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 I’s are dotted and all your T’s 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.