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Evaluations and Validations post Carter

Evaluations and Validations post Carter . Keith Perry, Head of Evaluations Evaluations & Standards Laboratory. BSMT, November 2006. Today’s presentation. Carter review of NHS Pathology Ways we currently assess Evaluations post-Carter

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Evaluations and Validations post Carter

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  1. Evaluations and Validations post Carter Keith Perry, Head of Evaluations Evaluations & Standards Laboratory BSMT, November 2006

  2. Today’s presentation • Carter review of NHS Pathology • Ways we currently assess • Evaluations post-Carter • Evaluations & managed introduction of new technology?

  3. 2002 Need for standardised methods Need for co-ordinated system for evaluation managed intro of new technology

  4. 2006 Need for standardised methods Need for co-ordinated system for evaluation managed intro of new technology

  5. What was found ? Carter review of NHS Pathology • Little evidence of a strategic programme of investment for new & replacement technology • Little automated ‘front end’ & sample tracking • NHS too focussed on cost not benefit • Difficult to cost pathology services • Silos • Fragmented pathology services • Relatively small investment can make a difference • Labs can influence expensive treatments

  6. Recommendations Carter review of NHS Pathology • Managed introduction of new technology • - Benefits realisation - Competition • Appropriate investment • Work equipment harder • Healthcare closer to home • More PoC testing – accreditation & links with labs • Common national framework • Standardisation of test results • CEP – PASA role • Evaluations

  7. CE Marking Ways we currently assess • But does not cover: • Ease of Use • Monitoring of internal QCs • External QA • Use of combinations ie kits/equipment • Comparative data • Evaluation and validation

  8. Evaluations Ways we currently assess • Focus on device performance • Comparative • Independent and unbiased • Provide informative reports • Must be accurate and timely • Relevant to standardisation of methods • Encourage development • Should influence managed introduction of new technology

  9. Murex HIV 1/2 VK84/85 Vironostika HIV Uni-form II Ag/Ab Vitros ECi anti-HIV 1/2 Murex HIV Ag/Ab combination Timing of detection of primary HIV following seroconversion Ortho Ab-capt. ELISA BiotestHIV 1/2 recombinant Access HIV 1/2 NEW AxSYM HIV Ag/Ab Combo Innotest HIV-1/-2 GENSCREEN PLUS HIV Ag-Ab Enzygnost HIV 1/2 plus Biotest Anti-HIV TETRA ELISA Biotest Anti-HIV TETRA ELISA 5 0 10 15 20 days Murex HIV 1.2.0 GE94/95 Murex ICE HIV 1+2 VIDAS HIV DUO *Earliest anti-HIV detection Earliest HIV detection Abbott 3rd gen Plus Enzygnost HIV Integral Clonesystems Detect-HIV v1 Vironostika HIV Uniform II plus O IMx HIV1/2 III plus Wellcozyme Anti-HIV Pasteur Genscreen Version 2 AxSYM HIV 1/2 gO = combined antigen-antibody = immunometric = antiglobulin / indirect = Class specific antibody capture Ways we currently assess

  10. Assessments Ways we currently assess Molecular Assessments with CVN in collaboration with ESL to reassure users that their in-house assays give comparable results • In-house real-time PCR assays • Assays assessed to date (DNA viruses: HSV1 and 2; ADV; CMV) • Viral targets chosen via CVN committee & members • Labs submit SOPs • Panel of 25/target, comprising dilutions of strong or tissue-culture grown material extracted using two methods (9), plus clinical specimens (6) sent out for assessment • Next RSV, VZV, Norovirus, & Enterovirus

  11. Quick Look/See Ways we currently assess • Any new equipment or kit • Molecular extraction machines • New media

  12. Clinical Assessments Ways we currently assess • Hospital based study of IDI-MRSA (direct detection of MRSA in nasal swabs by a rapid molecular method) • bioMérieux Vitek

  13. Ways we currently assess Validation • Validation is the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled (ISO 17025:2005) Validation is evaluation of the whole process& ability to achieve the correct result (not the kit or reagent in isolation)

  14. VALIDATIONFILE Ways we currently assess

  15. Ways we currently assess

  16. National framework ‘Evaluation’ issues post-Carter www.pasa.nhs.uk/evaluation

  17. Prioritisation ‘Evaluation’ issues post-Carter • The CEP-PASA Prioritisation Board meets 3 times per year to consider proposals • Projects that are innovative, related to government priorities or purchasing exercises will gain higher scores • Next closing date for proposals: 31st January 2007 • Next meeting: 14th March 2007 • website www.pasa.nhs,uk.evaluation/propose_project

  18. Extent of NHS use Anyone can submit proposals Adoption/purchase Evaluation Evaluation project proposals Time Prioritisation Board • Chair • Head of CEP • Business Planning Manager • Head of Commissioning and Delivery • Technical Advisor • PASA / Hubs (2 reps) • NICE (1 rep) • NIIII (1 rep) • HTA (1 rep) • NPSA (1 rep) • MHRA (1 rep) National Evaluations Programme for Microbiology Priorities to be aligned to customer requirements& peer-organisations ‘Evaluation’ issues post-Carter

  19. Scope ‘Evaluation’ issues post-Carter • High rate of introduction of new diagnostic tests & automation • Many subject areas are not covered by evaluations

  20. Scope Virology Identification Serology Molecular Automation Bacteriology Parasitology ‘Evaluation’ issues post-Carter HIV EIAsHCV EIAsHBsAg EIAsPoCTs HSV Real-timePCRs Extraction,Processors,Closed systems SyphilisEIAs ChlamydiaNAATs Kiestraplate automation Culture media ToxoplasmaEIAs Products to reduce HAIs

  21. Evidence & processes ‘Evaluation’ issues post-Carter • Well designed studies • Well defined procedures • Challenging specimen panel • Expert input • Technical quality • Comprehensive quality system • Safeguards / checks in place • Project management

  22. ‘Evaluation’ issues post-Carter

  23. Recognised evaluation protocols ‘Evaluation’ issues post-Carter • e.g. for evaluations of lab automation • Developed in consultation with experts / users • Developed with reference to National Standard Methods • Process for review and authorisation

  24. Awareness ‘Evaluation’ issues post-Carter • National Evaluations Register • Study title • Status (proposal, preparation, technical, report in draft, completed) • Expected Output(evaluation report, look/see, literature review, market review) • Lead centre • Contact name, telephone, email

  25. Timing ‘Evaluation’ issues post-Carter • Evaluating relevance & utility is time consuming • Products are often in use prior to evaluation report • Matching evaluations and tender processes

  26. Mechanism ‘Evaluation’ issues post-Carter • The mechanism for where and how evaluations are done is still insufficiently defined • Central front-door through CEP evaluation centres? • Evaluation networks co-ordinated through CEP centres? • - with expert working groups - professional groups - reference laboratories - clinical user groups

  27. ‘Evaluation’ issues post-Carter Cost benefit • How large is the cost? • How large is the benefit? • Is introducing the test/device cost effective? • Resources • Integral to the work of CEP-PASA • CEP has Health Economist in post

  28. Chlamydia NAATs Evaluations & managed introduction of new technology? • Government priority • To tackle a specific issue (Chlamydia screening programme) • Money made available • Implementation of new technology preceded evaluation (used literature reviews) • Multi-site evaluation took >2 years

  29. Evaluations & managed introduction of new technology? Specimen sourcing Routine Transport Evaluation Urine25mls+ Aliquot,Label & Send RoutineScreenSource Labs (3) SDA SDA Portsmouth 2b 2a IdentifydiscordantsHPA-ESL SDA pouch TMA Liverpool TMA 3b 3a Add to TMA tube Report 1 Retest positives PCR UCLH / Kings PCR 4b 4a HPA-STBRL R-timePCR 5 Data collation,analysis, & report HPA-ESL Aim for 4 day turnaround Chlamydia NAATs evaluation

  30. Challenges • Responding to the need for a wide range of microbiological device evaluations • How to prioritise • Joining device performance with procurement • Earlier assessment and usage of innovative technologies • Improved access to available evaluation resultseg National Evaluations Register • Improved sharing of information • Impact on lab autonomy to choose equipment/kits • Funding of evaluations (eg PASA) • Funding for implementation (capital & revenue)

  31. Thanks to…. • All collaborators / advisors • All in Evaluations & Standards Laboratory, including: • - Valerie Bevan, Director ESL • - Standards, Quality Control Reagents & Quality System Units • - The Evaluations Team: • Katrina Barlow Christine Burgess Johanna Curtis Laura Dean Galit Gonen Fu Li

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