I recently assisted a laboratory that had some questions about quality assurance (QA) while in the process of preparing for their first laboratory inspection. As a continuous quality advisor, I spend a lot of time educating labs about QA so let’s focus on QA for this week’s topic.
For new labs devising a quality assurance plan can be a challenging task if the lab doesn’t have an understanding of what QA is or its scope. In the case of established laboratories, what I see most often is a failure to create a comprehensive plan or implement it effectively.
First and foremost, quality assurance is a review of all laboratory activities or processes that affect patient testing. A QA plan should have reviews that are ongoing, comprehensive and include elements from all the phases of testing (pre-analytic, analytic, and post-analytic).
Your implemented QA plan should describe what elements will be monitored within each phase and with what frequency. Quality assurance also entails corrective action in case errors are discovered and should clue the laboratory in to areas where improvement may be necessary even before errors occur. In other words, a comprehensive QA plan should yield important information to help the laboratory improve its processes.
It’s important to note that QA reviews should be done at frequent intervals; it is recommended laboratories perform QA reviews more frequently than once a year. A laboratory that performs QA once a year may have missed opportunities to improve its practices or take corrective action in a timely manner. Remember, QA is a self-audit of the laboratory’s processes that allows the lab to detect errors or improve processes before patient testing is affected.
For more information about QA, feel free to comment below.