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National Serology Reference Laboratory, Australia Assuring the Quality of Samples for Proficiency Testing or External Quality Assessment Schemes.

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Presentation on theme: "National Serology Reference Laboratory, Australia Assuring the Quality of Samples for Proficiency Testing or External Quality Assessment Schemes."— Presentation transcript:

1 National Serology Reference Laboratory, Australia Assuring the Quality of Samples for Proficiency Testing or External Quality Assessment Schemes

2 National Serology Reference Laboratory, Australia Aim l To explain how to ensure the quality of samples for an External Quality Assessment Scheme

3 National Serology Reference Laboratory, Australia Outline of Presentation l Issues involved in sample preparation l Distributing panels to EQAS participants in SEA/WP l Issues involved in sample preparation l Distributing panels to EQAS participants in SEA/WP

4 National Serology Reference Laboratory, Australia 1. Resources laboratory facilities, train stafflaboratory facilities, train staff equipment, spaceequipment, space materialmaterial 2. Material (sample bank) collect samplescollect samples characterise samplescharacterise samples maintain databasemaintain database 3. Panel preparation pose a questionpose a question select samples from the Bankselect samples from the Bank retest samples, prepare panelretest samples, prepare panel 4. Sample distribution produce documentsproduce documents coordinate shippingcoordinate shipping review sample statereview sample state Ensuring the quality of EQAS samples: Issues to be considered Ensuring the quality of EQAS samples: Issues to be considered

5 National Serology Reference Laboratory, Australia Preparing quality EQAS samples l Try and decide: Who? Who? What? What? Where? Where? When? When? Why? Why? How? How? l Try and decide: Who? Who? What? What? Where? Where? When? When? Why? Why? How? How?

6 National Serology Reference Laboratory, Australia 1. Resources laboratory facilities, train stafflaboratory facilities, train staff equipment, spaceequipment, space materialmaterial 2. Material (sample bank) collect samplescollect samples characterise samplescharacterise samples maintain databasemaintain database 3. Panel preparation pose a questionpose a question select samples from the Bankselect samples from the Bank retest samples, prepare panelretest samples, prepare panel 4. Sample distribution produce documentsproduce documents coordinate shippingcoordinate shipping review sample statereview sample state Ensuring the quality of EQAS samples: Issues to be considered Ensuring the quality of EQAS samples: Issues to be considered

7 National Serology Reference Laboratory, Australia 1. Resources required to coordinate an EQAS - Laboratory Samples need to be tested Therefore provider should have access to a: laboratory with testing facilities laboratory with testing facilities * provider may contract out laboratory services laboratory with technical competence laboratory with technical competence participate in other EQAS participate in other EQAS hold accreditations hold accreditations Samples need to be tested Therefore provider should have access to a: laboratory with testing facilities laboratory with testing facilities * provider may contract out laboratory services laboratory with technical competence laboratory with technical competence participate in other EQAS participate in other EQAS hold accreditations hold accreditations

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11 1. Resources required to coordinate an EQAS - Trained Staff l Provider should train staff in EQAS procedures significant amount of time is required to train staff during EQAS development significant amount of time is required to train staff during EQAS development l Staff need to: coordinate sample bank, perform testing coordinate sample bank, perform testing prepare panels, coordinate shipments prepare panels, coordinate shipments communicate with participants communicate with participants be prepared to educate participants be prepared to educate participants l Provider should train staff in EQAS procedures significant amount of time is required to train staff during EQAS development significant amount of time is required to train staff during EQAS development l Staff need to: coordinate sample bank, perform testing coordinate sample bank, perform testing prepare panels, coordinate shipments prepare panels, coordinate shipments communicate with participants communicate with participants be prepared to educate participants be prepared to educate participants

12 National Serology Reference Laboratory, Australia 1. Resources required to coordinate an EQAS - Equipment and Space Provider should have access to: l equipment required for testing of serology samples l general items such as: fridge, freezers, bottles fridge, freezers, bottles vials, shipping boxes vials, shipping boxes l space for packaging samples for distribution for packaging samples for distribution for general purpose storage for general purpose storage Provider should have access to: l equipment required for testing of serology samples l general items such as: fridge, freezers, bottles fridge, freezers, bottles vials, shipping boxes vials, shipping boxes l space for packaging samples for distribution for packaging samples for distribution for general purpose storage for general purpose storage

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14 Providers must develop and maintain a sample bank: l Significant resources required during development source material source material characterise new samples characterise new samples develop data base develop data base l Continual resources to maintain Providers must develop and maintain a sample bank: l Significant resources required during development source material source material characterise new samples characterise new samples develop data base develop data base l Continual resources to maintain 1. Resources required to coordinate an EQAS - Biological Material

15 National Serology Reference Laboratory, Australia 1. Resources laboratory facilities, train stafflaboratory facilities, train staff equipment, spaceequipment, space materialmaterial 2. Material (sample bank) collect samplescollect samples characterise samplescharacterise samples maintain databasemaintain database 3. Panel preparation pose a questionpose a question select samples from the Bankselect samples from the Bank retest samples, prepare panelretest samples, prepare panel 4. Sample distribution produce documentsproduce documents coordinate shippingcoordinate shipping review sample statereview sample state Ensuring the quality of EQAS samples: Issues to be considered Ensuring the quality of EQAS samples: Issues to be considered

16 National Serology Reference Laboratory, Australia 2. Sample Bank Collection of biological material (1) l large volumes l best possible quality l plasma or serum? thrombinisation and recalcification thrombinisation and recalcification technically difficult technically difficult risk of bacterial contamination risk of bacterial contamination Collection of biological material (1) l large volumes l best possible quality l plasma or serum? thrombinisation and recalcification thrombinisation and recalcification technically difficult technically difficult risk of bacterial contamination risk of bacterial contamination

17 National Serology Reference Laboratory, Australia 2. Sample Bank Collection of biological material (2) l Representative of the geographical area l Unusual samples may be required to purchase may be required to purchase l Collect from collaborating laboratories collaborating laboratories participants participants purchase purchase Collection of biological material (2) l Representative of the geographical area l Unusual samples may be required to purchase may be required to purchase l Collect from collaborating laboratories collaborating laboratories participants participants purchase purchase

18 National Serology Reference Laboratory, Australia 2. Sample Bank Processing and storage of material l l Allocate material with unique identifier l Aliquot material into smaller volumes l Monitor freeze/thaw cycles l Use polypropylene tubes and bottles l Label all bottles/tubes l Store at -20 C or -40 C Processing and storage of material l l Allocate material with unique identifier l Aliquot material into smaller volumes l Monitor freeze/thaw cycles l Use polypropylene tubes and bottles l Label all bottles/tubes l Store at -20 C or -40 C

19 National Serology Reference Laboratory, Australia 2. Sample Bank Characterisation of material l Test according to testing strategy determine disease status determine disease status l 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 material l Test according to testing strategy determine disease status determine disease status l 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

20 National Serology Reference Laboratory, Australia 2. Sample Bank Store data on all material in sample bank l l Store sample information in a Database l l For each sample store: volume available and location information provided with the material characterisation results assays used, S/Co ratio, disease status other information, e.g. subtype/genotype Store data on all material in sample bank l l Store sample information in a Database l l For each sample store: volume available and location information provided with the material characterisation results assays used, S/Co ratio, disease status other information, e.g. subtype/genotype

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22 1. Resources laboratory facilities, train stafflaboratory facilities, train staff equipment, spaceequipment, space materialmaterial 2. Material (sample bank) collect samplescollect samples characterise samplescharacterise samples maintain databasemaintain database 3. Panel preparation pose a questionpose a question select samples from the Bankselect samples from the Bank retest samples, prepare panelretest samples, prepare panel 4. Sample distribution produce documentsproduce documents coordinate shippingcoordinate shipping review sample statereview sample state Ensuring the quality of EQAS samples: Issues to be considered Ensuring the quality of EQAS samples: Issues to be considered

23 National Serology Reference Laboratory, Australia 3. Panel Preparation Design each panel to ask a question Specific questions that may be addressed: l 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: l 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?

24 National Serology Reference Laboratory, Australia 3. Panel Preparation Selection of EQAS Panel samples (1) l l Review sample bank database l l Select 8-10 specimens with a definite serostatus strongly reactive, weakly reactive and negative select different numbers of positive and negative samples for each panel Selection of EQAS Panel samples (1) l l Review sample bank database l l Select 8-10 specimens with a definite serostatus strongly reactive, weakly reactive and negative select different numbers of positive and negative samples for each panel

25 National Serology Reference Laboratory, Australia 3. Panel Preparation Selection of EQAS Panel samples (2) l l Replicates l l Diluted and pooled samples increases the available volume such samples are not representative of true samples Selection of EQAS Panel samples (2) l l Replicates l l Diluted and pooled samples increases the available volume such samples are not representative of true samples

26 National Serology Reference Laboratory, Australia 3. Panel Preparation Preparation of EQAS Panel samples (1) l l Biocides Not recommended but can use Bronidox L (0.05%) l l Heat Inactivation 60 minutes at 56ºC for HIV Better to treat everything as infectious Preparation of EQAS Panel samples (1) l l Biocides Not recommended but can use Bronidox L (0.05%) l l Heat Inactivation 60 minutes at 56ºC for HIV Better to treat everything as infectious EQAS samples should be representative of routine diagnostic specimens

27 National Serology Reference Laboratory, Australia 3. Panel Preparation Preparation of EQAS Panel samples (1) l l Lyophilisation May be necessary if transport conditions indicate May be necessary if transport conditions indicate Requires expensive equipment Requires expensive equipment Preparation of EQAS Panel samples (1) l l Lyophilisation May be necessary if transport conditions indicate May be necessary if transport conditions indicate Requires expensive equipment Requires expensive equipment EQAS samples should be representative of routine diagnostic specimens

28 National Serology Reference Laboratory, Australia 3. Panel Preparation Preparation of EQAS Panel samples (2) l Ensure traceability use checklists, record who did what and when use checklists, record who did what and when Preparation of EQAS Panel samples (2) l Ensure traceability use checklists, record who did what and when use checklists, record who did what and when l Remove material from sample bank thaw, if material was stored in >1 bottle - pool centrifuge re-test sample to ensure serostatus has not changed specific confirmatory test e.g. Western blot l Remove material from sample bank thaw, if material was stored in >1 bottle - pool centrifuge re-test sample to ensure serostatus has not changed specific confirmatory test e.g. Western blot

29 National Serology Reference Laboratory, Australia 3. Panel Preparation Preparation of EQAS Panel samples (3) l Tube integrity and labelling leak proof screw capped plastic tubes good quality labels, electronically prepared segregated tube labelling segregated tube labelling Preparation of EQAS Panel samples (3) l Tube integrity and labelling leak proof screw capped plastic tubes good quality labels, electronically prepared segregated tube labelling segregated tube labelling

30 National Serology Reference Laboratory, Australia 3. Panel Preparation Preparation of EQAS Panel samples (3) l Aliquot material segregated aliquotting segregated aliquotting only one sample in hood at one time only one sample in hood at one time store panel at 4º, dispatch as soon as possible store panel at 4º, dispatch as soon as possible Preparation of EQAS Panel samples (3) l Aliquot material segregated aliquotting segregated aliquotting only one sample in hood at one time only one sample in hood at one time store panel at 4º, dispatch as soon as possible store panel at 4º, dispatch as soon as possible

31 National Serology Reference Laboratory, Australia 3. Panel Preparation Sample Validation: Homogeneity Testing l Panel samples should be tested to ensure that they are homogenous. Sample Validation: Homogeneity Testing l Panel samples should be tested to ensure that they are homogenous. Homogenous (evenly distributed) Non-Homogenous

32 National Serology Reference Laboratory, Australia 3. Panel Preparation Sample Validation: Stability Testing l Panel samples should be tested to ensure that their reactivity is stable over time Sample Validation: Stability Testing l Panel samples should be tested to ensure that their reactivity is stable over time Unstable

33 National Serology Reference Laboratory, Australia 1. Resources laboratory facilities, train stafflaboratory facilities, train staff equipment, spaceequipment, space materialmaterial 2. Material (sample bank) collect samplescollect samples characterise samplescharacterise samples maintain databasemaintain database 3. Panel preparation pose a questionpose a question select samples from the Bankselect samples from the Bank retest samples, prepare panelretest samples, prepare panel 4. Sample distribution produce documentsproduce documents coordinate shippingcoordinate shipping review sample statereview sample state Ensuring the quality of EQAS samples: Issues to be considered Ensuring the quality of EQAS samples: Issues to be considered

34 National Serology Reference Laboratory, Australia 4. Sample Distribution l Documentation to be included with the panel i) Covering letter identifies the sample details identifies the sample details gives instructions for testing gives instructions for testing designated the due date for return of results designated the due date for return of results ii) Result forms iii) Ask laboratories to confirm: that samples were received that samples were received confirm contact and shipping address details confirm contact and shipping address details l Documentation to be included with the panel i) Covering letter identifies the sample details identifies the sample details gives instructions for testing gives instructions for testing designated the due date for return of results designated the due date for return of results ii) Result forms iii) Ask laboratories to confirm: that samples were received that samples were received confirm contact and shipping address details confirm contact and shipping address details

35 National Serology Reference Laboratory, Australia 4. Sample Distribution Co-ordinate panel distribution l Panels should be distributed in accordance with IATA regulations for other regulation for shipping dangerous goods l Ensure all documents are supplied Co-ordinate panel distribution l Panels should be distributed in accordance with IATA regulations for other regulation for shipping dangerous goods l Ensure all documents are supplied

36 Shipping of samples to the South East Asian and Western Pacific Regions: Anti-HIV, anti-HCV and HBsAg. National Serology Reference Laboratory, Australia

37 The NRL experience Problems encountered l Complex contact details l Complex paperwork l Complex communications Problems encountered l Complex contact details l Complex paperwork l Complex communications

38 National Serology Reference Laboratory, Australia The NRL experience Problems encountered l Results are often not returned by some participants l Obtaining accurate information from participants is often difficult and time consuming Problems encountered l Results are often not returned by some participants l Obtaining accurate information from participants is often difficult and time consuming

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40 The NRL experience Tips for minimizing shipping costs l Cost savings: good courier company good courier company collaborators picking up samples from the airport collaborators picking up samples from the airport collaborators redistributing samples within one country collaborators redistributing samples within one country Tips for minimizing shipping costs l Cost savings: good courier company good courier company collaborators picking up samples from the airport collaborators picking up samples from the airport collaborators redistributing samples within one country collaborators redistributing samples within one country

41 National Serology Reference Laboratory, Australia Summary l Good quality samples are required for participants to have confidence in the EQAS. l Best quality samples are planned for at each step of the EQAS. l Resources are required to achieve the best possible quality samples l Good quality samples are required for participants to have confidence in the EQAS. l Best quality samples are planned for at each step of the EQAS. l Resources are required to achieve the best possible quality samples

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