Protocol For Lot to Lot Crossover

Crossover to a new Lot of Quality Control Material
Periodically there will be a need to change over to a new lot number of Auto Cartridge QC material (A-QC) on your pHOx/CCX analyzer. This will happen when the current lot expires, or you have run out of supplies and must order new A-QC material. The pHOx/ CCX analyzer can accommodate only one box A-QC material at a time (note: CCX can accommodate only one of each type of A-QC material at a time). It is not possible to run parallel lots of A-QC at the same time. With the installation of a new lot number of A-QC, the data from the previous lot number is erased from memory. Please note, that the statistics of each lot on the CCX is kept in memory, however, it is not recommended to switch between boxes of different lot numbers of A-QC.

In order to facilitate the crossover to a new lot number of A-QC, Nova recommends the following protocol.

  1. Acquire a sufficient amount of Nova External Quality Control (amounts will vary depending on your QC requirements).
  2. Establish the QC range for the external controls by analyzing a sufficient number of replicates for each level of control (Nova recommends an N of 20).
  3. After a sufficient number of data points have been collected, enter the established values and ranges into your analyzer.
  4. When the crossover is to commence, remove the old lot of A-QC and install the new lot number.
  5. Analyze a sufficient number of each level of A-QC (Nova recommends an N of 20).
  6. During the data collection period, analyze the external controls as your daily QC.
  7. Verify that the external QC is within the range that you have established. If QC is within established ranges, you may analyze patient specimens. If QC fails, troubleshoot, correct the problem, then reanalyze the external QC.
  8. When a sufficient number of A-QC have been analyzed, verify that the range is acceptable.
  9. If acceptable, enter the new range for the new A-QC lot into your analyzer.
  10. You may proceed with analyzing patient specimens, using the A- QC to monitor instrument performance.
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