In our example case, the greatest potential for risk that was noted in the risk assessment occurred during the preanalytical phase of the testing process. Actions to mitigate the risks that were identified include:
- Standardizing procedures for positive patient identification
- Printing out collection and handling instructions along with patient labels for tests that have special sample requirements, such as ammonia. (Automating the process)
- Ensuring competency assessment is performed for all laboratory personnel, initially twice during the first year of hire and then annually thereafter. For phlebotomists, competency assessment will include direct observation of specimen collection and a written quiz. For lab aides, competency assessment will include direct observation of specimen processing procedures and a written quiz.
All of these actions will become part of the QCP. The QCP will be monitored for effectiveness and changes will be made, if necessary, based on any failures that occur. The risk will be evaluated using the risk matrix and if unacceptable, changes will be made to the QCP to further mitigate the risk.
