Date post: | 15-Dec-2015 |
Category: |
Documents |
Upload: | kieran-largent |
View: | 220 times |
Download: | 0 times |
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
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
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
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
Quality Control Reagents Unit
AxSym (Abbott Diagnostics) PRISM(Abbott Diagnostics)
Vitros (Ortho Clinical Diagnostics)
VIDAS (bioMerieux)
ACCESS (Beckman Coulter)
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
13
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
16
Process
Draft SOP SCBM WorkingGroup
Standards Unit
1st draft for comment
2nd draft for comment
SCBM WorkingGroup
Final version
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?
22
BSOP 28 Investigation of genital tract and associated specimens
Break-down of 47 labs surveyed
HPA6%
NHS60%
ex PHL34% ex PHL
HPA
NHS
23
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
24
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
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
28
BSOP 28 Investigation of genital tract and associated specimens
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
29
BSOP 28 Investigation of genital tract and associated specimens
'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
BSOP 28 Investigation of genital tract and associated specimens
HVS53%
HVS & ECX47%
Which specimen do you examine for Trichomonas vaginalis?
We recommend HVS, not ECX
31
BSOP 28 Investigation of genital tract and associated specimens
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
32
BSOP 28 Investigation of genital tract and associated specimens
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
BSOP 28 Investigation of genital tract and associated specimens
HVS21%
ECX4%
BOTH72%
NEITHER3%
Which specimens do you examine for anaerobes?
We recommend culture depending on clinical details
34
BSOP 28 Investigation of genital tract and associated specimens
FAA+Neo54%
Blood agar22%
FAA8%
Others16%
Media used for isolating anaerobes
We recommend FAA+neomycin (MSOP 4)
35
BSOP 28 Investigation of genital tract and associated specimens
02468
101214161820
Culture Wet prep AO Gram Nugent's
Do you look for Bacterial vaginosis?
24/47 said ‘Yes’
36
BSOP 28 Investigation of genital tract and associated specimens
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
38
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
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
42
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
43
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
www.HPA.org.uk
www.evaluations.standards.org.uk
Microsoft WordPassword protected:
Drafts
SOPs for review