MIC.63252 Documentation
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Is anyone willing to share how they monitor for the presence of false positive results in their molecular lab. Would you have a documentation log sheet to show as an example?
Here is the specific CAP checklist question, thanks:
MIC.63252 Quality Monitoring Phase I There are written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests.
There are written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests.
Here is the specific CAP checklist question, thanks:
MIC.63252 Quality Monitoring Phase I There are written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests.
There are written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests.
NOTE: Examples of this may include review of summary statistics (eg, monitoring percentage of results that are positive for Chlamydia trachomatis and/or Neisseria gonorrhoeae for an increase above historical positive rate within a run or over multiple runs), unexpected increase in positive results for seasonal pathogens outside of the standard epidemiology, performance of wipe testing, review and investigation of physician complaints on false positive results, use of process controls to minimize risk of contamination.
Evidence of Compliance:
✓ Written procedure for monitoring for presence of false positive results AND
✓ Records of data review, wipe testing, statistical data, and, evaluation and corrective action if indicated
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For my molecular platforms, we perform QC on the 6th of every month. We use EPIC Beaker, and have our QC auto order. To meet this requirement I followed what our microbiology department does and added in a monthly "Environmental Wipe Test" that auto orders with our positive and negative QC. The tech's use the kit's swab and swab surfaces around the instruments, and then follow the SOP, if any result is not charted as Not Detected, this "QC" fails and action is required. Also, this way I can run my QC report every month and review and acknowledge it's acceptable and have the documentation for inspectors.
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