Upload
camille-bunyan
View
219
Download
2
Tags:
Embed Size (px)
Citation preview
National Serology Reference Laboratory, Australia
Assuring the Quality of
Samples for Proficiency Testing
or External Quality Assessment
Schemes
Assuring the Quality of
Samples for Proficiency Testing
or External Quality Assessment
Schemes
National Serology Reference Laboratory, Australia
AimAim
To explain how to ensure To explain how to ensure the quality of samples for the quality of samples for an External Quality an External Quality Assessment SchemeAssessment Scheme
To explain how to ensure To explain how to ensure the quality of samples for the quality of samples for an External Quality an External Quality Assessment SchemeAssessment Scheme
National Serology Reference Laboratory, Australia
Outline of PresentationOutline of Presentation
Issues involved in sample preparationIssues involved in sample preparation
Distributing panels to EQAS participants Distributing panels to EQAS participants in SEA/WPin SEA/WP
Issues involved in sample preparationIssues involved in sample preparation
Distributing panels to EQAS participants Distributing panels to EQAS participants in SEA/WPin SEA/WP
National Serology Reference Laboratory, Australia
1. Resources1. Resources•laboratory facilities, train stafflaboratory facilities, train staff•equipment, spaceequipment, space•materialmaterial
2. Material 2. Material (sample bank)(sample bank)
•collect samplescollect samples•characterise samplescharacterise samples•maintain databasemaintain database
3. Panel preparation3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank
•retest samples, prepare panelretest samples, prepare panel
4. Sample distribution4. Sample distribution•produce documentsproduce documents•coordinate shippingcoordinate shipping
•review sample statereview sample state
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
National Serology Reference Laboratory, Australia
Preparing quality EQAS samples
Preparing quality EQAS samples
Try and decide:Try and decide:
Who?Who?What?What?Where?Where?When?When?Why?Why?How?How?
Try and decide:Try and decide:
Who?Who?What?What?Where?Where?When?When?Why?Why?How?How?
National Serology Reference Laboratory, Australia
1. Resources1. Resources•laboratory facilities, train stafflaboratory facilities, train staff•equipment, spaceequipment, space•materialmaterial
2. Material 2. Material (sample bank)(sample bank)
•collect samplescollect samples•characterise samplescharacterise samples•maintain databasemaintain database
3. Panel preparation3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank
•retest samples, prepare panelretest samples, prepare panel
4. Sample distribution4. Sample distribution•produce documentsproduce documents•coordinate shippingcoordinate shipping
•review sample statereview sample state
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
National Serology Reference Laboratory, Australia
1. Resources required to coordinate an EQAS - Laboratory
1. Resources required to coordinate an EQAS - Laboratory
Samples need to be testedSamples need to be tested
Therefore provider should have access to a: Therefore provider should have access to a: laboratory with testing facilitieslaboratory with testing facilities
**provider may contract out laboratory servicesprovider may contract out laboratory services laboratory with technical competencelaboratory with technical competence
participate in other EQASparticipate in other EQAShold accreditationshold accreditations
Samples need to be testedSamples need to be tested
Therefore provider should have access to a: Therefore provider should have access to a: laboratory with testing facilitieslaboratory with testing facilities
**provider may contract out laboratory servicesprovider may contract out laboratory services laboratory with technical competencelaboratory with technical competence
participate in other EQASparticipate in other EQAShold accreditationshold accreditations
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
1. Resources required to coordinate an EQAS - Trained Staff
1. Resources required to coordinate an EQAS - Trained Staff
Provider should train staff in EQAS proceduresProvider should train staff in EQAS proceduressignificant amount of time is required to train staff significant amount of time is required to train staff
during EQAS developmentduring EQAS development
Staff need to:Staff need to:coordinate sample bank, perform testingcoordinate sample bank, perform testingprepare panels, coordinate shipmentsprepare panels, coordinate shipmentscommunicate with participantscommunicate with participantsbe prepared to educate participantsbe prepared to educate participants
Provider should train staff in EQAS proceduresProvider should train staff in EQAS proceduressignificant amount of time is required to train staff significant amount of time is required to train staff
during EQAS developmentduring EQAS development
Staff need to:Staff need to:coordinate sample bank, perform testingcoordinate sample bank, perform testingprepare panels, coordinate shipmentsprepare panels, coordinate shipmentscommunicate with participantscommunicate with participantsbe prepared to educate participantsbe prepared to educate participants
National Serology Reference Laboratory, Australia
1. Resources required to coordinate an EQAS - Equipment and Space
1. Resources required to coordinate an EQAS - Equipment and SpaceProvider should have access to: Provider should have access to: equipment required for testing of serology equipment required for testing of serology
samplessamples general items such as:general items such as:
fridge, freezers, bottlesfridge, freezers, bottlesvials, shipping boxesvials, shipping boxes
space space for packaging samples for distributionfor packaging samples for distributionfor general purpose storage for general purpose storage
Provider should have access to: Provider should have access to: equipment required for testing of serology equipment required for testing of serology
samplessamples general items such as:general items such as:
fridge, freezers, bottlesfridge, freezers, bottlesvials, shipping boxesvials, shipping boxes
space space for packaging samples for distributionfor packaging samples for distributionfor general purpose storage for general purpose storage
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
Providers must develop and maintain a Providers must develop and maintain a sample bank:sample bank:
Significant resources required during Significant resources required during developmentdevelopmentsource material source material characterise new samples characterise new samples develop data basedevelop data base
Continual resources to maintainContinual resources to maintain
Providers must develop and maintain a Providers must develop and maintain a sample bank:sample bank:
Significant resources required during Significant resources required during developmentdevelopmentsource material source material characterise new samples characterise new samples develop data basedevelop data base
Continual resources to maintainContinual resources to maintain
1. Resources required to coordinate an EQAS - Biological Material
1. Resources required to coordinate an EQAS - Biological Material
National Serology Reference Laboratory, Australia
1. Resources1. Resources•laboratory facilities, train stafflaboratory facilities, train staff•equipment, spaceequipment, space•materialmaterial
2. Material 2. Material (sample bank)(sample bank)
•collect samplescollect samples•characterise samplescharacterise samples•maintain databasemaintain database
3. Panel preparation3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank
•retest samples, prepare panelretest samples, prepare panel
4. Sample distribution4. Sample distribution•produce documentsproduce documents•coordinate shippingcoordinate shipping
•review sample statereview sample state
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
National Serology Reference Laboratory, Australia
2. Sample Bank2. Sample Bank
Collection of biological material (1)Collection of biological material (1)
large volumes large volumes best possible quality best possible quality plasma or serum?plasma or serum?
thrombinisation and recalcificationthrombinisation and recalcificationtechnically difficulttechnically difficultrisk of bacterial contaminationrisk of bacterial contamination
Collection of biological material (1)Collection of biological material (1)
large volumes large volumes best possible quality best possible quality plasma or serum?plasma or serum?
thrombinisation and recalcificationthrombinisation and recalcificationtechnically difficulttechnically difficultrisk of bacterial contaminationrisk of bacterial contamination
National Serology Reference Laboratory, Australia
2. Sample Bank2. Sample Bank
Collection of biological material (2)Collection of biological material (2)
Representative of the geographical areaRepresentative of the geographical area Unusual samplesUnusual samples
may be required to purchase may be required to purchase Collect from Collect from
collaborating laboratories collaborating laboratories participantsparticipantspurchasepurchase
Collection of biological material (2)Collection of biological material (2)
Representative of the geographical areaRepresentative of the geographical area Unusual samplesUnusual samples
may be required to purchase may be required to purchase Collect from Collect from
collaborating laboratories collaborating laboratories participantsparticipantspurchasepurchase
National Serology Reference Laboratory, Australia
2. Sample Bank2. Sample Bank
Processing and storage of materialProcessing and storage of material Allocate material with unique identifier Aliquot material into smaller volumes Aliquot material into smaller volumes Monitor freeze/thaw cyclesMonitor freeze/thaw cycles Use polypropylene tubes and bottlesUse polypropylene tubes and bottles Label all bottles/tubesLabel all bottles/tubes Store at -20Store at -20C or -40C or -40CC
Processing and storage of materialProcessing and storage of material Allocate material with unique identifier Aliquot material into smaller volumes Aliquot material into smaller volumes Monitor freeze/thaw cyclesMonitor freeze/thaw cycles Use polypropylene tubes and bottlesUse polypropylene tubes and bottles Label all bottles/tubesLabel all bottles/tubes Store at -20Store at -20C or -40C or -40CC
National Serology Reference Laboratory, Australia
2. Sample Bank2. Sample Bank
Characterisation of materialCharacterisation of material Test according to testing strategy Test according to testing strategy
determine disease statusdetermine disease status WHO recommend:WHO recommend:
two immunoassays (2nd with different Ags)two immunoassays (2nd with different Ags)one specific supplemental assay one specific supplemental assay Similar technology to assays used in region Similar technology to assays used in region
Characterisation of materialCharacterisation of material Test according to testing strategy Test according to testing strategy
determine disease statusdetermine disease status WHO recommend:WHO recommend:
two immunoassays (2nd with different Ags)two immunoassays (2nd with different Ags)one specific supplemental assay one specific supplemental assay Similar technology to assays used in region Similar technology to assays used in region
National Serology Reference Laboratory, Australia
2. Sample Bank2. Sample Bank
Store data on all material in sample bankStore data on all material in sample bank Store sample information in a Database For each sample store:
volume available and locationinformation provided with the materialcharacterisation results
assays used, S/Co ratio, disease status
other information, e.g. subtype/genotype
Store data on all material in sample bankStore data on all material in sample bank Store sample information in a Database For each sample store:
volume available and locationinformation provided with the materialcharacterisation results
assays used, S/Co ratio, disease status
other information, e.g. subtype/genotype
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
1. Resources1. Resources•laboratory facilities, train stafflaboratory facilities, train staff•equipment, spaceequipment, space•materialmaterial
2. Material 2. Material (sample bank)(sample bank)
•collect samplescollect samples•characterise samplescharacterise samples•maintain databasemaintain database
3. Panel preparation 3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank
•retest samples, prepare panelretest samples, prepare panel
4. Sample distribution4. Sample distribution•produce documentsproduce documents•coordinate shippingcoordinate shipping
•review sample statereview sample state
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Design each panel to ask a “question”
Specific questions that may be addressed:Specific questions that may be addressed: Do Laboratories:Do Laboratories:
identify the status of samples correctly?identify the status of samples correctly?produce consistent results? produce consistent results? follow their testing strategies?follow their testing strategies?follow the manufacturers protocol?follow the manufacturers protocol?check samples are correctly labelled?check samples are correctly labelled?
Design each panel to ask a “question”
Specific questions that may be addressed:Specific questions that may be addressed: Do Laboratories:Do Laboratories:
identify the status of samples correctly?identify the status of samples correctly?produce consistent results? produce consistent results? follow their testing strategies?follow their testing strategies?follow the manufacturers protocol?follow the manufacturers protocol?check samples are correctly labelled?check samples are correctly labelled?
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Selection of EQAS Panel samples (1) Review sample bank database Select 8-10 specimens
with a definite serostatusstrongly reactive, weakly reactive and
negativeselect different numbers of positive and
negative samples for each panel
Selection of EQAS Panel samples (1) Review sample bank database Select 8-10 specimens
with a definite serostatusstrongly reactive, weakly reactive and
negativeselect different numbers of positive and
negative samples for each panel
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Selection of EQAS Panel samples (2) Replicates Diluted and pooled samples
increases the available volumesuch samples are not representative of true
samples
Selection of EQAS Panel samples (2) Replicates Diluted and pooled samples
increases the available volumesuch samples are not representative of true
samples
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Preparation of EQAS Panel samples (1) Biocides
Not recommended but can use Bronidox L (0.05%) Heat Inactivation
60 minutes at 56ºC for HIVBetter to treat everything as infectious
Preparation of EQAS Panel samples (1) Biocides
Not recommended but can use Bronidox L (0.05%) Heat Inactivation
60 minutes at 56ºC for HIVBetter to treat everything as infectious
EQAS samples should be representative of routine diagnostic specimens
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Preparation of EQAS Panel samples (1) Lyophilisation
May be necessary if transport conditions indicateMay be necessary if transport conditions indicate
Requires expensive equipmentRequires expensive equipment
Preparation of EQAS Panel samples (1) Lyophilisation
May be necessary if transport conditions indicateMay be necessary if transport conditions indicate
Requires expensive equipmentRequires expensive equipment
EQAS samples should be representative of routine diagnostic specimens
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Preparation of EQAS Panel samples (2) Ensure traceabilityEnsure traceability
use checklists, record who did what and whenuse checklists, record who did what and when
Preparation of EQAS Panel samples (2) Ensure traceabilityEnsure traceability
use checklists, record who did what and whenuse checklists, record who did what and when
Remove material from sample bankthaw, if material was stored in >1 bottle - pool
centrifuge
re-test sample to ensure serostatus has not changedspecific confirmatory test e.g. Western blot
Remove material from sample bankthaw, if material was stored in >1 bottle - pool
centrifuge
re-test sample to ensure serostatus has not changedspecific confirmatory test e.g. Western blot
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel Preparation
Preparation of EQAS Panel samples (3) Tube integrity and labellingTube integrity and labelling
leak proof screw capped plastic tubesgood quality labels, electronically preparedsegregated tube labellingsegregated tube labelling
Preparation of EQAS Panel samples (3) Tube integrity and labellingTube integrity and labelling
leak proof screw capped plastic tubesgood quality labels, electronically preparedsegregated tube labellingsegregated tube labelling
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel PreparationPreparation of EQAS Panel samples (3)
Aliquot materialAliquot materialsegregated aliquottingsegregated aliquotting
only one sample in hood at one timeonly one sample in hood at one time
store panel at 4º, dispatch as soon as possiblestore panel at 4º, dispatch as soon as possible
Preparation of EQAS Panel samples (3)
Aliquot materialAliquot materialsegregated aliquottingsegregated aliquotting
only one sample in hood at one timeonly one sample in hood at one time
store panel at 4º, dispatch as soon as possiblestore panel at 4º, dispatch as soon as possible
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel PreparationSample Validation: Homogeneity TestingSample Validation: Homogeneity Testing Panel samples should be tested to Panel samples should be tested to
ensure that they are homogenous.ensure that they are homogenous.
Sample Validation: Homogeneity TestingSample Validation: Homogeneity Testing Panel samples should be tested to Panel samples should be tested to
ensure that they are homogenous.ensure that they are homogenous.
Homogenous (evenly distributed) Non-Homogenous
National Serology Reference Laboratory, Australia
3. Panel Preparation3. Panel PreparationSample Validation: Stability TestingSample Validation: Stability Testing Panel samples should be tested to ensure that their Panel samples should be tested to ensure that their
reactivity is stable over timereactivity is stable over time
Sample Validation: Stability TestingSample Validation: Stability Testing Panel samples should be tested to ensure that their Panel samples should be tested to ensure that their
reactivity is stable over timereactivity is stable over time
Unstable
National Serology Reference Laboratory, Australia
1. Resources1. Resources•laboratory facilities, train stafflaboratory facilities, train staff•equipment, spaceequipment, space•materialmaterial
2. Material 2. Material (sample bank)(sample bank)
•collect samplescollect samples•characterise samplescharacterise samples•maintain databasemaintain database
3. Panel preparation3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank
•retest samples, prepare panelretest samples, prepare panel
4. Sample distribution4. Sample distribution•produce documentsproduce documents•coordinate shippingcoordinate shipping
•review sample statereview sample state
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
Ensuring the quality of EQAS samples:Ensuring the quality of EQAS samples:
Issues to be consideredIssues to be considered
National Serology Reference Laboratory, Australia
4. Sample Distribution 4. Sample Distribution Documentation to be included with the panel Documentation to be included with the panel
i) Covering letteri) Covering letter identifies the sample details identifies the sample details gives instructions for testinggives instructions for testingdesignated the due date for return of resultsdesignated the due date for return of results
ii) Result formsii) Result forms
iii) Ask laboratories to confirm: iii) Ask laboratories to confirm: that samples were received that samples were received confirm contact and shipping address detailsconfirm contact and shipping address details
Documentation to be included with the panel Documentation to be included with the panel
i) Covering letteri) Covering letter identifies the sample details identifies the sample details gives instructions for testinggives instructions for testingdesignated the due date for return of resultsdesignated the due date for return of results
ii) Result formsii) Result forms
iii) Ask laboratories to confirm: iii) Ask laboratories to confirm: that samples were received that samples were received confirm contact and shipping address detailsconfirm contact and shipping address details
National Serology Reference Laboratory, Australia
4. Sample Distribution4. Sample Distribution
Co-ordinate panel distributionCo-ordinate panel distribution Panels should be distributed in accordance Panels should be distributed in accordance
with IATA regulations for other regulation with IATA regulations for other regulation for shipping dangerous goodsfor shipping dangerous goods
Ensure all documents are suppliedEnsure all documents are supplied
Co-ordinate panel distributionCo-ordinate panel distribution Panels should be distributed in accordance Panels should be distributed in accordance
with IATA regulations for other regulation with IATA regulations for other regulation for shipping dangerous goodsfor shipping dangerous goods
Ensure all documents are suppliedEnsure all documents are supplied
Shipping of samples to the South East Asian and Western Pacific Regions: Anti-HIV, anti-HCV and HBsAg.
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
The NRL experienceThe NRL experience
Problems encounteredProblems encountered Complex contact detailsComplex contact details Complex paperworkComplex paperwork Complex communicationsComplex communications
Problems encounteredProblems encountered Complex contact detailsComplex contact details Complex paperworkComplex paperwork Complex communicationsComplex communications
National Serology Reference Laboratory, Australia
The NRL experienceThe NRL experience
Problems encounteredProblems encountered Results are often not returned by some Results are often not returned by some
participantsparticipants Obtaining accurate information from Obtaining accurate information from
participants is often difficult and time participants is often difficult and time consumingconsuming
Problems encounteredProblems encountered Results are often not returned by some Results are often not returned by some
participantsparticipants Obtaining accurate information from Obtaining accurate information from
participants is often difficult and time participants is often difficult and time consumingconsuming
National Serology Reference Laboratory, Australia
National Serology Reference Laboratory, Australia
The NRL experienceThe NRL experience
Tips for minimizing shipping costsTips for minimizing shipping costs Cost savings:Cost savings:
good courier companygood courier companycollaborators picking up samples from the airportcollaborators picking up samples from the airportcollaborators redistributing samples within one collaborators redistributing samples within one
countrycountry
Tips for minimizing shipping costsTips for minimizing shipping costs Cost savings:Cost savings:
good courier companygood courier companycollaborators picking up samples from the airportcollaborators picking up samples from the airportcollaborators redistributing samples within one collaborators redistributing samples within one
countrycountry
National Serology Reference Laboratory, Australia
SummarySummary
Good quality samples are required for Good quality samples are required for participants to have confidence in the participants to have confidence in the EQAS.EQAS.
Best quality samples are planned for at Best quality samples are planned for at each step of the EQAS.each step of the EQAS.
Resources are required to achieve the Resources are required to achieve the best possible quality samplesbest possible quality samples
Good quality samples are required for Good quality samples are required for participants to have confidence in the participants to have confidence in the EQAS.EQAS.
Best quality samples are planned for at Best quality samples are planned for at each step of the EQAS.each step of the EQAS.
Resources are required to achieve the Resources are required to achieve the best possible quality samplesbest possible quality samples
National Serology Reference Laboratory, Australia