In our most recent educational webinar, Javier Guillén, DVM, the Senior Director for the Europe and Latin America AAALAC International (AAALAC), discusses how AAALAC uses performance standards in its accreditation process. Furthermore, Guillén explains how effectively implementing better performance standards worldwide requires harmonizing methods, not necessarily standardizing them. Before diving into what it means to harmonize lab animal care performance standards, it’s critical to distinguish engineering standards from performance standards.
Engineering standards are objective and measurable. Often, engineering standards are required in the legislation as a requirement. One example of an engineering standard is the minimum cage dimension required in animal research. An inspector can objectively measure if this standard is met or not. A performance standard isn’t as straightforward as an engineering standard but equally, and maybe very often, more valuable. Performance standards are outcome-oriented. They focus on expected results rather than the process used to achieve them. A defining feature of performance standards is that they are flexible. They can be adjusted to fit different situations or the varying needs of a study.
What is AAALAC International?
AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals through a voluntary accreditation program. AAALAC does not represent a government or agency. In other words, programs with AAALAC accreditation freely volunteer to be audited by AAALAC. As of this year, nearly 1,100 institutional animal care and use programs across fifty countries and regions are AAALAC accredited.
Independent professionals make up the Council of Accreditation at AAALAC. Note they are not AAALAC staff; they are professionals from academia, pharma, and other research institutions. All council members possess extensive experience and expertise in research with animals. They make their evaluations based on the following primary standards:
- The Guide for the Care and Use of Laboratory Animals
- Council of Europe ETS 123 Appendix A
- The Guide for the Care and Use of Agricultural Animals in Research and Teaching
In addition, compliance with applicable legislation in the country/region is evaluated.
What Does AAALAC Evaluate?
- Individual responsibilities
- Personnel training/competence
- Occupational health and safety
- Physical plant
- Animal environment and management
- Veterinary care
- Oversight and ethical review
Harmonizing vs. Standardizing Lab Animal Care Performance Standards
Javier Guillén highlights that critical research with animals happens worldwide, across diverse cultures, and in various regions of the world. He emphasizes that in the current diverse global environment of lab animal research, with varying legal requirements, types of research, cultures, and education – the best way to measure performance standards is by a harmonized approach, not a standardized one.
What’s the difference? According to Guillén, standardization won’t be effective globally due to all the stark differences in animal research across global regions. Expecting or asking all research programs to standardize their operations is unrealistic. However, he highlights that harmonizing (rather than standardizing) is more attainable and valuable. Rather than expecting all research programs to take the same steps, it’s more realistic to aim for similar outcomes.
For example, most research programs use bedding to keep research rodents dry and healthy. If researchers standardized this process, all research programs would require the same quantity and bedding type. But Guillén emphasizes how that’s an unrealistic expectation, considering the varying bedding types available globally. Instead, he sees value in harmonizing this effort and measuring the outcome, not the process. In other words, are the animals kept dry and free from toxins? If the answer is yes, they are successful, regardless of what kind of bedding they use.
How to Harmonize Lab Animal Care Performance Standards
As Javier Guillén explains, harmonizing performance standards across varying research programs worldwide is no simple feat. There are striking challenges, yet AAALAC measures and enhances performance standards in harmonized and meaningful ways across diverse programs. That’s how it evaluates different systems across the world. Javier Guillén suggests putting these practices into play to review and sharpen performance standards in your facility.
- Collecting information
- Effective protocol forms and review processes
- Review animal use strategies
- Audit existing policies and implementation
1. Collecting Information Helps Unify Lab Animal Care Performance Standards
The first step to reviewing and improving performance standards within any laboratory animal care center is to collect as much information about the research program as possible. Collecting and sifting through this information is the first step. Guillén suggests gathering information in two primary ways.
- Collect information from the program description, the document that has to be submitted to apply for the accreditation.
- Gather information by visiting the site.
Guillén emphasizes that evaluating the program description is the most efficient place to start. The program description will have the most pertinent information about the animal care and use program and should describe all its components. For example, about the oversight activities, the composition and function of the IACUC or equivalent oversight body. Also, it should include appointment procedures, frequency of meetings, review of animal programs and facilities, animal welfare concerns, disaster planning, adverse event management, and more.
However, independently reviewing the program description isn’t enough. Guillén describes the accreditation process including coupling a review of the program description with a visit to the site to gather all available information. During a visit, you can identify if the staff has adequate training and is implementing processes from the program description effectively. Guillén highlights the importance of engaging with personnel and asking them plenty of questions to gauge performance standards. You can learn more about the research program by interacting with the personnel.
2. Ensure Relevant Protocol Forms and Review Processes
Suitable and effective protocol forms are essential for accurately evaluating performance standards in lab animal care settings. Protocol forms should be clear and concise and reference the Guide and other pertinent resources. Guillén also emphasizes that these forms should include enough information to allow a harm-benefit analysis.
Not only is it critical to have effective protocol forms, but it’s essential to have successful review processes of those forms in place. Guillén asks, is there a full committee or body that assesses them regularly? Or perhaps by designated members? Either way, people with expertise must periodically review them to ensure effectiveness.
3. Measure Performance Standards by Observing Animal Use
Another way to evaluate research protocols and their performance standards is by analyzing animal use in the research facility. The first component AAALAC assesses is if all the animals used in the institution have a corresponding approved protocol for use. If any animals are present without an assigned protocol, it’s a red flag. One way to identify if the animal use complies with the protocol is to review ID cages during the facility visit.
Guillén explains that once you recognize if the animals are indeed assigned a protocol, you can assess how the program implements these protocols. Ensure that humane endpoint definitions mentioned in the program descriptions are, in fact, met in the facility. How can this be done? First, by observing the animals. Are there any obvious signs of neglect or misuse?
Next, the AAALAC site visitors have conversations with the research staff about animal use. For example, Guillén tells a case when a researcher was asked about the analgesia provided for a particular animal in surgery during a facility tour. The researcher replied with a blank face, indicating that no analgesia plan was in place. It’s in these types of conversations that the truth comes out.
Implementing Lab Animal Care Performance Standards: Published Works
Guillén highlights that measuring and implementing performance standards can lead to new, innovative, and more efficient processes and protocols. For example, multiple research areas studying performance standards of varying protocols found that new procedures produced the same results and worked better for their circumstances.
For instance, in a 2022 issue of the Journal of the American Association for Laboratory Animal Science (JAALAS,) researchers faced challenges meeting cage-changing protocols during the COVID-19 pandemic. They didn’t have enough staff to support the volume of cage changes they were performing previously. So, with the approval of IACUC, they switched to a spot-change-only process, “with the requirement to evaluate microenvironmental parameters under both practices to confirm acceptable equivalence”1
The bottom line is they changed their process to accommodate their new circumstance while maintaining the same outcome. In other words, they successfully reviewed and applied performance standards to rethink and reimagine their operations to better their unique needs.
More From Our Webinar: Effective Standard Operating Procedures
In our recent webinar, The Use of Performance Standards in the AAALAC Accreditation Process, Javier Guillén discusses why Standard Operating Procedures (SOP) are pertinent for success. Furthermore, all staff must understand and comply with those SOPs. To learn more about the AAALAC Accreditation process, performance standards, and SOPs, watch the video recording of our webinar today.
References:
- Jones, Tim, et al. “Evaluation and Refinement of a Spot-Change–Only Cage Management System for Mice.” Journal of the American Association for Laboratory Animal Science, vol. 61, no. 6, 2022, pp. 650–659. https://doi.org/10.30802/aalas-jaalas-22-000023.