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
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?
2
The New Health Protection Agency
Board
Chief
Executive
Communicable
Diseases
Surveillance
Centre
Specialist &
Reference
Microbiology
Division
Radiation
Protection
Chemical
Hazards
and
Poisons
Local and
Regional
Services
Emergency
Response
Commercial
Division
SRMD Organisational Structure
Evaluations and Standards
Laboratory
Laboratory
Director
Office Manager
A&C 5
Deputy Director &
Head of Quality System Unit
Head of Standards Unit/
Accreditation Officer
BMS 3+3
Head of Evaluations
Unit
CS B19
CS C
SOP
Administrator
A&C 5
Information
Officer
A&C 5
Standards
Microbiologist
BMS 3
SOP/
Quality Systems
Administrator
A&C 5
Standards
Microbiologist
BMS 3
Evaluations
Microbiologist
MTO 3 (MHRA)
Evaluations
Microbiologist
MTO 3 (NBS)
Evaluations
Laboratory
Assistant
(MHRA)
Evaluation and Standards Laboratory - October 03
Evaluations
Microbiologist
MTO 3 (MHRA)
Evaluations
Administrator
A&C 6 (MHRA)
Head of Quality
Control
Reagents Unit
MTO 5
Quality Control
Supervisor
MTO 3
Quality Control
Microbiologist
MTO 2
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 *
Vironostika
HIV Uni-form II Ag/Ab
Murex HIV Ag/Ab
Combination
0
Biotest
HIV 1/2
recombinant
Ortho
Ab-capt.
ELISA
Access HIV 1/2 NEW
10
5
VIDAS
HIV DUO
Enzygnost
HIV
Integral
Pasteur
Genscreen
Version 2
15
Murex ICE
HIV 1+2
Murex
HIV 1.2.0
GE94/95
IMx
HIV1/2
III plus
Innotest
HIV-1/-2
Enzygnost
HIV 1/2
plus
Biotest
Anti-HIV
Biotest AntiTETRA
HIV TETRA
ELISA ELISA
GENSCREEN
PLUS HIV Ag-Ab
Earliest HIV detection
Murex
HIV 1/2
VK84/85
Vitros ECi
anti-HIV 1/2
Abbott
3rd gen
Plus
Clonesystems
Detect-HIV v1
Vironostika
HIV Uniform II
Wellcozyme
plus
O
Anti-HIV
AxSYM HIV 1/2 gO
= combined antigen-antibody
* based on 38 seroconversion panels
= immunometric
= Class specific antibody capture
= antiglobulin / indirect
20
days
Quality Control Reagents Unit
Vitros
(Ortho Clinical Diagnostics)
AxSym (Abbott Diagnostics)
PRISM(Abbott Diagnostics)
ACCESS (Beckman Coulter)
VIDAS (bioMerieux)
Joe Vincini – Quality Control Reagents Unit
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
30
25
20
15
10
5
0
1998
1999
2000
2001
2002
Close liaison with MHRA, companies and users
2003
2004
June
13
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 (1st)
• BSOP 28 Genital Tract SOP first issued in 1998
• Revised in 2002
• Re-issued in December 2003
15
Process
Draft SOP
SCBM Working
Group
SCBM Working
Group
1st draft for
comment
Standards Unit
Final version
2nd draft for
comment
16
2002
Need for a broad based approach
to health protection
18
HQ
CPHL
CDSC
What
network
Network
of 46of
laboratories?
PHLs in 8 Groups
HPA
19
BSOP 28 Investigation of genital
tract and associated specimens
20
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?
21
BSOP 28 Investigation of genital
tract and associated specimens
Break-down of 47 labs surveyed
ex PHL
34%
ex PHL
HPA
NHS
NHS
60%
HPA
6%
22
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
23
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
24
BSOP 28 Investigation of genital
tract and associated specimens
25
BSOP 28 Investigation of genital
tract and associated specimens
26
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
27
BSOP 28 Investigation of genital
tract and associated specimens
Blood
agar
HVS
Sabouraud
agar
GC
selective
agar
Trichomonas
media
Target
organisms
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
28
BSOP 28 Investigation of genital
tract and associated specimens
Do you culture HVS or ECX swabs for GC?
Media used
VCNT
18%
NYC
47%
'GC'
35%
MSOP 5 recommends NYC: GC selective + amphotericin
(Nb VCNT + nystatin less effective)
29
BSOP 28 Investigation of genital
tract and associated specimens
Which specimen do you examine for
Trichomonas vaginalis?
HVS &
ECX
47%
We recommend HVS, not ECX
HVS
53%
30
BSOP 28 Investigation of genital
tract and associated specimens
How do you process the specimens for TV?
culture
15%
microscopy with
acridine orange
24%
microscopy/wet
prep
61%
We recommend culture but recognise that
microscopy/wet prep may be more practical
31
BSOP 28 Investigation of genital
tract and associated specimens
When do you look for anaerobes?
Target organisms
Anaerobes
Media
Neo FAA agar with
with MZ 5ug disc
Clinical details
Intra-uterine death
Septic abortion
Miscarriage
We recommend culture depending on clinical details
32
BSOP 28 Investigation of genital
tract and associated specimens
Which specimens do you examine for anaerobes?
NEITHER
3%
HVS
21%
ECX
4%
BOTH
72%
We recommend culture depending on clinical details
33
BSOP 28 Investigation of genital
tract and associated specimens
Media used for isolating anaerobes
Others
16%
FAA
8%
FAA+Neo
54%
Blood agar
22%
We recommend FAA+neomycin (MSOP 4)
34
BSOP 28 Investigation of
genital tract and associated
specimens
Do you look for Bacterial vaginosis?
20
18
16
14
12
10
8
6
4
2
0
Culture
24/47 said ‘Yes’
Wet prep
AO
Gram
Nugent's
35
BSOP 28 Investigation of genital
tract and associated specimens
Do you culture and
report Group B
streptococci from HVS
or ECX swabs?
HVS
17%
both
83%
36
We recommend Gp B Strep may be important from either specimen
BSOP 28 Investigation of genital
tract and associated specimens
37
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
• 1st draft SOP to be discussed at the next WG meeting
15 June
• Your comments will be invited
38
Your help is
needed!
39
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
41
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
42
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.evaluationsstandards.org.uk
43
Website for SOPs
PDF
www.HPA.org.uk
www.evaluations.standards.org.uk
Microsoft Word
Password protected:
Drafts
SOPs for review