National Serology Reference Laboratory, Australia Assuring the Quality of Samples for Proficiency...

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


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


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


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




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?


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


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


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


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


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


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




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


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



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



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



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





3. Panel preparation 3. Panel preparation •pose a ‘question’pose a ‘question’•select samples from the Bankselect samples from the Bank









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?



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



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



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



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



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



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


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


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


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


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


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.



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



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



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


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 Assuring the Quality of Samples for Proficiency...

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