During your routine quality control checks in a clinic laboratory, you notice that the control value for a glucose test is repeatedly falling outside the acceptable range. According to CLIA regulations and good practice, what is the most appropriate next step to take?
Run additional controls to see if the results fall within the acceptable range before taking any further action.
Troubleshoot the test system to identify and correct the problem, run new controls, and document all actions taken.
Adjust the acceptable range parameters for the glucose test to include the outlier control values.
Continue to test patient specimens and mark the control values as exceptions in the records.
When control values for a laboratory test fall outside the acceptable range, it suggests a potential issue with the test system, which must be addressed before patient specimens can be reliably tested. Validating the accuracy and reliability of the test through troubleshooting, correcting any problems, and documenting the actions taken are key steps to maintaining compliance with CLIA regulations and ensuring the confidence in patient test results. Running additional controls would be appropriate after addressing the potential issue and would not be the immediate next step. Continuing to test patient specimens without addressing the outlier control value risks reporting inaccurate results, and changing the acceptable range parameters would not resolve the underlying problem.
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