Choosing best laboratory practice

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 What WE do to help choose laboratory practice Background to where Standard Methods ‘sit’ within the HPA Background to development of SOPs About the Genital Tract SOP How much do people like the SOPs? Do they use them? Where are the new developments with SOPs?

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 Evaluations Unit Evaluates kits and equipment (MHRA, NBS, WHO, commercial) Quality Control Reagents Unit Provides virology/serology laboratories with IQC reagents to helps laboratories monitor own performance of kits and equipment and provides advice Quality System Unit Advises on quality and audit to NHS and HPA laboratories and in CPHL Manages quality system Runs audit courses Standards Unit Writes and co-ordinates consultation and distribution of SOPs and algorithms with NHS (AMM, CVN, IBMS, ACM) Looks after Technical Adverse Incident Reporting

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 Supplying clinical laboratories with IQC reagents Providing advice on best use of our reagents Helping laboratories monitor the performance of kits and equipment Providing help with problems associated with IQC Providing news on products, new reagents and new projects Joe Vincini – Quality Control Reagents Unit

Quality Control Reagents Unit Quality Control Reagents include: ▪ Hepatitis C ▪ Syphilis ▪ CMV ▪ Herpes Simplex ▪ Hepatitis B ▪ VZV ▪ HIV ▪ Malaria ▪ Rubella ▪ Toxoplasma Moving into molecular QCs…

Standards Unit Writes and co-ordinates consultation and distribution of SOPs and algorithms with NHS (AMM, CVN, IBMS, ACM) Looks after Technical Adverse Incident Reporting Sam Gillanders – Standards Unit

Technical Adverse Incidents Close liaison with MHRA, companies and users June

Standards Unit SOPs – current position 68 clinical microbiology 35 food water and environmental 50 media 37 guidance notes Sam Gillanders – Standards Unit

Historical background Standard methods first produced in 1996 BSOP 9 Throat swab SOP (1 st ) BSOP 28 Genital Tract SOP first issued in 1998 Revised in 2002 Re-issued in December 2003

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 Genital Tract SOP How much do people like the SOP? Do they use them? How? What do we need to change?

BSOP 28 Investigation of genital tract and associated specimens Break-down of 47 labs surveyed

BSOP 28 Investigation of genital tract and associated specimens The vast majority liked: introduction well referenced useful as benchmarks when labs merge force for improving quality benchmark for evaluation of new methodologies

BSOP 28 Investigation of genital tract and associated specimens However a few did not like: perceived cost implications length of some of the SOPs some disagreed with recommendations some methods are long winded, so broad they are ambiguous too much emphasis on clinical background

Genital Tract SOP Questions GC – when and how TV – when and how Anaerobes – when and how BV – when and how Gp B Streps – when and how

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 A new SOP is being produced (SU in conjunction with RSIL and HPA Forum) Investigation of Screening swabs for Group B streptococci 1 st draft SOP to be discussed at the next WG meeting 15 June Your comments will be invited

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 Close working with the Inspector of Microbiology Involvement and logos on front pages: ACM (not logo yet) AMM CVN IBMS ? SGM ? Other professional groups National SOPs

Where do standard methods fit in? SOPs Decision to collect specimen Type of specimen Specimen collection method Transport Time/Storage Variation in reporting Interpretation of result by clinician Decision how / whether to treat

Acknowledgements Thanks to Jerry Skinner, Ruhi Siddiqui, Janet Norcup, Sam Gillanders and all who responded to the telephone survey Also thanks to Keith Perry and Joe Vincini www.hpa.org.uk www.evaluations-standards.org.uk

Website for SOPs PDF www.HPA.org. uk www.evaluations.standards.org.uk Microsoft Word Password protected: Drafts SOPs for review

Choosing best laboratory practice

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