ࡱ> =?:;<u'` UbjbjLULU 8.?.?/E""""rrrtPPP8QR|T ,$S(LSUUUWNLXhXMD$<hrr \WW^ \ \""UUʈfff \"8UrUMf \MffZr)US P)_ "L0/azD))r=xX YhfrYTYGxXxXxXSdxXxXxX \ \ \ \T T '>T T >4""""""" Program Information for Participants Introduction The Australian National Quality Assurance Program (ANQAP) is coordinated at the Victorian Department of Primary Industries on behalf of the Sub-Committee of Animal Health Laboratory Standards (SCAHLS). The major focus of the program is proficiency testing of assays used in quarantine, export certification and national disease control programs. Sample panels are forwarded to laboratories as per the Annual Test Timetable. ANQAP aims to provide a high quality service: Test samples are selected to be homogeneous and stable, to minimise result variability within and between laboratories. ANQAP uses its subcontractors to test all samples for homogeneity and quality. All contractors chosen are NATA accredited or equivalent. Test samples will be, as far as is technically possible, matrix samples of a similar type to those routinely analysed by most participating laboratories. The levels of target analytes in the samples distributed are selected to represent levels that would be measured by most participating laboratories. The results from all laboratories are collated and evaluated, and reports prepared. Statistical analysis of the results will be undertaken where practicable. Confidentiality To protect the identity of participating laboratories, each laboratory will be allocated a confidential code number. The identity and codes of all participating laboratories will be known only to ANQAP staff. Laboratories are advised in writing of their confidential code number at the beginning of the years program. This laboratory identification is changed annually. Tests included in the program refer to the Annual Test Timetable All participants will be notified in writing if ANQAP needs to alter the timetable. Enrolment Registration Enrolment paperwork is forwarded to interested laboratories before each new cycle. It is also available on the ANQAP website.  HYPERLINK "http://www.anqap.com" www.anqap.com ate enrolments can be accepted however a laboratory may be too late to be included in some of the scheduled tests. Invoices are payable within 30 days from the date of invoice. Sample dispatch and/or reports may be delayed where payment is outstanding. Cancellation of participation If a laboratory wishes to cancel participation in the program, a partial refund may be possible. Notification of cancellation of participation must be in writing. If the laboratory wishes to cancel participation after the samples are dispatched, no refund will be granted. ANQAP will seek feedback from a laboratory that withdraws from the program. Scheduled Testing Sample dispatch Refer to the Annual Test Timetable for current year. Laboratories will be advised via email prior to ANQAP dispatching samples. They are asked to notify ANQAP if they have not received the samples within a certain time frame. For each test ANQAP will provide samples. Each sample will be clearly labelled with the test name, sample number and the nature of the sample where required. The sample panels are accompanied by a specimen advice form. Samples are forwarded at ambient air temperature. This method of transport and the mode of packaging has been validated by ANQAP and will not harm freeze dried samples. However, ANQAP suggests samples are stored at 20oC until required for testing. Instructions for storage requirements for the Aquatic samples are provided on the Specimen Advice Form. Testing Laboratories should test each sample in triplicate within the same test run and a single operator. Where triplicate testing requires a greater volume of sample than the 0.5mL provided by ANQAP the laboratory is asked to test in duplicate. Extraction for PCR tests should be done once for each sample with the extracted sample tested in triplicate within the same test run. Tests that require titration of samples must be taken out to read the endpoint for any positive samples identified. This is necessary for ANQAP to compare results, determine a consensus median and provide an accurate classification for each laboratory. Laboratories should treat the ANQAP samples as routine diagnostic specimens. They should be tested in-house and not sub-contracted to another laboratory. Results should be treated in confidence by participant laboratories. Reporting results The current version of the Result Reporting Form (QF 15 for Veterinary and QF 16 for Aquatic testing) must be used. Results can be reported electronically and emailed to ANQAP or the form may be photocopied, filled in by hand and faxed to ANQAP. Results should be reported: on time - late results will not be accepted unless ANQAP has been contacted before the due date with a reasonable explanation for the delay in a legible hand or typed to avoid transcription errors including details of the method used, the assay operator, the laboratory name, cut-off limits, raw and calculated results including means of replicate results where appropriate and interpretation of results (positive / negative). Any sample or test problems should also be described. Results should be reported as they would be for routine diagnostic samples. Where participants may not use a standard method to perform a test, they may not be included in statistical analysis. This is due to the discretion of the ANQAP coordinator and where the participant is not included; they will be notified when sent the final report. Results not submitted in a reasonable time will be classified as U, unable to submit results. When an unsatisfactory result is reported to a participant laboratory, the cause should be investigated and corrective action taken where appropriate. Retests ANQAP will calculate the result for each sample and an acceptable variation range. Laboratories reporting results outside the acceptable variation range (AVR) will be required to retest. For tests that are classified on interpretation only, laboratories will be asked to retest if their reported interpretation differs from the consensus. A retest report and notification of dispatch of retest samples and an expected report date will be forwarded. Retest results should be reported to ANQAP on the Result Reporting Form (QF15 and or QF 16). ANQAP reports ANQAP will aim to issue a report to each participating laboratory within three weeks of the results due deadline. Separate reports will be prepared for each test and will indicate whether the testing was satisfactory or unsatisfactory. Interim reports, if requested from the participant can be issued but no other results will be disclosed with that report until all participant results are received. The report also includes a summary table of results from all participating laboratories and where appropriate will also include test statistics (generally CFT, VNT and HI tests with sufficient participant numbers): split-level analysis will be done on two samples. ANQAP makes every effort to avoid transcription errors however participants are requested to check that their results are entered correctly. Should any errors be identified laboratories are asked to inform ANQAP as soon as possible. An amended report will be forwarded to the affected laboratory as soon as possible. Participants are encouraged to contact ANQAP to discuss reports if further clarification is required or if they disagree with the report in any way. On submission of all results a median value will be calculated for each sample. For many of the tests monitored, an acceptable variation range (AVR) will be calculated from the median and results should fall within this range. This forms the basis on which laboratories are classified for each test. Tests reported as positive or negative will not have an acceptable variation range and results will be assessed on correct interpretation. Results will be classified as: ( Initial results submitted by this laboratory are satisfactory as they fall within the acceptable variation range from the median. R Initial results submitted by this laboratory are outside the acceptable variation range from the median and retesting is required. U Initial results were not submitted by this laboratory. Retest results are classified as: R( Retest results submitted by this laboratory are satisfactory as they fall within the acceptable variation range or match the consensus interpretation. Rm Retest results submitted by this laboratory demonstrate minor variation as results fall just outside the acceptable variation range according to the defined criteria; these results are acceptable, however the minor variation is worthy of note. RU Retest results are not submitted or retest results submitted by this laboratory are outside the acceptable variation range or disagree with the consensus interpretation and are unsatisfactory. Determination of the Acceptable Variation Range (AVR) CFT, MAT, HI and VNT The acceptable range for the CFT, MAT, HI and VNT is a dilution factor either side of the median value. Example: A CFT median value of 3/32.The AVR is 3/16 to 3/64. Results falling within this range will be classified as Satisfactory (() Results falling outside the acceptable variation range are temporarily classified as Retest Required (R) Following retesting the result will be classified as Retest Result Satisfactory (R() - result within the AVR Retest Result Demonstrating Minor Variation (Rm) - result within 3/8-3/128 Retest Result Unacceptable (RU) - result (2/8 - ( 4/128 AGID and RBPT The acceptable variation range for AGID and RBPT results is one grading on either side of the median value. The exception to this is where the Consensus Median (CM) value calculated for the sample is a low positive, such as 1+. The AVR cannot include a non-positive value, thus the acceptable range will be identified as 1+ to 2+. Example: An AGID median value of 3+. The AVR is 2+ to >3+. Results falling within this range are classified as Satisfactory (() A negative result or a result of 1+ would be classified as Retest Required (R) and the laboratory would be required to retest Following retesting, results would be classified as Retest Result Satisfactory (R() - result within the AVR Retest Result Demonstrating Minor Variation (Rm) - for result within 1+ - >3+ Retest Result Unacceptable (RU) - for result outside the Rm ELISA and PCR The ELISA's included in the program will follow different methods and will vary in the interpretation of positive and negative results. ANQAP will report and classify laboratories based on the consensus interpretation, which will be positive or negative for most ELISAs. Some tests may also include ranges such as low / high positive, doubtful, suspicious and inconclusive ranges. In determining the consensus interpretation ANQAP will also take into account the previous testing history of the sample. To be classified as Satisfactory, a laboratory will be expected to report a positive result for a positive sample and a negative result for a negative sample for ELISA and PCR tests. Participants are expected to complete all calculations following the method used and report to ANQAP the interpretation, raw OD values and any further calculations (percent inhibition, ELISA Units and ELISA ratio, CT values for PCR. SAT The acceptable variation range for the SAT is a dilution factor either side of the median. Example: An SAT median of 160 IU (2+ at 1/80). The AVR is 80 IU (2+ at 1/40) to 320 IU (2+ at 1/160). Results falling within this range will be classified as Satisfactory (() Results falling outside the acceptable variation range are temporarily classified as Retest Required (R) Following retesting the result will be classified as Retest Result Satisfactory (R() - result within the AVR Retest Result Demonstrating Minor Variation (Rm) - result within range 40IU (2+@1/20) to 640IU (2+@1/320) Retest Result Unacceptable (RU) - result <40IU (2+@1/20) to >640IU (2+@1/320) Non Conforming Results The coordinator is responsible for the management of non-conformances and for ensuring that problems are corrected, affected parties are notified and that review of procedures is undertaken to avoid further non-conformances. The samples selected for use in the official panels are tested by at least two laboratories prior to use to establish an expected result range and to ensure the sample is appropriate for use. Testing is also done to ensure homogeneity and stability of the samples. Despite this thorough testing of samples, there may occasionally be a sample which gives an unexpected result. This may be attributed by a number of factors: The sample may have deteriorated. The sample may have lost activity and the result fall outside the fit for purpose cut off limits for a test. The sample may demonstrate bi-modal distribution patterns in its result. ie the laboratories get a result and the other may get another. The sample may be inappropriate for statistical evaluation. When a sample gives an unexpected result, this will be documented as a non conformance and the sample will be removed from use. Affected laboratories will be informed via the report that the sample has not performed as expected and results for that sample will not be used in classifying laboratories. The entire sample panel may also be re issued to laboratories due to a major non conformance of the panel. Report Statistics Where statistical analysis is appropriate this will be done on two samples (split-level analysis). The samples must have results with only minor differences or an identical pair is used. ANQAPs statistical analyses identify laboratories by their confidential code number. Youden plot A Youden plot shows the result of one sample as a function of the result of the other sample in a sample pair. The Youden plot gives an idea of the dominating sources of error in the results. The Youden plot is relevant for sample pairs in which two almost identical samples with only minor difference (split-level samples) are distributed. Laboratories with results in the upper left or lower right hand corner of the diagram have results dominated by random error and little systematic variation. Laboratories with results in the upper right or lower left hand corner of the diagram have results dominated by systematic error. An ellipse along the axis indicates results have been significantly affected by random variation for one of the samples. Youden Analysis for JD CFT  Z-scores Z-scores are calculated using the robust summary statistics (median and normalised IQR). For each pair of results two Z-scores are obtained - a between laboratory Z-score and a within laboratory Z-score. The values are tabulated in a results table, and results are graphically represented in bar charts. Two charts are generated, one for the between laboratory Z score and another for the within laboratory Z score. Results are plotted in order of magnitude. Lines at +3 and -3 are included so that outliers can be clearly identified. A Z-score close to zero means that a result agrees well with the other laboratories. A Z-score greater than 3 (Z >3 or Z <-3) identifies a result which demonstrates significant variation from other laboratories. These results are identified as outliers. Z-scores also provide information on the type of variation. Between laboratory Z-scores are based on the sum of the results and describe the variation between all laboratory results (reproducibility). A between laboratory outlier indicates results that demonstrate significant variation from the other laboratories. Positive between laboratory Z-scores indicate results are above the median value. An outlier with a positive >3 Z-score indicates significant increased sensitivity. Negative between laboratory Z-scores indicate results are lower than the median value. An outlier with a negative <-3 indicates significant decreased sensitivity. Within laboratory variation is based on the difference between the sample pair and describes the variation within a laboratory (repeatability). A within laboratory outlier indicates variation between the individual results submitted by that laboratory and low precision. Positive within laboratory Z-scores indicates the difference between the laboratorys sample pair is overestimated. Negative within laboratory Z-scores indicates the difference between the laboratorys sample pair is underestimated or has estimated the difference to be in the opposite direction to the median difference. Z-score bar charts The Z-score results are graphically represented in Z-score bar charts. Two bar charts are generated, a between laboratory bar chart and a within laboratory bar chart. Each laboratory is identified by their confidential identification number. Laboratories can compare their performance relative to the other laboratories. Lines at +3 and -3 are included so that outliers can be clearly seen on the bar charts as the bars extend over the cut off lines. JD CFT Between Laboratory Z-score bar chart  JD CFT Within Laboratory Z-score bar chart  Contact Details ANQAP actively seeks and welcomes your feedback. If there are any issues with reporting or your assessment of performance, please contact us. This matter will be dealt with as soon as possible and be dealt with in total confidence. Australian National Quality Assurance Program (ANQAP) Department of Primary Industries 475 Mickleham Road, Attwood, Victoria, 3049 Australia. Phone: 61 3 9217 4360 Fax : 61 3 9217 4371 e-mail:  HYPERLINK "mailto:anqap.quality@dpi.vic.gov.au" anqap.quality@dpi.vic.gov.au website: www.anqap.com      EMBED Word.Picture.8   DOCPROPERTY PdCompanyName \* MERGEFORMAT Department of Primary Industries Australian National Quality Assurance Program  DOCPROPERTY PdItemName \* MERGEFORMAT Program Information for Participants  EMBED Word.Picture.8   DOCPROPERTY PdCompanyName \* MERGEFORMAT Department of Primary Industries  Australian National Quality Assurance Program  DOCPROPERTY PdItemName \* MERGEFORMAT Program Information for Participants Authorised By:  DOCPROPERTY PdAuthorisor \* MERGEFORMAT Sonia Rizzi Group:  DOCPROPERTY PdGroupName \* MERGEFORMAT ANQAP Manual Version:  DOCPROPERTY PdVersion \* MERGEFORMAT 2.9.2 Date:  DOCPROPERTY PdVersionDateOnly \* MERGEFORMAT 31/10/2011 Doc ID#:  DOCPROPERTY PdItemID \* MERGEFORMAT 12745 Control Status:  DOCPROPERTY PdItemStatus \* MERGEFORMAT CURRENT DOCPROPERTY PdWaterMark \* MERGEFORMAT Uncontrolled When Printed Page:  PAGE 1 of  NUMPAGES 9 Authorised By:  DOCPROPERTY PdAuthorisor \* MERGEFORMAT Sonia Rizzi Group:  DOCPROPERTY PdGroupName \* MERGEFORMAT ANQAP Manual Version:  DOCPROPERTY PdVersion \* MERGEFORMAT 2.9.2 Date:  DOCPROPERTY PdVersionDateOnly \* MERGEFORMAT 31/10/2011 Doc ID#:  DOCPROPERTY PdItemID \* MERGEFORMAT 12745 Control Status:  DOCPROPERTY PdItemStatus \* MERGEFORMAT CURRENT DOCPROPERTY PdWaterMark \* MERGEFORMAT Uncontrolled When Printed Page:  PAGE 1 of  NUMPAGES 10  EMBED Word.Picture.8   DOCPROPERTY PdCompanyName \* MERGEFORMAT Department of Primary Industries Australian National Quality Assurance Program  DOCPROPERTY PdItemName \* MERGEFORMAT Program Information for Participants Authorised By:  DOCPROPERTY PdAuthorisor \* MERGEFORMAT Sonia Rizzi Group:  DOCPROPERTY PdGroupName \* MERGEFORMAT ANQAP Manual Version:  DOCPROPERTY PdVersion \* MERGEFORMAT 2.9.2 Date:  DOCPROPERTY PdVersionDateOnly \* MERGEFORMAT 31/10/2011 Doc ID#:  DOCPROPERTY PdItemID \* MERGEFORMAT 12745 Control Status:  DOCPROPERTY PdItemStatus \* MERGEFORMAT CURRENT DOCPROPERTY PdWaterMark \* MERGEFORMAT Uncontrolled When Printed Page:  PAGE 1 of  NUMPAGES 9 %&3n " }fR>R>*>f&hn/^B*OJQJaJhnH phtH &h 2B*OJQJaJhnH phtH &hCWB*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH #h>h:FOJQJaJhnH tH hSZOJQJaJh>h:FOJQJaJ3hSZh:F5B*CJOJQJaJhnH phtH h:F5B*hnH phtH /hSZh:F5B*CJ OJQJhnH phtH /hSZh\F5B*CJ OJQJhnH phtH %&3 < `abgdX+$a$gd:Fdgd:F$ & Fwd]wa$gd:F$a$gd:FgdSZgd:F/MUU" # Y_`abͺ}hN7,hc|7h:FB*OJQJaJhnH phtH 3hSZh:F5B*CJOJQJaJhnH phtH )h:F5B*CJOJQJhnH phtH h:F@CJOJQJhSZB*OJQJaJph!h>h:FB*OJQJaJph#h>h:FOJQJaJhnH tH %hSZh:FB*CJOJQJaJphh:FOJQJ,h>h:FB*OJQJaJhnH phtH &h:FB*OJQJaJhnH phtH  IdeԽp\H0H/jhI?B*OJQJUaJhnH phtH &hI?B*OJQJaJhnH phtH &hTB*OJQJaJhnH phtH /h{h:F5B*OJQJaJhnH phtH h:F5B*hnH phtH 3hSZh:F5B*CJOJQJaJhnH phtH  hud h:F h:F5,h>h:FB*OJQJaJhnH phtH )h:F5B*CJOJQJhnH phtH ,h=h:FB*CJOJQJhnH phtH CDVWh%&$a$gdX+dgd:F$a$gd?`gd{$a$gd:Fgd:FɵɡvbvN6/h{h{5B*OJQJaJhnH phtH &h{B*CJOJQJhnH phtH &hSZB*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH &h[EB*OJQJaJhnH phtH &hI?B*OJQJaJhnH phtH 'hr{hI?0JOJQJaJhnH tH /jhI?B*OJQJUaJhnH phtH ;jhphpB*OJQJUaJhnH phtH  #BCDVWhйТА}hP9%&hqUB*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH /hSZh:F5B*OJQJaJhnH phtH )hX+5B*OJQJaJhnH phtH %hSZh:FB*CJOJQJaJph#h?`h?`OJQJaJhnH tH ,h?`hSZB*OJQJaJhnH phtH ,h?`hqUB*OJQJaJhnH phtH ,h?`h:FB*OJQJaJhnH phtH /h{h:F5B*OJQJaJhnH phtH  JYjmUA&h:FB*CJOJQJhnH phtH / *h h:FB*CJOJQJhnH phtH &hSZB*OJQJaJhnH phtH &haB*OJQJaJhnH phtH /h>h:FB*H*OJQJaJhnH phtH &h)ZB*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH &hqUB*OJQJaJhnH phtH &hI9B*OJQJaJhnH phtH al'(мШЙlbN6/h>h:F5B*OJQJaJhnH phtH &h:FB*CJOJQJhnH phtH h:FCJOJQJ0h>h:FB*OJQJ^JaJhnH phtH 'h>h:FOJQJ^JaJhnH tH h>h:FOJQJ^JaJ&hI9B*OJQJaJhnH phtH &hX+B*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH /hSZh:F5B*OJQJaJhnH phtH ()./=>M[\ ϻwcwQ=Qw&h)Zh:F5OJQJaJhnH tH #h>h:FOJQJaJhnH tH &hTB*OJQJaJhnH phtH ,h>h:FB*OJQJaJhnH phtH )h5 5B*OJQJaJhnH phtH /h5 h5 5B*OJQJaJhnH phtH &h5 B*OJQJaJhnH phtH /h>h:F5B*OJQJaJhnH phtH /h5 h:F5B*OJQJaJhnH phtH  DEF>?Gh i j x y ##$$a$gd{gd:FgdX+$wd]wa$gd:F $ & Fa$gd:F$a$gd:F9MTCDEF=>?EFGحzeM8M)hSZ5B*OJQJaJhnH phtH /hSZh:F5B*OJQJaJhnH phtH )h55B*OJQJaJhnH phtH #h>h:FOJQJaJhnH tH #h>h5OJQJaJhnH tH h:FOJQJaJhnH tH ,h>h:FB*OJQJaJhnH phtH &h5B*OJQJaJhnH phtH &hB*OJQJaJhnH phtH &hSZB*OJQJaJhnH phtH G`= C D R T X e h j w x y թթթՀfO8,h{h{B*OJQJaJhnH phtH -h:F5B*CJOJQJaJhnH phtH 3h{h:F5B*CJOJQJaJhnH phtH &h:FB*CJOJQJhnH phtH )h5 5B*OJQJaJhnH phtH /h\Fh:F5B*OJQJaJhnH phtH &h\FB*OJQJaJhnH phtH ,h\Fh:FB*OJQJaJhnH phtH &h)ZB*OJQJaJhnH phtH y e! 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