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Documenting and Correcting Deficiencies
Once the IACUC’s semiannual review has been completed, all deficiencies in both the facilities inspection and program review must be divided into one of two categories:
• Significant
• Minor
The term “significant” is the term used and defined in AWRs and PHS Policy. Some institutions may use a different term, such as “major,” in place of “significant.”
Significant vs. Minor Deficiencies
A definition of “significant deficiency” combining language in the AWRs and PHS Policy is:
“A significant deficiency is one which, with reference to the USDA Animal Welfare Act Regulations and PHS Policy, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals.”
A “minor deficiency” is an area or situation that is not in compliance with AWRs or PHS Policy, but does not pose a threat to animal health and safety (for example, peeling paint). However, a minor deficiency can become a significant deficiency if it is not corrected. For example, if not corrected, a few drops of water staining the ceiling over a rack of cages could become a large leak.
Both the IACUC and the Institutional Official are given the authority to decide whether a facility or program deficiency is significant or minor. To help the IACUC and IO distinguish between significant and minor deficiencies, OLAW provides some guidelines. Examples of deficiencies that would likely be significant are:
• failures in heating, ventilating, and air conditioning systems (HVAC);
• inoperative watering systems;
• general power failures of sufficient duration to affect critical areas; and
• inadequate veterinary medical or post-surgical care for animals.
Examples of minor deficiencies in animal facilities might include:
• infrequent findings of peeling or chipped paint;
• burnt-out light bulbs;
• warped floor drain covers; and
• similar problems for which immediate solutions generally are not necessary to protect life or prevent distress.
Correcting Deficiencies
Once identified, the IACUC must provide the following for each deficiency (both significant and minor) in the report.
1. A reasonable and specific plan for correcting the deficiency; and
2. A schedule for completing the corrective actions.
The IACUC must be careful to set reasonable, well-considered schedules for correcting deficiencies because regulatory authorities will hold the institution to these schedules.
If the plan to correct a significant deficiency is not completed according to the schedule set by the IACUC, the AWRs state that the failure to correct must be reported in writing within 15 business days by the IACUC, through the Institutional Official, to USDA and any federal agency funding that activity.
PHS Policy does not have the same requirement to report a failure to adhere to the correction schedule for a significant deficiency, but PHS Policy does require that the following be reported by the IACUC through the IO to PHS, regardless of whether a corrective plan is completed according to schedule:
• any serious or continuing noncompliance with PHS Policy (including the Guide), and/or
• any suspension of an activity by the IACUC.
Accredited institutions are required to promptly notify AAALAC of adverse events relating to the Animal Care and Use Program. Examples of such adverse events include investigations by the USDA or OLAW, as well as other serious incidents or concerns that negatively impact animal well-being.
Although USDA does not regulate laboratory mice and rats at this time, it is considered a best practice to consistently notify USDA, PHS/OLAW, and AAALAC whenever deficiencies to USDA or OLAW must be reported, regardless of the species involved.
USDA and OLAW have a long-standing agreement to share relevant information gained on such matters with each other.
The two agencies have agreed to:
“…provide one another with information concerning significant adverse findings regarding animal care and use at organizations investigated, inspected, or site visited, and the actions taken by the agency in response to the findings”, and to “provide one another with information regarding evidence of serious noncompliance with required standards or policies for the care and use of laboratory animals at organizations that fall under the authority of the participating agencies.”