLaboratories (HSL)Health Services Laboratories (HSL)is a clinically-led provider of pathologyand diagnostic services.Our purpose is to deliver medically-leddiagnostics, innovation, value and long-terminvestment to healthcare.HSL is a progressive partnership betweenThe Doctors Laboratory, the Royal FreeLondon NHS Foundation Trust (the RoyalFree London), and University College LondonHospitals NHS Foundation Trust (UCLH).We combine The Doctors Laboratory’sspecialist pathology expertise with the RoyalFree London and UCLH’s internationallyrecognised heritage of continual research,development and academic excellence.We maintain rigorously high standardsof quality, while delivering efficiencies tohealthcare through careful workforce planning,pioneering technology, and significantinvestment in infrastructure and IT.2OUR PROMISEOur aim is to develop and deliver a sustainablebusiness that delivers quality and value for everyonewe work with.We recognise that this must be achieved in aresponsible manner and are committed to ensuringthat our activities have a positive impact on boththe communities in which we operate and thewider healthcare sector.To achieve this we will: play a key part in the development of healthcare inthe UK. We will listen carefully to the requirementsof NHS commissioners and the people theyare commissioning for, and develop qualitybased solutions that reflect their needs; engage with staff to ensure that they are treatedfairly, enable them to realise their full potential,and have an active role in developing theUK’s clinical pathology workforce; minimise any negative impact our businesshas on the environment. We have implementeda documented Environmental Management Systembased on the requirements of ISO 14001.HSL USER GUIDE 2020
HSLLocationsHSL has a network of clinical laboratories across the country.HALOSpread over 11 floors with five split-level basements,the Halo facility is home to more than 1000 staffworking within a connected suite of laboratoriesspanning more than 100,000 square feet. The Haloalso has dedicated clinical and non-clinical coresfor vertical connectivity.1 Mabledon Place, London WC1H 9AXMortimer MarketMortimer Market rapid response laboratory (RRL)provides urgent parasitology diagnostic work inassociation with the travel clinic and the Hospitalfor Tropical Diseases.3rd Floor Mortimer Market Centre,Mortimer Market, London WC1E 6JBRoyal Free London andNorth Middlesex University NHS TrustHSL has developed two RRLs at the Royal FreeLondon and North Middlesex University NHS Trust,which launched in the summer of 2016. The servicesthat are operated from the RRL include haematology,biochemistry, routine coagulation and bloodtransfusion.Barnet and Chase Farm HospitalsThe pathology laboratories at Barnet and ChaseFarm Hospitals joined HSL in October 2017.The RRL and SRA launched in the last quarterof 2018 at the Barnet site. The services that areoperated from the RRL include haematology,biochemistry, routine coagulation and bloodtransfusion.60 Whitfield Street60 Whitfield Street has been transformed intoa specialist centre for cellular pathology anda RRL for UCLH. The RRL serves all of UCLH’surgent work, including A&E, ITU and in-patient work.HSL USER GUIDE 20203
QualityassuranceHSL is committed to providing doctors withpathology of the highest quality.The quality of results is of fundamental importance,and HSL operates to stringent technical andadministrative standards. Internal quality assuranceis achieved by strict adherence to standard operatingprocedures for all analytical processes.Quality management teamThe quality management team assists the laboratories,and drives the quality management system to meet, asa minimum, the requirements of all relevant regulatoryand accreditation standards and expectations acrossthe group. These include, but are not limited to, ISO15189, MHRA Blood Directives, CQC and Monitor.The team is primarily responsible for theimplementation and management of a compliantand electronic document management programme,auditing schedule and audits, along with moretechnical elements associated with changemanagement processes and validation framework.AccreditationHSL participates in accredited National ExternalQuality Assessment Schemes. These schemesare subscribed to by NHS and private laboratories.Results are subjected to strict internal and externalquality control.Details of the laboratories that refers specialist testingto are available from HSL Referrals. These laboratoriesare UKAS accredited, or of equal accreditation status.Quality assurance is administered by HSL’s QualityManagement Group (QMG) who also adhere toregulatory and accreditation requirements.ADVANCED DIAGNOSTICSBLOOD SCIENCESDrugs of AbuseUKNEQAS ICC & ISH forUKNEQAS, WEQAS, RIQAS,BIORAD, LABQuality,RCPAQAP forEthanolACEGlucose/GlucometerACTH (with PTH)Glycated HaemoglobinsAFP/CEA & HCGGuildford PeptidesAntibiotics (Gentamicin,Vancomycin and Amikacin)HaematinicsRoutine IHC & ISH (FFPE)Routine IHC (Cytology)HER2 IHCALK IHCROS1 IHCPD-L1 22C3PD-L1 28-8PD-L1 SP142Mismatch repair (MMR) IHCp16 IHCHER2 FISH InterpretationALK FISH InterpretationROS1 FISH Interpretation4Led by a director of governance, the team alsoincludes quality advisors, quality managers, a qualityadministration team, and quality officers.Free Beta HCG and PAPP-AGFRAnti-HBs DetectionHealthcontrol Therapeutic DrugsScreen (TDM)AmmoniaHepatitis A (with B and C)Autoimmune (RF and TPO)Hepatitis B SerologyASOHepatitis C SerologyB2 MicroglobulinHepatitis D serologyBorrelia IgM/IgGHepatitis E SerologyCardiac MarkersHIV SerologyClinical ChemistryHSV 1 & 2 IgG & typingCMV IgG/IgM/AvidityHomocysteineCRP & Ultra-Sensitive CRPHTLV 1 & 2 serologyCSFIGF-1Cyclosporin and TacrolimusImmunity ScreenDEQASLipaseDiagnostic SerologyLipid InvestigationsDiagnostic Serology HepatitisMeasles and Mumps serologyHSL USER GUIDE 2020
Quality assuranceNT-Pro BNPAnti-Xa assayPaternity TestingPaediatric BilirubinsPlasma viscositiesParasitologyRCPAPrader-Willi and AngelmanSyndromesPeptide HormonesPSAPTH, ACTH and hCTPFA-100 analysisQF-PCR Aneuploidy DetectionSexually Transmitted Diseases(CT/NG/MGEN/TV)GENETICS ANDMOLECULAR VIROLOGYSpinal Muscular AtrophySteroid HormonesGENQA, ISFG, EMQN,UKNEQAS, ECAT,LABQUALITY forY Microdeletion PCR AssaySyphilis SerologyAcquired array (CLL/MDS)Rubella IgG SerologySalicylate and ParacetamolSpecific ProteinsThyroglobulin SurveysThyroid HormonesAcute Leukaemia FISH pilotThrombophilia(Factor II, V, MTHFR)QCMD, INSTANDAtypical MycobacteriumTotal IgEAcute Lymphoblastic Leukaemia(ALL) – G banding and FISHToxoplasma IgG/M SerologyBoBs Rapid Aneuploidy detectionBacterial 16STumour MarkersChlamydia & Gonorrhoeadetection by PCRB19 virus DNA Viral loadBK virus DNA Viral loadConstitutional Clinical Cytogenetics(Rounds for Amniocentesis, CVS,Solid Tissue, Blood, Array CGH)CMV DBS (dried blood spots)Toxoplasma IgM SerologyToxoplasma IgG SerologyTrace ElementsUrine ChemistryVitamin D (25 OH)HAEMATOLOGYUKNEQAS forAutomated DifferentialLeucocyte CountCystic FibrosisDuchenne/Becker MuscularDystrophyHereditary Haemochromotosis(C282Y H63D) genotyping reportingAdenovirus DNA Viral loadCMV DNA Plasma Viral loadCMV DNA Whole Blood Viral loadCMV ResistanceEBV DNA Plasma Viral loadEBV DNA Whole Blood Viral loadEnterovirus RNAGastroenteritis Virus PanelHLA Class I (HLA-A, HLA-B,HLA-C) Tissue Typing(low resolution)Hepatitis B GenotypingHepatitis B Viral LoadESR and NRBC (nucleated Rbc)HLA Class II (HLA-DRB1,HLA-DQB1) Tissue Typing(low resolution)Flow CytometryHLA-B27 GenotypingLeukaemia immunophenotypingHLA-B57*01 GenotypingMyeloperoxidaseHLA Disease TypingCytochrome P450 2D6/2C19genotypingBlood Film MorphologyCoagulation(Including PoCT Coagulation)Iron stainFull Blood CountHaematologyHaematology AnalysisMalariaParasite FilmsReticulocyteSickle ScreeningThrombophilia ScreeningFactor assays:Von Willebrand (vWD) screenLupus anticoagulantADAMTS-13 activity and antigenHSL USER GUIDE 2020Human Papillomavirus DNAMature B & T cell Neoplasms –FISH for CLL and LymphomaMature B & T cell Lymphoma –G-bandingMyeloid (AML/MDS/CML) –G-banding and FISHHepatitis B DrugResistance TypingHepatitis C genotypingHepatitis C Resistance genomedetection (NS5a & b)Hepatitis C Resistance Typing(NS3 & NS5a)Hepatitis C Viral LoadHepatitis D Virus Viral loadand Qualitative PCRHepatitis E Virus Viral loadand Qualitative PCRHIV-1 Drug Resistance (Pol)HIV-1 Drug Resistance (Integrase)HIV-1 RNA Viral loadMyeloma – sample FISH setup and analysis plus onlineHIV-1 RNA Qualitative PCRNGS AML gene panelNIPT for aneuploidiesHIV-2 Viral load andQualitative PCRNIPT for sexingHSV 1&2 DNAHIV-1 Tropism Genome Detection5
Quality assuranceHSV Drug ResistanceIMMUNOLOGYINSTAND e.V. forHuman Herpes virus 6 DNAAdrenal AntibodiesInfluenza Haemagglutinin typingUKNEQAS – Immunology,Immunochemistry and Allergy forJC virus DNAELISACSCQ forMeasles and Mumps PCRANA/DNALyme (Borelia) serologyMERS CoronavirusParechovirus RNAAutoimmune SerologyANCA/GBM AntibodiesIFQ – Lubeck forRespiratory panel IAllergen Component TestingRespiratory panel IIBullous Dermatosis AntibodiesSyphilis PCRC1IN & Functional ComplementTransplantation Virus PanelCoeliac Disease AntibodiesEQA, TEQA forVZV DNADiabetic markersNHSCSP (EQA forGynaecological Cytopathology)General Autoimmune serologyMICROBIOLOGYUKNEQAS, QCMD forAAFB for Microscopy Mycobacterium CultureAntifungal PanelInterferon Gamma ReleaseAssay (IGRA)Hep E IgG & IgM SerologyLiver AutoantibodiesCYTOLOGYNHSCSP (TEQA for PAP stain)Hologic Imager stain (TEQA)Myositis AntibodiesCardiolipin IgG & IgM ScreenSpecific Microbial AntibodiesANDROLOGYUKNEQAS forAntifungal SusceptibilityUKNEQAS – Microbiology forAntimicrobial SusceptibilityHIV SerologyClostridium Difficile MRSA ScreeningSyphilis SerologyInformation securityHepB surface AgCryptococcal AntigenDetection (Pilot Scheme)HepC SerologyAccredited by British StandardsInstituteFaecal ParasitologyFaecal Haemoglobin EQA schemeLyme (Borelia) SerologyLabquality EQAS forFungal Biomarkers (Pilot Scheme)CMV IgG avidityGeneral BacteriologyHSV 1 and 2 (IgG)Genital PathogensHelicobacter pylori IgG SerologyMycologyUrinary Antigen: LegionellaISO/IEC 27001:2013HepE SerologyFaecal Markers for Inflammation(Calprotectin)Molecular detection of MycobacteriaSemen Analysis SchemeAnti Streptolysin ORCPAQAP (The Royal College ofPathologists of Australasia QualityAssurance Programs) forUrinary Antigens (Legionellaand Pneumococcal antigen)Scleroderma AutoantibodiesWEQAS Urinanalysis schemeLegionella SerologyBrucella SerologyChlamydia SerologyStriated Muscle6HSL USER GUIDE 2020
Quality assuranceLinks to the UKAS Schedules of AccreditationHSL Blood Sciences dule uploads/00007/8169%20Medical%20Single.pdfHSL Infection Sciences dule uploads/00007/8860%20Medical%20Single.pdfHSL Molecular Pathology and Genetics dule uploads/00007/8059%20Medical%20Single.pdfTDL Manchester dule uploads/00007/8812%20Medical%20Multiple.pdfTDL Andrology edule uploads/00007/10199%20Medical%20Single.pdfHSL Cervical Screening dule uploads/00007/8511%20Medical%20Single.pdfHSL USER GUIDE 20207
DataprotectionIt is the policy of Health Services Laboratories(HSL) supported by its board of directors, totake steps to ensure that your information is keptconfidential and secure and to otherwise protect andrespect your privacy. HSL will only ever collect andprocess the minimum amount of information requiredin order to provide our pathology services. As wellas the steps set out in this policy, HSL is accreditedto the international standard for Information SecurityManagement Systems set out in ISO/ISE 27001, ourcertificate may be found at 18/05/IS-655966.pdfThis is a high level privacy notice describing theinformation that HSL processes, the purpose ofthat processing, and how we protect it. For moredetailed information including the lawful basis forprocessing please read the ‘Detailed Privacy Notice’at -Notice.pdfThe data controllerHSL is a part of The Doctors Laboratory Group,the largest independent provider of clinical laboratorydiagnostic services in the UK providing pathologyservices to the private and public sector, informationabout the companies that comprise our groupcan be found at the respective his policy together with your terms and conditionssets out the basis on which any information HSLcollects from you, or that you provide to HSL, willbe processed. The following explains our views andpractices regarding your information and how wetreat it.HSL as a data controller and/or processorIn providing products and services, HSL may be actingas a data processor on behalf of third parties (such asclinicians, hospitals and/or insurers) who will themselvesbe the data controllers, or as a data controller (if forexample you are an employee). Where acting as a datacontroller, HSL will comply in full with this policy. Whereacting as a data processor, HSL will be required to acton the instructions of the data controller.Information HSL maycollect from or about youTypically, the information about data subjects that isprocessed by HSL comes from clinicians that you visitfor healthcare purposes, but it may also be collectedvia email, over the phone or any other means ofcommunication. They send us personal information inaddition to pathology samples (body fluids or tissues)and request tests are carried out upon those samples.The information provided to HSL may include: your name, date of birth, gender, address, emailaddress and in some cases phone number andcard payment details, and medical history; practice details of the requesting clinician suchas address, specialities and secretary information; information that is necessary to process invoicesincluding patient demographics, financial,bank and credit card information, medical andinsurer specific information such as insurername and policy/ identification details.You may also give HSL information by accessing orfilling in forms on its websites at: www.tdlpathology.com, www.hslpathology.com, https://10to8.com/book/tdlandrology/, or by corresponding with HSL via itsproducts and services, by phone, email or otherwise.This includes information you provide when you registerto use HSL’s sites, place an order on HSL sites, whenyou report a problem with HSL sites, or participatein communications or discussions on other socialmedia platforms.Information regarding HSL’s use of cookies can befound at www.hslpathology.com/cookie-policy/8HSL USER GUIDE 2020
Data protectionUses of the information you provideHSL will use this information to carry out HSL’sobligations arising from any contracts entered intobetween your clinician and HSL and to provide themwith the information, products and services requestfrom HSL such as: the provision of pathology services, andassociated processing of bills for payment; providing test requesting and resultsdelivery management tools to process invoices on behalf of various parties,such as clinicians, hospitals and insurers; for process management and improvement; to notify you or your clinician about changes toHSL’s products and services and to otherwisemanage HSL’s communications with you; and/or; to ensure that content from HSL’s sites arepresented in the most effective mannerfor you and for your computer.HSL may also disclose your information to thirdparties if HSL are under a duty to disclose or shareyour information in order to comply with any legalobligation, or in order to enforce or apply HSL termsand conditions and other agreements; or to protectthe rights, property, or safety of HSL, its customers,employees, or others. This includes exchanginginformation with other companies and organisationsfor the purposes of fraud protection and creditrisk reduction.Where we store your informationUnless specific consent is sought and received, oranother of the conditions for transferring data outsidethe EEA under GDPR satisfied (such as the inclusionof EU model contractual clauses in our contract withthe supplier/ third party) we will not transfer yourinformation outside of the EEA. The policy of yourData Controller, which could be your hospital, clinician,insurer etc may be different to this so you shouldcheck carefully the relevant privacy policies in orderto fully understand their implications.Disclosure of your informationYour rightsHSL may share your information with selected thirdparties including:Under the General Data Protection Regulation,you are given certain rights to control aspects of theprocessing of your information. You can exercise theserights at any time by contacting HSL via the methodsset out in the ‘contact’ section below. any member of The Doctors Laboratory Group,which means its subsidiaries, ultimate holdingcompany and its subsidiaries, as defined insection 1159 of the UK Companies Act 2006; business partners, referral laboratories,suppliers, insurers, logistics companies, debtmanagement agencies, and sub-contractorsrequired for the performance of any contractHSL enter into with them, you or your clinician; for the purpose of investigating any potentiallegal claims against TDL, your informationmay be shared with our insurers in orderto obtain insurance advice and services; National screening or public health monitoringschemes such as Public Health England; Information about your interactions with our websitesmay be shared with organisations that assist HSLin the improvement and optimisation of websites.ContactQuestions, comments and requests regarding thisprivacy policy are welcomed and should be made to:HSL Data ProtectionThe Halo Building1 Mabledon PlaceLondonWC1H 9AXE dataprotection@hslpathology.comWhen HSL shares such information, it will ensurethat it is only sharing as much information as isrequired to fulfil the purpose for which it is sharing it.HSL USER GUIDE 20209
Measurementof uncertaintyMedical laboratories are responsible for ensuring thattest results are fit for clinical application by defininganalytical performance goals and selecting appropriatemeasurement procedures. All types of measurementhave some inaccuracy due to bias and imprecision;therefore measurement results can only be estimates ofthe values of the quantities being measured.To properly use such results, medical laboratoriesand their clinical users need some knowledge ofthe accuracy of such estimates. The completeresult of a measurement is a value, a unit and anestimate of uncertainty. This estimate of uncertainty isconventionally referred to as Measurement Uncertainty(MU) and incorporates the cumulative range of factorsinvolved in the testing procedure itself in addition toconsideration of the inter-individual and intra-individualbiological variation which will potentially influencethe overall test result.Evaluating mea
Royal Free London and North Middlesex University NHS Trust HSL has developed two RRLs at the Royal Free London and North Middlesex University NHS Trust, which launched in the summer of 2016. The services that are operated from the RRL include haematology, biochemistry, routine coagulation and blood transfusion. Barnet and Chase Farm Hospitals
EU Tracker Questions (GB) Total Well Total Badly DK NET Start of Fieldwork End of Fieldwork 2020 15/12/2020 16/12/2020 40 51 9-11 08/12/2020 09/12/2020 41 47 12-6 02/12/2020 03/12/2020 27 57 15-30 26/11/2020 27/11/2020 28 59 13-31 17/11/2020 18/11/2020 28 60 12-32 11/11/2020 12/11/2020 28 59 12-31 4/11/2020 05/11/2020 30 56 13-26 28/10/2020 29/10/2020 29 60 11-31
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Nov 11, 2010 · User Story 1 User Story 2 User Story 4 User Story 5 User Story 5 (Cont.) User Story 3 User Story 6 User Story 7 rint 1 User Story 8 2 User Story 1 User Story 2 User Story 4 . Process Template Light on security artifacts/documentati on. OWASP Making SDL-Agile Manageable Toolin
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credential ID, and then authenticates the credential ID and security code with VIP Authentication Services. In this method, you maintain the user database (user IDs and passwords) and VIP User Services manages the user ID to credential ID mapping. This guide focuses on the SOAP Web Services interface between VIP User Services and your client .
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Cognos - User-Defined Prompts and Maps Page 1 of 24 Updated - January 2013 COGNOS User-Defined Prompts and Maps User Guide Introduction This user guide will walk you through the steps of creating a user-defined prompt and maps in Cognos. The package we are using for this user guide is not open to the public, but is a genuine example of
