Environmental Monitoring Investigations

FOCUS Labs is sometimes the bearer of bad news. On occasion, we need to notify a customer of a failing Environmental Monitoring (EM) surface or air result. We do our due diligence, and conduct an internal laboratory investigation, to be sure we didn’t contaminate the plate in the lab. And then we report the result.

But what happens on our customer’s side of the process. Often, the sampler is not a microbiologist and does not know what the results mean or how to react. How many 483s have we read where the company is diligently taking air and surface samples, recording the failing result, and then filing the report away for posterity. No investigation, no remedial action. How many times have I heard, Well we plan to triple clean and then sample again. Does that really address the root cause of the contamination or just provide a quick passing grade? Especially in USP <797> clients, where the next exam isn’t for another six months, what is a retest after a clean going to do for patient safety? What’s happening in your facility between sample events?

FOCUS Laboratories is providing a free investigation worksheet, to help folks think like a microbiological detective, and find the root cause of failing results. Until the root cause is uncovered and appropriate preventive action is in place, aseptic process is compromised. You can download this worksheet from the
Useful Forms link on our website at http://focus-lab.com/useful_forms.html.

Some salient points what can the microbial identification tell you about the contamination source? What has changed in the clean room recently? Are processes and procedures strictly adhered to? Are routine disinfection and sterilization procedures adequate? Has the investigation uncovered problems in documentation? What else might be below par?

We are always available for free consultation to help you troubleshoot. Give us a call at 610 866-7272. Patient safety is our primary concern. Customer service is our FOCUS.


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