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When should external liquid controls be performed for quality control on CLIA waived point of care tests?

  1. Each time before patients are seen

  2. When a new lot number or kit is opened

  3. Once a month

  4. Only when errors are suspected

The correct answer is: When a new lot number or kit is opened

External liquid controls should be performed when a new lot number or kit is opened to ensure that the test system is functioning properly with the new reagents or materials. Each lot of test components can vary slightly in their performance, so verifying the accuracy and consistency of results is essential when switching to a new lot. Performing controls at this point allows the phlebotomist or technician to confirm that the test system is operating correctly with the new supplies and that the test results will be reliable for patient samples. While quality control practices can include performing controls more frequently or under specific circumstances, such as when errors are suspected or to assess ongoing reliability, the opening of a new lot number is a critical point at which controls must be conducted to maintain quality. This proactive approach helps to identify potential issues early on and ensures that only valid patient results are reported.