Share thisAs Animal Biosafety Level 3 (ABSL-3) suites become more prevalent within the biomedical research community, laboratory animal care professionals must increasingly meet the challenges posed by safety regulations and policy requirements. Developing the appropriate standard operating procedures (SOPs) within these environments holds the keys to achieving this.
This is, of course, a demanding task, but an efficient and well organized quality assurance (QA) program can meet these critical requirements and enhance the day-to-day operation of an ABSL-3 suite. This article provides a comprehensive overview of key QA program elements, along with practical suggestions for effective QA activities applicable in all ABSL-3 environments.
Establishing a Robust QA Program
A QA program must encompass many aspects of an ABSL-3 suite, including environmental parameters, equipment operation, staff knowledge/proficiency, SOP effectiveness, facility access, animal study proposal (ASP) review, occupational health requirements, and documentation.
Understanding the “whys” behind each practice conducted within the ABSL-3 suite allows the QA program to be tailored to each suite’s requirements. The individuals who perform QA must be knowledgeable of the ABSL-3 environment and the biohazards it contains, and capable of asking the proper questions. This brings proactive approaches to the forefront of operating the ABSL-3 facility, and ensures potential issues are noted and corrected before they engender a crisis. Therefore, facility- and position-specific training is a vital prerequisite for quality assurance.
There are several components that must be incorporated in an ABSL-3 QA program, including effective data collection and tracking; development, update, and evaluation of comprehensive SOPs; and regular reviews and observation to ensure that SOPs and best practices are consistently applied to operations.
Good data collection and tracking are critical to ensuring that occupational health requirements for each biohazardous agent are adhered to in an ABSL-3 environment. Achieving this hinges on complete and up to date information, consolidated from sources such as the biosafety office, occupational health specialist, and animal study proposals.
A database or spreadsheet must be developed and regularly reviewed/updated to capture the biohazardous agents and occupational health requirements for each animal study protocol. This helps ensure that managers and supervisors are aware of current safety and occupational health requirements for all animal care personnel and investigative staff. Similarly, the program must track inoculation requirements and due dates for all staff, since required vaccines have various administration schedules.