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RESEARCH COMPLIANCE

Is it realistic to keep an animal-research lab USDA inspection-ready at all times?

Reader Question: It's policy at our animal-research facility to be ready for a U.S. Department of Agriculture (USDA) inspector at any given moment. But a post-doc who runs one of the shifts says that’s more of an ideal than the reality, considering how hard we are working and how short-staffed we are. We can’t add staff right now. Is our policy on keeping things at that level of cleanliness (and passing other inspection checkmarks) unrealistic?

Expert Comments: No, it's not unrealistic at all.

The USDA absolutely expects areas to be kept clean. Unannounced visits will happen at institutions where USDA-regulated species are being tested. If inspectors were to find an area in disarray, they would cite the institution.

The reasons for keeping the area clean include:

• To ensure there's an appropriate environment to prevent or reduce the possibility of infecting the animals. You can't even leave a candy wrapper around.

• Occupational health and safety. You always want to ensure labs are kept clean and that bio-hazards are disposed of properly after use so that no one ends up being scraped or cut. Depending on the kind of bio-hazard, that can be very serious.

There are no excuses for not keeping labs clean ... period. It should be a non-issue, actually.

I don't know what set of regulations your lab operates under, whether it's USDA or the Public Health Service (PHS) and the Office of Laboratory Animal Welfare (OLAW). In either case, you also must adhere to rules set by your own Institutional Animal Care and Use Committee (IACUC). Your IACUC is required to perform semi-annual inspections where animals are manipulated.

If, during the course of an inspection, a laboratory were to be found in disarray, unclean and cluttered — perhaps needles laying around, bio-hazardous agents, or surgical materials — the IACUC inspectors would write that lab up. That would mean the institution would have to fix it, meaning that it would have to devote more resources to cleanliness. So lack of cleanliness cannot be excused by a lack of resources. Period. And the IACUC has the authority to actually shut down a lab.

When our IACUC inspectors find that a lab is not as neat and tidy as it should be, the lab is instructed to fix the problem by a certain date. We will re-inspect quite often, depending on the seriousness of the violation. If the problem hasn't been fixed, we can go all the way from writing up the lab and its principal investigator again to closing the operation entirely.

The corrective action and the consequences are dependent on the nature of the problem. But it's certainly not unrealistic to keep your lab clean and inspection-ready at all times. In fact, failure to do so is likely to get you into trouble.

Expert comments provided by Dr. Ernest Prentice, Associate Vice-Chancellor for Academic Affairs at the University of Nebraska, and Executive Chair of the IACUC.