NATIONAL STANDARD METHODS: ASSURING QUALITY IN UK Portugal

Transcription

1 NATIONAL STANDARD METHODS: ASSURING QUALITY IN UK Portugal Valerie Bevan Department for Evaluations and Standards Laboratory Centre for Infections Health Protection Agency October 2008

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3 Structure of talk Background to: Health Protection Agency (HPA) Centre for Infections (CfI) Department for Evaluations, Standards and Training (DEST) Standardising methods How we develop them Why What they look like How you can access them Department for Evaluations, Standards and Training (DEST)

4 HPA Board Executive Local & Regional Services Regional Microbiology Network Corporate Services Centre for Infections Centre for Emergency Preparedness & Response Centre for Radiation Chemicals & Environmental Hazards

5 Main purpose of HPA Dedicated to protecting people s health

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7 Centre for Infection Epidemiology / surveillance Reference Microbiology

8 Department for Evaluations, Standards and Training (DEST) Head of Department & Laboratory Director: Valerie Bevan Standards Unit Quality System Unit Evaluations Unit (MiDAS) Quality Control Reagents Unit Education & Training Unit Ruhi Siddiqui Professor Ian Sharp Dr Keith Perry Joe Vincini Dr Satnam Sagoo

9 Quality Assurance Patient Test selection Patient preparation Specimen collection Specimen preservation Specimen Selection QA EQA IQA IQC Specimen reception Unique lab identifier Analysis Analytical validation Laboratory SOPs Clinical validation Accreditation checks compliance Results dispatched Results interpreted Clinical management Reporting and Interpretation [Seth J. Quality Assurance. In: CP Price, DJ Newham (eds) Principles and Practice of Immunoassay. 2nd ed. London. pp ]

10 Title Lorian cycle (? 1982)

11 What do we mean by assuring quality? Working to a good quality system Adequate quality assurance (EQA, IQC, IQA) Having a service culture focussed on the user / clinician and patient Good reporting of all diseases for surveillance, according to local requirements Timeliness of reporting High quality clinical advice and interpretation of results Public health focus Meeting accreditation standards Having good standard operating procedures Quality manual

12 Department for Evaluations, Standards and Training (DEST) Head of Department & Laboratory Director: Valerie Bevan Standards Unit Quality System Unit Evaluations Unit (MiDAS) Quality Control Reagents Unit Education & Training Unit Ruhi Siddiqui Professor Ian Sharp Dr Keith Perry Joe Vincini Dr Satnam Sagoo

13 National Standard Methods (NSMs) Comprehensive collection of > 200 well referenced: clinical microbiology standard operating procedures algorithms (virology and serology) guidance notes

14 ~Over 200 National Standard Methods 84 Clinical bacteriology BSOPs 37 BSOP IDs / BSOP TPs Virology / serology algorithms and SOPs 40 Food, water and environmental 39 Guidance Notes 5 Syndromic algorithms (in development)

15 INVESTIGATION OF FAECES SPECIMENS FOR BACTERIAL PATHOGENS BSOP 30

16 SOPs (NSMs) Index Amendment procedure Scope Introduction Technical information Safety considerations Specimen collection Specimen transport & storage Specimen processing Reporting References

17 Working Group Meetings All day meetings 2-4 times a years for each group Working Groups: Bacteriology Virology Syndromic Algorithms Molecular Technology (being formed) Food, Water and Dairy Multi-professional composition: Chairperson Members of the Standards Unit - Unit Head - Co-ordinator/Secretariat Medical microbiologists Healthcare scientists Stakeholder representatives Editor (does not attend meetings)

18 Stakeholders experts and stakeholders Curator Stakeholders

19 SM Working Group Consult Write Draft Standards Unit 1 st draft Via Web Consult Process 2 nd draft Via Web

20 Access Final versions in Adobe.pdf format Access to drafts and reviews (in MS Word) requires password Over 1300 passwords in 75 countries to access our website for NSMs

21 11 May 2006

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24 National Standard Methods (VSOP) Laboratory testing strategies Minimum acceptable standards Frontline testing Confirmatory strategies - algorithm flowchart format or - working standard operating procedure (SOP) format Some with limited access eg H5N1 influenza

25 Anti HIV screening VSOP 11

26 Standard Operating Procedures (VSOP)

27 Clinical Guidance Notes (QSOP)

28 Syndromic algorithms Hepatitis in Neonates = PCR = Serology = Isolation

29 Acute Infective Hepatitis Syndromic Algorithm

30 Syndromic algorithms Bench level guide Front end Link bacteriology and virology testing Make informed decisions Selection of tests Appropriate samples Appropriate reporting Cross referencing to relevant NSMs

31 Why use National Standard Methods? Assist in Accreditation, Quality, Safety, Staff training Links with regulatory bodies, professional microbiology organisations, public health and epidemiologists Facilitates the movement of staff across laboratories Honest broker when laboratories merge Well referenced, provide advice, existing best practice Improve the quality of epidemiological data Removes the need for labs to produce methods from 1 st principles Wide consultation (>1300 password holders), regular review periods ensure documents are current Enables rapid responses to changes required Accessible to all for FREE via the Internet (and with a password)

32 Feedback received The introductions are very useful especially for the BMS examinations You provide reassurance to laboratories regarding methods employed The methods provide a good basis when applying for funding for infrastructure

33 What we are moving towards Documents to be interactive Documents taking presenting symptom to the diagnosis Facilitating molecular diagnostics Improving links with clinical microbiology Book of introductions Pathopedia (with Royal College of Pathologists)

34 Department for Evaluations, Standards and Training (DEST) Head of Department & Laboratory Director: Valerie Bevan Standards Unit Quality System Unit Evaluations Unit (MiDAS) Quality Control Reagents Unit Education & Training Unit Ruhi Siddiqui Professor Ian Sharp Dr Keith Perry Joe Vincini Dr Satnam Sagoo

35 See websites for published reports

36 Evaluations

37 CE Marking CE Marking does not cover: Comparative data Evaluation and validation Ease of Use Monitoring of internal QCs External QA Use of combinations ie kits/automated platforms

38 Murex HIV Access HIV 1/2 New Abbott HIV1/2 3 rd Gen Plus AxSYM HIV Ag/Ab Combo Murex HIV AgAb Combination Genscreen PLUS HIV AgAb Vironostika HIV Uni-Form II AgAb Murex HIV 1+2 Ortho Ab Capt. ELISA Enzygnost HIV1/2 plus Murex ICE HIV 1+2 Innotest HIV 1/2 Earliest HIV Detection Detect-HIV v.4 Prism HIV Ag/Ab Combo Genscreen ULTRA HIV Ag-Ab VIDAS HIV DUO Earliest anti- HIV Detection Enzygnost HIV Integral Genscreen HIV Version 2 Vitros ECi anti-hiv 1+2 Biotest Anti-HIV Tetra ELISA AxSYM HIV 1/2 go Biotest HIV 1/2 recombinant Vironostika HIV Uni-Form II plus O IMx HIV1/2 III plus Clonesystems Detect HIV v1 This figure is based on data generated by testing 21 seroconversion panels in each of the HIV screening tests shown. = Combined Ag/Ab assay = immunometric assay = Class specific antibody capture assay = antiglobulin assay.

39 Department for Evaluations, Standards and Training (DEST) Head of Department & Laboratory Director: Valerie Bevan Standards Unit Quality System Unit Evaluations Unit (MiDAS ) Quality Control Reagents Unit Education & Training Unit Ruhi Siddiqui Professor Ian Sharp Dr Keith Perry Joe Vincini Dr Satnam Sagoo

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41 Quality Control Reagents we provide Current list of reagents for serology Annex II List A HIV HTLV Hepatitis B Hepatitis C HIV p24 antigen Annex II List B Toxoplasma CMV Rubella Non-Annex II Hepatitis A HSV Syphilis Malaria Influenza H5

42 Countries where we sell Quality Control Reagents UK Canada China Denmark Eire Estonia France Germany Italy Netherlands Norway Singapore Sweden South Korea Taiwan Turkey USA Ukraine

43 Summary NSMs are based on a consensus supported by literature Wide consultation Led by professionals and consult with recognised experts Hosted by HPA Supported by NHS and other stakeholders Progressive and responsive Current and regularly reviewed Free! Quality if multifactorial!

44 Evaluations and Standards Laboratory

45 Acknowledgements Virology working group Ken Mutton (chair and editor for Clinical Virology Network) Medical Editor Dr Mark Farrington Members of Working Groups Department for Evaluations, Standards and Training All in DEST, especially: Keith Perry Ruhi Siddiqui, Jyotsna Vohra, Clare Harris, Russell Croker, Janet Norcup Ian Sharp Joe Vincini Health Protection Agency [2008]

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