citation_inspection

There was no one available during business hours to allow APHIS Officials to enter and inspect the facilities, property, records, and animals on04-JUN-19 at 11:15am. Called all contact persons. Main contact person was not available.

Upon IACUC investigation of the injured pig incident, they determined that the laboratory staff did not provide the analgesia to pigs as prescribed by the protocol. According to the laboratory technician, recovery from anesthesia was better for pigs without the use on analgesia. The Principal Investigator had not submitted an amendment to the IACUC for this change in procedures and did not consult the Veterinary Staff. Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further review and approval. Any changes in activity that involves the care and use of animals must be approved by the IACUC. This has been corrected by the IACUC through a corrective action and retraining of laboratory personnel.

On March 3rd, 2021 a pig was used in a cardiac study procedure. The pig’s recovery from anesthesia was monitor by two laboratory technicians and a post-doctoral fellow. According to the laboratory technician, the anesthesia recovery was difficult. The animal was checked on by the Principal Investigator multiple times. The pig was transported from recovery to its home enclosure at 8:15pm by the Senior Lab Technician. The pig was checked on by the Senior Laboratory Technician at 12:00am. On March 4th, 2021, the pig was identified as injured during routine observations performed daily by the Research Animal Resource Veterinary Staff. The pig was not able to stand on its own. The pig was immediately euthanized by Veterinary Staff and a necropsy was performed. The necropsy identified the pig sustained two broken elbows. The IACUC completed an investigation with the Principal Investigator and laboratory technicians. According to the Senior Laboratory Technician, the pig injured itself when transitioning from the transport cage to the home enclosure. The Senior Laboratory Technician decided to leave the pig after injury was sustained without communicating any of the concerns of animal health to the Veterinary Staff. Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma or physical harm. This has been corrected by the IACUC suspending the protocol and a corrective action plan. This inspection and exit interview were conducted with facility representatives. This inspection was conducted 08/24/2021 to 08/27/2021. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICEREnd Section

Protocols ACH-100, ASH-200 and ARB-400 contained surgical procedures for chinchillas, sheep and rabbits. The Principal Investigators for protocols ACH-100, ASH-200, and ARB-400 did not write narratives that clearly considered alternatives to potentially painful surgical procedures. The narratives provided by the Principal Investigators instead described the objectives and the rationale for the research. The IACUC shall determine that the principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and has provided a written narrative description of the methods and sources used. To Be Corrected By: July 29th, 2022

Paint was peeling on walls of 2 nonhuman primate rooms in the S444 suite. Paint has been scraped off an approximately 6ft long section of the wall in room S415. There was excessive dust and rust colored material evident on the exterior of PVC water lines located in multiple rooms including S410, as well as excessively dusty ventilation filters. Accumulation of dust and debris on surfaces in animal rooms can lead to unsanitary conditions that affect the health of the animals. Unsealed surfaces in primate rooms does not allow for proper cleaning to reduce disease hazards. Premises must be kept clean and in good repair to facilitate the husbandry standards set by the facility. Correct by May 28, 2022

Two enclosures of bats had thick guano deposits on water lines located below roosting spots. Guano was also present on the wire of the walls of the enclosures. Excreta must be removed from enclosures to minimize disease hazards for the animals. The facility must ensure that the enclosures are cleaned as often as necessary to remove excreta from surfaces. Correct by April 27, 2022. No non-compliant items identified during this inspection. This inspection and exit interview were conducted with facility representative. This inspection was conducted April 26, 2022 to April 28, 2022. Additional Inspectors: SARA TOBIAS, VETERINARY MEDICAL OFFICER GLORIA MCFADDEN, VETERINARY MEDICAL OFFICEREnd Section

On December 7th, 2022 during the USDA facility inspection, a female baboon was observed to have a round approximately quarter sized wound located on the on the left heel. The baboon was observed shifting weight between the right and left feet and lifting the left foot. Upon review of study observation records, the laboratory staff observed bilateral pressure ulcers on the feet on December 5th and applied Bacitracin. The laboratory staff did not inform the RAR veterinary staff about the bilateral ischial pressure abrasion until the scheduled weekly rounds on Wednesday December 7th. After rounds with the laboratory members, a RAR veterinarian observed the baboon and noted ulceration on both hind feet. The laboratory staff had started a treatment plan of Bacitracin and pain medication on December 5th. The treatment plan was reviewed by the RAR veterinary staff on December 7th. Daily observations may be done by someone other than the attending veterinarian provided there is a mechanism for direct and frequent communication on problems of animal health and behavior. The mechanism for reporting daily observations must ensure direct and frequent communication with the Attending Veterinarian to allow for a timely and accurate diagnosis and treatment of health issues. Corrected during the time of inspection.

Revised protocol A dated 12/20/21 indicated that potassium chloride (KCl) would be administered at rate of 40mEq 15 minutes into cooling to effect. However, study records indicate Dog #2 was administered an intravenous bolus of KCl and went into cardiac arrest. The laboratory staff attempted to provide care and called the RAR veterinarian on call. But, the animal expired. The route of administration for the potassium chloride was not included in the approved protocol. Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. This has been corrected by the IACUC through a corrective action plan and a protocol amendment. This inspection and exit interview were conducted with facility representatives. This inspection was conducted 02/28/2023 to 03/03/2023. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICEREnd Section

On January 19, 2024, a juvenile baboon was found unconscious and entangled in the lixit line that provided water to its cage. The caretaker disconnected the baboon from the lixit line and immediately contacted the supervisor and veterinarian. Attempts to resuscitate the animal were made but the animal remained unresponsive. The non-human primate was subsequently euthanized. The necropsy report indicated bruising was present around the neck, which is consistent with entrapment in the lixit line. The primary enclosure was not designed to prevent the nonhuman primate from pulling the lixit line into its enclosure. Primary enclosures must be constructed and maintained so that it protects the non-human primates from injury. Corrected before the time of inspection by a corrective action plan that included shortening all lixit lines and mesh was added to the sides and tops of the baboon caging. This inspection and exit interview were conducted with the facility representatives. This inspection was conducted from 4/22-26/2024. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER Jason Sifkarovski, VETERINARY MEDICAL OFFICER n

***Records of IACUC protocol reviews and meeting minutes were not available for review at the time of inspection. All IACUC records should be available for review by an APHIS official at the time of inspection in accordance with the standards of the Animal Welfare Act. A method to ensure records are available for review at the time of an inspection must be established to ensure that the facility is providing proper oversight of activity involving the use of animals. Correct by the next inspection. An exit briefing was conducted with the Executive Director.

This facility has no established IACUC and, therefore, does not have the required IACUC records. Research facilities must maintain minutes of IACUC meetings, records of proposed activities involving animals and proposed significant changes in activities involving animals, and records of semiannual IACUC reports forwarded to the Institutional Official (IO). Failure to maintain these records inhibits the ability to provide proper oversight to animal use and activities, which can negatively impact the health and welfare of animals being used in these activities. Correct by creating and maintaining required IACUC records. Correct by February 26, 2021. This inspection and exit interview were conducted with the Executive Director.

Between January 9, 2017 and July 5, 2017 the office of the Institutional Official (IO)was vacant. On July 5,2017 a new IO was appointed The facility did not report this change to the Eastern Regional Director.Major changes to the operation must be reported to the regional office within 10 days as required. Prompt reporting of substantial changes in operations of a research facility allows for USDA activities necessary to assure regulatory compliance for animal welfare, care and use by the facility. Correct by August 1, 2017.

IACUC completed a facility inspections on May 18, 2016, November 11, 2016, May 25, 2017. No completed semi-annual evaluation report has been sent to the Institutional Official. In order to apprise the Institutional Official of the status of the facility's programs and facilities and to allow the IO to follow up on correction of significant deficiencies, the IACUC must complete a report of its evaluations and submit it to the IO in a timely fashion. The IACUC shall prepare reports of its program for humane care and use of animals and facility inspection at least once every six months and submit them in a timely manner to the Institutional Official. Correct by August 25,2017.

Many of the non-human primates were singly housed as approved by the IACUC in protocol addendum reviewed yearly as required. A smaller subset of these were maintained in one section of a potentially multi-section enclosure. Additional space must be considered as a possible source of enrichment to decrease self-injurious behavior. Additionally, while every cage had multiple manipulanda, there was no indication that they were being rotated weekly as described in the enrichment plan to assure novelty. The weekly enrichment log books had periods of more than a week between notations. while these are additional to the daily enrichment they should be targeted more frequently rather than less and must also provide novelty. The NHP interaction needs to be recorded to assure the enrichment is effective.The physical environment in the primary enclosures must be enriched by providing means of expressing noninjurious species-typical activities. Correct from this point forward. An exit interview was conducted with the IACUC Chair, and representatives from facility VS and OAWA..

On August 24, 2020, laboratory investigators performed two procedures, chest drain placement and metal plate removal that were not approved in writing by the IACUC. The Principal Investigator submitted an amendment to the IACUC to add these procedures to the IACUC approved protocol. The Principal Investigator had not received approval in writing from the IACUC prior to performing the procedures. The amendment was approved for the two procedures by the IACUC on August 25, 2020. Under the same protocol, two laboratory personnel participated in animal procedures that were not approved to do so by the IACUC. They were approved by the IACUC to perform animal procedures under different protocols managed by the laboratory. The Principal Investigator submitted an amendment to add the two laboratory personnel on October 4, 2020. The IACUC approved the amendment on October 5, 2020. The IACUC shall notify principal investigators and the research facility in writing of its decision to approve or withhold approval of activities related to the care and use of animals. This was corrected by the facility through a corrective action plan and the approval amendments to the protocol by the IACUC.

Two protocols IACUC approved protocols under the same Principal Investigator require multiple caesarian sections in female baboons. According to both protocols, A005 and B001, multiple experimental protocols/surgeries will be carried out on each baboon over a 3-year period. Female baboons under these protocols would receive a maximum of 4 survival caesarian sections during the 3-year duration of the protocol. The protocols indicate animals will be undergoing multiple major surgeries to reduce animal numbers but did not provide a scientific justification nor have approval from the Administrator. At the time of inspection, the facility has not sought or received approval from the Administrator for any of the animals that have undergone multiple major operative procedures on these protocols. No animal will be used in more than one major operative procedure from which it is allowed to recover, unless justified for scientific reasons in writing by the principal investigator, require veterinary care and treatment, and/or in special circumstances as determined by the Administrator on individual basis. To Be Corrected By: December 23, 2021

During a Post Approval Monitoring (PAM) review for Study A conducted on August 1, 2022, the IACUC representative noticed the principal investigator was conducting a nerve injury pilot study using 12 swine. The pilot study was not described in the IACUC approved protocol. This pilot study included fewer weeks of post-operative monitoring and additional behavioral trials not included in the protocol. Additionally, there was little or no documentation of monitoring parameters and post-operative care for the swine as required in the protocol. A corrective action plan has been developed and implemented and the protocol amendment is pending IACUC review. Correct by November 30, 2022. On December 20, 2021, the IACUC noticed the Principal Investigator's annual report for ferret Study B described additional experimental procedures that included monitoring internal body temperature and initiating a righting and withdrawal reflex procedure to test the effects of study compounds on the animal. These procedures were were not outlined in the protocol reviewed and approved by the IACUC. Corrected at the time of inspection by corrective action plan and an IACUC approved amendment. Principal investigators must submit proposals involving the use of animals that include the appropriateness of the species and number of animals to be used, a rationale for their use, and a complete description of all procedures that will be performed. Submitting such significant changes allows the IACUC to approve procedures to ensure animals are not subject to unnecessary pain or distress. This inspection and exit interview were conducted with facility representatives. This inspection was conducted 10/11/2022 to 10/13/2022. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER n

During the inspection, inspectors noted that two pigs wearing jackets had red skin from rubbing at the leg opening of the jacket. Research staff indicated they reported the condition to the study director on June 7, 2023. The condition was not reported to the veterinary staff. Corrected at the time of inspection through implantation of a treatment plan. On 11/26/21 two pigs were with lesions on the cranial aspect of the front limbs above the elbow were reported to the veterinarian by an animal technician. The animal technician indicated there were issues with the fit and placement of the jackets. The fit of the jackets were causing erosions/ulcerations in the skin. Technicians started treatment for the pigs and contacted the laboratory staff. According to the lab staff member, they were aware of the problem and were watching the development of the lesions. They did not contact the clinical veterinarian for treatment. The veterinarian prescribed a treatment plan that included pain medication and topical ointment. After review of the clinical notes for the lab staff, there is no documentation of the treatment for pig #529. Corrected before the time of inspection through corrective action plan. Daily observation of all animals to assess their health and well-being; provided, however that daily observation of animals may be accomplished by someone other than the attending veterinarian. A mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian.

On November 22nd, 2023, the IACUC conducted a Post Approval Monitoring (PAM) survey for a rabbit user laboratory. The PAM reviewed surgical records and interviews were conducted with laboratory staff. It was determined that under protocol #RA005 animals that underwent survival procedures did not receive any form of analgesia, pre-emptively and post-procedurally at the frequency outlined in the approved protocol. According to the laboratory staff, analgesia was not required because protocol #RA005 was Category E. According to the approved protocol, analgesics should be administered at least 10 minutes prior to the initial incision at all peripheral catheterization and surgical sites. The IACUC required a response to the Committee from the Principal Investigator (PI) and retraining of the laboratory staff by December 7th, 2023. The PI provided a response and amendment. Following the amendment the IACUC approved the amendment and renewed the protocol (#RA006). The IACUC reviewed the response from the PI and decided a follow-up PAM survey was needed to assess compliance and determine the number of rabbits that may not have received the appropriate analgesia. During the follow-up PAM survey on December 5, 2023, the IACUC determined none of the 395 rabbits were administered analgesia according to the approved protocol and 306 of those rabbits received no analgesia at all. On April 10th and April 11th, 2024, it was noted that the laboratory staff was still not administering the analgesia as outlined in the protocol. On April 10, 2024, the IACUC representative told the laboratory member that BID meant the next post procedural dose of analgesia must occur on the same day and not the next morning. The 4 study rabbits identified on April 10th did not receive the second dose of analgesia until the next morning. The laboratory member did not ensure analgesia was administered according to the protocol and as directed by the facility veterinarian and the IACUC representative on April 10th and 11th. The IACUC suspended all activity on protocol #RA006 on April 11, 2024. The IACUC shall review and approve, require modifications (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities. Corrected by the IACUC on April 11, 2024, by suspending the protocol and placing the remaining rabbits on a holding protocol.

Due to a miscommunication, an animal caretaker was not present from March 30-31, 2024 to provide the baboons their daily ration of the primate biscuits. The enrichment technician provided the required food enrichment for the animals as scheduled, which included apples, broccoli, carrots, and peanuts. All animals had access to water from a lixit. On April 1, 2024, the baboons were examined by a Veterinary Resources clinical veterinarian, and no abnormalities were noted. Nonhuman primates must be fed at least once each day except as otherwise might be required to provide adequate veterinary care. Infant and juvenile nonhuman primates must be fed as often as necessary in accordance with generally accepted professional and husbandry practices and nutritional standards, based upon the animals' age and condition. Corrected before the time of inspection through a corrective action plan. This inspection and exit interview were conducted with facility representatives. The inspection was conducted from April 10-15, 2024. Additional Inspectors: GLORIA MCFADDEN, VETERINARY MEDICAL OFFICER n

Not all procedures performed on animals by facility staff and students is described in an IACUC protocol. Specifically, Protocol VETT 222 does not describe restraint methods to be used. and protocols are lacking for laboratory and Large animal procedures. The IACUC must assure all animal use is covered by a protocol and that: A proposal to conduct an activity involving animals (Protocol), or to make a significant change in an ongoing activity involving animals (Amendment), must contain A complete description of the proposed use of the animals. Correct before performing activities on animals. An exit interview was conducted with facility Program Director.

The IACUC has not been conducting facility inspections at least once every six months. The facility was reviewed on May 4, 2017. Prior to that date, the last program and facility review was conducted July 13,2016. Animal facility inspection by the IACUC ensures optimal animal welfare by identifying, prioritizing, and making plans for correcting areas which may contribute to animal harm or disease. The IACUC must inspect, at least once every six months, all of the facility's animal use areas including housing and study areas. Correct by August 26, 2017.

***The registrant self reported an incidence in which bats did not receive a prescribed treatment in a timely manner. An increase mortality rate was noticed in the bat colony. Based upon the results of the necropsies, the attending veterinarian prescribed a treatment to prevent further illness. Directions for administering the treatment were given to the research staff on December 20, 2014. Treatment was not provided to the affected bats until January 7, 2014. Bats did not receive treatment for 3 weeks and additional bats died before the treatment was started. The delay in treatment was detemined to be the result of miscommunication. A system must be in place to ensure direct and frequent communication with the attending veterinarian to ensure timely and accurate treatment for all illnesses. The IACUC took timely and appropriate corrective action to prevent a reccurence of such incidents. The exit briefing was conducted with the facility presentative.

*** The Peromyscus mice are housed in open top cages in a room with air conditioning. However, there is a strong urine smell in the room. To minimize strong odors, the room should be provided with fresh air or an effective method to move the air should be implemented. Measures must be taken to adequately ventilate the room for the health and comfort of the animals. Correct by July 9, 2015. NOTE: Cages are scheduled to be changed the next day. The exit briefing was conducted with the facility representative.

During a Semi-Annual Inspection in April 2019, IACUC members discovered guinea pigs used for Protocol GB that had a surgical procedure performed two days prior. However, there were no or insufficient surgical and post-operative care records, as required by protocol. There was no indication that one guinea pig received post-operative analgesics. The IACUC reviewed records over a period of time for the research group and noted a lack of consistent daily observations of the animals. The daily observation was not performed for one post-surgical guinea pig for two (2) days. On the subsequent observation, the guinea was sick and was euthanized two (2) days later. The research group did not follow established surgical recordkeeping requirements and post-operative care of the guinea pigs as outlined in the protocol which may have led to unnecessary pain and distress. The facility must maintain programs of adequate veterinary care that includes guidance on post procedural care to principal investigators and all personnel involved in the care of animals to ensure pre- and post-surgical procedures are implemented to minimize distress and suffering of the guinea pigs. Correction: The IACUC established and implemented an effective corrective action plan that included intensive training. This inspection and exit interview were conducted with facility representatives. End Section

***Protocol A, an infectious disease protocol, states there is the potential for an animal to experience loss of coordination and behavioral changes. Appropriate endpoint criteria have been outlined. Most animals may not experience these symptoms, however the potential exists as part of the disease process. The pain and distress category is listed as C in the protocol. If there is the potential for animals to experience any pain or distress the pain and distress category should be D. The protocol must be amended to reflect the appropriate pain category on the initial review of a protocol to ensure animals are reported under the appropriate pain and distress category on the Annual Report and to ensure that animals do not experience unnecessary pain and distress. This NCI was corrected during the inspection by the established IACUC procedures. An exit briefing was conducted with the facility representatives

Compatibility ***On September 8, 2014, two (2) non-human primates were shipped in a double compartment transport enclosure with no divider. The animals arrived with minor wounds and blood was present in the transport enclosure. There was no paperwork indicating the breeding or pairing status of these animals. Only one non-human primate should be shipped in a single transport enclosure to prevent possible fighting or injury to the animals while in transit. Measures must be taken to ensure that only one non-human primate is present per transport enclosure, except under certain provisions, for the overall health and safety of the animal. Correction: The IACUC conducted a review. New double compartment enclosures have been purchased and new transportation policies have been put in place. This item has been corrected. The exit briefing was conducted with the facility representatives. This is an electronic version of the inspection report dated 11 September 2015. This inspection report is amended to add the following header for both NCIs: "PRIMARY ENCLOSURES USED TO TRANSPORT NONHUMAN PRIMATES"

In a study involving 24 Rhesus Macaques, the number of animals utilized in each group did not conform to the number of animals justified in the protocol by the principal investigator and approved by the IACUC. Four groups of six animals were approved. The actual distribution was two animals in Group 1, four in Group 2, and nine in Groups 3 and 4. The IACUC must be able to review any modifications to the proposed use of animals in order to assure the proper care and use of animals. Proposed modifications to the protocol must be submitted to and approved by the IACUC. Correct by: From this day forward. This inspection and exit interview were conducted with facility representatives. Additional Inspectors Nooyen Amy, Veterinary Medical Officer

The floors in the animal rooms (the older part of the facility) are pitted and stained floors. The condition of the floors are past normal wear and tear and can no longer be adequately cleaned and sanitized. The floors have not been maintained at a frequency that facilitates good husbandry practices. The floors must be replaced for effective cleaning and sanitization and a proper gradient that will allow water to flow towards the drains. established. Worn floors must be replaced when it cannot be readily cleaned and sanitized. Correct by following a schedule for replacement and developing a plan to ensure proper maintenance of the floors on a regular basis. Correct by March 31, 2022. This inspection and exit interview were conducted with the facility representatives. The protocol review was conducted under site 001. End Section

Three live roaches were seen on the wall of one room on the 3rd floor of the facility. The room had some areas of drywall that was peeling due to excessive moisture in the room from a recent wash down. The level of moisture in the room after cleaning may contribute to the presence of the pests. A pest control program must be effective in preventing the attraction or harborage of pests. Effective measures must be implemented to minimize the harborage of pests. Correct by October 15, 2021 This inspection and exit interview were conducted with the facility representatives. End Section

There are areas of drywall damage in Rooms 214 and 329 due to the removal of particle board and the rigors of daily hosing of the surfaces. The damage renders a rough surface that exposes under layers of the drywall. The damaged surfaces cannot be readily cleaned and sanitized. Surfaces in non-human primate housing areas must be maintained on a regular basis to facilitate all established husbandry practices. The damages surfaces must be replaced or repaired to ensure proper cleaning and sanitization of the walls. Correct by July 10, 2022.

Protocol A indicated blood will be withdrawn from the non-human primate study animals. However, the frequency of such blood withdrawals is not outlined in the protocol. Without this information, the IACUC will not be able to effectively determine if the proposed amount of blood withdrawn will exceed the maximum allowable amount as outlined in the facility SOP – Nonhuman Primates Withdrawal Limitations. A complete description of all proposed uses of study animals is necessary to ensure the procedures avoid or minimize discomfort, distress, and pain as in accordance with the animal welfare regulations. The Institutional Animal Care and Use Committee (IACUC) should ensure that a proposal to conduct an animal activity includes a complete description of the proposed use of the animals. Corrected prior to inspection by protocol amendment and review. This inspection and exit interview were conducted with the facility representatives and the IO. n

*** Protocol 256: A procedure was performed on a species not specified in the approved animal use protocol. Any changes to a protocol must be reviewed and approved by the IACUC prior to conducting any activity associated with the change. An IACUC review of protocol changes is to ensure that animals do not experience unnecessary pain and distress and to verify that personnel are adequately trained to handle and conduct procedures on a particular specied. The IACUC must amend the protocol to include goats as a species and/or implement appropriate procedures to ensure protocol changes are reviewed and approved by the IACUC for all protocol deviations involving the use of animals. Correct by May 30, 2014. NOTE: The goat did not experience any pain or distress as it was a terminal procedure performed under anesthesia.

The facility failed to submit their Annual Report to USDA for Fiscal Year 2014. The facility must submit a report of it's use of USDA covered species in research for the period covering Oct 1 to Sept 30 (the fiscal year) by December 1 of each calendar year to the Animal Care Eastern Regional Office. Correct by March 23, 2015 An exit briefing was conducted with the IACUC Chair and the Research Administrator.

Section 2.38(b) - Access and inspection of records and property: Each research facility shall, during business hours, allow APHIS officials: (1) To enter its place of business. A facility representative was not available to allow access at 12:00 on 10/28/2015.

The IACUC conducted semi-annual program review and facility inspections in March 2023. A report of the IACUC's evaluations was submitted to the Institutional Official on March 3rd, 2023, but was not signed by a majority of the committee members. In order to ensure the committee has the opportunity to review the report and ensure minority views are represented, the report must be signed by a majority of the IACUC members. The facility implemented corrective actions at the time of inspection to have the March report reviewed and signed by the committee for resubmission to the Institutional Official. To remain corrected after June 2nd, 2023. This inspection and exit interview were conducted with facility representatives. n

Consideration of Alternatives. 1. Protocol #14-05 included a procedure that would be considered more than momentarily painful or distressful and the written narrative of the animal use proposal referenced the use of a database in the search for alternatives. However, the database search included in the proposal that was approved by the IACUC in August 2014 had been conducted by the principal investigator in the year 2002 and therefore did not describe a search that was adequate to determine that alternatives were not available for the procedure. Per this Section of the Regulations, whenever a proposal for animal use contains procedures that may cause more than momentary pain or distress to the animals, the investigator is required to consider alternatives to those procedures and provide a written narrative description of the methods and sources used to determine that alternatives were not available. Whenever a database search is utilized to fulfill this requirement, it should be conducted closer to the time the proposal is submitted in order to determine that alternatives were not currently available. The IACUC needs to address this issue that was identified for this protocol. Correct by 6/29/15.

Consideration of Alternatives. 1. Protocol #15-20 includes a procedure that would be considered more than momentarily painful or distressful but the protocol approved by the IACUC did not contain a written narrative description of the methods and sources used to determine that alternatives were not available to that procedure. 2. Protocol #15-15 includes several procedures that would be considered more than momentarily painful or distressful and the written narrative of the animal use proposal referenced the use of a database search in the consideration for alternatives. However, the database search contained in the protocol that was approved by the IACUC did not include a consideration of alternatives for one of the surgical procedures described in the protocol. Per this Section of the Regulations, whenever a proposal for animal use contains procedures that may cause more than momentary pain or distress to the animals, the investigator is required to consider alternatives to those procedures and provide a written narrative description of the methods and sources used to determine that alternatives were not available. This requirement is important to ensure that all procedures involving animals minimize pain and distress to the animals. The IACUC needs to address this deficiency that was identified for these two protocols.

Description of Procedures to Minimize Pain and Discomfort. 1. Protocol #15-20 that was approved by the IACUC in April 2016 did not contain a description of procedures to assure that discomfort and pain to the study animals will be limited. The protocol includes surgical procedures performed under general anesthesia that would be considered more than momentarily painful or distressful to the animals in the post-operative period. Although it was confirmed that post-operative analgesics were administered to the study animals used after the protocol was approved and the animals did not exhibit any signs indicative of pain in the post-operative period, there are no details in the approved protocol for the post-operative analgesia used such as the name of the drug(s), dose, frequency and route of administration, and duration of treatment. Per this Section of the Regulations, a proposal to conduct activities involving animals must contain a description of procedures designed to assure that discomfort and pain to the animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, and include provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to the animals. This requirement is important so the IACUC can determine during their review of the proposal that all of the components of the proposed activities related to the care and use of animals minimize pain and distress to the animals. The IACUC needs to address this deficiency that was identified for this protocol. Correct by 8/1/16. NOTE - This was a FOCUSED inspection based on the non-compliant items identified at the time of the last inspection. The non-compliant items from the last inspection have been corrected. Exit interview held 7/13/16 on-site with facility representative. Report delivered by e-mail 7/14/16. *END OF REPORT*

The semi-annual reports to the IO dated 5/1/21 and 10/28/21 were reviewed. Both semi-annual reports did not contain all of the required information as described in this Section. The two semi-annual reports were not signed by a majority of the IACUC members, and they did not contain a specific plan and schedule with dates for correcting each of the minor deficiencies identified by the IACUC during the facility inspections. In addition, during the review of the semi-annual reports and the minutes for the IACUC meetings when the semi-annual evaluations were conducted (4/28/21 and 10/22/21), it was noted that there were discrepancies between the two sets of documents for the deficiencies identified during the facility inspections. Per this Section, one of the functions of the IACUC is to prepare semi-annual reports to the Institutional Official following the Committee’s review of the program of animal use and the animal facilities. The report shall be reviewed and signed by a majority of the IACUC members and must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. The content of these reports should describe the nature and extent of the research facility’s adherence with the AWA Regulations for the Program and animal facilities to provide the Institutional Official with accurate information on the status of all aspects of the research facility. Correct from this date 5/13/22 forward.

The written Program of Veterinary Care (PVC) for dogs was incomplete and does not address the details required for the preventative care and treatment for the dogs. There was no information about the preventative care and treatment to ensure healthy and unmatted hair coats, properly trimmed nails, and clean and healthy eyes, ears, skin, and teeth of the dogs. Per this Section, the written Program of Veterinary Care for dogs must address the requirements for adequate veterinary care of the dogs and must include information regarding preventative care and treatment to ensure healthy and unmatted hair coats, properly trimmed nails, and clean and healthy eyes, ears, skin, and teeth, unless otherwise required by a research protocol approved by the IACUC at research facilities. Correct by 6/12/22. This inspection and exit briefing were conducted 5/10/22 with facility representatives. *END OF REPORT* End Section

Handling. In July 2016, the animal care staff, upon routine daily observation, noted an injury to a rabbit and treated the animal appropriately. The facility questioned the investigator, who then reported that one of the rabbits had jumped out of it's 2nd level enclosure two days prior. The rabbit looked fine to him so he did not report the event to the animal care staff at the facility. The rabbit could have become injured, therefore the animal care staff must be notified of the incident so they can make the determination of the health of the animal, as well as, to allow the facility to determine how to prevent a recurrence of the incident. Animals must be handled carefully and in a manner that does not cause trauma and in response to this incident, the facility has implemented several measures to prevent recurrence. This item has been addressed by the facility. This inspection and exit interview were conducted with facility representatives.

On 3/14/2021, an investigator locked a divider that separates macaques housed in adjacent enclosures. The bolt that secures the divider did not fully engage, which allowed the animals to open the divider and resulted in two females being housed together. On the morning of 3/15/2021, both females were observed to have injuries consistent with fight wounds. Animal #2-16 sustained minor injuries to extremities. Animal #128-07 sustained bruising and scratching, as well as injuries to both feet that resulted in non-weight bearing lameness and required daily veterinary care. Per this section of the regulations, primary enclosures must be maintained so that they contain the non-human primates securely and prevents accidental opening of the enclosure, including opening by the animal. In response to this incident, the research facility retrained research staff on securing enclosures. To remain corrected from this date (September 7th, 2021) forward. This inspection and exit interview were conducted with facility representatives. Additional Inspectors: PAULA GLADUE, VETERINARY MEDICAL OFFICEREnd Section

On September 20th, 2023, an investigator was returning a non-human primate to a bank of 4 enclosures, or "quad," housing another non-human primate. The animals were not pair housed with one another and were not intended to have contact. These types of enclosures have a grid-style floor panel above a solid barrier that prevents contact when another animal is housed in an enclosure below. At the time of the incident, the solid barrier below an enclosure housing a non- human primate had been removed during husbandry activities, leaving only a grid separating the animal from the other enclosure, allowing some physical contact. The empty lower enclosure had been secured with a padlock by husbandry staff. The investigator, who did not recognize the vertical access between the two enclosures, unlocked the lower enclosure and secured an animal inside. Once in that enclosure, the animal was able to bite and fracture the tail and cause a laceration to the skin beneath the tail base of the animal housed above. Two animals were handled in a manner that resulted in injuries when an investigator placed a primate into the lower enclosure beneath another primate in error. Handling of all animals must be done as carefully as possible and in a manner that does not cause behavioral stress, physical harm, or unnecessary discomfort. This incident was self reported by the facility and corrective measures had been implemented prior to inspection. To remain corrected from February 28th, 2024 forward.

Handling. An adverse event occurred involving an anesthetized pig undergoing a surgical procedure. The use of an electrocautery device ignited alcohol vapors and a localized flame caused injury to the animal. Immediate actions included extinguishing the flame and euthanizing the anesthetized animal under veterinary oversight. Handling of all animals must be done in a manner that does not cause trauma. The facility addressed this incident in several ways, including: instructing the team to revise procedures and posting specific instructions on surgical fire prevention in the operating room for reference. This item has been addressed by the facility and was self- reported to USDA.

Adequate pre-procedural and post-procedural care. ***In January 2017 an NHP was noted to be recumbent in its enclosure the morning following an operative procedure conducted as per the IACUC approved protocol. The facility veterinarian was contacted, immediately assessed the animal, and began treatment. The condition of the animal declined during the day despite intensive appropriate treatment and the NHP was euthanized. Upon being notified and in response to this information, the IACUC and AV immediately looked into the incident. It was determined that there were inconsistencies in the actions of investigator staff for some of the procedures described in the approved protocol related to compound dosing, timing of the administration of compound relative to the operative procedure, and the monitoring the animal following dosing of the compound. In addition, investigator staff failed to contact the facility veterinarian when the NHP developed unexpected symptoms intra and post operatively. These inconsistencies contributed to the adverse effects experienced by the NHP that resulted in the euthanasia of the animal. ***In June 2016 an NHP was noted to be weak and recumbent in its enclosure several days following the administration of a compound that was given to the animal as per the IACUC approved protocol. The facility veterinarian was contacted, immediately assessed the animal, and began treatment. Following several days of intensive treatment, the animal went on to make a full recovery. Upon being notified and in response to this information, the IACUC and AV immediately looked into the incident. It was determined that the NHP was not monitored and treated by investigator staff as described in the IACUC protocol following the administration of the compound that resulted in the animal experiencing adverse effects that required veterinary intervention. In addition, investigator staff failed to notify the facility veterinarian of the unforeseen changes in the NHP’s condition that were identified prior to the onset of the illness. Per this Section of the Regulations, each research facility shall establish and maintain program of adequate veterinary care that includes adequate pre-procedural and post-procedural care that are in accordance with current established veterinary medical and nursing procedures. Investigator staff must follow the pre and post procedural care as described in the IACUC approved protocols to ensure the health and well-being of the animals, and to ensure the provision of adequate veterinary medical care. The research facility acted promptly to address both of these incidents by conducting an investigation, reporting the incident to OLAW and USDA, and swiftly implementing appropriate corrective actions to prevent similar incidents in the future. Corrective actions included but were not limited to implementing changes to study procedures and providing additional retraining of investigator staff. To date, no additional incidents have occurred. This item has been appropriately addressed and corrected by the research facility. NOTE – Inspection conducted 6/19/17 thru 6/21/17. Exit briefing held on-site 6/21/17 with facility representatives. *END OF REPORT*

- A total of eight surgical biopsies are approved for animals enrolled on protocol #XXXXN000128. On June 10, 2021, a ninth biopsy procedure was performed on one animal enrolled on this protocol. Increasing the number of procedures constitutes a significant change to ongoing activities which was not reviewed and approved prior to being implemented. - An animal enrolled on IACUC approved protocol #XXXXN000018 had a surgical biopsy performed on Friday, May 20, 2022. The approved pain management plan on the protocol included the administration of a long-acting opioid and meloxicam daily 5 days post-procedure. The animal received analgesics per protocol on the day of surgery but did not receive meloxicam on May 21 or May 22, 2022. Failure to administer post-operative analgesia in accordance with the protocol constitutes a significant change that did not undergo IACUC review and approval. - IACUC approved protocol #XXXXN000020 includes the administration of immunosuppressive agents after a transplant procedure, up to six total doses. One animal received a transplant on July 27, 2022 and was subsequently treated with six doses of the immunosuppressive agents per protocol. On August 15, 2022, an additional dose was administered to the animal, which constituted a significant change that did not undergo IACUC review and approval. -A rabbit enrolled on IACUC approved protocol #XXXXN000015 underwent a study procedure on January 26, 2023. The monitoring schedule on the protocol includes twice daily monitoring for three days after the procedure. On January 27th, only one observation was performed. Failure to monitor animals in accordance with the protocol may compromise the ability of the researchers to detect problems of animal health and constitutes a significant change that did not undergo IACUC review and approval. These deviations from IACUC approved protocols were identified by the facility and voluntarily reported to USDA. Corrective measures had been implemented prior to inspection; to remain corrected after July 18th, 2023.