How to Prepare for a CLIA Inspection?

Scientists, medical specialists, and lab technicians all attempt to keep their workspaces clean, sanitary, and free of contaminants that may, at best, introduce errors into their work and research but that may, at worst, make someone sick or even kill them. Because of this, many governmental bodies have attempted to develop guidelines that can be used not only for ensuring that labs and equipment are sterile, but also for the inspection and accreditation of those labs. Of those organizations, perhaps no one has the same recognition for dedication to excellence as the Centers for Disease Control, the CDC. The CDC is an agency that specializes not only in laboratory techniques, but also in helping other labs remain clean and effective. In order to do this, the CDC has developed what it calls the Clinical Laboratory Improvement Amendments of 1988, or the CLIA. The CLIA are a set of guidelines that all American laboratories engaged in human testing must adhere to and the CDC field offices conduct biannual inspections of each lab. These inspections cover both state and federal guidelines for human testing labs, and failure to successfully complete a CLIA inspection can have consequences ranging from steep fines to the lab being shut down entirely.

Luckily, the CDC, as well as many other state and federal agencies, not only have frequent workshops on keeping your lab up to date with CLIA rules, but also they offer help in ensuring all CLIA guidelines are being followed. Also, CLIA field offices also sponsor continuing education courses for lab personnel that helps them learn, and to teach others, the basics of CLIA certification and adherence. By attending these meetings and by following a few simple guidelines, a biannual CLIA inspection can be not only simple and easy, but cheap as well. Some guidelines for preparing for a CLIA inspection include:

Always ensure that signature-required documents have signatures. Many routine signature-required documents go unsigned in busy offices, and technicians assume they will have time to sign off on them later. Unfortunately, CLIA inspections officers will check these documents first, and if discrepancies are found they will note them for their review.

Double and triple check supply expiration dates. CLIA inspections focus on the details, and having products in the lab that are even a single day out of date can be a cause for a steep penalty. To keep this from happening, and to make sure that your clients and patients remain safe, always dispose of these supplies, and make sure you do so properly.

Never allow food or drink in the lab. Everyone knows that contaminations can occur from food and drink, and the possibility of your staff becoming sick increases if they eat or drink around the lab. However, everyone is human and mistakes are bound to happen if a tight watch isn't kept over lab technicians and staff. CLIA inspectors will be carefully searching for crumbs and water rings as a sign of food being in the lab. So the best solution is to head it off at the pass and not allow it to begin with.

Regardless of the type of lab you run, and regardless of its size, CLIA inspection will only take a few hours. Because CLIA inspectors are often seen as an enemy, it is common for staff to be discourteous to them. However, it's important to remember that CLIA inspectors are performing an important job, and that they have the backing of state and federal governments. Because of this, it's best to attempt to head off any deficiencies before the inspector arrives, rather than to argue or persuade them to change their mind once they are there.