GEN.43825 Result Verification
Hi all,
How are you performing result verification in your computer system for manual entered POC tests?
GEN.43825 Result Verification Phase II
Manual and automated result entries are verified before final acceptance and reporting by the computer.
NOTE: Data entered into the computer system either manually or by automated methods must be reviewed by an authorized individual who verifies the accuracy of the input data before final acceptance and reporting by the computer. An example of best practices for this step is checking the result against the reportable range and critical results for the test. Depending on the local environment, this may or may not require a second person. Verification procedures must generate an audit trail.
This checklist requirement does not apply to autoverification procedures (see below).
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We do a quarterly audit of POC tests resulted in the HIS. We do a representative sample of 6 results per POC test and location. This helps us determine if one testing area is having result entry issues, and for all we can verify the reference range and units are reported along with the result. We keep two years hardcopy of the audits for the inspectors. We are JC right now and this practice came about from a JC inspection two years ago. Hope this helps.
thanks Karen. I do not believe this requirement can be accomplished by a POC audit for a selection of tests/results but must occur before results are entered in to the LIS by POC operator "who verifies the accuracy of the input data before final acceptance and reporting by the computer".