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Wake Forest Baptist Medical Center Settles Agreement with the USDA Regarding Past Inspections

In January 2013, Wake Forest Baptist Medical Center paid a $35,000 fine to the U.S. Department of Agriculture (USDA) after reaching a settlement agreement with the agency in response to the USDA’s investigation of eight events that were cited during four inspections from 2009-2012.

This is the first time the Medical Center has been assessed fines for violations of the Animal Welfare Act.

The following is a detailed summary of these eight events:
• The escape of one monkey which received local and national news coverage. The monkey was recovered unharmed (July 2012).
• A leak in a condensation pipe coming from a cage wash device (January 2011). No animals were impacted.
• Insufficient training of one researcher in sterile technique and the research team in record-keeping of blood pressure readings (January 2011). No animals were impacted.
• Failure of research staff to get internal approval before changing two experimental protocols, which resulted in a higher than expected death rate of diabetic rabbits and contributed to bruised ears in three rabbits (June 2010).
• Lack of sufficient glucose monitoring of diabetic rabbits, which led to the death of one rabbit (June 2010).
• Insufficient training of three research staff in the monitoring of diabetic rabbits, administration of insulin and euthanasia (June 2010).
• Meeting minutes of the Institutional Animal Care and Use Committee (the Medical Center’s internal review board) did not contain deliberations that occurred outside of the convened meetings (June 2010).
• Lack of documentation for enhanced environmental enrichment of two monkeys (May 2009).
All of the above issues that prompted the citations were resolved within 40 days of their occurrence and confirmed by USDA re-inspection. The Medical Center also took additional steps to prevent similar future events. These steps include an enhanced training program for personnel, an improved reporting system that ensures timely communication of unexpected events, and comprehensive investigation of all animal welfare concerns.

“These events were very unfortunate. The loss of any animal is regrettable and genuinely affects our staff members, who work tirelessly to ensure our animals receive the best care,” said Janice D. Wagner, D.V.M, Ph.D., vice president and senior associate dean for research. “Animal studies are a vital part of research that advances both human and animal health. The Medical Center takes this privilege and responsibility very seriously and is committed to the humane and responsible care of animals used in research.”

“In any process, human errors are bound to occur, but it is our duty to have protocols that can immediately identify and address issues and prevent them from happening in the future. We have taken the necessary steps to correct these issues and are working closely with staff, regulatory agencies and training experts to ensure these types of problems do not happen again.”

Because the USDA’s news release and documentation of the investigation are limited, we are providing summaries of the incidents as well as the Medical Center’s response to each individual event and additional institutional improvements. 

Details of the 2009-2012 Events Investigated by the USDA

June 2012 Inspection

Monkey escape
Summary: A monkey escaped on June 28, 2012, while its enclosure was being cleaned. The animal made contact with a latch, which opened the door of the enclosure. The monkey was recovered, unharmed, on July 10, 2012, by Medical Center and county officials. At the time of the escape, the Medical Center alerted the public through the media and reported the escape to federal authorities. A USDA investigator came to the Medical Center in response to our self-reporting of the event and issued a citation for failure to maintain secure housing.

The Medical Center’s response:
• On the day of the escape, an enhanced latching device was installed and the USDA inspector approved the solution during the inspection.

The Medical Center appealed the citation, but it was denied.

January 2011 Inspection

Event: Insufficient training of researcher regarding sterile technique and the research team in recording of blood pressure readings
Summary: During a review of animal clinical records, the USDA inspector found a note in which a staff member mentioned seeing a researcher using inadequate sterile technique during a procedure. The inspector issued the citation during a future inspection in January 2011. Additional training was provided to the research team at the time of the email by our veterinary staff before the USDA inspection. In addition, this research team had difficulty obtaining accurate blood pressure readings due to equipment problems.

The Medical Center’s response:
• The research team attended mandatory training classes on sterile surgical technique and record keeping.
• Each staff member was required to demonstrate proficiency to veterinary and oversight staff in the proper conduct of procedures done in this study.
• New blood pressure monitors were purchased and improved technique was implemented.

Event: Facility maintenance issue
Summary: During an inspection in January 2011, the USDA inspector noticed a small drip in a condensation pipe coming from the cage wash device. There was no evidence or suggestion that this had any impact on animal health.

The Medical Center’s response:
• The pipe was repaired shortly after the inspection and continues to operate without incident.
• The equipment is routinely monitored to maintain optimal operation.

June 2010 Inspection

Event: Failure of research staff to get internal approval before making changes to two experimental protocols
–This citation involved two protocols, both of which were terminated. Each is described in more detail below.–

Summary (Protocol A):
The Medical Center was cited for the failure to obtain approval from the Institutional Animal Care and Use Committee (IACUC) before changing a research protocol regarding the number of animals used, glucose monitoring, and the route and dose of insulin. The USDA Inspector felt it was a change that required IACUC approval.

This protocol was approved for two phases. Due to unexpected deaths in phase 1, the researchers used animals that were allocated for phase 2 to complete phase 1. This study initially used insulin pellets to stabilize glucose levels. It was changed to injectable insulin. In addition, the protocol specified that insulin would be administered subcutaneously, but records show that it was given intramuscularly. In the opinion of the attending veterinarian, this last item alone did not constitute a significant change; both routes of administration were effective.

 The Medical Center’s response:
• The study was terminated.
• Prior to the inspection, researchers were corrected and retrained, once the route of insulin administration was noted by the staff veterinarian.
• Pilot studies are required for experiments that develop new models and for experiments using novel procedures.

Summary (Protocol B): The Medical Center was cited by the USDA for failure to obtain approval from the IACUC before deciding not to use a pressure bandage on the ears of three rabbits following surgery on one ear. The rabbits developed bruises (hematomas), which might have been prevented by using a pressure bandage. The animals were being thoroughly and appropriately treated by veterinary staff, including the administration of pain relief medication, and further surgeries had been postponed prior to the inspection. The inspector observed the bruises and cited the Medical Center.

The Medical Center’s response:
• The study was terminated.
• The researcher was issued a letter of reprimand.
• The matter was reported to federal authorities, who were satisfied with the actions taken.

Event: Lack of sufficient glucose monitoring of diabetic rabbits, which led to the death of one rabbit
Summary (Protocol A): In June 2010, the Medical Center was cited by the USDA for failure to obtain adequate justification for monthly glucose monitoring of diabetic rabbits. This study involved the use of implanted insulin pellets which, according to the published scientific literature, would maintain stable blood glucose levels and not require frequent blood glucose checks. However, one rabbit died due to hypoglycemia. The protocol was immediately revised to include more frequent blood glucose monitoring. This occurred before the June inspection and was noted by the inspector during a review of the study records.

The Medical Center’s response:
• The protocol was revised within one month of original approval for increased monitoring of blood glucose levels.

Event: Insufficient training of three research staff regarding monitoring diabetic rabbits and administration of insulin and euthanasia
Summary (Protocol A): During an inspection in June 2010, the USDA inspector cited the Medical Center for three instances of insufficient training of research staff that resulted in an animal welfare concern.

In Feb. 2010, a research team member made a decision for humane reasons to use an unapproved method to euthanize a rabbit that was in distress. The staff member was retrained in the approved methods of euthanasia. The Medical Center reported this event to federal authorities.

 In April 2010, a researcher administered improper doses of insulin, which resulted in the death of two rabbits and the euthanasia of another rabbit due to hypoglycemia. In addition, it was discovered that other personnel did not have adequate experience monitoring diabetic animals and failed to document when blood glucose was monitored. All staff involved was instructed by a staff veterinarian in the correct method of insulin administration. The IACUC partially suspended work on this study, such that experiments could continue on animals already in the study, but no additional animals could be used. The Medical Center reported these events to federal authorities.

The Medical Center’s response:
• A thorough review of all protocols in the unit was conducted and a comprehensive assessment of compliance was completed.
• A training coordinator was hired to provide training for all personnel in the unit.
• The two senior researchers involved had their animal use privileges revoked and have since left the institution.
• Other staff attended mandatory training classes on record-keeping.
• The National Institutes of Health’s Office of Laboratory Animal Welfare reviewed the matters and found the Medical Center’s response to be appropriate.

Event: Insufficient IACUC meeting minutes
Summary: In June 2010, the Medical Center was cited for failing to maintain complete minutes of the IACUC meetings because it did not include committee deliberations that occurred before and after convened meetings. This was strictly a record-keeping matter concerning the proper place for recording pre- and post-meeting deliberations. At the time of this inspection, the IACUC meeting minutes contained information that was discussed only during the meeting. Both pre- and post-meeting deliberations were retained and were made available to the inspector during the inspection.

The Medical Center’s response:
• The pre- and post-meeting deliberations are now contained in the IACUC meeting minutes for instantaneous retrieval.
Additional Institutional Improvements Made in Response to the June 2010 Inspection
• A training coordinator was hired and available to provide direct training to animal research staff. This includes hands-on and individual training.
• The basic training program was upgraded through a partnership with the American Association for Laboratory Animal Science.
• The mechanism to document competency of research staff was revised to increase accountability of training.
• A quality assurance team was established to manage and resolve any concerns for animal care or compliance across the institution.

May 2009 Inspection

Event: Lack of documentation for enhanced environmental enrichment for two monkeys
Summary: During an inspection in May 2009, the Medical Center was cited for failure to document a written enrichment plan for special attention for two monkeys. Both animals were identified as having hair loss (alopecia). These monkeys were receiving environmental enrichment as described in a written standard operating procedure and were getting additional environmental enrichment because of their alopecia. However, there was no written plan for the additional enrichment for the alopecia.

The Medical Center’s response:
• A written plan was immediately provided and separate environmental enrichment logs were maintained for both monkeys.
• Now, all monkeys receiving additional environmental enrichment for any reason have individual written special attention plans and individual logs document these additional activities.

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