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CRI Lab Quality Advisor

The Best Gift

Published January 8, 2014 11:41 AM by Nancy Alers

As a laboratory quality advisor, I offer advice and guidance to laboratories that are preparing for their upcoming laboratory inspection. The goal is to not only reduce the number of citations that labs receive, but most importantly offer advice on how to improve their processes and ultimately provide better patient care.  It is not uncommon for laboratorians to feel that, when it comes to ensuring a lab's readiness for inspection, the list of things to check seems never ending. Each laboratory is unique and may have different requirements depending on the complexity level and the test menu that it offers.

If you are a laboratory manager who oversees different laboratories in multiple locations, with different requirements, this makes even more sense to you.  From quality control, to calibration & personnel files, quality assurance, temperature logs, corrective action, maintenance, training, competency assessment, etc. the list goes on and on. Fortunately, many accrediting organizations provide a pre-inspection checklist also called a self-assessment questionnaire that can be of assistance to ensure that all your Is are dotted and all your Ts are crossed.

What is the problem, you would ask? That most labs don't use it! The pre-inspection checklist (Self-assessment) is one of the most underutilized tools laboratories have available! A pre-inspection checklist is a comprehensive instrument to ensure that your laboratory has met the level of compliance expected by the Accrediting Organization.

An interesting phenomenon is that laboratories that do use the self-assessment tend to answer the questionnaire as if trying to obtain a perfect score, when in fact the goal is to uncover deficiencies preemptively and correct them before the inspection takes place. Utilized correctly, a pre-inspection checklist can help a laboratory lower the number of citations and improve the overall level of quality. As a quality advisor, I recommend not waiting until the last couple of months before inspection to perform a self-assessment. This tool is more effective when the laboratory has plenty of time to make the necessary changes.

Next time your laboratory is up for inspection, I encourage you to utilize your accrediting organization's pre-inspection checklist (self-assessment). Performing a self-assessment is the best way to prevent citations and to ensure the laboratory is aligned with the level of quality that is expected.

posted by Nancy Alers

4 comments

Hi, Laura! what a great question!  Some labs may choose to perform a self-assessment 3-6 months prior to the inspection. I would say as long as there are no major changes in the lab, that could be a reasonable timeline. However, my recommendation is to do the self-assessment as close as possible to the expected date. This will allow you to get a more accurate picture of how the lab will perform on the big day! Thank you.

Nancy Alers, Quality - CQA January 30, 2014 2:29 PM
Baltimore MD

When do you recommend a self-assessment be performed before an inspection?

Laura Rubalcava January 24, 2014 9:17 AM
Raleigh NC

You bring up a great point Michael! Thank you for your feedback

Nancy Alers, Quality - CQA January 13, 2014 4:33 PM
Baltimore MD

It might be useful to have another individual familiar with the checklist other than the section manager or director to review the pre-inspection checklist item by item.  Often the section manager is the one who wrote all the procedures so when he/she answer the pre-inspection checklist it is base on memory instead of actual audit and review. Items that one thought were included or documented often time is not there when the inspector actually check.  Other qualifying individual to perform audit can be a manager from another section, lead CLS, outside consultants or in an integrated system management personnel from another system lab.

Michael Yu January 10, 2014 1:14 AM
CA

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