Roche ACCU-CHEK® Inform II QC and Levey-Jennings

  1. Why can’t I print Levey-Jennings from the report page?
    You can, but the charts must be reviewed in the L-J page before they can be printed or viewed at the Reports page. Reviewed or unreviewed L-J charts may be printed from the L-J page. From the Levey-Jennings page, click on Print Charts or click View Charts, then Print. NOTE: the Levey-Jennings grid can be printed from File, Print.

  2. How can I look at the Levey-Jennings pages and know which charts have been reviewed?
    Enter specific month’s date range in L-J main page; the review date will populate the screen based on the date the charts were viewed and saved not on the actual review date.

  3. How do I pull up previously reviewed charts?
    From the Levey-Jennings page, click on Reviewed Charts. Check date - should be the same as when you built the charts, click APPLY. A grid of reviewed charts will appear, highlight one or all and click on View Charts.

  4. How can I exclude out of range QC results?

    1. On the Results Review page:
      You can exclude out of range QC from Results Review by clicking on Criteria, choose Sample Type-QC Results, uncheck Reason for Failure box and choose Control Out of Range, click Apply. Highlight the rows that need to be excluded and click on the Review button. Check the box 'Exclude Results from Statistics and Charts’ and click OK.

    2. On the Levey-Jennings page:
      You can exclude out of range QC from the Levey-Jennings page by clicking on View Charts, Result Details. Highlight the rows that need to be excluded and click on the Data Point Review button. Check the box ‘Exclude Results from Statistics and Charts’ and click OK.

  5. How can I look at only excluded QC results?
    From the Levey-Jennings page, click View Charts, Result Details, and select ‘Only Excluded Results.’

  6. What is the best way to review out of range QC?
    At the Results Review page, click Criteria, click Sample Type, choose QC Results from the drop-down menu, uncheck Reason for Failure, and choose Control Out of Range from the drop-down menu. Click Apply.

  7. My coefficient of variation (CV) is 88 and my range is -122 to 62 – why?
    QC outlier results were not excluded from statistics. NOTE: On the left side of the page, be sure and look at each L-J chart’s included outliers, standard deviation (SD) and CV. If there is an outlier or the CV is greater than 10, you may want to exclude the data point that is skewing the results. Remember that the range is preset by the device vendor.

    Target range is on the outside of the strip vial. The calculated range is what the meter is actually getting.

    The outlier is a result outside of the target range. If a result outside the target range is not excluded, then it is included in the statistics. Example: Range is 45-70, but 2 results are 356 and 389. If you add these 2 incorrect values in the months 45-70 range and then take an average, it will shift the range upward to 216. So this is how an incorrect range is developed.

  8. If a POCC fails to exclude an outlier, which results in a CV of 27, how can she/he correct this problem?
    Assuming the chart has already been reviewed, open L-J, Reviewed Charts, highlight the chart with the outliers, Click Delete and then go back to the L-J grid page for the specific date range and this new chart should be the only chart that hasn’t been reviewed. (Hint - look at the Review Date column.) Highlight this specific chart, View, remove the outliers and Review the chart.

  9. Where are the two places that I can review CV and SD for a site?

    1. On each L-J chart

    2. Reports: QC Reports: Glucose Device Statistic Summary. Remember, be sure to enter the same date as the L-J charts were viewed and saved.

  10. If I adjust my QC target range, will the previous one still be available?
    No, once it is changed the new range will over-ride previous ranges with the same Strip Lot#. If you want to change the QC Range, print out all L-J Charts using that lot# before you change the range in Reagents. Remember you can’t change the QC Range if you are sharing the Alere RALS Core Server (RCS) with other institutions.

  11. Can I establish my own QC range based on my calculated range?
    Where do I do this?
    You can find the calculated range in Strip Code Statistics Summary located under Reports/QC Reports. You can edit the values in the Reagents Page under Strip Lots.

  12. Do I have to print my L-J charts?
    That depends on your policy. L-J charts can be reviewed with POCC’s note, name and date and can be displayed for an inspector at anytime.

  13. How do I enable my Next and Previous buttons on the displayed Levey Jennings chart?
    From the main L-J screen, highlight more than one grid line. Next and Previous will be enabled and you click Next or Previous to go from one chart to another.

  14. Can I just print a report for the QC outliers?
    Certainly: Under System, Reports, QC Reports, QC Test Results, Default. Under Available Criteria, Select Date Range (set Start Date and End Date). Select Flag and choose Control Out of Range from the drop-down list under Value. Click Print.

  15. Why are the meters requiring QC more than twice during a shift?
    Check to see when you have the QC set to be required at DCU, as operators MUST perform the QC at that time or after, for example:

    - If QC is set for 12:00 AM, QC must be performed at 12:00 AM or after.
      Note, if QC is performed before 12:00 AM the meter will require it again at 12:00 AM.