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Choosing Best Laboratory Practice   Valerie Bevan Jerry Skinner Ruhi Siddiqui Janet Norcup Sam Gillanders www.HPA.org.uk www.evaluations-standards.org.uk [email_address]     standardsunit @HPA.org. uk   14 May 2004
Today’s talk ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
SRMD Organisational Structure
Office Manager A&C 5 SOP  Administrator A&C 5 Information  Officer A&C 5 Deputy Director & Head of Quality System Unit CS C Standards Microbiologist BMS 3 Standards Microbiologist BMS 3 SOP/ Quality Systems Administrator A&C 5 Head of Standards Unit/ Accreditation Officer BMS 3+3 Evaluations Microbiologist MTO 3 (MHRA) Evaluations Administrator A&C 6 (MHRA) Evaluations Laboratory  Assistant (MHRA) Head of Evaluations Unit CS B19 Quality Control Microbiologist MTO 2 Quality Control Supervisor MTO 3 Head of Quality  Control  Reagents Unit  MTO 5 Laboratory Director Evaluations and Standards Laboratory Evaluation and Standards Laboratory - October 03 Evaluations Microbiologist MTO 3 (NBS) Evaluations Microbiologist MTO 3 (MHRA) Quality Control Microbiologist MTO 2 Quality Control Microbiologist MTO 2 Quality Control Microbiologist MTO 2
ESL ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evaluations Unit Keith Perry   Microbiological Diagnostics Assessment Service
Results: Timing of Detection of Primary  HIV  Following seroconversion * = combined antigen-antibody = immunometric = Class specific antibody capture  = antiglobulin / indirect * based on 38 seroconversion panels
Quality Control Reagents Unit Joe Vincini – Quality Control Reagents Unit AxSym (Abbott Diagnostics) PRISM(Abbott Diagnostics) Vitros  (Ortho Clinical Diagnostics) VIDAS (bioMerieux) ACCESS (Beckman Coulter)
Quality Control Reagents Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],Joe Vincini – Quality Control Reagents Unit
Quality Control Reagents Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Standards Unit ,[object Object],[object Object],[object Object]
Technical Adverse Incidents Close liaison with MHRA, companies and users June
Standards Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Historical background ,[object Object],[object Object],[object Object],[object Object],[object Object]
Process Draft SOP SCBM Working Group Standards Unit 1st draft for comment 2nd draft for comment SCBM Working Group Final version
 
Need for a broad based approach to health protection 2002
What network of  laboratories? HPA HQ Network  of 46  PHLs in 8 Groups CPHL CDSC
BSOP 28 Investigation of genital tract and associated specimens
Our discussions  with users ,[object Object],[object Object],[object Object],[object Object],[object Object]
BSOP 28 Investigation of genital tract and associated specimens ,[object Object]
BSOP 28 Investigation of genital tract and associated specimens   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BSOP 28 Investigation of genital tract and associated specimens ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BSOP 28 Investigation of genital tract and associated specimens
BSOP 28 Investigation of genital tract and associated specimens
Genital Tract SOP Questions ,[object Object],[object Object],[object Object],[object Object],[object Object]
BSOP 28 Investigation of genital tract and associated specimens * Trichomonas media T. vaginalis Clinically suspected TV STD  Pregnancy S. aureus Lancefield Groups A, C and G streptococci yeasts N. gonorrhoeae * * * Urethral swab/ Cervical swab S. aureus Lancefield Groups A, C and G streptococci yeasts * * HVS Target organisms GC selective agar  Sabouraud agar Blood agar
BSOP 28 Investigation of genital tract and associated specimens Media used MSOP 5 recommends NYC: GC selective + amphotericin  (Nb VCNT + nystatin less effective ) Do you culture HVS or ECX swabs for GC?
BSOP 28 Investigation of genital tract and associated specimens Which specimen do you examine for  Trichomonas vaginalis? We recommend HVS, not ECX
BSOP 28 Investigation of genital tract and associated specimens How do you process the specimens for TV? We recommend culture but recognise that microscopy/wet prep may be more practical
BSOP 28 Investigation of genital tract and associated specimens When do you look for anaerobes? We recommend culture depending on clinical details Intra-uterine death Septic abortion  Miscarriage Neo FAA agar with with MZ 5ug disc Anaerobes Clinical details Media Target organisms
BSOP 28 Investigation of genital tract and associated specimens Which specimens do you examine for anaerobes? We recommend culture depending on clinical details
BSOP 28 Investigation of genital tract and associated specimens Media used for isolating anaerobes We recommend FAA+neomycin (MSOP 4)
BSOP 28 Investigation of genital tract and associated specimens Do you look for Bacterial vaginosis? 24/47 said ‘Yes’
BSOP 28 Investigation of genital tract and associated specimens Do you culture and report Group B streptococci from HVS or ECX swabs? We recommend Gp B Strep may be important from either specimen
BSOP 28 Investigation of genital tract and associated specimens
BSOP 28 Investigation of genital tract and associated specimens ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Access to HPA SOPs Global access Over 1000 passwords issued for the Extranet site Password requests from 48 countries outside of the UK
National Standard Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Where do standard methods  fit in?   SOPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Acknowledgements ,[object Object],[object Object],[object Object],[object Object]
Website for SOPs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Choosing best laboratory practice

  • 1. Choosing Best Laboratory Practice Valerie Bevan Jerry Skinner Ruhi Siddiqui Janet Norcup Sam Gillanders www.HPA.org.uk www.evaluations-standards.org.uk [email_address] standardsunit @HPA.org. uk 14 May 2004
  • 2.
  • 3.  
  • 5. Office Manager A&C 5 SOP Administrator A&C 5 Information Officer A&C 5 Deputy Director & Head of Quality System Unit CS C Standards Microbiologist BMS 3 Standards Microbiologist BMS 3 SOP/ Quality Systems Administrator A&C 5 Head of Standards Unit/ Accreditation Officer BMS 3+3 Evaluations Microbiologist MTO 3 (MHRA) Evaluations Administrator A&C 6 (MHRA) Evaluations Laboratory Assistant (MHRA) Head of Evaluations Unit CS B19 Quality Control Microbiologist MTO 2 Quality Control Supervisor MTO 3 Head of Quality Control Reagents Unit MTO 5 Laboratory Director Evaluations and Standards Laboratory Evaluation and Standards Laboratory - October 03 Evaluations Microbiologist MTO 3 (NBS) Evaluations Microbiologist MTO 3 (MHRA) Quality Control Microbiologist MTO 2 Quality Control Microbiologist MTO 2 Quality Control Microbiologist MTO 2
  • 6.
  • 7. Evaluations Unit Keith Perry Microbiological Diagnostics Assessment Service
  • 8. Results: Timing of Detection of Primary HIV Following seroconversion * = combined antigen-antibody = immunometric = Class specific antibody capture = antiglobulin / indirect * based on 38 seroconversion panels
  • 9. Quality Control Reagents Unit Joe Vincini – Quality Control Reagents Unit AxSym (Abbott Diagnostics) PRISM(Abbott Diagnostics) Vitros (Ortho Clinical Diagnostics) VIDAS (bioMerieux) ACCESS (Beckman Coulter)
  • 10.
  • 11.
  • 12.
  • 13. Technical Adverse Incidents Close liaison with MHRA, companies and users June
  • 14.
  • 15.
  • 16. Process Draft SOP SCBM Working Group Standards Unit 1st draft for comment 2nd draft for comment SCBM Working Group Final version
  • 17.  
  • 18. Need for a broad based approach to health protection 2002
  • 19. What network of laboratories? HPA HQ Network of 46 PHLs in 8 Groups CPHL CDSC
  • 20. BSOP 28 Investigation of genital tract and associated specimens
  • 21.
  • 22.
  • 23.
  • 24.
  • 25. BSOP 28 Investigation of genital tract and associated specimens
  • 26. BSOP 28 Investigation of genital tract and associated specimens
  • 27.
  • 28. BSOP 28 Investigation of genital tract and associated specimens * Trichomonas media T. vaginalis Clinically suspected TV STD Pregnancy S. aureus Lancefield Groups A, C and G streptococci yeasts N. gonorrhoeae * * * Urethral swab/ Cervical swab S. aureus Lancefield Groups A, C and G streptococci yeasts * * HVS Target organisms GC selective agar Sabouraud agar Blood agar
  • 29. BSOP 28 Investigation of genital tract and associated specimens Media used MSOP 5 recommends NYC: GC selective + amphotericin (Nb VCNT + nystatin less effective ) Do you culture HVS or ECX swabs for GC?
  • 30. BSOP 28 Investigation of genital tract and associated specimens Which specimen do you examine for Trichomonas vaginalis? We recommend HVS, not ECX
  • 31. BSOP 28 Investigation of genital tract and associated specimens How do you process the specimens for TV? We recommend culture but recognise that microscopy/wet prep may be more practical
  • 32. BSOP 28 Investigation of genital tract and associated specimens When do you look for anaerobes? We recommend culture depending on clinical details Intra-uterine death Septic abortion Miscarriage Neo FAA agar with with MZ 5ug disc Anaerobes Clinical details Media Target organisms
  • 33. BSOP 28 Investigation of genital tract and associated specimens Which specimens do you examine for anaerobes? We recommend culture depending on clinical details
  • 34. BSOP 28 Investigation of genital tract and associated specimens Media used for isolating anaerobes We recommend FAA+neomycin (MSOP 4)
  • 35. BSOP 28 Investigation of genital tract and associated specimens Do you look for Bacterial vaginosis? 24/47 said ‘Yes’
  • 36. BSOP 28 Investigation of genital tract and associated specimens Do you culture and report Group B streptococci from HVS or ECX swabs? We recommend Gp B Strep may be important from either specimen
  • 37. BSOP 28 Investigation of genital tract and associated specimens
  • 38.
  • 39.
  • 40. Access to HPA SOPs Global access Over 1000 passwords issued for the Extranet site Password requests from 48 countries outside of the UK
  • 41.
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  • 43.
  • 44.

Editor's Notes

  1. Number of issued SOPs Others still in draft
  2. Number of issued SOPs Others still in draft
  3. Drafts written by Standards Unit. Food methods different, impractical to employ 1 person just to work on food method – act as co-ordinators for internal recognised food experts. Will explain SMWG in next slide Time – 1 year for completion
  4. First SOP issued in 1996
  5. “As for microbiology laboratories, they are under a variety of management arrangements and follow no standard diagnostic criteria in their operations. There is a need to bring consistency to the delivery of public health functions of laboratories and standardise on current good practices” Action proposed: rationalisation of microbiology laboratories and introduction of standards for diagnosis and profiling of micro-organisms
  6. 82% if GC and NYC taken together
  7. SOPs used to be controlled paper copies Not flexible enough Now web based
  8. 7
  9. PDF only – drafts not displayed nor SOPs under review Laboratories unable to customise them to suit local circumstances
  10. PDF only – drafts not displayed nor SOPs under review Laboratories unable to customise them to suit local circumstances