OHSU statement on USDA settlement agreement

 

BACKGROUND 

In August 2021, two investigators with the U.S. Department of Agriculture’s Investigation Enforcement Services visited OHSU and spoke with employees involved in animal research about several instances of alleged noncompliance with the Animal Welfare Act between February 2018 and October 2021. These instances were previously documented in the USDA’s regular (at least once yearly) inspection reports for OHSU’s West, Marquam Hill and South Waterfront animal care facilities.  

Following their visit, the investigators from IES – an agency which provides investigative, enforcement and regulatory support to programs overseen by the USDA’s Animal and Plant Health Inspection Service -- submitted their report to enforcement staff. This report has not yet been shared with OHSU representatives.  

In October 2022, the IES director notified OHSU that they believed the university had violated the Animal Welfare Act and provided a settlement agreement with two options: 1) pay a penalty of $37,900, or 2) submit a written request for a hearing.  

To avoid a potentially lengthy and costly litigation process, OHSU leaders elected to pay the fine.  

The IES settlement agreement included several alleged violations for which OHSU is being penalized. OHSU had self-reported these incidents as required to the National Institutes of Health’s Office of Laboratory Animal Welfare at the time of their occurrence.  

In support of OHSU’s core value of transparency, following are the alleged Animal Welfare Act violations along with OHSU’s mitigation measures implemented during that same time periods: 

• A nonhuman primate being transferred between enclosures got its tail caught in a gap between enclosures. OHSU veterinary staff immediately treated the animal, who fully recovered, but the injury led to a section of the animal’s tail being amputated.  

OHSU mitigation measures: An Oregon National Primate Research Center committee conducted a root-cause analysis, and the OHSU IACUC chair and the OHSU Animal Care and Use director conducted a separate investigation. All determined the incident was caused by human error. Corrective and preventive actions included: 

• Retraining of the animal care technician responsible and addressing the issues with all husbandry personnel.  
• Husbandry practices – practices that include the care and breeding of animals -- were updated to verify that enclosures are returned to their proper configuration before animals are reintroduced.  
• Training and husbandry documentation and the design of the equipment were reviewed. 
   

• A young nonhuman primate got its head caught between two PVC pipes which served as a resting platform or perch. The animal was immediately treated by veterinary staff but later developed neurological symptoms and was humanely euthanized. 

OHSU mitigation measures: An Oregon National Primate Research Center committee conducted a root-cause analysis, and the OHSU IACUC chair and the OHSU Animal Care and Use director conducted a separate investigation. Corrective and preventive actions included: 

• A perch design working group was convened comprising husbandry and facilities staff, along with Animal Resources and Research Support leadership. They considered perch refinements and construction/installation of improved perch designs. 
• To minimize the possibility of a recurrence the following actions were taken:
  • Immediate removal of the side-by-side flexibility of the PVC pipe of the perch involved in this incident. All other perches of similar design were immediately evaluated and none were identified with similar side-to-side flexibility of the PVC pipe. 
  • PVC perch pipes are now checked daily for damage, wear or instability. Documentation of the perch evaluation was added to the daily task list, and concerns are reported and properly addressed. 
  • All PVC perches were inventoried to assess stability, possibility of entrapment and ease of daily sanitization, and to identify and prioritize possible refinements.  

 

• APHIS officials observed the outside of containers of dressing supplies used for cleaning a ferret’s brain cap were stained and determined they were unable to be cleaned and disinfected. During a surgical procedure on a ferret, APHIS officials observed the lab coat of an OHSU member breach what they interpreted as the sterile field by touching used instruments located on a table behind the member. APHIS officials also observed that neither the attending veterinarian nor Department of Comparative medicine veterinarians were made aware that two ferrets required treatment related to the maintenance of their skull caps. After notifying the veterinarians, both ferrets immediately received examinations and treatment was initiated.  

OHSU mitigation measures: OHSU IACUC suspended research protocols for this laboratory, the animals were transferred to a holding protocol, animal facility access was suspended for all laboratory staff and the sponsors of the research were notified. A correction and prevention action plan was implemented and included the following: 

• Veterinary staff have unlimited access to all animals at all times. 
• Protocols are now reviewed annually by laboratory staff. 

• Standard operating procedures were refined to address animal health, behavior and post-procedural care. Veterinary consultation and approval of SOPs were required. 
• A laboratory manager was assigned to oversee daily animal care and use in collaboration with veterinary staff, as well as ensuring compliance with standard operating procedures, training, recordkeeping, occupational health and safety, and maintaining a planning calendar.  
• Laboratory staff certified their understanding of the responsibilities for using animal models and the importance of reporting animal health and welfare concerns. 
• Monthly continuing education in animal welfare was provided for the PI and laboratory personnel. 
• Signs were posted stating that animal health or compliance concerns must be reported. 

• External IACUC-related training was completed by the principal investigator. 
• Online training through the AALAS Learning Library was completed by the research assistant. 
   

• A medical emergency created opportunity for a miscommunication between animal care personnel and resulted in prairie voles in five cages not receiving water bottle replacements in a timely manner. Four voles were found dead the next day and a fifth was near death and humanely euthanized. The remaining voles were examined, given full water bottles and soft food support, and recovered without incident.  

OHSU mitigation measures: OHSU IACUC-approved correction and prevention actions included requiring a health check, including observations of the animals and of food and water supplies, for all cages in any room if a worker needs to leave the facility before they complete all room husbandry tasks. 
 

• A young nonhuman primate was found trapped under a stainless steel trough drain cover that was not properly secured after cleaning and sanitizing. The animal was discovered and released and immediately treated for partial paralysis and poor muscle control. The animal recovered over three weeks and continues to thrive without sustained harm from the injury.  

OHSU mitigation measures: An Oregon National Primate Research Committee conducted a root-cause analysis, and the OHSU IACUC chair and the OHSU Animal Care and Use director conducted a separate investigation. All concluded human error was the cause of the incident. A corrective and preventive action plan was implemented, including: 

• Retraining the employee regarding the importance of ensuring the equipment has been returned to its original state. The issue also was addressed with all husbandry staff responsible for washing in the housing area.  
• Husbandry practices were modified to include verification that equipment and housing features, such as drain covers, have been returned to their former state prior to the reintroduction of animals to the area.  
• ONPRC education and training staff reviewed and revised training and husbandry procedures.  A working group was appointed to review the design of the drain covers. 
   

• Two nonhuman primates were accidentally placed in a cage washing machine and the machine was started. The OHSU animal care technician realized the error and removed the animals, but one died and the other had to be humanely euthanized due to its injuries. 

OHSU mitigation measures: A detailed summary, along with the results of internal and external investigations, is available here. 
 

• Two marmosets were humanely euthanized due to intracranial abscesses. 

OHSU mitigation measures: Laboratory personnel were instructed to alert the veterinarians at any sign of abnormality in the animals, even if expected, so treatment could begin promptly. The frequency of scheduled veterinary examinations of experimental animals was increased.   
 

• Five gerbils were not given their daily food ration because a verbal request for services by a laboratory staff member to the husbandry supervisor was not communicated to the husbandry technician responsible for feeding in the room. Despite immediate feeding and treatment when the error was discovered, one animal died. 

OHSU mitigation measures: Corrective and preventive actions included:  

• Requiring use of a formal electronic request for husbandry services that is broadly disseminated to husbandry employees. 
• Training of laboratory and husbandry staff on the use of the procedure. 
• Clearly identifying cages containing animals on restricted diets. 
• Having caretakers initial a log confirming daily feeding when animals are observed. 
• Posting pictures in the animal room on where feeders are to be placed in the cage. 
   

• The slide mechanism of adjacent cages housing two nonhuman primates failed. The animals had direct access to each other, they fought and injured each other. The animals were treated for lacerations and abrasions and recovered from their injuries. 

OHSU mitigation measures: The malfunctioning cage was immediately removed from service and all other cages were examined for defective mechanisms. The cage manufacturer indicated the tongue and groove design of the slide and bolt mechanism presents a potential weakness for excessive wear. The cage manufacturer no longer uses this design, and Oregon National Primate Center Research Center staff worked with the manufacturer to identify any other caging at the ONPRC that could include the slide and bolt mechanism design. All cages known to use this bolt mechanism have been welded to ensure the bolts cannot fail and to prevent the ability of the slides to be pushed open unintentionally. 
 

ADDITIONAL INFORMATION  

OHSU supports and adheres to the appropriately robust Health Research Extension Act and Public Health Service Policy; the Animal Welfare Act and Animal Welfare Regulations. As soon as any serious issue or event is identified, OHSU immediately takes action to correct it, puts a mitigation plan in place to prevent it from recurring, and self-reports to OLAW as required by the regulations.  USDA inspectors visit OHSU at least once yearly to review the animals, facilities, food supply, medications and records. Their reports, once finalized, are publicly available on the USDA website, OHSU’s West Campus and Marquam Hill websites, for anyone interested in viewing them.  

The Marquam Hill and West campuses have been continuously accredited by AAALAC, International's voluntary accreditation process for more than 50, and more than 30 years, respectively. The most recent accreditation visit at the ONPRC in 2022 led to a laudatory review. OHSU’s Marquam Hill and Waterfront campuses will host AAALAC site visitors in winter of 2023.  

Animal research at ONPRC and other world-class universities and institutions around the world has led to countless life-saving medical discoveries, including: vaccines for polio, smallpox, mumps and measles; a vaccine platform for HIV/AIDS, tuberculosis and West Nile virus; new treatments for infertility, heart disease and diabetes; breakthroughs in Parkinson’s disease, blindness, stroke and depression.  

OHSU strongly believes that knowledge gained through biomedical research using relevant animal models is essential to developing new ways to identify, prevent, treat or eradicate disease and to improve human and animal health. 

OHSU only conducts animal studies when other nonanimal research methods, such as laboratory-based cell culture, simulation, gene chips or computer modeling are scientifically inadequate and/or when experimental designs are too dangerous for human participants. We look forward to a time when nonanimal research methods are capable of faithfully modeling the complexity of a living system; however, we are many years away from realizing that goal. The global scientific community doesn’t completely understand how cells, tissues and organs integrate in biological systems and nonanimal research models currently are incapable of providing information necessary for accurate interpretation.

---