Preventing Adverse Events at Research Facilities.

Abstract

In this article, adverse events are defined as events that lead to significant injury or illness, unrelieved pain or distress, or the death of an animal, excluding those caused by IACUC-approved research procedures. The ability to identify possible adverse events is an essential step in planning for risk prevention and mitigation. Using data from news sources and the Animal and Plant Health Inspection Service (APHIS) website, this article provides guidance to research facilities regarding various types of adverse events to consider in risk management plans because these events might occur or have occurred and, in some cases, have been documented as noncompliances at APHIS-regulated research facilities. APHIS classifies noncompliances as 'direct' when they currently (at the time of the inspection) have a serious or severe adverse effect on the health and wellbeing of animals. Not all direct noncompliances are associated with adverse events, and not all adverse events are documented as direct noncompliances (for example, a past adverse event that does not currently affect the wellbeing of animals is not a direct noncompliance). However, because APHIS does not require reporting of adverse events, the information regarding direct noncompliances was the only APHIS data available to study adverse events at research facilities. Direct noncompliances documented by APHIS were 4% of all documented noncompliances from 2010 through 2014. The greatest number of direct noncompliances was in the category of veterinary care issues (44%), followed by animal husbandry issues (34%), 'other issues' (15%), and physical plant issues (7%). The category of other issues included events due to human error, equipment failures, and accidents.