CDC Acts to Preserve Accreditation Animal Care and Use Program Undergoes Serious Scrutiny
Over the past year, CDC successfully restructured its animal care and use program after it was put on notice that it risked losing its accreditation with the Association for the Assessment and Accreditation of Laboratory Animal Care--International (AAALAC-International) because of serious program oversight and animal care problems.
CDC conducted a comprehensive review and determined that there was no single cause for the deficiencies, but a series of issues that led to these failings, including fragmented oversight, lack of centralized accountability, inadequate training, programs that outgrew resources, and outdated information management systems and equipment.
“CDC is now committed to being an exemplar of excellence in animal care and use, but remains severely chastened by its past failings. We are deeply committed to maintaining the world class animal care and use program that we have now established,” said Julie L. Gerberding, M.D., M.P.H., Director, CDC.
In January, CDC told its workforce that AAALAC-International had reported
serious concerns about CDC’s animal care and use program, following a
site visit to Atlanta in late 2005. In February 2006, AAALAC-International
decided to allow CDC to maintain its accreditation on a probationary basis.
Late last month, a five-member panel from AAALAC-International conducted a
follow-up site visit to CDC’s Atlanta campus. While the official outcome
will not be announced until next year, during an exit briefing members of the
review panel said they now found CDC’s animal care and use program “commendable” in
every area examined.
“CDC's animal research is done where essential to develop needed knowledge
to improve health and save human lives. This research is vital and must continue,” noted
Gerberding. “To carryout this critical research, we must protect our
community, our workers, and the animals entrusted to us.”
In December, 2005, AAALAC-International submitted a preliminary report to CDC that galvanized the agency to do better on a number of fronts: provide better and safer care for its animals, train and support the workers who care for the research animals, ensure the scientists who have oversight of the research adhere to best practices, and modernize the dated infrastructure to support animal research.
“Last year’s AAALAC's report to CDC was really distressing,” said Tanja Popovic, M.D., acting Chief Science Officer, CDC, and the new Institutional Official for Animal Research. “No one wants to believe that the things that went wrong did—it was a series of problems which evolved over many years that we attempted to fix with patches. We know now that this system needed a total reworking. We take full responsibility for the deficiencies we had. We are more determined than ever to treasure the animal care and use program, not just because it is something that we had to do, and not even because it is the right and moral thing to do, but because we ourselves are passionate about the care of the animals entrusted to us.”
AAALAC reported to CDC in late 2005 that it was concerned about some practices that did not meet their standards. While many of AAALAC’s findings involved administrative issues, some were serious and involved infection control and animal care safety issues. For example, they identified instances of multiple ultrasound-directed percutaneous biopsy attempts on a single animal; problems with sipper tubes on some cages that limited access to water, which resulted in the death of two animals from dehydration; and inadequate cage-washing procedures that could have offered a theoretical risk to animal caretakers and nearby communities.
There were also errors in the 2005 AAALAC report, resulting from miscommunications during the 2005 visit. As a result, the report erroneously indicated things such as CDC withheld post-operative medication for a squirrel monkey, limited the amount of food chimpanzees received, and did not have records for the use of veterinary drugs. “CDC was gravely concerned that the accreditation visitors left CDC with these impressions in 2005 and provided evidence to the group that countered these assumptions,” said Dixie Snider, M.D. who provided the agency’s first response to the 2005 report.
Nonetheless, CDC was highly concerned about the 2005 site-visit report from AAALAC-International. CDC conducted an investigation and took immediate and decisive actions to review its procedures to ensure the safety and well-being of its workforce and the animals entrusted to its care for important public health research. Steps taken included:
- CDC recruited additional professional staff and outside consultants with expertise in managing laboratory animal facilities. Working together with CDC’s regular staff, these experts were charged with the mission to quickly modernize the animal care procedures and practices. This charge included ensuring both the continued safety of workers and the highest standards of ethical and humane care of animals in CDC's research program.
- CDC invested the additional $3 million provided by Congress in 2006 to complete important upgrades to laboratory research facilities and to purchase an electronic records management system for its animal care program.
- Workers completed additional safety training and job-risk analyses. Appropriate employees are now followed in a medical surveillance program.
- CDC enlisted the help of experts to develop an environmental enrichment program (i.e., a stimulating environment that improves psychological well-being) tailored to non-human primates and also to other animals housed at CDC. CDC animal caretakers have been trained in animal enrichment and all animals have enrichment items. (CDC has many animal species and they differ over time. They include primates such as rhesus monkeys, owl monkeys, chimpanzees, as well as ferrets, mice, rats, rabbits, raccoons and hamsters.)
- CDC centralized overall accountability from a Center to the Office of the Director and adjusted lines of authority and responsibility to ensure impartial and highly credible oversight, including the assignment of three veterinarians and two animal caretakers with independent access to CDC's most secure biosafety containment laboratories (BSL-4 laboratories).
These actions and others have involved leadership oversight, worker-safety, animal care, and upgrades to laboratory facilities. “The intent of these actions has been to boldly and fully demonstrate CDC's absolute commitment to worker safety and to ethical and humane animal care,” explained Popovic. “We are very humbled by the experiences of the past year, and very thankful to AAALAC for their guidance throughout this process.”
Dr. Gerberding added, “I have seen first-hand the wonderful energy, expertise, and passion that our cross-agency team of animal caretakers, scientists, and oversight managers put forward to get this important priority accomplished on a fast track. They were, and will continue to be successful, and I am proud of their effort.”
AAALAC-International's voluntary accreditation program evaluates organizations that use animals in research. Those that meet or exceed AAALAC standards are awarded accreditation. CDC has had AAALAC accreditation since 1967. At the October 24, 2006, AAALAC site-visit debriefing, their experts stated that CDC's animal care and use program was commendable, including CDC's institutional support, the energy of current staff to address concerns, and the hiring of 18 new employees in the program. Other areas mentioned as commendable included controlled-drug inventory; and clinical recordkeeping, especially for primates.
“In the last 12 months, CDC has made tremendous strides in re-energizing and building a world-class animal care and use program,” noted Popovic. “Before this year we had a fractured system with too many elements reporting through too many channels. Now, we’ve raised the oversight for animal care and use to the level of the office of the CDC director. This now has equal standing with our scrutiny of human-subject research. This is about accountability.”
CDC expects to hear a formal report from AAALAC-International about its accreditation status in the first quarter of 2007. Accreditation, while voluntary, is important in attracting world-class scientists to CDC and ensuring the public’s confidence in the agency’s public health research that involves animals.
For additional information about rules and regulations related to CDC animal
care and use program, please visit: http://www.cdc.gov/ncidod/srp/animals/laboratory.html.
To review the Office of Laboratory Animal Welfare: Public Health Service Policy
on Humane Care and Use of Laboratory Animals (Amended August, 2002) visit: http://grants2.nih.gov/grants/olaw/references/phspol.htm.