Choosing Best Laboratory Practice Valerie Bevan Jerry Skinner Ruhi Siddiqui Janet Norcup Sam...

Choosing Best Laboratory Practice

Valerie Bevan

Jerry Skinner

Ruhi Siddiqui

Janet Norcup

Sam Gillanders

www.HPA.org.uk

www.evaluations-standards.org.uk

[email protected] [email protected] 14 May 2004

http://www.hpa.org.uk/

http://www.evaluations-standards.org.uk/

mailto:[email protected]




2

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?

Board

ChiefExecutive

ChemicalHazards

andPoisons

Local andRegionalServices

RadiationProtection

EmergencyResponse

Specialist &Reference

MicrobiologyDivision

CommercialDivision

CommunicableDiseases

SurveillanceCentre

The New Health Protection Agency

SRMD Organisational Structure

Office ManagerA&C 5

SOP Administrator

A&C 5

Information Officer

A&C 5

Deputy Director &

Head of Quality System Unit

CS C

StandardsMicrobiologistBMS 3

StandardsMicrobiologistBMS 3

SOP/Quality SystemsAdministratorA&C 5

Head of Standards Unit/Accreditation Officer

BMS 3+3

EvaluationsMicrobiologistMTO 3 (MHRA)

EvaluationsAdministratorA&C 6 (MHRA)

EvaluationsLaboratory Assistant(MHRA)

Head of EvaluationsUnit

CS B19

Quality Control

MicrobiologistMTO 2

Quality ControlSupervisor

MTO 3

Head of Quality Control

Reagents Unit MTO 5

LaboratoryDirector

Evaluations and Standards Laboratory

Evaluation and Standards Laboratory - October 03

EvaluationsMicrobiologistMTO 3 (NBS)

EvaluationsMicrobiologist

MTO 3 (MHRA)

Quality Control

MicrobiologistMTO 2

Quality Control

MicrobiologistMTO 2

Quality Control

MicrobiologistMTO 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 *

BiotestAnti-HIVTETRAELISA

WellcozymeAnti-HIV

50 10 15 2020days

OrthoAb-capt.ELISA

Vitros ECianti-HIV 1/2

BiotestHIV 1/2

recombinant

MurexHIV 1/2

VK84/85

IMxHIV1/2III plus

MurexHIV 1.2.0GE94/95

VironostikaHIV Uni-form II Ag/Ab

EnzygnostHIV 1/2

plusBiotest Anti-HIV TETRA

ELISA

ClonesystemsDetect-HIV v1

InnotestHIV-1/-2

VironostikaHIV Uniform II

plus O

Murex ICEHIV 1+2

GENSCREENPLUS HIV Ag-Ab

Murex HIV Ag/AbCombination

AxSYM HIV 1/2 gO

Abbott3rd gen

Plus

PasteurGenscreenVersion 2

Access HIV 1/2 NEW

Earl

iest

HIV

dete

cti

on

EnzygnostHIV

Integral

VIDASHIV DUO

= combined antigen-antibody = immunometric = Class specific antibody capture = antiglobulin / indirect

* based on 38 seroconversion panels


AxSym (Abbott Diagnostics) PRISM(Abbott Diagnostics)

Vitros (Ortho Clinical Diagnostics)

VIDAS (bioMerieux)

ACCESS (Beckman Coulter)

Joe Vincini – 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 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

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Technical Adverse Incidents

0

5

10

15

20

25

30

1998 1999 2000 2001 2002 2003 2004

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

15

Historical background

• Standard methods first produced in 1996

• BSOP 9 Throat swab SOP (1st)

• BSOP 28 Genital Tract SOP first issued in 1998

• Revised in 2002

• Re-issued in December 2003

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Process

Draft SOP SCBM WorkingGroup

Standards Unit

1st draft for comment

2nd draft for comment

SCBM WorkingGroup

Final version

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Need for a broad based approach to health protection

2002

19

HQ

Network of 46 PHLs in 8 Groups

CPHL

CDSCWhat network

of laboratories?

HPA

20

BSOP 28 Investigation of genital tract and associated specimens

21

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?

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Break-down of 47 labs surveyed

HPA6%

NHS60%

ex PHL34% ex PHL

HPA

NHS

23


The vast majority liked:

• introduction

• well referenced

• useful as benchmarks when labs merge

• force for improving quality

• benchmark for evaluation of new methodologies

24


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

25


26


27

Genital Tract SOPQuestions

GC – when and how

TV – when and how

Anaerobes – when and how

BV – when and how

Gp B Streps – when and how

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Blood agar

Sabouraud agar

GC selective agar

Trichomonas media

Target organisms

HVS

* *S. aureus

Lancefield Groups A, C and G streptococci

yeasts

Urethral swab/ Cervical swab * * *

S. aureus

Lancefield Groups A, C and G streptococci

yeasts

N. gonorrhoeae

Clinically suspected TV STD Pregnancy

* T. vaginalis

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'GC'35%

NYC47%

VCNT18%Media used

MSOP 5 recommends NYC: GC selective + amphotericin

(Nb VCNT + nystatin less effective)

Do you culture HVS or ECX swabs for GC?

30


HVS53%

HVS & ECX47%

Which specimen do you examine for Trichomonas vaginalis?

We recommend HVS, not ECX

31


microscopy/wet prep61%

culture15%microscopy with

acridine orange24%

How do you process the specimens for TV?

We recommend culture but recognise that microscopy/wet prep may be more practical

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Target organisms Media Clinical details

Anaerobes

Neo FAA agar with with MZ 5ug disc

Intra-uterine death

Septic abortion

Miscarriage

When do you look for anaerobes?

We recommend culture depending on clinical details

33


HVS21%

ECX4%

BOTH72%

NEITHER3%

Which specimens do you examine for anaerobes?

We recommend culture depending on clinical details

34


FAA+Neo54%

Blood agar22%

FAA8%

Others16%

Media used for isolating anaerobes

We recommend FAA+neomycin (MSOP 4)

35


02468

101214161820

Culture Wet prep AO Gram Nugent's

Do you look for Bacterial vaginosis?

24/47 said ‘Yes’

36


HVS17%

both83%

Do you culture and report Group B streptococci from HVS or ECX swabs?

We recommend Gp B Strep may be important from either specimen

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38


• A new SOP is being produced

• (SU in conjunction with RSIL and HPA Forum)

• Investigation of Screening swabs for Group B streptococci

• 1st draft SOP to be discussed at the next WG meeting

15 June

• Your comments will be invited

39

Your help is needed!

Access to HPA SOPs

Global access

Over 1000 passwords issued for the Extranet site

Password requests from 48 countries outside of the UK

41

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

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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

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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 WordPassword protected:

Drafts

SOPs for review



http://www.evaluations.standards.org.uk/

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