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CRI Lab Quality Advisor

Top 5 Deficiencies for Laboratories, Part II

Published April 1, 2014 1:24 PM by Nancy Alers

In part II of this blog, we will touch on Calibration and Quality Assurance. These two areas are among the most common areas of deficiencies and also tend to be frequently cited.

Calibration: I get it. Out of sight, out of mind, right? Calibration being missed is among the most common citations for laboratory deficiencies. Some instruments have safety features that prevent you from running patient samples if calibration needs to be performed. Others do not. If your instrument allows you to run samples even if calibration is out, beware! One of my recommendations is to create some sort of alert or calendar to ensure that calibration is done on time. Such an alert can be setup using the lab’s email system or simply posting a notice by the instrument. The idea is to create some sort of reminder to ensure that it is not missed. It is important to keep all calibration documentation together, including instrument tapes. Also, be sure to evaluate the data and document if the calibration was found to be acceptable or not.

Another issue with calibration is that it is often confused with calibration verification. These are two different processes. Calibration verification is required for non-waived tests (moderate and high complexity) to ensure that the instrument is accurately measuring values of known concentration throughout the reportable range. So, while calibration sets or adjusts the instrument readout, calibration verification checks to ensure the instrument is recovering the right values. There are instances where calibration and calibration verification will be due at different times in which a reminder for both must be setup in order to prevent issues.

Last but not least, we have… drumroll please….

Quality Assurance (QA): this is the one area I spend most of my time on as a Quality Advisor. One issue laboratories face is that QA can be a very broad topic and a task that is easy to forget when worried about the day to day activities. What I often tell labs is not to take QA for granted, QA is your friend! A good quality assurance plan is an internal quality improvement tool that can help detect issues labs may not be aware exist, for example calibration not being performed on time. Something I often clarify for labs is that a good quality assurance review looks at not only what’s wrong in the lab or known areas of deficiencies (complaints, rejected specimens, incorrect results reported out, etc.), but ALL AREAS. The goal is to select elements of the entire testing process (pre, analytic, post-analytic) to assess the quality of lab operations and help detect areas that may need improvement.

And that concludes my Top 5 deficiencies for Laboratories. How did you do? What are some other areas you would list here? Stay tuned for my next blog titled: Not another STAT, please!

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